Pneumatic Dilation versus Laparoscopic Heller's Myotomy for Idiopathic Achalasia (N Engl J Med 2011;364:1807-1816)

Abstract

Achalasia is a primary esophageal motility disorder which is characterized by impaired relaxation of lower esophageal sphincter and aperistalsis of esophagus. These motor abnormalities result in impaired food bolus transit in the esophagus, which causes symptoms such as dysphagia, regurgitation, chest pain and weight loss. Every year, about 1 in 100,000 people develop achalasia. The exact etiology of achalasia is not entirely clear but an immune mechanism with inflammation and loss of esophageal myenteric neurons has been implicated. To date, the mainstay of treatment of achalasia is the mechanical disruption of the lower esophageal sphincter muscle fibers by either endoscopic pneumatic dilation or surgical myotomy, so as to reduce the lower esophageal sphincter pressure. In recent years, laparoscopic Heller's myotomy (LHM) has been considered to be superior to endoscopic pneumatic dilation for the treatment of achalasia with favorable results from single center studies.1-3 The addition of Dor's partial fundoplication to Heller's myotomy significantly reduces the incidence of postoperative occurrence of gastroesophageal reflux disease.4 As a result, LHM becomes the preferred treatment for achalasia especially in United States. In a prospective multicenter randomized trial that involved 15 centers in 5 countries, the European Achalasia Trial Investigators group compared pneumatic dilation to laparoscopic Heller myotomy.5 Two hundred and one patients with newly diagnosed achalasia were randomly assigned to pneumatic dilation or LHM with Dor's fundoplication. Symptoms, including weight loss, dysphagia, retrosternal pain and regurgitation, were assessed with the use of the 0-12 point Eckardt score. The dilation protocol was modified during the early phase of the trial because the initial dilation protocol (35 mm Rigiflex balloon inflated at a pressure up to 8 psi for 1 minute) led to esophageal perforations in 4 of the first 13 patients. All these patients were excluded from the final analysis and a modified 2-session protocol was adopted instead. The patients underwent 30 mm balloon dilation in the first procedure, followed by a 35 mm balloon 1 to 3 weeks later. A third procedure was done using at 40 mm balloon if the Eckardt score was still above 3. The primary outcome was therapeutic success, which was defined as a drop in the Eckardt score to ≤ 3 at the yearly follow-up assessment. The secondary outcomes included the need for retreatment, pressure at the lower esophageal sphincter, esophageal emptying on a timed barium esophagogram, quality of life and the rate of complications. Over a mean follow-up time of 43 months, there was no significant difference between the 2 groups in the primary outcome; the rate of therapeutic success with pneumatic dilation was 90% after 1 year of follow-up and 86% after 2 years, as compared with 93% after 1 year and 90% after 2 years in LHM group (P = 0.46). There was no significant difference in the lower esophageal sphincter pressure (LHM, 10 mmHg; pneumatic dilation, 12 mmHg; P = 0.27); esophageal emptying as assessed by the height of column of barium contrast (LHM, 1.9 cm; pneumatic dilation, 3.7 cm; P = 0.21); or quality of life. Abnormal exposure to esophageal acid was observed in 15% and 23% of the patients in the pneumatic dilation and LHM groups, respectively (P = 0.28). The 2 treatment modalities had comparable adverse events. Perforation of the esophagus occurred in 4% of the patients during pneumatic dilation, whereas mucosal tears occurred in 12% during LHM. The predictors of treatment failure included age under 40, preexisting daily chest pain, esophagus less than 4 cm in width, high degree of contrast retention as evidenced by a column higher than 10 cm shown in after-treatment barium esophagogram. In conclusion, LHM with Dor's fundoplication is not superior to endoscopic pneumatic dilation for the primary treatment for achalasia, at least after a mean follow-up period of 43-month.