Strong Symptomatic Improvement at 1 Year and Beyond Following Refluxstop Surgery for Gastro-Esophageal Reflux Disease: A 40-Patient Cohortt

Abstract Background Despite well-established medical and surgical options for gastro-esophageal reflux disease (GERD), there remains a high unmet need for a treatment that improves symptoms without adverse effects. Symptoms of bloating, inability to belch or vomit, and dysphagia are among the more common side effects of standard anti-reflux surgery. RefluxStop is a novel device for the treatment of GERD that does not encircle the food passageway to avoid such side effects. The surgical technique is based on restoration of the normal anatomy of the gastroesophageal junction and maintaining the lower esophageal sphincter within the abdomen. Methods This study presents a case series of 40 patients who underwent RefluxStop surgery between July 2021 and November 2022 reaching at least 12 months of follow-up. A retrospective review of medical records was conducted. Baseline GERD Health-Related Quality of Life (GERD-HRQL) score was reported in addition to demographic and clinical characteristics. At follow-up, GERD-HRQL score, patient-reported GERD symptoms, and proton-pump inhibitor (PPI) use were reported. Peri-operative procedure-related and device-related adverse events (AEs) were recorded. Results Baseline patient characteristics are presented in Table 1. Mean follow-up was 14.5 (range 12-19) months. Mean GERD-HRQL score decreased dramatically from 19.5±3.8 at baseline to 1.1±2.2 at follow-up, reflecting a 91.9% improvement. At follow-up, reflux was reported as a symptom in only two patients (5%) (described as mild and occasional in one of them). None reported regurgitation or dysphagia. Only two patients (5%) reported bloating. The necessity for PPI therapy decreased from 97.5% (n=40) at baseline to 2.5% at follow-up. There were no intra-operative AEs or reoperations. Conclusion These data provide real-world evidence on the performance of RefluxStop in clinical practice. In this series of patients, the outcomes at 1 year and beyond indicate excellent effectiveness in reducing or eliminating GERD symptoms, as demonstrated by spontaneously reported symptoms and the validated, disease-specific, quality-of-life questionnaire. The discontinuation of PPI therapy is an additional indicator of effective symptomatic improvement. Importantly, this treatment did not induce dysphagia, a common consequence of established anti-reflux surgical techniques. RefluxStop is a promising option for patients with chronic GERD seeking definitive treatment while minimizing AEs.