title: Transoral incisionless fundoplication 2.0 procedure using EsophyX™ for gastroesophageal reflux disease.
abstract: BACKGROUND
  Transoral incisionless fundoplication (TIF) using the EsophyX™ system has been introduced as a possible alternative for the treatment of gastroesophageal reflux disease (GERD). The efficacy of this procedure in our centers was evaluated.
  
  
  METHODS
  Patients were selected for treatment if they had typical GERD symptoms, failed management with proton pump inhibitors (PPIs), a positive esophageal pH test with symptom correlation, and no hiatus hernia larger than 2 cm.
  
  
  RESULTS
  Nineteen patients (11 men, 8 women) underwent the TIF procedure between April 2008 and July 2009. Mean age was 48.2 years and body mass index was 24.6. The major complication rate was 3/19, including esophageal perforation, hemorrhage requiring transfusion, and permanent numbness of tongue. At mean 10.8 months follow-up, 5/19 had completely discontinued PPIs, and 3/19 had decreased their PPI dose. However, 10/19 had been converted to laparoscopic fundoplication for recurrent reflux symptoms and an endoscopically confirmed failed valve. Nine of 17 were dissatisfied with the outcome, and eight were satisfied. Thirteen of 19 (68%) were considered to have been unsuccessful.
  
  
  CONCLUSIONS
  At short-term follow-up, the TIF procedure is associated with an excessive early symptomatic failure rate, and a high surgical re-intervention rate. This procedure should not be performed outside of a clinical trial.
authors.affiliation: Division of Thoracic and Foregut Surgery, The Heart, Lung and Esophageal Surgery Institute, Shadyside Medical Center, University of Pittsburgh Medical Center, Suite 715, 5200 Centre Avenue, Pittsburgh, PA 15232, USA.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Hoppo
authors.forename: Arul
authors.initials: A
authors.lastname: Immanuel
authors.forename: Matthew
authors.initials: M
authors.lastname: Schuchert
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Dubrava
authors.forename: Andrew
authors.initials: A
authors.lastname: Smith
authors.forename: Peter
authors.initials: P
authors.lastname: Nottle
authors.forename: David I
authors.initials: DI
authors.lastname: Watson
authors.forename: Blair A
authors.initials: BA
authors.lastname: Jobe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D018662:Fundoplication / Q000295:instrumentation* / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth