Introduction
Peroral endoscopic myotomy (POEM) has emerged as a safe and efficacious therapeutic
option for patients with achalasia with efficacy rates upwards of 90 % [1]. However, with successful decrease in lower esophageal sphincter (LES) pressure
to relieve symptoms of dysphagia comes the reciprocal consequence of increased acid
exposure into the esophagus often requiring long-term proton-pump inhibitor (PPI)
use [1]
[2]
[3]
[4]
[5]. Given the known association between long-standing gastroesophageal reflux (GERD)
and the development of Barrett’s esophagus (BE) [6] and esophageal adenocarcinoma [7], as well as the increasing adverse health effects of long-term PPI use [8]
[9], such high incidences of post-procedural esophageal acid exposure have significant
potential consequences.
Endoscopic transoral fundoplication (TIF) is a novel therapeutic endoscopic technique
for the management of patients with chronic GERD [10]. The feasibility of performing TIF after POEM has previously been described in a
single video case presentation [11]. We present the first case series evaluating the role of TIF for management of post-POEM
GERD.
Methods
Study overview
Consecutive patients 18 years or older who underwent a POEM procedure and subsequently
underwent a TIF at our institution between December 2014 and June 2017 were included
in a prospective registry. All included patients had reflux symptoms post-POEM. All
included patients were offered TIF versus long-term PPI therapy or surgical fundoplication
and opted for TIF. Patient demographic information, clinical and procedural data,
and follow-up data were collected for all patients. The institutional review board
approved the prospective registry (ClinicalTrials.gov Identifier: NCT02162589).
Definitions
The primary outcome was discontinuation of proton-pump inhibitor (PPI) use and healing
of esophagitis (when initially present) on post-procedure esophagogastroduodenoscopy
(EGD). Technical success was defined as successful completion of the endoscopic fundoplication.
Adverse events (AEs) were recorded for all patients.
Procedural technique
All procedures were performed under general anesthesia by endoscopists (AT, MK) with
expertise in
performing TIF. Peri-procedural antibiotics were given in all cases. A flexible endoscope
(GIFH
190; Olympus; Center Valley, PA, United States) was used to evaluate the esophagus
and assess
for a hiatal hernia before the procedure. The Esophyx Z device (Endogastric Solutions;
Redmond,
WA, United States) was then introduced transorally over a flexible endoscope (GIF-XP190,
Olympus) into the stomach. The endoscope was retroflexed and the plastic jaw was advanced
fully
into the stomach under direct visualization. The endoscope was retracted back into
the device
and the plastic jaw was closed. Subsequently, the endoscope was re-advanced into the
gastric
lumen and retroflexed to gain visualization of the device. The plastic jaw was rotated
to the
11 o’clock position and oriented to just proximal to the lip of gastric tissue distal
to the
gastroesophageal junction ([Fig. 1a]). The helical retractor was
inserted into the gastric tissue, coiled and retracted to secure the tissue within
the device
([Fig. 1b]). The device was then rotated counter-clockwise creating
the wrap, and the plastic jaw was closed and locked in place. An invaginator was activated
to avoid involvement of the diaphragm. Polypropylene fasteners were then deployed
through the apposed esophageal and gastric walls. The invaginator was then disengaged
and the tissue released. The process was then repeated until a 270 degree fundoplication
was achieved ([Fig. 2]). The device was then removed through the oropharynx, and a flexible endoscope was
used to examine the fundoplication. A total of 20 fasteners were used in each procedure.
Post-procedure, all patients were admitted to the hospital for at least 1 night for
observation.
Fig. 1 a, b Esophyx device creating the wrap.
Fig. 2 Successful 270 degree fundoplication.
Outcome measurements
Patients were continued on PPI for 6 weeks post-TIF procedure after which they were
tapered off as tolerated. All patients underwent follow-up endoscopy post-TIF at 3 months
post-procedure. All patients were evaluated post-procedure in follow-up via an office
visit and/or phone encounter.
Results
Five patients were included (60 % male, average age 55 ± 14 years). Two patients (40 %)
were
status-post posterior approach POEM, two patients (40 %) were post anterior approach
POEM, and
one patient (20 %) underwent anterior followed by posterior POEM. All patients were
on PPIs
pre-TIF with either complete improvement or some improvement without complete relief.
All
patients underwent pH testing post-POEM and pre-TIF. Three patients had positive DeMeester
scores on pH study with esophagitis on EGD, two categorized as class B and one categorized
as
class D; one patient had a positive pH study without esophagitis, and one patient
had regurgitation symptoms ([Table 1]).
Table 1
TIF post-POEM patient data.
|
Age, years
|
Gender
|
Indication for TIF
|
On PPI pre-TIF
|
Esophagitis on EGD pre-TIF
|
Off PPI post-TIF
|
Healed esophagitis post-TIF
|
|
Patient 1
|
39
|
F
|
+ pH study
|
Y
|
Y, Class B
|
Y
|
Y
|
|
Patient 2
|
70
|
F
|
Regurgitation
|
Y
|
N
|
Y
|
n/a
|
|
Patient 3
|
51
|
M
|
+ pH study
|
Y
|
Y, Class D
|
Y
|
Y
|
|
Patient 4
|
44
|
M
|
+ pH study
|
Y
|
N
|
Y
|
n/a
|
|
Patient 5
|
69
|
M
|
+ pH study
|
Y
|
Y, Class B
|
Y
|
Y
|
EGD, esophagogastroduodenoscopy; POEM, peroral endoscopic myotomy; PPI, proton-pump
inhibitor; TIF, transoral fundoplication.
Procedural data
Technical success was achieved in 100 % of patients. The average amount of time between
POEM and TIF was 13.5 months (range 4 – 27 months). All patients spent at least 1
night in the hospital post-TIF; one patient spent 2 nights.
Primary and secondary outcomes
Discontinuation of PPI use was achieved in 5/5 patients (100 %). Post-procedure EGD
was
performed in all patients 3 months post-procedure. All patients with esophagitis pre-procedure
were noted to have resolution of inflammation on post-procedure EGD. Four out of five
patients
had their PPIs stopped 6 weeks after TIF; one patient remained on PPIs for 1 year
post-procedure
due to persistent symptoms despite resolution of esophagitis on EGD but has been off
PPIs since.
No patients had pH testing post-TIF. Average follow-up time was 27 months (range 5 – 34 months).
There were no adverse events ([Table 2]).
Table 2
TIF post-POEM results.
|
Technical success
|
100 % (n = 5)
|
|
Off of PPI
|
100 % (n = 5)
|
|
Healing of esophagitis
|
100 % (n = 2)
|
|
Adverse events
|
0
|
|
Mean follow-up time
|
27 months (range 5 – 34 months)
|
POEM, peroral endoscopic myotomy; PPI, proton-pump inhibitor; TIF, transoral fundoplication.
Discussion
Patients with achalasia who undergo POEM have high rates of esophageal acid exposure
putting them at risk for development of BE and esophageal adenocarcinoma [6]
[7]. Routine post-procedure pH testing and EGD evaluation have demonstrated rates of
abnormal acid exposure and esophagitis in the range 28 – 58 % and 17 – 31 %, respectively
in published series [1]
[2]
[3]
[4]
[5]. Endoscopic fundoplication (TIF) is an exciting new treatment option for patients
with GERD. The procedure involves creation of a 270 – 330 degree full-thickness esophagogastric
fundoplication via an over-the-scope device [9]. In randomized control trials, this technique has shown superiority over high-dose
medical therapy and/or a sham procedure in relieving GERD symptoms with efficacy rates
comparable to surgical Nissen fundoplication [12]
[13]. However, the procedure is indicated only for patients with a hiatal hernia less
than 2 cm, somewhat limiting its widespread generalizability. Patients who are status-post
POEM and suffering from increased acid exposure represent an ideal population to benefit
from TIF. These patients do not have a hiatal hernia as a contributing cause of their
reflux, and due to their underlying achalasia, they would in theory benefit from a
270 – 330 degree wrap compared to a 360 degree surgical wrap to prevent recurrent
post-procedure dysphagia. Additionally, they are potentially at increased surgical
risk due to scarring from the myotomy.
To date, only one video case report has demonstrated the feasibility and safety of
performing TIF post-POEM [11]. Our study represents the first case series of 5 patients who successfully underwent
TIF after POEM procedure. We showed 100 % technical success and no adverse events,
confirming the procedure to be safe and feasible. Additionally, 100 % of patients
were able to discontinue their PPIs and all patients with esophagitis had resolution
of their inflammation on repeat EGD, confirming that the procedure was also efficacious.
In patients with achalasia who undergo Heller myotomy (HM), a surgical fundoplication
is typically performed concurrently. Although rates of esophageal reflux are lower
post-HM compared to POEM with this technique, a recent meta-analysis showed that over
10 % of patients are still affected and at a cost of a mild decrease in dysphagia
efficacy [14]. Combining POEM with staged TIF allows for selective treatment of only those patients
who require treatment for acid exposure. Additionally, separating the myotomy from
the fundoplication may allow for post-procedure healing from each intervention, again
increasing efficacy.
Recently, concerns have emerged over the association between many adverse health risks
and long-term PPI use. These include kidney disease, dementia, bone disease, micronutrient
deficiencies, infections such as pneumonia and clostridium difficile, and most recently
gastrointestinal malignancy, specifically gastric cancer [8]
[9]. While these health risks are mainly felt to be associative risks and a cause and
effect relationship is yet to be clearly elucidated, cessation of PPI use after POEM
is especially important to avoid potential complications related to these medications.
The main limitation of this study is the small number of patients. Additionally, while
esophagitis improved and patients were able to come off their PPIs, objective pH testing
post-TIF was not performed. And lastly, TIF was performed from a range of 4 – 27 months
post-POEM in our study; the optimal timing post-POEM is yet to be elucidated.
In conclusion, TIF post-POEM appears feasible, safe, and efficacious in improving
symptoms and esophagitis, decreasing long-term risks of acid exposure, and decreasing
risks of long-term PPI use in patients post-POEM in this small cohort of patients.
Patients post-POEM with symptomatic reflux should be offered TIF as a therapeutic
option. Larger prospective studies are needed to confirm these initial findings.
Tyberg A, Choi A, Gaidhane M et al. Transoral Incisionless fundoplication for reflux
after peroral endoscopic myotomy: a crucial addition to our arsenal Endoscopy International Open 2018; 06: E549–E552. DOI: 10.1055/a-0584-6802
In the above mentioned article was a mistake in the title. Correct is: Transoral Incisionless
fundoplication for reflux after peroral endoscopic myotomy: a crucial addition to
our arsenal
