title: Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.
abstract: OBJECTIVE
  Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device.
  
  
  METHODS
  We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared.
  
  
  RESULTS
  Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years.
  
  
  CONCLUSIONS
  Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.
authors.affiliation: Minnesota Gastroenterology PA, Plymouth, Minnesota. Electronic address: rganz@mngastro.com.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Ganz
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Edmundowicz
authors.affiliation: Knox Regional Heartburn Treatment Center, Mount Vernon, Ohio.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Taiganides
authors.affiliation: 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: Department of Surgery, Mayo Clinic, Jacksonville, Florida.
authors.forename: C Daniel
authors.initials: CD
authors.lastname: Smith
authors.affiliation: Department of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida.
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: DeVault
authors.affiliation: Department of Surgery, University of California at San Diego, San Diego, California.
authors.forename: Santiago
authors.initials: S
authors.lastname: Horgan
authors.affiliation: Department of Surgery, University of California at San Diego, San Diego, California.
authors.forename: Garth
authors.initials: G
authors.lastname: Jacobsen
authors.affiliation: Division of Thoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: James D
authors.initials: JD
authors.lastname: Luketich
authors.affiliation: Southern Reflux Center at Albany Surgical Center, Albany, Georgia.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Smith
authors.affiliation: Department of Gastroenterology, Gundersen Health System, LaCrosse, Wisconsin.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Schlack-Haerer
authors.affiliation: Department of Surgery, Gundersen Health System, LaCrosse, Wisconsin.
authors.forename: Shanu N
authors.initials: SN
authors.lastname: Kothari
authors.affiliation: Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic, Portland, Oregon.
authors.forename: Christy M
authors.initials: CM
authors.lastname: Dunst
authors.affiliation: Department of Surgery, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Watson
authors.affiliation: University Hospitals, Cleveland, Ohio.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Peters
authors.affiliation: Department of Surgery, University of Washington, Seattle, Washington.
authors.forename: Brant K
authors.initials: BK
authors.lastname: Oelschlager
authors.affiliation: Department of Surgery, The Ohio State University, Columbus, Ohio.
authors.forename: Kyle A
authors.initials: KA
authors.lastname: Perry
authors.affiliation: Department of Surgery, The Ohio State University, Columbus, Ohio.
authors.forename: Scott
authors.initials: S
authors.lastname: Melvin
authors.affiliation: Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
authors.affiliation: Division of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: André J P M
authors.initials: AJ
authors.lastname: Smout
authors.affiliation: Division of Surgery, Abbott-Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Dan
authors.initials: D
authors.lastname: Dunn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D005260:Female; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D059346:Magnets; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: Clinical Trial; Heartburn; Hiatal Hernia; Surgery