1. health and fitness
2. disease

Doctors Don’t Agree on How to Reform Medicare Payment
By Jane Anderson
Elsevier Global Medical News
Physicians are dissatisfied with the current Medicare reimbursement system and want reform, yet
they disagree on what type of reform they would be willing to accept.
“Most physicians believe that Medicare reimbursements are inequitable, and yet there is little
consensus among them regarding major proposals to reform reimbursement,” Dr. Alex D.
Federman and his colleagues from Mount Sinai School of Medicine, New York, said regarding their
national survey of physicians’ opinions on reform.
“Overall, physicians seem to be opposed to reforms that risk lowering their incomes. Thus,
finding common ground among different specialties to reform physician reimbursement, reduce
health care spending, and improve health care quality will be difficult,” the investigators noted.
The investigators surveyed physicians between June and October 2009 – at the height of the
congressional debate on health reform. Of 2,518 physicians who received a version of the survey
addressing reimbursement reform, 1,222 (49%) responded.
A total of 78% of respondents agreed that under Medicare some procedures are compensated
too highly while others aren’t compensated enough to cover costs, according to the survey results.
However, when asked about specific methods to reform Medicare payment, the physicians
surveyed showed little agreement.
More than two-thirds of physicians said they opposed bundled payments, with surgeons – who
have the most experience with bundling – expressing the lowest levels of support for this strategy
(Arch. Intern. Med. 2010;170:1735-42).
“Because bundled payments are likely to be implemented in one form or another, this mechanism
ought to be carefully explained to physicians to promote broad acceptance and smooth
implementation,” Dr. Federman and colleagues wrote.
Half of the responding physicians said they supported financial incentives to improve quality, and
“support for incentives was more common and more consistent across all specialties compared with
shifting and bundling payments,” the investigators wrote. “Actual experience with financial
incentives to improve quality could have directly informed physicians’ generally more positive views
of these types of reimbursement mechanisms.”
Physicians disagreed on whether to shift some portion of payments from procedures to
management and counseling, with those who conduct procedures saying they were against it and
those who do more management and counseling coming out in favor of it, the study said.
Still, about 17% of surgeons and 27% of physicians in other more procedurally-oriented
specialties said they supported such a shift, “indicating that underpayment of management and
counseling even in procedurally-oriented specialties is a concern for many physicians.”
The investigators reported no relevant conflicts of interest.
“Despite physician concerns about payment reform, failure to change payment systems may be
worse for providers,” Michael E. Chernew, Ph.D., wrote in an accompanying commentary to Dr.
Federman’s article. “If we retain the current fee-for-service system, there will likely be significant
downward pressure on payment rates for all providers … hoping that payment reform (or fee cuts)
will not materialize seems overly optimistic.”
It’s likely that any payment reform will have significant effects on the basic business model of
many physician practices, but providers can find ways to save costs within most of the reforms by
Table of Contents
Pg 1
Doctors Don’t Agree
on How to Reform
Medicare Payment
Pg 2 High Sodium and
Sugar Diet Predicts
Vascular Dysfunction
in Healthy Black
Women
Pg 3
Cognition Improves
After Endarterectomy
for Carotid Stenosis
Pg 4
Postop Hyperglycemia
Called the Primary
Risk Factor for
Surgical Site Infection
Pg 5
Rivaroxaban Scores
High Marks for DVT in
EINSTEIN Trial
Pg 6
Daily Fondaparinux
Cuts Risk of
Complications, Death
in Lower-Limb
Superficial-Vein
Thrombosis
Pg 7
SVS News
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1
reducing redundant and unnecessary care, according to Dr.
Chernew (Arch. Intern. Med. 2010;170:1742-4).
“Payment reform will surely generate some provider backlash,
and surely bundled payments will create tension between
physicians and other types of providers, among different
specialties, and between primary care and specialist physicians,”
he wrote. “Moreover, the transition to new payment systems may
not be easy, requiring considerable investment and
organizational change.” But failing to act could lead to worse
consequences for physicians, he wrote.
Dr. Chernew is a professor of health care policy at Harvard
Medical School. He reported no relevant financial conflicts of
interest.
PERSPECTIVE
When asked to comment on this article, Dr. Russell H. Samson
stated: “This article encapsulates why the medical profession has
been the voodoo doll for Washington. As long as we remain a
house divided our legislators will stick it to us! Bringing us all
together, however, may be an insurmountable task. We have
specialties that historically have been reimbursed considerably
more than others and this breeds jealousy and resentment.
There is also the divide between the so-called "cognitive" and
procedural specialties (as if surgeons don't think when they treat
patients!). There is often disparity in income between academic,
hospital employed and community practice doctors which also
causes a lack of unity. And we increasingly have a divide in
philosophy between newly minted doctors and those nearing
retirement.
“However, we now acknowledge that most of us realize that
the system is broken and something needs to be done about it,
but we either don't know how to change it or are too scared to
change it for fear of losing what little we still have left. Vascular
surgeons may be even more threatened because we are such a
small specialty,” Dr. Samson added.
“So, as the article suggests, our professions inertia can only
lead to legislative action that will in all likelihood negatively affect
our income and our patient's health. So what should we do in the
interim as vascular surgeons? I think the answer is obvious become involved in our specialty society and donate to our PAC,”
he concluded.
Dr. Samson is a clinical associate professor of
surgery at Florida State University Medical
School and an associate medical editor of
Vascular Specialist.
High Sodium and Sugar Diet
Predicts Vascular Dysfunction
in Healthy Black Women
By Doug Brunk
Elsevier Global Medical News
SAN DIEGO – Low adherence to the Dietary Approaches to Stop
Hypertension diet, including increased intake of dietary sodium
and sweetened beverages, predicted vascular dysfunction and
insulin resistance among a cohort of healthy black women,
regardless of body weight.
Although the reason for the association remains unclear,
genetic susceptibility and lifestyle factors may play a role, Dr.
Priscilla E. Pemu said in an interview during a poster session at
the annual meeting of the Obesity Society. Endorsed by the
National Institutes of Health, the principles of the DASH diet are
based on a low-sodium eating plan rich in fruits and vegetables,
along with low-fat or nonfat dairy products (www.dashdiet.org).
“One of the main components of the DASH diet is intake of
low-fat dairy products,” said Dr. Pemu, an internist at Morehouse
School of Medicine, Atlanta. In the black population, “there tends
to be avoidance of dairy products because of lactose intolerance.
Offering people alternatives – things they can tolerate – would be
important in this population.”
Dr. Pemu and her associates enrolled 52 healthy,
normotensive, lean and obese black women (aged 18-45 years)
in an effort to determine the contribution of dietary factors to
vascular dysfunction. The women completed the Willett Food
Frequency Questionnaire, and blood was collected for
measurement of endothelial progenitor cells, C-reactive protein,
adiponectin, tumor necrosis factor–alpha, and insulin resistance
by homeostasis model assessment (HOMA), in which a level of
2.2 or greater was defined as insulin resistance.
The researchers also used high-frequency ultrasound to
measure flow-mediated dilatation and nitroglycerine-dependent
dilatation.
Study participants had less adherence to a DASH-type diet,
compared with a reference population from the Nurses’ Health
Study (Arch. Intern. Med. 2008;168:713-20), as evidenced by
lower mean dietary intake of fruits per day (1.27 vs 1.4,
respectively), as well as a significantly higher mean daily intake
of sodium (2,360 mg vs. 2,070 mg) and number of daily servings
of sweetened beverages (2.33 vs. 0.26).
Lower DASH adherence scores among the study participants
were associated with worse nitroglycerine-dependent dilatation, a
correlation that was unaffected by age, blood pressure, or body
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mass index, Dr. Pemu reported.
Low DASH adherence scores, including higher intake of
sodium and sugar-sweetened beverages, also predicted insulin
resistance as measured by HOMA.
Based on these findings, Dr. Pemu recommends that black
women “increase the amount of fruits and vegetables that they
consume, as well as nuts, legumes, and low-fat dairy products,
because we are starting to see a relationship with vascular
dysfunction even in the absence of cardiovascular disease.”
Dr. Pemu, who is also director of clinical trials at the clinical
research center at Morehouse, acknowledged certain limitations
of the study, including its small sample size and the potential for
error in the self-reported food frequency questionnaires.
“However, our data compared favorably with a much larger data
set in the Nurses’ Health Study, giving us confidence in the
relationships we have identified.”
The study was supported by grants from the National Center
for Research Resources. Dr. Pemu said that she had no relevant
financial disclosures.
PERSPECTIVE
When asked to comment on this article, Dr. Cynthia K. Shortell
stated: “This work addresses an issue of ongoing concern among
all health care providers, but to vascular surgeons in particular –
the persistent disparity between African Americans and
Caucasians with regard to cardiovascular health and healthcare
delivery. In this study, Dr. Pemu presents preliminary data
suggesting that non- or reduced adherence to a DASH-type diet
adversely impacts vascular and endothelial health as measured
by nitroglycerin-dependent dilatation. While the study tests a
surrogate marker, rather than a clinical outcome, this is a wellestablished and validated marker, and thus lends credibility to
the study.
“The real question, of course, is how to impact this issue in a
positive way, considering the barriers to improving dietary habits
in this patient population. Not only must patients be educated
and motivated to develop lasting dietary habits, the DASH-type
diet may also be more costly to a group of patients who can least
afford it. As vascular surgeons, it is incumbent upon us to help in
this process by emphasizing to our patients and there families
the importance of healthy habits in preventing the development
and progressing of vascular disease.
Dr. Shortell is professor of surgery and
program director, vascular residency and Vice
Chair of Faculty Affairs, Department of
Surgery. She is also an associate medical
editor for Vascular Specialist.
Cognition Improves After
Endarterectomy for Carotid
Stenosis
By Laird Harrison
Elsevier Global Medical News
SAN FRANCISCO – Cognitive function improved for most
patients in the year after they underwent endarterectomy for
carotid stenosis, according to the results of an ongoing
prospective study.
Benefits seem to come gradually from improved blood flow,
said Dr. Zoher Ghogawala, a neurosurgeon at Yale University in
New Haven, Conn., who reported on the study at the annual
meeting of the Congress of Neurological Surgeons. “After 1
month, there was no change in any of the domains we
measured,” he said. “However, if we followed these patients for a
year, there was significant improvement.”
The benefit of surgery also appeared to be most pronounced in
those with a right-sided lesion or impairment in middle cerebral
artery blood flow.
Although carotid endarterectomy is a well-established
technique to treat carotid stenosis as a means of preventing
stroke, its effects on cognitive function are poorly understood, Dr.
Ghogawala said.
To learn more, he and his colleagues enrolled 36 patients from
three sites. Overall, 61% had right-sided stenosis and 39% had
left-sided stenosis; 54% were male, and 14% were symptomatic
at presentation.
To estimate the extent that these patients’ circulation was
compromised, the researchers generated quantitative phasecontrast magnetic resonance angiography (qMRA) flow maps for
their internal and middle cerebral arteries. This technology
images blood flow in multiple phases of the cardiac cycle and
then calculates volume, velocity, and direction.
The researchers used this technique because conventional MR
techniques usually do not show changes in blood flow.
Using these data, they calculated the ratio of contralateral to
ipsilateral flow rates. They found that 12 patients had middle
cerebral artery (MCA) flow impairment (defined as at least 15%
less flow than the contralateral side) and 18 had impairment of
internal carotid artery flow.
Lower blood flows were associated with a higher rate of
stenosis. “It’s what you might expect,” said Dr. Ghogawala, who
also is director of the Wallace Trials Center at Greenwich (Conn.)
Hospital.
Following surgery, new qMRA maps showed improved blood
flow in these patients. Of the 12 patients who had preoperative
impairment in MCA blood flow, 10 had improved flow after
surgery.
After a month, there were no significant improvements in
cognitive functioning. But in 29 patients who completed follow-up
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at 1 year, there was improvement in executive functioning (as
measured by the Trail Making Test, Part B), verbal fluency (on
the Controlled Oral Word Association FAS test), and memory
(total recall score on the Hopkins Verbal Learning Test). The
changes were statistically significant (P less than .05).
Scores improved on the Trail Making Test in all 9 patients with
improvement in blood flow following surgery, compared with 8 of
20 patients with no improvement in blood flow.
The presence of a right-sided lesion and impairment in middle
cerebral artery blood flow were both significant, independent
predictors of improved Trail Making Test scores.
Dr. Ghogawala said that patients with those features may have
benefited the most because their cognitive function had been
most impaired by their constricted blood flow.
“Further study is needed to understand the cerebral flow
limitations associated with reversible dementia in some patients,”
he concluded.
Dr. Ghogawala disclosed that one of his coauthors received
research support from VasSol Inc., the company that made the
technology for producing the qMRA maps used in the study.
Another coauthor owns shares in the company.
“This is a very interesting study that may become more
important as the debate between CAS and CEA continues, as
well as further questions regarding intervention vs. medical
management for asymptomatic patients. If these findings are
reproducible on a larger scale, this might become an important
testing modality for asymptomatic patients to determine who is
most likely to benefit from intervention. If the technology proves
successful, it would also be very interesting to see if there are
differences between CAS and CEA with regard to improvement
in cognitive function,” commented Dr. Linda Harris.
Dr. Harris is an ACS Fellow and vice chair, faculty
development, department of surgery, Millard Fillmore Gates
Hospital-Kaleida, Buffalo, N.Y.
PERSPECTIVE
When asked to comment, Dr. Magruder C. Donaldson, chairman
of surgery at Metrowest Medical Center in Framingham, MA,
recalled anecdotal patients from his practice who claimed they
felt “smarter” after carotid surgery.
“Beyond anecdotes, this small study must be confirmed by
independent peer reviewed, large and carefully controlled
research using sophisticated means of correlating improved flow
caused by vascular intervention with improved cognitive function.
The effect of other variables such as comorbidity and
adjustments in medication must be factored in, to say nothing of
reassessing carotid territory flow at the time of late cognitive
retesting. Such research may even make it clear why right
carotids seem to make people smarter than left carotids,” he
added.
Dr. Donaldson is also an associate medical
editor of Vascular Specialist.
Postop Hyperglycemia Called
the Primary Risk Factor for
Surgical Site Infection
By Maryann Moon
Elsevier Global Medical News
Postoperative hyperglycemia, independent of the presence of
diabetes, appears to be the single most important risk factor for
surgical site infection in general and colorectal procedures,
according to a report in the September issue of the Archives of
Surgery.
Hyperglycemia is a recognized risk for infection in cardiac and
surgical intensive care units, and intensive insulin therapy is
frequently used to prevent infection in those settings. This study
found that serum glucose levels higher than 110 mg/dL also
increased the rate of surgical site infection (SSI) in patients
undergoing general and colorectal surgery and that the risk of
infection rose dramatically at even higher glucose levels, said Dr.
Ashar Ata and associates at Albany (N.Y.) Medical Center.
The investigators examined the relationship between
hyperglycemia and SSI using information in the American
College of Surgeons’ National Surgical Quality Improvement
Program database. They assessed the records of 2,090 surgery
patients aged 16 years and older who were treated at the
medical center between 2006 and 2009.
The rate of superficial, deep incisional, or organ space
infection was 1.8% among patients with postoperative glucose
levels of 110 mg/dL or less. That rate rose with increasing
glucose levels to a high of 17.7% in patients with levels of 220
mg/dL or higher.
Compared with patients whose first postoperative glucose level
was 110 mg/dL or less, those whose first level was 111-140
mg/dL had 3.6 times the risk of developing SSI, and those whose
first level was 220 mg/dL or higher had 12 times the risk.
Analysis of the subgroup of patients without diabetes showed
similar results: increasing postoperative glucose levels were
significantly associated with increasing risk of SSI in a doseresponse fashion.
Similarly, analysis of the subgroup of patients undergoing
colorectal surgery showed that postoperative serum glucose
levels of 140 mg/dL or higher were the only significant predictor
of surgical site infection. The rate of infection was three times
higher in patients with that level of hyperglycemia (21%) than in
patients with serum glucose levels below 140 mg/dL (7%).
Initial analysis showed that several other variables – including
patient age, severity of illness, need for emergency surgery, need
for transfusion, and operative time – also raised the risk of SSI.
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However, after the data were adjusted to account for serum
glucose levels, all those risk factors except for operative time
ceased to be significant predictors of SSI. This suggests that the
effect of these other risk factors may be exerted through the
alteration of serum glucose levels, Dr. Ata and colleagues said.
In contrast to the findings with general and colorectal surgery,
postoperative serum glucose level showed no association with
infection risk in vascular surgery. The reason for this discrepancy
is not yet known, they said (Arch. Surg. 2010;145:858-64).
For vascular surgery, the rates of SSI were relatively high
across all categories of serum glucose level, from 13.2% in the
lowest category to 20% in the highest category. After adjustment,
the likelihood of SSI in vascular surgery patients increased by 6%
for every 10 minutes increase in operative time. Patients with
diabetes were 1.84 times more likely to develop SSI in vascular
surgery than were nondiabetic patients.
These results must be confirmed in larger, prospective,
multicenter studies, the researchers noted. Meanwhile, “based on
the results of this study, a revised protocol targeted at achieving
glucose levels less than 140 mg/dL will be considered for a future
prospective study.”
If the findings are confirmed, it is possible that clinicians may
be able to reduce the risk of postsurgical infection by managing
perioperative hyperglycemia, they added.
“This study supports the conclusion that postoperative
hyperglycemia is not benign and dispels the notion that surgical
site infections are beyond our control,” according to Dr. Joseph
H. Frankhouse, whose invited critique accompanied Dr. Ata’s
report (Arch. Surg. 2010;145:864).
However, there are two problems with the study design, he
pointed out.
First, only 75% of patients had reliable data on postoperative
glucose levels and in only half of those cases were those levels
obtained within 12 hours of surgery. Much of the data was
derived from routine lab tests done the day after surgery, so
“there is quite a variance as to when glucose monitoring began,
how it was performed, and when, or even if, attempts at glycemic
control began,” he noted.
Second, the failure to find any association between serum
glucose levels and site infection after vascular surgery was
“striking.” This patient group is the very one that presumably has
the highest rates of diabetes. They also had a higher rate of
surgical site infection than did patients undergoing general or
colorectal surgery. So a lack of association “leads one to wonder
whether factors such as hemoglobin A1c level, nutrition, tobacco
use, obesity, operative time, and tissue perfusion/oxygenation
may be more powerful factors in the equation,” Dr. Frankhouse
said.
Dr. Frankhouse is with Legacy Health System, Portland,
Oregon. He reported no financial disclosures.
Rivaroxaban Scores High
Marks for DVT in EINSTEIN
Trial
By Bruce Jancin
Elsevier Global Medical News
STOCKHOLM — Fixed-dose rivaroxaban is at least as effective as
current standard treatment for acute deep vein thrombosis—and
far simpler to use, according to the large phase III EINSTEINDVT trial presented in a hotline session at the annual congress of
the European Society of Cardiology.
“Results from EINSTEIN-DVT could transform the way
physicians treat deep vein thrombosis,” Dr. Harry R. Büller
predicted in presenting the data.
Congress program chair Dr. Fausto J. Pinto of Lisbon
University agreed. Indeed, in a wrap-up session at the close of
the conference he singled out EINSTEIN-DVT as one of the
meeting’s several top highlights, citing the trial’s likely practicechanging impact for the treatment of a problem that affects 2-3
per 1,000 adults per year in the Western world.
EINSTEIN-DVT was an open-label study involving 3,449
patients at 253 centers in 32 countries. All had acute
symptomatic DVT but no pulmonary embolism. Participants were
randomized to oral rivaroxaban, an investigational direct inhibitor
of factor Xa, at 15 mg twice daily for 3 weeks, followed by 20 mg
once daily, or to current standard therapy consisting of
subcutaneous enoxaparin, typically for about 7 days, followed by
warfarin or another vitamin K antagonist at a target international
normalization ratio (INR) of 2-3. Treatment duration could be 3, 6,
or 12 months at the physician’s discretion.
EINSTEIN-DVT was designed to show whether rivaroxaban is
noninferior to standard therapy, which is known to be highly
effective, reducing the recurrent venous thromboembolism rate
by about 90% compared to no treatment. But standard therapy is
also quite cumbersome because of warfarin’s well-known
shortcomings, explained Dr. Büller, chairman of vascular
medicine at the Academic Medical Center, Amsterdam.
Recurrent venous thromboembolism, the primary study end
point, occurred in 2.1% of the rivaroxaban group, compared with
3.0% of those on standard therapy. The resultant 32% relative
risk reduction was so robust that it not only established
rivaroxaban’s noninferiority, it came within a hair’s breadth of
demonstrating statistically significant superiority for the singledrug regimen, he continued.
The primary safety end point in EINSTEIN-DVT was the
combined rate of major bleeding or clinically relevant nonmajor
bleeding. This adverse outcome occurred in 8.1% of both groups.
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For the prespecified secondary combined end point of
recurrent venous thromboembolism or major bleeding, the rates
were 2.9% in the rivaroxaban arm compared with 4.2% with
standard therapy, for a highly significant 33% reduction in risk.
The rivaroxaban regimen was equally safe and effective
regardless of patient age, gender, body mass index, creatinine
clearance, or the presence of cancer. Monthly monitoring of liver
function tests showed no evidence of hepatotoxicity with the
drug. In the standard therapy arm, once patients were off lowmolecular-weight heparin and on warfarin they were within the
target INR 58% of the time.
American physicians often initially hospitalize patients with
DVT for 5-7 days or more of therapy with unfractionated heparin.
Asked to comment on this strategy, Dr. Büller was blunt: “It’s time
to change.”
“I visit the United States often, and I am absolutely surprised
that so many physicians there hospitalize their DVT patients for
unfractionated heparin. In many other parts of the world, 80%90% of these patients are treated out of hospital with lowmolecular-weight heparin followed by a vitamin K antagonist,” he
said.
Discussant Dr. Harald Darius, noting that the oral direct
thrombin inhibitor dabigatran is widely expected to be the first of
the new antithrombins to receive marketing approval for
treatment of acute DVT, observed that rivaroxaban’s
performance in EINSTEIN-DVT appeared to be roughly
comparable to that of dabigatran in the RE-COVER trial (N. Engl.
J. Med. 2009;361:2342-52). Rivaroxaban had a 2.1% incidence
of recurrent venous thromboembolism, while dabigatran at 150
mg twice daily for 6 months had a 2.4% rate. However, the use of
dabigatran was preceded by at least 5 days of subcutaneous
low-molecular-weight heparin or intravenous unfractionated
heparin, he noted.
Dr. Darius declared, “I’m quite positive that we’re facing a new
era of antithrombotic therapy in patients with DVT, but with some
questions still to be resolved.”
Chief among these questions in his view is the optimal
treatment duration using rivaroxaban and the other new agents.
Neither EINSTEIN-DVT nor RE-COVER was designed to provide
an answer.
“If you look at the guidelines, the treatment duration is
extended with every new edition,” noted Dr. Darius of Vivantes
Hospital, Berlin.
Rivaroxaban is also under development for other potential
indications, including stroke prevention in patients with atrial
fibrillation, secondary prevention of acute coronary syndrome,
treatment of acute pulmonary embolism, and prevention of
venous thromboembolism in high-risk hospitalized, medically ill
patients.
Dr. Büller disclosed having received research grants and
serving as a consultant to Bayer Schering Pharma, which
sponsored the EINSTEIN-DVT trial. Dr. Darius declared no
financial conflicts.
Daily Fondaparinux Cuts Risk
of Complications, Death in
Lower-Limb Superficial-Vein
Thrombosis
By Kerri Wachter
Elsevier Global Medical News
Daily fondaparinux significantly reduced the relative risk of
symptomatic thromboembolic complications or death by 85% –
without increasing the incidence of bleeding – in a study of some
3,000 patients with acute symptomatic lower-limb superficial-vein
thrombosis.
“Fondaparinux also reduced the risk of symptomatic
recurrence of superficial-vein thrombosis and, more important, its
extension to the saphenofemoral junction – a finding that is
clinically relevant because such extension is considered to
increase the risk of deep-vein thrombosis and pulmonary
embolism, thereby prompting escalation of therapy (for example,
to full-dose anticoagulation or surgery),” Dr. Hervé Decousus and
his coinvestigators reported in the New England Journal of
Medicine
The results may help fill in knowledge gaps about the
appropriate treatment for superficial-vein thrombosis. Currently,
therapeutic strategies range from no treatment to the use of antiinflammatory drugs, anticoagulant agents, or even surgery.
Investigators in the study, known as the Comparison of Arixtra
in Lower Limb Superficial Vein Thrombosis with Placebo
(CALISTO) trial, compared the efficacy and safety of the specific
factor Xa inhibitor fondaparinux with placebo in reducing
symptomatic venous thromboembolic complications or death
from any cause. The study comprised 3,002 patients with acute,
isolated superficial-vein thrombosis of the legs (N. Engl. J. Med.
2010;363:1222-32).
Patients 18 years or older with acute, symptomatic lower-limb
superficial-vein thrombosis at least 5-cm long were eligible for the
study. They were excluded from the study if they met various
specific criteria, such as a documented history of SVT within the
past 3 months or DVT or PE within the past 6 months.
Between March 2007 and May 2009, a total of 3,002 patients
were enrolled and randomized to receive 2.5 mg subcutaneous
fondaparinux per day or daily subcutaneous placebo for 45 days.
Overall, 1,481 patients in the fondaparinux group and 1,467 in
the placebo group completed the follow-up visit at day 75, wrote
Dr. Decousus of the Centre Hôpitalier Universitaire Saint-Étienne
in France, and his coinvestigators.
Patients could choose whether to self-administer the injections,
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were encouraged to use graduated compression stockings, and
were allowed to take acetaminophen or topical NSAIDs as
needed. Concomitant treatment with other thrombolytic,
anticoagulant, or antiplatelet agents was prohibited.
The primary efficacy outcome – the composite of death from
any cause, symptomatic confirmed PE or DVT, or confirmed
symptomatic extension to the saphenofemoral junction or
symptomatic recurrence of superficial-vein thrombosis up to day
47 – occurred in a significantly greater percentage of those in the
placebo group (5.9% vs. 0.9%; relative risk with fondaparinux,
0.15). Twenty patients would need to be treated to prevent one
death, PE, DVT, extension to the saphenofemoral junction or
symptomatic recurrence of superficial-vein thrombosis.
In addition, the incidence of each component of the primary
efficacy outcome was significantly reduced in the fondaparinux
group, except for the incidence of death, which did not differ
significantly. The risk of the composite of DVT or PE was
significantly reduced by 85% with fondaparinux, compared with
placebo (0.2% vs. 1.3% affected in each group, respectively). To
prevent one DVT or PE, 88 patients would need to be treated.
“This benefit was evident within the first days after treatment
was initiated, supporting the adequacy of the prophylactic dose
of 2.5 mg of fondaparinux and in accord with the substantial
efficacy data already available with respect to a dose of 2.5 mg of
fondaparinux in various clinical settings,” the investigators wrote.
In addition, more patients in the placebo group underwent
surgery for superficial-vein thrombosis than in the fondaparinux
group (3.5% vs. 0.5% by day 77), including ligation of the
saphenofemoral junction.
Major bleeding had occurred in one patient in each group by
day 47. The rates of clinically relevant nonmajor, minor, and total
bleeding and arterial thromboembolic complications did not differ
significantly between groups.
The study was supported by GlaxoSmithKline, which markets
Arixtra (fondaparinux). In addition, 8 of the 11 study authors
reported significant financial relationships with several
pharmaceutical companies, including GlaxoSmithKline.
While overall efficacy and safety are crucial information for the
approval and widespread use of a new drug, so is cost
effectiveness, Dr. Lee Goldman and Dr. Jeffrey Ginsberg wrote in
an accompanying commentary.
In this study, the researchers determined that 88 patients
would need to be treated with fondaparinux to prevent one
nonfatal episode of deep-vein thrombosis or pulmonary embolism
(N. Engl. J. Med. 2010;363:1278-80). “We found that in New York
City, the price of a 45-day regimen of 2.5 mg of fondaparinux
once daily ranged from $2,124 to $7,380 at four major
pharmacies. Even at the lowest quoted price and considering the
98.3% estimated adherence rate, the cost of the treatment for
1,500 patients would be about $3.13 million,” they wrote.
“On the basis of the incremental 1-year costs for the medical
care of a patient with a pulmonary embolus or deep-vein
thrombosis, an estimated $250,000 or so in medical care costs
-Story Continues on Next Column-
would be averted, resulting in a net cost of fondaparinux
treatment of about $2.88 million, or about $1,900 per treated
patient, without any lives saved.”
However, no clinical trial phases currently assess this
important information. Likewise, decisions regarding Medicare
reimbursement in the United States do not “consider the cost or
cost-effectiveness of the agent itself or of the strategy into which
it is incorporated,” according to Dr. Goldman and Dr. Ginsberg.
“We recommend that the Food and Drug Administration give
serious thought to mandating phase 3.5 trials to document the
costs, the effects on quality of life, and the cost-effectiveness of
new interventions so as to reach a consensus regarding their
worthiness. Until such data are available and consensus is
reached, it would seem premature to recommend that
fondaparinux be used routinely in the treatment of superficialvein thrombosis.”
Dr. Goldman is the executive vice president for Health and
Biomedical Sciences and dean of the Faculties of Health
Sciences and Medicine at Columbia University in New York. Dr.
Jeffrey Ginsberg is a professor of hematology and
thromboembolism at McMaster University in Hamilton, Ontario.
Both Dr. Goldman and Dr. Ginsberg reported that they have no
relevant financial relationships.
SVS News
SVS’ Journal of Vascular Surgery Ranks 14
Among 166 Surgical Journals
Highly respected among surgical journals, the Society for
®
Vascular Surgery’s (SVS), official scientific publication, the
®
Journal of Vascular Surgery (JVS), is ranked 14 among 166
surgical journals. This ranking is based upon JVS’s Impact
Factor, calculated by Thomas Reuters and published in the
®
Journal Citation Reports . The JVS’s most recent Impact Factor
is 3.517. This means that on average, every article published by
JVS is cited more than three times.
“The increasing success of JVS is due in part to the
dedication of Dr. Bruce Perler, our two associate editors, four
assistant editors, and 41editorial board members,” said editor-inchief Anton N. Sidawy, MD. “These dedicated surgeons donate
their time and are able to review most manuscripts within two
weeks.” In 2010, the volunteers assessed nearly 1,600
manuscripts. Most submissions (40 percent) were either clinical
papers or case reports, and 40 percent were submitted by
surgeons from Europe, Japan, and the United Kingdom. JVS and
corresponding supplements are mailed to nearly 6,000
subscribers including the SVS’ membership of nearly 3,350.
JVS was first published in January 1984 by founding
editors, Drs. Michael DeBakey and Emerick Szilagyi. Its
coverage of clinical and basic science studies, and case reports
has expanded to include new sections including Historical
Vignettes, Education Corner, and Trans-Atlantic Debates. JVS is
available on line at jvascsurg.org.
SVS Vascular Specialist: Online Edition | December 22, 2010 | Vascularweb.org ®
Copyright © 2010. Society for Vascular Surgery®. All rights reserved.
Page
7
AVA Funds Empower Young Vascular Surgery
Scientists
The Call for Abstracts Deadline is Approaching
for 2011 Vascular Annual Meeting
The American Vascular Association® (AVA), the charitable
foundation of the Society for Vascular Surgery®, has provided
US$666,000 in 2010 Mentored Clinical Scientist Development
(K08) and Mentored Patient-Oriented Research Career
Development (K23) awards to young vascular surgery scientists.
The Society for Vascular Surgery® Vascular Annual Meeting® to
be held in Chicago, June 16-18, 2011 is accepting abstracts and
surgical videos. Submissions will be accepted through 11:59 pm
ET on Jan. 3, 2011. Complete information appears on
VascularWeb.org®.
AVA awards enable young scientists to participate in mentored
opportunities to develop into independent investigators.
Ultimately, the researchers can develop techniques that reduce
the number of deaths and disabilities from vascular disease.
“In contributing to the young researchers supported by the AVA,
SVS members have demonstrated remarkable leadership and
vision,” said Dr. Bruce Gewertz, Chairperson of the AVA
Development Committee.
“In cooperation with the NIH, we are insuring that the intellectual
underpinnings of our discipline will be driven by vascular
surgeons with real clinical expertise. Even a brief review of the
substantial accomplishments of AVA funded investigators shows
that our hopes have been realized.”
To continue to advance vascular research, the AVA launched the
fundraising campaign, Open the Pathway. The successful 2008
initiative secured five-year financial commitments from many
individuals and vascular device companies. The campaign raised
US$2.3 million in pledges payable over five years.
Of the 224 pledges received from SVS members, the average
donation was US$2,470. Despite the success of the campaign,
the yearly pledge payments do not cover the cost of the awards.
Annual gifts remain an important source of funding for AVA.
As vested partners in the future of vascular surgery, the taxdeductible donations (where applicable) from SVS members to
AVA will help ensure the continuation of leading-edge research.
The names of 2010 AVA donors appear on VascularWeb.org.
To make a 2010 donation to AVA:
•
access the secure portal on VascularWeb.org;
•
make a credit card payment through fax number 312334-2320;
•
mail a check to AVA, 35312 Eagle Way, Chicago, IL
60678-1353.
For additional information, email the AVA at
[email protected] or telephone 312-334-2300.
The submission of abstracts will be accepted for four session
types:
•
•
•
•
Plenary Sessions on Thursday through Saturday
Rapid Paced Paper Session on Friday and Saturday
afternoon
Peripheral Vascular Surgery Society (PVSS) Session on
Wednesday afternoon
Poster Session presentation on Friday afternoon
Open and endovascular procedure surgical videos will be
featured during each plenary session at the Vascular Annual
Meeting. The categories for surgical videos are:
•
•
•
•
•
•
•
•
•
•
•
•
•
Aortic disease
Cerebrovascular including great vessels
Dialysis access
Educational / training credentialing
Peripheral arterial disease
Practice management
Renal / visceral disease
Vascular laboratory and imaging
Vascular medicine
Vascular trauma: aortic, arterial, venous
Venous disease
Basic research (poster only)
Other
Abstracts and surgical videos must be submitted electronically
via the official SVS submission site. Paper abstract submissions
will not be accepted.
The guidelines, policies, and instructions for submitting abstracts
and surgical videos appear online. All authors are required to
disclose any conflict of interest when submitting their abstract or
surgical video.
For the first time this year, abstracts describing basic science
research or early translational research under the topic of basic
research will be primarily evaluated for poster presentations.
For questions about the call for abstracts and surgical videos,
please contact: [email protected].
SVS Vascular Specialist: Online Edition | December 22, 2010 | Vascularweb.org ®
Copyright © 2010. Society for Vascular Surgery®. All rights reserved.
Page
8
Society for Vascular Surgery Launches New
Vascular Quality Initiative
®
The Society for Vascular Surgery (SVS) announced a new
quality initiative to improve the care of patients with vascular
disease. The Vascular Quality Initiative includes a registry and
regional study groups to analyze the data collected from the
registry. The initiative expands SVS’ focus on clinical outcomes
and benchmarked reporting. SVS is partnering with M2S on this
project which was originally established by the Vascular Study
Group of New England.
“The Vascular Quality Initiative enhances SVS’ mission to assist
its members in understanding and improving patient outcomes by
encouraging the collection, aggregation, and analysis of clinical
data,” said Robert Zwolak, SVS president. “Through this
partnership, SVS oversees the electronic registry and manages
the Patient Safety Organization. This organization has oversight
from a scientific advisory board comprised of SVS and regional
group representatives, with Jack Conenwett, MD, DartmouthHitchcock Medical Center and former SVS president, serving as
its medical director. M2S provides the web-based registry
platform for data collection and analysis.”
The partnership with M2S positions SVS as the leader in
vascular outcomes tracking by providing a platform for its
members to analyze outcomes, reinforce best practices, and
share quality improvement efforts across regions. Currently the
Vascular Quality Improvement Initiative has 30 centers across 11
states and Canada. In addition to the 20 institutions in the New
England regional group, there are two new regional study groups
in the Carolinas, led by Jeb Hallett, MD of Roper St. Francis, and
in Texas, led by Mark Davies, MD at Methodist Hospital,
Houston. Additional groups are forming in Florida, California,
New Jersey, Georgia, Pennsylvania, and Michigan.
“We are excited to partner with SVS to provide the platform for
the Vascular Quality Initiative. M2S has been committed to
improving vascular patient outcomes for more than 10 years with
our advanced imaging technology. We believe the Vascular
Quality Initiative, combined with standardized pre-operative and
post-operative imaging, will significantly improve patient care,”
said Greg Lange, president and chief operating officer of M2S.
The Vascular Quality Improvement Initiative utilizes MDS’s
secure, web-based system, Clinical Data Pathways, for data
entry and report generation. Through Clinical Data Pathways
participants generate real-time benchmarked reports on seven
vascular procedures for major outcomes and processes of care
to allow for the continuous assessment of them compared to a
blinded group of peers based on key performance measures. For
more information contact [email protected] or telephone 603-2985509.
Get Involved Today with Find the AAAnswers
Professional football legend Joe Theismann has teamed up with
Find the AAAnswers, an educational campaign designed to
educate the public about Abdominal Aortic Aneurysms (AAA) and
encourage screening. In September 2010, Kmart Pharmacies
became a partner of the campaign and began offering free
screening in select pharmacies.
With the help of Joe Theismann and Kmart Pharmacies Find the
AAAnswers made national headlines in the Wall Street Journal
blog, on “The Dr. Oz Show”, and on “Fox and Friends”. Media
coverage reached more than 20 million viewers.
Screening events at Kmart Pharmacies continue to reiterate the
campaign’s message across the country. Events have taken
place at 10 locations. Throughout flu season, AAA risk
assessment is offered at Kmart Pharmacy Flu Clinics free of
charge. Educational materials are at 900 stores nationwide. More
than 800 people were screened between September 10, 2010 to
October 31, 2010. During this timeframe 28 AAA were detected.
“The partnership with Kmart Pharmacies has been very
successful at raising awareness,” Dr. R. Clement Darling said.
“The employees of Kmart Pharmacies are excited to take part in
this initiative, and I think the pharmacy location is a perfect venue
to reach at-risk individuals. Taking part in this initiative has been
®
very rewarding.” The Society for Vascular Surgery (SVS) is a
campaign partner.
There are several ways that SVS members may become
involved in this effort.
•
•
•
•
•
•
Volunteer onsite during local screening events. Doctors
may meet with patients to answer questions related to
vascular health. If you wish to volunteer at a local
screening event, email [email protected].
2011 screening event dates and locations have not
been announced yet; check FindtheAAAnswers.org for
the latest screening announcements.
Sign up to be part of the DoctorFinder directory. The
free directory is found at FindtheAAAnswers.org. It
allows patients to search for physicians in their area
who are familiar with AAA and its symptoms.
Order free educational materials for offices or waiting
rooms at FindtheAAAnswers.org/patienteducation.
AAA risk assessment quiz
Find the AAAnswers toolkit
Learn more by visiting FindtheAAAnswers.org.
SVS Vascular Specialist: Online Edition | December 22, 2010 | Vascularweb.org ®
Copyright © 2010. Society for Vascular Surgery®. All rights reserved.
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