Technical feasibility and safety of a new, implantable reflux control system to prevent gastroesophageal reflux in patients with stents placed through the lower esophageal sphincter (with video)

Background When an esophageal stent is placed through the lower esophageal sphincter (LES), gastroesophageal reflux symptoms may persist despite high-dose proton pump inhibitor therapy. A recently developed, short segment, uncovered nitinol stent with a tricuspid-like valve can be placed inside a previously placed esophageal stent. Objective To evaluate the technical feasibility and safety of a reflux control system (RCS) in distally placed esophageal stents. Design A prospective case series. Setting Two tertiary-care referral centers. Patients This study involved 10 patients who had an “open” stent placed through the LES and 1 patient with severe bile reflux after esophagojejunostomy. Intervention Placement of an RCS with fluoroscopic and (in selected cases) endoscopic guidance, from April to October 2010. Main Outcome Measurements Technical success of RCS placement and complications. Results Placement of an RCS was successful on the first attempt in all patients; complete expansion to the wall of the host stent was confirmed by fluoroscopy in all cases. In 3 patients, the host stent migrated in