Prospective Study of Upper Esophageal Sphincter Assist Device for Treating Extraesophageal Reflux
DOI:
https://doi.org/10.17140/OTLOJ-2-109Keywords:
GERD, Reflux, Extraesophageal reflux (EER), Laryngopharyngeal reflux (LPR)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.
References
Hom C, Vaezi MF. Extraesophageal manifestations of gastro-esophageal reflux disease. Gastroenterol Clin North Am. 2013; 73: 1281-1295. doi: 10.1007/s40265-013-0101-8
Madanick RD. Extraesophageal presentations of GERD: where is the science? Gastroenterol Clin North Am. 2014; 43: 105-120. doi: 10.1016/j.gtc.2013.11.007
Francis DO, Rymer JA, Slaughter JC, et al. High economic burden of caring for patients with suspected extraesophageal reflux. Am J Gastroenterol. 2013; 108: 905-911. doi: 10.1038/ ajg.2013.69
Szczesniak MM, Williams RB, Cook IJ. Mechanisms of esophago-pharyngeal acid regurgitation in human subjects. PLoS One. 2011; 6: e22630. doi: 10.1371/journal.pone.0022630
Szczesniak MM, Williams RB, Brake HM, et al. Upregulation of the esophago-UES relaxation response: a possible pathophys-iological mechanism in suspected reflux laryngitis. Neurogas-troenterol Motil. 2010; 22: 381-386, e89. doi: 10.1111/j.1365- 2982.2009.01452.x
Shaker R, Babaei A, Naini SR. Prevention of esophagopha-ryngeal reflux by augmenting the upper esophageal sphincter pressure barrier. Laryngoscope. 2014; 124: 2268-2274. doi: 10.1002/lary.24735
Belafsky PC, Postma GN, Koufman JA. Validity and reliabil-ity of the reflux symptom index (RSI). J Voice. 2002; 16: 274- 277.
Weaver TE, Laizner AM, Evans LK, et al. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep. 1997; 20: 835-843.
Reichel O, Dressel H, Wiederanders K, et al. Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux. Otolar-yngol Head Neck Surg. 2008; 139: 414-420. doi: 10.1016/j. otohns.2008.06.003
Steward DL, Wilson KM, Kelly DH, et al. Proton pump in-hibitor therapy for chronic laryngo-pharyngitis: a randomized placebo-control trial. Otolaryngol Head Neck Surg. 2004; 131: 342-350. doi: 10.1016/j.otohns.2004.03.037
Groen JN, Smout AJ. Supra-oesophageal manifestations of gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 2003; 15: 1339-1350.
Vaezi MF. Therapy insight: gastroesophageal reflux disease and laryngopharyngeal reflux. Nat Clin Pract Gastroenterol Hepatol. 2005; 2: 595-603. doi: 10.1038/ncpgasthep0358
Jack CI, Calverley PM, Donnelly RJ, et al. Simultaneous tra-cheal and oesophageal pH measurements in asthmatic patients with gastro-oesophageal reflux. Thorax. 1995; 50: 201-204.
Tuchman DN, Boyle JT, Pack AI, et al. Comparison of air-way responses following tracheal or esophageal acidification in the cat. Gastroenterology. 1984; 87: 872-881.
Adhami T, Goldblum JR, Richter JE, et al. The role of gas-tric and duodenal agents in laryngeal injury: an experimental canine model. Am J Gastroenterol. 2004; 99: 2098-2106. doi: 10.1111/j.1572-0241.2004.40170.x
Torrico S, Kern M, Aslam M, et al. Upper esophageal sphinc-ter function during gastroesophageal reflux events revisited. Am J Physiol Gastrointest Liver Physiol. 2000; 279: G262-G267.
Andersen N. Changes in intragastric pressure following the administration of suxamethonium. Preliminary report. Br J An-aesth. 1962; 34: 363-367. doi: 10.1093/bja/34.6.363
Sellick BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961; 2: 404-406. doi: 10.1016/S0140-6736(61)92485-0
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
All content published in Otolaryngology (OOJ) is licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows anyone to copy, distribute, transmit, and adapt the work — including for commercial purposes — provided appropriate credit is given to the original author(s) and source.
