Stapling peroral endoscopic myotomy over Heller?

Peroral endoscopic myotomy (POEM) has been considered a safe and effective endoscopic therapeutic option for idiopathic achalasia. However, loosening the lower esophageal sphincter inevitably increases the risk of reflux, and the benefits of POEM may be compromised compared with laparoscopic Heller myotomy (LHM), which can be accompanied by simultaneous partial fundoplication. Owing to limitations in the methodological quality of most studies, and the inconsistent assessment used, the rate of reflux varies significantly among different studies [1]. In a multicenter, randomized trial of 221 patients, POEM demonstrated noninferiority to LHM plus Dor fundoplication in controlling symptoms of achalasia at 2 years, but the incidence of reflux was significantly higher [2]. At 3 months, 57 % of patients in the POEM group and 20 % of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44 % and 29 % [2].

In this issue of Endoscopy, Maydeo et al. from the Global Hospital Mumbai, India, report on a sham-controlled study to evaluate the effectiveness of endoscopic full-thickness plication (EFTP) using the new GERDX device (G-SURG GmbH, Seeon-Seebruck, Germany) in post-POEM patients who were dependent on proton pump inhibitors (PPIs) for treatment of documented gastroesophageal reflux disease (GERD) [3]. This device allows the application of one to multiple transmural sutures at the gastroesophageal junction to remodel the gastroesophageal flap valve. A previous sham-controlled study in patients with GERD demonstrated the safety and improvement in GERD-related quality of life and severity of reflux symptoms in the short and long term [4].

“By stapling and remodeling the gastroesophageal junction, endoscopic full-thickness plication provides a promising option for selected patients with reflux after peroral endoscopic myotomy.”

In the current study, patients randomized to EFTP achieved the primary end point with a significant reduction in esophageal acid exposure time (AET) < 6 % on 24-hour pH impedance at 3 months. They also showed improvement in GERD questionnaire score and reduction in PPI usage up to the 6-month follow-up, with a satisfactory safety profile [3].

One major advantage of this study is that it is a prospective, randomized, well-powered trial according to the primary end point. Several studies have reported the performance of endoscopic treatment in relation to post-POEM reflux but most of them were either retrospective or limited in sample size. For example, a multicenter, retrospective study evaluating transoral incisionless fundoplication using the EsophyX Z device (Endogastric Solutions, Redmond, Washington, USA) included 12 patients and set technical success as the primary outcome [5]. Although the authors assessed parameters of reflux as secondary outcomes, the statistical power of the study was not adequate to draw conclusions on the effect of the device for control of post-POEM reflux.

Another advantage of the Maydeo et al. study is the objectiveness of the primary outcome. Not only is an objective outcome more reliable in clinical trials because potential reporting bias is reduced, but the primary end point of AET < 6 % is more appropriate to the condition itself (i. e. reflux). As considered by the authors, GERD post-POEM is frequently asymptomatic, with the majority of patients with abnormal AET or evidence of esophagitis having no symptoms. Ambulatory reflux monitoring with the use of impedance may be a good option for the diagnosis for these patients, in whom symptoms and use of PPI are complicated by impaired peristalsis, food stasis, and fermentation.

One of the limits of this study is that the follow-up period of 6 months may not be long enough to detect the effect on GERD after POEM. There is also always concern about whether the endoscopic sutures can persist, with any loosening over time possibly causing the flap valve to unravel [6]; indeed, the effect of laparoscopic fundoplication actually diminishes over time [7]. It would be helpful if the investigators could continue the follow-up and release long-term efficacy at 2–5 years.

The study by Maydeo et al. demonstrated that symptom improvement and reduced acid exposure with EFTP are not due to a sham effect. Clinicians may also be interested in whether EFTP is superior to other endoscopic antireflux solutions or even a surgical fundoplication in terms of safety and efficacy, as well as economically.

Even though the rate of post-POEM GERD is high, a fundoplication is not necessary in all patients. With the low rate of adverse events and high quality of life, POEM is still worth attempting, and if reflux develops, some patients could benefit from an endoscopic plication instead of an unnecessary surgical fundoplication; furthermore, a failed endoscopic plication does not make a subsequent laparoscopic fundoplication more difficult or impossible.

By stapling and remodeling the gastroesophageal junction, EFTP provides a promising option for selected patients with post-POEM GERD. POEM with a potential EFTP may become a better choice over LHM plus simultaneous partial fundoplication in the balance of safety, efficacy, reflux, and economics. Additional research into these issues is still warranted before a wise recommendation can be made.

Publication History

Article published online:
11 May 2023

• References

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