By Gene Emery
NEW YORK (Reuters Health) May 11 -- Patients with the constricted esophagus of achalasia recover equally well whether doctors use an abruptly inflated balloon to force it open or they perform a Heller's myotomy to cut through esophageal muscle fibers, a new study of 201 volunteers has concluded.
The research, reported in the May 12 New England Journal of Medicine, appears at a time when Heller's is developing a reputation for being the procedure of choice for achalasia.
Every year, about 1 in 100,000 people develop achalasia, in which the sphincter leading to the stomach fails to relax properly during swallowing and the smooth muscle of the esophagus doesn't propel food toward the stomach.
In a randomized trial comparing pneumatic dilation to laparoscopic Heller myotomy, a European team used the 0- to 12-point Eckardt scale to assess symptoms such as weight loss, difficulty swallowing, regurgitation and chest pain.
At the two-year mark, 86% of the 95 patients who received pneumatic balloon dilation were rated a therapeutic success (because their score was 3 or less) compared to 90% of the 106 people treated with laparoscopic Heller's myotomy and Dor's fundoplication (P=0.46).
Pressure at the lower esophageal sphincter pressure was 10 mmHg for Heller's and 12 mmHg for pneumatic dilation (P=0.27).
The dilations were done at least twice because doctors initially tried a 35-mm balloon inflated at a pressure as high as 8 psi for one minute, only to have that produce esophageal perforations in 4 of the first 13 patients. All 13 were excluded from the final analysis.
A 30-mm balloon was subsequently used in the first procedure, followed by a 35-mm balloon 1 to 3 weeks later. If the Eckardt score was still above 3, a third procedure was done using at 40-mm balloon.
The Heller's technique failed in 15 of the 106 patients, and they were treated with dilation.
Dilation failed to provide sufficient relief in 4 patients and 23 had their symptoms return. Seventeen were redilated (6 declined) and redilation didn't work in 5 of the 23, all of whom were referred for surgery.
Twelve percent of the myotomy recipients developed a mucosal tear; 4% in the dilation group had an esophageal perforation.
The risk of failure, regardless of treatment, was 2.8 times more likely among patients with preexisting daily chest pain (P=0.03), 3.5 times more likely with an esophagus less than 4 cm in width (P=0.02) and 1.3 times more likely if an after-treatment barium esophagogram showed a column higher than 10 cm (P=0.01). Age under 40 also increased the risk.
"On the basis of our data, we conclude that LHM (laparoscopic Heller's myotomy) with Dor's fundoplication does not result in rates of therapeutic success that are superior to those with pneumatic dilation for the primary treatment for achalasia, at least after a mean follow-up period of 43 months," the researchers concluded.
In a Journal editorial, Dr. Stuart Jon Spechler of the University of Texas Southwestern Medical Center in Dallas said that if patients can't decide which treatment they would prefer, "my preference is pneumatic dilation, primarily because it is clear what to do if pneumatic dilation eventually fails: perform the surgery. Data on what to do if LHM fails are very limited. The safety and efficacy of rescue pneumatic dilation in this setting are not clear, and esophageal reoperations are notoriously difficult."
"Perhaps," he said, "the road to Heller's myotomy should be paved with good distentions."
The study by the European Achalasia Trial Investigators group was done at 15 centers in five countries.
N Engl J Med 2011; 364:1807-1816.
Reuters Health Information © 2011
Cite this: Common Treatments Found Comparable for Esophageal Achalasia - Medscape - May 11, 2011.