Prospective Study of Upper Esophageal Sphincter Assist Device for Treating Extraesophageal Reflux

Background: Extraesophageal reflux (EER) is a heterogeneous disease, caused by the regurgitation of gastroduodenal contents into the larynx. The Upper Esophageal Sphincter (UES) Assist Device is a novel medical device designed to prevent gastroduodenal reflux into the laryngopharynx. Objective: A multicenter prospective study assessing safety and effectiveness of the UES Assist Device in patients with EER. Methods: Patients with Reflux Symptom Index (RSI) >13 were enrolled. The device was fit and adjusted to at least 20 mmHg applied external cricoid pressure. The primary effectiveness end-point was reduction in RSI at 4-weeks compared to baseline. 36-Item Short Form Health Survey or SF-36® Health Survey (SF-36), patient and physician satisfaction, and Functional Outcomes of Sleep Questionnaire (FOSQ) were secondary end-points. Safety was based on reported adverse reactions. Results: Eighty-nine of 95 patients completed the study [mean(Standard Deviation (SD)) age=48.8(+/-13.7); mean(SD) Body Mass Index (BMI)=25.5(+/-4.2); 69.5% female, 81.1% Caucasian]. Most common troublesome symptoms included chronic cough (21.3%) and excess mucus/post nasal drip (20.2%). There was a significant (p<0.0001) reduction in median (Intelligence Quotient (IQ)) RSI at 2and 4-weeks [12.5(8.0-20.0) and 10.0(5.8-16.5), respectively] compared to baseline [25.6(21.0-30.0)]. Eighty-two percent (82%) reported improvement greater than 25% with 30.1% having an improvement of 75% or more. 84.7% of patients and 95.2% of providers reported satisfaction. Adverse events were generally mild and transient with no withdrawals due to adverse events. Conclusion: The UES Assist Device is a safe and effective for the treatment of extraesophageal symptoms and may be an alternative for the many patients that do not respond to Proton Pump Inhibitors (PPI) therapy.