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J Gastrointest Surg

DOI 10.1007/s11605-016-3310-0

SSAT

POEM vs Laparoscopic Heller Myotomy and Fundoplication:


Which Is Now the Gold Standard for Treatment of Achalasia?
Marco G. Patti 1 & Ciro Andolfi 2 & Steven P. Bowers 3 & Nathaniel J. Soper 4

Received: 19 July 2016 / Accepted: 13 October 2016


# 2016 The Society for Surgery of the Alimentary Tract

Introduction
Achalasia is a rare idiopathic disease of esophageal motility
characterized by a failure of the esophageal gastric junction
(EGJ) to relax during swallowing, combined with aperistalsis
of the esophageal body. The lower esophageal sphincter
(LES) is hypertensive in about 50 % of patients. 1
Dysphagia, regurgitation, retrosternal pain, heartburn, respiratory symptoms, and weight loss are the most common
symptoms,1 and esophageal dilation and tortuosity ultimately
develop over time without treatment.
Esophageal achalasia is a relatively rare esophageal motility disorder, occurring in approximately one of every 100,000
Americans.2 The diagnostic criteria for achalasia have recently been changed to reflect findings on high-resolution motility
studies, potentiating a greater number of patients to be diagnosed with achalasia rather than other spastic esophageal

Authors Bowers, Patti, and Soper are considered co-first authors as they
shared equally in the preparation of the manuscript. This manuscript is
derived from the contents of the debate presented at the 2016 annual
meeting of the Society for Surgery of the Alimentary Tract. Dr. Bowers
presented the talk, BFrame the Debate^; Dr. Soper presented the talk,
BPOEM is now the Gold Standard^; Dr. Patti presented the talk,
BLaparoscopic Heller is Still the Gold Standard.^
Dr. Andolfi contributed to literature review and creation of tables.
* Steven P. Bowers
bowers.steven@mayo.edu

University of North Carolina, Chapel Hill, NC, USA

University of Chicago, Chicago, IL, USA

General Surgery Davis 3N, Mayo Clinic Florida, 4500 San Pablo
Road, Jacksonville, FL 32224, USA

Northwestern Medicine, Chicago, IL, USA

disorders. The condition was also subtyped by the Chicago


Classification,3 based on the presence of esophageal pressurization (type 2) and spastic esophageal body contractions
(type 3), a subtyping which influences the prognosis after
endoscopic and surgical therapies, with type 3 (spastic) being
the least common and associated with the worst outcome after
undergoing current modes of treatment.
As there is currently no treatment of the underlying cause
of this neuromuscular disorder, therapy is directed at
disrupting the muscles at the EGJ to allow esophageal emptying by gravity. Although the sphincter muscle can be disrupted
endoscopically using pneumatic balloon dilation, surgical
myotomy has been shown to be the most effective and definitive treatment.
Approximately 10 years ago, a study of the National
Inpatient Sample (NIS), a national hospital admission database, quantified the number of patients in the USA undergoing
surgical esophagogastricor BHeller^myotomy at just
over 2000 patients per year, or about half the number of patients diagnosed with achalasia annually.4 From the NIS study
of the years 1993 to 2005, Heller myotomy by means of minimally invasive surgery was associated with an increase in the
annual number of patients undergoing surgical treatment for
achalasia.
Per oral endoscopic myotomy (POEM) is the latest innovation
in the treatment of achalasia and has disseminated in just over 5year time from a single center in Asia to major medical centers in
every continent and every geographic area of the USA. Based on
the average annual cases in reports published by centers in the
USA (Fig. 1), the POEM procedure is currently reported in just
over 200 cases annually.515 However, the authors surveyed industry representatives for essential POEM equipment to identify
unpublished POEM centers (Fig. 2) and estimate its annual incidence at 500 cases in the USA, or approximately 25 % of annual
surgical procedures for treatment of achalasia.

J Gastrointest Surg

Fig. 1 Published reports of POEM in the USA. This map depicts the average annual POEM case volume (total volume per elapsed year of study) in the
11 centers in the USA reporting POEM outcomes515

It is thus reasonable to debate not only whether POEM


should be considered in the mainstream of surgical treatments
(and treated as such by payors), but also whether POEM can
be considered the new standard procedure for achalasia treatment. For any procedure to be considered the Gold standard of
treatment, it must be considered the most successful procedure
for a condition, against which other procedures are compared.
This means that the procedure should be efficacious and safe
in unselected use across the entire spectrum of disease. The
goal of this manuscript is to present the available data, choosing the strongest evidence in order to define the current role of
each of the available interventions in the treatment algorithm
of achalasia.

Laparoscopic Heller Myotomy (LHM)


with Fundoplication Remains the Gold
StandardPro Argument
The so-called Heller myotomy was first performed more than
100 years ago and until the early 1990s required either a laparotomy or thoracotomy for its performance. More recently,
the laparoscopic approach to Heller myotomy (LHM) has
been popularized, with good results and minimal morbidity.
In January of 1991, Pellegrini et al. performed the first
thoracoscopic myotomy for achalasia in the USA.16 The

procedure reproduced the operation done by Ellis through a


left thoracotomy, with a myotomy extending for about 5 mm
onto the stomach without a fundoplication.16, 17 This pilot
study showed that the operation was technically feasible and
that it determined a relief of dysphagia similar to open surgery.
However, it soon became evident that it was associated with a
very high incidence of postoperative reflux.18 At this point,
there was a shift in the surgical approach of this disease, focusing not only on the relief of dysphagia but also on the
prevention of reflux. Therefore, the procedure of choice at
University of California San Francisco became a laparoscopic
myotomy with a partial anterior fundoplication. This approach
enabled a decrease in the incidence of postoperative pathologic reflux from 60 to 10 %.18
Subsequently, many studies confirmed the need for a
fundoplication to decrease the incidence of postoperative reflux.
For instance, Richards and others performed a prospective and
randomized trial comparing the incidence of postoperative reflux
after a myotomy alone or after a myotomy with a Dor
fundoplication.19 Postoperatively, pH monitoring showed abnormal reflux in 48 % of patients after myotomy alone but in only
9 % when a Dor fundoplication was added to the myotomy.19
Other prospective and randomized trials and a large metaanalysis confirmed these results, showing an incidence of postoperative reflux after myotomy and fundoplication of 10 % or
less.2023 The use of a Nissen fundoplication after myotomy was

J Gastrointest Surg
Fig. 2 a, b POEM centers of the
USA, graphic depicts location of
all 11 USA published and 41
known non-published POEM
centers with human experience,
based on survey of POEM-related
medical industry representatives
(April 2016)

initially proposed but eventually abandoned, as it was shown that


while it was effective in preventing reflux, it was associated with
a higher incidence of recurrent dysphagia as compared to a Dor
fundoplication.20
A prospective and randomized trial to identify the best
partial fundoplication for reflux control showed no difference
between a partial anterior and a partial posterior
fundoplication. Unfortunately, this trial did not have enough
power to make any meaningful conclusion.24 It also showed

an incidence of post-myotomy reflux much higher than any


other study. This finding was probably due to the reporting of
the reflux score or the percentage of time the pH was below 4,
rather than a careful analysis of the tracings to distinguish
between real reflux and false reflux secondary to stasis and
fermentation of the esophageal contents.21 Overall, a laparoscopic Heller myotomy provides relief of dysphagia in more
than 90 % of patients,2033 with an incidence of postoperative
reflux around 10 %1823 (Tables 1 and 2).

J Gastrointest Surg
Table 1

Success rate of LHM with partial fundoplication

Authors

Follow-up (months)

Excellent/good results

Perrone et al.25
Patti et al.26
Khajanchee et al.27
Rosen et al.28
Rebecchi et al.20
Zaninotto et al.29
Rosemurgy et al.30
Persson et al.32
Moonen et al.33
Total

60
55
9
34
125
30
31
60
60

95 %
91 %
91 %
95 %
97 %
97 %
95 %
92 %
84 %

51

93 %

A European multicenter, prospective, and randomized


trial comparing pneumatic dilatation (PD) and laparoscopic Heller myotomy showed similar results between the
two techniques, with relief of dysphagia in 82 and 84 %
of patients, respectively, after 5 years.33 This study had
some limitations, as repeated dilatations were allowed to
treat recurrent dysphagia after pneumatic dilatation but
not after Heller myotomy. This is not a reflection of practice in most centers, as dilatation usually relieves recurrent dysphagia after a myotomy, avoiding in most patients
the need for a second myotomy or an esophagectomy.29
Another prospective and randomized trial comparing
pneumatic dilatation and laparoscopic Heller myotomy
and fundoplication was conducted in Sweden by the
group of Professor Lundell.32 At a follow-up of 5 years,
good results were obtained in 65 % of patients after pneumatic dilatation but in 95 % after laparoscopic myotomy.
Based solely on the best available long-term evidence, the
treatment algorithm of esophageal achalasia would be as follows: when adequate surgical expertise is present, a LHM
with a partial fundoplication should be the procedure of
choice. For patients who experience recurrent dysphagia, PD
should be tried first. If a patient fails PD, either a redo
myotomy or POEM should be considered before resorting to
an esophagectomy.34

Con Argument
Are results of the Heller myotomy across a population as good
as reported results? The POEM procedure was derived in part
on the feeling that there is room for improvement in the treatment of achalasia by the laparoscopic Heller myotomy and
fundoplication. As currently practiced, the rates of subsequent
reflux and dysphagia after Heller myotomy are likely considerably higher than those reported by high-volume academic
centers.
The Vanderbilt University prospective randomized trial from
2004 showed that when the laparoscopic myotomy was extended
only a short distance onto the stomach, a Dor (anterior 180)
fundoplication was associated with a 9 % rate of postoperative
GERD compared to 48 % when a fundoplication was not
performed.19 Subsequently, longer myotomies have been advocated, including a 23-cm myotomy onto the stomach. When the
longer myotomy is performed along with a partial
fundoplication, GERD may be seen in up to 42 % of patients
following LHM.35 The rate of symptomatic success at 1 year
following LHM/partial fundoplication in most series is approximately 90 %. Extended outcomes of Heller myotomy are generally good, but with overall failure rates between 15 and 35 %
over the long term reported by the highest volume centers.
Dysphagia which recurs following Heller myotomy may be
due to inadequate myotomy, GERD with stricture, fibrosis, an
end stage and/or torturous esophagus, or a slipped or herniated
fundoplication.29
There is evidence that centralization of surgical care for
achalasia yields improved results with higher volume centers
demonstrating improved perioperative outcomes.4 However,
the dissemination of laparoscopic Heller myotomy is no longer a driver of centralization of achalasia care, and recent data
report that over a 3-year period, at least one Heller myotomy
was performed in almost 30 % of inpatient hospitals in the
USA.4 While no national data are available on the effectiveness of laparoscopic Heller myotomy, it is the authors experience that there is an increasing incidence of patients presenting with recurrent dysphagia after laparoscopic Heller
myotomy performed at low volume centers.36

POEM Is Now the Gold StandardPro Argument


Table 2 Incidence of
reflux after LHM with
anterior partial
fundoplication

Authors

Patients with reflux

Patti et al.18

10 %
9%
2.8 %
8.8 %
4.7 %
8.6 %
7.3 %

Richards et al.19
Rebecchi et al.20
Campos et al.23
Novais et al.21
Salvador et al.22
TOTAL

The POEM procedure was described by Inoue et al. in 2010,37


and large clinical series have subsequently been accrued around
the world. In this operation, an endoscopic mucosotomy is performed in the mid-esophagus and a submucosal tunnel is created
between the muscularis and mucosa down onto the stomach. The
inner circular layer of muscle is then divided using electrosurgery
of the distal esophagus and down onto the stomach for a distance
of 23 cm, and the mucosotomy is then closed with clips or
endoscopic sutures. Technically, therefore, the POEM procedure

J Gastrointest Surg

does not incise the abdominal wall, disrupt the phrenoesophageal


membrane, mobilize the distal esophagus, divide the longitudinal
esophageal muscle, or create a fundoplication, all of which are
necessary with a Heller myotomy performed either by laparoscopy or laparotomy. Furthermore, the myotomy can be performed significantly higher (more proximally) on the esophagus
than when performed in a trans-hiatal fashion. Performance of
the POEM procedure requires advanced flexible endoscopic
technical skills, and the learning curve has been reported between
15 and 25 cases.5
A number of large clinical series have now been reported
internationally. There have even been several systematic reviews
and meta-analyses comparing LHM with the POEM
procedure.38 These studies generally show that the POEM can
be performed with very low morbidity and virtually no mortality,
with a duration of operation and length of hospital stay equivalent
to, or less than, the LHM. Postoperative studies routinely show a
marked decrease in the lower esophageal sphincter pressure,
more complete emptying of the esophagus on esophagram, and
early symptomatic success in more than 90 % of patients.
Postoperative GERD is seen in between 10 and 50 % of patients
but can usually be easily managed with proton pump inhibitors.
The systematic reviews suggest a trend toward an increased rate
of GERD in those undergoing the POEM procedure when compared to LHM.
In the Northwestern Medicine series of POEM patients now
followed for more than a year postoperatively (mean of 2 years),
the overall symptomatic results are excellent with a failure rate of
only 8 % and documented GERD in 40 %.39 The rate of postprocedure GERD is significantly higher in obese patients and
those with hiatal hernias.
Emerging evidence shows that patients with type 3 achalasia
have significantly greater relief of symptoms with POEM when
compared to Heller myotomy, by nature of the longer myotomy
not achievable by the laparoscopic Heller myotomy.40 The authors have treated several patients with type III achalasia utilizing
long myotomies corresponding to the area of spasm, and the
results have also been excellent in this challenging group.
POEM has also been used for the treatment of recurrent dysphagia after Heller myotomy. Onimaru and colleagues described
excellent results in 10 patients,41 suggesting that this procedure
can obviate the need for a redo myotomy or an esophagectomy.
Finally, POEM is now considered a 23-h observation operation that no longer needs to be done in an operating room.15
POEM can be performed in a GI suite; so, there are potentially
great savings in terms of total healthcare costs.

will ultimately result in esophagectomy. In the authors experience of revisional operations for achalasia, the median time
for patients to seek reoperation after failed Heller myotomy is
3 years.16 As is seen with other endoscopic treatments (pneumatic dilation and botulinum toxin therapy), short-term relief
of dysphagia is a poor surrogate for an actual measure of
efficacy.
In Inoues initial reporting of POEM results in patients, the
results were excellent with a decrease in the dysphagia score
from 10 to 1.3.37 Post-POEM manometry showed a residual
LES pressure of 19.8 mmHg: this finding might have important clinical implications as a LES pressure of more than
10 mmHg after pneumatic dilatation has been shown to be a
predictor of long-term failure.42
POEM was popularized in the USA by Dr. Swanstrom who
presented in 2012 the results in 18 patients.43 At a follow-up
of 11 months, the symptomatic relief was excellent in all patients (median Eckardt Score <1) (see Table 3).44 The postPOEM LES pressure was 16.8 mmHg, 28 % of patients had
esophagitis, and 46 % had a pathologic amount of reflux detected by pH monitoring. The results of this study underlined
many important facts: (1) the short-term results in terms of
relief of symptoms were excellent; (2) the incidence of postPOEM reflux was very high; and (3) the real incidence of
abnormal reflux can only be determined by ambulatory pH
monitoring because many patients have pathologic reflux in
the absence of esophagitis.
In 2013, Von Renteln reported the results of a multicenter
international study of POEM in patients with achalasia.45 At a
follow-up of 12 months, only 82 % of patients were doing
well. In addition, endoscopy showed esophagitis in 42 % of
patients (pH monitoring was not performed). In 2014, Dr.
Swanstrom reported the results of POEM in a larger group
of patients and compared them to the results of a laparoscopic
Heller myotomy and fundoplication.5 At a follow-up of
6 months, all patients after POEM had no dysphagia, but failure of the myotomy occurred in 29 % of patients. These results
are in contrast to a publication by the same authors where they
described a 91 % success rate after laparoscopic myotomy.27
Familiari and colleagues reported the results of POEM in
100 patients with an 11-month follow-up.46 The procedure
was completed in 94 patients with a 94.5 % success rate.
Interestingly, a tense pneumo-peritoneum requiring decompression occurred in 31 % of patients, and pH monitoring
Table 3

Eckardt score 44

Score Weight loss (kg) Dysphagia Retrosternal pain Regurgitation

Con Argument
Although early results from the limited number of centers in
the USA are promising, it is unclear what the failure rate of
POEM will be, and whether failures will be easily remedied or

0
1
2
3

None
<5
510
>10

None
Occasional
Daily
Each meal

None
Occasional
Daily
Each meal

None
Occasional
Daily
Each meal

J Gastrointest Surg

was abnormal in 53.4 % of patients. Finally, three centers


specialized in POEM jointly reported their results at a
follow-up of 29 months.47 The failure rate was 21.5 %, with
3 patients developing Barretts esophagus and 1 patient developing a reflux stricture.
While in the past, many different parameters were used to
evaluate the effect of treatment, today the Eckardt score is
universally used.44 It is based on 4 elementsweight loss,
dysphagia, regurgitation, retrosternal painand it varies from
0 to 12. A score of 3 or less is considered an excellent result,
while a score of more than 3 is indicative of treatment failure.
Treatment success with POEM has been justified by improvement in the Eckardt score. Weight loss contributes significantly to the score. As such, pre- and post-procedure testing will
show a reduction in the score of up to three points even in the
absence of any actual effectiveness, if the patients weight loss
has reached a plateau at the time of procedure.
There are a growing number of gastroenterology practices
that offer POEM and do not have any capability to offer the
Heller myotomy. This would suggest that patients presenting
to an advanced Gastroenterology-POEM center are not given
the option of a Heller myotomy. Unfortunately, there is considerable bias among surgeons performing POEM as well. In
reported surgery practices that perform POEM, with increasing surgeon experience, the percentage of presenting achalasia
patients undergoing POEM approaches 90 %.5 It remains unclear whether this is an effect related to the surgeons needs to
build greater experience or due to perceived improved outcomes in POEM patients.
Based on the currently available data, we feel that the initial
results of POEM in relieving dysphagia are very good and that
this endoscopic technique will have a place in the armamentarium for esophageal achalasia (Table 4). However, today,
some concerns are present:
&

The authors switched from a thoracoscopic to a laparoscopic myotomy in order to add a fundoplication to prevent reflux. This was a major shift in the treatment of
achalasia as the focus was not only on the relief of

&
&

dysphagia but also on the prevention of reflux. The available data on POEM show that the incidence of reflux is
around 50 %, similar to that of a myotomy alone4, 13, 4245,
47
(Table 5).
The post-POEM LES pressure is frequently well above
10 mmHg. This has been shown to be a predictor of
long-term failure.42
In most studies, the follow-up is very short, between 6 and
12 months, so that it is impossible to have a comparison
with pneumatic dilatation or laparoscopic myotomy.
Interestingly, the only study with a follow-up of 29 months
showed a 21.5 % failure rate46).

Conclusion
In summary, the POEM procedure seems to be here to stay. In
fact, in many markets in the USA, there are multiple competing POEM centers, and the global number of POEM centers
will continue to grow. Until there are prospective and randomized trials comparing POEM to both pneumatic dilation and
LHM, what we know of the effectiveness of POEM will be
based on intermediate-term outcome studies from a limited
number of centers. At this point in time, there are no longterm outcome studies of POEM extending beyond 2 or 3 years.
Short- and medium-term outcomes are similar to those of the
LHM with the exception of perhaps a greater rate of GERD,
which can generally be easily treated by PPIs.
Advanced flexible interventional endoscopic skills are required for good technical outcomes, and currently, there are
fewer advanced endoscopists with the skills to perform POEM
than there are surgeons with the skills to perform laparoscopic
Heller myotomy. Because the POEM procedure is performed
by gastroenterologists and surgeons with an interest and expertise in esophageal diseases, greater centralization is likely
to result in an overall improvement in achalasia care.
Additionally, due to the lack of a fundoplication, the subset
Table 5

Table 4

Success rate of POEM

Authors
45

Von Renteln et al.


Bhayani et al.5
Familiari et al.46
Werner et al.47
Hungness et al.39
Total (mean)

Follow-up (months)

Patients with ES 3

12
6
11
29
24
18

82 %
100 %
94.5 %
78.5 %
92 %
88 %

Von Renteln, Bhayani, and Familiari studies contributed to Werner study


subjects
Eckardt score (ES)

Incidence of reflux after POEM

Authors

Patients with reflux

Von Renteln et al.45


Bhayani et al.5
Familiari et al.46
Werner et al.47
Hungness et al.39
Total

42 %*
39 %
53.4 %
37.5 %*
40 %*
43.1 %

Von Renteln, Bhayani, and Familiari studies contributed to Werner study


subjects

Results based on pH monitoring


Results based on endoscopic findings

J Gastrointest Surg

of patients who develop postoperative dysphagia due to a


dysfunctional or herniated fundoplication may be avoided in
those undergoing POEM.
While there are individual patients who may be better
served with either POEM (type 3) or LHM (hiatal hernia), it
will take some time for the best medical evidence to reveal
what is the single best choice for a patient that is an acceptable
candidate for both POEM and Heller myotomy procedures.
That is, it may take 3 to 5 years for patients with POEMs who
have severe reflux to develop a complication that would necessitate another operation to control reflux. Recurrent dysphagia due to inadequate gastric myotomy may also present
several years after POEM. And so, the true rate of reintervention after POEM will not be known for some time.
However, due to the rate of growth of POEM in the greater
than 50 known POEM centers in the USA, POEM will soon
be utilized in over half of achalasia patients undergoing a
surgical procedure. When this tipping point occurs, it may
be only an academic question of which procedure is the
Gold Standard.

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