264. A RETROSPECTIVE CHART REVIEW OF 85 PATIENTS UNDERGOING THE REFLUXSTOP PROCEDURE TO MANAGE GASTROESOPHAGEAL REFLUX DISEASE: SAFETY AND EFFICACY

Abstract

RefluxStop is a novel surgical device that manages gastroesophageal reflux disease (GERD) by restoring the normal structure of the antireflux barrier. This is accomplished by reinstating the acute angle of His and anchoring the gastroesophageal sphincter adequately in the intraabdominal cavity. This study reports the safety and efficacy of 79 patients in the postoperative period. A retrospective chart review was performed on 79 patients that underwent the RefluxStop procedure at a single institution between July 2021 and November 2022 to manage GERD symptoms after informed consent was obtained. Measures were evaluated to assess the feasibility, safety, and clinical outcomes during the follow-up period. 79 patients (age 49.8 ± 14 years), 46 of which were male, had a mean BMI of 25.8 ± 4.5. Associated conditions noted included esophagitis (45.6%), Barrett’s esophagus (17.7%), and hiatal hernia (57%). Hiatal hernias were large in 35% of cases, with an overall average size of 2.9 cm. Baseline symptoms included general GERD symptoms (35.4%), heartburn (29.1%), cough (13.9%), regurgitation (11.4%), retrosternal burning (10.1%), hoarseness (5.1%), abdominal pain or pressure (3.8%), nausea (2.5%), and others. Baseline GERD health-related quality of life (GERD-HRQL) score was 21.5 ± 5.2 and patients were receiving proton pump inhibitors (PPIs) for a mean of 4.7 ± 6.8 years. After surgery (10.7 ± 3.1 months), all subjects experienced significant improvement in GERD-related symptoms including dysphagia. Only 2.5% of patients required use of PPIs and no subjects required postoperative esophageal dilatation or reoperation. Additionally, there were no severe perioperative complications. Postoperatively, the mean GERD-HRQL score was significantly reduced to 1.6 ± 3.2 (92.6% improvement). This study adds to a growing body of evidence that the RefluxStop procedure is safe and effective in management of GERD patients. Notably, a considerable improvement in PPI usage and health-related quality of life parameters were appreciated. Additional studies are required to further validate the role of this procedure in disease management.