Abstract
RefluxStop surgery reconstructs the antireflux barrier without encircling the esophagus, a pioneering mechanism designed to treat gastroesophageal reflux disease (GERD) while reducing adverse events (AEs) like dysphagia. With adoption at multiple clinics throughout Europe, we report the safety data from the largest sample to date (n=602). From 22 participating centers in six European countries, AEs and serious AEs were reported via retrospective analysis with a mean (SD) follow-up of 2 (1.25) years (ranging 2-81 months). The incidence of serious safety events and reoperation was low (1.99% or n=12/602) after RefluxStop surgery and all resolved satisfactorily. Hiatal hernia (HH) recurred in eight (1.33%) cases from total collapse of hiatal repair, successfully managed by straightforward redo hiatal repair after fundus was repositioned with the device intact in the invagination pouch. Asymptomatic penetration in the early postoperative phase occurred in four (0.66%) cases without reoperation needed, with device pieces exited through the digestive tract (one subsequent fundoplication later at 9 months). These cases deemed as learning experience with a too tight invagination pouch (video review). Dilatation for new-onset dysphagia was performed in one patient. No other severe events transpired with frequency >1 in 602 (0.17%), such as postoperative bleeding (short gastric vessels) and improperly closed invagination pouch, all resolved satisfactorily. The RefluxStop Evaluation Group presents an extensive safety analysis in the largest independent RefluxStop study thus far (n=602) with mean 2 years (2 months to 6.75 years) of follow-up. Notwithstanding the learning curve of a new technique (22 centers), inter-surgeon variability, and inclusion of large proportions of patients with esophageal dysmotility and large hiatal hernia, results demonstrate consistently low rates of serious safety events and reoperation (1.99% or n=12/602). Overall, our experience shows vastly consistent and excellent safety with RefluxStop surgical treatment of GERD, even in difficult-to-treat patients.