Prospective Study of Upper Esophageal Sphincter Assist Device for Treating Extraesophageal Reflux
Journal Title: Otolaryngology – Open Journal - Year 2016, Vol 2, Issue 1
Abstract
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 2- and 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.
Authors and Affiliations
Stacey L. Silvers
Keywords
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- EP ID EP548256
- DOI 10.17140/OTLOJ-2-109
- Views 152
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