| Coverage Policy Manual | |
| Policy #: | 2013034 |
| Category: | Medicine |
| Initiated: | September 2013 |
| Last Review: | November 2023 |
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| Peroral Endoscopic Myotomy (POEM) | |
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| Description: |
Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for patients to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure that uses the oral cavity as a natural orifice entry point to perform myotomy of the lower esophageal sphincter (LES). This procedure is intended to reduce the total number of incisions needed and thus the overall invasiveness of surgery.
Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for patients to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. The estimated prevalence of achalasia in the United States of 10 cases per 100,000, and the estimated incidence is 0.6 cases per 100,000 per year (Cheatham, 2011). Treatment options for achalasia have traditionally included pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy (Cheatham, 2011; Pandolfino, 2013). Although the last two are considered the mainstay of treatment because of higher success rates and relative long-term efficacy compared to pharmacotherapy and botulinum toxin injections, they both are associated with a perforation risk of about 1%. Laparoscopic Heller myotomy is the most invasive of the procedures, requiring laparoscopy and surgical dissection of the esophagogastric junction (Pandolfino, 2013). One-year response rates of 86% and major mucosal tear rates requiring subsequent intervention of 0.6% have been reported (Yaghoobi, 2013).
Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure developed by a Japanese surgeon, Dr. Haruhiro Inoue and colleagues (Pandolfino, 2013; Inoue, 2010). POEM is performed with the patient under general anesthesia (Hungness, 2013). After tunneling an endoscope down the esophagus toward the esophageal gastric junction, a surgeon performs the myotomy by cutting only the inner, circular lower esophageal sphincter (LES) muscles through a submucosal tunnel created in the proximal esophageal mucosa. POEM differs from laparoscopic surgery, which involves complete division of both circular and longitudinal LES muscle layers. Cutting the dysfunctional muscle fibers that prevent the LES from opening allows food to enter the stomach more easily (Pandolfino, 2013; Hungness, 2013).
Coding
There are no specific CPT codes for this procedure. It would likely be reported with the unlisted procedure, esophagus code 43499.
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Policy/ Coverage: |
Effective July 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Peroral endoscopic myotomy for any indication, including but not limited to pediatric and adult esophageal achalasia, gastroparesis, and GERD, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, peroral endoscopic myotomy for any indication, including but not limited to pediatric and adult esophageal achalasia, gastroparesis, and GERD, is considered investigational as a treatment for pediatric and adult esophageal achalasia. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Gastric per-oral endoscopic myotomy (G-POEM) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, gastric peroral endoscopic myotomy is considered investigational for all indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective June 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Peroral endoscopic myotomy as a treatment for pediatric and adult esophageal achalasia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, peroral endoscopic myotomy as a treatment for pediatric and adult esophageal achalasia is considered investigational as a treatment for pediatric and adult esophageal achalasia. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Gastric per-oral endoscopic myotomy (G-POEM) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, gastric peroral endoscopic myotomy is considered investigational for all indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2019 through May 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Peroral endoscopic myotomy as a treatment for pediatric and adult esophageal achalasia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, peroral endoscopic myotomy is considered investigational as a treatment for pediatric and adult esophageal achalasia. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to November 2019
Peroral endoscopic myotomy as a treatment for esophageal achalasia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, peroral endoscopic myotomy is considered investigational as a treatment for esophageal achalasia. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy was created in September 2013 with a search of the MEDLINE database through August 1, 2013. The literature on the efficacy of POEM consists primarily of small, case series and one nonrandomized trial with historical controls. No randomized controlled trials comparing POEM with other treatment options. Following is a summary of the larger series (≥50 patients) on this procedure.
In a nonrandomized, historical control trial, Hungness and colleagues (2013) reported on perioperative outcomes in patients with achalasia treated with POEM (n=18) or laparoscopic Heller myotomy (LHM) (n=55) at a single US center (Hungness, 2013). Operative times were shorter for POEM than for LHM (113 and 125 minutes, respectively, p<0.05). Additionally, estimated blood loss was less in patients treated with POEM (≤10 mL in all POEM cases vs. 50 mL for LHM, p<0.001). Myotomy lengths, complication rates, and length of stay were similar between groups. Pain scores were similar upon post-anesthesia care and postoperatively on the first day, but were higher at two hours for POEM patients (3.5 vs. 2.0, p=0.03). Narcotic use was similar between groups, although fewer patients treated with POEM received ketorolac. POEM patients’ Eckardt scores decreased (median 1 post-op vs. 7 pre-op, p<0.001), and 16 (89%) patients had a treatment success (score ≤3) at a median of six-months follow-up (Hungness, 2013).
In a prospective case series, von Renteln and colleagues (2013) reported on outcomes of 70 patients who underwent POEM at five centers in Europe and North America (Von Renteln, 2013). The mean follow-up period was 10 months (range, 3–12 months). Follow-up evaluation at six months and one-year showed sustained treatment success of 89% and 82%, respectively. The mean Eckhardt score pretreatment was 6.9 compared with 1.3 at 6 months and 1.7 at one-year (p<0.001 for both comparisons). Multivariate analysis showed that neither age, previous treatment (Botox/dilatation), length of the myotomy, pre-procedure LES pressure, initial Eckardt score, sex, procedure duration, nor full-thickness dissection during POEM were significant predictors of treatment failure at one year. At three months after POEM, esophagitis was observed in 42% of cases. However, the severity of esophagitis was only minor (grade A or B) and all patients could be managed adequately with proton pump inhibitor (PPI) therapy. At 3 months, 22% of patients required occasional and 12% required daily PPI therapy. The one-year follow-up evaluation showed overall rates of gastroesophageal reflux disease (GERD) of 37%, and PPI use of 29%. Other complication rates of POEM ranged from 1%-4% (Von Renteln, 2013).
The largest published POEM series to date, by Ren and colleagues (2012), highlights some of these POEM-specific complications (Ren, 2012). In their series of 119 cases, 23% of patients developed subcutaneous emphysema intraoperatively and an additional 56% postoperatively. Three of these patients required treatment with subcutaneous needle decompression. Additionally, 3% of their patients developed a pneumothorax intraoperatively and another 25% postoperatively. Postoperatively, the incidence of thoracic effusion was 49%, and of mild inflammation or segmental atelectasis of the lungs was 50%. All complications were resolved with conservative treatment (Ren, 2012).
At least two small case series have evaluated the efficacy and feasibility of POEM for patients with failed Heller myotomy/achalasia recurrence; success rates have been reported in over 90% of cases up to 10 months after rescue POEM (Onimaru, 2013; Zhou, 2013). Studies have also been undertaken comparing different POEM techniques; comparable outcomes have been reported between patients undergoing full-thickness versus circular myotomy (Li, 2013). An international survey involving 16 centers reported 841 POEM procedures performed as of July 2012; these centers comprised of seven in North America, five in Asia, and four in Europe, including high-volume centers (≥30 POEMs per center) (Stavropoulos, 2013).
Ongoing Clinical Trials
Sixteen active POEM studies were registered in the National Clinical Trials database (ClinicalTrials.gov) as of August 20, 2013, with five U.S. centers currently participating in or sponsoring trials. Three studies are randomized controlled trials:
Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial (NCT01768091)
The purpose of this Chinese single-center study is to determine the efficacy and safety of POEM compared with pneumatic dilation in the treatment of esophageal achalasia. The primary outcome measure is therapeutic success (as measured as symptom control to an Eckardt score of 3 or less) at two years of follow-up. This study is currently recruiting participants (N=200) with an estimated completion date of December 2013.
Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial (NCT01601678)
The purpose of this international study (conducted across 18 centers within Europe and North America) is to compare the feasibility, safety and efficacy of POEM with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia up to five years of follow-up. The primary outcome measure is the non-inferiority of POEM compared to LHM based on LES pressure on manometry after POEM compared to LHM at three months after procedure. This study is currently recruiting participants (N=220) with an estimated completion date of December 2019.
A Prospective Randomized Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia (NCT01793922)
The purpose of this study (Belgium single-center) is to compare the efficacy of POEM to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized by the study investigators that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia. The primary outcome measure is therapeutic success (as measured from date of pneumatic dilation or POEM to date of relapse of symptoms) at two years of follow-up. This study is not yet open for recruitment (N=150) with an estimated completion date of January 2023.
Summary
Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure for treatment of esophageal achalasia that uses the oral cavity as a natural orifice entry point for LES myotomy. The intent of this approach is to reduce the total number of incisions needed and, thus, the overall invasiveness of surgery. The evidence base consists of case series and one non-randomized comparative trial with historical controls. Two of the larger case series, enrolling a total of 189 patients with achalasia treated with POEM, and one nonrandomized, historical control trial of 18 patients treated with POEM and 55 patients treated with Heller myotomy were included. Treatment success at short follow-up periods was reported for a high percent of patients treated with POEM. However, there were relatively high rates of adverse effects, with, POEM-specific complications reported across studies including subcutaneous emphysema, pneumothorax, and thoracic effusion. In addition, a substantial proportion of patients undergoing POEM developed esophagitis requiring treatment. In the nonrandomized historical control trial, investigators reported that POEM resulted in shorter operative times and less blood loss than laparoscopic Heller myotomy, although myotomy lengths, complication rates, length of stay, and narcotic use were similar between surgical groups.
The evidence shows that POEM is a technique in evolution that does not have a strong evidence base at this time. Uncontrolled case series demonstrate that it can improve symptoms in patients with achalasia, but that side effects can occur commonly. There are no controlled studies to determine the efficacy and safety above a control group, and there are no comparative effectiveness studies to evaluate long-term outcomes of POEM compared to alternative treatment, .
Regulatory Status
POEM uses available laparoscopic instrumentation and, as a surgical procedure, is not subject to regulation by the U.S. Food and Drug Administration (FDA).
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Several systematic reviews have evaluated the outcomes of POEM. Three recent reviews have summarized outcomes of case series studies (Akintoye, 2016; Crespin, 2015; Patel, 2016).The systematic review by Akintoye and colleagues evaluated outcomes for 2373 patients from 36 studies (Akintoye, 2016). Clinical success rates were achieved in 98% of patients (95% confidence interval [CI], 97% to 100%) and mean Eckardt scores decreased from baseline at 1, 6, and 12 months. The systematic review by Crespin and colleagues evaluated outcomes for 1299 patients from 19 studies (Crespin, 2016). Improvements in Eckardt score were statistically significant in all studies. The most frequently reported complications were mucosal perforation, pneumothorax, pneumoperitoneum, and subcutaneous emphysema. The systematic review by Patel and colleagues evaluated outcomes for 1122 patients from 22 studies (Patel, 2016). Eckardt scores changed from 6.8 baselines to 1.2 post-operatively. There were improvements in lower esophageal sphincter (LES) pressure and symptoms.
Two systematic reviews only selected studies in which POEM was compared to an alternative surgical treatment (Marano, 2016; Zhang, 2016). Only the results of the systematic review by Marano and colleagues are cited here because it includes the period of time covered in the other review and includes more patients and studies (Marano, 2016). In this study, outcomes for 486 patients (196 receiving POEM, 290 receiving laparoscopic Heller myotomy [LHM]) from 11 studies were evaluated. None were randomized. Reviewers rated all studies to have a moderate risk of bias. No information on differences in severity of disease between treatment groups was provided. There was no significant difference in the reduction of Eckardt score between the 2 procedures. Hospital length of stay was shorter for POEM. There was no difference in postoperative pain scores and requirement for analgesics.
Conclusions on comparative efficacy cannot be determined from these systematic reviews, because reviews of case series do not have a comparator treatment. The systematic reviews evaluating comparative studies only include nonrandomized studies and do not appear to have taken differences in patient characteristics into account.
Sanaka and colleagues compared outcomes in their own institution for 36 patients undergoing POEM, 142 undergoing LHM, and 36 undergoing pneumatic dilation (Sanaka, 2016). At baseline, patients undergoing different procedures had different characteristics. POEM patients were older, had higher BMI, and had more prior treatments. After treatment, patients undergoing all 3 procedures had significant improvements in measurements made by high-resolution esophageal manometry and timed barium esophagram. Eckhardt symptom scores were only available for POEM patients. Long-term outcomes were not reported. Wang and colleagues retrospectively reviewed outcomes for POEM (n=21) and pneumatic dilation (n=10) in patients aged 65 years of age and older (Wang, 2016). All were treated successfully, with decreases in Eckhardt score. At a mean follow-up of 21.8 months for POEM and 35 months for pneumatic dilation, 1 POEM case failed and 2 pneumatic dilation procedures failed.
The nonrandomized studies comparing POEM to other procedures are retrospective and involved patients who may not be comparable. Although outcomes were generally similar between POEM and the comparator treatments (LHM or pneumatic dilation), potential confounding and selection bias make the outcome comparison uncertain. The comparative studies did not report long-term outcomes.
ONGOING AND UNPUBLISHED CLINICAL TRIALS
Some currently unpublished trials that might influence this review are listed below:
Ongoing:
(NCT02138643) Laparoscopy Heller Myotomy with Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM); planned enrollment of 30; projected completion date February 2017.
Unpublished:
(NCT02138643) Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia; planned enrollment of 100; projected completion date December 2012 (unknown).
(NCT01750385) Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia; planned enrollment 60; projected completion date August 2013 (unknown).
2017 Update
A literature search conducted through October 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through October 2018. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Martins et al conducted a systematic review and meta-analysis of the largest number of comparative observational studies and patients treated with POEM (n=359) or LHM (n=534) (Martins, 2020). Study quality was assessed using the Modified New Castle Ottawa Scale and all included studies were considered to be adequate for analysis. POEM demonstrated small improvements in Eckardt scores and reduced length of stay, comparable operative time, but more major adverse events. Most of the major adverse events were described as being related to unrecognized intraoperative mucosal perforation. An important limitation of this meta-analysis is that it did not take into account between-group differences in pre-operative Eckardt score levels at baseline.
Aiolfi et al conducted a systematic review and Bayesian random-effects network meta-analysis that compared POEM to LHM and pneumatic dilation (Aiolfi, 2020). Overall, 19 studies of 4407 patients were included. Of those, 10 studies of 645 patients directly compared POEM and LHM and none directly compared POEM and pneumatic dilation. POEM was associated with improved dysphasia remission and Eckardt scores, but higher risk of GERD compared to LHM. Important limitations of this network meta-analysis include its inclusion of arm-based indirect comparisons and the inherent bias of its reliance on observational studies.
Awaiz et al conducted a systematic review and meta-analysis of 7 studies that compared LHM (N=250) to POEM (N=233) for the treatment of esophageal achalasia (Awaiz, 2017). Study quality was assessed using the Modified New Castle Ottawa Scale and was found to be moderate to high. Meta-analysis results found POEM and LHM to be comparable on operative time (weighted mean difference [WMD]=26.28; 95% CI, -11.20 to 63.70), overall complication rate (OR=1.25; 95% CI, 0.56 to 2.77), postoperative GERD, long-term GERD, length of hospital stay, and postoperative pain score (WMD=-0.26; 95% CI, -1.58 to 1.06). LHM was associated with a significantly higher short-term clinical treatment failure rate (OR=9.82; 95% CI, 2.06 to 46.80). However, as there was no standard definition of treatment failure across studies, findings from this meta-analysis are unreliable. Meta-analysis of dysphasia, Eckardt scores, clinical success and serious/major complications was not undertaken. An important relevance limitation of this meta-analysis is that because the follow-up periods in all the studies were short-term, no conclusions can be drawn about long-term comparative effectiveness of the 2 interventions.
Zhong et al conducted a meta-analysis of 7 observational studies comparing POEM (n=298) to pneumatic dilation (n=321) (Zhong, 2020). Achalasia type varied, with 33% type I, 55% type II, and 12% type III. The mean age of the patients in the included studies ranged from 14 to 69 years; thus, including 2 pediatric studies and 2 studies of older adults. Follow-up ranged from 2 to 49.23 months. POEM improved the clinical success rate (24-month RR=1.35; 95% CI, 1.10 to 1.65; I2=70%) and change in Eckardt scores (MD 1.19, 95% CI 0.78 to 1.60, I2=70%); however, the risk of GERD and other complications was higher for POEM compared with pneumatic dilation (RR=4.17, 95% CI, 1.52 to 11.45, and RR=3.78; 95% CI, 1.41 to 10.16, respectively). Important limitations of this meta-analysis include the inherent bias of reliance on observational studies and the high between-study clinical and statistical heterogeneity.
Werner et al published a randomized, noninferiority trial that compared POEM to LHM plus Dor's fundoplication in patients with idiopathic achalasia (Werner, 2019). The primary outcome was clinical success at 2 years, defined as an Eckardt score < 3, without the use of additional treatments. A noninferiority margin of -12.5 percentage points was prespecified as "clinically acceptable" for the primary end point, based on input from the interventional gastroenterologists and surgeons involved in the trial. Analyses were primarily performed in a modified intention-to-treat population of 221 patients, which excluded 20 (8%) of patients who withdrew consent, had exclusion criteria discovered post-randomization, or did not undergo treatment. Among the modified intention-to-treat population, the mean age was 48.6 years, 64.2% had no previous therapy, 26.2% had a previous endoscopic pneumatic dilation, and their mean Eckardt symptom score was 6.8. POEM was noninferior to LHM plus Dor's fundoplication for clinical success at 2 years, but rates of reflux esophagitis were higher for POEM. This resulted in more patients in the POEM group receiving daily low-dose proton-pump inhibitors at 24 months. Although a higher rate of serious adverse events was reported in the LHM group, the difference was not statistically significant. This was likely owing to insufficient statistical power for measuring differences in rare outcomes. The most common serious adverse event in the LHM group was mucosal perforation (n=3, 2.7%). The RCT was limited by the lack of blinding of outcome assessment.
In 2020, the American College of Gastroenterology issued evidence-based clinical guidelines on the diagnosis and management of achalasia (Vaezi, 2020). The quality of the evidence and the strength of recommendations were rated based on the GRADE framework. The evidence review includes the 2 RCTs of POEM compared to LHM or pneumatic dilation. Based on their evaluation, the College made the following recommendations:
In 2020, ASGE issued an evidence-based guideline on the management of achalasia (Khashab, 2020). The methodologic quality of systematic reviews was assessed using the Methodological Quality of Systematic Reviews-2 (AMSTAR-2) tool and the certainty of the body of evidence was rated as very low to high based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. ASGE rated the strength of individual recommendation based on the aggregate evidence quality and an assessment of the anticipated benefits and harms. ASGE used the phrase "we suggest" to indicate weaker recommendations and "we recommend" to indicate stronger recommendations. This guideline did not include either of the 2 available RCTs of POEM. Based on their evaluation, ASGE issued the following recommendations:
These 2020 ASGE guidelines were endorsed by the American Neurogastroenterology and Motility Society and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Dirks et al (2021) conducted a systematic review and meta-analysis that evaluated the efficacy and safety of POEM in comparison to LHM and PD (Dirks, 2021). The review included 28 studies (2 RCTs and 26 observational studies). Most comparative studies on POEM included LHM (n=21), with a minority involving POEM versus PD (n=8). One study included all 3 interventions. Since POEM is a relatively new intervention, studies evaluating POEM often had shorter follow-up. Two studies included children, with 1 each comparing POEM to PD and LHM. The majority of included studies had a baseline achalasia subtype that was either predominantly type 2 and/or type 1; only 1 study had predominantly type 3 achalasia. The vast majority of included studies had less than 100 total patients. Results revealed POEM to have similar efficacy to LHM. However, POEM treated dysphagia better than PD in a RCT and observational studies and POEM needed reintervention less than PD in a RCT (risk ratio [RR] 0.19; 95% CI, 0.08 to 0.47) and LHM in an observational study (RR 0.33; 95% CI, 0.16 to 0.68). POEM had similar safety outcomes to LHM and PD. The authors concluded that POEM has similar outcomes to LHM and greater efficacy than PD.
Facciorusso et al completed a systematic review and network meta-analysis of first-line therapeutic interventions for achalasia (Facciorusso, 2021). The review included 6 RCTs in adults with achalasia that compared the efficacy of PD (n=260), LHM (n=309) and POEM (n=176). Four trials compared LHM with PD, 1 compared POEM to PD, and 1 compared POEM with LHM. Overall, low-quality evidence, based primarily on direct evidence, supported the use of POEM over PD for treatment success at 1 year while there was no significant difference observed between LHM and POEM. Severe esophagitis occurred at an incidence of 5.3%, 3.7%, and 1.5% for POEM, LHM, and PD, respectively. Procedure-related serious adverse events after POEM, LHM, and PD were 1.4%, 6.7%, and 4.2%, respectively. The authors concluded that POEM and LHM have comparable efficacy and may increase treatment success as compared to PD, with low confidence in estimates.
Zhong et al published an updated systematic review and meta-analysis evaluating clinical outcomes of POEM for the treatment of achalasia in children (Zhong, 2021). The review included 11 studies published between January 2009 to June 2020 (N=389; 222 boys). The mean age of the patients ranged from 5.5 to 15.2 years with symptom duration ranging from 1.7 to 26.4 months. The pooled technical success (completion of the POEM procedure successfully) was achieved in 385 children (97.4%; 95% CI, 94.7% to 98.7%) and the pooled clinical success (decrease in Eckhardt score to ≤3 during follow-up) was achieved in 343 children (92.4%; 95% CI, 89% to 94.8%). The Eckhardt score was significantly reduced by 6.76 points following POEM (95% CI, 6.18 to 7.34; p<.00001). Regarding adverse events, the pooled major adverse event rate was 12.8% (95% CI, 4.5% to 31.5%) with a pooled gastoesophageal reflux rate of 17.8% (95% CI, 14.2% to 22%). The authors concluded that POEM was effective and safe for treating children with achalasia; however, all included studies in the analysis were observational in nature.
In 2021, SAGES issued its own evidence-based guidelines for the use of POEM for the treatment of achalasia (Kohn, 2021). The expert panel agreed on 4 recommendations for adults and children with achalasia. These include:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Aiolfi A, Bona D, Riva CG, et al.(2020) Systematic Review and Bayesian Network Meta-Analysis Comparing Laparoscopic Heller Myotomy, Pneumatic Dilatation, and Peroral Endoscopic Myotomy for Esophageal Achalasia. J Laparoendosc Adv Surg Tech A. Feb 2020; 30(2): 147-155. PMID 3136491 Akintoye E, Kumar N, Obaitan I, et al.(2016) Peroral endoscopic myotomy: a meta-analysis. Endoscopy. Sep 12 2016. PMID 27617421 Awaiz A, Yunus RM, Khan S, et al.(2017) Systematic Review and Meta-Analysis of Perioperative Outcomes of Peroral Endoscopic Myotomy (POEM) and Laparoscopic Heller Myotomy (LHM) for Achalasia. Surg Laparosc Endosc Percutan Tech. Jun 2017; 27(3): 123-131. PMID 2847201 Cheatham JG, Wong RK.(2011) Current approach to the treatment of achalasia. Curr Gastroenterol Rep 2011; 13(3):219-25. Crespin OM, Liu LW, Parmar A, et al.(2016) Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature. Surg Endosc. Sep 15 2016. PMID 27633440 Dirks RC, Kohn GP, Slater B, et al.(2021) Is peroral endoscopic myotomy (POEM) more effective than pneumatic dilation and Heller myotomy? A systematic review and meta-analysis. Surg Endosc. May 2021; 35(5): 1949-1962. PMID 33655443 Facciorusso A, Singh S, Abbas Fehmi SM, et al.(2021) Comparative efficacy of first-line therapeutic interventions for achalasia: a systematic review and network meta-analysis. Surg Endosc. Aug 2021; 35(8): 4305-4314. PMID 32856150 Hungness ES, Teitelbaum EN, Santos BF et al.(2013) Comparison of perioperative outcomes between peroral esophageal myotomy (POEM) and laparoscopic Heller myotomy. J Gastrointest Surg 2013; 17(2):228-35. Inoue H, Minami H, Kobayashi Y et al.(2010) Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010; 42(4):265-71. Khashab MA, Vela MF, Thosani N, et al.(2020) ASGE guideline on the management of achalasia. Gastrointest Endosc. Feb 2020; 91(2): 213-227.e6. 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