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.

A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication.

BACKGROUND: This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. STUDY DESIGN: Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up. RESULTS: One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02). CONCLUSIONS: Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.