442. REFLUXSTOP PROCEDURE AS A NOVEL TECHNIQUE FOR MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE: TWO-YEAR FOLLOW-UP DATA AT A HOSPITAL IN SWITZERLAND

Abstract

Abstract Background RefluxStop is a nonactive implantable medical device that aims to reduce gastroesophageal reflux disease (GERD) symptoms without compression of the food passageway. It restores the normal anatomy of the lower esophageal sphincter, gastroesophageal flap valve, and angle of His. This study presents data from two-year follow-up of patients managed with the RefluxStop procedure at a tertiary level hospital. Methods A total of 45 patients with GERD were treated with RefluxStop between January 2019 and December 2022 at a single institution in Switzerland. Two-year follow-up was recently completed for 20 of these patients. Reported outcome measures include GERD health-related quality of life (GERD-HRQL) score, proton pump inhibitor (PPI) usage, and intra- or postoperative adverse events (AEs). Results Patients were aged 49 ± 13.6 years with a body mass index of 27 ± 2.9 kg/m2. The mean size of hiatal hernia was 2.81 ± 1.97 cm. GERD-HRQL score at baseline was 21 ± 9.28 with two-year postoperative follow-up demonstrating a 85.7% reduction to 3 ± 3.66. All patients showed significant improvement in primary GERD symptoms such as heartburn and regurgitation, with one exception. This patient was converted to Toupet fundoplication but experienced recurrent symptoms. Of the 19 patients managed by RefluxStop, only one patient (5.2%) required use of PPIs for refractory symptoms. Serious AEs were experienced by 3 patients at one-year follow-up, none of which were device-related. Conclusion The effectiveness of RefluxStop as a novel technique to manage GERD was demonstrated by this study. Further investigation via ongoing prospective studies, such as head-to-head trials comparing RefluxStop to fundoplication techniques, are already in preparation.