title: The LINX® reflux management system: confirmed safety and efficacy now at 4 years.
abstract: BACKGROUND
  Sphincter augmentation with the LINX® Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years.
  
  
  METHODS
  In a multicenter, prospective, single-arm study, 44 patients underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction (GEJ). Each patient's baseline GERD status served as the control for evaluations post implant. Long-term efficacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored.
  
  
  RESULTS
  For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years (p < 0.001), with 80 % (18/20) of patients achieving pH normalization (≤ 5.3 %). At ≥ 4 years, 100 % (23/23) of the patients had improved quality-of-life measures for GERD, and 80 % (20/25) had complete cessation of the use of PPIs. There have been no reports of death or long-term device-related complications such as migration or erosion.
  
  
  CONCLUSIONS
  Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.
authors.affiliation: Department of Surgery, University of Southern California, 1510 San Pablo Street, HCC-514, Los Angeles, CA 90033, USA. jlipham@surgery.usc.edu
authors.forename: John C
authors.initials: JC
authors.lastname: Lipham
authors.forename: Tom R
authors.initials: TR
authors.lastname: DeMeester
authors.forename: Robert A
authors.initials: RA
authors.lastname: Ganz
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.forename: Greta
authors.initials: G
authors.lastname: Saino
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Dunn
authors.forename: Paul
authors.initials: P
authors.lastname: Fockens
authors.forename: Willem
authors.initials: W
authors.lastname: Bemelman
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004869:Equipment Safety; D050782:Esophageal pH Monitoring; D004943:Esophagogastric Junction / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D019736:Prostheses and Implants; D011474:Prosthesis Design; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors