Treatment of Achalasia in 2013: Dilation,
Heller, or POEM?
AATS, Nov. 15, 2013
Nathaniel J. Soper, M.D., FACS
Northwestern Medicine Department of Surgery
Chicago, IL
Presenter Disclosure
Nathaniel J. Soper, MD, FACS
The following relationships exist related to this
presentation:
No Relationships to Disclose
Achalasia
• Rare, idiopathic disease of esophageal motility
• Failure of esophagogastric junction (EGJ)
relaxation and aperistalsis of the esophageal
body
• Results in dysphagia, regurgitation, and
esophageal dilation
Diagnosis
• Based on history and manometry
• Upper endoscopy – rule out pseudoachalasia
• Esophagram – define anatomy
High-resolution manometry
Pressure
mmHg
≥110
Clouse Plot
90
70
50
30
Manometric port
10
-10
0
2.5
4.5 5.6
7.1
8.5
8.8
11.0
13.0
Achalasia HRM criteria
1. Impaired relaxation
2. Absent peristalsis
Normal
Achalasia
Achalasia Subtypes:
Chicago Classification**
• Type I (‘classic achalasia’):
absence of esophageal
pressurization
• Type II: panesophageal
pressurization
• Type III: spastic contractions
• **Pandolfino and Kahrilas
Achalasia: Historical Aspects
• Thomas Willis (1672)
- pt. starving, unable to swallow
- whalebone dilator
• Von Mikulicz (1881)– “cardiospasm”
• Einhorn (1888) – impairment of normal reflex
relaxation of the cardiac sphincter
• Hurst (1913) – “achalasia”- (a, not; χαλάω, I relax)
-coined by Sir Cooper Perry
Achalasia: Historical Aspects
•Heller (1913) – Extramukose cardioplastik belm
chronischen cardiospasmus mit dilatation des
Ösophagus. Mitt Grenzgeb Med Chir 27: 141-5
•Zaaijer (1923) – Anterior myotomy only
• Rake (1927) - progressive destruction of the cells
of Auerbach’s plexus (post-mortem)
Current Treatment of Achalasia
Medical
• Pharmacotherapy: Nitrates/Ca-channel blockers
– ~20% partial response
• Endoscopic Botox (botulinum toxin A) injection*
Mechanical
• Endoscopic pneumatic dilation*
• Esophagomyotomy (Heller or POEM)
(Excisional
• End-stage disease)
*Renders subsequent myotomy more difficult
Botox®
Advantages
Easy
Safe
Reversible (with time)
PJK
Disadvantages
Temporary
Relatively ineffective
Expensive
• Considering limited
efficacy
No physiological
improvement
Doesn’t halt progression
May impede myotomy
Pneumatic Dilators used for
Treating Achalasia
Microvasive® Dilator (3.0, 3.5, or 4.0 cm)
Passed over guidewire, imaged with fluoroscopy
PJK
Pneumatic Dilation
35 mm dilator
PJK
Pneumatic Dilation
35 mm dilator
“Waist”
locating the
LES
PJK
Pneumatic Dilation
35 mm dilator
Effacement of
“Waist”
PJK
Pneumatic dilation
Advantages
Outpatient procedure
Can be repeated
Potentially long-term
solution
Halts disease
progression
Rare post-Rx reflux
Disadvantages
2-4% perforation risk-may require thoracotomy
Less efficacious than myotomy
• 58% SI >3 years
– Campos et al 2008 (meta)
May need 2 or even 3
successive dilations
• 44% SI at 6 years
– Vela et al 2006
• 72% excellent or good at 6 years
– Hulselmans et al 2010
– serial and graded
Modified from PJK
The European Achalasia Trial:
2 year results
All patient without
previous treatment
Successful treatment (%)
(Eckardt score < 3)
Eckardt score
(n=97)
Pneumatic
dilation (n=85)
90%
86%
1.1 ± 0.1
1.5 ± 0.1
(p = 0.06)
LES pressure (mmHg)
10
12
Timed barium swallow
(cm)
1.9
3.7
23%
15%
Abnormal pH
PJK
Heller myotomy
Boeckxstaens GE, et al. NEJM 2011; 364(19):19
The European Achalasia Trial:
Concerns
• Surgeon experience: > 5cases
• 106 cases at 14 sites over 5 years
= 1.5 cases/site/year
• 12% perforation rate during LHM
• Myotomy only 1-1.5 cm onto stomach
•30% initial perforation rate
•4% perf for PD after protocol revision
•Less experience among U.S. GIs
Adverse Events
Response Rates
Heller vs. Pneumatic Dilation; Meta-analysis of RCTs
(Yaghoobi, et al, GI Endosc 2013)
Esophageal myotomy
Advantages
The most effective
treatment
The most definitive
treatment
Halts disease
progression
PJK
Disadvantages
Requires hospitalization
and general anesthetic
Operative morbidity and
mortality
Expensive
Post-Rx reflux
Surgical Myotomy: Which Approach?
Open vs Laparoscopic
• Laparoscopic myotomy resulted in shorter LOS, less
pain and more rapid recuperation along with similar
symptomatic outcome compared to open myotomy
(Dempsey, et al, Surg Endosc, ‘99)
Laparoscopic vs Thoracoscopic
• Laparoscopic associated with shorter OR time, fewer
conversions and shorter LOS along with better
symptomatic outcome than thoracoscopic myotomy
(Stewart, et al, JACS, ‘99)
Fundoplication?
• Partial fundoplication decreases pathologic reflux
-47 vs. 9% (Richards et al, Ann Surg 2004)
• No difference between Dor or Toupet (small PRT)
- GERD in 42% vs. 21% [p=NS] (Rawlings et al,
Surg Endosc 2011)
•Nissen fundoplication results in higher rates of
dysphagia compared with partial fundoplication
- 15 vs. 2.8% (Rebecchi et al, Ann Surg 2008)
•
Laparoscopic Myotomy
Current Preferred Approach
Heller-Dor: Minimal posterior
dissection; anterior 1800
fundoplication; covers exposed
mucosa, but may ‘close the door’
OR
Heller-Toupet: Full
fundal/esophageal mobilization;
posterior ~1800 fundoplication to
edges of myotomy; may hold
myotomy open
From Hunter
Partial Fundoplication
Toupet
Dor
From Mastery of Surgery, Chap 62.
Swanstrom LL. Surg Endosc 1995
Outcomes of Heller Myotomy:
Meta-analysis
Symptomatic
improvement (%)
GERD (%)
Laparotomy (732, 87)
84.5
12
Thoracotomy (842,
102)
83.3
24.6
Thoracoscopy (211,
36)
77.6
28.3
Laparoscopy (3086,
35)
89.3
14.9
- without fundo
89.0
41.5
- with fundo
90.3
14.5
(n, mean follow-up
months)
Campos, et al, Ann Surg 2009
Long-Term Outcomes of Heller
Myotomy
 Treatment failures in 7% at 2 yrs, 10% at 5 yrs and 18% at
10 yrs—failure associated with lower preop LESP and
sigmoid esophagus
– Zaninotto, et al Ann Surg 2008: 248: 986
 Satisfactory results >90% at 5 years75% at 15 yrs
– Ortiz, et al Ann Surg 2008; 247: 258
 Excellent/good results in 80% at 10 yrs and 65% at 20
yrs—failures due to GERD (Visick scores)
– Csendes, et al Ann Surg 2006; 243: 196
Effect of endoscopic treatments
before myotomy
Prior Botox resulted in increased symptoms of
dysphagia, regurgitation and heartburn after
laparoscopic Heller
• Finley et al 2010
Prior treatment increased failure rate:
• 3.7% to 16.8% (Schuchert et al 2008)
• 10.1% to 19.5% (Smith et al 2006)
―At this time in history, the
best primary therapy for
achalasia in a fit patient is a
laparoscopic Heller myotomy
and fundoplication.‖
John Dent, Professor of Medicine,
University of Adelaide – ISDE state of the
art lecture-1998
Per-Oral Esophagomyotomy (POEM）
…Pasricha initially reported a method of submucosal
endoscopic myotomy with no skin incision in an
experimental model [1]. Subsequently, Inoue modified
the technique and applied it clinically…[2].
１. Pasricha, et al. Submucosal endoscopic esophageal myotomy: a novel
experimental approach for the treatment of achalasia. Endoscopy 2007;39(9):
761-4.
２. Inoue H, et al. First clinical experience of submucosal endoscopic myotomy for
esophageal achalasia with no skin incision. Gastrointest Endosc 2009;69: A122
POEM
(1) Enter into the submucosa
in the mid esophagus
View through
transparent
distal cap on
endoscope
Triangle
tip knife
Courtesy of H. Inoue
POEM
(2) Creation of submucosal
tunnel ≈ half esophageal
circumference
mucosal
layer
palisade vessels
Courtesy of H.
POEM
(3) Myotomy begun ≈ 3 cm
distal to entry, ≈ 6 cm above
EGJ
Courtesy of H.
POEM
(3) Myotomy completion
Courtesy of H. Inoue
POEM
(4) Clip mucosotomy
Courtesy of H. Inoue
Northwestern Protocol
IRB – >70 cases to date
Exclusion criteria:
• Prior Botox or dilation for first 10 cases
• Sigmoid esophagus for first 20 cases
Pre-op multidisciplinary evaluation
• HRM
• FLIP
• Questionnaires
Esophagram on POD #1
EndoFLIP Pre/post POEM
Technical differences between POEM and
Heller
1) No skin incisions
2) Myotomy of only the circular muscle layer
3) No disruption of the diaphragmatic hiatus
4) No concurrent anti-reflux procedure
from Inoue et. al. Peroral endoscopic myotomy (POEM) for
esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71
from Vaziri, Soper. Laparoscopic Heller myotomy: technical aspects and
operative pitfalls. J Gastrointest Surg. 2008 Sep;12(9):1586-91.
Do the differences matter?
1) Perioperative safety and outcomes
2) Resulting anatomy
3) EGJ physiology
4) Learning curve for POEM
5) Long term outcomes after POEM
from Inoue et. al. Peroral endoscopic myotomy (POEM) for
esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71
from Vaziri, Soper. Laparoscopic Heller myotomy: technical aspects and
operative pitfalls. J Gastrointest Surg. 2008 Sep;12(9):1586-91.
Perioperative outcomes
• Comparison of intraoperative and immediate
postoperative outcomes at Northwestern
• Limited to treatment naïve patients
Baseline Characteristics – Treatment
Naïve Patients
POEM
LHM p-value
Number
Female
Age
26
28%
42
55
48%
50
BMI
ASA classification
I
27
28
11%
8%
67%
68%
22%
3.1
24%
2.3
NS
29
27
NS
II
III
Duration of
symptoms (years)
Preoperative EGJ
relaxation
pressure (mmHg)
NS
.02
NS
NS
Perioperative Outcomes
p-value
POEM
LHM
Number
26
55
Operative time (mins)
110
126
.01
Myotomy length (cm)
9.2
8.5
.03
EBL (ml)
<10
91
<.001
Major complications
1 (6%)
1 (2%)
NS
Minor complications
4 (15%)
7 (13%)
NS
Length of stay (days)
1.6
1.5
NS
Pain Scores and Narcotic
Requirements
POEM
LHM
POEM LHM p-value
Narcotic requirements
(mg morphine equivalents)
Day of surgery
POD #1
Ketorolac usage
10
4
28%
8
5
80%
NS
NS
<.001
POEM Follow-up Manometry
*
*
*
: p < .008
POEM Follow-up Esophagram
and Endoscopy
*
*
*
Pre
: p < .001
*
Post
Long-term Results at NU*
• 27 patients >1 yr followup
• Eckardt score 7.5 +-2.11.5 +/-2.1; 2 failures (7%;
E.S.>3)
• 2 failures underwent laparoscopic Heller myotomy
• IRP 28 +/-1211 +/-4 mmHg
• TBE column height at 5 min. 15 +/-85 +/-4 cm
• On EGD (N=14), Grade A esophagitis in 57% (40% with
retained clips!), but only one pt with abnormal 24 hr pH
test (N=7)
∆ Symptomatic success in 93%, objective reflux in only one
patient
*Unpublished results
Published POEM Results
Inoue et al: n=17 (mean f/u 5 months)
• Decreased dysphagia symptom score from 10 to 1.3
• Reduced mean LES from 52.4mmHg to 19.9mmHg
• 1/17 with reflux esophagitis (LA grade B)
Inoue, et al, Endoscopy 2010
Swanstrom et al: n=18 (mean f/u 11 mos)
• 3 minor complications
• Median LOS 1 day, return to normal activity 3 days
• Relief of dysphagia in all
• Mean IRP 8.5 mm Hg
• 50% with some return of peristalsis
• 50% with evidence of acid reflux
Swanstrom, et al, Ann Surg 2012
POEM Results (cont)
International Prospective Registry
70 pts, multiple centers
Symptomatic remission in 97% at 3 months, 89% at 6
months, but in only 82% at 12 months
von Renteln, et al, Gastroenterology 2013
Shanghai Group
N = 234
Symptomatic success in 95% at 6-12 mos
Circular and full-thickness myotomy—no difference in longterm outcome
Li, et al, JACS 2013
Response Rates of Achalasia
Treatments
categorized by pressure topography subtype
Type I
Classic
Type II, with
compression
Type III
spastic
Botulinum toxin
0% (0/2)
86% (6/7)
22% (2/9)
39% (7/18)
Pneumatic dilation
38% (3/8)
73% (19/26)
0% (0/11)
53% (24/45)
Heller Myotomy
67% (4/6)
100% (13/13)
0% (0/1)
85% (17/20)
All (any) interventions
44% (7/16)
83% (38/46)
9% (2/21)
56% (47/83)
Achalasia subtype
First Intervention
All
types
Pandolfino JE et al, Gastroenterology
2008;135:1526
Heller myotomy (n=246)
85.4% (82/96)
95.3% (121/127)
69.6% (16/23)
p<0.007
Salvador R et al, J Gastrointest Surg 2010;14:1635
POEM: Utility in Type III Achalasia?
 LHM limited in proximal extent of myotomy (S.I. <70%)
 Trans-thoracic extended myotomy not tested
 Targeted extended myotomy via POEM:
65 y.o. F with dysphagia and chest pain; HRM:
• Type III
• Spasms to
~ 8 cm prox
to EGJ
Preoperative
Postoperative
POEM; myotomy 9 cm prox to EGJ; currently asymptomatic
Clinical experience
China > 500 cases
Japan >375 cases
Germany >200 cases
United States >250 cases
•
•
•
•
•
•
•
Legacy – 110
Northwestern – >70
Long Island > 50 (?)
Case Western - 40
UCSD - 25
Hopkins - 20
Misc. groups
Summary—POEM*
• Per-oral esophageal myotomy (POEM) is a feasible
procedure for creating an endoscopic myotomy across
the EGJ in patients with achalasia
• Published results have been variable and short-term,
and most have included the learning curve
• POEM is a difficult procedure, requiring both advanced
endoscopic and surgical skills
• POEM may be particularly useful for Type III achalasia
• Further investigation is needed regarding long-term
symptomatic and physiologic outcomes after POEM
• *Acknowledge: Eric Hungness, Ezra Teitelbaum, Peter
Kahrilas, John Pandolfino
Conclusions—Achalasia Treatment
2013
• Botox should only be used as a temporizing measure
• Pneumatic dilation highly operator dependent and inferior
to myotomy
• Laparoscopic Heller myotomy with partial fundoplication is
time-tested option with good long-term symptom control
• POEM is emerging as a promising alternative and may be
especially useful for Type III achalasia