1. science
2. medicine
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BNEWS
ARIATRIC
Capsule effective in
pre-diabetic patients
The first outcomes
from the FLOW
study reported that
the Gelesis100
resulted in greater
weight loss in
overweight and
obese individuals compared with those
who receive a placebo capsule.
6
Obesity in Australia
Bariatric News talks
to Dr Michael Talbot
about what can be
done to curb the
rise of obesity and
current trends in
Australian bariatric treatment.
11
Staple line reinforcement
for LSG
IV noninva International
Symposium report
16
ICE ENDO 2014
20
Country News 34
Clinical Updates 36
Industry and Product News 38
Events 42
Page 28
Landmark IFSO Global
Registry Report published
The report includes 100,092 operation records from 18 countries
The overall reported mortality for all operations was 0.03%
T
he First IFSO Global Registry Report
(2014) has been released at the 19th World
Congress of IFSO in Montreal, Canada. Published by Dendrite Clinical Systems, under
the auspices of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), the
publication reports data on baseline obesity-related disease, operation types, operative outcomes and disease
status after bariatric surgery in over 100,000 patients
accumulated from 25 local and national databases and
registries from all over the world.
“The report provides fascinating county-to-country
and region-to-region comparisons, as well as demonstrating the safety and effectiveness of bariatric and
metabolic surgery on a global scale,” commented
Professor Michel Gagner, IFSO Council Member and
IFSO 2014 Congress President.
Global IFSO Registry Pilot Project
The report is the culmination of months of research and
analyses from the IFSO Global Registry Pilot (IGRP),
which was established in January 2014 to demonstrate
that it is possible to merge and analyse bariatric and
metabolic surgical data from different countries and
centres.
A recent study shows the use of the
bioabsorbable staple line reinforcement
material may decrease life-threatening
leaks after LSG, according to a single
centre study of over 500 patients. 12
Bariatric professionals
and ASMBS: Are you
putting patients first?
Alex Brecher
THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL
IN THIS ISSUE…
ISSUE 21 | AUGUST 2014
IFSO GLOBAL REGISTRY
“This report is a tribute to the professionalism and
willingness of bariatric surgeons in 18 countries to
share data on over 100,000 patients,” said Mr Richard
Welbourn, Chair IGRP committee. “It could be the
Michel Gagner, Richard Welbourn
beginning of an important journey in bariatric surgery,
and demonstrates a professional commitment to hardcountry analysis and notes a wide variation in the
nosed analysis of results.”
gender ratios of patients having surgery (ranging from
Outcomes
48.7% female patients in China to 81.8% female paThe report includes 100,092 operation records from 18 tients in the Netherlands), as well as a wide variation in
countries and from five continents, and has detailed in- the rate of public funding of procedures (overall, 63.2%
formation on 65,636 gastric bypass operations (65.6% were funded by public health services and 36.9% were
of the total operations submitted), 16,735 sleeve funded privately), suggesting inequality of access to
gastrectomy operations (16.7%) and 12,365 gastric surgical services.
banding operations (12.4%).
On a country basis, there are marked differences in
Continued on page 3
The publication has some fascinating county-to-
15-year SOS outcomes
show surgical superiority
EEC cells could hold key to
gastric bypass success
ariatric surgery was associated with greater remission
from diabetes and fewer complications than patients who received
usual care, according the 15-year
outcomes from the Swedish Obese
Subjects (SOS) study. Published in
JAMA, the reported diabetes remission
rate two years after surgery was 16.4%
(11.7%-22.2%; 34/207) for control
patients and 72.3% (66.9%-77.2%;
219/303) for bariatric surgery patients
(p<0.001). However, at 15 years, the
diabetes remission rates decreased to
cientists from the University
of Manchester are a step closer
to understanding why diabetes is
resolved in the majority of patients that
undergo gastric bypass surgery, which
they state is probably due to the actions
of specialised cells in the intestine that
secrete a cocktail of powerful hormones
when we eat.
“Our research centred on enteroendocrine (EEC) cells that ‘taste’ what we
eat and in response release a cocktail of
hormones that communicate with the
pancreas, to control insulin release to the
B
6.5% (4/62) for control patients and to
30.4% (35/115) for bariatric surgery
patients (p<0.001).
Furthermore, the cumulative incidence of microvascular complications
was 41.8 per 1,000 person-years for
control patients and 20.6 per 1,000
person-years in the surgery group
(p<0.001). Macrovascular complications were observed in 44.2 per 1,000
person-years in control patients and
31.7 per 1,000 person-years for the
surgical group (p=0.001).
Continued on page 3
S
brain, to convey the sense of being full
and to optimize and maximize digestion and absorption of nutrients,” said
lead author, Dr Craig Smith, a Senior
Lecturer in Molecular Cell Physiology.
“Under normal circumstances these
are all important factors in keeping us
healthy and nourished. But these cells
may malfunction and result in under or
over eating.”
In this study, they investigated the
hormonal profile of murine FACS-sorted
duodenal I cells using semi-quantitative
Continued on page 3
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Graphs data source: UK National Bariatric Surgery Registry Report
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bariatricnews.net 3
ISSUE 21 | AUGUST 2014
15-year SOS outcomes show
surgical superiority
Continued from page 1
The Swedish Obese Subjects (SOS) is a
prospective matched cohort study conducted
at 25 surgical departments and 480 primary
health care centres in Sweden. From the patients recruited between September 1987 and
January 2001, 260 of 2,037 control patients
and 343 of 2010 surgery patients had type 2
diabetes at baseline.
Adjustable or nonadjustable banding
(n = 61), vertical banded gastroplasty (n = 227),
or gastric bypass (n = 55) procedures were performed in the surgery group, and usual obesity
and diabetes care was provided to the control
group. All types of bariatric surgery were associated with higher remission rates compared
with usual care.
Diabetes status was determined at SOS
health examinations until May 2013 and
information on diabetes complications was
EEC cells could hold key to
gastric bypass success
obtained from national health registers until
December 2012. Remission was defined as
blood glucose <110mg/dL and no diabetes
medication.
Participation rates at the two-, ten-, and 15year examinations were 81%, 58%, and 41%
in the control group and 90%, 76%, and 47%
in the surgery group. For diabetes assessment,
the median follow-up time was ten years in
the control and surgery groups. For diabetes
complications, the median follow-up time was
17.6 years and 18.1 years in the control and
surgery groups, respectively.
“In this very long-term follow-up observational study of obese patients with type 2
diabetes, bariatric surgery was associated with
more frequent diabetes remission and fewer
complications than usual care. These findings
require confirmation in randomized trials,” the
authors conclude.
Continued from page 1
RT-PCR, liquid chromatography tandem mass spectrometry (LC-MS/MS) and immunostaining methods.
The research, published in the journal Endocrinology, shows that gut hormone cells previously thought
to contain just one hormone, had up to six hormones
including the hunger hormone ghrelin.
“This is where things start to get really interesting
because the most common type of gastric bypass
actually also bypasses a proportion of the gut hormone
cells. It is thought that this causes the gut hormone
cells to change and be reprogrammed. For us, understanding how these cells change in response to surgery
is likely to hold the key to a cure for diabetes,” said
Smith. “Understanding the messages the gut sends out
when we eat food and when things go wrong, as is the
case in diabetes, is our next challenge and hopefully
one that will result in the development of drugs which
could be used instead of surgery to cure obesity and
prevent diabetes.”
They report that I cells are enriched in mRNA transcripts encoding CCK and also other key gut hormones
including neurotensin (NTS), glucose dependent insulinotropic peptide (GIP), secretin (SCT), peptide YY
(PYY), proglucagon (Gcg) and ghrelin (Ghrl).
Furthermore, LC-MS/MS analysis of FACSpurified I cells and immunostaining confirmed the
presence of these gut hormones in duodenal I cells.
Immunostaining highlighted that subsets of I cells in
both crypts and villi co-express differential amounts of
CCK, Ghrl, GIP or PYY, indicating that a proportion
of I cells contain several hormones during maturation
and when fully differentiated.
“Our results reveal that although I cells express
several key gut hormones including GIP or Gcg, and
thus have a considerable overlap with classically defined K and L cells, approximately half express ghrelin
suggesting a potentially important subset of duodenal
EEC cells that require further consideration,” the
authors conclude.
Landmark IFSO Global Registry Report published
n The available two-year data after primary surgery showed the
procedure type with centres submitting data from Mexico (92.2%),
average %EWL was 76.4% (interquartile range: 59.2-94.4%) for
the Netherlands (94.0%) and Sweden (96.3%) recording the highest
all operations; the equivalent % weight loss was 31.4% (interproportion of gastric bypass operations and those submitting data from
quartile range: 25.0-38.5%). See Figure 1.
Peru (100.0%), Saudi Arabia (100.0%) and India (91.1%) recording
n One year after primary surgery 65.8% of patients recorded as
the highest proportion of sleeve gastrectomy surgery.
taking medication for diabetes beforehand were no longer on
Unsurprisingly, 98.0% of all procedures were performed laparomedication.
scopically.
“I applaud this first report of the IFSO global bariatric surgery registry.
The report also records a wide variation in the average initial BMI
It marks an historic first step in bringing together real world data from
between different countries, ranging from 39.6 in Chile to 53.4 in
around the globe. It will provide essential support in understanding risk
Germany for male patients; and 36.1 in Peru to 49.1 in Germany for
stratification, and refining those most likely to benefit from surgery,”
female patients.
Professor John Dixon writes in the report. “It will allow new procePeter Walton, Johan Ottosson and Ingmar Naslund dures to be assessed, devices to be tracked, and provide information
The publication also notes:
n The overall reported mortality for all
regarding surgical learning curves, and may
Figure 1: Primary surgery for patients on medication for type 2 diabetes: Medication for type 2 diabetes 12 months
operations was 0.03%.
define minimal surgical loads for surgeons
after surgery, weight loss & gender; calendar years 2009-2013
n 91.2% of gastric banding patients were
and their institutions.
discharged by post-operative day one; 91.6%
“Together with IFSO, we are delighted
of gastric bypass patients by day three and
to publish this first report. I would like to
88.3% of sleeve gastrectomy patients by day
thank all the contributors for submitting
three.
their data,” said Dr Peter Walton, Managn The average rate of diabetes was 30.5% for
ing Director of Dendrite. “I hope this
males (range: 5.4-57.1%) and 16.8% for
publication will be the first in a series of
females (range: 8.3-30.3%).
groundbreaking reports that will record and
n The average rate of hypertension was 46.9%
analyse clinical outcomes that may be usefor males and 28.1% for females
ful in promoting an increase in bariatric and
n The average rate of sleep apnoea was 29.4%
metabolic surgery provision.”
for males (range: 3.8- 86.5%) and 11.2% for
The Global IFSO Registry Pilot Project
females (range: 0.0-52.9%).
was headed by Mr Richard Welbourn (UK),
n One year after primary surgery performed in
Dr Ingmar Naslund (Sweden), Dr Johan Ot2009-2013, the average percentage excess
tosson (Sweden), Professor Michel Gagner
weight loss was 75.9% (inter-quartile range:
(Canada) and Dr Peter Walton (Dendrite
58.6-90.5%) for all operations; the equivalent
Clinical Systems). Mr Welbourn will prespercentage weight loss was 30.5% (range
ent the report for the first time on Friday
25.3-36.5%).
29th August at the IFSO World Congress.
Continued from page 1
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4 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
9th IBC Symposium at IFSO Brussels
M
s Cynthia-Michelle Borg,
a Consultant Bariatric and
Upper GI Surgeon, UHL,
Lewisham and Greenwich NHS Trust,
London, UK, and Symposium Director,
reports from 9th International Bariatric
Club Symposium at IFSO Brussels.
The 9th International Bariatric Club
Symposium was held on the 30th April
2014 at the Sqare Congress Centre in
Brussels as part of the IFSO-European
Chapter conference. The session was
very well attended with standing room
only at times.
Dr Luc Lemmens, the President of
the congress opened the meeting. The
symposium started with two keynote
lectures. The first was about the current
status of robotic bariatric surgery and
was presented by Dr Ramon Vilallonga
Puy. Robotic surgery has been used for
different bariatric procedures in a safe
and feasible manner. While it confers
some technical advantages, studies have
shown that these have not translated into
an improved outcome in clinical practice
when compared to standard laparoscopic
surgery. Operative time, learning curve
and costs remain amongst the issues that
need to be addressed. Exciting developments may however be on the way with
the advent of new platforms, mini-robots
and nanotechnology.
Prof George Eid gave an overview
of his experience with endoluminal
options for weight regain after primary
bariatric surgery in the second lecture.
Several endoscopic devices have been
developed and used to improve or
restore restriction for weight regain. He
suggested that these technologies should
be used early rather than later in the
patients’ weight regain curve. Patients’
expectations however need to be managed to ensure that these are realistic.
These technologies should be safer
and easier than revisional laparoscopic
surgical procedures.
Debates followed on from the lectures
section. The role of staple line reinforcement when performing sleeve gastrectomy was debated by Prof Michel Gagner
and Dr Catalin Copaescu. Prof Gagner
pointed out that we still lack accurate
knowledge regarding stomach thickness
and its blood supply. He presented a recent study showing decreased incidence
of bleeding and overall complications
with the use of staple line reinforcement.
A recent metanalysis also showed that
the leak rate was lowest when absorbable
buttress material was used (1.09%) compared to suturing (2.04%), no reinforcement (2.6%) and non-absorbable bovine
pericardium (3.3%).
Dr Copaescu insisted that buttressing
is costly and complications in sleeve
gastrectomy can be reduced by careful
attention to detail like raising the blood
pressure at the end of the operation to
ensure adequate haemostasis. Large
randomized trials are required.
Dr Martin Fried and Dr Antonio
Torres Garcia lead the debate about
the future of malabsorptive bariatric
surgery. Unless there is a significant
breakthrough in obesity management in
the next decade, it is unlikely that these
operations were will obsolete as they
are currently associated with the best
outcome in terms of weight loss and
resolution of metabolic conditions.
The role of adjustable band in
revisional surgery was the first topic
Some of the faculty at the 9th IBC Symposium
discussed by the expert panel lead by
George Eid. Several faculty members
agreed that adjustable banding may have
a role in patients who fail to achieve sufficient weight loss or who have weight
regain after gastric bypass. However
they stressed that patient selection is
very important. The reasons why the
initial operation failed need to be investigated and taken into consideration. The
size of the pouch and gastrojejunostomy
should be evaluated by the bariatric
surgeon with an upper GI contrast study
and endoscopy. There was a difference
in opinion regarding the erosion rates
when bands are used in revisional cases
with some experts warning strongly
about the high incidence of this complication. Alternative revisional techniques
including conversion to a malabsorptive
procedure and the use of endoluminal
techniques were also discussed. More
long term data regarding the outcome of
these revisional techniques is required.
Extreme weight loss after gastric
bypass was another selected topic for
the expert panel discussion, this time
lead by Mr Evangelos Efthimiou. The
importance of careful reassessment of
the underlying anatomy with exclusion
of marginal ulcers, internal hernias,
gastro-colonic fistula or inadvertent distal bypass configurations was stressed.
The panel agreed that patients with
unexpected excessive weight loss
require a comprehensive clinical as well
as psychological work-up. Alcoholism,
laxative abuse and new pathology such
as inflammatory bowel disease and cancer need to be excluded. Adequate nutritional status and supplementary feeding
using a feeding gastrotomy tube in the
bypassed stomach was recommended.
In severe and persistent cases, reversal
of the operation may be considered once
the patient is nutritional stable.
The last expert panel discussion was
about ileal interposition and its future.
Dr Surendra Ugale suggested that the
amelioration of type 2 diabetes after
ileal interposition is due to a combination of factors and the different parts of
the operation have an additive effect.
The panel agreed that more research is
required regarding the effects, reproducibility and long-term issues of this
operation. Concerns were also raised
regarding internal hernias post-op.
At the end of the session, Dr Marius
Nedelcu presented a case from the IBC
Facebook page about a patient with
weight regain after sleeve gastrectomy.
Most of the panel suggested that OGD
and imaging of the sleeve with CT volumetry is required prior to offering revisional procedures including re-sleeving.
Patient selection is important and
compliance regarding diet and psychological issues should be rectified prior to
offering other bariatric procedures. Prof
Verhaege shared his experience with the
management of sleeve failures and the
use of CT scan gastric volumetry postoperatively. If patients have a residual
volume of over 400cm3, had insufficient
weight loss or were re-gaining weight,
resleeving could be an option. At least
early in the learning curve however
these operations can be longer and have
a longer in-hospital stay than primary
sleeve procedures.
I would like to thank Dr Marius
Nedelcu and Dr Ramon Vilallonga Puy
(co-directors), the IBC board and the
IFSO-EC Brussels organizing committee. IBC is also very grateful to the
distinguished faculty – Luc Lemmens,
Sanjay Agrawal, Luigi Angrisani, JeanMarc Chevallier, Catalin Copaescu,
Bruno Dillemans, Evangelos Efthimiou,
George Eid, Martin Fried, Michel Gagner, Jacques Himpens, Antonio Torres
Garcia, Surendra Ugale and Rudolf
Weiner for their time and commitment.
The next IBC symposium will be in IFSO 2014
in Montreal on the 27 August 2014.
Highlights from the 23rd ACCE annual meeting
Post-bypass hypoglycaemia
P
atients presenting with hypoglycaemia
following a gastric bypass can be treat effectively with a conservative approach which
avoids expensive and unnecessary invasive studies,
according to a case study (‘‘Conservative management in persistent hypoglycaemia: a cost effective
option’, abstract No. 409) presented at the meeting.
They researchers from SUNY Upstate Medical
University, NY, found that using this approach, with
dietary modification, was successful in managing
the condition, as well as preventing the patient from
having to undergo invasive studies that can reduce
their morbidity allowing them to maintain a good
quality of life.
They said that incidents of post-gastric bypass
surgery hypoglycaemia may increase with the rise
in such procedure numbers and there is “uncertainty” as to the pathophysiologic mechanisms. With
an estimated <1% post-gastric patients developing
severe hypoglycaemia an optimal management
strategy is required.
The case study concerned a 50 year old Caucasian
female who was found unconscious at home. She
had a gastric bypass surgery one year ago, with no
diabetes mellitus or previous syncopal episodes. Her
physical examination, preliminary labs and CT head
revealed nothing except low blood glucose on BMP.
A 72 hour fasting test was discontinued in two
hours due to symptomatic hypoglycaemia with
blood glucose 47mg/dL, and simultaneous blood
work showed normal insulin (8.4 uU/mL), proinsulin (6.0 pmol/L) and C peptide levels (3.0 ng/mL)
with low beta-hydroxybutyrate (0.03mmol/L), consistent with Insulinoma vs non-insulinoma pancreatogenous hypoglycaemia syndrome (NIPHS). The
CT abdomen and an octreotide scan were normal.
The patient elected not to undergo invasive
testing with selective arterial calcium stimulation
test (SACST) or endoscopic ultrasound, but agreed
to initiate conservative management with frequent
small meals of high protein content without large
carbohydrate loads. Since then, her BG has been
well maintained with no new syncopal episodes.
“This unique case of persistent hypoglycemia despite continuous D10
infusion supports the hypothesis of
increased stimulation of insulin
release in NIPHS,” the researchers said. “In contrary to
multiple previous reports, invasive testing, including SACST
and diagnostic and therapeutic
laparotomies was not required.
We expect that the incidence of
this [hypoglycaemia] will increase,
with increasing rates of gastric bypass
procedures. Raising awareness of an effective
conservative approach with dietary modification is
helpful for successful and safe management.”
Post-op insulin sensitivity
Bariatric surgery has immediate effect on insulin
sensitivity and the effect is more pronounced if
associated with pre-operative lifestyle interventions and weight loss, according to a case study
‘Reversal of severe insulin resistance immediately
after bariatric surgery’, abstract No. 255 presented
at the meeting.
The case report concerned a 49 year old male
with a longstanding history of morbid obesity (BMI
59), T2DM (more than five years), obstructive
sleep apnoea and hypertension. The patient was insulin dependent for at least three years with severe
insulin resistance requiring a total of 300 units of
insulin U-500 per day and Metformin 1000mg BID.
Prior to surgery he was placed on a medical
weight management programme (dietician super-
vised calorie count and regular exercise) for six
months. He lost 40 lbs (8.9% of his initial body
weight) and his insulin requirements decreased to
a total of 55 units of U-500 per day.
The patient then had a sleeve gastrectomy and at
one hour postoperatively required only two units
of regular insulin subcutaneously. His
fasting blood glucose, fasting insulin
level and C-peptide were measured
at 24, 48 and 72 hours postop and
HOMA-IR was calculated and
the results were 18.82, 11.43
and 5.84 respectively.
He required no further insulin and was discharged home
with no diabetic medications. At
two-week follow-up and following a liquid diet, his fasting glucose
was 113mg/dl with a simultaneous insulin level of 16.5 (uIU/ml), his HOMA was
4.6. The patient was off his diabetic medications.
The researchers from St Vincent Medical Center, Cleveland, OH, said that the case illustrates
the effect of lifestyle changes can have on insulin
sensitivity and ”demonstrates the effect of bariatric
surgery on insulin resistance in the immediate
postop as reflected by the dramatic improvement of
his HOMA score and his null postop insulin needs.”
LSG effective, but not permanent
T2DM solution
Laparoscopic sleeve gastrectomy (LSG) may offer
better diabetes control and improved outcomes
compared to patients who follow medical care only
but the T2DM improvements for surgical patients
may not be a permanent solution, according to a
comparative study ‘Clinical outcomes of sleeve
gastrectomy in veterans with type 2 diabetes’,
abstract No. 277) presented at the meeting.
Investigators from the University of Nebraska
Medical Center compared long term diabetes
outcomes in patients undergoing LSG as compared
to controls who undergo nonsurgical diabetes care.
They reviewed the records of veterans between 18
and 80 years of age with T2DM undergoing LSG at
a VA medical centre.
Primary study outcomes included measures
of diabetes control including HbA1C and BMI
and secondary outcomes included total and LDL
cholesterol, hospitalisations and mortality. Data
from surgery patients were compared to data from
diabetic controls that did not undergo surgery
using descriptive analyses, t-tests, and repeated
measures ANOVA.
A total of 30 surgery patients and 23 controls
were analysed from 2010 to 2013, 96% were male
with an average age of 57 years (range 29-80 years).
The median BMI at baseline was 41 (range 36-60)
and median Hba1c was 7.3.
Post-surgery, there were significant improvement in BMI and Hba1c in after one year follow
up; improvements were sustained through the end
of two years after surgery. Mean BMI decreased
from 41 to 34 over two years (p<0.001) and mean
Hba1c decreased from 7.25 to 5.98 (p<0.001).
Similar outcomes were not seen in controls
during the study period. Differences in these
outcomes between surgery patients and controls
were significant over short term and long term
follow up (p<0.001).
No changes were seen in total cholesterol or
LDL cholesterol for surgery patients. However, it
was noted that the changes in outcomes plateau
after the first year of surgery.
“It is interesting to note that LSG may offer
better diabetes control and improved outcomes
compared to patients who follow medical care
only,” said the researchers. “However, the improvement in outcomes in surgery patients may not be a
permanent solution for diabetes outcomes.”
6 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
VivaSight aids intubation and surveillance during LSG
Mallampati scores were significantly higher in the
test group than in the control group
For difficult intubations the VivaSight SL might an
improvement over current devices
T
he VivaSight Single Lumen tube is helpful during endotracheal intubation and aids continuous surveillance of tube position during laparoscopic sleeve gastrectomy (LSG), according
to a study ‘The use of VivaSight™ single lumen endotracheal tube
in morbidly obese patients undergoing laparoscopic sleeve gastrectomy’, published in BMC Anesthesiology.
The VivaSight is an endotracheal tube (ETT) with a camera embedded in its tip that continuously monitors tube position during bariatric
surgery, assisting the anaesthesiologist in ventilating and intubating
patients. This single-use ETT has an integrated high-resolution imaging
camera embedded in the tube’s tip (Figure 1). The external structure
and dimensions of the VivaSight SL ETT are similar to those of the conventional ETT, and the device is available in sizes 7.0, 7.5 and 8.0mm.
According to the manufacturer (ETView Ltd, Misgav, Israel), the
appliance (a) facilitates fast and efficient intubation, (b) provides
visual assurance during intubation, and (c) permits continuous, realtime images of tube position, which can be viewed on a battery- or
cable-operated liquid-crystal display (LCD) monitor (Figure 2 and 3).
The VivaSight SL is approved for use in Europe and the US (Figure
3). The patient after endotracheal intubation with the VivaSigh SL
endotracheal tube. The patient’s carina is seen on the screen of the
VivaSigh monitor.
Study
Researchers from Technion-Israel Institute of Technology, Haifa, and
the Baruch Padeh Medical Center, Poriya, Tiberias, Israel, carried out
Figure 1
the study to compare the VivaSight to conventional endotracheal tube
as an aid in the intubation and surveillance of tube position during
surgery in a group of morbidly obese patients.
The primary outcome of the study was intubation time; secondary outcomes were direct laryngoscopic view, number of attempts to
accomplish intubation and post-operative consequences (such as soft
tissue injury).
Seventy-two adult obese patients who underwent LSG were randomly assigned to be intubated by either the VivaSight (40 patients)
or a conventional endotracheal tube (32 patients, control group).
Outcomes
The groups were similar in terms of their demographics and ASA
physical status, and all study patients in the two groups were successfully intubated.
The researchers report that Mallampati scores were significantly
higher in the test group than in the control group (p= 0.01), with
endotracheal intubation taking 29±10 and 24±8 seconds using the
Figure 2
Figure 3
VivaSight and a conventional tube respectively (p=0.02). Three
patients in the control group versus none in the test group had soft
tissue injury (p<0.05). No statistically significant differences in the
other study parameters of the two groups were found.
One of the limitations of the study is the small sample size and the
researchers admit in order to obtain significant results in a prospective
study hundreds of patients would be needed.
Nevertheless, the investigators state that for difficult intubations
the VivaSight SL might an improvement over current devices, as the
anaesthesiologist can use the device as a standard ETT as well as
direct the ETT into the vocal cords without changing equipment or
position or repeat the direct laryngoscopy.
“In this study we found the VivaSight SL ETT to be an interesting addition to the armamentarium of airways devices,” the authors
concluded. “Intubation with this device took longer and was less
injurious than with the conventional ETT in groups of obese patients
that differ in their Mallampati scores distribution. Its benefits in the
management of the patient with difficult airway are yet to be tested.”
Capsule effective in pre-diabetic patients
Patient receiving the 2.25g dose
of Gelesis100 had greater weight
loss than did the others, losing 8.2
percent of their body weight on
average
A
new ‘smart pill’, the Gelesis100, resulted
in greater weight loss in overweight and
obese individuals compared with those
who receive an active comparator/placebo capsule
and was particulalry effective in pre-diabetic
patients, according to the three-month results from
the First Loss Of Weight (FLOW) study presented
at the joint meeting of the International Society of
Endocrinology and the Endocrine Society: ICE/
ENDO 2014 in Chicago.
“Given the excellent safety profile observed
in the FLOW study, Gelesis100 has the potential
to fulfil the unmet need for a safe and effective
weight loss agent,” said Dr Hassan Heshmati, chief
medical officer for Gelesis, the company behind the
device and a study co-investigator. “This is particularly impactful for individuals with mildly elevated
blood sugar, pre-diabetic patients, for whom weight
loss is particularly important because they are at
increased risk for diabetes.”
Gelesis100 (formerly Attiva) is an orallyadministered capsulated device designed to cause
weight loss by inducing satiety and reducing
caloric intake. Gelesis100 capsules contain
thousands of tiny hydrogel particles that
expand in the stomach and mix with digested
foods, explained Gelesis’ founder and chief
executive officer, Yishai Zohar.
Gelesis100 capsules are taken orally
prior to a meal and contain small particles
that expand ~100 times when hydrated in
the stomach and small intestine. Gelesis100
has several built in safety features: a) the
volume it creates is limited by the amount
of water consumed, b) the hydrated particles
which are ~2mm in size, cannot aggregate to
form a larger mass and have similar elasticity
(rigidity) to ingested food, and c) the particles
partially degrade in the colon, releasing absorbed water.
The particles absorb the water and swell
to 100 times their original size in the stomach,
mixing with food to create greater volume. After
the particles travel through the small intestine,
enzymes in the large intestine degrade them, and
they release the water and are excreted.
This proof-of-concept study tested two doses
of Gelesis100, a superabsorbent hydrogel, when
taken twice a day with water before a meal. Fortythree subjects were randomly assigned to receive
2.25g of Gelesis100 before lunch and dinner,
another 42 subjects
received 3.75g of
Gelesis100 and a third
group of 43 subjects
received a placebo capsule
containing cellulose, a fibre
which is used as a bulking agent.
All subjects were instructed to eat
600 fewer calories a day. Neither the
subjects nor the investigators knew which
treatment they received during the 12 weeks
of the study.
Among 125 subjects who weighed in at the
start of the study and at least once after treatment,
the average reductions in body weight by group at
the end of treatment were as follows: 6.1 percent
for 2.25g of Gelesis100, 4.5 percent for 3.75g of
Gelesis100 and 4.1 percent for placebo.
For subjects receiving the 2.25g dose of Gelesis100, those with initial high fasting blood sugar
(greater than the median level of 93mg/dL) had
The particles
absorb the water
and swell to 100
times their original
size in the stomach,
mixing with food to
create greater volume
“Gelesis100 has the potential
to fulfil the unmet need for
a safe and effective weight
loss agent.”
greater weight loss than did the others, losing 8.2
percent of their body weight on average.
“Gelesis100 represents an entirely new approach
to treating obesity,” said lead study investigator, Dr
Professor Arne Astrup, a leading obesity expert
and Head of The Department of Human Nutrition,
Exercise and Sports at the University of Copenhagen, Denmark. “These results are exciting and
show that Gelesis100 has the potential to provide
a truly novel alternative for weight loss that does
not involve surgery, injections, or systemically
absorbed drugs,”
The greatest weight loss reportedly occurred
in prediabetic subjects whose starting fasting
blood sugar level was 100 to 125.9mg/dL.
They lost an average of 10.9 ± 4.3% (5.3%
placebo adjusted; p=0.019) of their body
weight in three months. There was a
significant inverse correlation between
fasting glucose at baseline and change
in body weight in Gelesis100 2.25 g
arm (p<0.001), contrasting with a
lack of correlation in the placebo
arm (P=0.708).
Heshmati said he thinks the
higher dose of Gelesis100 resulted in less weight loss because
of lower tolerability leading to
lower compliance with the study
requirements.
The most common side effects
reported were bloating, flatulence,
abdominal pain and diarrhoea,
which he said occurred less often
with the smaller dose and were
tolerable at that dose. No apparent serious problems occurred in
either Gelesis100 group.
“The Gelesis technology represents an important advance in
material science,” said Dr.Robert
Langer, Institute Professor at MIT,
and a leading expert in polymers and
materials science. “It is the first and
only superabsorbent hydrogel that I know
of which is constructed from food ingredients and doesn’t use potentially toxic organic
solvents. By cross-linking two components
together using a proprietary synthesis, Gelesis
scientists created a three dimensional structure
that is engineered to ideally function through
the gastrointestinal tract to increase satiety and
reduce hunger.”
bariatricnews.net 7
ISSUE 21 | AUGUST 2014
Proteins central to T2DM
resolution following RYGB
Greater decrease of both Fetuin-A and
RBP4 seen after bypass than after
sleeve
proximately three days prior to surgery and three days
post-surgery blood samples were collected for analysis.
Outcomes
The researchers identified six proteins that were
oux-en-y gastric bypass results in a greater significantly lower and four significantly higher after
early decrease in several proteins and several both surgery types, four proteins increased and one demetabolites compared with laparoscopic sleeve creased after sleeve, while only one protein increased
gastrectomy (LSG), which could explain why bypass after bypass. Two proteins, retinol binding protein 4
patients present with enhanced resolution of type 2 (RBP4) and Fetuin-A have been previously reported in
diabetes according to a study published in PlosOne the context of insulin resistance and significantly de(Mia et al. Lower fetuin-A,
creased: RBP4 decreased
retinol binding protein 4 and
to 72% after bypass,
several metabolites after
p<0.01, and Fetuin-A
gastric bypass compared to
decreased to 75% after
“Our proteomic analysis
sleeve gastrectomy in patients
bypass, p<0.05 (Figure 1).
with type 2 diabetes).
“The greater decrease
showed a significant decrease
The outcomes seem to
of both Fetuin-A and
in two proteins involved in
support the foregut hypothesis
RBP4 seen after GBP
that nutrient bypass of the
than after SG is consistent
insulin resistance”
upper gut leads to reduction
with an impact of foregut
in secretion of an unidentified
exclusion on reducing
gut peptide which promotes
these proteins…Further
insulin resistance.
studies are required to
The researchers from the University of Auckland, document the functional evolution of gut microbiota
North Shore Hospital, Middlemore Hospital, Auckland after foregut excluding GBP compared to restrictive
City Hospital, Auckland, New Zealand, the Univer- types of bariatric surgery such as SG in order to test
sity of Hong Kong, and the University of New South these hypotheses” the authors write.
Wales, Sydney, Australia, sought to identify the insulin
“Our proteomic analysis showed a significant
resistance-associated proteins and metabolites, which decrease in two proteins involved in insulin resisdecrease more after bypass than after sleeve gastrec- tance, RBP4 and Fetuin-A, three days after GBP but
tomy (LSG) prior to diabetes remission.
not SG,” they conclude. “Notably, although insulin
They carried out a non-randomised, matched, resistance had not improved significantly three days
prospective controlled intervention trial that compared after bariatric surgery, the statistically significant
the acute effect of bypass to sleeve, compared with correlations between the levels of RBP4 and Fetuin-A
matched caloric intake, on glycaemia among 21 obese with HOMA-IR support a direct relationship between
patients with type 2 diabetes.
lower levels of these proteins and improved insulin
Eight patients had a bypass and seven a sleeve. Ap- resistance in our dataset.”
R
Figure 1: Proteomic results for Fetuin-A and RBP4
Fobi made Honorary
Member of Spanish Society
D
r Mal (Mathias) Fobi was recently
inducted as an Honorary Member of the
Spanish Obesity Surgery Society (SECO)
in Leon, Spain. Dr Fobi (MD FACS, FASMBS,
FACN, FICIS) who is Medical Director Center for
Surgical Treatment of Obesity, and the Founder &
President Bariatec Corporation, is an internationally recognised bariatric surgeon.
He was born in Nkwen, Cameroon, and arrived
in the US via the African Scholarship Program for
American Universities (ASPAU) in 1966. Dr Fobi
received his Pharmacy degree from the University
of Michigan and his medical degree from Univer-
sity of Cincinnati. He is a Board Certified General
Surgeon and Fellow of the American College of
Surgeons.
He is a past-President of IFSO (2008-2009), a
past-President (2005-2007) of the American Society for Metabolic and Bariatric Surgery Foundation,
current Chairman pf the IFSO Board of Trustees,
and author of more than 40 publications on Obesity
and Bariatric Surgery.
8 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
ASMBS calls for CPT Code for bariatric revisions
CPT code could lead to
greater access to revisional
surgery
I
n the July 2014 issue of Connect, the
ASMBS’ monthly news update, ASMBS Insurance Committee Chair,
Dr Matthew Brengman, has called for
a CPT code for re-operative procedures
that will the society believes could lead
to greater access to revisional surgery.
He states that gaining a code for
laparoscopic gastric bypass revision
is one of the highest priorities of the
ASMBS and the insurance committee
and is driven by a combination of need,
procedure uniformity, safety and efficacy. However, the application to obtain
a new CPT code must demonstrate all
components in a meaningful way.
“We can effectively demonstrate
need,” he writes. “Conservative esti-
mates suggest 20 percent of patients following bariatric surgery have significant
recurrent obesity,”
To address the issues of uniformity,
safety and efficacy, the ASMBS convened a task force, headed by Dr John
Morton, to review the current literature
on reoperative bariatric surgery. Their
findings were published in {{Systematic
review on reoperative bariatric surgery:
American Society for Metabolic
and Bariatric Surgery Revision Task
Force.||SOARD}}. The paper concluded
that: “The indications and outcomes for
reoperative bariatric surgery are procedure-specific but the current evidence
does support additional treatment for
persistent obesity, co-morbid disease,
and complications.”
“Our national data registries effectively capture the number of
bariatric reoperations very well,”adds
Brengman.”However, these databases do
not effectively capture the indication for
the reoperation or what exactly was done
at the reoperation. Because our current
registry is CPT code driven, the lack of
specific CPT codes limits the resolution
of the database to provide meaningful
data on occurrence, safety and weight
loss outcomes for reoperative procedures
directed at recurrent obesity.”
To address this issue, the MBSAQIP
Data committee, is working to create
a prospective registry of re-operative
surgery using codified language, which
will collect data on what exactly is
being done in re-operative procedures,
the complications associated with those
procedures and most importantly the
effect on weight and comorbid illnesses.
“Clearly this is a multi-year process,”
he concludes. “In addition, this process
requires participation by surgeons who
are performing re-operative bariatric
surgery, especially for the indication of
recurrent obesity. With continued effort
and physician participation we hope to
be able reach our goal of appropriate
CPT codes for re-operative bariatric
surgery.”
To access the article, please visit http://
connect.asmbs.org/
ASMBS Hosts Spring Educational Event in Miami, Florida
The American Society for Metabolic
and Bariatric Surgery’s Spring
Educational Event brought
hundreds of attendees, educators
and exhibitors to Miami, Florida to
discuss the most important issues
in metabolic and bariatric surgery.
T
he Spring Event is the smaller of two
events hosted annually by ASMBS.
The second event, ObesityWeek 2014,
combines the ASMBS and The Obesity Society’s
annual meetings, creating the largest obesity-focused conference in the world. The Spring Event,
according to ASMBS, serves as both an alternative to the larger ObesityWeek, and as an opportunity for those looking to get the latest information
about their field.
“This event provides an alternative for attendees
that may prefer smaller events, or are not able to
easily travel in November due to their busy call
coverage or travel schedules,” ASMBS Executive
Director Georgeann Mallory said. “The Spring
Event allows for one-on-one engagement with
exhibitors, speakers, and ASMBS leadership.”
For three days, attendees were able to experience a range of courses focusing on both surgeons
and integrated health professionals. These ranged
from roundtable discussions, medico-legal issues,
hands-on surgical labs and video tips from the ex-
John Morton
Ranjan Sudan, MD - ASMBS Carolinas State Chapter
President, and Georgeann Mallory, RD - ASMBS
Executive Director
Joseph Nadglowski - Obesity Action Coalition
PresidentChief Executive Officer
perts. All courses are lead by ASMBS speakers and
faculty, including members of ASMBS leadership.
The exhibit hall and social events used the
smaller event size to their advantage, taking on a
more personal atmosphere. The exhibit hall opted
for single tabletops over the larger booths seen at
ObesityWeek and other large conventions, focusing more on conversation with representatives.
Similarly, the social event encouraged direct engagement with ASMBS leaders, allowing attendees
to speak directly to ASMBS leaders in a relaxed,
friendly environment.
Both the Spring Educational Event and ObesityWeek aim to increase engagement with inter-
national attendees. For the Spring Event, ASMBS
incorporated in-room Spanish translation into some
of their most popular events, including a special
debate on several controversial issues.
“Many of the issues that are debated at ASMBS
meetings have global implications. ASMBS is a
world leader on many important issues, and our
position statements can influence the views of
dozens of other organizations. We want to make
sure the global bariatric community can be involved in these conversations, so we encourage
international attendance to all of our meetings,”
Mallory said.
ASMBS has held thirty annual meetings since
their creation, and a multitude of smaller events, including the Spring Educational Event. While each
event has its own uniquely designed program and
invited speakers, Mallory explained, many specific
courses and sessions are built on year-after-year,
incorporating new information and responding to
the needs of ASMBS members.
ASMBS will be hosting their 31st annual meeting at ObesityWeek 2014 in Boston, Massachusetts,
from November 2nd-7th. Registration for this event
is currently open. ASMBS has also announced
that the 2015 Spring Event will be in Las Vegas,
Nevada, with additional details available in the
coming weeks on ASMBS’s website.
Bariatric surgery causes remission of food addiction
They reported that remission of food addiction
in 13 of the 14 subjects (93%) and no new cases
were identified after surgery
income level.
They reported that remission of food addiction in 13 of the 14
subjects (93%) and no new cases were identified after surgery. The
prevalence of food addiction in this study population decreased from
32% to 2% (p< 0.00001) and reduced the median number of symptoms in all subjects (p< 0.0001).
Surgery was found to decrease food cravings in both groups, but
the decrease was greater in patients addicted to food. Unsurprisingly,
the addicted patients craved foods more frequently before, but not
after surgery. Interestingly, surgery decreased cravings for all types of
foods but cravings for starchy foods were still more frequent in in the
food addicted group (p=0.009).
B
ariatric surgery-induced weight loss induces remission
of food addiction and improves several eating behaviours
that are associated with the condition in extreme obesity,
according to the study published in the journal {{Bariatric surgeryinduced weight loss causes remission of food addiction in extreme
obesity.||Obesity}}.
Although, bariatric surgery is believed to be one most effective
available weight loss therapy for obesity and impacts on patients
desire to eat, it is not known whether it can affect food addiction
in patients who meet diagnostic criteria for the condition before
surgery.
Therefore, researchers from the Center for Human Nutrition and
Atkins Center of Excellence in Obesity Medicine, Washington University School of Medicine, St Louis, MO, assessed whether weight
loss induced gastric bypass, gastric banding and sleeve gastrectomy
induced remission of food addiction, as well as normalising eating
behaviours associated with the condition.
They recruited 44 obese patients (39 women, mean BMI48 ± 8)
before and after bariatric surgery (after they lost ∼20% of their body
weight). Twenty five patients had gastric bypass, 11 gastric banding
and eight sleeve gastrectomy).
Food addiction was identified in 14 of 44 subjects (32%) before
surgery, with no significant differences in factors that could affect
the condition such as age, race, level of formal education, and
Effect of surgery-induced weight loss on eating behavior
“Our findings demonstrate that weight loss can induce remission of
food addiction, even though subjects are still obese,” the authors write.
“These data suggest that obesity itself does not cause food addiction,
but that food addiction is a contributing, but modifiable, risk factor for
obesity. Additional studies are needed to determine the mechanism(s)
responsible for food addiction remission, and to determine whether
the presence of food addiction influences the weight loss efficacy of
bariatric surgery.”
To access this article, please visit http://onlinelibrary.wiley.com/doi/10.1002/
oby.20797/full.
bariatricnews.net 9
ISSUE 21 | AUGUST 2014
Banding the sleeve to prevent weight regain
Laparoscopic sleeve gastrectomy is a safe and effective procedure that results
in weight loss and improvements in comorbidities. Nevertheless, some patients
do present with insufficient weight loss or weight regain once the initial impact
and effectiveness of their LSG procedure has subsided. Professor Konrad Karcz,
University of Lübeck, Germany, believes one solution to prevent failure is to employ
the MiniMizer Ring (Bariatric Solutions). In an interview with Bariatric News, he
discusses the indications for banded sleeve gastrectomy and the advantages for
using the MiniMizer Ring.
“T
he gastric sleeve is gaining in popularity because it is a short and effective procedure. In the first and second
year after surgery the weight loss and metabolic
changes, such as resolution of type 2 diabetes, are
exactly the same as a gastric bypass,” said Prof.
Karcz.
In Germany, the majority of bariatric patients
have BMI>45 and more than half of Prof. Karcz’s
patients have a BMI>50. In his intuition, it is
planned for most patients in the BMI>50 category
to have a two-stage procedure: first a sleeve and
if their weight loss is unsatisfactory, an additional
malabsorption procedure.
“However, if the patient is on medication it is
a contraindication to a malabsorption procedure,
or patients may not want a second procedure,” he
added. “So what do we do with patients who were
not losing enough weight due to dilatation of the
gastric sleeve, who cannot have a malabsorption
procedure? We realised we needed to consider
additional options, such as the banding sleeve.”
Prof. Karcz and his team currently use the
MiniMizer Ring in the primary procedure on
super obese patients and perform banded sleeve
procedure on those patients who are receiving
medication or who are reluctant to have a second
procedure.
He explains that the MiniMizer Ring does
not really have an impact on weight loss for the
first 8-12 months, because the sleeve passage is
narrower than the Ring, the device is used as a
‘preventative measure’ against the dilatation,
“It is important not to make the Ring too tight
at the time of the procedure, as this may cause the
Ring to migrate. However, complications such as
migration dislocation, infection and dysphagia
are rare,” adds Prof. Karcz.
MiniMizer Ring
He explained that the design of the MiniMizer
Ring has several significant
advantages including the ease
of placement and closure,
and the intra-operative flexibility allowing adjustments
to the desired diameter. The
procedure is aid by the blunt,
silicone covered introduction needle that simplifies
retrogastric placement, as
this enables the operator to
get behind the pouch.
“The MiniMizer Ring is very easy to implant.
I make a small incision at the peritoneum on
the small curvature so I can work the needle of
the ring through, otherwise you may have some
resistance and you’ll have to apply more pressure
that could be dangerous because of the vessels.”
says Prof. Karcz.
Konrad Karcz
The Ring can be tailored to
suit several closing positions
from the largest to the smallest
ring size: from 8.0cm length (approx. 26mm internal diameter),
to 7.5cm length (approx. 24mm
internal diameter, 7.0cm length
(approx. 22mm internal diameter)
and 6.5cm length (approx. 20mm
internal diameter). This feature
also allows for re-opening if the
ring is either too tight or too loose.
“The banded sleeve gastrectomy operation is
a logical evolution when you need to enhance the
restrictive mechanism of the operation” concluded
Prof. Karcz. “The MiniMizer Ring is easy-to-use,
with a choice of diameters facilitating flexibility
and adjustments if needed.”
10 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
offee
time
C
with Bariatric News was delighted to speak with Professor Michel Gagner,
Congress President of the XIX IFSO World Congress and one of the pioneers of
laparoscopic bariatric surgery in North America. We discussed his career and the
challenges facing bariatric surgery…
Did you always want to enter
medicine?
When I applied for medicine, I also applied for
chemical engineering and I was accepted. But
at the last minute, I decided to go into medicine
primarily because my dad was a gynaecologist
so that influenced my decision. I am the eldest
of four boys, but I am the only one who entered
medicine.
Why did you decide to specialise in
bariatric surgery?
I entered medicine at the age of 18 and
graduated at 22 and very early on I realised I
wanted to become a surgeon. When I did my
surgical training, bariatric surgery at McGill
University was part of the general surgery
training programme. I was exposed to bariatric
surgery by Dr Lloyd D MacLean, who later
became President of the American College of
Surgeons, and he undertook open bariatric
surgery in a very scientific and controlled
way, performed randomised studies and was
supported by a great bariatric team. I was
impressed by his methods and it certainly made
an impression on me.
However, when I finished my training I
wanted to become a hepato-biliary surgeon
so I performed liver surgery in Paris with two
of the foremost liver transplant surgeons at
the time, Drs Henri Bismuth and Dominique
Franco. After my time in Paris, I then moved
to Boston for a year under the guidance of Dr
John Braasch. This year saw the advent of
laparoscopic cholecystectomy and I realised
that despite all of my surgical training if the
future was procedures such as laparoscopic
cholecystectomy, then I was not prepared at all.
So before starting my job in Montreal, I went
to Nashville, Tennessee, for one month to
be a free assistant to Drs Eddie Joe Reddick
and Doug Olsen. At the time, they were the
pioneers of laparoscopic cholecystectomy in
North America. When I returned to Montreal,
I started to organise courses in laparoscopic
cholecystectomy for Canadian surgeons. I
established a research laboratory and began to
look at other laparoscopic techniques such as
hepatectomy, pancreatectomy, adrenalectomy
and splenectomy. The first years of my early
laparoscopic career were focused on hepatobiliary and solid organs, and I even explored
endoscopic thyroidectomy in pigs.
Unfortunately at Montreal they did not have
a bariatric surgery programme nor a history of
bariatric surgery, and I was told by the Chief
of Surgery that I could not perform bariatric
surgery there.
It was when I arrived at the Cleveland Clinic
in 1995, I really re-started to perform bariatric
surgery and I established their first laparoscopic
bariatric programme. At the time there was
only really Drs Alan Wittgrove and Wesley Clark
from San Diego who were really performing
laparoscopic RYBG in the United States.
Who have been your greatest
influences and why?
The great influences on my career have been
Lloyd MacLean, Henri Bismuth, Dominique
Franco and John Braasch.
What experience in your training/
career has taught you the most
valuable lesson?
I think every day we learn from new
experiences. One of the most important
things for a surgeon is humility. Sometimes we
perform surgery and you think all is going well
and then complications occur. It is important
to remember that we are all human and these
things happen every day.
Another lesson is to persevere and be
persistent. When I wanted to perform a
laparoscopic bypass in Montreal, I was
prevented from doing so by the Chief of
General Surgery. We had already done all the
necessary animal research, performed the
procedure in pigs and published our findings.
Unfortunately, the procedure was cancelled
and I was very disappointed. Nevertheless,
I continued my work at the Cleveland Clinic
and re-doubled my efforts to establish a
laparoscopic bariatric surgery programme. So
I learnt that it is important
to believe in yourself and
be persistent. Just because
you face hurdles and have
setbacks does not mean
you should stop.
Michel Gagner
gastric bypass, we were using a generation
of staplers that were not as good as today’s
devices. At the time, the staplers were poorly
designed and as first generation devices they
were only 30mm long. They were also very
limited in terms of staple height and ability to
manoeuvre the stapler.
In the last 20-25 years, the industry has
really responded to the challenge, and we have
seen vast changes in the technology. So in
the early days we had more leaks from gastric
bypass and what we learned is not to rely on
mechanical staplers but to add more sutures. I
believe that as you become more experienced
with bariatric surgery you tend to re-enforce
more by adding more sutures, be very delicate,
and respect the tissue and blood supply.
Are there any plans to update the
laparoscopic sleeve gastrectomy
consensus paper?
Yes, at the XIX IFSO World Congress in
Montreal we will be hosting the 5th International
Conference on Sleeve Gastrectomy and on the
second day, Dr Raul Rosenthal will be hosting a
consensus discussion. We are requesting that
the experts in the discussions have performed
more than a 1,000 sleeves. Our goal is to have
100 surgeons from all over the world so we
can hopefully have a combined experience of
100,000 sleeves.
It has been nearly two years since the last
consensus so I think it will be interesting to see
what discussions emerge, whether it is about
new data or new devices that are helping to
achieve better outcomes. We especially want to
know how these experts manage complications
such as leaks and reflux.
We will be asking similar questions to those
asked in 2012 and some new ones. The results
will be shown at the end of the conference, and
published in a peer-reviewed journal at the end
of this year or early next year.
“I think laparoscopic
surgery whether it’s
a bypass, duodenal
switch or sleeve, is the
most effective way to
treat obesity and I don’t
see anything that will
change that in the next
ten years.”
Do you think you
would face the same opposition
today?
I think so. At the beginning, laparoscopic
surgery faced a lot of resistance from the
more conservative general surgeons, who
believed the best procedure was an open
procedure. Many surgeons at the time said
laparoscopic surgery was a ‘gimmick’ or a
‘fad’, and we were heavily scrutinised by
our more conservative colleagues. Some of
the advocates of laparoscopic surgery were
penalised and had their licence suspended or
their hospital privileges removed. There were a
lot of difficulties in the beginning.
When I started laparoscopic bariatric surgery
at Cleveland Clinic I had to undergo the ten
cases special review by a committee from the
Department of Surgery. For me, persistence
and belief was the key.
What have we learned over the last
15 years to prevent higher instances
of anastomotic leaks and stapleline haemorrhages?
When we first started performing laparoscopic
Do you think
any of the new
technologies may
replace more
tradition surgical
procedures?
percentage is decreasing, so we are not having
an impact on society.
I have always said that obesity and diabetes
are the healthcare challenges of the 21st
century and as a bariatric community, we must
demonstrate that bariatric surgery is safe so
it becomes part of main stream healthcare
provision in battling obesity.
In the 20th century, we created hospitals for
treating cancer, we created hospitals dedicated
to coronary and pulmonary disease (TB), when
both were seen as the challenges of the time.
But we have not yet created hospitals dedicated
to treating obesity and diabetes, and we need
super hospitals that are dedicated to this
problem so we can treat the huge number of
patients needing treatment. I am not just talking
about surgery; we are at the tip of the pyramid
but at the bottom there are huge numbers
of people who would benefit from improved
medical care, improvements in lifestyle changes,
dietary education and psychology. If we really
want to make a difference we need hospitals
everywhere dedicated to this.
It is an economic and political issue. As
surgeons we know what needs to be done but
the politicians are not listening. As surgeons,
physicians and patients, we need to come
together to lobby governments to make societal
changes. It is our biggest challenge.
What are you current areas of research?
I am interested in trying to make surgery less
and less invasive through laboratory and
clinical research. I am also involved in refining
procedures such as the single anastomosis
duodenal switch, I think this procedure is
likely to expand and could assist sleeve
patients who have regained weight after
their procedure. We are now at the stage in
bariatric surgery where we recognise that
each procedure has its failures. A single
anastomosis duodenal switch offers one such
solution, if we can find a solution to make
it easier to perform and less problematic in
terms of complications.
Finally, when you have time away
from surgery, how do you relax?
As you know we live in Canada so half of the
year its winter and since I was young I have
There have been a lot
enjoyed cross-country and downhill skiing. We
of start-up companies
do this as a family and we invite friends and
in the last few years but
although everyone has a different level of skiing,
many of them seem to
everyone enjoys it.
have a short lifespan.
I also enjoy mountaineering with my Canadian
I think laparoscopic
friends. I started about 12 years ago and now
surgery whether it’s a
every year we climb the Andes and regularly
bypass, duodenal switch climb to over 6,000m. Over the years we have
or sleeve, is the most
gone to Ecuador, Bolivia and Peru, and I hope
effective way to treat obesity and I don’t see
our next climb will be in Argentina.
anything that will change that in the next ten
I still enjoy playing squash and have
years. I think some of these new technologies
done since I was introduced to the sport in
might be used to decrease the risk from surgery Newcastle-upon-Tyne in the UK when I was a
for some of our patients in order to allow them
sixteen-year-old student … and I still beat my
to have surgery, in similar way the gastric
sons, although at my age I don’t think that is
balloon can be used.
going to happen for much longer!
I think one of the biggest challenges these
Would you like to make any
companies face is the issue of cost and some
of these devices are expensive at a time when additional comments regarding your
career?
cost needs to be reduced. I am sorry to say
I first started in laparoscopic surgery in 1990
that for a lot of these innovations, although
and nearly 25 years later I look back and think
very interesting concepts and I always enjoy
hearing about them, I do not see them making it has been a meteoric rise. From the beginning
we were doing one or two procedures and now,
a breakthrough at this time.
I find it’s non-stop teaching courses, writing
What are the biggest challenges
papers or presenting to colleagues around the
facing bariatric surgeons in Canada, world. I am very thankful for the opportunities
and the world, over the next ten
and experiences laparoscopic surgery has
years?
provided for me and my family.
Our biggest challenge is accessibility, to make
Laparoscopic surgery has provided me with
bariatric surgery accessible to a much larger
some wonderful experiences for which I am
percentage of the population. Year after year
very grateful. I am also thankful for the support
obesity and diabetes keeps increasing and the
of my wife of 30 years, France, and my three
number of patients put forward for surgery as a sons, Xavier, Guillaume and Maxime.
ISSUE 21 | AUGUST 2014
bariatricnews.net 11
In focus: Obesity in Australia
Effectiveness
Dr Talbot believes that with regards to the effectiveness of bariatric
procedures, it is very much ‘horses for courses’, as each procedure has
its own advantages and pitfalls.
“Our own data suggests that they have reasonably equivalent outcomes, but broadly speaking some individuals or group of individuals
may do better with one operation than another,” he said.
y impression is that whenever a Western country
For example, gastric banding is safe and effective but requires
performs a demographic survey about obesity they
a great after care team and the patient must interact with their
reveal data that puts their country in lead position
aftercare team. If a patient tends not to interact with their team or
for the worst figures in obesity until they are leapfrogged by the next
there is no funding for aftercare, then results will be poor. In conwestern country to do a survey” said Dr Talbot. “What is happening
trast, sleeve gastrectomy patients do not require as much aftercare
in Australia is mirroring what is happening in every other developed
to lose weight, which can be seen as an advantage. I don’t believe
country in the west with obesity prevalence continuing to increase
that we can discharge sleeve patients completely from followdespite our concerns.”
up Dr Talbot says. There have been some reported instances of
Nevertheless, he added that there is some evidence to suggest that
malnutrition following a sleeve procedure and reports about the
the rate or prevalence of obesity may slow down or plateau and sugstability of weight loss long term appear variable. While gastric
gested that Australia may end up with a situation where one-third are
bypass patients seem to do better ‘pound for pound’ with regards
obese and problematic, one-third are overweight and one-third are of
to weight loss and diabetes, there can’t be any debate about their
a normal weight.
aftercare due to risk of nutritional disturbances and internal hernia
He explains that trying to curb the obesity epidemic will be difformation.
ficult and one which will require a coordinated approach from all
“In a mature bariatric system, all bariatric procedures have their
public health stakeholders. Indeed, he stated that across all western
place. As a physician treating a patient you certainly don’t want to
countries there are no effective co-ordinated public health or primary
limit your ability to offer them treatment. There are some system barricare measures so far instituted. Prevention is hampered by public
ers in all western countries which makes performing some procedures
health specialists lacking sufficient political clout to introduce health
more difficult than others.” We are very lucky in Australia that we
policy, and treatment hampered by lack of dedicated obesity treatment
are able to offer such a range of treatments too our patients, but the
streams in primary and hospital care systems.
barriers to uninsured patients remain prohibitive.
“Obesity is multifactorial and too
Dr Talbot has been performing bariatric surgery for ten years and
big a problem for any one government
carries out banding, sleeve, non-banded and banded bypass proceThe availability of a
department to develop policy around, so
dures. He currently favours the banded bypass in heavier patients
rather than having a situation whereby
primarily due to concerns about maintaining weight loss or preventing
standardised, easy-to-use
small changes are implemented we end
weight regain.
band has allowed me to
up doing nothing. If you take smoking
“Originally, I was using a band that was made in theatre, but that
as an example, it was decades after
put limit on the number of bands I was prepared to place because
liberalise the bandedscientists documented the link between
there is always a concern that if you a placing a non-approved
bypass to the majority of
smoking and cancer, before governmedical device in patients you want a good reason for it. The
the bypass patients… In
ments took action and even longer until
availability of a standardised, easy-to-use band has allowed me to
those actions started to produce results.
liberalise the banded-bypass to the majority of the bypass patients.
ten years of performing
It needed decades of wrangling and
I tend to use the Minimizer Ring as it is easy to place and you can
banded-bypass, I have yet
incremental steps to change the health
calibrate it to the patient at the time of surgery. If you think you
of largest swathes of the population and
need a ring of a certain size and you are wrong, it doesn’t matter
to have a band-related
it will be the same for obesity.”
as you calibrate it to stomach size at the time of surgery. In ten
complication.”
years of performing banded-bypass I have yet to see a band-related
Legislation
complication so I feel more and more comfortable placing a ring at
According to Dr Talbot, it takes years for changes have a measurable
the time of gastric bypass.”
Michael Talbot
effect when creating public health policy and that public health policy
He added that one of the reasons was happy with the band was
generally requires effective legislation to produce results.
because he felt he had been able to avoid dysphagia by keeping ring
“Previous studies and data have clearly shown that education is could amputate the leg of a diabetic they would not be allowed to offer size at about 7cm.
mostly ineffective in managing population health,” he explains. “You them surgery to help manage their diabetes condition. We have been
“I am worried about creating unmanageable dysphagia in patients.
cannot place responsibility for managing complex risks onto the in dialogue with our State Government and Health Department for ten Patients who can’t eat normal food tend to eat carbs and fat and
individual as this is known to fail. We legislate to
years, asking for a state-funded obesity service and we are that does not aid weight loss. These days I almost always perform a
control seatbelts, smoking, lead in petrol,
getting nowhere,” said Dr Talbot. “In our private hospital banded-bypass as a primary procedure, and am very keen also to place
drink driving and road speeds. The
we are doing some 800 procedures a year, in our public a band if revising an LAGB or VBG to gastric bypass. In patients
public health specialists know
hospital we are lucky if we perform 20.”
with weight regain after gastric bypass the data tends to suggest that
what to do – but it took them a
if you are going to using a band to
Procedures
decade or more to convince
control weight regain following a
Over the last six years,
the politicians and then
bypass you are probably better using
“I am not overly impressed
Australia has seen the
the public that a change
an adjustable band.”
by many of the new
number of bariatric proto smoking was
The future
cedures plateau, and
needed. Of course,
technologies because
Dr Talbot believes the future of adas with all healthcare
now that these
they are not designed to
vances in bariatric surgery will probsystems the number
changes
have
ably not be with new technologies,
of procedure appears
occurred nobody
be permanent – they are
but rather adjunct treatments and
‘semi-cyclical’, in
would go back.
temporary treatments to
more personalised medicine, which
that whenever there
Once you change
a permanent condition.
will allow physicians to decide who
is a crisis (such as the
public
health
will do better with a less complex
financial crisis in 2008)
policy people never
Some of these technologies
procedure and who will require a
the numbers decrease,
want to go back. The
could results in a
more complex procedure.
but overall the numbers
difficulty is getting
“I am not overly impressed
have remained unchanged.
policy to change and
permanent gastric injury,
by many of the new technologies
There has been a noted
start moving forward.”
yet the effectiveness of the
because they are not designed to
shift in the case mix with a
“Public health policy
procedure is only going to
be permanent – they are temporary
decrease in less complex prowithout legislation is known to be ineffective, so until we
treatments to a permanent condicedures, such as gastric banding,
have legislation that supports public policy with regards to
be transient.”
tion. Some of these technologies
to more complex procedures like
obesity I predict we will continue to have vulnerable patients
could result in a permanent gastric
sleeve gastrectomy, and according to Dr
exposed to lifestyle factors that promote obesity and obesity related
injury, yet the effectiveness of the
Talbot the sleeve is now the dominant procedure in
illness,” said Dr Talbot.
procedure is only going to be transient.”
Australia accounting for 60-70% of the surgery.
Bariatric surgery
He added that pharmaceutical companies could play a key role
It is difficult to know whether the rise in sleeve gastrectomy proDiscussing the current status of bariatric surgery in Australia, he said cedures is due to the ‘prevailing fashion’ or due to data. Despite the in future therapies, however he suggested that rather than finding a
that the vast majority of procedures are performed on a private basis sleeve not having been tested for its long-term durability and safety, it ‘cure’ for obesity they will end up offering treatments in combination
and the in his home State of New South Wales, publically-funded has immediate effectiveness which is obviously one of the drivers of with surgery with specifically designed adjunct therapies.
surgery is about one percent or less.
“Bariatric surgery may become more common, but less complex as
its popularity, he explained.
He said that the State governments in Australia seem to be “franti“With regards to bypass, it is unusual that the rate is so low com- our understanding of the disease increases. By minimising the impact
cally” trying to avoiding providing a bariatric service as part of the pared with other Western countries, but I think as surgeons become a treatment has on a patient you are able to increase the number of
public system, adding that the debate arouses “horrible ethical and more confident in what is a highly-complex procedure, it may increase patients you can treat. We must remember that bariatric surgery as
equity discussions”.
from current levels,” he added. “The bypass does have a longer learn- an academic profession is still young compared with many other
“We are allowed to treat a whole raft of “lifestyle” disease includ- ing curve compared with a band or sleeve so this may explain why specialities, it’s a relatively new profession and there is a still lot to
ing cancer, stroke, cardiac disease and diabetes, and while a surgeon more surgeons do not adopt the procedure.”
be learned.”
Australia has one of the highest rates of obesity in the world, Bariatric News talks to Dr Michael Talbot (University of
New South Wales Senior Lecturer, Bariatric Surgeon and OSSANZ Committee Member), about what can be done to
curb the rise of obesity and current trends in Australian bariatric treatment.
“M
12 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Study supports staple line
reinforcement for LSG
Patients who had reinforcement
material reported no postoperative
staple line leaks or bleeding
The reinforcement-material group had
a significantly shorter operating time
and smaller bougie size
Glial cells could be targeted for
drugs that treat metabolic disorders,
including obesity and diabetes
I
T
he use of the bioabsorbable staple line
reinforcement material may decrease
life-threatening leaks after laparoscopic
sleeve gastrectomy (LSG), according to a single
centre study of over 500 patients published in
Obesity Surgery.
Gastric leakage from the staple line is a lifethreatening complication of LSG, however there
is some debate as to whether buttressing the staple
line with a reinforcement material reduces leaks.
Several methods of reinforcement are utilised for
preventing leaks and bleeding after LSG, such
as oversewing the staple line, applying a fibrin
sealant, and using a buttressing material.
In addition, the study authors from The Life
Weight Loss Centre Liverpool, NSW, Australia,
note that in addition to the method of reinforcement other technical aspects of the procedure
such as bougie size and distance from the pylorus
need to be taken into consideration.
Study
Therefore, the researchers retrospectively reviewed 518 medical records of all patients who
underwent LSG at their centre between September
2007 and December 2011. They note that patients
treated before August 2009 did not receive the
staple line reinforcement material (n=186),
whereas all patients treated afterward did (n=332).
They used the Gore Seamguard Bioabsorbable Staple Line Reinforcement (WL Gore &
Associates), a synthetic bioabsorbable material
composed of the copolymer polyglycolic acid/
trimethylene carbonate.
Leptin influences
brain cells that
control appetite
Results
Follow up data was available from 409 patients at six
months postoperatively, 329 patients at one year and
258 patients at two years.%EWL was 67.1% at six
months, 81.2% at one year and 83.8% at two years.
Patients who had reinforcement material reported no postoperative staple line leaks or
bleeding. The no-reinforcement group had three
leaks (p=0.045) and one case of bleeding.
The reinforcement-material group also had a
significantly shorter operating time and smaller
bougie size, as well as a significantly higher rate
of hiatal hernia repairs. The overall adverse-event
rate was 1.7%.
“We believe that use of a smaller bougie
produces greater weight loss, but we are aware
that employing a small bougie may increase the
risk of staple line leaks caused by an increase in
intraluminal pressure, especially at the angle of
His,” the authors write. “However, our results
provide new evidence that using the PGA/TMC
reinforcement material mitigates that risk.”
Conclusion
“Patients in whom synthetic PGA/TMC staple
line reinforcement material was applied during
LSG had no postoperative leaks or haemorrhages
from the staple line,” the authors conclude. “The
difference in leak rate between the reinforcementmaterial group and the no-reinforcement-material
group was significant (p = 0.045).”
They also note that using a bougie that was
40F or smaller and limiting the antrum size to 2
to 4cm resulted in ‘excellent’ short-term%EWL
results at six months and one and two years after
surgery. Further, the resolution of or improvement
in T2DM and hypertension occurred in 89 and
72% patients, respectively.
n addition to influencing neurons to help regulate
metabolism, appetite, and weight Leptin also acts
on other types of cells to control appetite, according
to researchers from the Yale School of Medicine. The
findings could lead to development of treatments for
metabolic disorders.
“Up until now, the scientific community thought that
leptin acts exclusively in neurons to modulate behaviour
and body weight,” said senior author, Dr Tamas Horvath,
the Jean and David W Wallace Professor of Biomedical
Research and chair of comparative medicine at Yale.
“This work is now changing that paradigm.”
Leptin is a naturally occurring hormone known for its
hunger-blocking effect on the hypothalamus and is one
of the molecules that signal the brain to modulate food
intake. It is produced in fat cells and informs the brain of
the metabolic state. If animals are missing leptin or the
leptin receptor, they eat too much and become severely
obese.
Leptin’s effect on metabolism has been found to
control the brain’s neuronal circuits, but no previous
studies have definitively found that leptin could control
the behaviour of cells other than neurons.
In the study, published in the journal Nature Neuroscience, Horvath and his team selectively knocked out
leptin receptors in the adult non-neuronal glial cells of
mice. The team then recorded the water and food intake,
as well as physical activity every five days.
They found that animals responded less to feeding
reducing effects of leptin but had heightened feeding
responses to the hunger hormone ghrelin.
“Glial cells provide the main barrier between the
periphery and the brain,” added Horvath. “Thus glial
cells could be targeted for drugs that treat metabolic
disorders, including obesity and diabetes.”
A NEW range of vitamins and minerals for your bariatric patients
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n UK formulated and manufactured
n Rigorously tested for purity and stability
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t is widely accepted that lifelong multivitamin and mineral supplementation is
essential for patients both before and after
weight-loss surgery1. There is currently no UK
manufactured bariatric product which complies
with expert recommendations on post-operative
micronutrient supplementation. Forceval® is
a vitamin and mineral supplement commonly
prescribed for surgical weight-loss patients in
the UK and other European countries. However,
Forceval® was never specifically formulated for
bariatric patients and is deficient in a number of
important respects. The concentrations of some
essential vitamins and minerals are inadequate
for the surgical weight loss patient, whilst other
important micronutrients are missing altogether
(see comparison link below). Likewise, over-thecounter vitamins and minerals from high street
pharmacies fall well short of the needs of patients
undergoing weight-loss surgery. It was to fill this
obvious need that VitaWeight™ was developed.
VitaWeight™ delivers optimal micronutrient
I
support for bariatric patients, in a simple dosing
regimen and is fully compliant with expert recommendations for post-operative supplementation2.
Advantages of VitaWeight™
VitaWeight™ products are rigorously tested for
purity and stability and have a number of important
advantages for the surgical weight loss patient.
n Concentrated B Vitamins. The multivitamin
contains all eight of the required B vitamins;
Thiamin (B1), Riboflavin (B2), Niacin (B3),
Pantothenic Acid (B5), Pyridoxine (B6), Biotin
(B7), Folic Acid (B9) and Cyanocobalamin
(B12). All eight B vitamins work together
in various combinations to help the body
metabolize food, protect the heart, regulate
nerve growth and boost the immune system.
Note: the high concentration of crystalline
B12 in VitaWeight™ removes the need for B12
injections in RYGBP and other patients.
n Calcium citrate. Most standard multivitamin
formulations use calcium carbonate, which
needs to combine with hydrochloric acid in
the stomach to be absorbed. Following weight
loss surgery, however, the amount of acid
in the stomach is decreased and patients are
often prescribed medication (e.g. PPIs) to
reduce stomach acid secretion even further.
For this reason we have use the citrate salt
Procedure
Multivitamins and Minerals
(Tablets/day)
Calcium
(Tablets/day)
Gastric Band
1
1
Sleeve gastrectomy
1
3
Roux-en-Y gastric bypass
2
4
which is well digested and
absorbed, even when stomach
acid is decreased.
n Trace elements. Our
multivitamin preparation
includes comprehensive trace
element support, including zinc,
selenium, copper, molybdenum
and chromium.
n Iron. Our iron source is ferrous
bisglycinate. This is important
because the bisglycinate salt
is less irritating to the gastric
mucosa and therefore has
significantly fewer side effects
such as nausea, epigastric
pain and vomiting39. In addition, we have a
significantly higher dose of iron in accordance
with ASMBS recommendations (18-27mg/
day).
n Vitamin D. With regard to Vitamin D,
Vitaweight has the D3 (cholecalciferol) form
rather than the D2 (ergocalciferoal). This
is because vitamin D2 has a much lower
potency and a shorter duration of action when
compared with vitamin D3. In fact, vitamin
D2 has a potency less than one-third that of
vitamin D3.
n Vitamin K2. Vitaweight™ contains both
Vitamin K1 and K2, which have distinct
functions. Vitamin K1 is involved in blood
coagulation, whereas K2 helps to direct
calcium into bone and blood, rather than
arteries, muscle or other soft tissues. Studies
now indicate that vitamin K2 also works to
prevent certain cancers and bone loss. There
are several active forms of
vitamin K2: MK4, MK7, MK8
and MK9. The most relevant to
health is the MK-7 form which
is the form included in the
Vitaweight™ formula.
Recommended Dosage
The micronutrient needs of
patients post-operatively will depend primarily upon the type of
procedure performed. The table
below provides general dosage
guidelines, though results from
blood measurements may require
a modified daily regimen.
References
1.Pournaras DJ, le Roux CW. After bariatric surgery, what vitamins
should be measured and what supplements should be given? Clin
Endocrinol (Oxf) 2009; 71:322-5.
2.Aills L, Blankenship J, Buffington C et al. Bariatric Nutrition: Suggestions for the Surgical Weight Loss Patient. ASMBS Allied Health
Sciences Section Ad Hoc Nutrition Committee. Surg Obes Relat Dis.
2008;4(5 Suppl):S73-108.
How to prescribe
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14 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Y
ou must be very excited that the
IFSO world congress is coming to
Montréal?
We are having a great response from our colleagues
around the world have had almost 1,000 abstracts,
from which we have accepted nearly 20 percent
and as a result we have some excellent high quality
papers that will be presented in Montréal.
Interestingly, there are very few papers on gastric banding and there will be only one session that
will focus on banding and this is certainly a change
on previous years. There were also a smaller number of abstracts submitted on gastric plication than
we were expecting. In comparison, we have had a
higher number of papers on mini gastric bypass.
One could conclude that perhaps IFSO is more of
a forum for those procedures that are not yet officially accepted or available in the United States.
For example, we have more presentations of
single anastomosis gastric bypass, sleeve gastrectomy with duodenal jejunal bypass and single-anastomosis duodenal switch. You will not see many of
these presentations at the ASMBS meetings. IFSO
is certainly a meeting which delegates can witness
presentations on procedures that are a deviation
from the norm and I think it is important to give
these interesting procedures a forum in which
they can be analysed and discuss by bariatric and
metabolic experts from around the world, and let
them just whether they are experimental or worthy
of consideration.
This year’s meeting includes a
comprehensive postgraduate
programme?
There are several postgraduate courses to be held
in Montréal, which we believe reflects what delegates want.
There will be a two-day ‘5th International
Conference on Sleeve Gastrectomy’, this will
include 23 live cases and delegates will see sleeve
gastrectomies performed with different techniques,
with different tubes and with different instruments.
There will also be live revision sleeve cases, cases
looking at stenosis, leak repair, hiatal hernia, onestage band to sleeve, plication to sleeve, as well as
‘banded’ or ring sleeve gastrectomy. In addition,
we will also show conversion from bands to sleeve,
sleeve to single anastomosis gastric bypass, sleeve
to single-anastomosis duodenal switch, as well are
the classic procedures such as conversion to Rouxen-Y gastric bypass or duodenal switch.
The first day consist of live surgery and lots of
discussion, so if delegates are interested in sleeve
gastrectomy this is the place to see and discuss the
entire spectrum of sleeve gastrectomy in one day –
it will be of great interest to all participants.
We will also host a ‘Single Anastomosis Gastric
Bypass Course’ and has been organised by the same
group who held the First and Second Mini Gastric
Bypass Conference in Paris, France, in October
2012 and 2013. They have experts from around the
world who will discuss variants of the technique,
results, complications, issues comparing the miniand Roux-en-Y gastric bypass. The course has been
well organised and should be attended by those
with an interest in the single anastomosis gastric
bypass procedure.
We are delighted that Francesco Rubino, Ricardo
Cohen and Marco Bueter will be hosting a course on
‘Metabolic Surgery’, designed for practicing bariatric
surgeons, integrated health professionals (including
basic scientists) and endocrinologists involved in the
treatment of type 2 diabetes mellitus (T2DM). The
course will examine the mechanisms behind control
of T2DM after gastrointestinal operations and well
as the rationale behind weight loss independent
mechanisms of T2DM control/remission.
We will also have a course on ‘Robotic Bariatric
Surgery’ that will include a liver case from Orlando.
The concept of Robotic Bariatric Surgery is one
that has not yet grabbed the attention of mainstream
surgeons so I think the discussion from the course
will be interesting.
There will also be a ‘Scientific And Medical
Writing Course’, organised by Jane Buchwald,
and should be attended by those, perhaps younger
surgeons, who wish to learn how to write a medical
paper and improve their chances of having their
research published in a peer review journal.
The ‘Duodenal Switch: An Introduction to
Metabolic Surgery’ course is an introduction to
understand the anatomy and physiology of BPD-DS
with a sleeve gastrectomy. In Quebec, duodenalswitch is a popular procedure and Canada is one of
the few countries in which the procedure has much
An interview with Michel Gagner
The IFSO 2014 Congress will be taking place at the Palais des Congrès
de Montréal in Montréal, Québec, Canada from August 26-30, 2014.
Bariatric News looks forward to the meeting with Professor Michel Gagner,
Congress President of the XIX IFSO World Congress, who discusses the
highlights of this year’s scientific programme from cutting-edge research
and world-class plenary sessions to a record number of live surgery cases.
larger percentage of the total of bariatric procedures
performed, and keeps increasing year after year. The
team from Quebec will present their 25 year experience of the procedure, and experts from around
the world will discuss the technical aspects of the
procedure, and there will also be two live duodenal
switch cases, a classic duodenal switch procedure
and a revision.
Christopher Thompson from Harvard and Manoel Neto from Brazil have designed the ‘Bariatric
Endoscopy’ course and will include live broadcasts
of bariatric endoscopic procedures , as well as
didactic lessons presented by worldwide experts integrating the surgical procedure anatomy, surgical
approach and therapeutic endoscopic options and
will examine the ‘multi-dimensional’ aspects of
these procedures. The course will include live cases
including endoscopic sleeve gastroplasty from the
Mayo Clinic, POSE procedure, endolumenal
duodeno-jejunal bypass, intragastric balloon implant and explant, as well as endoscopic treatment
of bariatric surgery complications such as gastric
band and RYGB ring erosions, RYGB and sleeve
gastrectomy leaks and stenosis.
Last, but not least, we have a course of the
principles of obesity management hosted by Arya
Sharma and will be an intensive educational
experience with a strong emphasis on the practical
aspects of obesity management and the role of
inter-professional bariatric care.
Wednesday will include the 10th International
Bariatric Club Symposium organised by Haris
Khwaja, Mervyn Deitel, Manoel Galvão Neto,
Ariel Ortiz Lagardele and Tomasz Rogula. They
have a very interesting programme with keynote
speakers and debates asking whether mini bypass
will kill RYGB in ten years and if duodenal switch
is the best revisional surgery for weight re-gain after sleeve gastrectomy. In addition, there will also
be an experts forum asking when should RYGB
be reversed.
There is also a Gore sponsored symposium
discussing revisional bariatric surgery entitled
‘Complications and Considerations when Converting Bands to Sleeves and Sleeves to Duodenal
Switches’.
At the end of the day, there will be a Welcome
reception and we are delighted to have music and
act from Montréal’s world famous circus, as well
as culinary delights from across our country as
we welcome delegates from all over the world to
Montréal and to the IFSO’s 19th World Congress.
How you incorporated any new elements
to the World Congress this year?
We have decide to have a ‘Meet the Experts Luncheon’ so everyday delegates can meet with experts
from around the world and have a one-to-one
conversation about difficult cases, ask advice and
their opinion, it really is a unique opportunity for attendees to listen to the advice and recommendations
of 10-20 experienced surgeons each lunch time.
The Congress will include comprehensive live
surgeries with nearly 50 interventions, free WiFi
with iPhone and Android applications that give
users access to abstracts, programme, schedule,
speakers, videos and CME Credits.
Delegates can look forward to more
than 20 sessions, what are some of the
sessions you are looking forward to?
There are so many sessions that I believe will be
interest to delegates, the scientific programme is
one of the most comprehensive I have seen and
there is something for everyone at the meeting.
From nearly 1,000 abstracts submitted, we had a
team of over 80 reviewers who in teams of three or
four assessed each abstract and marked it accordingly. Of course, the reviewers were blinded to the
authors and centres, eliminating possible bias.
The papers with the highest score will be presented in the ‘Top Paper Session’ and will include
some high quality randomised studies. We also
have six additional video sessions – and for the first
time each video was submitted online and reviewed
instead of being reviewed via a paper abstract. So
the quality, content, sound and appeal of the videos
are all of a high quality this year.
On Thursday, we will have sessions on ‘Revisions’, Pre- and post-operative management’, as
well as a very good session on ‘Long-term results’
that will witness the outcomes and assessment
of a range of procedures from all over the world
including Canada, Europe, Mexico and India. We
are also delighted to welcome our colleagues from
Latin-America who will host an all-day ‘IFSO
Latin American Chapter Symposium’
The latest and emerging technologies will be
presented and discussed in the ‘Emerging Technologies Session: The Future of Obesity Surgery
Symposium’, hosted by Laurent Biertho and
Jerome Dargent.
There is also a lot in this year’s programme on
‘Allied Health’ and will include presentations from
psychologists, nutritionists and bariatric physicians, as well as sessions hosted by the Canadian
Obesity Network.
Ethicon will also be hosting a ‘Metabolic Applied Research Surgery (MARS)’ symposium
and will feature updates on what is new from the
science of bariatric and metabolic research by
Drs Kaplan and Seeley. We have a symposium on
‘Petersen’s and other mesenteric defects’ and this is
still a controversial area and a lot of surgeons still
do not close them. This session will also include a
debate, videos and a Keynote Lecture by Dr Eric
De Maria.
There are several sessions on surgery and
diabetes and this is reflective on the fact that it is
widely accepted that surgery now has a metabolic
component. In addition, there is a ‘Roundtable on
BPD and DS’ that will ask why one of the most effective procedures are only done in 2% of patients,
I am sure we will see some fascinating discussions.
And sessions on ‘Sleeve gastrectomy – outcome
study, ‘Comparative Trials’, Management of Complications’, Medical management’ and ‘Health and
Economy’ sessions.
Thursday will close with a Covidien symposium
on ‘SIPS viability as a primary or revision procedure: debate on the efficacy of a single loop DS’,
moderated by Ninh Nguyen.
On Friday, we have a session on ‘20 Years
Follow-Up Post Bariatric Surgery’, in which
Richard Welbourn will present the first report
from the IFSO Bariatric Registry Pilot that has
over 100,000 patients.
This will be followed by the ‘Mason Lecture:
Severe Obesity Is A Congenital Disease – Epigenetic’ by Picard Marceau, and the ‘Scopinaro Lecture:
Why Obesity Is A Disease?’ by Arya Sharma. In
addition, we have several ‘Honorary Membership
Awards’ and this year’s recipients are Shrihari
Dhorepatil from India, Lloyd D MacLean from
Canada and Lars V Sjostrom from Sweden. This
session will be concluded with Luigi Angrisani’s
‘Presidential Address’.
There are many more sessions to follow from
‘Sleeve gastrectomy and GERD’ and ‘Disasters in
the OR’ to ‘Genetics and Obesity’. Not forgetting
an Apollo Endosurgery symposium on low BMIs, a
symposium ‘On Enhanced Recovery After Bariatric Surgery’, a session on ‘Ileal Interposition As An
Option: Physiology, Pathophysiology, Technique,
Clinical Trends’, a session on the ‘Management Of
Barrett’s In Patients Having Bariatric Surgery’, as
well as more video and poster sessions.
On the Friday evening, we will also have the
Gala Dinner with a cocktail reception and a ‘Montréal Jazz Festival evening’ with live jazz band and
singers, a three-course plated dinner with wines, an
award ceremony, ending with fabulous music and
dancing. I hope many delegates will attend and
enjoy a fantastic evening at the Arsenal, a contemporary art exposition gallery in Griffintown.
On Saturday, we will have more live surgery
from Canadian centres that will show ‘Unusual
Situations in Bariatric Surgery’ and ‘Revisional
Surgery’.
I believe that this year’s programme is the most
comprehensive ever witnessed at an IFSO World
Congress. I would encourage colleagues from
around the world to come and visit Montréal, meet
old friends and make new ones, join in the debates
and discussions, and enjoy all this wonderful city
has to offer!
The final programme for IFSO 2014, can be viewed here
(http://www.ifso2014.com/temp/201472947352/IFSO_
Preliminary_Program_-_July_29_lv.pdf)
bariatricnews.net 15
ISSUE 21 | AUGUST 2014
Initial experience with the HARMONIC ACE®+ 7
E
thicon recently launched the HARMONIC ACE®+ 7, the first ultrasonic
surgical device indicated to seal vessels
up to and including 7mm. Bariatric News talked
with the first surgeon outside of the US to use
the device, Mr Marco Adamo from University
College Hospital London, UK, to discuss his inital
experience with the new device.
“I have been using the Harmonic range of devices
for 15 years so I have seen first-hand how the device
has evolved over the years. In my opinion, the new
HARMONIC ACE®+ 7 is the best HARMONIC
device so far,” said Mr Adamo. “For me, the HARMONIC has always been a very good instrument and
with the new HARMONIC ACE®+ 7, the company
has not radically altered too much, they have just
made small but significant improvements. ”
Advanced hemostasis mode (third button)
One such change is the addition of the Advanced
hemostasis mode located on the new third button.
According to Mr Adamo, the inclusion of the third
button is “quite revolutionary” because traditionally all the energy devices on the market have two
buttons – fast and slow.
He also stated that the intuitive design of the
HARMONIC ACE®+ 7 and the location of the
Advanced hemostasis mode button, not only
provides the surgeon with the ability to treat large
vessels but improves the handling and efficiency
of the operation.
“You can see when you use the device that
Ethicon has done a huge amount of work in terms
of ergonomics with the third button. The design is
very intuitive, so it is as though the third button
has always been there and you can press the button
with your thumb or index finger,” he explained.
“When surgeons are treating a very big patient and
struggling for space with their hands in an uncomfortable position, being able to fire the instrument
with your thumb is a real benefit for the surgeon
as we are no longer required to twist our wrists.”
So far, Mr Adamo has carried out approximately
ten cases using the HARMONIC ACE®+ 7, performing a mixture of gastric sleeves
and bypasses and commented on
the additional refinements that
have been made to the device.
“Regardless of the level
of power required sometimes
you can use the first setting,
which is the slowest, not because
you are treating a big vessel but
because it is more comfortable using the device
with your thumb. At the moment it acts as a third
setting. I think in the future they should use the
handle as a platform for future devices. I can see
lots of new applications for that.”
“It gives you more power and is more versatile,
it allows you to divide tissue much more quickly.
However, the more efficient the device the less
margin for error,” he added. “I think there may be
some less experienced surgeons who may require
some training or guidance when initially using this
Marco Adamo
new device because of the like to see a HARMONIC device that has three
buttons and the third button to do something
improved efficiency. “
different, rather than having three buttons with
Greater confidence
three settings. I would like the third button
“You use each device to the limit to provide double the speed to improve effiand each surgeon – depending on his or her tech- ciency, but with the same level of coagulation,”
nique – has a different limit. It is a question of he concluded. “I suspect that there will be adconfidence; some surgeons do not feel comfort- ditional refinements to the technology by the
able pushing the limits of a vessel. You need to company.”
ask the question; “Is this vessel large enough to
In addition to bariatric procedures, the Harbe sealed by the instrument or not? For me, the monic ACE®+7 is designed for use in numerous
HARMONIC ACE®+ 7 will give less experienced procedures and specialties including general,
surgeons greater confidence.”
colorectal, gynaecology, thoracic, and urology,
and according to the company is best suited for
Future refinements
cases which require dissection, mobilisation and
“In the next stage of development, I would large vessel sealing.
First IFSO Global Registry Report 2014
This is the first pilot, international analysis of outcomes from bariatric
(obesity) and metabolic surgery, gathered under the auspices of the
International Federation for the Surgery of Obesity and Metabolic
Disorders (IFSO).
• Over 100,000 patient records from 18 countries
• Analyses on procedure type, BMI, mortality, weight loss,
comorbidities and more
• Quantifies gender inequalities and the inequality of access to
surgery in many countries
• Demonstrates the improvement in diabetes and the profound
treatment effect that bariatric surgery has on this disease
“I applaud this first report of the IFSO global bariatric surgery registry.
It marks an historic first step in bringing together real world data from
around the globe. It will provide essential support in understanding risk
stratification, and refining those most likely to benefit from surgery.”
John Dixon
To purchase this
report, please visit
Dendrite Clinical
Systems in the
Exhibition area
Stand 113
Price:
C$30
US$30
£20
€25
ISBN 978-0-9568154-9-1
“The report provides fascinating
county-to-country and region-to-region
comparisons, as well as demonstrating the
safety and effectiveness of bariatric and
metabolic surgery on a global scale.”
Michel Gagner
Under the auspices of
Published by
16 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
IV noninva
International
Symposium
report
Jerome Dargent
This year’s IV International Symposium on Non Invasive Bariatric Techniques meeting in Lyon, France, again focused
on various innovations that should make operations and treatments for morbidly and or severely obese patients
easier and more comfortable.
The evolution and the speed at which new concepts emerge have such an extent that one year is a long period of
time while expecting news from this fascinating field. Some devices have been discarded, some are still promising
but encounter difficulties... and fortunately others are flourishing.
Apart from the light that that has been shed on both updates and revelations, our particular goal this year has been
to enlarge the perspective of the bariatric field and highlight some future aspects of innovations, including the non
surgical field: what can we learn from “small surgical improvements or variations”? Can we expect a breakthrough
from brown adipose tissue manipulations? Is local vibration a sensible way to treat abdominal obesity? etc. Finally,
the conflicts that exist between the necessities of innovation, the economics and the ethical background have been
once more outlined.
of robotic gastric bypass in obesity surgery – the learning curve, tricks
and tips. Previous experience and literature have noticed an important
added duration for the procedures (e.g. Ayloo, Surg Endosc 2014):
187 minutes on average. Ghavami said he favours the hybrid type of
Surgical techniques and surgical management: updates
operation: the gastrojejunal anastomosis only is performed through
and upgrades
the robotic approach, while the making of the pouch is performed via
Marie-Cécile Blanchet (Lyon, France) presented her impressive the standard laparoscopic approach.
experience with the “Fast-track bariatric programme’ that has been
Patrick Noel (France) advocated the Routine sleeve gastrectomy
implemented in her hospital. The principles of fast track programme
or ERAS in digestive surgery have been initiated by Henrik Kehlet in
Sweden (1997). They involve minimal invasive surgical techniques,
rapidly acting agents in anesthesia, optimal pain and anti-emetic
control, aggressive postoperative rehabilitation (early oral nutrition
and ambulation). Bariatric surgery has rapidly become a sensible application for ERAS.
Since 2010, 4,009 patients have received a laparoscopic gastric
band. Ambulatory procedure was chosen as a primary treatment modality. This shift has involved the surgeons, the anaesthesiologists, the
administration and the nursing staff. The process has benefited from
authorities and insurance companies, with a change in the pricing
system starting March 2012. These results have demonstrated that applying an ERAS protocol was feasible, safe, and associated with a low
morbidity and a low 30-day hospital re-admission rates. The existence
of multiple medical co-morbidities did not prevent this protocol in
bariatric patients. The rate of ambulatory surgical procedures has increased from 3.1% in 2010 to 88.5% in 2013 for patients operated with
laparoscopic gastric banding. In the meantime, unplanned hospital
admission and readmission rate has decreased to 0.6% in 2013. Following the day one phone-call after surgery, patients satisfaction rate
was above 99%. Other publications have demonstrated the possibility
of performing gastric bypass and sleeve gastrectomy in an ambulatory
setting.
Karl Miller (Salzburg, Austria) introduced Airseal laparoscopic
bariatric surgery as a possible new paradigm while improving greatly
the performance of common laparoscopic surgical techniques.
Contrary to current laparoscopic insufflation devices, the Airseal
system (Surgiquest) allows a constant level of intra-abdominal pressure during a laparoscopic procedure, and reduces the absorption of
CO2 for the patient and the surgical team. The trocar that is inserted is
valve-free. The drop of pressure in case of suction (even continuous)
does not exist anymore. The toxic content of surgical smoke (carrying
mutagenic agents, viral pathogens) is suppressed for the benefit of
both the patients and medical staff in the theatre.
Bijam Ghavami (Lausanne, Switzerland) reported his experience
Jerome Dargent Conference organiser, Non-Inva Lyon
through the SILS approach and the SPIDER system. Sleeve Gastrectomy with the SPIDER System has been introduced by Michel Gagner
(Canada). The Single Port Instrument Delivery Extended Reach (SPIDER) is a flexible laparoscopic system, with dedicated instruments
allowing a real intra-abdominal triangulation.
It establishes a stable platform with instruments independent motion, up to 360°, and minimises torque on the abdominal wall. One
additional trocar is used for placement of the stapler and the energy
device. The technique competes with the regular SILS approach, and
with robotics as well, both becoming less popular. The operative time
has dropped to 40 minutes in P Noel’s experience, and the costs seem
competitive in his hospital.
Elie Chouillard (Poissy, France) detailed the Comparison between
Laparoscopic Vertical Gastric Plication and Sleeve Gastrectomy, in
terms of postoperative complications and short-term outcomes. Laparoscopic sleeve gastrectomy (LSG) is nowadays the most commonly
performed bariatric procedure in France. However, newer surgical and
endoscopic techniques are emerging. Among these, laparoscopic vertical gastric plication (LVGP) is presented as an alternative for LSG
with theoretical advantages including a lower postoperative morbidity,
a higher efficiency, and reversibility. Moreover, published weight-loss
results suggest that LSG and LVGP are comparable, at least in terms
of short and medium follow-up.
The goal of this retrospective case-control study was to compare
early morbidity and mortality, and short term outcome in two groups
of morbid obese patients. Methods: From March 2011 to January
2013, 40 patients had LVGP (Group I) and 280 patients had LSG.
Rudolf Weiner (left) and Karl Miller
bariatricnews.net 17
ISSUE 21 | AUGUST 2014
From these, 40 (Group II) were matched with Group I patients according to age, sex, and BMI. The primary endpoints were morbidity and
mortality rates. Secondary endpoints included operative time, hospital
stay, costs, six-months and 12-months EWL, and outcome of associated comorbidities. Results: There was no postoperative mortality in
either group. One patient in each group had postoperative bleeding
with conservative management and no reoperation. Morbidity rate
(including nausea and vomiting) was 20% in Group I and 10% in
Group II (P=0.04). The most common complication was nausea: 20%
of patients in Group I and 5% of patients in Group II (P<0.001). There
were leaks. Mean operative time was 91.5 +/- 18.6 min in Group I and
81 min +/- 16.8 min in Group II (P=0.104). Mean hospital stay was
3.2 +/- 1.1 days in Group I and 3.4 +/- 1.2 days Group II (P=0.614).
Average total Operating Room (OR) cost was €1736 for LVGP compared to €2842 euros for LSG (P<0.001). At six-months follow-up,
comorbidities including hypertension and sleep apnea, improved identically in both groups. At 12-months, mean EWL was 56.5% +/- 9.8%
in Group I and 71.3% +/- 10.4 in Group II (P=0.041). Conclusion:
LVGP is a sure and feasible bariatric procedure with a low rate of
complications. Compared to LSG, LVGP entails more postoperative
nausea. Regarding direct OR cost, LVGP is more efficient than LSG,
saving more than 1000 euros per procedure. However, LVGP has a
lower EWL at 12-months (p=0.041). ASMBS statement has deemed
that this procedure was still investigational, which can be explained
as additional prospective and comparative studies with long-term
follow-up are required; unexpected complications have been reported
(intussusception); finally there is a lack of standardisation in the operative technique.
Rudolf Weiner (Frankfurt, Germany) presented endoscopic solutions for complicated sleeve gastrectomy: to stent or not to stent? During the years 2001-2009, two surgeons were practicing in his hospital,
661 patients were operated on, with a 0.7% leak rate; 2009-2012:
seven surgeons, 686pts, 12 leaks: 1.7%. Conclusions: oversewing has
a low success rate; covered stents and clips are advised, but with no
more than two stent attempts; in case of late fistula: try and transform
the leak into a low pressure system, similar to bypass fistula cases.
Elise Magnin-Feysot (France, Ethicon – Johnson and Johnson)
presented the latest developments in linear staplers innovation from
J&J company. Enhanced compression capabilities and safety issues
have been taken into consideration, new devices are expected by the
end of 2014 and shall be released to customers at that time.
Gastric neuromodulation with the abiliti system, an update: Günther Meyer (Germany). Alterations of eating behaviour in obese subjects treated with the Abiliti System (IntraPace) were assessed in an
ongoing prospective clinical multicentre trial. More than 200 devices
have been implanted. It is a closed loop gastric electrical stimulation
device which features a transgastric sensor to detect food intake and
an accelerometer to record physical activity. The stimulator delivers a
tailored gastric stimulation in response to food consumption, inducing
early satiety. EWL at 12 months is in line with the objectives. Weightloss is achieved due to the assessed alteration of eating behaviour
in particular the reduction of loss of control and hunger. The abiliti
system has been developed to deliver tailored gastric stimulation in response to consumption and provide behavioral feedback from onboard
sensors. Objectives: This randomized multicenter controlled study,
conducted in nine European centers, compared 12 months efficacy and
safety of gastric band to GES for treatment of obesity. Methods: 150
obese subjects (35≥ BMI ≤ 55kg/m2) were randomized 1:2 to either
GES or GB (any available commercial system). Both systems were
laparoscopically implanted and the subjects were then seen regularly
for weight measurement, diet counseling, and in the case of the GES
group, download and review of sensor data, and stimulation regimen
adaptation if required. Results: At 12 months, the percent weight
loss (%WL) and percent excess weight loss (%EWL) were not significantly different between the two groups (GES vs GB): mean%WL
13.7±7.4 vs 16.2±8.4 (p=0.06), and mean%EWL was 35.3±19.6 vs
39.4±22.9 (p=0.2). The%EWL delta of 4.1% was less than the 10%
margin considered to be a clinically relevant difference. The incidence
of device/procedure related adverse events was significantly greater
in the GB vs GES group (2.0 vs 0.5 per patient/year, p <0.001), with
no difference in incidence of serious adverse events between groups
(0.09 vs 0.05 per patient/year, p=0.37). Conclusion: In this randomized, controlled study, GES therapy proved to be a safe and effective
treatment leading to a clinically equivalent weight loss to GB, with a
superior safety outcome.
“Endoscopic procedures”
Jacques Devieres (Belgium) outlined the variety of medical devices
and procedures that have been evaluated in recent years; the current
perspective looks less promising than last year, some devices stalling,
hence the title of the presentation: Endoluminal bariatric treatments:
from sunset to sundown? With the exception of the intragastric balloon, the numbers of patients treated limits the evaluation of these
procedures. A significant number of projects have been aborted these
last few years: TOGA, ACE, Hourglass and TERIS. IRB approvals
and the necessity of tight registries have slowed down the pipeline.
Endotherapy is likely best suited for non-morbid obese individuals
with BMI ranging from 30 to 39 or as a bridge to bariatric surgery.
This specific BMI range has been targeted by the National Institutes
of Health for these emerging technologies. Pre-surgical weight loss
to reduce surgical risk is another potential target group for such
procedures. On the other hand, there is a rising role for endoscopy
in the diagnosis and management of complications after bariatric
surgery as bleeding, ulcers, foreign bodies, stenosis, leaks, fistulas,
bilio-pancreatic diseases, weight regain, and dilated outlets. The possibility of endoscopic gastrojejunal anastomosis with a magnet or a stent
Evzen Machytka
Jan Greve
could be promising as well. Likewise, alternative options are being
developed, like endoscopic instruments available with triangulation
(DDES, Anubis, Endomina, Endosamourai), and a Master and Slave
transluminal robot.
Henrik Forssell (Sweden) presented the preliminary results of a
study of a novel endoscopic bariatric device, the Aspire Assist. A new
device for treating obesity has been evaluated, the AspireAssist Aspiration Therapy System, which consists of an endoscopically-placed
gastrostomy tube PEG (A-Tube) and siphon assembly. The food is
conveniently stored and then flushed. With the AspireAssist, patients
aspirate gastric contents 20 min after meal consumption, removing
about 30% of ingested calories. Twenty-five obese subjects (mean
BMI of 39.9kg/m2 [range 35.1–49.0], median age of 48 years [range
33–65]) were enrolled in a prospective and ongoing study, starting
July 2012, at Blekinge County Hospital in Sweden. Six subjects had
diabetes. The AspireAssist A-tube was placed during a gastroscopy
performed under conscious sedation with midazolam and cetobemidone. Approximately 14 days after A-tube placement, allowing
the fistula to heal, a low-profile valve (the AspireAssist Skin-Port)
was installed. Aspiration Therapy, along with a cognitive behavioral
weight loss program, was initiated at this time. Results: Weight reduction: 16 weeks after inclusion in the study mean weight reduction
was 12.4 (range 3.8-21.9)kg, 32.2% (range 13.0%-58.7%) excess
weight loss, and 11.4% (range 4.4%-18.1%) absolute weight loss.
Short-term results have shown two re-hospitalizations (pain, small
leakage of air), there were two would infections, and one skin break
around the PEG. One case of infection at six months, and 12 cases of
skin irritation around the stoma. EWL one-year has been 60%. This
method for weight reduction is a less invasive procedure and does not
alter gastrointestinal tract anatomy, making it an alternative for obese
patients who are reluctant to get bariatric surgery. Additional remarks
were made by Evzen Machytka (Ostrava, Czech Republic), who has
introduced the promising European super-obese study (BMI>55),
involving three centers, and including 30 patients in the first center
(Czech Republic), with seven cases performed to date, average BMI:
63.4 (range 59.5–71.9). There was no problem with the implantations.
It seems that higher BMI-patients could benefit the most from this
procedure according to social standards. One can view it as a pos-
Alfredo Genco
sible gold standard in the future for super-obese subjects, either as a
definitive therapy or as a bridge to surgery. It is a safe and effective
long-term obesity treatment, in super-obese patients as well.
Jan Greve (Maastricht, the Netherlands) reviewed metabolic surgery in the light of endoscopic techniques, particularly the endoscopic
duodenal-jejunal bypass liner, that rapidly improves type 2 diabetes.
The current anchor is meant to last one year. In a non randomized
study, single center, 22 patients, HBA1c dropped from 8.8% to 6.5%
at 52 months and 6.6% at 72 months. Bariatric procedures excluding
the proximal small intestine improve glycemic control in type 2 diabetes within days. To gain insight into the mediators involved, factors
regulating glucose homeostasis in patients with type 2 diabetes treated
with the novel endoscopic duodenal-jejunal bypass liner (DJBL)
have been investigated. Seventeen obese patients (BMI 30–50) with
type 2 diabetes received the DJBL for 24 weeks. Body weight and
type 2 diabetes parameters, including HbA1c and plasma levels of
glucose, insulin, glucagon-like peptide-1 (GLP-1), glucose-dependent
insulinotropic polypeptide (GIP), and glucagon, were analyzed after a
standard meal before, during, and one week after DJBL treatment. At
24 weeks after implantation, patients had lost 12.7±1.3kg (p<0.01),
while HbA1c had improved from 8.4±0.2 to 7.0±0.2% (p<0.01). Both
fasting glucose levels and the postprandial glucose response were
decreased at one week after implantation and remained decreased at
24 weeks (baseline vs. week one vs. week 24: 11.6±0.5 vs. 9.0±0.5
vs. 8.6±0.5mmol/L and 1,999±85 vs. 1,536±51 vs. 1,538±72mmol/L/
min, both p<0.01). In parallel, the glucagon response decreased
(23,762±4,732 vs. 15,989±3,193 vs. 13,1207±1,946 pg/mL/min,
p<0.05) and the GLP-1 response increased (4,440±249 vs. 6,407±480
vs. 6,008±429 pmol/L/min, p<0.01). The GIP response was decreased
at week 24 (baseline-115,272±10,971 vs. week 24-88,499±10,971 pg/
mL/min, p<0.05). Insulin levels did not change significantly. Glycemic control was still improved after explantation. The data indicate
DJBL to be a promising treatment for obesity and type 2 diabetes,
causing rapid improvement of glycemic control paralleled by changes
in gut hormones.
Gontrand Lopez-Nava (Madrid, Spain) reported on the current
experience with the per-oral Incisionless Operating Platform™
Continued on page 18
18 BARIATRIC NEWS IV noninva
International
Symposium
report
Continued from page 17
(IOP) (USGI Medical) in Spain. It places transmural plications in
the gastric fundus and distal body using specialized suture anchors
(the Primary Obesity Surgery Endoluminal [POSE] procedure). A
prospective observational study was undertaken with institutional
Ethics Board approval in a private hospital in Barcelona. Patients were
WHO obesity class I-II, or III if refusing a surgical approach. Between
February 2011 and March 2012, the POSE procedure was successfully
performed in 45 patients: 75.6% female; mean age 43.4±9.2 SD (range
21.0-64.0). At baseline: mean absolute weight (AW,kg), 100.8±12.9
(75.5-132.5); body mass index (BMI, 36.7±3.8 (28.1-46.6). A mean
8.2 suture-anchor plications were placed in the fundus, 3.0 along
the distal body wall. Mean operative time, 69.2±26.6 min (32.0126.0); patients were discharged in <24 h. Six-month mean AW was
87.0±10.3 (68.0-111.5); BMI decreased 5.8 to 31.3±3.3 (25.1-38.6)
(p<0.001); EWL was 49.4%; TBWL, 15.5%. No mortality or operative morbidity was observed. Minor postoperative side effects were
resolved with treatment by discharge. Patients reported less hunger
and earlier satiety post procedure. Liquid intake began 12 hours post
procedure with full solids by six weeks. At six-month follow-up of a
prospective case series, the POSE procedure appeared to provide safe
and effective weight loss without the scarring, pain, and recovery issues of open and laparoscopic bariatric surgery. Long-term follow-up
and further study are required. A US pivotal trial should start soon,
involving 11 sites and 380 patients.
Lopez-Nava also presented the results of the DUO-balloon (Duoshape, US). It is a CE approved device, with pending FDA authorization. This 900cc dual balloon has a shape that ensures better tolerability and safety (migration and obstruction). A US pilot trial has been
conducted on 30 patients, then a US pivotal trial (326 patients), and a
trial in Madrid (60 patients). The pilot trial has involved 21 treated patients and nine control patients, EWL was 32% at removal. The pivotal
trial has been randomized, with a sham group, and met study efficacy
according to the FDA requirements (2013). In the Madrid experience,
there were one deflation (1.6%), 11 gastric erosions (8.3%), threemg
early explants (one for gastric perforation, two for vomiting).
Evzen Machykta (Ostrava, Czech Republic) report from a study on
weight maintenance two years after extraction of the SPATZ adjustable balloon, in association with G Lopez Nava and L Bene. The Spatz
Adjustable Balloon System was developed to provide an adjustable
intragastric balloon approved for one-year implantation. Weight loss
results of more than 20kg/year have been reported in the literature.
The question is whether a treatment with this gastric balloon also leads
to better weight loss maintenance after balloon removal. A prospective
study on the BIB balloon has reported maintenance of > 10% weight
loss in 25% of patients for up to 2.5 years after BIB balloon removal.
Generation 1 of this balloon had 4.8% complications. The Spatz 3 is
implanted without guide-wire, it has an easy-grasp and an easy-extract
system. 187 patients in seven centers had 48.1% EWL at 12 months,
4.9 at 9, 35.2 at 6. The initial volume is 500 cc, there have been 11
down adjustments (100cc) and 38 upward adjustments (327 cc, range
150-500). 76% maintained the WL >10% versus 25% with BIB. 79
patients from three centers who were implanted with the Spatz Adjustable Balloon for one year were contacted and asked to provide their
weight one year and two years post balloon extraction. Net weight
changes were recorded, and percentage weight loss was calculated
based on weight prior to balloon implantation. Net weight loss > 10%
was considered successful weight maintenance. Conclusions: The
maintenance of > 10% weight loss at one year and two years after
Spatz Adjustable Balloon extraction has been retrospectively documented in 75.7% and 76.4% of patients, respectively. This study is
limited by its retrospective review and the small numbers in year two
and requires prospective review to confirm these findings. Nonetheless, it suggests a long-term benefit to longer implantation time and/or
adjustable balloon function and warrants further study.
Alfredo Genco (Rome, Italy) introduced a new strategy to treat
morbid obese patients refusing surgery, using long-term repeated
multiple Balloons. A prospective study has been conducted in 100
patients, with diet or a second balloon after the first one had been
removed, when and if the patient had achieved more than 50% EWL.
The follow-up was 76 months. 83% of the patients had a second
balloon, and 22% a third one, one patient had four. 22.2% requested
surgery afterwards (between 12 and 72 months). BMI dropped from
43.7 to 37.6. To be published in SOARD 2014.
Genco also presented the initial results of the swallowable balloon.
This new device, made by the US company Obalon, seems interesting since it is intended to avoid endoscopy and anaesthesia during
its placement (not during removal). Early results are promising in
terms of morbidity and weight-loss. 3,000 patients have been treated
worldwide. A CE mark was obtained in 2012. There have been two US
ISSUE 21 | AUGUST 2014
feasibility studies: one with a single arm, one with a randomized control design. The second generation balloon has been released in 2012.
A navigation system is considered in the near future, that could allow
following the balloon till the gastric lumen, thus avoiding X-Ray.
Genco summarized the best practice according to the current clinical
experience: patients with BMI>27 should be considered. The absence
of preoperative endoscopy is acceptable for young patients. HP is
neither treated nor detected before implant; PPI is routinely given after
implant, 40mg omeprazole for one month, then 20mg for the remaining two months except if heartburn. Large hiatal hernia (>5cm) is a
contra-indication. In March 2013, 103 patients have been treated, BMI
37.3 +/- 7.3. Endoscopy was performed in 6% of the cases. Nausea at
day 1: 5% vs 68% with the BIB, vomiting 0% vs 51%, epigastric pain
20% vs 65%, regurgitations 13% vs 75%. BMI-Loss has been 4 U
(from 37.7 to 33.7), and EWL 29.4%. He suggested a “Four quarters
management”, i.e. three months-sequences with Obalon x 2 followed
by diet (improvement of satiety with fibers). The second (or third)
balloon should not be placed after a three-week interval. The alteration
of the pressure-receptors in the gastric wall lasts two months, the delay
of gastric emptying lasts for all the period. The margin of tolerance
for removal is four months at most, but before that the balloon may
appear slightly deflated because the nitrogen “shrinks” owing to the
temperature inside the stomach. Finally, the treatment suggestion is:
one balloon in overweight patients, two in obesity class I-II, three in
obesity class III.
Machytka also described the First human experience with the
Elipse™: A novel, swallowed, self-emptying, and excreted intragastric balloon for weight loss (Allurion Technologies Inc., USA).
Background: The intragastric balloon (IGB) has been used effectively
for decades as a weight loss device. Current generation IGBs require
endoscopy for placement and removal and have not been designed to
safely transit the gastrointestinal (GI) tract. The need for endoscopy
and the risk of spontaneous balloon deflation
a n d
small bowel obstruction have limited
the use of IGB therapy. The aim
of this pilot study was to assess
the feasibility and safety of the
Elipse™ (Allurion Technologies, USA), a swallowed,
self-emptying, and excreted
IGB. Methods: Eight
patients (seven female and
one male) were enrolled
after Ethics Committee and
Competent Authority approvals were obtained. Each
patient swallowed one Elipse
device which was filled with
450mL bacteriostatic water through
a delivery catheter. The catheter was then
removed. Each device was designed to remain in the
stomach for six weeks, empty, and pass in the stool. The
patients were not prescribed a specific diet or exercise plan
and were not pre-medicated with anti-emetics. Mean baseline
patient characteristics were BMI 31.0 (27.1-35.5), total body weight
88.4kg (range: 75.0-113.0), and excess weight 28.7kg (18.6-47.3).
Results: All eight patients successfully swallowed the Elipse capsule.
All devices were successfully filled to 450 cc (mean fill time = 15
minutes), and intragastric positioning was confirmed on ultrasound
and x-ray. As expected with balloon therapy, seven out of eight patients experienced self-limiting nausea and vomiting over the first 48
hours. There were no other adverse events. Six week post-treatment
day data demonstrate a mean total body weight loss of 3.0kg (1.2-6.8)
and mean% excess weight loss of 13% (5%-33%). In one patient, the
balloon appeared partially collapsed on ultrasound after 11 days of
therapy. The balloon was endoscopically punctured and passed in the
stool after four days. One asymptomatic patient elected to have the
balloon endoscopically punctured after 19 days of therapy, because
she “no longer enjoyed eating.” The balloon passed in the stool after
four days. In both cases, careful endoscopic examination of the upper
GI tract showed no abnormalities. In the remaining six patients, the
balloon emptied and passed in the stool without endoscopic intervention after having remained in the stomach for six weeks.
Conclusion
This pilot study demonstrates the feasibility and safety of the Elipse,
a swallowed, self-emptying, and excreted IGB. The ease of administration and natural passage of the Elipse may improve the safety,
customizability, and accessibility of IGB weight loss therapy. Future
studies will assess larger and longer term Elipse™ devices and will
be designed to assess weight loss in the presence of a prescribed diet.
François Mion (Lyon, France) outlined the problems that could
be related to the absence of endoscopy before the implantation of a
swallowable ballon. Typically, contra-indications to balloons are:
Anti-coagulant therapy, records of gastric surgery, active gastric ulcer,
severe esophagitis, and a large hiatal hernia. In the absence of digestive
symptoms, the review of the literature shows that the likelihood of unexpected pathologies is low. For Vakil et al. (Gastroenterology, 2009),
in case of dyspepsia without alarm symptoms in 1963 patients <51
years: Erosive esophagitis was seen in 13%, esophageal ulcer in 0.6%,
gastric ulcer in 1.4%, duodenal ulcer in 2.5%, malignant lesions in
0.1%; in 770 patients aged 51-70 years, erosive esophagitis was present in 19%, esophageal ulcer in 1.0%, gastric ulcer in 4.5%, duodenal
ulcer in 3.3%, malignant lesions in 0.5%. The rate of complications
with balloons in general is 2.8% (Genco et al., 2005, among 2,515
patients): gastric perforation 0.2% (two deaths), gastric ulcer 0.2%,
esophagitis 1.3%, occlusion 1.1%. Regarding the swallowable balloon, complications might depend on: the smoothness of the surface,
the balloon volume and weight (water/air), the number of balloons
and their duration of stay. Regarding endoscopy, Good Practice Recommendations exist currently in France for pre-operative evaluation
before bariatric surgery, in order to detect GERD complications and
H. Pylori (HP), especially before gastric bypass. The maximal security
level consists in performing an upper GI endoscopy + biopsies (especially if digestive symptoms are present), and in treating HP before, if
present. The intermediate level of security applies to patients without
digestive signs: look for HP (serology, UBT), and treat. The minimal
security level concerns young patients, without digestive signs, and
when balloon duration is considered for less than three months: no
test before, PPIs while the balloons are in the stomach, no NSAIDs
or aspirin use.
Jerome Dargent (Lyon, France) presented the final results of the
OBENDO study regarding Hyaluronic Acid injection at the GE junction, verus or in combination with Intragastric Balloon. An update on
the research with a sub-GE junction injection of hyaluronic acid (HA)
for four years shows good results when the injection is made a few
months before balloon implantation. The trial has been a prospective,
single blind, randomized and controlled study, comparing the effects of
HA injection, balloon, and the combination of both in a sequential mode
(98 patients included from 2010 to 2012). It has involved three groups
of patients: group one (balloon alone), group 2 (balloon followed by
injection at the time of removal, i.e. six months), group 3 (injection,
and balloon placement at six months). There were five patients lost for
follow-up at two years. Results at six-months in terms of EWL% showed
a difference between group 1 and 2 (21.3% and 34.8% respectively)
versus a less favorable in group 3 (17.3%).
On the other hand, EWL% at 12, 18 and
24 months (table 4-6): were 18.5%,
9.9% and 9.7% for group 1; 26%,
20.8% and 31.1% for group
2; 32.2%, 31.1% and 37.5%
for group 3. The difference
between group 3 and groups
1-2 at two years is favorably significant (p<0.001).
If one takes into account
the delay between groups
in terms of weight-loss and
weight-regain, results at 12
months of groups 1-2 should
also be compared to the 18
months results of group 3 (i.e. six
months after balloon explantation):
15.3% versus 27,5% EWL respectively.
This treatment represents a promising lead, and
requires further study.
Marc Barthet (Marseille, France) described the Gastrojejunal anastomosis with a lumen-apposing stent. It is a first step towards a fullendoscopic gastrojejunal bypass. GJA with a lumen-apposing stent is
feasible and reproducible, using a pure NOTES approach and standard
endoscopic equipment. The procedure is simple, efficient, with an
acceptable operative time, and results in a reliable anastomosis. A
significant weight loss has been observed in animals; a sole human
non bariatric-case has been performed in Marseille for pancreatic obstruction. Difficulties regarding intraperitoneal navigation and spatial
orientation should be resolved. There was no problem for retrieval of
the prosthesis, although a tendency to stenosis was observed, requiring
dilation and restenting of the anastomosis for a three month period. An
ongoing protocol is evaluating the metabolic impact, determining the
length of the jejunal loop bypass, and exploring ways to decrease the
fibrosis around the anastomosis. This technique should be preferred in
the future implementation of the procedure in humans for obesity treatment. Among other digestive procedures, it represents an endoscopic
alternative to biliary and pancreatic bypass; in benign or malignant
antro-pyloro-duodenal obstructions, it is a simple option; in bariatric
surgery, it is a genuine endoscopic bypass. The main objective in bariatric surgery would be the evaluation of the safety and efficiency of
GJA associated with pyloric closure. The secondary objective would
be the confirmation of the feasibility of GJA by exclusive NOTES,
using a Brace Bar suturing device.
Adjacent fields
Georgia Long (Canada) presented The Metabolic Applied Research
Strategy (MARS) initiative, sponsored by Ethicon. New therapies are
likely to harness the “magic” of bariatric surgery. The MARS initiative
dates back to 2007 and aims at understanding the obesity epidemic.
Live courses and online courses (MOOC) have been set, with a six
weeks program on an educational platform. A global advisory board
has been established, in order to answer the following questions:
How does bariatric surgery work? How can we devise less invasive
ways to achieve similar results? Why is surgery effective on diabetes?
Five myths have been addressed: “Weight can be reliably controlled
by voluntarily adjusting energy balance through diet and exercise”;
“Bariatric surgery induces weight-loss primarily by mechanical
restriction and nutrient malabsorption”; “Vertical sleeve gastrectomy
is not a metabolic procedure”; “Diabetes improvement after bariatric
bariatricnews.net 19
ISSUE 21 | AUGUST 2014
surgery is dependent on weight-loss”; “Patient behavior is the primary
determinant of outcomes after bariatric surgery”.
Antonio Iannelli (Nice, France) reviewed preoperative weight-loss
and preparation to bariatric surgery with amino-acids and omega-3
lipids. NASH (non-alcoholic steato-hepatitis) is characterized by
steatosis, inflammation, cell ballooning, + /- fibrosis, and leads to
cirrhosis. A prospective study has been conducted in a preoperative
cohort in Nice, enrolling 815 patients who had a wedge biopsy during
bariatric surgery: 80.5% had steatosis and 19.5% had NASH. The
adjunction of poly-unsaturated acids and Omega 3 has contributed
to reduce inflammation and liver fat content. A randomized trial has
been recently implemented, with sequential liver biopsies. Four weeks
of prior supplementation before surgery are scheduled. A prospective
survey had also been conducted in Montpellier and reported in 2013.
It involved 25 patients who were treated for six weeks before bariatric surgery, in order to reduce liver steatosis. They had a diet and 2
doses of BARIAMED Phase 1® daily. Steatosis decreased by 13.06%,
liver volume by 4.69%, and waist circumference by 4.4cm. Moreover,
obese patients may have deficiencies in amino- acids (tryptophane,
leucine), vitamins (B6, B9, D), minerals (magnesium, calcium, zinc)
or poly-unsatured fatty acids (omega 3).
Radwan Kassir and Jean-Pierre Barthelemy (Saint-Etienne, France)
presented an original protocol of Vagal transcutaneous stimulation in
obesity treatment. It has been observed that some of the comorbidities
associated with obesity are related to the autonomous nervous system,
e.g. elevated blood pressure or depression. Vagal neurostimulation
may act upon these diseases. In small samples of patients, vagal stimulation that had been performed in cases of depression and epilepsy had
also a positive effect on weight-loss. The main goal is to compare in a
double-blind randomized prospective study the effect of non invasive
(transcutaneous) vagal neurostimulation on weight-loss in morbid
obese patients (BMI > 40), who are candidates for a bariatric surgery,
from one to two years post-implantation. This minimally invasive
approach is possible through the vagal branches that permeate in the
subcutaneous external part of the ear (concha). This has been shown
effective in epilepsy treatment. An electrode will be placed in the
external left ear and activated by the patient himself four to five hours
a day with intervals of one hour at least, with no feeling of electricity
intensity (1.0mA, frequency 25 Hz). In the control group, the stimulator will not be activated. Sixty male subjects will be enrolled. The
secondary objectives will be the follow-up of related comorbidities
and bio-markers (such as digestive hormones), and the assessment of
autonomous nervous system according to the weight-loss.
Yves Schutz, from the Department of Medicine/Integrative
Physiology, Fribourg University, Switzerland, presented The effect
of diffuse ultrasound combined to muscular work, performed on a
vibration platform, on body composition in moderately obese women.
The objectives were to study the effects of diffuse ultrasound application in the abdominal area combined to muscular work on a vibrating
platform in obese patients. This dual method aimed at accelerating the
mobilization of adipose tissue. Methods: 40 sedentary obese women,
age 18 to 55, BMI >30 and <40, were randomized into three groups: a
control group (n=13), a vibration group (VIB, n=16), and a vibration
+ ultrasonic group in combination (VIB+US, n=11). Results: The
VIB+US group has significantly diminished waist circumference (by
8%), and increased total body fat mobilisation (by 7%) in six weeks.
In the VIB group, similar results were obtained (7% and 5% reduction
respectively) in 12 weeks. Conclusion: This study indicates the efficacy of a dual treatment combining muscular work on the vibrating
platform and diffuse ultrasounds, on mobilization of total body fat,
in particular in the abdominal subcutaneous area, which is generally
refractory to mobilization. These results could justify, for carefully
selected patients, the use of this method in the treatment of the android
(abdominal) obesity. These preliminary results would require further
validation by independent laboratories in a larger group of obese
patients, with a study of longer duration in different phenotypes of
obese patients, with biochemical, cellular and molecular approaches,
in order to understand the underlying mechanisms
Louis Casteilla (Toulouse, INSERM, France) detailed the recruitment and activation of brown and/or BRITE adipocytes, and their
potential therapeutic effects against metabolic diseases. In mammals,
typically two types of adipose tissues are described: the white and the
brown adipose tissue (WAT and BAT). Whereas WAT represents the
main energy storage in the organism, BAT dissipates energy as heat
through the expression of the uncoupling protein UCP1 (uncoupling
protein-1). BAT plays a central role in non shivering thermogenesis.
Its regulation takes place through free fatty acids, and the sympathetic
nervous system; it plays an anti-obesity and anti-diabetic part. The
plasticity of adipose tissue is demonstrated in mammals, through
post-natal development, denervation, cold exposure, Beta 3 agonists,
pheochromocytoma… Whereas BAT was thought mainly the result
of fetal life and birth, one considers now that classical adipose tissue
is not derived from cell lineage, but from skeletal muscles. Another
type of brown adipose cells is related to white cells. Beige cells are a
distinct type of thermogenic fat cells in mouse and humans. Are beige
cells metabolically active and involved in the energy balance? BAT is
present in 2–9% of humans with a great disparity, and it increases or
appears after bariatric surgery. Moderate exercise is also an inducer
of BAT.
While both white and brown adipocytes have been considered for a
long time as two very close cellular types sharing a common precursor,
recent data challenge these conclusions and propose the existence of
a new possible type of adipocyte, the BRITE (brown-in-white) adipocyte. In parallel, the recent discovery of significant amounts of BAT in
human adults has renewed the interest of the scientific community for
this tissue. Given its considerable capacity to dissipate substrates, BAT
appears again as a therapeutic target against metabolic diseases such as
diabetes and obesity. The treatment perspectives consist in pharmacology, Cell therapy, i.e. recruiting cells in muscles and WAT (on fat and
muscle samples), in order to reimplant them.
Rémy Burcelin (Toulouse, INSERM, France) explained the Intestinal microbiota and novel therapeutic perspectives for the treatment of
metabolic diseases. A new organ has emerged over the course of the
last century: the intestinal microbiota. It is characterized by numerous
functions provided by several billions of bacteria inhabiting and living
in harmony in the lumen and in the mucosal layer of the intestinal epithelium. More than four million genes composed by more than 1,500
species interact with each other, with the host and the environment, to
set up a mutualistic ecological group. A nutritional stress will modify
the terms of the symbiosis between the host and the microbiota for the
control of energy homeostasis. One considers now that the pandemic
of diabetes and obesity, not being due to the sole variations of our
genome, could be attributed to changes in our metagenome, i.e. our
intestinal bacteria. This organ which genomic varies on a day-to-day
basis is inherited from our mother and the closed environment at birth.
The corresponding diversity, the rapid evolution of gene expression,
its influence on metabolism, as well as the very recent discovery of
the existence of a tissue microbiota within the host, open new therapeutic pharmacological and nutritional opportunities as well as the
identification of very accurate biomarkers constituting a personalized
metagenomic identity card. There is a link between microbiota and
the inflammatory status of the adipose tissue. Intravenous metafactors
induce macrophage inflammation, changes in the size and distribution
of the adipocytes. Translocation of microbiota from the gut to other
tissues could modify their function (molecular crosstalk, regulation of
gene expression).
8th Frankfurter Meeting 2014: “Laparoscopic Surgery in
Obesity and Metabolic Disorders”
T
he Frankfurter Meeting takes place
every second year and since 1999
has become one of the most famous
international meetings in the field of bariatric
surgery. Organized by the president elect of
IFSO, Prof Rudolf Weiner, and his daughter
and surgeon Sylvia Weiner, MD, the meeting
will again take place in a historic atmosphere
in the very city center of Frankfurt am Main,
Germany.
This year, the historical Palais of the
worldwide known Frankfurt Zoo has been
chosen as the venue. During the two-day
meeting there will be a number of sessions
held in the main congress area especially
regarding new developing fields, but also
standards and complication management in
bariatric surgery. Additionally there will be
live-surgeries performed on both days, transmitted from Prof
Rudolf Weiner´s hospital: Krankenhaus Sachsenhausen. International Experts from Central Europe, as well as from the US will
perform different procedures and discuss them with the audience.
As far as the Frankfurter Meeting is an officially IFSOendorsed congress and the official annual meeting congress of the
German Society for Bariatric Surgery, there will be political meet-
ings within the congress and a press
conference of the expert group on
metabolic surgery. Moreover, the
congress will again offer the possibility for a bariatric skills course
for young surgeons to train their
abilities within the Vet Training
Course.
The main program will be
proceed In the official congress
language in English, Prof. Weiner
and his daughter will offer extra
course to the German members of
their society in German especially
regarding national requirements,
insurance problems and the set-up
of certified centers.
Despite the high level scientific value of the meeting, the Frankfurter Meeting
will again be a place for hospitality, friendship, exchange and meeting the experts. In 2012 the last eight
IFSO presidents were present and active within this
meeting. The Frankfurter Meeting is well-known as
very intimate meeting with high-quality catering in a
lovely atmosphere.
Dear colleagues,
My father and I have been performing a
very special
meeting in Frankfurt for 15 years already
and we are
very proud to have established one of the
main meetings
in the world, which are able to take plac
e only every
second year. Our aim is to offer a high-qu
ality meeting for
a comparatively cheap price to all surgeon
s in Europe,
but also colleagues from all over the Wo
rld. We do want
to give a chance to really meet the exp
erts and not only
to listen to them, to present cases and
complications to
discuss them in an intimate atmosphere
.
Therefore we will again restrict the max
imum number
of participants to 500 people – we do not
want to exceed
this size, because we do not want our
meeting to lose its
character, for which it is well-known.
We would like to welcome especially the
young
surgeons to our meeting, so we will offe
r an extra session
for the young surgeons to gain the cha
nce presenting
their papers.
The website www.frankfurter-meeting.d
e is already
open and we are looking forward to rece
ive your abstracts
for the session “Highway to Hell” and the
“Young IFSO
session”.
Looking forward to meeting you in Fran
kfurt
Kind regards
Sylvia Weiner
20 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Sleeve betters medical care for diabetes control
76% of surgery patients were
able to reduce their use of
diabetes medications, compared
with only 26% of patients in the
nonsurgical group
A
dults with T2DM achieve better
blood glucose (control two years after
undergoing laparoscopic sleeve gastrectomy than do patients who receive standard
medical diabetes care without surgery, according to the results of a study presented at
the joint meeting of the International Society
of Endocrinology and the Endocrine Society:
ICE/ENDO 2014 in Chicago.
“Individuals with obesity now have another treatment option that can help reduce
weight and manage diabetes,” said the study’s
principal investigator, Dr Pietra Greenberg,
an endocrinologist at James J Peters Veterans
Affairs (VA) Medical Center in Bronx, NY.
“This research highlights the benefits of a
surgical approach such as sleeve gastrectomy
to help improve diabetes outcomes, especially
compared to more conservative medical management.”
Greenberg and fellow researchers compared
the medical records from 2010 to 2014 of 53
veterans with type 2 diabetes: 30 patients who
underwent sleeve gastrectomy and 23 who
received medical diabetes care but did not
receive any weight loss surgery (controls).
Study participants, 96% who were men, ranged
in age from 29 to 80 years (mean 57), and had
diabetes for an average of ten years.
Nonsurgical control subjects did not lose
weight on average over a two-year follow-up
period and therefore had no change in average
BMI. In the sleeve gastrectomy group, BMI
decreased from 41 to 34 two years after surgery
(p<0.001).
Haemoglobin A1c also was significantly
different between the two groups. It fell from
an average of 7.25 percent before sleeve
gastrectomy, but after lifestyle changes, such
as diet and exercise, to 5.98 percent (p<0.001).
Among controls, the average haemoglobin A1C
at two years was not significantly changed.
Seventy-six percent of the sleeve gastrectomy patients took fewer diabetes medications,
post-surgery. However, the improvement in
diabetes measures in the surgical group reached
a plateau at the end of two years.
“Surgery may not be a permanent solution to
improving diabetes control,” said Greenberg.
However, the procedure does have immediate
benefits that appear to set the patient on a path
to a healthier future.”
Laparoscopic sleeve
gastrectomy
Surgery reduces adverse
effects of obesity on QoL
Bone loss persists two
years after weight loss
Obese patients with T2DM who a
gastric bypass reduces their risk of
heart disease
Bone loss occurred
despite patients losing
no more weight and
reporting stable blood
levels of calcium and
vitamin D
G
astric bypass surgery improves obese
diabetic patients’ physical and mental
health, more than an intensive weight loss
programme involving lifestyle modifications over
two years, according to the results from a study
presented at the joint meeting of the International
Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.
“Patients with obesity and type 2 diabetes should
consider these long-term results when making
decisions about their weight loss treatment,” said
the study’s lead investigator, Dr Donald Simonson
from Brigham and Women’s Hospital, Boston.
The researchers evaluated the effects of weight
loss on 38 patients’ self-reported health status for
both physical and mental health, as well as the impact of their weight on their quality of life and on
problem areas in managing their type 2 diabetes.
Fifteen men and 23 women participated in
the Surgery or Lifestyle with Intensive Medical
Management in the Treatment of Type 2 Diabetes
(SLIMM-T2D) trial. Of the 38 patients, 19 were
randomly assigned to undergo gastric bypass
surgery at Brigham and Women’s Hospital, and
19 patients, to a medical diabetes and weight management programme, called Why WAIT (Weight
Achievement and Intensive Treatment), at the
Joslin Diabetes Center in Boston.
The programme consisted of exercise, diet
with meal replacements, 12 initial weekly group
sessions and nine additional months of individual
counselling. Follow-up evaluation ranged from 18
to 24 months.
Before treatment, patients reported high scores
on the questionnaire Impact of Weight on Quality
of Life, which included physical function, selfesteem, sex life, public distress and work. Up to
two years after treatment, patients who underwent
gastric bypass surgery had nearly twice the improvement (reduction) in the adverse effects of
weight on their quality of life, which Simonson
said strongly correlated with the greater amount of
weight they lost.
Two years after treatment, the surgical patients
lost an average of 64.4lbs vs. 11lbs in the Why
WAIT group.
At 18 to 24 months after treatment, patients
in the surgical group also reported a 60 percent
greater reduction in problems with managing their
diabetes, as found by an eight-point better score on
the Problem Areas in Diabetes scale than the medi-
cal group. Problems surveyed included emotional
distress, eating behaviours, and difficulty with
diabetes self-management.
Although the Why WAIT program improved
self-reported physical and mental health more than
gastric bypass did at three months, improvements
were generally similar in the two groups after one
and two years of follow-up and were in the moderate range.
Heart disease
The researchers also reported that obese patients
with T2DM who a gastric bypass reduces their risk
of heart disease.
When they compared the effectiveness for cardiometabolic outcomes of bariatric surgery vs. intensive
medical weight management at 12 months, there
was greater reduction in weight (-28±2 vs -7±2 kg;
RYGB vs IMWM, p<0.0001) and fat mass by bioelectrical impedance (-23±1 vs -6±2 kg, p<0.0001)
post-RYGB; and at 18-24 months, weight loss
(-29±2 vs -5±2 kg, p<0.0001) and loss of fat mass
(-23±2 vs -2±2 kg, p<0.0001) were sustained postRYGB. HbA1c reduction was greater post-RYGB
(-2.0±0.4 vs 0.0±0.4, p<0.001) at 12 months and
maintained at 18-24 months (-1.7±0.4 vs -0.2±0.3,
p<0.01). Reductions in systolic blood pressure (BP)
(-12±3 vs -1±3, p<0.05) and triglycerides (-47±9 vs
-5±9, P<0.001) and increase in HDL (10±2 vs 0±2,
p<0.001) were greater post-RYGB at 12 months.
At 18-24 months improvement in systolic
BP (-10±5 vs 7±3, P<0.01) and HDL (15±4 vs
2±2, P<0.05) were maintained, and reduction in
diastolic BP (-9±3 vs 1±2, P<0.05) emerged only
post-RYGB.
Changes in UKPDS cardiometabolic risk scores
from baseline of 10.3±8.2% for coronary heart
disease (-2.8±1.2 vs 0.3±1.0%, p<0.05), 6.7±6.4%
for fatal coronary heart disease (-2.1±1.0 vs
0.7±0.7%, p<0.05), 4.0±3.3% for stroke (0.23±0.25
vs 1.04±0.25%, p<0.05) and 0.54±0.49% for fatal
stroke (-0.04±0.06 vs 0.19±0.05%, p<0.01) were all
more favourable at 18-24 months following bypass.
“There is emerging evidence highlighting the
potential health benefits of bariatric surgery in
managing obese patients with type 2 diabetes,” said
Dr Su Ann Ding, a research fellow at Joslin. “In
the past, lifestyle advice and medications provided
the mainstay of treatment for this group of patients,
but despite the substantial improvements in pharmacotherapy for adults with type 2 diabetes, many
patients still do not achieve targeted health goals.
Roux-en-Y gastric bypass surgery is an acceptable
therapeutic option for risk reduction in heart disease
in obese patients with type 2 diabetes in whom
surgical risk is not excessive.”
P
atients continue to
lose bone, even after their
weight stabilises, at least
two years after a gastric bypass,
according to results presented at
the joint meeting of the International Society of Endocrinology
and the Endocrine Society: ICE/
ENDO 2014 in Chicago.
“The long-term consequences
of this substantial bone loss are
unclear, but it might put them
at increased risk of fracture, or
breaking a bone,” said Dr Elaine
Yu, the study’s principal investigator and an endocrinologist at
Massachusetts General Hospital,
Boston. “Therefore, bone health
may need to be monitored in
patients undergoing bariatric
surgery.”
Yu’s
team
previously
reported that patients who
have gastric bypass lose bone
mineral density, an indicator of
bone fragility, within the first
year after the surgery. As the
rate of bone loss was high, the
researchers continued to monitor
them in this study, funded by the
National Institutes of Health.
The
standard
imaging
method for bone mineral density,
dual-energy x-ray absorptiometry (DXA), can sometimes
give inaccurate results in obese
individuals. Therefore, the
researchers also measured bone
density using a method that is
often more accurate, quantitative
computed tomography (CT).
They compared bone density
at the lower spine and the hip
in 50 very obese adults: 30 who
had baratric surgery and 20 who
lost weight through nonsurgical
ways but were similar to surgical
patients in baseline age, sex and
body mass index. After surgery,
nearly all patients received
calcium and high-dose vitamin
D supplementation, Yu said.
Two years later, bone density
was 5 to 7 percent lower at the
spine and 7 to 10 percent lower
at the hip in the surgical group
compared with the nonsurgical
control group, as shown by both
DXA and quantitative CT.
In addition, the surgical
patients had substantial and
persistent increases in markers
of bone resorption, the process
of breaking down old bone that
may play a role in bone loss.
The bone loss in the surgical
patients occurred despite the
fact that they were not losing
any more weight in the second
year after surgery and had stable
blood levels of calcium and
vitamin D.
“Therefore, the cause of the
bone loss is probably not related
to weight loss itself,” she said.
“The question is, when is the
bone loss going to stop? Over
time this could be a problem in
terms of fracture.”
None of the gastric bypass
patients has required osteoporosis treatment.
The researchers plan to investigate possible causes of the bone
loss observed. Yu speculated that
major changes in gastrointestinal
and fat hormones, which occur
almost immediately after bariatric surgery, could affect bone.
Although obese adults tend
to have higher bone densities
than non-obese people, they
reportedly have similar rates of
fracture at the wrist and a higher
fracture rate at the lower leg.
Yu recommended that bariatric
surgery patients who have risk
factors for osteoporosis receive
bone density tests.
“This surgery is the most
effective treatment for severe
obesity and offers phenomenal
health benefits,” she concluded.
bariatricnews.net 21
ISSUE 21 | AUGUST 2014
RM-493 peptide increases REE in obese patients
RM-493 increased resting
energy expenditure vs.
placebo by 6.85%, on
average by 111 kcal/24h
R
M-493, a small peptide melanocortin 4 receptor (MC4R)
agonist, increases resting energy
expenditure (REE) in obese patients,
according to study presented at the joint
meeting of the International Society of
Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.
“This is the first human study to test
the hypothesis that an MC4R agonist
increases energy expenditure,” said Dr
Monica Skarulis, investigator at the National Institutes of Health (NIH). “The
drug’s effect was significant with shortterm treatment and has the potential to
be clinically meaningful for treating
obesity.”
There is compelling scientific evidence that when dieting causes weight
loss, the body tries to regain the weight
by decreasing energy expenditure. In effect, changes in metabolic rate can make
it difficult to maintain the weight loss.
Accordingly, approaches to the management of obesity that target decreasing
food intake along with increasing the
metabolic rate have the potential to
improve treatment.
RM-493 is in Phase 2 clinical development for the treatment of obesity,
including for obesity caused by genetic
deficiencies in the MC4 pathway. The
MC4 receptor mediates a key pathway
in humans that regulates energy homeostasis and food intake. The MC4
pathway is well validated in humans;
loss-of-function mutations of MC4R
are associated with obesity and have
a reported prevalence of 4%-6% in
severe obesity. In the population with a
genetic deficiency in the MC4 pathway,
RM-493 may restore MC4 function by
increasing activity in the one healthy
copy of MC4R.
A total of 12 obese, but otherwise
healthy individuals, were randomised
and completed both RM-493 and
placebo periods in this double-blind,
placebo-controlled, two-period crossover study to evaluate the effects of
RM-493 on resting energy expenditure.
The primary outcome measure was
resting energy expenditure measured
in a room calorimeter on the third day
of treatment with either RM-493 or
placebo.
RM-493 increased resting energy
expenditure vs. placebo by 6.85% (95%
CI: 0.68, 13.02%), on average by
111 kcal/24h (95% CI: 15, 207 kcal,
p=0.03). Resting energy expenditure
measured by hood method also tended
to increase with RM-493 treatment (4.72
± 8.14%, p=0.06). Twenty-four hour
energy expenditure tended to be higher
while the thermic effect of a test meal
and exercise energy expenditure did not
differ significantly.
The twenty-four hour respiratory quotient was lower during RM-493
treatment (0.833 ± 0.021 vs. 0.848 ±
0.022, p=0.02) and RM-493 treatment
was also associated with slightly higher
fasting plasma free fatty acid (0.445 ±
0.089 vs. 0.327 ± 0.071mEq/L, p=0.01),
glucose (94.9 ± 5.8 vs. 91.1 ± 3.6mg/dl,
p=0.002), and insulin (26 ± 16 vs. 19 ±
12mcU/mL, p=0.007).
“These changes were small, and their
clinical relevance needs to be established in larger trials,” said the researchers. “No adverse effects on heart rate or
blood pressure were observed and few
side effects occurred; all were mild and
resolved completely.”
“These study results are exciting
clinical support for the mechanisms
underlying RM-493’s efficacy for
weight loss that we have seen in
preclinical studies,” said Dr Keith
Gottesdiener, CEO of Rhythm, the
developer of RM-493. “It is well
known that the MC4 receptor modulates weight through a combination
of effects on food intake and energy
homeostasis. But this is the first time
that administration of an MC4 product
candidate has demonstrated a substantive effect on energy expenditure in
obese patients.”
The company is developing peptide
therapeutics that address unmet needs
in metabolic diseases and is developing
the ghrelin peptide agonist, relamorelin
(RM-131), for the treatment of diabetic
gastroparesis and other gastrointestinal
functional disorders; and the MC4R
peptide agonist, RM-493, for obesity
and diabetes.
Surgery and drugs preferred to diets and exercise
Extremely or very satisfied with
their weight loss method was 39.3
percent in the Surgery/Rx group
P
atients report greater overall satisfaction with bariatric surgery and prescription
weight loss medications compared with
diet, exercise and other self-modification methods,
an Internet survey has reported. The results were
presented at the joint meeting of the International
Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.
“This finding may mean that diet and exercise
alone just don’t work for a lot of people,” said Dr
Z Jason Wang, the study’s principal investigator
and director of Health Economics and Outcomes
Research at Eisai in Woodcliff Lake, NJ. “Drug
treatment and bariatric surgical procedures
should be considered an integral part of weight
management for eligible patients to achieve better treatment satisfaction, which may in turn help
patients achieve and maintain better long-term
weight loss.”
The study, sponsored by Eisai the manufacturer
of prescription weight loss medication, lorcaserin
(marketed as Belviq), is an analysis of data from
more than 39,000 respondents to the 2012 National
Health and Wellness Survey.
Wang and his co-worker, Sharoo Gupta from
Kantar Health in Princeton, NJ, analysed survey
responses from 22,927 obese adults (50 percent
women) and 19,121 overweight or obese adults
who had at least one weight-related health problem
(44 percent women).
They found that 58.4 percent of obese people
were not currently taking any steps to lose weight.
Wang said this finding suggests “a dire need to better educate the public about the health consequences
of obesity and the importance of addressing the
problem with their doctors.”
Among obese individuals who were trying to
lose weight, 2.3 percent reported that they underwent bariatric surgery or they were taking prescription weight loss medication. Together, these people
made up the ‘Surgery/Rx’ group.
The remaining 39.3 percent of obese respondents reported using a self-modification method,
which included diet, exercise, weight management
programs, and over-the-counter weight loss drugs
or supplements.
The percentage of obese respondents who
reported being extremely or very satisfied with
their weight loss method was 39.3 percent in the
Surgery/Rx group vs. only 20.2 percent in the
group that used self-modification methods (39.3%
vs. 20.2%, p<0.001). There was no difference in
treatment satisfaction between those using Rx and
those whom had a surgical procedure (p>0.05).
Similar results were found in overweight and
obese patients (BMI≥27) with ≥1 weight related
comorbidity (type 2 diabetes, hypertension, or dyslipidemia).
Satisfaction was higher for the Sur/Rx group vs.
the self-modification group with 44.4 percent of the
Surgery/Rx group being extremely or very satisfied
with their treatment compared with 19.7 percent of
participants who used self-modification (p<0.001).
Liraglutide improves risk factors for heart disease
Liraglutide 3mg produced improvements in a
wide range of cardiometabolic risk factors in
overweight or obese individuals
Drug was superior to placebo in reducing the
prevalence of prediabetes and T2DM after 56 weeks of
treatment
L
iraglutide, in combination with diet and exercise, led to
a significant reduction in weight and improved a number of
cardiovascular risk factors, including high blood pressure and
high cholesterol, according to the results from a multi-centre study
presented at the meeting.
“If these improvements continue over time, they may result in a
lower risk of heart disease,” said the study’s principal investigator, Dr
Carel Le Roux, Diabetes Complications Research Centre, University
College Dublin. “Current obesity treatment options are limited and
there is a need for new treatment options for people who struggle
with obesity and obesity-related diseases that can help in reducing
their weight.”
Liraglutide is currently undergoing testing at a 3mg dose for longterm weight management as part of the SCALE (Satiety and Clinical
Adiposity -- Liraglutide Evidence in Nondiabetic and Diabetic
Subjects) Obesity and Prediabetes trial, and is marketed as Victoza in
1.2mg and 1.8mg injectable doses for adults with type 2 diabetes to
help control blood glucose when used along with diet and exercise.
The drug does not have approval for weight loss.
The study, sponsor by the drug’s manufacturer Novo Nordisk,
included 3,731 non-diabetic obese adults and overweight adults who
had at least one other risk factor for diabetes and heart disease, such
as pre-diabetes, high blood pressure or high cholesterol. As part of the
study’s weight loss efforts, all subjects exercised and ate 500 fewer
calories per day than usual.
In addition, they were randomly assigned, in a 2 to 1 ratio, to a
once-daily injection with either 3mg of liraglutide (2,487 subjects)
or placebo (1,244 subjects) for 56 weeks. Neither the subjects nor the
investigators knew who received the active drug.
Of 3,731 randomised pateints (age 45.1 years, gender 78.5%
female, body weight 106.2 kg, BMI 38, glycaemic status 61.2% with
pre-diabetes), 71.9% with liraglutide 3mg and 64.4% with placebo
completed 56 weeks.
At week 56, more weight loss was observed with liraglutide
3mg (˗8.0%) (n=2,432) than with placebo (˗2.6%) (n=1,220) (5.4%,
p<0.0001) and nearly 1.7 more inches (4.2cm) around their waist than
did those who received placebo.
Fasting and post-load glycaemia was improved with liraglutide
3mg, as both FPG and glucose AUC were lower with liraglutide 3mg
than with placebo (p<0.0001). Post-load insulin and C-peptide were
also improved as AUCs were higher with liraglutide 3mg than with
placebo (p<0.0001). Improvements applied to individuals both with
and without pre-diabetes, but glucose-lowering was most prominent
in individuals with pre-diabetes (p<0.0001).
Improved post-load glucose with liraglutide 3mg, as compared
to placebo, was accompanied improved beta-cell function (35% vs.
11%) (p<0.0001,). Similar effects were seen in individuals both with
and without pre-diabetes.
The researchers said that liraglutide 3mg, as adjunct to diet and
exercise, led to weight loss and improvements in insulin secretion
and action, all of which likely explain the observed improvements in
fasting and post-load glycaemia in overweight and obese individuals
with and without pre-diabetes.
They said that liraglutide 3mg produced improvements in a
wide range of cardiometabolic risk factors, including inflammatory
markers, in overweight or obese individuals, which if sustained
in the long term may be associated with reduced cardiovascular
events. In addition, liraglutide 3.0mg was superior to placebo in
reducing the prevalence of prediabetes and T2DM after 56 weeks
of treatment.
The researchers also added that liraglutide 3mg has a safety profile
that is similar to that found in previous clinical trials of the drug in
individuals with Type 2 diabetes treated with lower doses.
22 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Pre-diabetes label has no medical value
There is no proven benefit
of giving diabetes treatment
drugs to people in this
category before they develop
diabetes
Healthy diet and physical
activity remain the best ways to
prevent and to tackle diabetes
L
abelling
people
with
moderately high blood sugar as
pre-diabetic is a drastically premature measure with no medical value
and huge financial and social costs, according to researchers from University
College London and the Mayo Clinic,
MN. The analysis, published in the
BMJ, assessed whether a diagnosis of
pre-diabetes carried any health benefits
such as improved diabetes prevention.
“Pre-diabetes is an artificial category
with virtually zero clinical relevance,”
said Professor John S Yudkin from UCL.
“There is no proven benefit of giving
diabetes treatment drugs to people in this
category before they develop diabetes,
particularly since many of them would
not go on to develop diabetes anyway.”
The authors report that treatments
to reduce blood sugar only delayed the
onset of type 2 diabetes by a few years,
and found no evidence of long-term
health benefits.
People with an A1c over 6.5% can
be diagnosed with diabetes but the latest
guidelines from the American Diabetes
Association (ADA) define anyone with
an A1c between 5.7% and 6.4% as having pre-diabetes.
If the ADA guidelines were adopted worldwide, a third of the UK adult
population and more than half of adults
in China would be diagnosed with prediabetes.
The latest study questions the logic of
putting a label on such huge sections of the
population, as it could create significant
burdens on healthcare systems without
conferring any health benefits. Previous
research has shown that type 2 diabetes
treatments can do more harm than good
for people with A1c levels around 6.5%,
let alone people below this level.
“The ADA recommends treating prediabetes with metformin, but the majority
of people would receive absolutely no
benefit,” said Yudkin. “There are significant financial, social and emotional
costs involved with labelling and treating
people in this way. And a range of newer
and more expensive drugs are being
explored as treatments for ‘pre-diabetes.’
The main beneficiaries of such recommendations would be the drug manufacturers, whose available market suddenly
leaps to include significant swathes of
the population. This is particularly true in
emerging economies such as China and
India, where regulating the healthcare
market is a significant challenge.”
Approximately 3.2 million people
in the UK are currently diagnosed with
type 2 diabetes, but approximately 16
million would fall into the ADA’s prediabetes category. People with impaired
glucose tolerance (IGT) that affects
around 3.7 million adults in the UK
(8%), are at high risk of diabetes but
the test is more time-consuming than a
simple A1c blood test.
There is evidence to suggest that interventions can delay the progression of
IGT into diabetes, but the ADA category
of pre-diabetes also includes another 12
million people who are at a much lower
risk of progressing to diabetes, for whom
any benefit from treatment is unknown.
“Sensibly, the WHO and NICE and
the International Diabetes Federation
do not recognise pre-diabetes at present
but I am concerned about the rising
influence of the term. It has been used
in many scientific papers across the
world, and has been applied to a third
of adults in the UK and half of those
in China,” he added. “We need to stop
looking at this as a clinical problem
with pharmaceutical solutions and
focus on improving public health. The
whole population would benefit from
a more healthy diet and more physical
activity, so it makes no sense to single
out so many people and tell them that
they have a disease.”
Previous studies have tested the effectiveness of giving people with IGT
a drug called metformin, which is used
to lower blood sugar in people with
diabetes. The drug reduced the risk of
developing diabetes by 31% over 2.8
years, probably by delaying its onset
rather than by completely halting its
development. But people who go on to
develop diabetes are often treated with
metformin anyway and there is no evidence of long-term benefits to starting
the treatment early.
“Healthy diet and physical activity
remain the best ways to prevent and to
tackle diabetes,” said co-author Victor
Montori, Professor of Medicine at the
Mayo Clinic. “Unlike drugs they are associated with incredibly positive effects
in other aspects of life. We need to keep
making efforts to increase the overall
health of the population, by measures
involving public policy rather than
by labelling large sub-sections of the
population as having an illness. This is a
not a problem to be solved at the bedside
or in the doctor’s surgery, but rather by
communities committed to the health of
their citizens.”
Obesity is now a global pandemic
50 percent of the world’s 671 million
obese people live in ten countries
62 percent of the world’s obese
individuals live in developing countries
Rates of overweight and obesity rose
from 29 percent to 37 percent among
men and from 30 percent to 38 percent
among women
O
besity is a major public health epidemic
in both developing and developed nations,
claim researchers at the Institute for Health
Metrics and Evaluation (IHME) at the University
of Washington, Seattle. They made the claim following the publication of a study, ‘Global, regional,
and national prevalence of overweight and obesity
in children and adults during 1980–2013: a systematic analysis for the Global Burden of Disease
Study 2013, in The Lancet that showed that in the
past three decades the number of overweight and
obese people worldwide has jumped from 857 million to 2.1 billion.
“Obesity is an issue affecting people of all ages
and incomes, everywhere,” said IHME Director,
Dr Christopher Murray. “In the last three decades,
not one country has achieved success in reducing
obesity rates, and we expect obesity to rise steadily
as incomes rise in low- and middle-income countries in particular, unless urgent steps are taken to
address this public health crisis.”
The study also found that more than 50 percent
of the world’s 671 million obese people live in
ten countries: the United States, China, Russia,
Brazil, Mexico, Egypt, Germany, Pakistan and
Indonesia. The US has the highest proportion of
the world’s obese people (13 percent), whilst 62
percent of the world’s obese individuals live in
developing countries.
The study was led by Professor Emmanuela
Gakidou from IHME and included a team of international researchers, who carried out a search
of the available data from surveys, reports, and
the scientific literature (n=1,769) to track trends
in the prevalence of overweight and obesity in
188 countries in all 21 regions of the world from
1980 to 2013.
Findings
Rates of overweight and obesity rose from 29
percent to 37 percent among men and from
30 percent to 38 percent among women.
Rates of overweight and obesity among
men were higher in developed nations,
while rates among women were higher in
developing nations.
Over the past three decades, the highest rises in obesity levels among women
have been in Egypt, Saudi Arabia, Oman,
Honduras and Bahrain, and among men in
New Zealand, Bahrain, Kuwait, Saudi Arabia,
and the USA.
Rates of overweight and obese children
worldwide rose by nearly 50 percent between
1980 and 2013. In 2013, more than 22 percent of girls and nearly 24 percent of boys in
developed nations were overweight or obese.
The rates in developing nations were nearly 13
percent for both boys and girls. The researchers
also found that peak obesity rates are occurring at
younger ages in developed nations.
“Unlike other major global health risks, such
as tobacco and childhood nutrition, obesity is
not decreasing worldwide,” said Gakidou. “Our
findings show that increases in the prevalence of
obesity have been substantial, widespread, and
have arisen over a short time. However, there
is some evidence of a plateau in adult obesity
rates that provides some hope that the epidemic
might have peaked in some developed countries
and that populations in other countries might
not reach the very high rates of more than 40%
reported in some developing countries.”
In adults, estimated prevalence of obesity
exceeded 50% in men in Tonga and in women in
Kuwait, Kiribati, Federated States of Micronesia,
Libya, Qatar, Tonga, and Samoa. Since 2006, the
increase in adult obesity in developed countries has
slowed down.
In high-income countries, some of the highest
increases in adult obesity prevalence have been in
the US (where roughly a third of the adult population are obese), Australia (where 28% of men and
30% of women are obese), and the UK (where
around a quarter of the adult population are obese).
“Our analysis suggests that the UN’s target to
stop the rise in obesity by 2025 is very ambitious
and is unlikely to be achieved without concerted
action and further research to assess the effect of
population-wide interventions, and how to effectively translate that knowledge into national
obesity control programmes,” added Gakidou.
“In particular, urgent global leadership is
needed to help low-and middle-income countries intervene to reduce excessive calorie
intake, physical inactivity, and active promotion of food consumption by industry.”
“To prevent unsustainable health
consequences, BMI needs to return to
what it was 30 years ago,” said Professor
Klim McPherson from Oxford University.
“Lobstein calculated that to reduce BMI
to 1980 levels in the UK would require an
8% reduction in consumption across the
country, costing the food industry roughly
£8.7 billion per year. The solution has to be
mainly political and the questions remain,
as with climate change, where is the international will to act decisively in a way that
might restrict economic growth in a competitive
world, for the public’s health? Nowhere yet, but
voluntary salt reduction might be setting a more
achievable trend. Politicians can no longer hide
behind ignorance or confusion.”
The study was funded by the Bill & Melinda Gates
Foundation.
24 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Surgery reduces OSA in
severely obese patients
Study shows rise in BMI
increases cancer risk
Surgery reduced neck and waist
circumference respiratory sleep
disorders, specifically OSA, and
increased maximum ventilatory
pressures
A single point population-wide
increase in BMI would result in
3,790 additional annual UK patients
developing one of the ten cancers
positively associated with BMI
B
ariatric surgery results in a reduction
in the symptoms of obstructive sleep
apnoea (OSA), according to the results of
a randomised clinical trial and subequent paper
entitled, ‘Obstructive sleep apnea and pulmonary
function in patients with severe obesity before
and after bariatric surgery: a randomized
clinical trial’, published in the journal
Multidisciplinary Respiratory Medicine.
The researchers from Brazil and Italy
wanted to assess the daytime sleepiness,
sleep architecture and pulmonary function
in patients with severe obesity before and
after bariatric surgery. They hypothesised
that in severely obese patients significant
weight loss (from bariatric surgery) would
provide an effective improvement in pulmonary function and sleep quality.
The patients were divided into a control
group and a bariatric surgery group and
polysomnography (PSG) performed before
and after bariatric surgery (gastric banding) in the bariatric surgery group with a
90-day interval between evaluations.
Eighty patients were recruited for
the study; eighteen subjects refused to
participate and ten were excluded for not
meeting the eligibility criteria. The final 52
patients were randomised and 16 patients
(13 women) who were in the bariatric
surgery group were evaluated before and
after surgical intervention.
The patients who had bariatric surgery had a significant reduction in BMI
(p=0.004) and waist circumference of
23.34% and 15.33% (p<0.001), respectively, at three months following bariatric
surgery. A significant reduction of 13.45%
(p<0.001) in neck circumference was found
and it was positively correlated with reductions of
body weight (p=0.015) and BMI (p=0.049).
“The findings of this study demonstrate that
weight loss following bariatric surgery led to a reduction of apnoea–hypopnea index and enhanced
sleep architecture…Moreover, significant increases were found in the percentage of REM sleep
and percentage of the deepest sleep stage N3,”
the authors write. “The findings demonstrate that
bariatric surgery for patients with severe obesity
effectively reduces neck and waist circumference,
improves pulmonary function, improves sleep arc
hitecture and reduces respiratory sleep disorders,
especially OSA.”
B
eing overweight and obese puts people at
greater risk of developing ten of the most
common cancers, according to a study
published in the Lancet. The study investigators
sought to examine the links between BMI and the
most common site-specific cancers and examined
over five million patient records, which included
166, 955 cases of the ten most common cancers.
“There was a lot of variation in the effect of
BMI on different cancers,” said lead researcher,
Dr Krishnan Bhaskaran from the London School
of Hygiene and Tropical Medicine, UK. “For
example, risk of cancer of the uterus increased
substantially at higher body mass index, for other
cancer we saw a more modest increase in risk or
no effect at all. This variation tells us BMI must
affect cancer risk through a number of different
processes, depending on cancer type.”
They found that BMI was associated with 17
of 22 cancers, but effects varied substantially by
site. Although obesity was associated
with the development of the most common cancers - which represent 90% of
the cancers diagnosed in the UK, some
showed no link at all. In addition, there is
some evidence to suggest a higher BMI is
associated with a lower chance of getting
prostate cancer.
Each five point increase in BMI was
roughly linearly associated with cancers
of the uterus (p<0·0001), gallbladder
(p<0·0001), kidney (p<0·0001), cervix
(p=0·00035), thyroid (p=0·0088), and
leukaemia (1p≤0·0001). BMI was also
positively associated with liver, colon,
ovarian and postmenopausal breast
cancers, but these effects varied by
underlying BMI or individual-level
characteristics.
More worryingly, they estimated that
single point population-wide increase in
BMI would result in 3,790 additional annual UK patients developing one of the ten
cancers positively associated with BMI.
Led by scientists from the London
School of Hygiene and Tropical Medicine
researchers gathered data on five million
people living in the UK, monitoring
changes to their health over a period of
seven years.
The study was funded by the National
Institute for Health Research, Wellcome
Trust and Medical Research Council.
Surgery reduces cancer rates but reasons unknown
Unknown if lower cancer
rates following surgery are
related to the metabolic
changes associated with
weight loss or if lower BMIs
result in earlier diagnosis
B
ariatric surgery induced
weight loss can help reduce the
risk of cancer to rates almost
similar to those of people of normal
weight, according to the findings of the
first comprehensive review published
in Obesity Surgery. The review, which
takes into account relevant studies
about obesity, cancer rates and bariatric
surgery, concluded that the reasons for
the findings were unknown but likely
associated with weight loss or better
awareness/diagnosis post surgery.
Some previous studies suggested a
relationship between bariatric surgery
and reduced cancer risk among obese
people, as a result Dr Daniela Casagrande of the Universidade Federal do
Rio Grande do Sul in Brazil. and her
colleagues contrasted and combined results from 13 relevant studies that focus
on the incidence of cancer in patients
following bariatric surgery. These in-
clude both controlled and uncontrolled
studies, and the relevant information of
54,257 participants.
They found that the cancer incidence density rate was 1.06 cases
per 1,000 person-years within the
surgery groups up to 23 years after the
surgery was performed. This is markedly better than the rate for the global
population of obese people. Importantly, the effect of bariatric surgery
was found within both controlled and
uncontrolled studies. Four controlled
studies showed that bariatric surgery
was associated with a reduction in the
risk of cancer.
In the meta-regression, there was
an inverse relationship between the
pre-surgical BMI and cancer incidence
after surgery (beta coefficient −0.2,
p<0.05).
It is still unknown whether the
lower cancer rates following bariatric
surgery are related to the metabolic
changes associated with weight loss,
or if lower BMIs following surgery result in earlier diagnosis and improved
cancer treatment outcomes among
patients.
Casagrande said that it is difficult to
separate the effects of the surgery from
the multiple associated changes it yields
in patients. She believes that undergoing
a surgical procedure of the magnitude
of bariatric surgery raises awareness
and possible earlier diagnosis of cancer
among such patients.
Although bariatric surgery is associated with reduced cancer risk in morbidly obese people, Casagrande notes
that conclusions should be drawn with
care because there was high heterogeneity among the studies.
In addition, there were some limitations about the data available among
the studies and variables associated
with cancer should still be measured in
prospective bariatric surgery trials.
Weight loss following bariatric surgery can reduce liver damage
Fat deposits on the liver resolved in 70 percent of
patients
62 percent of patients with stage two liver fibrosis had
an improvement or resolution of the fibrosis
B
ariatric surgery can result in significant improvement in
nonalcoholic fatty liver disease (NAFLD), according to new
research presented at Digestive Disease Week (DDW). Researchers at the University of South Florida-Tampa (USF) found that
bariatric surgery resolved liver inflammation and reversed early-stage
liver fibrosis, the thickening and scarring of liver tissue, by reducing
fat deposits in the liver.
“About 30 percent of the US population suffers from this disease,
which is increasing, and more than half are also severely obese,” said
Dr Michel Murr, lead researcher of the study, professor of surgery and
director of Tampa General Hospital and USF Health Bariatric Center.
“Our findings suggest that providers should consider bariatric surgery
as the treatment of choice for NAFLD in severely obese patients.”
Murr and his colleagues suggest that bariatric surgery be considered for patients with a BMI>35 and obesity-related co-morbidities
or BMI>40. They note that traditional interventions, such as medications, have a low success rate with these patients.
Researchers compared liver biopsies from 152 patients, one at the
time of the bariatric procedure and a second an average of 29 months
afterwards. Mean pre-op BMI was 52±10 and mean excess body
weight loss was 62±22% at the time of the subsequent biopsy.
In examining pre-operative biopsies, researchers identified patients with cellular-level manifestations of NAFLD, specifically, fat
deposits and inflammation of the liver. These types of liver damage
can lead to liver fibrosis and cirrhosis.
After reviewing post-operative biopsies, they found that bariatric
surgery resulted in improvements for these patients. In the postoperative biopsies, researchers found that fat deposits on the liver
resolved in 70 percent of patients. Inflammation was also improved,
with lobular inflammation resolved in 74 percent of patients, chronic
portal inflammation resolved in 32 percent, and steatohepatitis resolved in 88 percent.
In addition to these improvements, 62 percent of patients with
stage two liver fibrosis had an improvement or resolution of the fibrosis. One of three patients with cirrhosis also showed improvement.
Murr noted that these findings on fibrosis reversal apply only to
early-stage fibrosis, and not late-stage liver disease.
“We are in the midst of an obesity epidemic that can lead to an
epidemic of nonalcoholic fatty liver disease,” added Murr. “As a
tool in fighting obesity, bariatric surgery could also help prevent the
emergence of widespread liver disease.”
bariatricnews.net 25
ISSUE 21 | AUGUST 2014
Preloaded
nutrients
could mimic
bypass
surgery
Can the lower intestine
be targeted by specially
formulated nutritional
supplements to trick the
digestive system into
convincing the body that
enough food had been eaten?
B
Advert
y refining nutrient preloads and
formulating them to target the distal
gut, researchers from Queen Mary
University of London, UK, hope to develop
a successful weight loss and anti-diabetic
strategy prior to, and possibly in place of,
bypass surgery.
“At the moment, obese patients undergo
gastric bypass surgery where they are essentially re-plumbed,” said lead author,
Professor Ashley Blackshaw, Professor
of Enteric Neuroscience at Queen Mary
University. “Undigested food bypasses the
small intestine and is shunted straight to the
lower bowel where it causes the release of
hormones which suppress the appetite and
help with the release of insulin. That makes
the patient feel full and stops even the
hungriest individual from eating.”
It is already known that in some obese
people, the lower intestine does not signal
the brain to say it is full. Therefore, the
investigators wanted to assess whether the
lower intestine could potentially be targeted
by specially formulated nutritional supplements to trick the digestive system into
convincing the body that enough food had
been eaten.
When we eat, nutrients stimulate
enteroendocrine cells (EEC) to release
gut hormones and several specific nutrient receptors may be located on EEC that
respond to dietary sugars, amino acids and
fatty acids.
The researchers wanted to find out
which nutrient receptors are expressed in
which gut regions and in which cells in
mouse and human, how they are associated
with different types of EEC and how they
are activated leading to hormone and 5-HT
(enterochromaffin cells) release.
The study, published in GUT, found that
distal gut of humans and mice has sensors
for products of fat and protein digestion,
and that these associate with specific signalling pathways.
“By refining nutrient preloads and
formulating them to target the distal gut,
we expect to develop a successful weight
loss and anti-diabetic strategy prior to and
possibly in place of bypass surgery,” the
paper concludes.
It has been suggested that the gut could
be targeted with a capsule containing
naturally occurring food supplements. The
supplements would target the lower bowel
and would intervene with the pathway of
fatty acid, amino acid and protein towards
the lower bowel.
“We believe it’s possible to trick the
digestive system into behaving as if a
bypass has taken place,” he added. “This
can be done by administering specific food
supplements which release strong stimuli in
the same area of the lower bowel. It’s a bit
like sending a special food parcel straight
to the body’s emergency exit, and when
it gets there, all the alarms go off. It’s a
totally novel idea, and we’re very excited
at the results so far. We are hopeful that the
treatment will be widely available in NHS
hospitals in the next five years.”
26 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Increased secretion and action of GLP-1 post-RYGB
Increased role of GLP-1 in the
insulin response following gastric
bypass
T
he increased secretion and action of GLP-1
after gastric bypass surgery is not entirely
due to rapid passage of nutrients into the
lower gut, according to a single case study by
investigators from University of Cincinnati (UC).
The study appears on in the journal Diabetologia
(Salehi et al. Evidence from a single individual that
increased plasma GLP-1 and GLP-1-stimulated insulin secretion after gastric bypass are independent
of foregut exclusion).
“In patients with severe hypoglycaemia, gastric
bypass reversal is a consideration,” said Dr Marzieh Salehi, associate professor in the division of
endocrinology, metabolism and diabetes. “But our
new findings show that simply reversing gastric
bypass several years after surgery may not reverse
the hormonal effects brought on by the surgery
itself, namely a new ‘cross-talk’ between gut and
pancreas.”
The investigators compared glucose metabolism
in an eight-year post-surgery gastric bypass patient,
with an existing gastric feeding tube due to other
medical reasons, to a group of healthy controls.
Uniquely, the patient could ingest nutrients
both orally and via the gastric feeding tube (going
through or bypassing foregut, a re-routed stomach
pouch attached to the small intestine), allowing
researchers to test whether the actual route of meal
ingestion made a difference when it came to how
the participant’s body metabolized glucose.
While it is commonly agreed that weight lossindependent effects of gastric bypass on glucose
metabolism are due to the enhanced secretion,
and action, of one of the gut hormones, GLP-1,
the question remained as to whether this increase
is due to the rapid transit of nutrients through the
reconfigured gastrointestinal tract.
They reported that the patient had increased
plasma GLP-1 concentrations and GLP-1 action
independent of the route of feeding compared to
healthy controls.
“It is likely that the increased secretion and
action of GLP-1 after gastric bypass surgery is
not entirely due to rapid passage of nutrients into
the lower gut,” said Salehi. “Understanding the
underlying mechanisms by which gastric bypass
improves blood sugar levels will guide the development of therapeutic options, as GLP-1 based drugs
have been utilized for treatment of diabetes over the
last decade.”
Although these findings pertain to a singleperson case study, they researchers said that they
are in keeping with previous results that indicated
an increased role of GLP-1 in the insulin response
following gastric bypass.
Marzieh Salehi
First experience of lap adjustable banded LSG
Khatkov I.E.1,2,
Askerkhanov R.G.1,2,
Feidorov I.J.1, Bodunova N.A.2
1 Moscow Clinical and Scientific Centre. Moscow. Russia.
2 Moscow State University of Medicine and Dentistry
named after A.I. Evdokimov, chair of Faculty Surgery.
In a case study from Russia,
investigators report on
their first experience of
laparoscopic adjustable
banded sleeve gastrectomy
with one year follow-up to
treat a super-super obese
patient.
S
urgical approach is the most
effective treatment for patients
with morbid obesity1. It’s generally known, that surgical treatment of
super-super obesity (BMI>60kg/m2) and
high-risk patients with comorbidities, is
responsible for an increased risk of postoperative morbidity and mortality after
bariatric surgery2. Moreover, there are
some specific difficulties in laparoscopic
surgery for extremely obese patients
such a neediness for increased pressure
CO2 in abdomen, long instruments,
increased resistance of abdominal wall,
sometimes additional ports or modification of a ports placement. Sleeve
gastrectomy is a recently used surgical
technique, with an acceptable rate of
postoperative complications3. It was
describe as a first step before a gastric
bypass or biliopancreatic diversion with
duodenal switch. The advantages of this
procedure include lack of an intestinal
bypass, thus avoiding gastrointestinal
anastomoses, metabolic derangements,
and internal hernias, shorter operating
times, and no implantation of a foreign
body4. There are not rare cases when
laparoscopic sleeve gastrectomy was described as a revision bariatric procedure
Igor Khatkov
for failed gastric banding. 5-7 But there
are some publications about banded
sleeve gastrectomy in case extremely
obese patients for gastric dilatation prevent, that may limit weight loss8-10. This
case report presets our first experience of
laparoscopic adjustable banded sleeve
gastrectomy with one year follow-up in
case of super-super obesity patient.
Patient N., 38-year-old female, the
biggest Russian woman, weight 267kg.
and BMI 84.3kg/m2 was admitted to our
clinic for assessment current status about
bariatric procedure. From her medical
history, in her twenties she has a 70–74kg
weight with 178cm height and works as a
confectioner. Then step by step she began
to notice an increase in weight about 1 or
2kg per every month. In her 30s she has
a 120kg (BMI 37,87kg/m2), then in 34
years, during the pregnancy her weight
increasing 70kg more and was 240kg.
After the childbearing (by the Caesarian)
by the diet 50kg weight loss, but after
dietotherapy was stopping her weight
was regain till the admission to hospital.
Related diseases: purulent meningitis
and then suicide attempt by the medicines, stabbing, two cranial traumas,
rheumatism with heart disease, high
Figure 1: Surgical team and ports placement
grade myopia, varicose without any
trophic changes, anxious depression.
During the preoperative instrumental
examination was performed: upper
endoscopy – duodenal reflux, ultrasound
(thyroid, abdominal cavity and gynecology) with no significantly changes,
echocardiography – middle pulmonary
hypertension; Doppler ultrasound of
feet vessels was not informative, 24
hours electrocardiography with middle
rate of ventricular ectopic beats (186)
and low rate of supraventricular ectopic
beats (16), 24 hours monitoring of blood
pressure with no pathology changes. In
her laboratories tests there was iron deficiency (without clinical signs) was no
signs of hyperglycemia (5.4–5.9mmol/l),
Hgb–11.5 g/dL, Protein total – 66.9 g/l,
Cholesterol (serum) – 3.88mmol/l, HDL
– 0.93mmol/l, LDL – 2.28mmol/l, K+4.03mmol/l, Na+- 139.6mmol/l, Ca++2.27mmol/l, Fe++ – 7.7 mkmoll/l. In
order of preparation for surgery was appoint course of antidepressants (Zoloft
100mg one time per day), light diet, no
pre-surgery CPAP therapy or sleep studies, no cardiorespiratory referral.
In April 2013 patient N. was operated. The patient was placed in the supine
position with a spread her legs, and then
Trendelenberg after first port placed.
Four ports technique were used (Figure
1): 10mm – camera port., 12mm. – main
surgeon port, 5mm – surgeon assistant
port, 5mm assistant port, and epigastric
5mm port for Nathanson liver retractor
to retract the left lateral liver segment.
Gastric mobilization by the Harmonic
scalpel (Johnson and Johnson, USA),
using it, the window into omental bursa
was made about 5cm proximal to the
pylorus. Big gastric curvature was mobilized till the left diaphragmatic crus and
esophagus visualization, short gastric
vessels was carefully seal and divided.
Sleeve was created on the 33 Fr bogie by
the Endo GIA stapler (Covidien, Ireland)
using 45mm green cassettes two pieces,
60mm blue cassettes four pieces. In order
to prevent staple line leaks, staple line
was oversewed by the vicryl 3-0 run suture. Then the adjustable gastric banding
system (Medsil, Russia) was placed on
the gastric sleeve 3cm lower esophagogastric junction without gasro-gastric
sutures. Thereby gastric band ring was
fixed only in lesser omentum. At the end
of surgery abdomen cavity was drained
in splenic sinus area and banding system
port was placed on the aponeurosis of the
external oblique abdominal muscles by
the anterior axillary line. The patient has
a favorable for early and later postoperative period, she starts to drink at two day
after surgery and then during three weeks
has a soft diet. At the third day after
surgery patient was transferred at general
therapy unit and then discharged at sixth
day after surgical procedure.
The patient N was admitted to our
clinic after three and six months after
surgery for alimentary, laboratory and
psychological status assessment and
instrumental examination. There are
no pathological changes in laboratory
and instrumental (X-ray barium scan,
upper endoscopy and abdomen ultrasound scan) tests and good laboratory
results: Hgb – 14.5 g/dL, Protein total
– 71.9 g/l, Glucose 5.37–7.09mmol/l,
Cholesterol (serum) – 4.28mmol/l,
HDL – 1.34mmol/l, LDL – 2.35mmol/l,
K+-3.75mmol/l, Na+- 139.2mmol/l,
Ca++- 2.45mmol/l, Fe++ – 8.2 mkmoll/l
(hide iron deficiency without clinical
signs). Weight loss year after bariatric
procedure about 100kg, BMI-52.7kg/m2.
Stable weight loss during the whole year
without band adjustments. Favorable
psychological status with no depression
conditions after psychotherapy course.
This case presented laparoscopic
adjustable banded sleeve gastrectomy as
safe and effective bariatric procedure for
extremely obese patient with high risks
for surgery.
References:
1. Catheline J-M, Fysekidis M., Dbouk R. Weight Loss after Sleeve Gastrectomy in Super Superobesity J Obes.
2012;2012:959260.
2. Gagner M, Gumbs AA, Milone L, Yung E, Goldenberg
L, Pomp A. Laparoscopic sleeve gastrectomy for the
super-super-obese (body mass index >60kg/m(2)).
Surg Today. 2008;38(5):399-403.
3. Dillemans B, Van Cauwenberge S, Agrawal S, Van
Dessel E, Mulier JP. Laparoscopic adjustable banded
roux-en-y gastric bypass as a primary procedure for the
super-super-obese (body mass index > 60kg/m²). BMC
Surg. 2010 Nov 14;10:33.
4. Eisenberg D, Bellatorre A, Bellatorre N. Sleeve gastrectomy as a stand-alone bariatric operation for
severe, morbid, and super obesity. JSLS. 2013 JanMar;17(1):63-7.
5. Marin-Perez P, Betancourt A, Lamota M, Lo Menzo
E, Szomstein S, Rosenthal R. Outcomes after laparoscopic conversion of failed adjustable gastric banding
to sleeve gastrectomy or Roux-en-Y gastric bypass. Br
J Surg. 2014 Feb;101(3):254-60.
6. Silecchia G, Rizzello M, De Angelis F, Raparelli L, Greco
F, Perrotta N, Lerose MA, Campanile FC. Laparoscopic
sleeve gastrectomy as a revisional procedure for failed
laparoscopic gastric banding with a “2-step approach”:
a multicenter study. Surg Obes Relat Dis. 2013 Nov 11.
pii: S1550-7289(13)00369-9.
7. Liu KH1, Diana M, Vix M, Mutter D, Wu HS, Marescaux J. Revisional surgery after failed adjustable gastric
banding: institutional experience with 90 consecutive
cases. Surg Endosc. 2013 Nov;27(11):4044-8.
8. Alexander JW, Martin Hawver LR, Goodman HR:
Banded sleeve gastrectomy – initial experience. Obes
Surg 2009;19:1591–1596.
9. Agrawal S, Van DE, Akin F, Van CS, Dillemans B: Laparoscopic adjustable banded sleeve gastrectomy as a primary procedure for the super-super obese (body mass
index > 60kg/m2). Obes Surg 2010;20:1161–1163.
10.Karcz WK, Marjanovic G, Grueneberger J, Baumann
T, Bukhari W, Krawczykowski D, Kuesters S. Banded
sleeve gastrectomy using the GaBP ring--surgical technique. Obes Facts. 2011;4(1):77-80.
Bariatric surgery reduces risk of atrial fibrillation
Study shows positive correlation
between bariatric surgery and
reduced risk of atrial fibrillation
B
ariatric surgery is an effective way to
control weight in morbidly obese patients
who are at risk for developing atrial fibrillation (AF), according to a study presented at Heart
Rhythm 2014, the Heart Rhythm Society’s 35th
Annual Scientific Sessions.
“Obesity has become an epidemic in our culture
and prevention efforts are more important now than
ever,” said Dr Yong-Mei Cha, professor of medicine at Mayo Clinic, MN, an author of the study.
“Bariatric surgery is a preventative measure that
obese patients may choose to take and our study
shows that the surgery helps them not only lose
weight, but also reduces their risk of developing a
serious cardiac condition, like AF. It is important
to continue the conversation about how to help
prevent this epidemic from becoming even more
widespread.”
The retrospective study was conducted in 438
patients with a BMI>40 or higher and identified as good candidates for bariatric surgery. Of
these patients, 326 elected to undergo surgery for
weight reduction and 112 controls were managed
medically. The diagnosis of AF was documented
by electrocardiogram or ambulatory monitors and
metabolic profiles were collected at baseline and
follow-up.
The baseline BMI was different in the patients
that underwent surgery versus those who did not
have surgery (46.9 vs. 43.2). The prevalence of AF
at baseline was not significantly different between
the two groups (surgical 3.7 percent vs. control 4.5
percent, p=0.63) at baseline. After a mean followup duration of 7.2±3.7 years, new onset of AF occurred in 3.1 percent of surgical group, significantly
lower than 12.5 percent (p<0.01) in the medically
treated group.
Additionally, the researchers found that the
group receiving bariatric surgery had a significant
reduction in BMI compared with the control group
(−12.1±0.4 vs. 0.2±0.7; p<0.001) and some improvements in metabolic profile.
bariatricnews.net 27
ISSUE 21 | AUGUST 2014
Preoperative ghrelin levels could indicate weight regain
Leptin levels were decreased
overall after RYGB (p< 0.001),
but increased in the weight
regain group between years one
and two
E
arly weight regain after RYGB is not
associated with a reversal of improvements in insulin sensitivity and higher
preoperative ghrelin levels might identify
patients that are more susceptible to weight
regain after RYGB, those are the conclusion
of a study ‘Early weight regain after gastric
bypass does not affect insulin sensitivity but
is associated with elevated ghrelin’, published
in the journal Obesity.
The investigators sought to determine: (1)
if early weight regain between the first and
second years after RTGB was associated with
worsened hepatic and peripheral insulin sensitivity, and (2) whether preoperative levels
of ghrelin and leptin are associated with early
weight regain after RYGB.
The recruited 45 patients and assessed
their hepatic and peripheral insulin sensitivity
and ghrelin and leptin plasma levels before
RYGB and at one month, six months, one
and two years postoperatively. They defined
weight regain as ≥5% increase in body weight
between years one and two. Forty-nine percent of patients (22/45) has type 2 diabetes
before surgery.
Results
They report that weight regain occurred in
33% of subjects, with an average increase in
body weight of 10±5% (8.5 ± 3.3kg). The gain
in body weight consisted primarily of fat mass
and not lean mass (Figure 1A and 1B). There
was no significant difference in preoperative
age, sex, type 2 diabetes, BMI, or weight be-
tween those participants that regained weight
and those that maintained or continued to lose
weight.
The researchers also reported that weight
regain was not associated with worsening
of peripheral or hepatic insulin sensitivity.
However, patients with weight regain had
higher preoperative and postoperative levels
of ghrelin compared to those who maintained
or lost weight during this time.
Although peripheral and hepatic insulin
sensitivity increased significantly over time
(p< 0.001), they did not record a difference
between the weight regain and maintain/
lose groups in the trajectories of peripheral
insulin sensitivity (Figure 1C; group by time
interaction p=0.191) or hepatic insulin sensitivity (Figure 1D; group by time interaction
p=0.137).
Figure 1F demonstrates that the weight
regain group maintained these higher levels
of ghrelin after surgery (main effect of group
p=0.014, group by time interaction effect
p=0.707).
Interestingly, leptin levels were decreased
overall after RYGB (p< 0.001), but increased
in the weight regain group between years one
and two (overall interaction p=0.011, 1-2 years
interaction contrast p=0.017) (Figure 1E). The
trajectories of leptin levels corresponded with
fat mass (Figure 1A).
They note that the findings suggest ghrelin
does not impact degree of initial weight loss,
but the maintenance of surgical weight loss.
“These findings indicate that early weight
regain does not adversely affect insulin sensitivity after RYGB,” the authors conclude.
“Importantly, we report that preoperative
ghrelin levels might identify those patients
more susceptible to weight regain after RYGB
and should receive more intense post-surgical
follow-up to prevent post-RYGB weight
recidivism.”
Figure 1. Weight regain at two years after RYGB is not associated with worsened insulin sensitivity, but is associated with
elevated plasma ghrelin levels. Weight regain was defined as ≥5% weight change between one and two years after RYGB,
and occurred in 33% of the cohort. Trajectories of fat (A) and lean (B) mass losses were similar between groups up to one
year after RYGB. There was no effect of weight regain on peripheral (C) or hepatic (D) insulin sensitivity (both group by time
interaction P ≥ 0.137). Leptin levels (E) increased between one and two years after RYGB in the weight regain group (group
by time interaction P = 0.011). Ghrelin levels (F) were higher in the weight regain group at baseline (P = 0.009) and this
stratification was maintained over time (group by time interaction P = 0.707). Data are mean ± SEM.
Impact of bypass aids β-cell function post-surgery
Weight loss appears to be
the strongest predictor
A
lthough β-cell dysfunction
can continue after Roux-enY gastric bypass (RYGBP)
surgery, the procedure leads to gastrointestinal changes crucial for improved
β-cell function after surgery, according
to a paper published in the journal Diabetes. They note that pre-surgery β-cell
function, weight loss and glucagon-like
peptide 1 (GLP-1) response were all
predictors of post-surgery β-cell function, with weight loss appearing to be the
strongest predictor.
Much is still unknown as to why gastric
bypass can result in resolution of type 2 diabetes and although both caloric restriction
and weight loss are important contributors,
it is also believe that altered gut physiology
contributes to the resolution.
Therefore, researchers from St
Luke’s-Roosevelt Hospital Center, the
Albert Einstein School of Medicine, and
Columbia University College of Physicians and Surgeons, New York, and the
Centre de Recherche Clinique EtienneLe Bel, Université de Sherbrooke,
Sherbrooke, Quebec, Canada, assessed
the change in β-cell function up to three
years after RYGBP in severely obese
individuals with type 2 diabetes who
experienced clinical diabetes remission
post-RYGBP (OB-DM).
The patients were then compared
to both non-operated, obese normal
glucose-tolerant (OB-NGT) and lean
NGT (LEAN) patients. They also measured β-cell function during an oral and
isoglycaemic glucose challenge to assess
if improvements in β-cell function after
RYGBP were mediated by the gut
Study
Sixteen severely obese subjects with
type 2 diabetes of short duration (mean
3.0 ± 2.6 years) were studied before
(OB-DM0; n=16) and at one month (OBDM1M; n=16), one year (OB-DM1Y;
n= 15), two years (OB-DM2Y; n=16 for
OGTT, n=14 for iso-IVGC), and three
years after RYGBP (OB-DM3Y; n=13).
Eleven severely OB-NGT and seven
LEAN subjects were used as control
subjects (all OB-NGT control subjects:
fasting plasma glucose <5.5mmol/L, 2h
postprandial glucose <7.7mmol/L, and
HbA1c <6.5%).
Results
The outcomes revealed that weight loss
was ~11% at one month, ~31% at one
year, and sustained at two and three
years. All subjects in OB-DM were
in diabetes remission from one month
onwards except one subject that did not
remit until one year and relapsed (relapse
defined as no longer meeting ADA criteria for remission) at three years.
Plasma concentrations of incretins
were significantly increased after
RYGBP. At all-time points after surgery,
GLP-1 and GIP peak responses in
OB-DM were significantly higher than
both control subjects. β-cell function
normalised after surgery.
The researchers report that weight
loss, pre-surgery β-cell function and
GLP-1 response were all significant predictors of post-surgery β-cell function,
although weight loss was consistently
the strongest predictor. Age, pre-surgery
BMI and diabetes duration and control
were not significant.
“This study is the first to demonstrate
the importance of the oral route to
improvements in β-cell function after
RYGBP and to show that improvements
persist three years after surgery,” write
the authors. “Despite the important
influence of intestinal factors, we cannot
discount the contribution of weight loss
to improvement in β-cell function after
RYGBP.”
They added that future studies comparing β-cell function in a diabetic population, compared with caloric restriction
and/or restrictive bariatric surgery will
help elucidate the impact of weight loss
versus gut-mediated factors.
“RYGBP does not rescue impairment
in insulin secretion and β-cell function
when the gastrointestinal tract is not engaged,” conclude the authors. “However,
oral glucose stimulation rescues impairment rapidly, at one month, and this is
sustained up to three years after RYGBP,
demonstrating the essential role of the
gut in this effect.”
COE status does not equate to lower in-hospital complications
From 2010-2012, there were
199,926 in-hospital bariatric
procedures performed and 4.83% of
patients experienced one or more
in-hospital complications
A
ccording to the latest report form
Healthgrades, Center of Excellence
(COE) designation alone does not equate
to high performance in terms of in-hospital complications. The 2014 Healthgrades Bariatric Surgery
Excellence Award is an annual report representing
the top 10% of hospitals evaluated performing
bariatric surgery.
“The results of our 2014 report underscore the
importance of doing your homework before selecting a healthcare provider for bariatric surgery,” said
Evan Marks, Chief Strategy Officer, Healthgrades.
“The hospitals recognized by Healthgrades stand
above the rest for their commitment to quality care.”
In its related report, Healthgrades explores
whether hospitals performing bariatric surgery
with a Center of Excellence (COE) designation
have lower complication rates than those hospitals
that do not.
The Healthgrades analysis suggests that a statistically higher percentage of hospitals with COE
designation are rated 5-stars for bariatric surgery
(21% of those with designation relative to 8% of
those without). However, COE designation alone
is not enough.
In addition to top performers, over 27%
of the COE designated facilities performed
statistically worse than expected, according to
the Healthgrades methodology. As a group, the
risk-adjusted complication rate for COE designated facilities is not statistically different from
the non-designated facilities (5.18% vs. 5.37%).
This suggests that COE designation alone does
not equate to high performance in terms of inhospital complications.
The latest analysis revealed that from 2010
through 2012, across the states studied, there were
199,926 in-hospital bariatric procedures performed
and 4.83% of patients experienced one or more inhospital complications1.
In addition, patients having bariatric surgery
at hospitals with 5-star performance in bariatric
surgery had 70% lower risk of experiencing an inhospital complication2.
From 2010 to 2012, if all hospitals had
performed at the same level as Bariatric Surgery
Excellence Award recipients, 4,349 patients could
have potentially avoided a major, in-hospital
complication2.
References
1.Statistics for first bullet based on analysis for three years for all-payer data
(2010-2012) from 19 states where all-payer data was publicly available
during any year(s) of the three year timeframe.
2.Statistics for final bullets based on analysis for three years for all-payer
data (2010-2012) from 17 states where all-payer data was publicly available during all three years of the analysis timeframe.
28 BARIATRIC NEWS BariatricPal
publishes how to
live healthy after
surgery book
The book is targeted toward
individuals who are considering
weight loss surgery or who already
have had it
W
eight loss surgery BariatricPal is announcing the release of ‘The Big Book on
Bariatric Surgery: Living Your Best Life
After Weight Loss Surgery’, written by Alex Brecher
and Natalie Stein. It provides advice for patients to
live healthy lives and control their weight after bariatric surgery. The book is targeted toward individuals
who are considering weight loss surgery or who
already have had it.
The book is the fourth book on weight loss surgery
that is co-authored by Brecher and Stein, and focuses
exclusively on long-term management of diet, lifestyle, and psychological health after the surgery.
The authors
explain that:
“Weight loss
surgery is not
a single event;
it is a lifelong
process. For
many,
the
surgery
is
another chance
at life. It does
not end when
you
leave
the operating
room or when
your surgery
wounds have
healed. It lasts
beyond
the
first year and continues past goal weight. It is a
lifelong journey. You focus on protein, measure each
bite, chew slowly, and drink plenty of water. You read
nutrition labels, go for walks or to the gym, and avoid
high-fat, high-sugar foods. You weigh yourself, try
on new clothes, and take your vitamin and mineral
supplements.”
The first three books in the series focused on the
adjustable gastric band, the vertical sleeve gastrectomy or gastric sleeve, and the gastric bypass, and
address preparation for and recovery from bariatric
surgery.
The first three books were titled:
n The BIG book on the lap-band: everything you
need to know to lose weight and live well with
the adjustable gastric band
n The BIG book on the gastric sleeve: everything
you need to know to lose weight and live well
with the vertical sleeve gastrectomy
n The BIG book on the gastric bypass: everything
you need to know to lose weight and live well
with the roux-en-y gastric bypass surgery
The fourth book discusses life after surgery and has
sections on meal plans, food groups, goal setting,
exercise programmes and support systems, as well
as discussing holidays, staying motivated, coping
with setbacks and managing challenging family and
friends. And, finally there are 60+ pages packed with
high-protein recipes, dessert recipes, snack recipes,
family friendly recipes, and party recipes.
The book and the others in the series are available
directly from BariatricPal and on Amazon and Barnes
& Noble. It is available as a hard copy and in ereader
form for Kindle, Nook, and Kobo.
Alex Brecher, the book’s lead author, is an advocate for weight loss surgery as a treatment for obesity
and the founder of BariatricPal. He is a weight loss
surgery patient who has kept off over 100lbs in the 11
years since his procedure. Natalie Stein is a nutritionist and writer with extensive experience in the field.
BariatricPal is an online social network dedicated
to the weight loss surgery community. Among the
site’s main features are discussion forums that are
available for all members to use.
More information about all four books in the series, please
visit the BariatricPal website: www.bariatricpal.com/
ISSUE 21 | AUGUST 2014
Clinical comment
Bariatric professionals and ASMBS:
Are you putting patients first?
Alex Brecher is the founder and CEO
of BariatricPal, an online social network
for weight loss surgery patients and potential patients. Mr. Brecher has been
an advocate for bariatric surgery since
his own laparoscopic adjustable gastric band in 2003 and subsequent weight
loss and maintenance. Mr. Brecher has
served on the Corporate Council of the
American Society for Metabolic and Bariatric Surgery (ASMBS), was a consultant for Allergan from 2008 to 2013, and
attends obesity and bariatric surgery-focused conferences nationally. BariatricPal is an online social network dedicated
to the weight loss surgery community. Its
hundreds of thousands of members include potential and post-op weight loss
surgery patients who visit the site’s forums for peer-to-peer support. Surgeons
and integrated health professionals can
join the BariatricPal directory and explore premium membership options.
S
urgeons, integrated health professionals, and other weight loss surgery advocates share a common goal: to use weight
loss surgery to treat patients with obesity. We all
agree that patients do not deserve to feel hopeless in their fight against obesity. They merit the
best medical support that we can provide to help
them fight obesity and become healthier.
Most surgeons and integrated health professionals are working hard, day in and day out, to
help patients meet their goals. However, there
is still room for improvement as we work to
carry out the mission of the ASMBS. By working together productively, presenting a unified
front, and putting patients first, we can make
far greater strides towards fighting obesity than
treating the field of bariatrics like a competition.
Functions of ASMBS
ASMBS is the leading national body for bariatric surgery whose purpose is “to advance the art
and science of metabolic and bariatric surgery
by continually improving the quality and safety
of care and treatment of people with obesity and
related diseases.” It pursues its purpose in the
following ways.
nAdvancing the science of metabolic and
bariatric surgery and increase public
understanding of obesity.
n Fostering collaboration between health
professionals on obesity and related
diseases.
n Providing leadership in metabolic and
bariatric surgery the multidisciplinary
management of obesity.
nAdvocating for health care policy that
ensures patient access to prevention and
treatment of obesity.
n Serving the educational needs of our
members, the public and other professionals.
But what happens when the ASMBS goes off
course? What if we make patient healthcare
decisions based on subjective data rather than
hard science? What if we stop sharing our experiences with each other and keep our knowledge
secret? What if we don’t bother to reach out to
other bariatric healthcare specialists to ensure
that our patients receive the services they need?
If we don’t work together, we might see:
n Lack of progress in refining and advancing
surgical techniques.
n Stalled growth in our base of scientific
knowledge regarding patient outcomes.
n Poor patient outcomes due to lack of
comprehensive support.
A Divided Voice is a Weak One
Unchecked fighting amongst ourselves does a
disservice to the field of bariatric surgery and
to bariatric surgery patients and candidates. It
weakens our collective voice, making us less
influential. An inability to present a unified front
harms the very patients that we are trying to
protect.
n Mixed messages give the media opportunities to write unsympathetic stories that
make patients seem at fault for obesity
or make weight loss surgery seem like an
irresponsible choice.
n Patients who are trying to gather information about weight loss surgery don’t know
what to believe or whom to trust.
n Policymakers are less likely to take weight
loss surgery seriously and pass policies such
as requiring health insurance companies to
cover weight loss surgery and employers to
be sympathetic to the needs of recovering
patients.
Sleeve, Bypass, or Band?
A perennial question in the field of bariatric
surgery is which bariatric procedure to perform
on a given patient. The answer to this question
should be based solely on the interests of the
patient, but this does not always seem to be the
case. The respective prevalence of the difference procedures seems to come in waves. This
is justifiable for some reasons, since increased
knowledge and improved techniques make
some options obsolete while giving us new
viable choices. However, far too much of the
decision seems to be based on current popularity
than on the patient’s interest.
The adjustable gastric band was all the
rage about a decade ago. Since then, many
surgeons have soured on it and are more likely
to encourage the vertical gastric sleeve. Neither
type of surgery is the single “right” solution.
Disadvantages of the band include risk of slippage, obstruction, and erosion, while the sleeve
in turn is irreversible and can carry risks of
staple line leakage. The gastric bypass remains
a popular option, but has its own drawbacks,
including greater risk for malnutrition, dumping
syndrome, and bowel obstruction.
The band, bypass, and sleeve all have the
potential to lead to weight loss as long as the
patient sticks to the required diet. When it
comes to weight loss and maintenance, none
of the surgery types is fail-proof, although the
gastric bypass may have a slight edge. Weight
regain is almost certain if patients remove the
band without getting another procedure. And,
inappropriate eating habits will lead to weight
regain regardless of whether the patient has the
band, bypass, or sleeve.
The Patient Comes First
The decision about which procedure a certain
patient should receive should never be based
on a surgeon’s own comfort in performing a
certain procedure. It should have nothing to do
with what is currently popular in the surgical
community. The only important consideration
when choosing a procedure is what is in the best
interest of the patient. Which procedure:
n Can help the patient lose weight?
nHas a relatively low risk of complications?
n Is most likely to help the patient keep it off
long-term?
You can address these questions by keeping up
with the scientific literature and staying in touch
with colleagues in the ASMBS community.
The decision gets more complicated, though,
and two patients of the same age, health status,
and weight may not be best off with the same
procedure. As an expert in the field, you have
the ability and the duty to dig a little deeper and
learn a little more about the individual patient.
For example, the following discussions are
based on patient preference and lifestyle rather
than scientific data.
Alex Brecher
n If a patient is hoping to become pregnant,
you might want to discuss the band because
of its ability to be unfilled during pregnancy.
n If a patient has an uncontrollable sweet
tooth, the bypass may be a good tool to aid
in the avoidance of sugary foods.
n If a patient is against the band because it
involves placement of a foreign object, you
might ask them to consider the sleeve.
Patients Are Entitled to Information
Your patients are entitled to the most accurate,
unbiased, and current information on differences between bariatric procedures. This information is more readily available when ASMBS
members work together to come to a consensus
on best practices, and when you are familiar
with current knowledge and trends in bariatric
surgery.
You are responsible for making sure patients
have access to this information in a form they
can understand. Your job is to answer all of their
questions, as many times as they want, without
pressuring them to rush a decision.
n They may not know where to find or how
to interpret scientific findings or ASMBS
position statements, but you do.
nAlso offer your opinion and recommendations based on your experiences.
n Dig a little deeper to find out why a
patient seems to want or not want a certain
procedure. For example, a patient might
seem adamant about the band, but upon
further investigation, you might discover
that she is expecting it to be temporary
because it is irreversible. In this case, you
would need to explain that band patients
who remove their bands and do not have
another procedure have almost no chance of
keeping the weight off.
Stand Together for Patients and
for Professionals
This is a very exciting time in bariatric surgery.
We are starting to see long-term outcomes of
earlier procedures, improvements in current and
emerging techniques, and new discoveries about
the potential health benefits of bariatric surgery.
Weight loss surgery is increasingly becoming
accepted as a mainstream treatment for obesity,
as evidenced by increasing numbers of patients
and more widespread coverage by health insurance companies.
Surgeons, integrated health professionals,
and ASMBS have the potential to keep these
positive changes going strong, but our loud voice
can be threatened. Jumping onto the bandwagon
of whichever surgical procedure is currently
hot is a surefire way to give patients suboptimal
care. Instead, we need to collaborate with and
learn from each other to be able to provide the
best possible counsel and care to patients, and to
make ASMBS an effective advocate for weight
loss surgery.
bariatricnews.net 29
ISSUE 21 | AUGUST 2014
Diet or surgery alters our perception of food
Bariatric participants were not
as focused on food and their
post-weight loss scans showed
decreased activation in medial PFC
H
ow we lose weight affects how our brains
respond to images of food, according to
brain imaging research conducted at the
University of Kansas School of Medicine.
The study, published in the journal Obesity,
examined brain changes associated with different
methods of weight loss.
The findings suggest that food means more to
people who lose weight by changing their behaviour (calorie watching, regular exercise) than it
does to people who people who undergo surgery.
The authors of the study say the surgery patients
appear to be more “disconnected” from the experience of hunger.
“They’re not as interested in eating,” said lead
author Dr Amanda Bruce, a psychologist with appointments at the University of Missouri–Kansas
City and the University of Kansas School of Medicine. “They’re not as motivated by food.”
Researchers used functional magnetic resonance
imaging (fMRI) to measure the brain responses of
individuals who lost weight after having laparoscopic banding surgery and individuals who lost
weight through lifestyle interventions. When
shown images of pizza and other ‘appetising’ food,
the brains of individuals who lost weight without
surgery were more active in the medial prefontal
cortex, the part of the brain known to regulate emotion and evaluate how we feel.
The scans were performed at the Hoglund Brain
Imaging Center at the University of Kansas Medical
Center. Instruments recorded the study participants’
brain activation levels as they looked at pictures of
food. The participants were tested before and after
they lost weight.
The 16 diet participants and 15 surgery participants in the study were similar in age, education
levels and, most important, BMIs. The bariatric
participants had lost about 9.3 percent of their body
weight. The dieters had shed 10.8 percent, which
was not significantly different.
Although the researchers expected to see differences in the brain activation changes between the
two groups, the thought the dieters would show
increased activity in regions of the brain associated with impulse control or self-regulation. There
were differences, but not in the region of the brain
expected.
“A huge strength of this paper is that the people
in the two different groups were matched on the
weight that they lost,” said Bruce. “The brain area
that showed greater change in activation for the
diet participants is an area that is associated with
attentional processing, salience, how much you
value something.”
It makes sense that the dieters had more activity
in areas of the brain known to be relate to motivation and the experience of hunger.
“When people are working hard to lose weight,
they’re still really focused in on food stimuli,” she
added. “They’re thinking about food a lot. That’s
one of the challenges. They’re often thinking about
the foods they maybe shouldn’t eat. They’re still
very motivated by these food stimuli. They’re
focused on them.”
In comparison, the bariatric participants were
not as focused on food and their post-weight loss
scans showed decreased activation in (PFC), which
the authors write, “supports the notion that surgical weight loss patients undergo a ‘forced’ dietary
restriction in avoiding discomfort that renders food
cues to be less rewarding and less salient.”
The papers concludes that “Behavioural dieters showed increased responses to food cues in
medial PFC – a region associated with valuation
and processing of self-referent information – when
compared to bariatric patients. Bariatric patients
showed increased responses to food cues in brain
regions associated with higher level perception
– when compared to behavioural dieters. The
method of weight loss determines unique changes
in brain function.
Single injection of FGF1 restores normal glucose levels
Researchers found that
with a single dose, blood
sugar levels quickly dropped
to normal levels in all the
diabetic mice
The discovery could lead to a
new generation of safer, more
effective diabetes drugs
A
single injection of the protein
Fibroblast growth factor 1
(FGF1) is enough to restore
blood sugar levels to a healthy range for
more than two days in mice with dietinduced diabetes (the equivalent of type
2 diabetes in humans), researchers from
the Salk Institute for Biological Studies,
La Jolla, CA. The paprer, ‘Endocrinization of FGF1 produces a neomorphic and
potent insulin sensitizer’, published in
the journal Nature, could lead to a new
generation of safer, more effective diabetes drugs, the study investigators claim.
“Controlling glucose is a dominant
problem in our society,” said Ronald M
Evans, director of Salk’s Gene Expression Laboratory and corresponding
author of the paper. “And FGF1 offers
a new method to control glucose in a
powerful and unexpected way.”
The team found that sustained
treatment with the protein not only
keeps blood sugar under control, but
also reverses insulin insensitivity, the
underlying physiological cause of
diabetes. Equally exciting, the newly
developed treatment does not have the
side effects common to most current
diabetes treatments.
In 2012, Evans and his colleagues
reported that that a long-ignored growth
factor had a hidden function: it helps the
body respond to insulin. Unexpectedly,
mice lacking the growth factor, called
FGF1, quickly develop diabetes when
placed on a high-fat diet, a finding suggesting that FGF1 played a key role in
managing blood glucose levels.
FGF1 is an autocrine/paracrine regulator whose binding to heparan sulphate
proteoglycans effectively precludes its
circulation. This led the researchers to
wonder whether providing extra FGF1 to
diabetic mice could affect symptoms of
the disease.
Evans’ team injected doses of FGF1
into obese mice with diabetes to assess
the protein’s potential impact on metabolism. Researchers found that with a single
dose, blood sugar levels quickly dropped
to normal levels in all the diabetic mice.
“Many previous studies that injected FGF1 showed no effect on healthy
mice,” said Dr Michael Downes, a senior
staff scientist and co- author of the study.
“However, when we injected it into
a diabetic mouse, we saw a dramatic
improvement in glucose.”
The researchers found that the FGF1
treatment had a number of advantages
over the diabetes drug Actos, which is
associated with side effects ranging from
Figure 1: In the liver tissue of obese animals with type 2 diabetes, unhealthy, fat-filled
cells are prolific (small white cells, panel A). After chronic treatment through FGF1
injections, the liver cells successfully lose fat and absorb sugar from the bloodstream
(small purple cells, panel B) and more closely resemble cells of normal, non-diabetic
animals. Courtesy of the Salk Institute for Biological Studies
unwanted weight gain to dangerous heart
and liver problems. Importantly, FGF1
(even at high doses) did not trigger these
side effects or cause glucose levels to
drop to dangerously low levels, a risk
factor associated with many glucoselowering agents.
Research team caption: From left: Jae
Myoung Suh, Annette Atkins, Michael
Downes, Maryam Ahmadian, Ronald
Evans and Ruth Yu of the Gene Expression Laboratory. Courtesy of the Salk
Institute for Biological Studies
Instead, the injections restored the
body’s own ability to naturally regulate
insulin and blood sugar levels, keeping
glucose amounts within a safe range,
effectively reversing the core symptoms
of diabetes.
“With FGF1, we really haven’t seen
FGF1 research team
hypoglycaemia or other common side effects,” said Salk postdoctoral research fellow Jae Myoung Suh, a member of Evans’
lab and first author of the new paper. “It
may be that FGF1 leads to a more ‘normal’
type of response compared to other drugs
because it metabolizes quickly in the body
and targets certain cell types.”
The mechanism of FGF1 still isn’t
fully understood, nor is the mechanism
of insulin resistance, but the group
discovered that the protein’s ability to
stimulate growth is independent of its
effect on glucose, bringing the protein a
step closer to therapeutic use.
“There are many questions that
emerge from this work and the avenues
for investigating FGF1 in diabetes and
metabolism are now wide open,” said
Evans.
Pinning down the signalling pathways
and receptors that FGF1 interacts with
is one of the first issues and there are
plans to initiate human trials of FGF1,
although it will take time to fine-tune the
protein into a therapeutic drug.
“We want to move this to people by
developing a new generation of FGF1
variants that solely affect glucose and
not cell growth,” he concluded. “If we
can find the perfect variation, I think we
will have on our hands a very new, very
effective tool for glucose control.”
Other researchers on the study were
Maryam Ahmadian, Eiji Yoshihara,
Weiwei Fan, Yun-Qiang Yin, Ruth T Yu,
and Annette R. Atkins of the Salk Institute
for Biological Studies; Weilin Liu, Johan
W Jonker, Theo van Dijk, and Rick Havinga of the University of Groningen, The
Netherlands; Christopher Liddle of the
University of Sydney, Australia; Denise
Lackey, Olivia Osborn, and Jerrold M.
Olefsky of the University of California
at San Diego; and Regina Goetz, Zhifeng
Huang, and Moosa Mohammadi of the
New York University School of Medicine.
30 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Study links Helicobacter pylori treatment to weight gain
The rate of obesity and overweight
were inversely and significantly
correlated with the prevalence of
H pylori infection
P
eople treated for the Helicobacter pylori
infection developed significant weight gain
compared to subjects with untreated H pylori colonisation, suggesting that treating the bacteria is linked to weight gain, according to research
published in the journal Alimentary Pharmacology
& Therapeutics.
There is currently a debate over the effect of H pylori infection on BMI with a recent study demonstrating that patients who underwent H pylori eradication
developed significant weight gain as compared to
subjects with untreated H pylori colonisation.
Therefore, the researchers wanted to assess the association between H pylori colonisation and the prevalence of overweight and obesity in developed countries.
They undertook a literature search and identi-
fied 49 studies with data from ten European
countries, Japan, the US and Australia. The mean
H pylori rate was 44.1% (range 17–75%), the
mean rates for obesity and overweight were 46.6
(±16)% and 14.2 (±8.9)%. The rate of obesity
and overweight were inversely and significantly
(r=0.29, p<0.001) correlated with the prevalence
of H pylori infection.
“The rate of obesity and overweight were inversely
and significantly correlated with the prevalence of H
pylori infection,” said lead author of the study, Profes-
sor Gerald Holtmann, Director of Gastroenterology
and Hepatology at the Princess Alexandra Hospital
in Brisbane, and Associate Dean Clinical at the
University of Queensland, Australia. “The gradual
decrease of the H pylori colonisation observed in
recent decades could be causally related to the obesity
endemic observed in the Western world”.
It is estimated that 50% of the global population
may be infected with H pylori however, only 20% of
infected people experience symptoms. The bacteria
is the most common cause of stomach ulcers.
1st BOMSS accredited SG dietary booklet is launched
The working group involved experienced
specialist bariatric dietitians from around the UK,
patients and surgeons
T
he 1st BOMSS accredited dietary advice for sleeve gastrectomy patients has been published. This dietary information
provides a resource for dietitians to use with patients following
sleeve gastrectomy surgery.
The sleeve gastrectomy diet sheet development project was led by
Nerissa Walker in Sheffield, working in collaboration with BOMSS
and Nutrition and Diet Resources UK (NDR-UK). The working group
involved experienced specialist bariatric dietitians from around the
UK, patients and surgeons.
The dietary information contains nutritional advice for sleeve
gastrectomy patients through the dietary stages, with appropriate
practical food choice advice and meal ideas for each stage. There is
also comprehensive information regards portion sizes, dietary rules to
follow after sleeve gastrectomy surgery and food group advice.
The dietary stages have been written to allow the bariatric dietitian
to determine the length of time on each dietary stage, providing flexibility for the dietitian to adapt the timeline to complement the local
bariatric centre preference.
“This long awaited resource is the first collaboration between
BOMSS and the NDR- UK to produce a good quality, peer-reviewed
sleeve gastrectomy dietary for dietitian’s to use with patients,” said
Nerissa Walker, Specialist Dietitian for bariatric surgery. “I hope that
the sleeve gastrectomy dietary information will be used routinely by
bariatric dietitian’s and that BOMSS and NDR-UK can work together
in the future to produce other good quality bariatric dietary resources.”
The resource is available from Nutrition and Diet Resources UK
(NDR-UK). Contact the NDR-UK Team on 0141 202 0690/info@
ndr-uk.org. Please note that the sample copy is password protected
and can be viewed by a registered Dietitian only.
Nutritional deficiencies in surgical and non-surgical teens
cludes the portion of the small intestine where many
nutrients, especially iron, are most absorbed,” said
Dr Stavra Xanthakos, medical director the Surgical Weight Loss Program for Teens at Cincinnati
Children’s and a co-author of the study. “What this
shows us is that nutritional deficiencies occur even
in teens who don’t undergo surgery. Severely obese
patients should be screened for nutritional deficiencies, regardless of whether they’ve undergone
he risk of nutritional deficiencies exists in weight loss surgery.”
severely obese adolescents, whether they
The results revealed that at least five years after
have had bariatric surgery or not, according
to a study by researchers from Cincinnati Children’s Table 1: Nutritional measures
Hospital Medical Center. The study, presented at the
annual meeting of the Pediatric Academic Societies
in Vancouver, Canada, is believed to be the first Hypoalbuminemia (albumin <3.4g/dL)
study to compare the nutritional status of severely Low serum iron (M<67 µg/dL; F< 50)
obese teens who did not undergo bariatric surgery to Hypoferritinemia (M< 26 ng/dL; F< 8)
those who did have bariatric surgery.
Anemia (M< 13.3 g/dL; F< 11.7)
“We knew there were nutritional difficulties Hypovitaminosis B12 (M< 210 pg/mL; F< 211)
in teens who had undergone bariatric surgery, but
Elevated PTH (>84 pg/mL)
everyone thought it was primarily the surgery that
caused these problems since gastric bypass ex- Hypovitaminosis D (< 20 ng/mL)
Gastric bypass patients were at risk
of low iron, mild anaemia and low
vitamin D
Severely obese teenagers who did not
undergo weight loss surgery were low
iron and low vitamin D
T
undergoing gastric bypass surgery, teens and young
adults maintained significant weight loss but were at
risk of nutritional deficiencies, particularly low iron,
mild anaemia and low vitamin D.
In addition, the researchers also reported that
severely obese teenagers who did not undergo
weight loss surgery were low iron and low vitamin
D. Those who did not have surgery also had low
levels of protein in their blood.
The researchers studied 61 obese teens who either received laparoscopic RYGB surgery (n=37) or
Non-surgical
Surgical
p-value
12.5%
2.9%
0.29
43.5%
67.7%
0.10
8.7%
50%
<0.01
4.4%
46%
<0.01
13%
23.5%
0.50
26.1%
42.4%
0.26
81.8%
76.5%
0.75
were evaluated but did not receive surgery (n=24).
The patients were evaluated between 2001 and 2007
and contacted to participate in the study between
2011 and 2014.
The mean baseline age and BMI differed
between nonsurgical (15.3 years, 50.4) and surgical groups (16.8 years, 60.1; each p<0.01). The
groups were similar by sex (75% vs. 67% female;
p=0.58).
At a mean of seven years from baseline for each
group, the mean BMI in the nonsurgical group
was higher than in the surgical (54.2 (+7.5%) and
45.1 (-25%) respectively; p=0.01). The nutritional
measures are shown in the Table 1.
The researchers conclude that “Durable and
significant BMI reduction was seen after adolescent
RYGB, but not in non-surgical patients. Numerous micronutritional deficiencies were detected in
both groups, but low iron stores and mild anaemia
were more prevalent after RYGB. Chronic care of
severely obese individuals should include careful
attention to micronutrient status irrespective of
bariatric surgical history.”
Nutritional guidance is essential post-surgery
Study sought to evaluate the
dietary intake of macro- and
micronutrients in patients
before and after RYGB
T
he intake of macronutrients increases three months post-surgery
but the micronutrient intake
remains at a ‘worryingly low level’ and
it is essential that nutritional guidance is
provided to patients following bariatric
surgery, according to researchers from
Belgium.
The investigators from Leuven University College, University Hospitals
Leuven and KU Leuven/University
Hospitals Leuven, Leuven, Belgium, said
that although bariatric surgery remains the
sole medical intervention that achieves
considerable and sustained weight loss,
it is associated with nutritional deficiencies. As a result, their study sought to
evaluate the dietary intake of macro- and
micronutrients in patients before and after
Roux-en-Y gastric bypass (RYGB).
Reporting the findings during a poster
presentation at the Proceedings of the
Fourth Belgian Nutrition Society Symposium 2014, Brussels, the prospective
observational study recruited 32 patients
who were asked to compete a dietary
record of two non-consecutive days
before RYGB and one and three months
after RYGB. Intake of macronutrients and
micronutrients was calculated for the different time-points.
They report that intake of macro- and
micronutrients is markedly decreased
one month after RYGB. At three months
post-surgery, the intake of macronutrient
increases (Table 1) but the micronutrient
intake remains identical at a worryingly
low level (Table 2).
“Our data clearly suggest that nutritional guidance is essential following
bariatric surgery,” the conclude.
The study was published in the
Achives of Public Health, as a part of
an educational supplement ‘Proceedings
of the Fourth Belgian Nutrition Society
Symposium 2014: Genes and nutrition,
is personalised nutrition the next realistic
step’ from the meeting.
Table 1: Intake of macronutrients at different time-points, shown as mean±SD
n=22
Intake pre-RYGB
Intake 1 month
post-RYGB
Intake 3 months
post-RYGB
Significance
Carbohydrates (g)
245.2±72.4
81.8±39.1
110.9±51.42
1,2
Proteins (g)
87.3±23.8
37.2±16.6
48.0±14.4
1,2,3
Fat (g)
92.2±40.4
20.5±12.6
36.3±16.2
1,2,3
1 p<0.01:pre-op vs post-op 1 month; 2 p<0.01:pre-op vs post-op 3 months; 3 p<0.01:post-op 1 month vs post-op 3 months
Gesquiere et al. Archives of Public Health 2014 72(Suppl 1):P4 doi:10.1186/2049-3258-72-S1-P4
Table 2: Intake of micronutrients at different time-points, shown as mean±SD
Intake pre-RYGB
(32 patients)
Intake 1 month
post-RYGB (28
patients)
Intake 3 months
post-RYGB (26
patients)
Ca (mg)
970.4±519.6
638.4±287.9
695.1±352.3
Fe (mg)
12.6±3.7
5±2.9
6.0±1.8
Cu (mg)
2.1±1.5
1.0±0.9
4.9±18.6
Zn (mg)
46.6±92.1
10.2±21.1
6.6±3.7
Vitamin A (µg)
962.8±405.2
721.5±490.0
787.5±716.6
Significance
1,2
Vitamin B1 (mg)
1.7±0.7
0.6±0.3
0.8±0.3
1,2
Vitamin B12 (µg)
5.4±2.5
2.3±1.5
3.3±1.8
1,2
Vitamin C (mg)
138.9±83.8
70.3±56.7
85.1±52.2
1,2
Vitamin D (µg)
8.4±5.1
5.2±3.3
4.2±3.2
1 p<0.01:pre-op vs post-op 1 month; 2 p<0.01:pre-op vs post-op 3 months; 3 p<0.01:post-op 1 month vs post-op 3 months
Gesquiere et al. Archives of Public Health 2014 72(Suppl 1):P4 doi:10.1186/2049-3258-72-S1-P4
bariatricnews.net 31
ISSUE 21 | AUGUST 2014
Depression linked to obesity, drugs linked to weight gain
MDD with atypical features
associated with a higher
increase in adiposity in terms
of BMI, incidence of obesity
and waist circumference
Antidepressants differ modestly
in their propensity to contribute
to weight gain
T
wo studies have provided new
insights into the issue surrounding
depression, antidepressants and
obesity. The first concludes that major
depressive disorder (MDD) appears to be
associated with obesity, whilst a second
paper reports that some antidepressants
can lead to weight gain among patients.
Writing in JAMA Psychiatry (‘Depression With Atypical Features and
Increase in Obesity, Body Mass Index,
Waist Circumference, and Fat Mass – A
Prospective, Population-Based Study’),
Dr Aurélie M Lasserre of Lausanne
University Hospital, Switzerland, and
colleagues, note that understanding the
mechanisms underlying the association
between MDD and obesity is important.
In order to determine whether the
subtypes of major depressive disorder
(MDD; melancholic, atypical, combined,
or unspecified) are predictive of adiposity
in terms of the incidence of obesity and
changes in BMI, waist circumference
and fat mass, they designed a prospective
population-based cohort study, CoLaus
(Cohorte Lausannoise)/PsyCoLaus (Psychiatric arm of the CoLaus Study), that included 3,054 randomly selected residents
(mean age 49.7; 53.1% were women) of
the city of Lausanne, Switzerland.
Results
At baseline, 7.6 percent of participants
met the criteria for MDD. Among the
participants with MDD, about 10 percent
had atypical and melancholic episodes,
14 percent had atypical episodes, 29
percent had melancholic episodes and 48
percent had unspecified episodes.
They found that participants with the
atypical subtype of MDD at baseline
revealed a higher increase in adiposity during follow-up than participants
without MDD. The associations between
this MDD subtype and body mass index
(β = 3.19; 95% CI, 1.50-4.88), incidence
of obesity (odds ratio, 3.75; 95% CI,
1.24-11.35), waist circumference in both
sexes (β = 2.44; 95% CI, 0.21-4.66), and
fat mass in men (β = 16.36; 95% CI,
4.81-27.92) remained significant after
adjustments for a wide range of possible
cofounding.
The study suggests the higher BMI
increase in participants with MDD with
atypical features also was not temporary
and persisted after remission of the depressive episode.
“The atypical subtype of MDD is
a strong predictor of obesity,” they
conclude. “This emphasises the need to
identify individuals with this subtype of
MDD in both clinical and research settings. Therapeutic measures to diminish
the consequences of increased appetite
during depressive episodes with atypical
features are advocated.”
Antidepressants
In the second study also published in
JAMA Psychiatry (‘An Electronic Health
Records Study of Long-Term Weight
Gain Following Antidepressant Use’),
Sarah R Blumenthal from the Massachusetts General Hospital, Boston, and
colleagues sought to assess the weight
gain associated with specific antidepressants over the 12 months following
initial prescription in a large and diverse
clinical population.
Using electronic health records from
a large New England health care system,
they identified 22, 610 adult patients who
began receiving a medication of interest
with available weight data. They extracted prescribing data and recorded weights
for any patient with an index antidepressant prescription including amitriptyline
hydrochloride, bupropion hydrochloride,
citalopram hydrobromide, duloxetine
hydrochloride, escitalopram oxalate,
fluoxetine hydrochloride, mirtazapine,
nortriptyline hydrochloride, paroxetine
hydrochloride, venlafaxine hydrochloride, and sertraline hydrochloride.
As measures of assay sensitivity,
additional index prescriptions examined
included the antiasthma medication
albuterol sulfate and the antiobesity
medications orlistat, phentermine hydrochloride, and sibutramine hydrochloride.
Mixed-effects models were used to
estimate rate of weight change over 12
months in comparison with the reference
antidepressant, citalopram.
Results
A total of 19,244 adults were treated
with an antidepressant for at least three
months and 3,366 received a nonpsychiatric intervention. Compared
with citalopram, in models adjusted for
sociodemographic and clinical features,
significantly decreased rate of weight
gain was observed among individuals
treated with bupropion (−0.063 [0.027];
p=0.02), amitriptyline (−0.081 [0.025];
p=0.001), and nortriptyline (−0.147
[0.034]; p<0.001). Differences were less
pronounced among individuals discontinuing treatment prior to 12 months.
They noted that although short-term
studies suggest antidepressants are associated with modest weight gain little
is known about longer-term effects and
differences between individual medications in general clinical populations. The
potential health consequences could be
significant because more than 10 percent
of Americans are prescribed an antidepressant at any given time.
“Taken together, our results clearly
demonstrate significant differences between several individual antidepressant
strategies in their propensity to contribute to weight gain,” the authors write.
“While the absolute magnitude of such
differences is relatively modest, these
differences may lead clinicians to prefer
certain treatments according to patient
preference or in individuals for whom
weight gain is a particular concern.”
Bariatric fathers can influence overweight boys
Overweight boys who lived with an
adult who had bariatric surgery had
a lower-than-expected BMI postsurgery
A
parent’s bariatric surgery history could be
an opportunity to break the cycle of obesity
in an overweight son, according to a Geisinger research study published in Obesity. This study
is thought to be the largest study of the effect of an
adult’s Roux-en-Y gastric bypass (RYGB) surgery
on the weight of children in the same household.
“The relationship between parent and childhood
obesity is likely attributable to a combination of
genetic and family environmental influences,”
said Dr Christopher D Still, director of Geisinger’s
Obesity Institute. “We believe that environmental
influences, including parental modelling of eating
behaviour, responsiveness to child signals, and
availability of certain foods in the home, may offer
possible opportunities for intervention.
The aim of the study was to evaluate the impact
of adult bariatric surgery on the BMI of children
living in the same household. In this retrospective case-control study, case dyads (n = 128) were
composed of one adult who had bariatric surgery
and one child at the same address. Control dyads
(n = 384) were composed of an adult with obesity
but no bariatric surgery and a child at the same address. Two-sample t-test determined whether the
differences between actual and expected BMI at
follow-up (post-surgery) differed between children
in the case and control dyads.
They found that overweight boys who lived with
an adult who had bariatric surgery had a lowerthan-expected BMI post-surgery, while overweight
boys who did not live with an adult with a history
of bariatric surgery had a higher-than-expected BMI
at follow-up (p=0.045). Differences between actual
and expected BMIs of children were not significantly different between cases and controls in girls
or in children in other weight classes.
While the Geisinger study does not support a collateral benefit of bariatric surgery in most children,
it clearly demonstrates a benefit in boys with a BMI
of 25-34.
“Parental obesity is one of the strongest risk
factors for childhood obesity,” explained Still. “The
prevalence of obesity among children living with
bariatric surgery in our study was 40 percent – twice
the national average. Obese children are more likely
to suffer from physical and emotional ailments like
high blood pressure, acid reflux, knee and back
pain, and low self-esteem.”
According to the authors, identifying an opportu-
nity to lower BMI in overweight boys is particularly
important, given there has been a significant increase
in obesity prevalence among men and boys over
the last decade, while obesity rates have remained
stable in girls and women.
“Children of parents who undergo bariatric
surgery are at a high risk of obesity. We may be
able to leverage bariatric surgery to help us target
children at high risk of obesity for a weight loss intervention,” said Dr Annemarie Hirsch, a research
investigator from Geisinger’s Center for Health
Research. “Specifically, because the adult family
member is already engaged in making lifestyle
changes, this may present an opportunity to target
the parent in a family-based healthy lifestyle intervention.”
The researchers added that future studies may be
warranted to determine the mechanisms by which
these children experience collateral weight loss.
Weight Watchers and Qsymia found to be best value
Cost per kg lost to cost per QALY saved showed
Weight Watchers and Qsymia the best value for
money
W
eight Watchers and the drug Qsymia showed the best
value for the money, according to a cost-effectiveness
analysis of commercial diet programmes and drugs
published in the journal Obesity. The authors claim that the findings
provide important information on the health and weight-loss benefits
per dollar spent as insurance carriers consider coverage for weight loss
programmes and drugs.
“The obesity epidemic is raising serious health and cost consequences, so employers and third-party payers are beginning to consider
how to provide some coverage for commercial weight loss programs,”
said senior author Dr Eric Finkelstein, professor at Duke-NUS and the
Duke University Global Health Institute. “These results will help them
make better purchasing decisions to maximise the health gains using
available resources.”
Finkelstein and research assistant Eliza Kruger conducted a literature review to identify high-quality clinical trials of commercially
available diet/lifestyle plans and medications with proven weight loss
at one year or more. Weight loss was measured in terms of absolute
change in kilograms lost compared to a control group in which patients underwent a low cost/low intensity intervention, or a placebo in
the case of the pharmaceutical trials.
They found that three diet/lifestyle programmes and three medications met the inclusion criteria for the cost-effectiveness analysis:
Weight Watchers, Jenny Craig and VTrim, along with the diet pills
Qsymia, Lorcaserin and Orlistat.
Several meal replacement products were excluded despite showing some weight loss success (including Medifast, Optifast and
Slimfast) because they did not meet one or more inclusion criteria.
Weight-loss surgery was also excluded.
Outcomes
They report that the average cost per kilogram of weight lost ranged
from US$155 for Weight Watchers to US$546 (for Orlistat). The
incremental cost per QALY gained for Weight Watchers and Qsymia
was US$34,630 and US$54,130, respectively. All other interventions
were prohibitively expensive or inferior in that weight loss could be
achieved at a lower cost through one or a combination of the other
strategies.
In terms of cost, Weight Watchers was also shown to be the least expensive intervention, consisting of an average annual cost of US$377.
The expected annual cost for Vtrim users was US$682. Jenny Craig
food was the most expensive intervention, with an annual cost of more
than US$2,500. However, Jenny Craig regimen also generated the
greatest weight loss.
The expected annual costs for the diet pills was US$1,743 for
Lorcaserin; US$1,518 for Orlistat; and US$1,336 for Qsymia.
Average weight loss at one year ranged from 2.4kg for Weight
Watchers to 7.4 kg for Jenny Craig. Those on Orlistat lost 2.8 kg
whereas those on Vtrim and Lorcaserin both lost an average of 3.2 kg.
Weight loss for those on Qsymia averaged 6.7kg.
Based on the cost and weight-loss data, the average cost per kilogram lost ranged from US$155 per kg for Weight Watchers to US$338
or more for Jenny Craig. Qsymia came in at US$232 per kg.
When the analysis was extended from cost per kilogram lost to cost
per quality adjusted life year saved (QALY), the researchers found
that Weight Watchers and Qsymia showed the best value for money.
QALYs are often used to benchmark the value of a particular health
innovation, with high value interventions typically improving QALYs
at a rate of US$50,000 or better.
“Health policy makers do not understand value in terms of cost
per kilogram lost, but if you tell them that an intervention improves
QALYs at better than US$50,000 per QALY saved, they recognize
that as good value for money,” said Finkelstein. “But looking at cost
per weight lost or QALY saved, Weight Watchers looked best because
it’s the least expensive. Qsymia also showed good value for money
because the additional weight loss came at a fairly low cost. To remain
competitive, the other programmes will either need to up the benefits
and/or reduce costs, perhaps through cost-sharing or via other incentive strategies.”
Dr Finkelstein disclosed that he has been a paid consultant for
Jenny Craig, Weight Watchers, Takeda, Orexigen, and Vivus. Eliza
Kruger reported no conflicts of interest.
32 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Costs barrier to body contouring after surgery
Bariatric surgery plus bodycontouring surgery group had
a significantly lower mean
age (p=0.011) and reported
longer time since surgery
(p=0.022)
Cost was the most commonly
reported barrier (87.8 percent,
n=36)
H
igh perceived costs are the
major barrier to body contouring
surgery for patients who have
undergone bariatric surgery to remove
excess skin folds, according to a study
‘Body contouring surgery after bariatric
surgery: a study of cost as a barrier and
impact on psychological well-being’,
published in Plastic and Reconstructive
Surgery, the official medical journal of
the American Society of Plastic Surgeons.
The study, by psychiatrist Dr Raed
Hawa and colleagues of University of
Toronto, adds to recent evidence that
body contouring surgery (BCS) has
demonstrable mental and physical
health benefits.
The investigators sought to examine
barriers to access and to compare socioeconomic variables and psychological
variables between bariatric surgery
patients who have undergone body
contouring and those who have not.
Their cross-sectional study included a
questionnaire packet that was administered to (1) patients who underwent bariatric but not body-contouring surgery
and (2) patients who underwent both.
The questionnaire included perceived
barriers to body-contouring surgery,
socioeconomic barriers, measures of
anxiety (Generalized Anxiety Disorder
seven-item scale), depression (Patient
Health Questionnaire nine-item scale),
and quality of life (Short Form-36).
Patients were recruited from the
Toronto Western Hospital Bariatric
Surgery Program, a Level 1A bariatric
center accredited by the American
College of Surgeons, during follow-up
appointments between February 1,
2013, and August 1, 2013. All patients
underwent a Roux-en-Y gastric bypass
unless a sleeve gastrectomy was surgically indicated. Consent was obtained
from patients for the study if they were
between the ages of 18 and 65 years and
had undergone bariatric surgery at least
one year previously. Of the 71 patients
who were approached for consent, 64
provided consent, and 58 completed the
entire questionnaire, resulting in a response rate of 82 percent. This study was
approved by the Institutional Research
Ethics Board at the University Health
Network in Toronto, Ontario, Canada.
The study included 58 patients from
the Toronto Western Hospital Bariatric
Surgery Program, a Level 1A bariatric
centre during follow-up appointments
between February 2013 and August
2013. Their average age was 46 years
and they lost about 40 percent of their
previous body weight.
Outcomes
Among the 58 study participants (48
underwent bariatric surgery alone and ten
patients underwent both bariatric surgery
and body-contouring surgery), 93.1 percent reported having excess skin folds.
Mean scores on the Generalized
Anxiety Disorder scale (6.08±5.97 versus 3.50±3.10; p=0.030) and the Patient
Health Questionnaire (6.40+6.77 versus
2.40±2.37; p=0.002) were significantly
higher for the bariatric surgery group
versus bariatric surgery plus body con-
touring group. Patients in the latter group
had significantly higher Short Form-36
physical health component scores (56.80
± 4.88 versus 49.57 ± 8.25; p=0.010).
Compared with the bariatric surgery–
alone group, the bariatric surgery plus
body-contouring surgery group had a
significantly lower mean age (p=0.011)
and reported longer time since surgery
(p=0.022). No significant differences
between groups were reported in any
other demographic variable collected.
For the 41 patients desiring bodycontouring surgery, cost was the most
commonly reported barrier (87.8
percent, n=36), followed by a desire
for more weight loss before considering
body-contouring surgery (9.8 percent,
n=4) and a fear of the operation (2.8
percent, n=1). Despite cost being reported as a major barrier to undergoing
body-contouring surgery, the bariatric
surgery–alone group and the bariatric
surgery plus body-contouring surgery
group did not significantly differ from
each other with respect to any of the
measured socioeconomic variables
(income, education, and employment).
“Our exploration of potential barriers
to accessing body-contouring surgery
suggests that, as hypothesized, cost was
reported as the most common barrier
in accessing body-contouring surgery
for this patient population,” the authors
write. “However, participants who pursued body-contouring surgery did not
report higher income or education, and
were not more likely to be employed…
our study identified a relationship
between lower age and body-contouring
surgery in univariate analysis and a
trend toward significance in multivariate
analysis. Although this has not been
previously identified in the literature, it
is possible that patients who are younger
are more invested in their appearance
and may pursue unconventional methods
of paying for body-contouring surgery
(e.g., loans, borrowing from family).
Additional research is needed to further
explore this study finding.”
Although this study confirms that cost
remains a major barrier to accessing bodycontouring surgery, other socioeconomic
factors, including income, may not significantly differ in patients who undergo
body-contouring surgery relative to those
who do not undergo the procedure.
Moreover, this research also suggests
that patients who undergo body-contouring surgery report less anxiety and
depression relative to bariatric surgery
patients experiencing excess skin folds.
“Longitudinal studies are needed to
compare the long-term physical and psychological adjustment in bariatric surgery
patients who undergo body-contouring
surgery following surgery and those who
do not,” they conclude. “If our findings
are replicated in longitudinal studies,
funding for body-contouring surgery
may need to be revaluated if the goal of
bariatric surgery is to enhance the physical and mental well-being of patients.”
New BMI thresholds for ethnic minorities
T
he rate of diabetes observed among whites classified as obese
with a BMI 30, was matched by South Asians with a BMI 22,
Chinese with a BMI 24 and Black people with a BMI 26
Researchers from the University of Glasgow have suggested new
BMI thresholds for defining overweight and obese individuals in ethnic communities. In an attempt to define new thresholds, researchers
from the University of Glasgow analysed data on nearly half a million
people who participated in UK Biobank.
They found that the rate of diabetes observed among whites classified as obese with a BMI 30, was matched by South Asians with a
BMI 22, Chinese with a BMI 24 and Black people with a BMI 26.
This finding supports the use of lower BMIs to define obesity in these
differing groups (Figure 1).
“This study confirms that we need to apply different thresholds
for obesity interventions for different ethnic groups. If not, we are
potentially subjecting non-white groups to discrimination by requiring a higher level of risk before we take action,” said Professor Jill
Pell, Director of the Institute of Health and Wellbeing. “Furthermore,
a blanket figure for all non-white groups is inappropriate. We need
to apply different thresholds for South Asian, black and Chinese
individuals.”
Presently, a BMI 30 or above is defined as obese but South Asian,
Chinese and black populations have an equivalent risk of diabetes at
lower BMIs than white people. The UK’s National Institute of Clinical Excellence has previously issued guidance on the subject to health
professionals but recommended that further studies be undertaken to
Figure 1: BMI thresholds and waist circumference between groups
White
South Asian
(Pakistani)
South Asian (Indian)
Chinese
Black
BMI (kg/m2)
30
21.5
22
26
26
Waist (cm/inches)
102/40
78/30.7
80/31.5
88/34.6
88/34.6
BMI (kg/m2)
30
21.6
22.3
24
26
Waist (cm/inches)
88/34.6
68/26.7
70/27/5
74/29
79/31
Men
Women
define the thresholds for ethnic minorities.
They used baseline data on the 490,288 participants from the four
largest ethnic subgroups: 471,174 (96.1%) white, 9,631 (2.0%) South
Asian, 7,949 (1.6%) black, and 1,534 (0.3%) Chinese. Regression
models were developed for the association between anthropometric
measures (BMI, waist circumference, percentage body fat, and waistto-hip ratio) and prevalent diabetes, stratified by sex and adjusted for
age, physical activity, socioeconomic status, and heart disease.
Among women, a waist circumference of 88cm in the white subgroup equated to the following: South Asians, 70cm; black, 79cm; and
Chinese, 74cm. Among men, a waist circumference of 102 m equated
to 79, 88, and 88cm for South Asian, black, and Chinese participants,
respectively (Figure 1).
The study also showed the differences between South Asian sub-
groups were small. The new BMI cut-offs were 21.5 in Pakistani men
compared with 22.0 in Indian men, and 21.6 in Pakistani women
compared with 22.3 in Indian men. Therefore, it would seem reasonable to apply the same cut-offs across all South Asian communities.
The results are published online in the journal Diabetes Care.
“Obesity is the main cause of the worldwide increase in diabetes.
Intervening at lower obesity cut-points in people from non-white
descent could save many lives,” said Uduakobong Efanga Ntuk, a
PhD student who conducted a large part of the research. “Diabetes
prevention programs need to be ethnic specific. People from South
Asian, Chinese and black descent need to be made aware that they
are at a higher risk of diabetes. By adopting a healthy lifestyle including physical activity and a healthy diet, they can significantly reduce
their risk.”
Extreme obesity can reduce life expectancy by 14 years
Years of life lost ranged from 6.5
years for participants with a BMI of
40-44.9 to 13.7 years for a BMI of
55-59.9
A
dults with extreme obesity could have
their life expectancy reduced by 6.5 years
if they have a BMI 40-44.9 to 13.7 years
for a BMI 55-59.9 due to the increased risks of
dying at a young age from cancer and many other
causes including heart disease, stroke, diabetes, and
kidney and liver diseases, according to results of
an analysis of data pooled from 20 large studies of
people from three countries. The study is published
in PLOS Medicine.
“Given our findings, it appears that class III
obesity is increasing and may soon emerge as a
major cause of early death in this and other countries worldwide,” said Dr Cari Kitahara, Division
of Cancer Epidemiology and Genetics, NCI, and
lead author of the study. “Prior to our study, little
had been known about the risk of premature death
associated with extreme obesity.”
The 20 studies that were analysed included
adults from the United States, Sweden and Australia. These groups form a major part of the NCI
Cohort Consortium, which is a large-scale partnership that identifies risk factors for cancer death.
After excluding individuals who had ever smoked
or had a history of certain diseases, the researchers
evaluated the risk of premature death overall and
the risk of premature death from specific causes
in more than 9,500 individuals who were class III
obese and 304,000 others who were classified as
normal weight.
The researchers found that the risk of dying
overall and from most major health causes rose
continuously with increasing BMI within the class
III obesity group. Statistical analyses of the pooled
data indicated that the excess numbers of deaths in
the class III obesity group were mostly due to heart
disease, cancer and diabetes.
“Given our findings, it appears that class III
obesity is increasing and may soon emerge as
a major cause of early death in this and other
countries worldwide,” said Dr Patricia Hartge,
Division of Cancer Epidemiology and Genetics,
and senior author of the study. “While once a
relatively uncommon condition, the prevalence
of class III, or extreme, obesity is on the rise.
In the United States, for example, six percent
of adults are now classified as extremely obese,
which, for a person of average height, is more
than 100lbs over the recommended range for
normal weight.”
To provide context, the researchers found that
the number of years of life lost for class III obesity
was equal or higher than that of current (versus
never) cigarette smokers among normal-weight
participants in the same study.
The accuracy of the study findings is limited
by the use of mostly self-reported height and
weight measurements and by the use of BMI as
the sole measure of obesity. Nevertheless, the researchers noted, the results highlight the need to
develop more effective interventions to combat
the growing public health problem of extreme
obesity.
“We found that the reduction in life expectancy associated with class III obesity was
similar to (and, for BMI values above 50 kg/
m2, even greater than) that observed for current
smoking,” the authors concluded. “If current
global trends in obesity continue, we must expect
to see substantially increased rates of mortality
due to these major causes of death, as well as
rising health-care costs. These results underscore
the need to develop more effective interventions
to combat this growing public health problem.”
34 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Country News
Canada: Surgery procedures
increase as outcomes improve
T
he number of bariatric surgeries performed in Canadian hospitals has nearly quadrupled since 2006–2007, according to a study from the Canadian Institute
for Health Information (CIHI). At the same time,
patient safety has improved with complication
and readmission rates declining over the past
few years with a readmission rates after bariatric surgery similar to that for all surgical patients in Canada.
“One in five Canadian adults has obesity
and with those rates continuing to grow, so
too will the need to understand the implications for the health care system,” said Kathleen Morris, director of Health System Analysis and Emerging Issues at CIHI. “Bariatric
surgery can be effective to help some patients reach a healthy weight. However, it is
not without risks. Supervised weight-management programs and lifestyle changes such
as healthy diet and increased physical activity
can be effective too.”
Report
The study, ‘Bariatric Surgery in Canada’, examines the current state of bariatric surgery in
the country and reports the types of surgeries,
costs and regional variations in surgery, as well
as patient outcomes.
The report states that 5,989 bariatric surgeries were performed in 2012–2013, up from
1,600 procedures in 2006–2007. The rise is
due largely to increased funding, surgical capacity and treatment programmes in some
provinces, most notably Ontario.
Over the same period, the number of hospitals performing the procedures also grew, from
34 to 46. It is estimated 1,000 additional procedures were performed in private clinics across
Canada in 2012 however, the report states that
“Comprehensive data is not currently available
on how many patients might be pursuing this
option.”
In 2012–2013, most procedures took
place in Ontario (2,846) and Quebec (1,988),
with Ontario accounting for almost half (48%)
of all hospital procedures done in Canada.
From 2006–2007 to 2012–2013, procedures
increased in the province from 297 to 2,846.
“Despite recent increases in funding in
some jurisdictions, access to bariatric surgery remains a challenge in Canada,” the report states. “Expanding the guidelines for the
surgery to potentially include those with less
excess weight, such as individuals with class I
obesity, may result in significantly more people
being eligible for the surgery.”
Figure 1: Changes in volume of different types of bariatric procedures performed in Canadian hospitals,
The report estimates that the total cost
2006–2007 to 2012–2013
for nearly 6,000 bariatric surgeries performed
in 2012–2013 was approximately C$48 million
(excluding physician compensation).
banding and gastric bypass were the most bariatric surgery.
common procedures. However, gastric by“There remains a great deal of variation
Patient characteristics
pass and sleeve procedures have increased across provinces in the specific procedures
Although there have been significant changes sharply since 2009–2010, while the overall provided to patients and in how long patients
in bariatric surgery volumes in recent years, the number of other procedures (such as biliopan- wait to receive their surgery,” the report conreort notes that patient characteristics have re- creatic diversion) has declined (Figure 1).
cluded. “More research is required to considmained relatively consistent. In 2012–2013,
er the impacts of government policy (such as
80% of hospital bariatric surgery patients were Complications
coverage for band procedures), patient preferwomen, reflecting the higher percentage of In 2012–2013, approximately 5.3% of bariat- ence and physician practice patterns in ongowomen among Canadians with class II (52%) ric surgery patients experienced a complication ing efforts to improve access to and outcomes
and class III (60%) obesity. The average age of during their hospitalisation, a decrease from of publicly covered bariatric procedures.”
patients was 45, ranging from 43 in Manitoba 8.2% in 2009–2010.
“We clearly will never have the capacity in
to 47 in British Columbia. The age distribution
The most common complications were Canada to help all of those who would qualishows that almost six out of ten (56%) patients bleeding; puncture and laceration; infection; fy for bariatric surgery with bariatric surgery,”
were age 30 to 49. The most common obe- and mechanical complications of inserted de- said Dr Yoni Freedhoff, assistant professor of
sity-related comorbidities documented among vices as a result of displacement, leakage or family medicine at the University of Ottawa and
bariatric patients in this study were sleep ap- perforation.
founder of Ottawa’s Bariatric Medical Institute,
noea (15%); hypertension (14%) and type 2 diIn 2012–2013, 14% of bariatric surgery pa- a nutrition and weight management centre.
abetes (13%).
tients who experienced in-hospital complica- “Bariatric surgery, when performed on approtions were readmitted to hospital within 30 days. priate patients by skilled surgeons, and when
Surgical procedures
In comparison, only 6% of patients who did not supported by a robust and well-designed edIn 2012–2013, gastric bypass was the most experience a complication were readmitted.
ucational component that helps support a
commonly performed bariatric surgery in CaThe declines in both in-hospital complica- healthy post-surgical lifestyle—increases life
nadian hospitals (53%), followed by sleeve tion and readmission rates suggest that reduc- expectancy, decreases or cures many medical
gastrectomy (28%) and gastric banding (15%). ing in-hospital complication rates can potential- comorbidities and improves many other asBetween 2006–2007 and 2009–2010, gastric ly reduce the likelihood of readmission following pects of quality of life.”
Public hospitals left to
AMA supports evidence-based obesity
revise private bariatric procedures treatment services
C
anada’s National Post is reporting a ‘crisis’ of public hospitals having to revise bariatric procedure for patients who
have previously undergone treatment
at private weight loss clinics.
According to the report, it is a
growing problem between private
and public medicine in the country and bariatric surgeons working
in taxpayer-funded hospitals claim
they are routinely treating patients
who have had privately performed
weight-loss operations.
The article quotes Daniel Birch, a
surgeon from Edmonton, who claims
that the cost to taxpayers of treating
patients who had gastric bands implanted by for-profit clinics in Canada.
“I think it’s a crisis, to be honest.
It may explode at some point when
all these people have ongoing issues,” said Birch. “It’s a tremendous
cost to the patient and to the system, with no sustainable quality-oflife change.”
Although the report does tress
that a procedure performed privately
does not mean sub-standard care or
provision, it does highlight that there
may be a lack of pre-operative and
post-operative consultation, compared with a publically-funded procedure.
However, this is not the case for
all private centres, only some. Moreover, there is no evidence to suggest
that the results from private hospitals
are any worse or better than those
that are publically-funded.
The experience of Canadian hospitals is similar to those in the UK. At
the 2014 BOMSS meeting, researchers from St Georges Healthcare NHS
Trust, London, UK, assessed the activity of a 24 hour emergency bariatric surgical on-call service provided by specialist bariatric surgeons
with particular emphasis on patient
who had undergone previous private
(non-NHS) bariatric surgery. They reported that “...there is a significant
volume of private patients who present as emergencies with complications related to bariatric surgery requiring NHS intervention. “These
findings have potentially important financial implications for both the private sector and the NHS.”
T
he House of Delegates of the American Medical Association has adopted a policy advocating the need for patient access to a continuum
of medically proven treatment options for obesity.
The AMA’s passage of the “Patient Access to EvidenceBased Obesity Services” resolution gives the AMA decisive direction to support advocacy efforts to improve patient access to all evidence-based obesity treatments.
“We are thrilled that through this and last year’s decisions, AMA has affirmed its commitment to working with us and fellow medical specialty societies focused on solving our global obesity crisis,” said ASBP
President Dr. Eric C. Westman, who also served as the
ASBP 2014 delegate to AMA.
These include behavioural, pharmaceutical, psychosocial, nutritional and surgical interventions as being possible obesity treatment options, each of which
are effective according to evidence-based medical research and practice.
The decision comes one year after AMA’s decision
recognising obesity as a “disease requiring a range
of medical interventions to advance obesity treatment
and prevention.”
Although AMA decisions do not have recognised
legal implications, these policy decisions are often referenced by federal and state legislators and other decision makers when setting medical policy and health
regulations.
With this and last year’s AMA policy adoptions on
obesity, the implications for patients and the health
care community may be far reaching, including:
n
improved training in obesity at medical schools and
residency programmes,
n
reduced stigma of obesity by the public and physicians,
n
improved insurance benefits for obesity-specific
treatment, and
n
increased research funding for both prevention and
treatment strategies.
While the Affordable Care Act (ACA) requires insurance
coverage for individuals affected by obesity and other related conditions like diabetes, insurers, including those
participating in the health insurance exchanges, are not
required to cover proven obesity treatment options. Furthermore, coverage for bariatric surgery for severe obesity is sporadic, whilst coverage for obesity drugs and
other evidence-based treatment options are excluded.
“Last year, the AMA’s declaration of obesity as a
disease greatly elevated the issue of obesity,” said Joe
Nadglowski, OAC President and CEO. “With today’s
announcement, we’re hopeful that healthcare providers will now utilise evidence-based treatments for obesity, such as behavioural counselling, obesity medications and bariatric surgery, when combating this
disease. In addition, we are now confident that our
continued advocacy efforts will make an impact in improving access. More than 93 million Americans are
impacted by the disease of obesity. The need for coverage of evidence-based treatments is critical in helping those impacted.”
bariatricnews.net 35
ISSUE 21 | AUGUST 2014
Kuwait looks
to establish
bariatric surgery
database
K
uwait’s Ministry of Health
(MoH) is contemplating on
whether to compile a database to track patients undergoing bariatric surgery in the State.
This comes in the wake of the rapid
increase in bariatric surgeries in the
State with obesity and its co-morbidities like type-2 diabetes reaching
epidemic levels.
It is currently estimated that
about 10,000 bariatric surgeries are
performed in Kuwait each year and
this number is expected to grow.
However, very little is known about
the exact procedures followed by different surgeons and their outcomes
on a national level. Bariatric surgery
is proving to be an effective strategy in the treatment of obesity and related chronic diseases, especially in
the backdrop of the economic strain
these medical conditions put on the
country’s healthcare system.
If the MoH’s plans for a registry comes through it would make
data on surgeries, investigations and
treatments readily available. Such a
robust, reliable and integrated data
collection registry would include reporting and data analysis, which
would yield a quality assurance programme within any hospital.
Moreover, having a unified cen-
tral clinical database would
enable different bariatric surgery departments within the MoH to produce systematic risk stratified outcome reports for each location.
These reports would further enhance
the whole department’s national and
international reputation and enable
the MoH to deliver high-quality bariatric practices in Kuwait, consistent
with international standards.
The database would provide the
required data to the ministry, bariatric
surgery specialists, and patients in
Kuwait to track, analyse, and benchmark service delivery in the country,
as well as patient outcomes, and enhance medical education in bariatric
surgery in Kuwait.
At the hospital level, this will also
facilitate clinical workflow and data
collection, analysis and reporting in
each bariatric surgery center in the
state. Another advantage of the database is that it would enable the
MoH to monitor individual bariatric centers and even surgeons over
time. The data would also facilitate
medical education and help in the
development of bariatric surgery in
the country, benefiting a larger number of patients with morbid obesity
and co-morbidities.
The data may also be used for
international service analysis and
benchmarking with other countries.
This will help demonstrate the quality and safety of bariatric surgery in
Kuwait.
As demonstrated by the ‘First UK
National Bariatric Surgery Report’,
the Kuwait database would produce
accumulated data that would allow
the publication of a comprehensive
report on outcomes following bariatric surgeries.
Nearly 80% of over
50s in Ireland are
overweight or obese
O
ver 8,000 people aged 50 and over in Ireland
shows nearly four out of five adults over the age
of 50 are overweight or obese. The report by
the Irish Longitudinal Study on Ageing (TILDA),
and led by Trinity College Dublin, Ireland, 36% of Irish
over 50s are obese and a further 43% are overweight.
“TILDA is the first study to look specifically at obesity
in the over 50s in Ireland,” said Dr Siobhan Leahy, TILDA Research Fellow and lead author of the report. “Our
findings show not only worryingly high levels of obesity
but also the impact of these levels on health and everyday activity among the over 50s in Ireland. The proportion of over 50s in Ireland who are overweight or obese
is significantly higher than that of the general adult population in Ireland. While this age group is already more
likely to be affected by age-related illness, frailty and
cardiovascular disease, these conditions are exacerbated by the presence of obesity and significantly higher levels of disease and disability are evident in obese
individuals. Our study highlights the combined impact
of the obesity crisis and a rapidly ageing population on
health and health service demand.”
The report also showed that based on waist circumference measurements, 52% of Irish over 50s
are ‘centrally obese’, with a ‘substantially increased’
waist circumference, while a further 25% have an ‘increased’ waist circumference. In addition, they researchers found that using BMI as an indicator of obesity, a higher proportion of men (38%) are obese than
women (33%); however, using waist circumference as
an indicator of obesity, a higher proportion of women
(56%) have a ‘substantially increased’ waist circumference than men (48%).
The prevalence of obesity in Irish men over 50 is
comparable with US men over 50 (while English rates
are much lower), whereas the prevalence of obesity in
Irish women over 50 is lower than among comparable
women in the US, and broadly similar to the prevalence
among older English women.
They also report that there is a much stronger relationship between obesity and socioeconomic status
for Irish women than for Irish men; for example, 39%
of women in the lowest quintile of wealth are obese,
in comparison to 24% of women in the highest wealth
quintile.
There is also a strong relationships between obesity, particularly central obesity, and cardiovascular diseases such as angina, heart failure and heart attack;
21% of centrally obese men report at least one cardiovascular disease compared to 14% of men with a
normal waist circumference. Corresponding rates for
women are 17% compared to 11%.
In addition, chronic conditions such as arthritis are
more common among obese individuals; for example, the prevalence of arthritis among obese women
is 44%, compared with 25% of women with a normal
weight. The relationship between obesity and physical
activity is stronger in women than men: 47% of obese
women report ‘low’ levels of physical activity, indicating that they do not meet the recommended levels of
physical activity, compared to 30% of normal weight
women.
The report highlights the serious burden that these
levels of obesity and overweight are placing on Ireland’s health services. Obese older adults visit their GP
more frequently, take more medications, and a higher proportion report polypharmacy (i.e., concurrent use
of five or more medications) than normal weight individuals.
As previously reported here overweight and obesity
cost the economy of the Republic of Ireland €1.3-6 billion through increased health services utilisation, work
absenteeism and premature mortality.
“At a time when the Irish health service is faced with
the challenge of delivering services with fewer resources, the finding that obesity is associated with a significantly higher use of health services is a cause for concern,” said Dr Anne Nolan, TILDA Research Director
and co-author of the report. “A greater focus on health
promotion and prevention is required to not only improve population health and well-being, but also to ensure the future sustainability of our health system.”
UK proposes surgery for BMI 30 with diabetes
N
ew draft guidance by the National Institute of Health and
Care Excellence (Nice) has proposed that anyone with a
BMI 30 should be considered for the surgery if they have
been diagnosed with diabetes in the last decade. This
could mean up to a million more people could be offered surgery on the NHS.
Currently, surgery is given to patients on the NHS to those
who are morbidly obese with a BMI 40 or to those with a BMI
over 35 if they have another condition, such as type 2 diabetes.
“Obesity rates have nearly doubled over the last ten years
and continue to rise, making obesity and overweight a major issue for the health service in the UK,” said Professor Mark Baker,
director of the Centre for Clinical Practice at NICE. “Updated evidence suggests people who are obese and have been recently diagnosed with type 2 diabetes may benefit from weight loss
surgery. More than half of people who undergo surgery have
more control over their diabetes following surgery and are less
likely to have diabetes related illness; in some cases surgery can
even reverse the diagnosis.”
As well as meaning diabetics with a BMI of at least 30 could
be eligible, the recommendations state those from an Asian
background should be considered even if they are not obese,
because of evidence that body fat carries higher risks of diabetes in such populations.
“The first line of attack will be diet and exercise and we
would expect clinicians to consider the risks and benefits of surgery for patients,” added Baker.
He said some would not be operated on because of age,
concluding: “It would be between 5,000 and 20,000 operations
a year, but we haven’t done the modelling.”
The draft guidance states that there is evidence to suggest
that around 60 per cent of morbidly obese diabetics (those with
a BMI of 40 and over) could put the condition in remission by
having bariatric surgery.
Research indicates that the costs of obesity-associated
health issues means the typical cost of an operation is repaid in
savings to the NHS within three years, resulting in saved costs
of around £4,000 a year per patient in the long-term.
It is estimated diabetes costs the NHS £14billion a year,
much of which spent treating debilitating complications such as
blindness, strokes, kidney failure and amputations. NICE says
evidence shows bariatric surgery helps patients control their diabetes and in some cases effectively resolves the condition.
Diabetes UK estimates that the new criteria mean between
850,000 and 900,000 extra people could qualify to be considered
for surgery. Currently, there are only around 9,000-10,000 weight
loss procedures funded by local NHS organisations annually.
“Expecting the UK to have the provision to operate on nearly a million people is an unrealistic proposition. The majority of
people, their degree of obesity will be corrected by exercise
alone,” James Halstead, a bariatric surgeon at Leeds hospital
told Radio 4’s Today programme. “The idea that the NHS could
deal with 900,000 extra patients with this alone is nonsensical.”
The surgery can cost between £3,000 and £15,000 and the
move by NICE has raised concerns that the NHS will not be
able to afford the treatment, even if there are savings in the longer term.
“We’ve got a mismatch between what Nice recommended
and what the country can afford,” said Tam Fry from the National
Obesity Forum. “Clearly there are going to be thousands of people who will look at this and say, I fit that criteria, I want the surgery. We could end up with a situation where clinical commissioning groups say we can’t get the extra midwives we need for
the local hospital, we can’t pay for life-saving drugs for people
with cancer – because other people have been given the right to
have expensive bariatric surgery.”
Current guidelines state that patients must have tried and
failed to achieve clinically beneficial weight loss by all other appropriate non-surgical methods and be fit for surgery. This recommendation has not changed.
The updated draft guidelines include additional recommendations on bariatric surgery for people with recent-onset type 2
diabetes. These recommendations include:
n
Offering an assessment for bariatric surgery to people who
have recent-onset type 2 diabetes and are also obese (BMI of
35 and over).
n
Considering an assessment for bariatric surgery for people
who have recent-onset type 2 diabetes and have a BMI between 30 and 34.9. People of Asian origin will be considered
for surgery if they have a lower BMI than this, as the point at
which the level of body fat becomes a health risk varies between ethnic groups. Asian people are known to be particu-
larly vulnerable to the complications of diabetes.
The draft guideline also makes recommendations regarding very
low-calorie diets (800kcal per day or less). These include:
n
Not routinely using very low-calorie diets to manage obesity.
n
Only considering very low-calorie diets for a maximum of 12
weeks (continuously or intermittently) as part of a multicomponent weight management strategy with ongoing support.
This would be for people who are obese and have a clinically assessed need to rapidly lose weight – for example, people
who require joint replacement surgery or who are seeking fertility services.
n
Giving counselling and assessing people for eating disorders or
other mental health conditions before starting them on a very
low-calorie diet. This is to ensure the diet is appropriate for them.
“This raises really important issues, such as the morality [and
cost] of giving a surgical procedure for what is essentially a behavioural disease,” Dr Simon Heller from the academic unit of
diabetes, endocrinology, and metabolism at the University of
Sheffield, United Kingdom, told Medscape Medical News. “This
is something that we as a society have really got to think about,
and that’s true for every country in the world.”
“This is an extremely difficult situation with all kinds of vested interests,” he said. “The pharmaceutical industry, for example, presumably doesn’t want to see surgery adopted too widely, because these extremely expensive [obesity and diabetes]
drugs they have developed are undoubtedly more expensive
than bariatric surgery.”
The charity Diabetes UK is currently funding the largest study
in the UK into this approach, the Diabetes Remission Clinical Trial (DIRECT) to compare the long-term health effects of current
type 2 diabetes treatments with those of a very low-calorie diet,
followed by a long-term approach to weight management.
“For most people, losing weight can be very difficult. For
some, as well as a healthy diet and physical activity, additional
treatments include medication and surgery,” said Simon O’Neill
from the charity Diabetes UK. “Although studies have shown
that bariatric surgery can help with weight loss and have a positive effect on blood glucose levels, it must be remembered that
any surgery carries serious risks. Bariatric surgery should only
be considered as a last resort if serious attempts to lose weight
have been unsuccessful and if the person is obese.”
36 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Clinical Updates
Enrolment completed in ESSENTIAL incisionless study
E
SSENTIAL Trial is one of the largest
multi-centre, randomised, sham-controlled
studies of an endoscopic procedure for
weight loss ever conducted
USGI Medical has completed enrolment for
the ESSENTIAL Trial, the company’s US-based
pivotal study designed to prospectively compare
weight loss results between an endoscopic procedure known as POSE (Primary Obesity Surgery,
Endolumenal) and a sham procedure.
The trial has recruited 332 patients at 11 sites
across the US who are participating in the investigational device exemption (IDE) study. Patients
enrolled in the trial will be followed for weight
loss and other efficacy endpoints for a year and
receive a total of at least two years of follow up
and nutritional care.
“The sham-controlled ESSENTIAL Trial was
designed to generate the highest-quality data
possible for a procedure. If the outcomes from the
POSE procedure are positive and consistent with
smaller trials, it could mean that tens of thousands
of patients may have an incredibly compelling
option to consider if they’ve struggled to lose
weight with diet and exercise, but aren’t candidates for or are not prepared to accept the risk of
traditional bariatric surgery,” said Dr Thomas
E Lavin, founder of The Surgical Specialists of
Louisiana and the Lead Investigator in the study.
“Based on preliminary studies of the POSE procedure conducted in Europe, we believe that this
new approach may help patients feel full sooner
during meals, improving satiety and reducing
hunger cravings so they can control their portions,
consume fewer calories and lose weight.”
The study will form the basis of the company’s
marketing application with the FDA seeking approval for a weight loss indication in the labelling
for the g-Cat EZ Delivery Catheter with Snowsho
Suture Anchors. All of the components of the
USGI’s Incisionless Operating Platform currently
have 510(k) clearance and CE Mark.
“Completing enrolment in our US pivotal study
marks a significant milestone for the company,”
said James White, Vice President of Medical Affairs for USGI. “We are fortunate to have partnered
with such an incredible and diverse investigative
team of US obesity experts and institutions. We
will continue to work with the ESSENTIAL Trial
investigators and their teams to ensure the highest
quality safety and outcomes for the subjects in
the study. The official efficacy analysis ends after
the patients’ one-year follow up appointments, at
which time we will work in earnest to complete
our marketing application for submission to the
FDA for an obesity indication in our label.”
SCALE: liraglutide demonstrates significantly greater weight loss
Proportion of adults achieving weight loss of 5
percent or more of their baseline body weight
was 64 percent for liraglutide 3mg treatment
compared to 27 percent for placebo
A
fter 56 weeks of treatment, liraglutide 3mg, in combination with diet and exercise, provided significantly greater
weight loss compared to placebo, according to the results
from the SCALE Obesity and Pre-diabetes phase 3a trial.
The outcomes, presented at the 23rd Annual Congress of the
American Association of Clinical Endocrinologists (AACE), showed
that liraglutide patients reported more weight loss from baseline, 8
percent (8.4kg) vs. 2.6 percent (2.8kg) with placebo (p<0.0001).
Liraglutide 3mg
Liraglutide 3mg is a once-daily glucagon-like peptide-1 (GLP-1)
analogue with 97 percent similarity to naturally occurring human
GLP-1. Like human GLP-1, liraglutide 3mg regulates appetite and
food intake by decreasing hunger and increasing feelings of fullness
and satiety after eating.
All treatment arms included a reduced-calorie diet and increased
physical activity. The proportion of adults achieving weight loss of 5
percent or more of their baseline body weight was 64 percent for liraglutide 3mg treatment compared to 27 percent for placebo (p<0.0001).
In addition, 33 percent of adults treated with liraglutide 3mg
achieved weight loss greater than 10 percent of their baseline body
weight compared to 10 percent for placebo (p<0.0001).
“It is known that a sustained weight loss of 5 to 10 percent
provides significant health benefits for adults with obesity,” said
Dr Xavier Pi-Sunyer, Co-Director of The New York Obesity Nutrition Research Center and lead investigator of the trial. “The high
proportion of adults achieving this clinically meaningful weight
loss is encouraging, particularly when seen in combination with the
additional benefits beyond weight loss that are also being evaluated
with liraglutide 3mg treatment.”
In conjunction with weight loss, treatment with liraglutide 3mg
significantly reduced waist circumference by -8.19cm, compared
to -3.94cm with placebo (p<0.0001). Furthermore, treatment with
liraglutide 3mg improved blood glucose levels, blood pressure and
lipids levels.
Side effects
The most frequently reported side effects associated with liraglutide
3mg treatment were gastrointestinal (nausea and diarrhoea), which
were mild to moderate, occurred shortly after liraglutide initiation,
and were transient. Incidences of gallbladder disorders and pancreatitis were low but higher than in placebo-treated individuals.
Gallbladder disorders were reported as 2.7 events per 100 patientyears of exposure (PYE) with liraglutide 3mg treatment compared
to 1.0 events per 100 PYE for placebo and pancreatitis as 0.3 events
per 100 PYE with liraglutide 3mg compared to 0.1 events per 100
PYE with placebo.
SCALE
The SCALE Obesity and Pre-diabetes trial is a randomised, doubleblind, placebo-controlled, multinational trial in non-diabetic obese
subjects and non-diabetic overweight subjects with co-morbidities.
There were 3,731 participants randomised to treatment with liraglutide 3mg or placebo in combination with diet and exercise. In addition, participants were further stratified to 56 weeks or 160 weeks of
treatment based on pre-diabetes status at screening.
The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks as well as investigate the long-term
efficacy of liraglutide 3mg to delay the onset of type 2 diabetes in
subjects with pre-diabetes status at screening.
This is the largest trial in the SCALE programme investigating
liraglutide 3mg, which encompassed more than 5,000 participants
who are obese or overweight with comorbidities.
In December 2013, Novo Nordisk submitted a Marketing Authorisation Application to the European Medicines Agency and a
New Drug Application to the FDA for liraglutide 3mg for chronic
weight management in adults who have obesity or are overweight
with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. These applications are under review.
Aspire completes enrolment of PATHWAY trial
A total of 171 patients have
been enrolled at ten clinical
sites in the US
A
spire Bariatrics has completed enrolment and device
implantation in the company’s
PATHWAY pivotal trial for obesity, a
randomized, controlled, pivotal study
testing the effectiveness and safety of
the AspireAssist Aspiration Therapy
System in the treatment of obesity in
patients with initial BMI 35.0 to 55.0.
The AspireAssist is a first in class
chronic weight loss treatment which is
designed to reduce caloric absorption
while gradually changing eating habits.
The device does not alter the patient’s
gastrointestinal anatomy, is minimally
invasive, and is reversible. A total of
171 patients have been enrolled at ten
clinical sites in the US.
“The Aspire approach to obesity is
exciting for many reasons,” said Dr
Christopher Thompson, a co-Principal
Investigator of the PATHWAY trial
and Director of Therapeutic Endoscopy at Brigham & Women’s Hospital.
“It’s safety profile, low cost, and focus
on modifying eating habits are all
compelling. We are very pleased with
how easily the study has progressed
and are currently busy with monitoring subject progress.”
Trial participants in the study were
randomised in a 2:1 allocation to treatment or control groups. The treatment
group receives both Aspiration Therapy
and lifestyle therapy, while the control
group receives lifestyle therapy alone.
Institutions involved in the trial include Boston University Medical Center, Brigham & Women’s Hospital, Cornell University, Howard University, the
Mayo Clinic, Northwestern University,
St. Mary Medical Center, University of
Pennsylvania, the Veterans Affairs San
Diego Healthcare System, and Washington University.
AspireAssist
The AspireAssist provides the patient
with a method for achieving effective
‘portion control’ of food intake at the
level of the stomach, which lowers the
threshold for successful weight loss and
facilitates lifestyle behaviour change
for long-term weight management.
The AspireAssist system consists of a
low-profile implantable gastrostomy
tube and a siphon system. Patients drain
the contents of their stomachs after a
meal, reducing caloric absorption by
approximately 30%.
The AspireAssist is given in conjunction with lifestyle therapy, in which
patients are taught portion control, careful chewing, and other healthy lifestyle
habits.
“Obesity is a worldwide problem
approaching epidemic proportions,”
said Dr Louis Aronne, the Sanford I
Weill Professor of Metabolic Research
at Weill-Cornell Medical College
and a co-Principal Investigator of
The AspireAssist system consists of
a low-profile implantable gastrostomy
tube and a siphon system.
the Pathway study. “With less than
one percent of patients who meet the
eligibility requirements for bariatric
surgery actually electing to undergo
bariatric surgery, there is clearly a need
for alternative approaches that are safer,
less invasive, reversible, less intrusive
on patients’ daily life, affordable to
the healthcare system and patients,
and suitable for long-term therapy.
The AspireAssist may help to address
this unmet need. Having reached the
milestone of completion of enrolment
for this pivotal study, we are now one
step closer to that goal.”
The company anticipates filing its
application for premarket approval of
the AspireAssist to the FDA in or about
June 2015.
The company also announced the
initiation of post-market studies in
Italy, UK, Austria and Germany, in
addition to ongoing post-market studies
in Sweden, Czech Republic and Spain.
The AspireAssist received CE Mark in
December 2011.
The AspireAssist is not approved for
sale in the US, but is available for sale
in Europe and New Zealand.
bariatricnews.net 37
ISSUE 21 | AUGUST 2014
Clinical Updates
FDA examines weight loss combination therapy
New drug combines antidepressant
and addiction medications
T
he FDA is reviewing a new prescription
weight-loss medication that combines a
popular antidepressant with a medication
for addiction. The new prescription medication is
a combination of two FDA-approved drugs, bupropion (an antidepressant), and naltrexone (which
reduces the desire for drugs and alcohol). Both have
been found to increase weight loss in independent
research trials and combining the two in one capsule
is believed to create a synergistic effect.
“Many medications for various conditions have
been found to have weight loss as a side effect, and
conversely, many medications can cause weight
gain,” Dr Bipan Chand, director of the Loyola
Center for Metabolic Surgery & Bariatric Care.
“Weight-loss medications commonly involve an
appetite suppressant and a metabolism booster.
But not all patients can tolerate prescription
weight-loss medication.”
In clinical trials, patients taking the new medication while following a diet and exercise program
lost more weight than those taking a placebo and
following the same diet and exercise regimen. In a
56-week period, the non-medicated group lost 1116lbs while the medicated patients lost 20- 2lbs.
In February 2011, the FDA requested a largescale study of the long-term cardiovascular effects
of the drug before considering approval.
More than two-thirds of American adults are
overweight or obese and one in three American
children and teens are considered obese. Americans spend an estimated US$20 billion annually
on weight-loss products, including medications.
“Behavioural therapy, nutrition counselling, physical exercise and surgery as well as
medication are all instruments in the weightloss toolbox,” added Chang. “Bariatric surgery
has been the most effective tool in achieving
long-term weight loss, which leads to overall
improvement in health, reducing or eliminating chronic conditions and medications and
increasing years of life.”
EndoBarrier Therapy reduces reliance on diabetes medication
Findings show that EndoBarrier Therapy can
reduce reliance on diabetes medications, from
oral agents to insulin therapy
Data show increased levels of bile acids following
treatment with Endobarrier
O
utcomes from three studies examining EndoBarrier
Therapy have concluded that the treatment further demonstrate its acute effects on glycaemic control, its ability to
reduce reliance on diabetes medications (including insulin), as well
as findings that help explain its potential mechanism of action. The
findings were presented in three poster presentations at the 74th
Scientific Sessions of the American Diabetes Association (ADA) in
San Francisco.
“The ability of the EndoBarrier to acutely affect glucose homeostasis, before significant weight loss has had a chance to occur is
fascinating and resembles reports on bariatric surgery,” stated Dr
Gabriella LiebermanInstitute of Endocrinology, Sheba Medical
Center, Tel Aviv, Israel. “The fact that the device impacts all weight,
glucose and appetite makes it attractive for the treatment of diabesity
and makes one curious as to the underlying mechanism by which this
device exerts its effects.”
The poster, “The Acute Effect of EndoBarrier Treatment on Glucose Homeostasis in Obese Uncontrolled Diabetic Subjects,” evaluated the effects of the EndoBarrier device on glucose homeostasis,
HbA1c, weight loss, insulin requirements and appetite in 33 patients.
Glucose was monitored continuously for one week beginning two
days before placement of the device.
Use of the EndoBarrier device resulted in an acute drop in average
daily glucose by 29% within days post implantation, despite a reduction of 50% in insulin dose during this time. As early as 12 weeks
after EndoBarrier insertion, subjects demonstrated a significant
reduction in both weight (-8.9kg) and HbA1c levels (-1.4%) leading
to a decrease in insulin requirements.
Interestingly, weight loss was accompanied by a decrease in appetite demonstrated by the visual analogue scale.
The poster, “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts
Robust Improvement in Glycemia and Body Weight in Obese Patients with Type 2 Diabetes,” was a pooled analysis of five open-label
studies that showed EndoBarrier Therapy continues to lower HbA1c,
accelerate weight loss and reduce reliance on diabetes medications.
This analysis evaluated 71 patients who completed 12 months of
EndoBarrier Therapy. The use of the EndoBarrier device resulted in
a 1.4% median decrease in HbA1c (from 8.2% at baseline to 6.8); of
these 57% achieved the recommended 7% HbA1c of the ADA.
Patients experienced a robust effect on total body weight loss with
EndoBarrier Therapy, resulting in a 10.4% reduction (from 106.2 at
baseline to 93.4kg). Notably, patients were able to reduce use of
background diabetes medications.
The presentation, “Duodenal-Jejunal Bypass Liner Increases Bile
Acids Levels in Patients with Severe Obesity and Type 2 Diabetes
Mellitus” investigated the use of the EndoBarrier device and its effects on bile acids to explore its potential mechanism of action.
Primary and secondary bile acids levels were measured in
seven patients with type 2 diabetes and obesity prior to placement
of the EndoBarrier device and following removal at 52 weeks of
treatment. After treatment, fasting total bile acids levels increased
to 4.3±0.8μmol/L (from 0.7±0.3μmol/L baseline; p<0.05). Also,
fasting primary (from 0.04±0.01 to 2.1±0.4μmol/L) and secondary
(from 0.07±0.02 to 1.5±0.4μmol/L) bile acids levels increased from
baseline (p<0.05 vs. baseline for both).
“The data presented at ADA expand upon already established
evidence presented recently at other medical meetings and further
validate how the EndoBarrier device works to affect and improve
glycaemic control,” said Dr David Maggs, chief medical officer, GI
Dynamics. “The findings from these studies and analyses show that
EndoBarrier positively impacts HbA1c and weight in patients with
type 2 diabetes and obesity. Importantly, the findings also show that
EndoBarrier Therapy can reduce reliance on diabetes medications,
from oral agents to insulin therapy. This is an important consideration for physicians as they contemplate treatment regimens for their
patients.”
Bile acids levels
In addition, EndoBarrier therapy also induces significant changes
in the level of bile acids (BAs), according to the latest data from
a joint study between GI Dynamics and GlaxoSmithKline (GSK)
into EndoBarrier and its potential mechanism of action. Presented
at Digestive Disease Week 2014 during an oral presentation titled,
‘Duodenal-jejunal Bypass Liner Increases Fasting and Postprandial
Serum Levels of Bile Acids in Patients with Severe Obesity’, the
study is the result of an agreement between the companies signed in
January 2013 to investigate the mechanism of action of the EndoBarrier and related hormonal and metabolic changes.
Researchers have proposed that increased postoperative levels of
BAs may be tied to the effectiveness of a common type of gastric
bypass surgery, Roux-en-Y gastric bypass (RYGB).
To better understand the method of action of the EndoBarrier and
how it may mimic RYGB, the study authors evaluated BA levels in
17 patients with severe obesity, with and without type 2 diabetes.
Findings show that after 52 weeks of treatment with EndoBarrier,
a 16% total body weight loss was accompanied by fasting total BAs
levels over two-fold higher than those observed at baseline (1.3±0.3
vs 3±0.5 μMol/L, p<0.05); and following a standard test meal,
nutrient-stimulated levels of total BAs were also increased by 70%
(475vs805 AU, p<0.05).
“The increased level of bile acids we observed suggest that there
may be a similar mechanism of action associated with EndoBarrier
in the treatment of obesity and diabetes to that observed with gastric
bypass,” said Dr David Maggs, chief medical officer, GI Dynamics.
“This mechanism may be the driver of the significant weight loss
and glucose stabilisation seen in patients treated with EndoBarrier.”
“These findings show that EndoBarrier induced significant
changes in the level of bile acids, which play a known role in the
regulation of energy and glucose homeostasis,” added Andrew
Young, vice president and head of endocrine biology, GlaxoSmithKline. “Although further exploration is needed, these data offer the
beginning of a mechanistic explanation for the robust effects on body
weight seen with EndoBarrier and support the continued investigation of EndoBarrier in patients with type 2 diabetes and obesity.”
The company has also raised approximately AUS$34.3 million in
its latest financing round, which it intends to fund its US pivotal trial,
to expand commercialisation efforts for EndoBarrier Therapy, and
for general working capital purposes.
“We are very pleased with the successful completion of this financing,” said Stuart A Randle, president and CEO of GI Dynamics.
“This financing provides additional resources to support our ongoing
pivotal trial in the US. This capital also allows us to continue to
execute on our global dual-pronged commercial strategy focused on
driving sales in the near term in self-pay markets, while building for
the long-term success and future growth of EndoBarrier Therapy in
reimbursed markets.”
Insulin therapy
Finally, EndoBarrier Therapy resulted in a rapid reduction in, and
elimination of, insulin therapy by patients with type 2 diabetes and
obesity, according to findings from a retrospective analysis of 100
patients in Australia presented at the American Association for Clinical Endocrinology 23rd Annual Meeting and Scientific Congress in
Las Vegas.
“While based on a small number of patients, these findings show
that EndoBarrier Therapy has a real, immediate impact on glycaemic
levels,” said Professor Reginald V Lord, St. Vincent’s Clinic and
Macquarie Hospital, Sydney. “We are pleased that EndoBarrier
Therapy offers the opportunity for patients to reduce their reliance on
insulin, which is often viewed as a last resort treatment for diabetes.
We view EndoBarrier Therapy as a non-surgical treatment option
that possibly extends the utility of their existing pharmaceutical
treatment regimens.”
The retrospective analysis reviewed the medical records and
nationwide patient registry of the first 100 patients in Australia who
received EndoBarrier Therapy. Of these 100 patients, 11 required
the use of insulin to manage their type 2 diabetes prior to receiving EndoBarrier Therapy. Following placement of the EndoBarrier,
there was an overall lowering of insulin requirements based on the
protocol at the two treatment centers.
The analysis revealed that six (54%) of the 11 insulin-treated
patients with type 2 diabetes were able to completely cease use of
insulin therapy during EndoBarrier Therapy. The remaining five
insulin-treated patients were also able to decrease their insulin
therapy in injection frequency, daily dosage or both. All patients
maintained use of oral diabetes medications.
Moreover, this overall reduction in concomitant insulin use was
accompanied by a lowering of HbA1c to 7.3%, from a HbA1c of
8.8% at baseline. The analysis also demonstrated the positive effects
of EndoBarrier Therapy on weight; patients achieved a median
weight loss of 11.1kg at study follow up.
“Earlier research has demonstrated that EndoBarrier Therapy has
rapid and sustained effects on glycaemic control and this analysis
further supports those findings,” said Dr David Maggs, chief medical
officer of GI Dynamics. “As we expand our global patient experience, we are learning more about how EndoBarrier Therapy can help
reduce or, in some cases, altogether eliminate the use of insulin in
those patients who have progressed to requiring insulin treatment.
Based on the data and patient experience to date, we believe EndoBarrier Therapy is emerging as a highly-attractive complement to
existing pharmaceutical regimens and an important treatment option
to consider for people with type 2 diabetes and obesity.”
The EndoBarrier is a flexible, tube-shaped liner that is inserted
endoscopically and placed at the beginning of the small intestine,
where it remains for up to one year; after which it is removed during
another endoscopic procedure. It is currently under investigation
in the US in a multicentre, pivotal clinical trial (The ENDO Trial)
for the treatment of patients who have uncontrolled type 2 diabetes
and are obese. EndoBarrier has been approved in select countries
internationally since 2010 and is available in Chile, Australia and
a growing number of countries in Europe and the Middle East. The
EndoBarrier is not approved for sale in the US.
38 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Product, Industry and Trial news
Ethicon to launch online course highlighting MARS findings
initiative and clinical evidence around the most
effective treatments for obesity and obesity-related
conditions.
The company is partnering with edX, the nonprofit online learning initiative co-founded by
Harvard and MIT. Conducting the course on the
Open edX platform will make Ethicon the first in
the healthcare industry to offer a MOOC specifically for a surgical audience.
Through the opportunities to discuss, debate,
and ultimately, to learn from other colleagues,
provided by the edX platform, and by providing
education with top surgeon faculty and researchers,
Ethicon aims to build a digital community of learners engaged with the latest research in obesity and
the metabolic mechanics behind bariatric surgery.
In addition to a surgical audience, the course
is open to anyone with interest in learning more
about the physiology of obesity, including endocrinologists, primary care physicians and other
healthcare professionals.
Conducting the course on the Open edX
platform will make Ethicon the first in the
healthcare industry to offer a MOOC specifically for a surgical audience
E
thicon is to launch a six-week massive
open online course (MOOC) highlighting
the critical findings of the Metabolic Applied Research Strategy (MARS) initiative. MARS
is a collaborative research programme between
major research institutions and the company to
understand the physiologic and metabolic changes
that occur after bariatric and metabolic surgery.
The approach is to deconstruct the procedures,
understand their mechanism of action, and then
leverage the findings to better predict outcomes,
improve existing therapies, and potentially reinvent new, less invasive weight- loss solutions.
“It’s important for surgeons to understand some
of the information that comes from MARS because
it helps you talk to patients – and to referring physicians – about why surgery works, and why it’s a
useful tool for a lot of patients in terms of trying to
fight obesity and diabetes,” said MARS Principle
Investigator Dr Randy Seeley, Chair, Donald C
Harrison Endowment and Professor of Medicine at
University of Cincinnati College of Medicine and
Director of the Cincinnati Diabetes and Obesity
Center.
Getting to the core of the science behind
obesity and the metabolic mechanics is something
Ethicon has committed to over the last decade, in
both basic scientific research through the MARS The online course begins in June 2014, to register visit
SCA introduces TENA
Stretch 3XL Bariatric Brief
S
CA has introduced TENA
Stretch 3XL Bariatric
Brief to its comprehensive product portfolio, the largest and most absorbent bariatric
brief offered by SCA Personal
Care. The product’s new high
rise design, larger waist size and
micro-bead technology guarantees better coverage, faster
acquisition rates, and added
comfort to help care facilities
provide more dependable incontinence protection to larger
residents.
The new TENA Stretch
3XL Bariatric Brief is
designed for hard-to-fit individuals with extreme obesity,
who require a full coverage,
high absorbency and ultradry incontinence product
to help protect them from
incontinence related skin
issues. Bariatric residents are
often challenged in managing their own self-care,
such as hygiene and toileting,
because of difficulty in moving
with ease, further emphasising
the need for comfortable and
effective incontinence products.
“With our new TENA
3XL Bariatric Brief, SCA has
responded to our customers’
requests for a larger and better
performing 3XL product that
delivers dependable incontinence protection and improved
comfort for their bariatric residents, while keeping costs low,”
said Eric Cohen, Absorbent
Product Manager, SCA Personal
Care North America
The new TENA 3XL Bariatric Brief features the same
look and feel as SCA’s existing
line of TENA Stretch products,
which maximizes wearer comfort and fit, and has been well
received by care homes. Pairing
a larger waist size of 69-96
inches (175-247cm) with a rise
increase from 38 inches to 44.3
inches, the product delivers an
improved, more flexible fit and
limits leakages while residents
are lying down and chances of
leakage are higher.
Superabsorbent microbeads
reduce odour and lock away
liquids, making the new
product 25% more absorbent
than the previous TENA
3XL brief. The increased
absorbency and improved
fit work together to keep
residents 35% drier. New,
fully-breathable side stretch
panels allow air and body
heat to easily circulate, while
full-length hook and loop
clasps enable more secure
product fastening.
Zafgen raises US$96million in latest IPO
Z
afgen has raised approximately US$96
million in its latest IPO, according to
some sources on Wall Street. In the latest offering the company sold some six million
shares – one million more than it initially planned
to sell – at US$16 each. Therefore, the company
some US$96 million before discounts due to underwriters, a number that could increase if its
underwriters exercise their right to buy another
900,000 shares at the IPO price.
The company’s obesity drug, beloranib,
utilises a unique mechanism of action and is the
first compound in its class that works by targeting
MetAP2, which controls the production and utilisation of fatty acids. Inhibitors of MetAP2 reduce
hunger while also reducing the production of new
fatty acid molecules by the liver and helping to
convert stored fats into useful energy.
Zafgen is targeting the drug towards severely
obese people and smaller subsets of patients
with more rare and dangerous conditions so that
it can run smaller, quicker trials and potentially
get to market faster. The company believes the
drug could eventually become an alternative to
bariatric surgery.
The FDA gave beloranib orphan drug status
as a Prader-Willi treatment, and Zafgen plans
to seek the same designation for beloranib in
craniopharyngioma-related obesity as well.
That designation gives beloranib longer market
exclusivity.
Zafgen plans to use the IPO funds to start a
Phase 3 in Prader-Willi, a Phase 2a trial in craniopharyngioma, and a Phase 2b trial in patients
with severe obesity,. Zafgen also has a preclinical
drug candidate called ZFG-839 for nonalcoholic
steatohepatitis, nonalcoholic fatty liver disease,
and other potential uses as well.
Zafgen will begin trading on the Nasdaq under
the ticker symbol ‘ZFGN’.
https://ethicon.edx.org
Medtronic to buy Covidien
for US$42.9 billion
The acquisition will allow
Medtronic to expand into new
areas especially the weight-loss
surgery and laparoscopic markets
M
edtronic has agreed to buy Dublinbased, Covidien, for US$42.9 billion
(£25.27 billion) and shift its executive
headquarters to Ireland. According to analysts,
the cash and stock deal will allow Medtronic to
reduce its overall global tax burden, which is
currently 18 percent, although the company emphasised the acquisition led by a complementary
strategy with Covidien on medical technology,
rather than tax considerations.
“The real purpose of this, in the end, is strategic, both in the intermediate term and the long
term,” said Medtronic Chief Executive Omar
Ishrak. “It is good for the US in that we will
make more investment in US technologies, which
previously we could not.”
The merger of Medtronic, the world’s largest
stand-alone medical device maker with a market
value of over US$60 billion, and Covidien will
create a close competitor in size to the medical
device business of industry leader Johnson &
Johnson, the parent company of Ethicon. The
acquisition will allow Medtronic to expand into
new areas especially the weight-loss surgery and
laparoscopic markets.
The deal values each Covidien share at
US$93.22, paid for by US$35.19 in cash and
0.956 Medtronic shares.
The combination, which will leave Covidien shareholders owning about 30 percent of
the combined company, is expected to result in
at least US$850 million of annual pre-tax cost by
the end of 2018. Medtronic said it would keep
its operational headquarters in Minneapolis and
pledged US$10 billion in US technology investments over the next decade.
Medtronic’s deal with Covidien is expected to
close in the fourth quarter of 2014 or early 2015.
The combined business will have more than
87,000 employees in more than 150 countries.
Aspire Bariatrics raises
US$5 million in funding round
A
spire Bariatrics has
raised US$5 million
in a private stock
sale, according to documents
filed with the Securities and
Exchange Commission. The
company has raised more
US$31.2 million since it was
founded in 2005.
The company has developed
the AspireAssist system, which
is an endoscopically-implanted
tube which leaves the stomach
through a stoma, and a pump
which attaches to a port on
the outside of the stomach and
removes a portion of the food
eaten after the meal, replacing
it with water.
The AspireAssist works
by reducing the calories
absorbed by the body. After
eating, food travels to the
stomach immediately, where
it is temporarily stored and the
digestion process begins. Over
the first hour after a meal, the
stomach begins breaking down
the food, and then passes the
food on to the intestines, where
calories are absorbed. The
AspireAssist allows patients
to remove about 30% of the
food from the stomach before
the calories are absorbed into
the body, causing weight loss.
Emptying the tube takes about
five minutes. The device can
be installed in a 20-minute
outpatient procedure, under
local anaesthetic.
The device was invented by
Samuel Klein, the William H
Danforth professor of medicine
and nutritional science and
director of the Center for Human Nutrition at Washington
University School of Medicine
in St. Louis, Missouri; Moshe
Shike, attending physician and
director of clinical nutrition
at Memorial Sloan Kettering
Cancer Center in New York;
and Stephen Solomon, attending physician and chief
of interventional radiology at
Memorial Sloan Kettering.
The inspiration for the
device came originally from
the surgeons’ experience using
percutaneous endoscopic gastrostomy tubes, which deliver
food directly into a patient’s
stomach. They realised that the
same concept in reverse could
work to remove food instead.
bariatricnews.net 39
ISSUE 21 | AUGUST 2014
Product, Industry and Trial news
Obalon to revolutionise obesity treatment in the Gulf
Since March 2014, Obalon has been
successfully used on more than 250 patients in
the Kingdom of Saudi Arabia
T
he Obalon balloon weight-loss technology launched in
March 2014 in Saudi Arabia by Alsultan Saudi Medical
Company, is fast replacing conventional treatment methods
and winning the support of patients and medical experts alike. The
technology, billed the first of its kind in Saudi Arabia, holds out
much promise to countless overweight adults helping in weight loss
without invasive medical procedures.
Obalon works on the basis of a capsule containing a balloon that
is orally ingested and subsequently inflated to occupy the upper
space in the stomach so as to create a feeling of fullness that helps
people eat less. Additional balloons can be swallowed and inflated
during the treatment period depending on the response and the needs
of the patient. At the end of the three month treatment period, the balloons are removed through a short endoscopic procedure. The entire
removal procedure takes only 15 minutes and requires no sedation.
Alfredo Genco, Professor at the Umberto Hospital, Sapienza
University, Italy, who specialises in the treatment of morbid obesity, highlighted how this novel non-surgical, easily removable safe
device for weight loss will offer a new and different approach for
people who have struggled with dieting in the past but haven’t succeeded in losing weight.
Further to his fruitful efforts in the development of this amazing
innovation reaching the stage of application, Professor Genco has
succeeded in conducting more than 1,500 Obalon treatments and
training many doctors in European Union countries and Middle East
region.
Studies have shown that patients who use Obalon technology lose
an average of 7.4% of their total body weight and 41% of excess
body weight within 12 weeks of the balloon application, which is
approximately eight to 12 kilos on average within three months.
Following its launch, Obalon has been successfully used on more
than 250 patients in the Kingdom. The overwhelming response from
medical experts and patients has set the stage for the technology’s
launch across the Gulf states before the end of 2014.
Explaining why the patients in the kingdom have responded enthusiastically to the technology, Mr Emad Alzaben, Group General
Manager of Al Sultan Saudi Medical Company, says Obalon offers a
quick, discreet, non-surgical and safe weight loss solution.
Hospitals across the kingdom are adopting this innovative
technology, which is set to become the most popular and preferred
method in the treatment of obesity. Experts in the field have given
their approval for its use after closely studying patients who underwent the procedure.
With obesity being a crucial factor in the onset of diseases such as
diabetes, high-blood pressure, and cholesterol, the Obalon technology is expected to play an important role in the nation’s health that is
hit hard by such lifestyle diseases. Easy procedure, effective results
and accessibility for all, make the technology a surefire tool in the
nation’s struggle for an improved health profile.
This message was sponsored by the Al Sultan Saudi Medical Company
Essentialis granted ODD for Prader-Willi drug
O
rphan drug designation entitles Essentialis to a seven-year period of marketing
exclusivity in the US for DCCR
Essentialis has announced that the FDA’s Office of Orphan Products Development has granted
orphan drug designation (ODD) to diazoxide
choline, the patent protected active in DCCR for
the treatment of Prader-Willi syndrome, a rare
complex neurobehavioral/metabolic disease for
which there is no FDA-approved therapy.
“We greatly appreciate the FDA’s support of
our efforts to evaluate the use of DCCR in the
treatment of Prader-Willi syndrome,” said Dr Neil
M Cowen, President and Chief Scientific Officer
of Essentialis. “We are actively recruiting PraderWilli syndrome patients for a recently initiated
clinical study. Initial results from that study should
be coming out during Q3 of this year.”
Orphan status is granted by the FDA to promote
the development of products that demonstrate
promise for the treatment of rare diseases affecting
fewer than 200,000 Americans annually. Orphan
drug designation entitles Essentialis to a seven-
year period of marketing exclusivity in the US
for DCCR, if it is approved by the FDA for the
treatment of Prader-Willi syndrome, and enables
the company to apply for research funding, tax
credits for certain research expenses, and a waiver
from the FDA’s application user fee.
DCCR is a proprietary crystalline salt of diazoxide in a controlled-release, once-a-day tablet
formulation. It is in development for the treatment
of Prader-Willi syndrome and hypothalamic obesity. DCCR is covered by multiple issued US and
granted EU patents, which provide composition of
matter protection until 2028. Essentialis has evaluated DCCR in more than 200 subjects in multiple
double-blind, placebo-controlled studies.
According to thecmopany’s website, “Insulin
and leptin coordinately regulate caloric intake and
energy expenditure by inhibiting Neuropeptide
Y/Agouti Related Protein (NPY/AGRP) neurons
and stimulating proopiomelanocortin (POMC)
neurons in the hypothalamus. Deficiencies in
the hypothalamus of either insulin or leptin, or
resistance to either will lead to dysregulation of
appetite and energy expenditure characterized by
increased appetite, which may present as hyperphagia, and reduced energy expenditure. Leptin
interacting with its receptor in these neurons,
or insulin interacting with its receptor triggers a
cascade, one effect of which is to open the KATP
channel. Those who have studied it most closely
have suggested that the KATP channel may function as the molecular end-point of the pathway
following leptin activation of the leptin receptor
in these hypothalamic neurons. Treatment with
DCCR can directly open the KATP channel in
these neurons offering the potential to overcome
hypothalamic resistance to the action of leptin
and/or insulin and, thereby, re-establish control
over appetite and energy expenditure.”
Prader–Willi syndrome afflicts about one in
15,000 to one in 25,000 individuals, with the
Prader-Willi syndrome population in the US
estimated between 12,500 and 21,000. There may
be as many as 350,000 Prader–Willi syndrome
patients globally.
Clinical features of Prader–Willi syndrome in-
clude hypotonia and poor feeding in infancy. Low
muscle mass and low resting energy expenditure
is present throughout life. Obesity typically begins
around age two years if the diet is not restricted.
Ultimately, the central neurological defect associated with the condition causes Prader–Willi
syndrome patients to sense that they are starving
and signals them to further conserve energy and to
significantly increase their caloric intake.
This results in even lower resting energy
expenditure, hyperphagia, morbid obesity, and a
progression to diabetes. Mental retardation, growth
hormone deficiency, behavioral problems and
neuroendocrine abnormalities are also characteristic of Prader–Willi syndrome and the death rate
among patients is about twice that of the general
population at all ages.
Essentialis is focused on the development of
breakthrough medicines targeted to the ATP-sensitive potassium channel, a metabolically regulated
membrane protein whose modulation has potential
to treat and prevent a wide range of metabolic,
CNS and cardiovascular diseases.
Solara releases BariMelts line of dietary supplements
S
olara Labs has launched its BariMelts
line of dietary supplements produced
for bariatric surgery patients. BariMelts
ingredients dissolve in the mouth so there is no
breakdown required from the adjusted digestive
systems of patients to dissolve the tablets, as is
often the case with traditional capsules, pills, and
hard-packed chewables, the company claims.
“I am thrilled to bring our great-tasting, allnatural melts to the cariatric community,” said
Solara Labs Founder and CEO, Dr J Rocca. “The
BariMelts brand represents our finest work and
is the result of more than 50 years of formulating
experience, fulfilling our vision of bariatric patients
having access to the world’s finest ingredients and
innovations in the natural products marketplace.”
BariMelts are also all-natural formulas and are
made with premium gluten-free, genetically modified organisms free ingredients and do not contain
any artificial flavours, sweeteners, and synthetic
federal food, drug and cosmetic dyes.
“The enhanced nutrient availability of BariMelts
provides patients with a new option for getting the
supplemental nutrition so important to their longterm success following Bariatric surgery,” added
Rocca.
40 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Product, Industry and Trial news
ReShape submits dual balloon system application to FDA
R
eShape Medical has
submitted a Premarket
Approval (PMA) application to the FDA for the ReShape Integrated Dual Balloon
System, the first and only dual
balloon for non-surgical weight
loss designed for people with a
BMI30-40.
The company claims that the
ReShape system is the first device
to meet its primary effectiveness
endpoints in a US, randomised,
sham-controlled pivotal trial for
weight loss. ReShape’s PMA
submission includes data from
the company’s REDUCE Trial
involving 326 patients at eight
sites in the US that measured
the safety and effectiveness of
the procedure as an adjunct to
diet and exercise. As previously
reported, patients undergoing
the ReShape procedure lost
significantly more weight than
the sham-control subjects who
received diet and exercise alone.
The device had an excellent
safety profile.
“With this PMA submission,
ReShape Medical is on track with
our regulatory timeline, achieving
an important milestone in our
mission to offer an effective, nonsurgical treatment option to those
for whom other weight loss efforts
have not proven sufficient,” said
Richard Thompson, President and
CEO of ReShape Medical.
While an estimated 50 million
Americans are classified as obese
with a BMI of 30-40, many nei-
ther qualify for nor want surgery,
creating a significant unmet need
for additional treatment options.
Obesity is a major risk factor for
serious health complications,
many of which are the leading
causes of preventable death,
including heart disease, stroke,
type 2 diabetes and certain types
of cancer, among others.
“Meeting
the
primary
endpoints is an important accomplishment, as it convincingly
demonstrates the superiority
of the ReShape procedure over
diet and exercise alone,” said Dr
Jaime Ponce, Dalton, Georgia,
Principal Investigator in the REDUCE trial. “The ReShape procedure offers a new alternative
to help patients kick-start weight
loss and learn new behaviours.
We are excited about what this
new treatment option may do
for millions of people needing to
lose excess weight.”
The ReShape procedure is
designed to help patients lose
weight and facilitate behavior
change. The integrated dual balloon is inserted endoscopically
FDA recommends VBLOC vagal blocking therapy
T
he FDA Advisory Gastroenterology and Urology Devices
Panel (GUDP) has voted eight
to one in favour of EnteroMedics’ neuroblocking technology to treat obesity,
the Maestro System. The Panel voted
that the device is safe when used as
designed and voted four to five against
on the issue of a reasonable assurance
of efficacy. The final vote, on whether
the relative benefits outweighed the
relative risk, was six to two in favour,
with one abstention.
Although the FDA is not bound by
the GUDP’s recommendation, it will
take the decision into consideration
when reviewing the Maestro System
Premarket Approval (PMA). The company expects a decision on approval
of the PMA later in 2014, which if
approved, the Maestro Rechargeable
System will be the first new medical
device approved for obesity by the FDA
in over ten years.
VBLOC vagal blocking therapy,
delivered by a pacemaker-like device
called the Maestro Rechargeable System, is designed to intermittently block
the vagus nerves using high-frequency,
low-energy, electrical impulses, which
helps control both hunger and fullness.
VBLOC allows people with obesity
to take a positive path towards weight
loss, addressing the lifelong challenge
of obesity and its comorbidities without sacrificing wellbeing or comfort.
In the most recent clinical trial, the
ReCharge Study, VBLOC Therapy
treated patients demonstrated a clinically
meaningful and statistically significant
excess weight loss (EWL) at 12 months
of 24.4%, sustained out to 18 months.
The majority (52.5%) lost 20% or
more of their excess weight and nearly
one-third of VBLOC Therapy treated
patients lost 30% or more. The 24.4%
average EWL far exceeds the 10% to
15% thresholds at which patients experience substantial positive health effects.
Statistically significant improvements were observed in the VBLOC
Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and
diastolic blood pressure, heart rate and
during an outpatient procedure
and remains in the stomach for
six months. The balloon takes
up space in the stomach and
helps patients feel full. While
the stomach-filling balloons are
in place, patients are counselled
by health care professionals on
nutrition, exercise and behaviour
modification to help them develop a healthier lifestyle. This
programme continues for an additional six months after removal
of the balloons to encourage new
habits and lasting results.
ReShape Medical has previously anticipated a launch in
the US in mid-to-late 2015. The
ReShape device has been available in the European Union since
December 2011.
waist circumference.
“Where existing options are clearly
failing to address the growing epidemic
of obesity, we believe VBLOC Therapy
may offer a unique approach to treating
obesity, a choice that fills this void by
offering a safe, reversible option that
does not alter the anatomy, allowing
patients to take a positive path towards
improving their overall health,” said
Greg Lea, Senior Vice President, COO
and CFO of EnteroMedics. “We thank
the Committee members for their insights and look forward to a continued,
productive dialogue with the FDA.”
EnteroMedics’ Maestro Rechargeable System has received CE Mark and
is listed on the Australian Register of
Therapeutic Goods.
Apollo Endosurgery launches ‘It Fits’ Lap-Band campaign
A
pollo Endosurgery has launched the ‘It Fits’ campaign to
publicise the Lap-Band System, as well as raising awareness about the advantages of minimally-invasive weight
loss procedures. The campaign will focus mainly on informing prospective patients about minimally-invasive weight loss procedures
and company has created a call centre to enhance customer care to
further improve outreach and support for patients.
“With the increasing prevalence of obesity in the United States,
the Apollo Endosurgery team decided that it was time to refresh the
brand and inspire people who have tirelessly tried everything else to
lose weight, with little to no success, to finally conquer their weight
issue with the Lap-Band System,” said Dennis McWilliams, President
and Chief Commercial Officer of Apollo Endosurgery. “The Lap-Band
System’s benefits speak for itself, so now is the time to raise awareness
and let people know this could potentially be their weight loss solution.”
The company is working to transform the Lap-Band System into
a process, rather than simply a procedure, which would include
strategic partners, nurturing communities, and a customised platform for personalised, sustainable weight loss, in order to improve
patients’ quality of life.
CloudVisit launches bariatric telemedicine platform
C
loudVisit Telemedicine has launched a bariatric telemedicine service to help patients establish and
maintain lifelong healthy habits.
Accordign to the company, its
fully-integrated
telemedicine
and telepsychiatry platforms
make bariatric telemedicine safe,
affordable and easy.
The
HIPAA-compliant
telemedicine platform is enabled
through Bluetooth health monitoring devices, a health-tracker
mobile app and secure video
appointments, as well as offering
private label bariatric platforms
with supporting co-branded
devices.
“For bariatric surgeons,
CloudVisit video appointments
and integrated body health
analysers bring the patient relationship full circle,” said Daniel
Gilbert, president and CEO
of CloudVisit Telemedicine.
“Everything from the very first
surgeon-patient meeting to longterm post-surgical support can
happen privately and efficiently
online.”
CloudVisit helps bariatric
surgeons establish telemedicine
programmes, allowing them to
deliver cost-effective support on
a continuing basis. Scheduled
video consultations facilitate
the ongoing dietary instruction,
“The revitalized system will also cater to physicians so that we
can better support their practices,” he added. “We support specialists
in being the best coach for their patients. The patient may be in the
driver’s seat, but the surgeon has to help them steer. The new system
will help address those needs.”
Despite some controversy behind gastric banding technology and
its risks, the Lap-Band system is currently under assessment in seriously obese adolescents. The clinical trial is still recruiting patients,
between 14 and 18 years old, with a BMI40 and a five-year history of
obesity, and is planned to give primary results in 2018.
exercise encouragement, and
psychological help critical to
post-bariatric long-term success,
the company claims.
Each encounter is assisted by
real-time health data from affordable devices such as in-home
body health analysers and blood
pressure machines, and weight,
BMI, and body fat percentage
are sent directly to the patient’s
mobile app and then onto the
bariatric surgeon.
“Our technology is very
manageable and cost-effective
for providers and patients,” said
Gilbert. “The privacy and ease
of accessing weight management resources from home is
very empowering for patients.
Consistent support is at their
fingertips, helping them preserve
their bariatric investment and
their long-term health.”
Secure video appointments
help surgeons reach out to
geographically diverse patients
in the early stages of bariatric
research. CloudVisit technology
also gives bariatric surgeons a
way to acheive the long-term
success of their patients through
face-to-face check-ins, health
and progress monitoring, and
custom-tailored support to keep
them on track.
“Bariatric weight loss success
stories are undoubtedly good for
the surgeon, the practice, and
their patients,” he concluded.
“Ultimately, more widespread
reductions in comorbidities
like metabolic syndrome, heart
disease, and cardiovascular disease are good for the healthcare
system as a whole.”
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42 BARIATRIC NEWS ISSUE 21 | AUGUST 2014
Calendar of events 2014/15
August 26–30
October 27–28
November 20–21
IXX IFSO World Congress
6th Homerton Bariatric
Surgery Training Course
OSSANZ 2014 Conference
Montreal, Canada
www.ifso2014.org
London, United Kingdom
Email: [email protected]
September 10–14
November 2–7
64th Annual Obesity & Associated
Conditions Symposium
Austin, Texas, United States
http://www.asbp.org/physiciansclinicians/
resources/events/details
September 15–19
Wellington, New Zealand
http://ossanzconference.com.au/
November 25–29
ObesityWeek 2014
Brazilian Society of Bariatric and
Metabolic Surgery 2014 Annual Meeting
Boston, United States
http://obesityweek.com/
Rio de Janeiro, Brazil
http://sbcbm2014.com.br/
November 13
European Childhood Obesity Group –
Congress 2014
50th EASD Annual Meeting
Vienna, Austria
http://www.easd.org/
Salzburg, Austria
http://www.ecog-obesity.eu/index.php/
ECOG2014
October 18–22
2015
January 24–25
Annual Conference of Obesity and
Metabolic Surgery Society of India –
Ossicon 2015
Mumbai, India
http://ossicon2015.com/
April 8–12
Diagnosis to Treatment: Recognizing
Obesity as a Disease
Denver, United States
www.asbp.org/cmecertification/livecme/
biannualconference.html
November 20–21
UEG Week
Vienna, Austria
https://www.ueg.eu/week/?no_cache=1
8th Frankfurter Meeting
Frankfurt am Main, Germany
http://www.frankfurter-meeting.de/
To list your meeting details here, please email:
[email protected]
The next issue of Bariatric News is out in November
Editorial deadline: 1st November 2014
Advertising deadline: 1st November 2014
If you are interested in submitting an article for the newspaper, please contact:
[email protected]
If you are interested in advertising in Bariatric News, please contact:
[email protected]
If you would like to submit a press release, please email:
[email protected]
EDITORIAL BOARD
Henry Buchwald
Simon Dexter
John Dixon
MAL Fobi
Ariel Ortiz Lagardere
BARIATRIC NEWS
Managing Editor
Owen Haskins
[email protected]
Industry Liaison Manager
Martin Twycross
[email protected]
Designer
Peter Williams
[email protected]
Publisher
Dendrite Clinical Systems
10 Floor, CI Tower
St George’s Square, High Street
New Malden, Surrey KT3 4TE – UK
Tel: +44 (0) 20 8494 8999
Managing Director
Peter Walton
[email protected]
Printed by CPL Associates
© 2014 Dendrite Clinical Systems Ltd. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form
or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of the Managing Editor. The views,
comments and opinions expressed within are not necessarily those of Dendrite Clinical Systems or the Editorial Board.
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