Title

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group

Document Type

Journal Article

Publication Date

4-1-2019

Journal

Otolaryngology - Head and Neck Surgery (United States)

Volume

160

Issue

4

DOI

10.1177/0194599818821938

Keywords

balloon catheter; eustachian tube dysfunction; normalization of tympanogram

Abstract

Objective: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. Study Design: Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. Setting: Twenty-one investigational sites across the United States. Subjects and Methods: Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. Results: Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire–7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). Conclusions: The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

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