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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.

This study aimed to assess the impact of transoral incisionless fundoplication (TIF) on patients with chronic gastroesophageal reflux disease (GERD) at 12-month follow-up.Clinical outcomes of 100 consecutive patients with chronic GERD who underwent TIF between January 2010 and February 2011 were analyzed.There were no major complications reported. Esophageal acid exposure was normalized in 14/27 (52%) of patients who underwent 12-month pH testing. Seventy-four percent of all patients were off proton pump inhibitors versus 92% on daily proton pump inhibitors before TIF, P0.001. Daily bothersome heartburn and regurgitation symptoms were eliminated in 66/85 (78%) and 48/58 (83%) of patients. Median reflux symptom index score was reduced from 20 (0 to 41) to 5 (0 to 44), P0.001. Two patients reported de novo dysphagia and 1 patient reported bloating (scores 0 to 3). Six patients underwent revision; 5 laparoscopic Nissen fundoplication and 1 TIF.TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.

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.

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.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.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; p0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p0.001. 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 (p0.02).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.

Background Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. Methods Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH 13 on PPIs (OR = 2.4, CI = 1.1–5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2–5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9–4.6, p = 0.036) was associated with successful outcomes. Conclusions Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.