Magnetic Sphincter Augmentation with the LINX Device for Gastroesophageal Reflux Disease after U.S. Food and Drug Administration Approval

Abstract

Magnetic sphincter augmentation (MSA) of the gastroesophageal junction with the LINX Reflux Management System is an alternative to fundoplication for gastroesophageal reflux disease (GERD) that was approved by the U.S. Food and Drug Administration (FDA) in March 2012. This is a prospective observational study of all patients who underwent placement of the LINX at two institutions from April 2012 to December 2013 to evaluate our clinical experience with the LINX device after FDA approval. There were no intraoperative complications and only four mild postoperative morbidities: three urinary retentions and one readmission for dehydration. The mean operative time was 60 minutes (range, 31 to 159 minutes) and mean length of stay was 11 hours (range, 5 to 35 hours). GERD health-related quality-of-life scores were available for 83 per cent of patients with a median follow-up of five months (range, 3 to 14 months) and a median score of four (range, 0 to 26). A total of 76.9 per cent of patients were no longer taking proton pump inhibitors. The most common postoperative complaint was dysphagia, which resolved in 79.1 per cent of patients with a median time to resolution of eight weeks. There were eight patients with persistent dysphagia that required balloon dilation with improvement in symptoms. MSA with LINX is a safe and effective alternative to fundoplication for treatment of GERD. The most common postoperative complaint is mild to moderate dysphagia, which usually resolves within 12 weeks.