| Coverage Policy Manual | |
| Policy #: | 2013034 |
| Category: | Medicine |
| Initiated: | September 2013 |
| Last Review: | December 2024 |
|
|
|
|||||||||||
| Peroral Endoscopic Myotomy (POEM) | |
|
|
|
| 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. Gastric peroral endoscopic myotomy (G-POEM) is a similar procedure with the exception that it myotomizes the pylorus rather than LES.
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 is 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 included pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy (Cheatham, 2011; Pandolfino, 2013). Although the latter two are considered the standard treatments because of higher success rates and relative long-term efficacy compared to pharmacotherapy, both are associated with a perforation risk of about 1%. 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 in Japan (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).
Gastroparesis is characterized by symptoms of nausea, vomiting, bloating, early satiety, and pain, which is caused by delayed gastric emptying without mechanical obstruction (Reddivari, 2023). The estimated U.S. prevalence is difficult to ascertain due to the weak correlation of symptoms with gastric emptying which results in a high rate of underdiagnosis. Using data from 1996 to 2006, the estimated incidence per 100,000 persons, adjusted for age, was 9.6 for men and 37.8 for women.
Treatment options for gastroparesis have included dietary modification (smaller meal sizes, avoidance of carbonated beverages, smoking or high doses of alcohol, and in some cases enteral nutrition via jejunostomy), optimization of hydration and glycemic control, pharmacotherapy (e.g., antiemetics or Metoclopramide, or off-label medications for symptom control such as domperidone, erythromycin, tegaserod or centrally acting antidepressants), gastric electrical stimulation, venting gastrostomy, feeding jejunostomy, intra-pyloric botulinum injection, partial gastrectomy, and pyloroplasty (Reddivari, 2023). Gastric peroral endoscopic myotomy (G-POEM), which endoscopically performs the equivalent of pyloroplasty, is being investigated for the treatment of gastroparesis. G-POEM myotomizes the pylorus rather than the circular LES but otherwise consists of the same techniques described above.
Regulatory Status
Peroral endoscopic myotomy uses available laparoscopic instrumentation and, as a surgical procedure, is not subject to regulation by the U.S. Food and Drug Administration.
Coding
There are no specific CPT codes for this procedure. It would likely be reported with the unlisted procedure, esophagus code 43499.
|
|
|
|
|
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.
|
|
|
|
| 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.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Mourna et al published an RCT that compared POEM to LHM and partial fundoplication in adult patients with achalasia at a single center (de Mourna, 2022). The primary outcome was reflux esophagitis assessed at baseline, 1 month, 6 months, and 1 year post-treatment. Both groups significantly improved from baseline Eckhardt scores at all time points follow-up, but no significant between-group differences were observed. In the combined LHM and partial fundoplication group, treatment success, defined as 3 or less point reduction in Eckardt score, was confirmed in all patients at each time point follow-up; the POEM group had 100% success at 1 month which fell to 90% and 95% at 6 and 12 months follow-up, respectively. The rates of esophagitis were significantly higher in the POEM group at 1, 6, and 12 months follow-up. No differences in the rate of adverse events were detected between groups.
Saleh et al published an RCT that compared POEM to pneumatic dilation in adult patients with persistent achalasia symptoms after LHM (Saleh, 2023). The primary outcome was clinical success at 1 year, defined as an Eckardt score 3 or less, without the use of additional treatments. Two patients in the POEM group were lost to follow-up after randomization or treatment, but analyses of the primary and secondary outcomes were intention-to-treat analyses, and a priori power calculations required only 43 participants in each study arm. The median age was 52.5 years with a range of 36% to 40% male participation. At enrollment, both groups had a mean Eckardt score of 6 (interquartile range of 4 to 8). Patients randomized to POEM were significantly more likely to have treatment success at 1-year follow-up than those in the PD group; however, the rate of endoscopic reflux esophagitis was higher amongst participants treated with POEM than PD. The rate of serious adverse events attributed to the intervention was equivalent between groups, but POEM was associated with a greater number of adverse events (31.1%) than PD (20%). Events included candida esophagitis (n=1), Heliobacter pylori infection (n=3), periprocedural mucosal bleeding (n=2), gastric perforations (n=2), foot impaction (n=1), and several other non-upper-gastrointestinal related adverse events (n=5). The RCT was limited by the lack of blinding of outcome assessment and having outcome data through 1-year follow-up.
Results at 5 years from the 2019 RCT by Ponds et al were published by Kuipers et al in 2022 (Ponds, 2019; Kuipers, 2022). A total of 62 patients in the POEM group and 63 in the PD group were available for analysis. Treatment success (Eckardt score 3 or less) at 5 years follow-up favored the POEM group with 50 (81%) having success when compared to 25 (40%) of those treated with pneumatic dilation (absolute difference, 41%; 95% CI, 25% to 57%; p less than .0001). The median time to treatment failure was 60 months in the POEM group compared with 24 months in the PD group. Retreatment occurred in 8 (13%) patients in the POEM group compared with 7 (11%) in the PD group. Recurrence of symptoms (defined as having an Eckhardt score less than 3) occurred in 11 (18%) of POEM patients and 25 (40%) of PD patients. The rate of adverse events was 0% in the POEM group and 2% in the PD group. Amongst patients still in clinical remission at 5 years, proton pump inhibitor (PPI) use was significantly more common in patients treated with POEM (46%) than participants treated with PD (13%; P=.0082). In this same subset of patients, the mean GERD questionnaire scores in the POEM group (7; range, 6 to 9) were also significantly higher (P=.0081) than in the PD group (6; range, 6 to 7) at 5 years follow-up.
Haseeb et al published a retrospective study using National Readmission Database data from 2016 to 2019 to compare short-term outcomes after POEM (n=1911) to LHM (n=9710) and PD (n=2453) in adults with achalasia (Haseeb, 2023). The rate of readmissions was highest in patients treated with PD (12.6%), followed by POEM (4.3%) and LHM (3.9%). PD had significantly greater adjusted odds of readmission compared to POEM (OR, 2.42; 95% CI, 1.56 to 3.75), but no difference was identified between POEM and LHM (OR, 0.91; 95% CI, 0.62 to 1.33). No significant differences were detected in the rate of mortality, length of stay, or periprocedural adverse events between POEM and LHM. Compared to PD, POEM had a lower rate of mortality (0% vs 1.1%; p=.012), sepsis (1% vs. 2.3%; p=.016), blood transfusions (0.7% vs 2.3%; p less than .001), and length of stay (3.4 days vs 6.29 days; p less than .001).
Shally et al conducted a retrospective cohort study of POEM compared to LHM in adult patients with achalasia at a single center from 2014 to 2021 (Shally, 2023). A total of 33 POEM and 25 LHM patients were included and were well-balanced on pre-operative characteristics. Treatment success was defined as having an Eckardt score of 3 or less at follow-up and was achieved by 88% of patients in the POEM group and 76% of patients in LHM group (p=.302). Patients in the POEM group had a significantly shorter median operative time (106 minutes) compared to those in the LHM group (145 minutes; p=.003); additionally, individuals treated with POEM had lengths of stay less than one day in 48.5% of patients compared to 0% in the LHM group (P less than .001). Both groups observed improvements in dysphagia, heartburn, regurgitation, Eckardt score, GERD health-related quality of life, and anti-reflux medication use. Between-group differences were observed in the improvement of dysphagia scores with POEM patients having a superior resolution of dysphagia (2.3 vs 1.12; p=.003).
Nabi et al published a meta-analysis pooling outcomes of POEM in pediatric achalasia. The review included 14 studies from 2010 to 2021 (N=419; 234 boys) (Nabi, 2022). The mean age of patients ranged from 10.9 to 15.2 years with symptom duration of 6.3 to 30.1 months. Technical success occurred in 415 individuals with a pooled rate of 97.1% (95% CI, 94.5% to 98.5%; I2, 0%). A pooled clinical success rate in the intention-to-treat-analysis population was 88% (95% CI, 84.4% to 90.9%). The MD from baseline in Eckhardt scores was available from 9 studies and was significantly different from baseline (MD, 6.71; 95% CI, 6.14 to 7.28; I2, 81%); however, this estimate had substantial heterogeneity. The overall pooled rate of any adverse event was 12.9% (95% CI, 7.4 to 21.7%, I2, 64.5%) and for major adverse events, the rate was 4.2% (95% CI, 2.4% to 7.4). The authors concluded that POEM was a safe and effective modality for treating children with achalasia, but noted that prospective studies with longer-term follow-up and objective evaluation of gastroesophageal reflux are necessary.
Bi et al published a retrospective cohort study of POEM for the treatment of pediatric achalasia and compared pediatric patients to a 1:1 matched adult cohort on gender, operating physician, surgery date, and baseline Chicago and Ling classification between 2012 and 2020 (Bi, 2023). A total of 48 pediatric patients were included with a median age of 16 years (range 7 to 18 years of age). Most patients (75%) lacked prior treatment for achalasia. Fourteen patients were lost to follow-up, and a total of 34 pediatric patients were available for long-term follow-up with a mean of 5.7 years (range, 2.6 to 10.6 years). The clinical success rate, defined as a post-POEM Eckhardt score of less than 3, was 97%. Pediatric patients had significant improvements between pre- and post-POEM for Eckhardt score (8 vs 1.1, p less than .001), Urbach score (24.7 vs 12.8, p less than .001), dysphagia, regurgitation, chest pain, and weight loss (p less than .001). In addition, the number of absences from school decreases from a median of 3.3 months versus 0.1 months post-POEM (p less than .001). Adverse events reported in the pediatric group following POEM at 5 years included symptomatic reflux (17.6%), reflux esophagitis (5.9%), and clinical reflux (11.8%); all adverse events were controlled with medical therapy. Compared to a matched adult cohort (n=34), pediatric patients had identical rates of complications post-treatment (14.6%), similar rates of clinical success, changes in Eckardt and Urbach scores, clinical reflux evaluations, and procedure times.
Petrosyan et al conducted a retrospective study of all patients who underwent POEM for pediatric achalasia from 2015 to 2021 at a single center (Petrosyan, 2022). A total of 37 children (mean age, 11.6 years) were treated; 43.2% had a pre-POEM intervention for achalasia. Participants were followed for a median of 15 months (range 5.5 to 74 months) following POEM. Baseline Eckhardt scores were 6.73 (standard deviation ±1.5), and following POEM, scores decreased to a mean of 0.6 ± 0.9. One patient failed POEM (2.7%). The reintervention rate was 16.2% (5 patients required PD and 1 patient required LHM). Intraoperative complications occurred in 16 (43.2%) patients; however, these complications did not require reoperation during index admission. Intraoperative complications included mucosectomy distal to submucosal tunnel entry (13.5%), pneumothoraxes (24.3%), pneumomediastinum (5.4%), pneumoperitoneum (27%). Post-operative complications were recurrent dysphagia (13.5%) and GERD (8.1%).
Symptom relief may be measured by the Gastroparesis Cardinal Symptom Index (GCSI), which is comprised of 3 major symptoms of gastroparesis: postprandial fullness/early satiety (4 items), nausea/vomiting (3 items), and bloating (2 items). Each item receives a score from 0 (none) to 5 (severe), for a maximum score of 45. An average GCSI score of 3 or more is defined as severe gastroparesis (Revicki, 2004).
Two systematic reviews and meta-analyses evaluating G-POEM for the treatment of gastroparesis were identified (Kamal, 2022; Canakis, 2023). Both reviews included only observational studies of G-POEM for gastroparesis in adult patients. Outcome data was reported up to 1-year post-treatment in the study by Kamal et al and up to 3 years post-treatment in the study by Canakis et al . Clinical success was found to be 60.7% (95% CI, 49.1% to 71.2%) at 1 year with high heterogeneity pooling data from 8 studies. Pooled clinical success rates at 3 years follow-up across 4 studies was 75% (95% CI, 68.2% to 80.5%) with low heterogeneity. Following G-POEM, mean GCSI scores decreased by -1.44 (95% CI, -1.91 to -0.97) at 1-year post-treatment in 7 studies and by -3.3 (95% CI, -1.8 to -4.7) in 4 studies at 3-years follow-up; both estimates had very high heterogeneity between studies. One study reported a pooled rate of adverse events at 1-year follow-up of 8.2% and the other meta-analysis reported strata of events (bleeding, perforation, pain or other) which ranged from 0.7% to 4.1% at 3-years following G-POEM.
Hernandez-Mondragon et al retrospectively analyzed data from a prospective cohort of adult refractory gastroparesis patients (N=374) collected at a single center from 2017 to 2021 (Hernandez Mondragon, 2022). Patients were followed for 4 years and evaluated at baseline and then following G-POEM at 1 month, 6 months and every 6 months thereafter through 48 months. The technical success of the procedure was 100% with an average hospital length of stay of 2 days. Prior to treatment with G-POEM, the mean GCSI score was 3.84±0.53 which was significantly reduced to 2.1±0.7 (p less than .001) at 4 years follow-up (n=102). The clinical success rate was 77.5% at 4 years follow-up. Adverse events occurred in 8.6% of patients and were all managed conservatively or treated endoscopically. Twelve patients (3.2%) had a treatment failure with G-POEM and 72 (19.2%) had a recurrence of gastroparesis symptoms. Patients were stratified by the etiology of their gastroparesis for the purposes of subgroup analyses: 141 patients (37.7%) had diabetic gastroparesis, 115 (30.7%) had idiopathic gastroparesis, 102 (27.3%) had postsurgical gastroparesis, and 16 (4.3%) had another etiology. Between group comparisons based on etiology showed variations in the rate of recurrence (with diabetic etiology having a lower rate) as well as in the rate of final clinical success (with diabetic etiology showing a significantly greater rate of success than idiopathic, postsurgical, or other etiologies of gastroparesis [p less than .01]).
Martinek et al published a randomized, multi-center trial that compared G-POEM to sham treatment in patients with gastroparesis (Martinek, 2022). From November 2017 to February 2021 a total of 41 participants were recruited who were randomized 1:1 to either G-POEM (n=21) or sham control (n=20); 1 individual in the sham control group withdrew consent and 1 participant in the G-POEM group could not have the procedure completed due to submucosal fibrosis and were not included in the per-protocol analysis. The median age of patients in the G-POEM arm was 43 years (range, 30 to 51 years) and was 51 years (range, 45 to 56 years) in the sham control group. Participants in the G-POEM group had a higher baseline GCSI score of 3.5 compared to 3.2 in the sham control group.
Treatment success (50% or more reduction in GCSI score) at 6 months post-intervention occurred in 15 (71%) of the G-POEM patients in the intention to treat (ITT) analysis and 14 (70%) in the per-protocol analysis compared with 21% or 22% in the sham control group. Twelve patients crossed over to G-POEM and 9 (75%) had treatment success 6 months after crossing over. At 6 months follow-up the median reduction in GCSI score favored G-POEM over sham control; in the patients that crossed over from sham control to G-POEM, an additional median reduction in GCSI of 0.3 (95% CI, 0.1 to 1.6) was observed 6 months from the time of crossing over. The authors found that gastric retention decreased significantly after G-POEM compared to sham control and that after crossing over from sham to G-POEM, a similar effect was observed in the cross-over patients. A sub-group analysis showed a greater level of treatment effect in patients with a diabetic etiology of gastroparesis over post-surgical or idiopathic etiologies.
Additional 2024 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Gonzalez et al conducted a French multi-center RCT (N=40 patients) comparing the clinical efficacy of G-POEM versus pyloric botulinum toxin injection for refractory gastroparesis (Gonzalez, 2024). Patients were medically managed for more than 6 months and confirmed by gastric emptying scintigraphy (GES), with follow-up of 1 year. The primary end point was the 3-month clinical efficacy, defined as a more than 1-point decrease in the mean GCSI score. Secondary end points were: 1-year efficacy, GES evolution, adverse events, and quality of life. POEM showed a trend towards higher 3-month clinical success than botulinum toxin, along with non-significantly higher 1-year clinical success on intention-to-treat analysis. The GCSI decreased in both groups at 3 months and 1 year. Only three minor adverse events occurred in the POEM group. The GES improvement rate was 72% in the POEM group versus 50% in the botulinum toxin group (non-significant).
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| 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. PMID 31839408 Kohn GP, Dirks RC, Ansari MT, et al.(2021) SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia. Surg Endosc. May 2021; 35(5): 1931-1948. PMID 33564964 Li QL, Chen WF, Zhou PH et al.(2013) Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg 2013; 217(3):442-51. Marano L, Pallabazzer G, Solito B, et al.(2016) Surgery or peroral esophageal myotomy for achalasia: a systematic review and meta-analysis. Medicine (Baltimore). Mar 2016;95(10):e3001. PMID 26962813 Martins RK, Ribeiro IB, DE Moura DTH, et al.(2020) PERORAL (POEM) OR SURGICAL MYOTOMY FOR THE TREATMENT OF ACHALASIA: A SYSTEMATIC REVIEW AND META-ANALYSIS. Arq Gastroenterol. Jan-Mar 2020; 57(1): 79-86. PMID 32294740 Onimaru M, Inoue H, Ikeda H et al.(2013) Peroral Endoscopic Myotomy Is a Viable Option for Failed Surgical Esophagocardiomyotomy Instead of Redo Surgical Heller Myotomy: A Single Center Prospective Study. J Am Coll Surg 2013 [Epub ahead of print]. Pandolfino JE, Kahrilas PJ.(2013) Presentation, diagnosis, and management of achalasia. Clin Gastroenterol Hepatol 2013; 11(8):887-97. Pasha SF, Acosta RD, Chandrasekhara V, et al.(2014) The role of endoscopy in the evaluation and management of dysphagia. Gastrointest Endosc. Feb 2014;79(2):191-201. PMID 24332405 Patel K, Abbassi-Ghadi N, Markar S, et al.(2016) Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. Oct 2016;29(7):807-819. PMID 26175119 Ren Z, Zhong Y, Zhou P et al.(2012) Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc 2012; 26(11):3267-72. Sanaka MR, Hayat U, Thota PN, et al.(2016) Efficacy of peroral endoscopic myotomy vs other achalasia treatments in improving esophageal function. World J Gastroenterol. May 28 2016;22(20):4918-4925. PMID 27239118 Stavropoulos SN, Modayil RJ, Friedel D et al.(2013) The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc 2013 [Epub ahead of print]. Vaezi MF, Pandolfino JE, Yadlapati RH, et al.(2020) ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. Sep 2020; 115(9): 1393-1411. PMID 32773454 Von Renteln D, Fuchs KH, Fockens P et al.(2013) Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology 2013; 145(2):309-11 e3. Wang X, Tan Y, Lv L, et al.(2016) eroral endoscopic myotomy versus pneumatic dilation for achalasia in patients aged >/= 65 years. Rev Esp Enferm Dig. Oct 2016;108(10):637-641. PMID 27649684 Werner YB, Hakanson B, Martinek J, et al.(2019) Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. Dec 05 2019; 381(23): 2219-2229. PMID 31800987 Yaghoobi M, Mayrand S, Martel M, et al.(2013) Laparoscopic Heller's myotomy versus pneumatic dilation in the treatment of idiopathicachalasia: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. Sep 2013; 78(3): 468-75. PMID 23684149 Zhang Y, Wang H, Chen X, et al.(2016) Per-oral endoscopic myotomy versus laparoscopic Heller myotomy for achalasia: a meta-analysis of nonrandomized comparative studies. Medicine (Baltimore). Feb 2016;95(6):e2736. PMID 26871816 Zhong C, Tan S, Huang S, et al.(2020) Peroral endoscopic myotomy versus pneumatic dilation for achalasia: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. Nov 2020; 32(11): 1413-1421. PMID 32516175 Zhong C, Tan S, Huang S, et al.(2021) Clinical outcomes of peroral endoscopic myotomy for achalasia in children: a systematic review and meta-analysis. Dis Esophagus. Apr 07 2021; 34(4). PMID 33316041 Zhou PH, Li QL, Yao LQ et al.(2013) Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. Endoscopy 2013; 45(3):161-6. |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association. |
|