Treating Acid Reflux Without Compressing the Food Passageway: 3-year Outcomes with the RefluxStop Implant

Introduction Recent expert consensus on esophagogastric junction integrity highlights the importance of an acute angle of His, in addition to the crural diaphragm and lower esophageal sphincter [LES]. The RefluxStop procedure for GERD restores angle-of-His anatomy and maintains the intra-abdominal esophagus, without esophageal compression that can cause dysphagia and bloating. Excellent 6-month investigation results led to CE mark approval; long-term results are crucial to establish the role of this device.

Objectives To present the 3-year effectiveness and safety results.

Methods A multicenter study of 50 patients with chronic advanced GERD undergoing RefluxStop surgery (December 2016-September 2017), with annual follow-up.

Primary outcome was the percentage of patients with≥50% reduction in GERD-HRQL. Patients with<50% improvement had additional pH testing and contrast swallow imaging.

Secondary outcomes were reduction in GERD-HRQL score, satisfaction rating, daily PPI usage, and reported regurgitation. Safety outcomes were device- or procedure-related serious adverse events, device migration, and dysphagia/odynophagia scores.

Results GERD-HRQL scores dropped from a median of 29.5 at baseline to 2 at three years, with a median 93.1% reduction and 91.5% (43/47) of patients had≥50% reduction in GERD-HRQL vs baseline. Of the 4 with<50% improvement, 3 had normal pH monitoring; in the patient with abnormal pH result, contrast swallow showed the device positioned too low (as seen postoperatively).

At baseline, most patients (45/50) were dissatisfied, this was reduced to 1/47 patients at 3 years, however, 24-h pH was normal. All patients were taking daily PPIs preoperatively; at 3 years, none were taking regular daily PPIs. Regurgitation was improved in 46/47 patients and were none or minimal in 45/47 patients with 91.5% having no daily regurgitation at year 3.

There were no device-related adverse events or device migration. Between years 1-3, one patient had heartburn (with suboptimal device position). The number of patients reporting a dysphagia score of>2 (bothersome every day) decreased from 22% at baseline to 2% at 3 years. Odynophagia score of>2 in 16% of patients at baseline reduced to 0% at 3 years.

Conclusions The excellent clinical results seen at 6 months and 1 year after RefluxStop implantation were sustained at 3 years: persistently low GERD-HRQL scores, one dissatisfied patient, no daily PPI use, and only one patient with dysphagia.

Publikationsverlauf

Artikel online veröffentlicht:
28. August 2023