Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia

Abstract

BACKGROUNDPneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODSIn a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplica-tion in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indi-cating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of −12.5 percentage points was used in the pri-mary analysis. Secondary end points included adverse events, esophageal function, Gas-trointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux. RESULTSA total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], −8.7 to 11.4; P= 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal func-tion from baseline to 24 months, as assessed by measurement of the integrated relax-ation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, −0.75 mm Hg; 95% CI, −2.26 to 0.76), nor did improve-ment in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, −4.01 to 4.28). 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%. CONCLUSIONSIn this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.) AAchalasia is an esophageal motor disorder consisting of defective relaxation of the lower esophageal sphincter and disturbed esophageal peristalsis. The clinical symptoms associated with the condition include dysphagia, regurgitation, chest pain, and weight loss. 1 Current treatment options include endo-scopic botulinum toxin injection, endoscopic pneumatic dilation, and surgical laparoscopic Heller's myotomy (LHM). 2 These therapies allevi-ate symptoms, mainly by reducing lower esopha-geal sphincter pressure and lowering the resis-tance to flow at the esophagogastric junction. On the basis of findings from randomized trials, 3,4 recent consensus statements and guidelines sup-port both pneumatic dilation an...

Outcomes of anterior versus posterior peroral endoscopic myotomy 2 years post-procedure: prospective follow-up results from a randomized clinical trial

“…The overall clinical success was 82 % at ≥ 2 years compared with 89 % at 1 year post-POEM. The overall drop in the rate of clinical success was consistent with results of the recent RCT by Werner et al [4], which reported a clinical success rate of 83 % at 2 years post-POEM. Moreover, there was no significant difference in clinical suc-cess between the anterior (85 %) and posterior (79 %) treatment arms at ≥ 2 years post-POEM.…”

“…Peroral endoscopic myotomy (POEM) is currently a well-established treatment for achalasia and has become a first-line management option at many high-volume centers [1 -3]. Clinical and technical outcomes are comparable to conventional laparoscopic Heller myotomy [4]. The procedure utilizes submucosal tunneling to access the lower esophageal sphincter and is essentially the endoscopic equivalent of the surgical myotomy.…”

Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 4 years: a multicenter study

“…Inoue et al reported a durable clinical success of 88.5 % at 3 years in 61 patients whereas Li et al reported a drop in the long-term durability of the early clinical success of POEM in only 48 of 562 patients, with 87 % having a clinical response at ≥ 4 years. The tendency toward decreased efficacy in the long-term following POEM [5,9,12,[18][19][20][21][22] is also apparent in LHM [23]. The study published in 2018 by Teitelbaum et al also showed a decrease in the clinical success rate ▶ of POEM in Achalasia patients to around 83 % at 5 years followup.…”

Peroral endoscopic myotomy is an effective treatment for diffuse esophageal spasm

“…Although HRM could not be performed adequately in the present case, it is the gold standard for diagnosis of DES. POEM is recognized as the first treatment choice for achalasia . Furthermore, even for abnormal peristaltic movement in DES, POEM can provide sufficient therapeutic effects …”