RefluxStop – A Novel Device to Address Gastroesophageal Reflux Disease in the Context of Esophageal Hypomotility

Abstract

Abstract Background RefluxStop is a non-active, implantable medical device intended to reduce esophageal acid exposure in patients with gastroesophageal reflux disease (GERD). RefluxStop does not affect the esophageal lumen and thus might also be suited for patients with esophageal hypomotility. Aims To report short-/midterm functional outcomes after implantation of RefluxStop. Methods All patients who received laparoscopic implantation of the RefluxStop device from 09/2018-12/2022 in a university hospital were included for retrospective analysis. Subjective (GERD-HRQL-questionnaires; after six weeks and every six-month thereof) and objective data (24h-pH-manometry, barium swallows and upper endoscopies) are reported as functional outcome parameters. Results Forty-five patients were included. Median age was 49.3y (min 28.1– max 76.8), median Body Mass Index 28kg/m2 (19-34), and 21 patients were female (46.7%). Nine patients (20%) had esophagitis Los Angeles grade C or more, 3 had non-acidic reflux (7%), and 32 (71%) had esophageal motility disorders. Primary presenting symptoms were typical in 31(69%), pain or dysphagia in 5(11%), respiratory in 8(18%) and nausea in 1 patient (2%). GERD-HRQL score was significantly reduced from baseline to 6 weeks postop (23.9 and 4.3 (p < 0.001)) and to last follow-up (6.8, p = 0.021). In the last follow-up, after a median of 3.2y, primary presenting symptoms were gone in 31(69%), improved in 6(13%), and stayed the same in 2(4%). Typical symptoms were gone or improved in 34 of 37 patients (92%), dysphagia and pain in 12 of 15 patients (80%), and respiratory symptoms in all of 14 patients. De novo bloating occurred in 1 patient and was improved or gone in 5 patients; no diarrhea was seen. Conclusions RefluxStop shows promising results over four years in a challenging patient population burdened with GERD and esophageal motility disorders.