725 A Multi-Center Prospective Study of the Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Extraesophageal Reflux

Abstract

Background: Extra-esophageal reflux (EER) is a heterogeneous disorder,caused by reflux of gastroduodenal contents resulting in symptoms such as chronic cough, hoarseness, throat clearing and globus. The cost of caring for EER exceeds $50 billion due predominately to over utilization of proton pump inhibitors (PPI's) which are often not effective. The Upper Esophageal Sphincter (UES) Assist Device is a novel medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. In this multicenter prospective study we aimed to assess efficacy and safety of this device in patients with suspected EER. Methods: Patients with extraesophageal presentations and reflux symptom index (RSI) > 13 were invited to participate in this multicenter study. Predominant presenting symptoms included chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing. The UES assist device, worn at bed-time, was fitted individually and a deviceapplied external cricoid pressure adjusted to above 20 mmHg. Applied cricoid pressure was monitored by external sensors in all subjects to ensure readings above 20 mmHg for study duration. RSI, SF-36, patient and physician satisfaction scores and Functional Outcomes of Sleep Questionnaire (FOSQ) were measured at 2and 4-weeks post enrollment. The study primary effectiveness endpoint was reduction in RSI at 4-weeks from baseline. Intend to treat (ITT) analysis conducted post intervention. Safety was based on reported adverse reactions. Results: 51 patients consented and 47 patients (ITT) completed study protocol in four centers [mean (SD) age=50 (+/-14.2); median (IQR) BMI= 25.8 (23-29); 72% female, 86% Caucasian]. Most common troublesome symptoms included chronic cough (28%), excess mucus/post nasal drip (19%), throat clearing (11%) and hoarseness (11%). There was a significant (p< 0.0001) reduction in median (IQR) RSI at 2and 4-weeks post therapy [14.0 (8.0-20) and 12.0 (7.0-19), respectively] compared to pre-therapy values (27 (21-32) (Figure). Eighty-six percent (86%) of patients reported improvement greater than 25%, The mean (+/-SD) improvement from baseline was 54% (+/-28.1%) with 30% of patients having an improvement of 75% or more. SF36 and FOSQ were unchanged; however, 75% of patients and 92% of providers reported satisfaction with the device. The adverse events reported during the course of the study were generally mild [device technical issues 14% and mild skin irritation (8%)] and there were no study withdrawal due to adverse events. Conclusion: The UES assist device is a safe and effective non-invasive method for the treatment of extraesophageal symptoms. Given poor response to PPI therapy in many such patients this device by serve as a potential alternative for this difficult to treat group of patients.