Long-term Outcomes of Endoscopic Fundoplication: 2 Year Results From the Prospective Multicenter U.S. Study

Reginald CW Bell, MD, FACS, William E Barnes, MD, FACS, Bart J Carter, MD, FACS, Robert W Sewell, MD, FACS, Peter G Mavrelis, MD, Glenn M Ihde, MD, Kevin M Hoddinott, MD, FACS, Mark A Fox, MD, FACS, Tanja Gunsberger, DO, Mark G Hausmann, MD, FACS, David Dargis, DO, Brian DaCosta Gill, MD, FACS, Erik Wilson, MD, FACS, Karim S Trad, MD, FACS

SurgOne, PC, Englewood, Colorado

Endoscopic fundoplication (EF) is a recognized procedure for the relief of chronic medically-refractory symptoms associated with gastroesophageal reflux disease (GERD). Safety and effectiveness of EF performed with the EsophyX devices have been demonstrated in >25 studies but few studies have reported long-term outcomes. The aim of this study was to prospectively assess long-term outcomes of EF in a multi-center setting.

To date, 33 patients who were enrolled in a multi-center registry completed 2-year follow-up. Clinical assessments, including the objective documentation of GERD such as abnormal esophageal acid exposure or esophagitis, suggested that these patients were appropriate candidates for fundoplication. Outcomes included symptom assessment using three GERD validated instruments [GERD-Health Related Quality of Life (GERD-HRQL), Gastroesophageal Reflux Symptom Scale (GERSS) and Reflux Symptom Index (RSI)], satisfaction with current health conditions, proton-pump inhibitors (PPIs) use, healing of esophagitis and normalization of esophageal acid exposure. Daily bothersome symptoms were considered eliminated if any scores >2 at baseline on each of the GERD-HRQL and RSI questions were ≤2 at 2-year follow-up. The normalization rate was calculated for patients who presented with an abnormal value of interest before EF.

At the time of the procedure, the mean age was 57 (SD 15.1) years, BMI was 26.3 (4.2) and 27% (9/33) were male. Esophagitis was present in 56% (18/33) of patients. The mean duration of GERD was 9.8 (5.6) years. All patients suffered from medically-refractory GERD symptoms while taking daily PPIs for a mean of 8.7 (5.7) years. At 2-year follow-up, 22 patients underwent endoscopy. No denovo esophagitis developed. Esophagitis was eliminated in 89% (8/9) and improved from grade C to grade B in one patient. Hiatal hernia remained the same or was reduced in 65% (11/17) and increased in size in 29% (5/17) of patients. One patient developed denovo hiatal hernia. The mean heartburn and regurgitation scores were reduced from 13.7 (8.0) and 13.5 (8.3) on PPIs to 5.8 (6.2) and 4.3 (5.5) respectively, p<0.001. Daily bothersome heartburn and regurgitation were eliminated in 64% (14/22) and 78% (14/18) of patients. The mean RSI score was reduced from 21.3 (10.8) on PPIs to 9.6 (7.6), p<0.001. Daily bothersome cough and globus sensation were eliminated in 65% (11/17) and 100% (13/13) of patients. The mean GERSS score was reduced from 30.3 (15.8) on PPIs to 12.5 (11.8), p<0.001. Seventy percent (23/33) of patients completely discontinued PPI therapy. The proportion of patients on daily PPI therapy was reduced from 97% (32/33) before to 21% (7/33) after EF, p<0.001. Fifteen percent of patients remained dissatisfied with their current health conditions compared to 93% before EF, p<0.001. Esophageal acid exposure and number of reflux episodes were normalized in 55% (5/9) and 67% (6/9) of patients with comparable pH tests.

According to the present data, the EF with the EsophyX device achieved sustained symptomatic control over a two year period in up to 78% of patients. The need for daily PPIs was eliminated in 79% of patients

Session: Podium Presentation

Program Number: S041

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