title: Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study.
abstract: BACKGROUND
  Transoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI).
  
  
  METHODS
  Fifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation.
  
  
  RESULTS
  Patients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4% of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill's grade I of the newly created valve persisted in all pre-procedure Hill's grade I patients, in 66.7% of grade II and 58.3% of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill's grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01).
  
  
  CONCLUSIONS
  TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75-80% of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.
authors.affiliation: Unit of Gastroenterology and Gastrointestinal Endoscopy, Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute - Vita-Salute San Raffaele University, Milan, Italy, testoni.pieralberto@hsr.it.
authors.forename: Pier Alberto
authors.initials: PA
authors.lastname: Testoni
authors.forename: Sabrina
authors.initials: S
authors.lastname: Testoni
authors.forename: Giorgia
authors.initials: G
authors.lastname: Mazzoleni
authors.forename: Cristian
authors.initials: C
authors.lastname: Vailati
authors.forename: Sandro
authors.initials: S
authors.lastname: Passaretti
mesh_terms: D000328:Adult; D050782:Esophageal pH Monitoring; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000295:instrumentation / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008365:Manometry / Q000379:methods; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors