title: Three-year results of a multicenter prospective study of transoral incisionless fundoplication.
abstract: BACKGROUND
  To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting.
  
  
  METHODS
  A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry.
  
  
  RESULTS
  Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years.
  
  
  CONCLUSIONS
  The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.
authors.affiliation: Department of Digestive Endoscopy, Centre Hospitalier Universitaire St Pierre, Brussels, Belgium. vinciane_muls@stpierre-bru.be
authors.forename: Vinciane
authors.initials: V
authors.lastname: Muls
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Eckardt
authors.forename: Michele
authors.initials: M
authors.lastname: Marchese
authors.forename: Boris
authors.initials: B
authors.lastname: Bastens
authors.forename: Michel
authors.initials: M
authors.lastname: Buset
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
authors.forename: Hubert
authors.initials: H
authors.lastname: Louis
authors.forename: Amin
authors.initials: A
authors.lastname: Rajan
authors.forename: Michael A
authors.initials: MA
authors.lastname: Daniel
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D000368:Aged; D050782:Esophageal pH Monitoring; D005260:Female; D018662:Fundoplication / Q000295:instrumentation / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors