The Effects of Endoscopic Fundoplication on Chronic GERD Patients: 12 Month Multicenter Experience: Presidential Poster

Abstract

Purpose: The therapeutic impact of transoral incisionless fundoplication (TIF) performed with EsophyX device on chronic GERD patients was evaluated at 12 month follow-up. Methods: We analyzed 100 consecutive medically refractory GERD patients who underwent TIF because they failed medical management and/or had extra-esophageal manifestation of GERD. These patients are part of a prospective multi-center registry currently underway in 14 centers across the United States. The preoperative evaluation and 12 month follow-up involved physical exam, history, and symptom assessment using 3 disease specific instruments: Gastroesophageal Reflux Disease Health-related Quality of Life (GERD-HRQL), Reflux Symptom Index (RSI) and Gastroesophageal Reflux Symptom Score (GERSS). Other diagnostic assessment included endoscopy, pH-metry and barium swallow. All patients who elected revisional procedure were assigned the worst clinical outcomes observed during the study. Last observation carried forward technique was used to impute missing data points in 4 patients. Changes between baseline and 12 month follow-up were analyzed using appropriate statistical tests. Results: The mean age was 52 years (SD 13.35), BMI was 26.5 (3.92) and 35% were male. The average GERD duration and PPIs use were 10 (6.9) and 8 (5.6) years, respectively There were no intra- or post-operative complications. Six patients were considered failure and underwent revision, 5 laparoscopic Nissen fundoplication and 1 TIF. 75% of patients were completely off PPIs compared to 92% on daily PPIs before TIF, p<0.001. Esophageal acid exposure was normalized or ≥ 50% improved in 10/19 (53%) of patients with available 12 month pH test. The mean GERD-HRQL was significantly reduced from 23.4 (12.6) on PPIs to 6.6 (9.5); p<0.001. The average heartburn and regurgitation scores were also significantly reduced from 16.1 (8.5) and 13.6 (9.4) on PPIs to 4.3 (6.4) and 3.2 (5.9) respectively; p<0.001. Daily bothersome heartburn and regurgitation symptoms were eliminated in 51/79 (65%) and 70/81 (86%) of patients. Atypical symptom resolution was supported by mean RSI score reduction from 19.9 (10.8) to 7.9 (8.6), p<0.001. 15% of patients remained dissatisfied with their current health conditions vs. 80 % before TIF. Two patients reported de novo dysphagia and one reported bloating (scores 0-3). Conclusion: In this study, TIF provided a safe and effective therapeutic option for carefully selected chronic GERD patients with unsatisfactory medical management or patients who elected to discontinue the long term PPIs use. Including 6 revisions, satisfactory long term symptomatic control and improvement in quality of life were achieved. The majority of patients (75%) were completely off PPIs at 12 month follow-up. Disclosure: Dr. Bell - Consultant: EndoGastric Solutions, Dr. Trad - Consultant: Endogastric Solutions. This research was supported by an industry grant. This work was supported in part by a small research grant from EndoGastric Solutions for data collection.