Transoral incisionless fundoplication 2.0 procedure using EsophyX™ for gastroesophageal reflux disease.

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.

Conclusion: 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.