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)

BackgroundWhen 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.ObjectiveTo evaluate the technical feasibility and safety of a reflux control system (RCS) in distally placed esophageal stents.DesignA prospective case series.SettingTwo tertiary-care referral centers.PatientsThis study involved 10 patients who had an “open” stent placed through the LES and 1 patient with severe bile reflux after esophagojejunostomy.InterventionPlacement of an RCS with fluoroscopic and (in selected cases) endoscopic guidance, from April to October 2010.Main Outcome MeasurementsTechnical success of RCS placement and complications.ResultsPlacement 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 <1 month with the RCS still inside. In 8 patients, the RCS was in place for a median of 134 days (range 33-225 days). Three patients died because of malignant disease progression. Eight RCSs were removed endoscopically, together with the host stent without complications. RCS migration did not occur.LimitationsSmall number of patients, nonrandomized design, lack of pH measurements.ConclusionPlacement of an RCS in a host stent is technically feasible and safe. An RCS can be considered in symptomatic patients with open esophageal stents to prevent gastroesophageal reflux.