Dysphagia, Safety, and Effectiveness of the RefluxStop Procedure in GERD Patients With Ineffective Esophageal Motility (IEM)

Background: Patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM) do not have optimal outcomes today. With standard-of-care antireflux procedures, dysphagia often worsens. RefluxStop treats acid reflux via a novel mechanism without encircling the esophagus. This study assesses dysphagia, safety, and efficacy of the RefluxStop procedure in subjects with IEM for up to 3 years.Methods: Clinical outcomes of RefluxStop in two IEM-GERD cohorts were evaluated retrospectively, in a combined investigator-initiated study at University Inselspital and Hirslanden Clinic Beau-Site in Switzerland. The primary outcome was incidence of dysphagia. The secondary outcomes included improvement in GERD Health-Related Quality of Life (GERD-HRQL), food passageway-related events, and serious procedure- or device-related adverse events (i.e., SAEs, SADEs).Results: Sixty (n=60) subjects with IEM underwent the RefluxStop procedure, with a follow-up ranging between 3-47 months (mean 13 months). Median (Q25-Q75) improvement in GERD-HRQL score was 89% (83-96%) with statistical significance (p<0.001; Wilcoxon test). At last follow-up, 92% of the subjects experienced >50% improvement in GERD-HRQL score. Of the 40 subjects that reached 1-year follow-up, n=14/40 (35%) had dysphagia at baseline, which resolved or improved in 12 subjects and worsened in one. Thus, there is a significant higher likelihood of dysphagia improvement compared to unchanged or worsened status (p=0.013).Conclusions: RefluxStop surgical management for GERD effectively treats subjects with IEM (n=60), who currently have no optimal treatment, while maintaining excellent results for up to 3 years with excellent improvement of GERD-HRQL score (median 89%) and dysphagia (86% resolved or improved at 1 year).