Rigiflex Balloon dilation without fluoroscopy for treatment of Achalasia: A long-term follow-up of 99 patients

Abstract: Achalasia is a well- defined esophageal motor disorder. Graded pneumatic dilation using Rigiflex ballon is one of the therapeutic modalities that had not been evaluated in a large long-term study. We aimed at evaluating long-term efficacy of graded Rigiflex pneumatic dilation in the treatment of achalasia. Symptomatic patients with achalasia who had been referred to our center were consecutively enrolled. The diagnosis was established by clinical, radiographic and endoscopic criteria. Exclusion criteria included pregnancy, coagulopathy, serious medical illness or malignancy. Initially all patients were clinically scored based on the severity of five main symptoms and then underwent pneumatic dilation wit at 3 cm ballon. Symptom scores were evaluated at 1, 6, 12. . months. Clinical recurrence was defined as an increase of symptom with 3.5 cm balloon dilation. If recurrence occurred again, third dilation was done with a 4 cm ballon. Over a five-year period, 99 patients [mean age: 35.6 (3.0-72) years.] were followed to an average length of 47.4 (18-20) months. 35 patients needed- retreatment, only 6 of them required third dilation. After third dilation two patients did not reveal improvement and underwent cardiomyotomy. Over this time period, cumulative remission rate was 65% without redilation and 94% with redilation. The mean remission period was 44.7 months (95% CI, 43.52-51.27) for single pneumatic dilation by use of Kaplan- Meier survival analysis. There was no significant predictive value for age, gender, previous treatment and severity of initial score to outcome (P>0.4) by use of Cox regression analysis. Pneumatic dilation by a Rigiflex balloon using a graded approach is effective long-term therapy for achalasia in majority of patients.