Pneumatic balloon dilatation in achalasia: a prospective comparison of safety and efficacy with different balloon diameters

BACKGROUND: Pneumatic dilatation is considered to be the first line therapy for achalasia, but long-term outcome studies are scarce and limited by their retrospective design. There is also no consensus on the optimal method for performing pneumatic dilation as regard to balloon diameter, amount and the rate inflation pressure. AIM: To address these questions in a large long-term prospective study. METHODS: Over a period of 10 years 262 achalasia patients referred to our centre were enrolled. All patients underwent a pre-treatment clinical evaluation and were followed every 6 months. The first 62 patients (group A) underwent dilatation with initial use of a 35 mm balloon with inflation pressure of 10 psi in 10 seconds (s). In group B (200 patients) we initially used a 30 mm balloon with inflation pressure of 10 psi in 30 s. Dilatation was repeated with incrementally larger balloons (35 and 40 mm) in case of relapse. We used rigiflex balloon and maintained pressure for 60 s after inflation in both groups. RESULTS: Three perforations occurred in group A whereas no perforation took place in Group B. The cumulative proportional remission rate with single dilatation in groups A and B decreased from 83 and 75% in 6 months to 60 and 57% after 30 months of therapy respectively, the differences did not reach statistical significance. In patients who had undergone further dilatations the probability of remaining in remission at 1 year after the first and the second dilatation was 38 and 88% in group A, 20 and 89% in group B respectively. The probability of remaining in remission for 2 years increased from 20% after the first dilatation to 70% after the second dilatation. CONCLUSION: Graded pneumatic balloon dilatation with 30 mm diameter and slower rate of balloon inflation is an effective and safe initial method of therapy for achalasia. The duration of remission can be extended by repeated dilatation with larger size balloon.