Introduction
Gastroesophageal reflux disease (GERD) is a consequence of the failure of the normal
anti-reflux barriers to protect against abnormal amounts of retrograde reflux of material
from the stomach to the esophagus [1]. Longstanding GERD can predispose to esophagitis, esophageal ulcers, peptic esophageal
strictures, Barrett’s esophagus, and adenocarcinoma of the esophagus. Proton pump
inhibitors (PPIs) are first-line treatment for GERD. They are antacid medications
that inhibit meal-stimulated and nocturnal acid secretion [2]. About 30 % to 40 % of patients with GERD are refractory to treatment with PPIs
[3]. Increased frequency or volume of reflux, ineffective PPI-induced control of gastric
secretion, esophageal hypersensitivity, bile content of gastric juice, and other co-existing
conditions such as obesity, hiatal hernia, and Helicobacter pylori infection are risk factors for refractory GERD [3].
Anti-reflux surgery such as laparoscopic fundoplication is beneficial in patients
with refractory GERD but 25 % of patients have postoperative dysphagia, gas bloat
syndrome, diarrhea, and increased flatus [4]. Moreover, 25 % to 62 % of patients require acid-suppressive medications 5 to 15
years after their anti-reflux surgery [5]. As a result, several novel surgical techniques that do not alter the anatomy of
the cardia have been developed, but they, too, are associated with procedural limitations
[6]
[7]. A series of endoscopic treatments for treatment of GERD, such as transoral incisionless
fundoplication (TIF) and magnetic sphincter augmentation (MSA), have also failed to
show long-term efficacy [8]. As a result, the American Gastroenterological Association Institute, in their technical
review on the use of endoscopic therapy for the treatment of GERD, reported that there
were no definite indications for endoscopic therapy for GERD [9].
Anti-reflux mucosectomy (ARMS) is a new endoscopic technique for treatment of refractory
GERD first reported by Inoue et al [10]. The aim of the procedure is to achieve fundoplication by submucosal fibrosis after
mucosectomy at the esophagogastric junction (EGJ) and it has the advantage of an endoscopic
approach. Since the introduction of ARMS, several prospective and retrospective studies
have been performed to assess outcomes with it. We performed a systematic review and
meta-analysis to assess the efficacy and safety of ARMS in treatment of refractory
GERD.
Methods
Search strategy
We conducted a comprehensive search of several databases from inception to March 2021.
The databases included Ovid MEDLINE and Epub Ahead of Print, In-Process and other
non-indexed citations, Ovid Embase, Ovid Cochrane Central Register of Controlled trials,
Ovid Cochrane Database of Systematic Reviews, and Scopus. An experienced medical librarian
using inputs from the study authors helped with the literature search. Controlled
vocabulary supplemented with keywords was used to search for studies of interest.
The full search strategy is available in Appendix 1. The MOOSE and PRISMA checklist were followed and are provided in Appendix 2 and Appendix 3
[11]
[12].
Study selection
In this meta-analysis, we included studies that evaluated outcomes of ARMS in patients
with refractory GERD. Studies were included irrespective of the study sample size,
inpatient/outpatient setting, and geography as long as they provided data needed for
the analysis.
Studies done in pediatric populations (age < 18 years), and studies not published
in English were our only exclusion criteria. In case of multiple publications from
the same cohort and/or overlapping cohorts, data from the most recent and/or most
appropriate comprehensive report were retained.
Data abstraction and quality assessment
Data on study-related outcomes in the individual studies were abstracted in a standardized
form by at least two authors (RG, AM), and two authors (RG, AM) did the quality scoring
independently. Primary study authors were contacted via email as needed for further
information and/or clarification on data.
The Newcastle-Ottawa scale for cohort studies was used to assess the quality of studies
[13]. This quality score consisted of eight questions, the details of which are provided
in Supplementary Table 1.
Outcomes assessed
-
Pooled rate of technical success.
-
Pooled rate of clinical success based on discontinuation or reduction of PPI after
ARMS. It was further categorized into complete if patients were able to discontinue
PPIs post-ARMS and partial if ARMS led to reduction in PPI dose.
-
Pooled rate of adverse events (AEs) after ARMS. It was further classified into dysphagia
and bleeding after ARMS.
-
Symptomatic improvement was further measured by validated pre-procedure and post-procedure
questionnaire to assess typical and atypical GERD symptoms: GERD-Health-Related Quality
of Life (HRQL) and Gastroesophageal Reflux Disease Questionnaire (GERD-Q).
-
Pre-and Post-ARMS DeMeester score and mean acid exposure time (AET) was also measured
based on 24-hour pH study.
Statistical analysis
We used meta-analysis techniques to calculate the pooled estimates in each case following
the methods suggested by DerSimonian and Laird using the random-effects model [14]. When the incidence of an outcome was zero in a study, a continuity correction of
0.5 was added to the number of incident cases before statistical analysis [15]. Mean difference between pre-procedure and post-procedure measures were calculated
by inverse variance method. We assessed heterogeneity between study-specific estimates
by using Cochran Q statistical test for heterogeneity and the I2 statistics.[16] In this, values of < 30 %, 30 % to 60 %, 61 % to 75 %, and > 75 % were suggestive
of low, moderate, substantial, and considerable heterogeneity, respectively [17]. Publication bias was ascertained, qualitatively, by visual inspection of funnel
plot and quantitatively, by the Egger test [18]. P ≥ 0.05 was used a priori to define significance of the difference between the groups
compared as provided the statistical software. We conducted further subgroup analysis
based on use of banding with ARMS.
The analysis was performed using Rstudio and Revman software.
Results
Search results and population characteristics
From an initial 909 studies, 560 records were screened, and 36 full-length articles
were reviewed. Ten studies were included in the final analysis that reported outcomes
of ARMS [19]
[20]
[21]
[22]
[23]
[24]
[25]
[26]
[27]
[28]. The schematic diagram of study selection is shown in [Fig. 1].
Fig. 1 Study selection flowchart.
A total of 307 patients with mean age 46.9 years (8.1) (range 37–56.8 years) were
included in our study. Gender was reported in seven studies and among them, 41.5 %
of patients were female. In six studies, ARMS-endoscopic mucosal resection (EMR) was
performed and four studies, ARMS with banding was performed. All patients were on
maximal PPI therapy before ARMS. The mean procedure duration was 40.3 minutes (8.5)
(range 31.2–54.7 minutes) reported in six studies. Patient characteristics and data
on assessed outcomes are shown in [Table 1].
Table 1
Study and population characteristics.
|
Author, year
|
Technique
|
Age, mean years (SD)
|
Females
|
No. patients
|
GERD-HRQL score
|
GERD-Q score mean (SD)
|
DeMeester score mean (SD)
|
Mean esophageal acid exposure time (%) (SD)
|
Procedure time, mean, minutes (SD)
|
Technical success
|
Follow-up mean time (SD)
|
Clinical success
|
Partial clinical success
|
Complete clinical success
|
Adverse events
|
Dysphagia
|
Bleeding
|
|
|
|
|
|
Pre-procedure
|
Post-procedure
|
Pre-procedure
|
Post-procedure
|
Pre-procedure
|
Post-procedure
|
Pre-procedure
|
Post-procedure
|
|
|
|
|
|
|
|
|
|
|
Bapaye et al, 2017
|
ARMS
|
40.8 (19.2)
|
4
|
15
|
40.4
|
7.6
|
NR
|
NR
|
85.8
|
5.9
|
NR
|
NR
|
|
15
|
1 mo
|
15
|
4
|
11
|
3
|
1
|
0
|
|
Debourdeau et al, 2020
|
ARMS-B
|
44 (7.5)
|
5
|
6
|
30.6 (7.7)
|
6.8 (3.7)
|
13.3 (1.1)
|
6.2 (4.0)
|
NR
|
NR
|
NR
|
NR
|
< 40 min
|
6
|
3 mo
|
3
|
2
|
1
|
2
|
1
|
1
|
|
Wong et al, 2020
|
ARMS-B
|
55 (17)
|
22
|
33
|
16.0 (12.0) (N = 24)
|
6.0 (7.1) (N = 15)
|
NR
|
NR
|
19.6 (10.1)
|
NR
|
NR
|
NR
|
36 (13)
|
33
|
6 mo
|
30
|
0
|
30
|
5
|
3
|
1
|
|
Kessler et al, 2013
|
ARMS-B
|
NR
|
NR
|
10
|
26.6 (0.4)
|
9 (1.6)
|
NR
|
NR
|
NR
|
NR
|
8.35 (0.04) (n = 9)
|
5.8 (1.19)
|
NR
|
10
|
6 mo
|
10
|
0
|
10
|
3
|
3
|
0
|
|
Prasad et al, 2019
|
ARMS
|
41–60
|
NR
|
11
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
11
|
6 mo
|
8
|
|
8
|
0
|
0
|
0
|
|
Monino et al, 2020
|
ARMS-B
|
56.87 (14.47)
|
10
|
21
|
25.6 (8.8) (N = 18)
|
16.8 (6.4)
|
12.5 (1.5) (n = 18)
|
9 (2) (n = 18)
|
NR
|
NR
|
> 6 %
|
NR
|
35 (11)
|
21
|
10 (5) mo
|
16
|
4
|
12
|
4
|
3
|
1
|
|
Ortega et al, 2019
|
ARMS
|
41
|
NR
|
7
|
NR
|
NR
|
19
|
3
|
37.1
|
NR
|
NR
|
NR
|
45 min
|
7
|
3 mo
|
4
|
|
4
|
3
|
0
|
3
|
|
Patil et al, 2020
|
ARMS
|
37 (9.9)
|
18
|
62
|
NR
|
NR
|
10.6 (1.9) (n = 44)
|
3.4 (1.5) (n = 44)
|
76.8 (18.3) (n = 45)
|
14.3 (6.1) (n = 45)
|
NR
|
NR
|
NR
|
62
|
12 mo
|
55
|
12
|
43
|
10
|
5
|
0
|
|
Sumi et al, 2020
|
ARMS
|
54.0 (15.7)
|
46
|
109
|
NR
|
NR
|
9.4 (2.7) (n = 88)
|
6.6 (2.5)
|
64.4 (75.7) (n = 27)
|
24.9 (36.0) (n = 27)
|
20.8 (24.3) (n = 27)
|
6.9 (10.4)
|
54.7 (27.0).
|
109
|
2–6 mo
|
42
|
|
42
|
17
|
14
|
2
|
|
Yoo et al, 2020
|
ARMS
|
51.3 (16.3)
|
11
|
33
|
NR
|
NR
|
11.1 (3.1) (n = 33)
|
6.8 (3.1)
|
14.3 (10.9)
|
7.7 (9.4)
|
3.1 (3.1)
|
1.8 (2.4)
|
33.5 (12.7)
|
33
|
6 mo
|
31
|
10
|
21
|
2
|
2
|
0
|
ARMS, anti-reflux mucosectomy; GERD, gastroesophageal reflux disease; GERD-HRQL, GERD
health-related quality of life; GERD-Q, GERD questionnaire; NR, not reported; SD,
standard deviation.
Characteristics and quality of included studies
Eight studies were prospective and two were retrospective in nature. Of the 10 observational
studies, four studies were high quality, five were medium and one was low quality.
Quality assessment is shown in Supplementary Table 1.
Meta-analysis outcomes
Technical and clinical success
The pooled rate of immediate technical success was 97.7 % (95 % confidence interval
[CI] 94.6–99.0, I2 = 0 %) ([Fig. 2a]). ARMS was performed most using EMR in six studies and four studies utilized banding
device with ARMS. Sumi et al also performed seven cases of ARMS with endoscopic mucosal
dissection (ESD) [26].
Fig. 2 Forest plots showing a pooled rate of technical success, b clinical success, c complete, and d partial clinical success.
Follow-up time ranged from 1 to 12 months. The pooled rate of clinical success was
80.1 % (95 % CI, 61.6–91.0, I2 = 84.9 %) ([Fig. 2b]). Rates of complete and partial clinical success were 65.3 % (95 % CI, 51.4–77.0,
I2 = 73.1) and 21.5 % (95 % CI, 14.2–31.2, I2 = 25.5), respectively ([Fig. 2c] and [Fig. 2 d]).
Adverse events
The pooled rate of overall AEs was 17.2 % (95 % CI, 13.1–22.2, I2 = 1.9 %) ([Fig. 3a]). There were a total of 49 AEs. The most common AE was dysphagia from esophageal
stricture (n = 32) followed by bleeding (n = 8), three cases of perforation, muscle
injury, and aspiration pneumonia each. Pooled rates of dysphagia and bleeding were
11.4 % (95 CI, 8.2–15.7, I2 = 0) and 5 % (95 % CI, 1.9–12.3, I2 = 51.3 %), respectively ([Fig. 3b] and [Fig. 3c]).
Fig. 3 Forest plot showing a pooled rate of overall adverse events, b dysphagia, and c bleeding after ARMS.
Symptomatic improvement
Symptom improvement was measured by two validated GERD-associated scoring systems.
Overall, mean GERD-HRQL (health-related quality of life) scores were reported in four
studies, and they significantly improved after ARMS as compared to pre-procedure scores
(mean difference [MD] = 14.9, [95 % CI, 9.30–20.6], I2 = 85 %, P < 0.001). GERD-Q was reported in five studies and significantly improved after ARMS
with MD of 4.85 [95 % CI, 2.7–7.03, I2 = 95 %, P < 0.001]. These results are shown in [Fig. 4a] and [Fig. 4b].
Fig. 4 Forest plot showing mean difference of a GERD-HRQL, b GERD-Q, c mean acid exposure time, and d DeMeester score pre-and post-ARMS.
pH monitoring
Objective measures of GERD improvement were determined by esophageal pH monitoring.
Three studies reported results of pre-ARMS and post-ARMS pH study. Mean AET (MD = 2.39,
95 % CI, 0.47–4.3, I2 = 74 %, P = 0.01) decreased significantly post-ARMS as compared to pre-procedure ([Fig. 4c]). Post-procedure DeMeester score was also reported in three studies. The mean difference
between post- and pre-ARMS DeMeester score was 36.02 (95 % CI, –8.83 to 80.87, I2 = 99, P = 0.12) ([Fig. 4 d]).
Subgroup analysis
We performed subgroup analysis based on ARMS with banding (ARMS-B) and without banding.
Among the 10 studies, six studies did not use banding with ARMS and four studies used
ARMS-B. Compared to ARMS-B, ARMS did not have any statistical significant difference
in pooled rater of technical succss (98.1 % [95 % CI, 94.3–99.4, I2 = 0 %] vs. 96.8 % [95 % CI, 88–99.2, I2 = 0 %], P = 0.55), clinical success (79.2 % [95 % CI, 53.3–92.7, I2 = 89 %] vs. 81.7 % [95 % CI, 49.0–95.4, I2 = 54.9 %], P = 0.87), complete clinical (63.4 % [95 % CI, 45.0–77.1, I2 = 68.5 %] vs. 71.6 % [95 % CI, 46.4–88, I2 = 79.6 %], P = 0.41) and partial clinical response (24.5 % [95 % CI, 14.9–37.7, I2 = 0 %] vs. 15.3 % [95 % CI, 6.6–31.7, I2 = 45.4 %], P = 0.3). The rates of AEs (16.5 % [95 % CI, 11.8–22.5, I2 = 24.7 %] vs. 20.7 % [95 % CI, 12.5–32.4, I2 = 0 %], P = 0.44), dysphagia (10.5 % [95 % CI, 7.1–15.3, I2 = 0 %] vs. 15.4 % [95 % CI, 8.4–26.5, I2 = 0 %], P = 0.28) and bleeding (4.4 % [95 % CI, 1.2–15.1, I2 = 69.9 %] vs. 5.9 % [95 % CI, 1.2–24.4, I2 = 0 %], P = 0.77) with ARMS were not significantly different than with ARMS-B. Results of subgroup
analysis are summarized in [Table 2].
Table 2
Summary of pooled rates with subgroup analysis.
|
Outcome
|
ARMS
|
ARMS without banding (A)
|
ARMS with banding (B)
|
P value (A vs B)
|
|
Technical success
|
97.7 (94.6–99.0), I2 = 0, 10 studies
|
98.1 (94.3–99.4), I2 = 0, 6 studies
|
96.8 (88.0–99.2), 4 studies, I2 = 0, 4 studies
|
0.55
|
|
Clinical success (reduction or discontinuation of PPI)
|
80.1 (61.6–91.0), I2 = 84.9, 10 studies
|
79.2 (53.3–92.7), I2 = 89 %, 6 studies
|
81.7 (49.0– 95.4), I2 = 54.9 %, 4 studies
|
0.87
|
|
Complete clinal response
|
65.3 (51.4–77.0), I2 = 73.1, 10 studies
|
63.4 (45.0–77.1), I2 = 68.5, 6 studies
|
71.6 (46.4–88), I2 = 79.6 %, 4 studies
|
0.41
|
|
Partial/reduction PPI
|
21.5 (14.2–31.2), I2 = 25.5, 7 studies
|
24.5 (14.9–37.7), I2 = 0, 3 studies
|
15.3 (6.6–31.7), I2 = 45.4 %, 4 studies
|
0.3
|
|
Adverse events
|
17.2 (13.1 to 22.2), I2 = 1.9, 10 studies
|
16.5 (11.8–22.5), I2 = 24.7, 6 studies
|
20.7 (12.5–32.4), I2 = 0, 4 studies
|
0.44
|
|
Dysphagia
|
11.4 (8.2 to 15.7), I2 = 0, 10 studies
|
10.5 (7.1–15.3), I2 = 0, 6 studies
|
15.4 (8.4–26.5), I2 = 0, 4 studies
|
0.28
|
|
Bleeding
|
5.0 (1.9 to 12.3), I2 = 51.3, 10 studies
|
4.4 (1.2 –15.1), I2 = 69.7, 6 studies
|
5.9 (1.2–24.4), I2 = 0, 4 studies
|
0.77
|
Values are shown as rate, 95 % confidence interval, I2, number of studies. ARMS, anti-reflux mucosectomy; PPI, proton pump inhibitor.
Validation of meta-analysis results
Sensitivity analysis
To assess whether any one study had a dominant effect on the meta-analysis, we excluded
one study at a time and analyzed its effect on the main summary estimate. On this
analysis, no single study significantly affected the outcome or the heterogeneity.
Heterogeneity
We assessed dispersion of the calculated rates using the I2 percentage values. I2 provides information about what proportion of the dispersion was true vs a chance
[29]. There was low heterogeneity in technical success and high heterogeneity in clinical
success outcome. Calculated I2 values are reported with pooled results.
Publication bias
Based on visual inspection of the funnel plot as well as quantitative measurement
that used the Egger regression test, there was no evidence of publication bias for
technical (Supplementary Fig. 2a, Eggers 2-tailed P = 0.07) and clinical success outcomes (Supplementary Fig. 2b, Eggers 2-talied P = 0.09).
Discussion
Our study demonstrates that ARMS is a technically feasible and effective procedure
for treatment of refractory GERD. It has a very high technical success rate of 97.7 %.
ARMS led to a significant discontinuation (65.3 %) and reduction (21.5 %) of PPI usage
after the procedure. ARMS is also a relatively safe and well tolerated procedure.
The rate of AEs is 17.2 %, with dysphagia and bleeding being the most common complications.
To our knowledge, this is the first systematic review and meta-analysis to assess
the technical success, clinical response, and AEs of ARMS in refractory GERD.
We also report that ARMS significantly improves GERD-related symptoms. The GERD-HRQL
scale is a disease-specific instrument, developed to help overcome variability in
evaluating response to treatments for GERD and has been validated as a significant
predictor of patient satisfaction. A reduction in the score by 50 % or more is considered
a successful intervention [30].
GERD-Q is a self-administered survey for GERD. It has a sensitivity of 65 % and a
specificity of 71 % for diagnosis of GERD [31]. In our analysis, in post-ARMS, there was a significant decrease in GERD-HRQL (14.9)
and GERD-Q (4.8) scores. While subjective scoring systems are biased by placebo effect
of undergoing treatment, objective measures of AET and DeMeester scores do not have
this limitation [32]
[33]. In our analysis, post-ARMS, the mean AET decreased significantly by 2.39 % and
there was a trend toward improved DeMeester score but it did not reach statistical
significance. Subgroup analysis was performed to compare ARMS with and without banding.
It is important to note that both procedures were associated with similar technical
success (98.1 % vs 96.8 %) without any significant difference. The addition of banding
to EMR was not associated with a higher rate of AEs. The pooled rate of clinical success
was not significantly different in patients undergoing ARMS (79.2 %) when compared
to ARMS-B (81.7 %).
The most common AE was dysphagia from strictures. We reported a 11.4 % risk of dysphagia
in our analysis. Patil et al hypothesized that resection on more than two-thirds of
the distal squamous esophageal mucosa is the cause of stricture formation [25]. Another hypothesis is that involvement of squamous mucosa in the resected area
leads to a high occurrence of strictures [34]. Further, Sumi et al reported that patients undergoing crescentic resection had
a higher risk of dysphagia when compared to those who had butterfly-shaped resection.
Twelve of 81 patients had stenosis after crescentic resection while only one of 21
had stenosis after butterfly-shaped mucosal resection [26]. Although the strictures can be easily treated with endoscopic balloon dilation,
there is a need to standardize the ARMS technique to prevent these AEs.
Approximately 40 % of patients with GERD fail to respond to aggressive acid-suppressive
therapy. Moreover, there are concerns about the long-term effects of PPI therapy as
well. Because fewer than 5 % of patients with refractory GERD undergo laparoscopic
fundoplication, there is a treatment gap [3]. Newer, less invasive techniques have been developed to fill this gap, but with
little success. The LINX reflux management system that augments the lower esophageal
sphincter (LES) function using a small expandable ring of linked magnetic beads, Enodstim
LES stimulating system, and LES electrical stimulation therapy that use electrical
energy to stimulate closure of LES are some of the alternative surgical approaches
to refractory GERD treatment [8]
[35]
[36]. Several endoscopic models have also evolved to treat refractory GERD. Stretta utilizes
a radiofrequency generator and a specialized balloon/catheter system that is used
to remodel the EGJ and LES [37]. Medigus is an endoscopic stapling system that is capable of creating a partial
fundoplication [38]. The newest approach is the TIF, which uses endoscopically placed polypropylene
fasteners to create a 200– to 270– degree fundoplication. Although there is initial
improvement in symptoms, over time, the fasteners tend to dislodge [39]
[40]. However, because of unclear long-term data, high economic burden, and inability
to mitigate acid reflux, these procedures have not yet gained widespread acceptance.
Based on current literature, ARMS appears to be effective and well tolerated. The
success of ARMS is likely related to its ability to cause submucosal fibrosis at LES. Relaxation
of the crura and LES is a normal physiological process that occurs while swallowing.
Transient lower esophageal relaxation (TLESR) is relaxation of the LES that is not
initiated by swallowing. TLESRs contribute to 90 % of reflux episodes [41]. ARMS prevents the frequent occurrence of TLESRs. Recently, the ARMS technique has
been further refined using a technique of anti-reflex mucosal ablation that causes
similar scarring [42]. Proper patient selection was always performed for all the studies. Patients with
hiatal hernia > 3 cm, esophageal motility disorders, major psychiatric illness, and
extremely obese were excluded. All patients underwent upper gastrointestinal endoscopy,
high-resolution manometry, and multichannel intraluminal impedance and pH monitoring
prior to the procedure.
ARMS is usually performed using a cap-fitted EMR device. A variation of this technique,
EMR with band ligation (ARMS-B) has been utilized in some studies. ARMS is performed
by mucosal resection of more than two-thirds of the mucosa on the lesser curvature
of the cardia below the gastroesophageal junction during retroflexed view in the stomach
[34]. A small amount of mucosa is left in the lesser curvature in a butterfly shape to
avoid transient stenosis. Rates of transient stenoses are significantly lower when
a butterfly-shaped resection is performed when compared to the original crescent-shaped
resection [26]. Care should be taken to avoid resection of squamous mucosa of the esophagus, which
is associated with high rates of stricture formation. ESD is another method to achieve
mucosal resection, but is associated with a higher rate of AEs [26]. After ARMS, a repeat endoscopic evaluation is performed in 2 to 3 weeks to assess
for stenosis. Patients are then assessed periodically after 2 months.
The strengths of this review are as follows: systematic literature search with well-defined
inclusion criteria, careful exclusion of redundant studies, inclusion of good quality
studies with detailed extraction of data, low heterogeneity, studies from throughout
the world, and rigorous evaluation of study quality. In addition, because we used
both subjective and objective measures to quantify efficacy of clinical outcome, the
results are generalizable. However, there are some limitations in this study, most
of which are inherent to any meta-analysis. The included studies were not entirely
representative of the general population and community practice, with most studies
being performed in tertiary-care referral centers. The cost associated with the procedure
was not evaluated in our analysis. We were also unable to compare ARMS with the current
standard of care for refractory GERD and laparoscopic fundoplication. Further, the
endoscopic procedure is highly operator-dependent. The success and safety profile
are dependent on the expertise of the person performing the procedure. We also could
not compare procedure time between the two techniques. In addition, follow-up was
quite variable in included studies, which added to heterogeneity for clinical success
along with small sample size. There is limited precision in our estimates as evidenced
by wide confidence intervals. We also could not directly compare outcomes of ARMS
with other endoscopic techniques such as TIF and MSA as data are not available. Additional
subgroup analyses were also not possible due to lack of data. Nevertheless, our study
is the first meta-analysis evaluating the feasibility, effectiveness, and tolerability
of ARMS.
Conclusions
In conclusion, ARMS seems to be an effective and well-tolerated endoscopic treatment
strategy for refractory GERD. It is a less invasive technique that can fill the treatment
gap between PPI therapy and laparoscopic fundoplication for treatment of refractory
GERD. Future prospective studies with long-term follow up are needed to validate our
findings.
