A safety and effectiveness evaluation of refluxstop in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up.

Background Standard-of-care surgical treatments for gastroesophageal reflux disease (GERD), with large hiatal hernia (HH), result in a reoperation rate of up to 50% at 5 years. RefluxStop, acting as a mechanical stop without encircling the food passageway, offers a novel approach to treat large HH patients. This study assesses the safety and efficacy of RefluxStop surgery comparing large and small HH groups followed for up to 4 years. Methods Two cohorts were retrospectively analyzed in a combined investigator-initiated study evaluating safety outcomes of RefluxStop in severe GERD subjects, comparing concomitant small (≤3 cm) and large HH (4-10 cm) in Switzerland. Primary outcomes were procedure-related adverse events (AEs/ADEs). The secondary outcome was improvement in GERD-HRQL score. Results Ninety-nine subjects underwent the RefluxStop surgical procedure, whereof 50 subjects had small (≤3 cm) and 49 subjects had large HH (4-10 cm). One surgeon at each site operated on both small and large hernia patients. No significant difference in AEs between patients with small and large HH was shown. At 1-year follow-up, subjects in both groups experienced statistically significant improvements in median (IQR) GERD-HRQL score of 93.8% (81.8%; 98.7%) for those with large HH and 85.7% (76.5%; 92.3%) for those with small HH. Conclusion RefluxStop surgery for GERD effectively treats patients with large HH that currently have no optimal treatment options, while showing significantly improved results for up to 4 years. Furthermore, RefluxStop provides equally favorable results and a robust low risk profile for subjects with either concomitant small (n = 49) and large (n = 50) HH.