Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study.

The aim of this study was to assess prospectively 2-year outcomes of transoral incisionless fundoplication (TIF) in a multicenter setting. A 14-center U.S. registry was designed to evaluate the effects of the TIF 2.0 procedure on chronic gastroesophageal reflux disease (GERD) in over 100 patients. Primary outcome was symptom assessment. Secondary outcomes were proton pump inhibitor (PPI) use, degree of esophagitis, safety, and changes in esophageal acid exposure. One hundred twenty-seven patients underwent TIF between January 2010 and April 2011, 19 (15%) of whom were lost to follow-up. Eight patients undergoing revisional surgery were included, as failures, in the 108 remaining patients. No serious adverse events were reported. GERD Health-related Quality of Life and regurgitation scores improved by 50 per cent or greater in 63 of 96 (66%) and 62 of 88 (70%) patients who had elevated preoperative scores. The Reflux Symptom Index score normalized in 53 of 82 (65%) patients. Daily PPI use decreased from 91 to 29 per cent. In patients amenable to postoperative testing, esophagitis healed in 12 of 16 (75%) and esophageal acid exposure normalized in eight of 14 (57%). TIF safely achieved sustained symptomatic control over a 2-year period in two-thirds of patients with a virtual absence of de novo side effects.