Abstract
BACKGROUND: RefluxStop is a unique implant for laparoscopic treatment of gastroesophageal reflux disease (GERD). It restores normal function of the gastroesophageal junction without the unwanted effects of encircling the esophagus, circumventing adverse events (AEs) associated with conventional anti-reflux surgeries. METHODS: Three-year follow-up of 50 patients with chronic GERD treated by RefluxStop was achieved in a prospective, single-arm, multicentric clinical trial analyzing safety and effectiveness of the procedure. RESULTS: The 3-year results included 47 of 50 patients. No cases of device-related AEs, erosion, device migration, or explantation occurred during the entire study period. Two AEs were reported between the 1- and 3-year results (1-year results previously published), including mild dysphagia (n = 1) and heartburn (n = 1). No subjects (n = 0/47) required regular daily proton pump inhibitor (PPI) therapy at 3-year follow-up. Subjects experienced a 93.1% reduction in median total GERD-HRQL score at 3 years (2.0) from baseline (29.5). One subject (n = 1) was dissatisfied with treatment but demonstrated normal 24-h pH monitoring results. Daily regurgitation improved by 97.9% from a baseline of 86% (n = 43/50) to 2.1% (n = 1/47) at follow-up. Dysphagia GERD-HRQL subscore of > 2 (i.e., bothersome everyday) decreased from 22% at baseline to 2% at 3 years. Baseline odynophagia (16%) completely resolved at 3 years. CONCLUSION: RefluxStop surgery treats GERD without encircling and applying pressure on the esophagus. Three-year follow-up demonstrates that the device is safe and effective in treating GERD with substantial improvements in quality of life via GERD-HRQL (median improvement 93%), PPI usage (0%), and 98% without dysphagia.