title: Esophageal sphincter device for gastroesophageal reflux disease.
abstract: BACKGROUND
  Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter.
  
  
  METHODS
  We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported.
  
  
  RESULTS
  The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed.
  
  
  CONCLUSIONS
  In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.).
authors: Minnesota Gastroenterology, Plymouth, Minnesota 55446, USA.
authors: Robert A
authors: RA
authors: Ganz
authors: Jeffrey H
authors: JH
authors: Peters
authors: Santiago
authors: S
authors: Horgan
authors: Willem A
authors: WA
authors: Bemelman
authors: Christy M
authors: CM
authors: Dunst
authors: Steven A
authors: SA
authors: Edmundowicz
authors: John C
authors: JC
authors: Lipham
authors: James D
authors: JD
authors: Luketich
authors: W Scott
authors: WS
authors: Melvin
authors: Brant K
authors: BK
authors: Oelschlager
authors: Steven C
authors: SC
authors: Schlack-Haerer
authors: C Daniel
authors: CD
authors: Smith
authors: Christopher C
authors: CC
authors: Smith
authors: Dan
authors: D
authors: Dunn
authors: Paul A
authors: PA
authors: Taiganides
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003680:Deglutition Disorders / Q000209:etiology; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D004941:Esophagitis / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D059346:Magnets; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D011474:Prosthesis Design; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors