Jeffrey L Cutler1, Ted A Meyer2, Shaun A Nguyen2, Ellen M O'Malley3, Lisa Thackeray4, Patrick W Slater5. 1. Colorado Sinus Institute, Denver, Colorado. 2. Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina. 3. Entellus Medical, Inc., Plymouth, Minnesota. 4. North American Science Associates (NAMSA), Minneapolis, Minnesota. 5. Austin Ear Clinic, Austin, Texas.
Abstract
OBJECTIVE: To gather long-term follow-up data on the efficacy of balloon dilation for treating patients with persistent Eustachian tube dysfunction (ETD). STUDY DESIGN: Extended follow-up study of the treatment arm of a prospective, multicenter, randomized controlled trial. SETTING:Tertiary care academic center and private practice. PATIENTS: Patients diagnosed with medically refractory persistent ETD. INTERVENTIONS:Balloon dilation of the Eustachian tube. MAIN OUTCOME MEASURES: The endpoints were the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction. RESULTS: A total of 47 participants enrolled in the extended follow-up study. Mean follow-up was 29.4 months (range, 18-42 mo). There was a statistically significant mean (SD) change from baseline in the overall ETDQ-7 score (-2.5 ± 1.2; p < 0.0001). A reduction of one or more in their overall ETDQ-7 score was observed by 93.6% (44/47) participants. The revision dilation rate was 2.1% (1/47). Among participants with abnormal baseline middle ear assessments, 76.0% had normalized tympanic membrane position (p < 0.0001), 62.5% had normalization of tympanogram type (p < 0.001), and 66.7% had positive Valsalva maneuvers (p < 0.0001). Participant satisfaction was 83.0% at long-term follow-up. CONCLUSIONS:Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.
RCT Entities:
OBJECTIVE: To gather long-term follow-up data on the efficacy of balloon dilation for treating patients with persistent Eustachian tube dysfunction (ETD). STUDY DESIGN: Extended follow-up study of the treatment arm of a prospective, multicenter, randomized controlled trial. SETTING: Tertiary care academic center and private practice. PATIENTS: Patients diagnosed with medically refractory persistent ETD. INTERVENTIONS: Balloon dilation of the Eustachian tube. MAIN OUTCOME MEASURES: The endpoints were the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction. RESULTS: A total of 47 participants enrolled in the extended follow-up study. Mean follow-up was 29.4 months (range, 18-42 mo). There was a statistically significant mean (SD) change from baseline in the overall ETDQ-7 score (-2.5 ± 1.2; p < 0.0001). A reduction of one or more in their overall ETDQ-7 score was observed by 93.6% (44/47) participants. The revision dilation rate was 2.1% (1/47). Among participants with abnormal baseline middle ear assessments, 76.0% had normalized tympanic membrane position (p < 0.0001), 62.5% had normalization of tympanogram type (p < 0.001), and 66.7% had positive Valsalva maneuvers (p < 0.0001). Participant satisfaction was 83.0% at long-term follow-up. CONCLUSIONS: Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.
Authors: Nicholas S Andresen; Jeffrey D Sharon; Carrie L Nieman; Stella M Seal; Bryan K Ward Journal: Laryngoscope Investig Otolaryngol Date: 2021-06-24
Authors: Robert T Standring; Ellen M O'Malley; Joshua B Greene; Joseph L Russell; Edward D McCoul Journal: Laryngoscope Investig Otolaryngol Date: 2021-09-10