Clinical Outcomes of a New Surgical Treatment for Gastroesophageal Reflux Disease: Retrospective Chart Review of 28 Patients From Germany

Abstract Background Gastroesophageal reflux disease (GERD) is a troublesome gastrointestinal ailment with significant prevalence worldwide. First-line treatment is attempted with proton pump inhibitor (PPI) therapy, but about 40% of patients experience irresponsiveness. Inadequate response, intolerance, or aversion to long-term therapy are indications for anti-reflux surgery. Fundoplication techniques, magnetic sphincter augmentation, and endoscopic techniques are existing surgical options, but are often associated with postoperative complications like dysphagia. The RefluxStop implant is an emerging technology that has demonstrated effectiveness in managing patients with chronic GERD. This report summarizes the clinical outcomes of 28 patients managed with RefluxStop at a German institution. Methods The RefluxStop procedure was performed on 28 patients with chronic GERD in a German center between July 2021 and November 2023. Data was obtained from a retrospective chart review to present the clinical outcomes following RefluxStop surgery, including GERD Health-Related Quality of Life (GERD-HRQL), PPI use, symptom resolution, patient satisfaction, and perioperative adverse events (AEs). Results Twenty-eight patients were followed for 14.1±4.7 months. Baseline patient characteristics are shown in Table 1. Median GERD-HRQL score decreased by 90% from a baseline of 40 (IQR 17) to 4 (IQR 5) at follow-up. PPI use decreased from 96.4% at baseline to 7.1% at follow-up. Almost 93% of reflux symptoms were eliminated. Only one patient (3.6%) was not satisfied with treatment. All patients with dysphagia at baseline (42.9%) experienced complete resolution. No reoperations or esophageal dilations were required. Seven patients experienced minor intraoperative AEs (e.g., neck emphysema) but none were procedure- or device-related. Conclusion This cohort of GERD patients in Germany demonstrated the safety and effectiveness of the RefluxStop procedure. Significant improvements in quality of life, PPI use, and reflux-related symptoms were observed without consequential safety concerns for over one year. Furthermore, this study corroborates the existing evidence of favorable postoperative safety outcomes associated with RefluxStop. Additional study is necessary to continue validation of this promising new treatment option.