Tu1761 Extra-Esophageal Symptoms in Patients Undergoing Magnetic Sphincter Augmentation for GERD: Clinical Outcomes At 3 Years

Abstract

BACKGROUND A prospective, multicenter clinical study to evaluate outcomes of patients undergoing anti-reflux surgery included patients with pre-operative extra-esophageal symptoms (EES) as well as heartburn and regurgitation. All patients underwent a laparoscopic procedure to mechanically augment the lower esophageal sphincter (LES) with a magnetic device (LINX Reflux Management System, Torax Medical). METHOD In post-hoc analysis, patients reporting at least one EES prior to implant were identified from a questionnaire administered before surgery. Patients with pre-operative EES were compared to those without EES. Comparisons included demographics, esophageal pH measurements, GERD-Health Related Quality of Life (GERD-HRQL) score, and PPI use. All clinical outcomes were based on 3-year data, with the exception of the esophageal pH, which was collected at 1-year post-implant. RESULTS 100 hundred patients were enrolled in this study. Prior to implant, all patients were taking daily PPIs and had confirmed abnormal esophageal acid exposure. Of the 100 patients, 51% (51/100) reported at least one EES at baseline. Recurrent cough was reported by 37% (37/100), change of voice by 25% (25/100), nocturnal cough by 13% (13/100) and asthma by 11% (11/100). Of the patients with EES, the mean age was 51.3 years and 41% (21/51) were male and 59% (30/51) female. Baseline characteristics for patients with and without EES were statistically non-significant, expect for gender. Females were more likely than males to report pre-operative extra-esophageal symptoms (p=0.03). After implant, the percentage of patients reporting no EES improved to 88% (84/95) at 1 year, 88% (79/90) at 2 years and 90% (78/87) at 3 years compared to 49% (49/100) at baseline. The median total % time pH , 4 improved from 10.2% at baseline to 2.3% at l year in the EES group and 11.6% to 4.2% in the non-EES group, and the median DeMeester score improved from 33.9 to 9.9 in the EES and 41.0 to 16.1 in the non-EES group. The median GERD-HRQL at 3 years was 2 for the EES group and 3 for the non-EES group compared to 26 and 27 before implant off PPIs, respectively. Cessation of PPIs at 3 years was achieved in 84% (38/45) of patients in the EES group compared to 88% (38/43) in the non-EES group. CONCLUSION In this study of a magnetic sphincter device for GERD, the majority of patients reported extra-esophageal symptoms along with typical symptoms such as heartburn and regurgitation at baseline. Following treatment, the number of patients reporting extra-esophageal symptoms decreased from 51% to 10% at 3 years. Improvement in quality of life, reduction in esophageal acid and cessation of PPIs were reported in patients with pre-operative extra-esophageal symptoms. Magnetic Sphincter augmentation appears to be effective in treating this difficult group of patients and deserves further study.