Abstract
RefluxStop is a novel surgical therapy for gastroesophageal reflux disease (GERD) that reestablishes the angle of His and maintains the lower esophageal sphincter intraabdominally while avoiding esophageal compression or encirclement to minimize adverse effects, such as dysphagia.
Twenty-eight patients underwent surgery (June 2022 - November 2023); their records were reviewed retrospectively. Effectiveness was assessed using GERD-HRQL (GERD Health- Related Quality of Life) scores, GERD-HRQL heartburn and regurgitation subscores, as well as PPI use. Dysphagia, odynophagia, and patient satisfaction were also evaluated.
Patient demographics (n=28) included age 47.5±13.1 years, 67.9% female, BMI 27.3±4.1 kg/m2, hiatal hernia size 3.4±0.8 cm, large hernia (>3 cm) 35.7%, esophagitis grade C 14.3%, and Barrett’s esophagus 3.6%. At a median (IQR) follow-up of 12 (3-12) months, total GERD- HRQL score decreased by 86.7% from 39.1±8.7 at baseline to 5.2±2.7 at follow-up. Median (IQR) total GERD-HRQL score decreased by 90% from a baseline of 40 (30-46.5) to 4 (3.5-8) at follow-up. Heartburn and regurgitation subscores decreased from a median (IQR) of 18 (13-22.5) and 12.5 (10-15) to 2 (1-3) and 2 (0.5-3) at follow-up, respectively, signifying elimination of heartburn and regurgitation in all patients. Ten patients reported dysphagia (score >2) at baseline; all had complete resolution at follow-up (>p>=0.007 chi-squared).
Four patients reported odynophagia (score >2) at baseline; none had odynophagia at follow- up. Satisfaction with treatment was reported in 96.4% of patients. Most (96.4%) patients had been using PPIs preoperatively with 92.9% discontinuing following RefluxStop surgery. No esophageal dilatation, hiatal hernia recurrence, device migration, or reoperation occurred.
RefluxStop surgery provided considerable improvement in GERD symptoms without new- onset dysphagia, a high level of patient satisfaction (96.4%), and allowed for discontinuation of PPIs. Further evaluation is required to validate the excellent safety and effectiveness results depicted in this cohort of 28 patients.
