title: Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement.
abstract: BACKGROUND
  As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here.
  
  
  METHODS
  A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated.
  
  
  RESULTS
  Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point.
  
  
  CONCLUSIONS
  Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.
authors.affiliation: 1 Division of General Surgery, IRCCS Policlinico San Donato, University of Milan Medical School , Milan, Italy .
authors.forename: Greta
authors.initials: G
authors.lastname: Saino
authors.affiliation: 1 Division of General Surgery, IRCCS Policlinico San Donato, University of Milan Medical School , Milan, Italy .
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.affiliation: 2 Department of Surgery, Keck School of Medicine, University of Southern California , Los Angeles, California.
authors.forename: John C
authors.initials: JC
authors.lastname: Lipham
authors.affiliation: 3 Division of Surgery, Abbot Northwestern Hospital , Minneapolis, Minnesota.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dunn
authors.affiliation: 4 Minnesota Gastroenterology PA, Plymouth, Minnesota.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Ganz
mesh_terms: D000328:Adult; D000368:Aged; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D050782:Esophageal pH Monitoring; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D059346:Magnets; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D011795:Surveys and Questionnaires; D063189:Symptom Assessment; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors