title: Transoral incisionless fundoplication (TIF 2.0) with EsophyX for gastroesophageal reflux disease: long-term results and findings affecting outcome.
abstract: BACKGROUND
  Transoral incisionless fundoplication (TIF) with the EsophyX(™) device is reported to be effective for creating a continent gastroesophageal valve and for good functional results, as measured by pH impedance in patients with gastroesophageal reflux disease (GERD). The aim of this study is to assess the long-term effect of TIF in patients with symptomatic GERD.
  
  
  METHODS
  TIF 2.0 fundoplication was done in 42 consecutive patients. All were studied with GERD-HRQL and GERD-QUAL questionnaires, upper gastrointestinal (GI) endoscopy, esophageal manometry, and 24 h pH impedance before and at 6, 12, and 24 months after TIF.
  
  
  RESULTS
  In all, 35 patients completed 6-month follow-up; 21 (60.0%) completely stopped proton pump inhibitor (PPI) therapy, 6 (17.1%) more than halved it, and 8 (22.9%) continued with the same dose as before the procedure. There were 26 patients with complete 24-month follow-up; 11 (42.3%) completely stopped PPI therapy, 7 (26.9%) more than halved it, and 8 (30.8%) were taking the same dose as before the procedure. Hiatal hernia and ineffective esophageal motility seemed to raise the risk of recurrence of symptoms (p = 0.02 and p < 0.001, respectively). The number of fasteners deployed during TIF was the only factor predictive of successful outcome (p = 0.018).
  
  
  CONCLUSIONS
  TIF using the EsophyX device allowed withdrawal or reduction of PPI in about 77% of patients at 6-month follow-up and about 69% at 24 months. Larger number of fasteners deployed during TIF was predictive of positive outcome; pre-TIF ineffective esophageal motility and hiatal hernia raised the risk of recurrence of GERD symptoms, but were not significant from a prospective point of view.
authors.affiliation: Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milan, Italy. testoni.pieralberto@hsr.it
authors.forename: Pier Alberto
authors.initials: PA
authors.lastname: Testoni
authors.forename: Cristian
authors.initials: C
authors.lastname: Vailati
authors.forename: Sabrina
authors.initials: S
authors.lastname: Testoni
authors.forename: Maura
authors.initials: M
authors.lastname: Corsetti
mesh_terms: D000328:Adult; D004941:Esophagitis / Q000209:etiology; D004945:Esophagoscopy / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000295:instrumentation* / Q000379:methods; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000601:surgery*; D006551:Hernia, Hiatal / Q000209:etiology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome