Akil Kaderbay1, Alexandre Karkas2, David Schmitt3, Thibault Mura4, Jean Pierre Lavieille5, Frédéric Venail3,6. 1. Oto-Rhino-Laryngology-Head and Neck Surgery Department, Montpellier University, CHU Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier, France. a-kaderbay@chu-montpellier.fr. 2. Oto-Rhino-Laryngology, Head and Neck Surgery Department, Saint-Etienne University, Hôpital Nord, Saint Etienne, France. 3. Oto-Rhino-Laryngology-Head and Neck Surgery Department, Montpellier University, CHU Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier, France. 4. Medical Information Department, Montpellier University, CHU La Colombière, Montpellier, France. 5. Oto-Rhino-Laryngology-Head and Neck Surgery Department, Aix-Marseille University, Assistance Publique des Hôpitaux de Marseille, Marseille, France. 6. Neurosciences Institute of Montpellier, INSERM U1298 and Montpellier University, Montpellier, France.
Abstract
PURPOSE: Balloon dilatation of the Eustachian tube (BDET) is an option for treating chronic obstructive Eustachian tube dysfunction (COETD). In this prospective multicentric study, the main objective was to evaluate the results of BDET in unilateral COETD refractory to medical treatment. METHODS: Adults with unilateral COETD whose Eustachian Tube Score (ETS) was less than 5 despite medical pressure therapy were included. The primary endpoint was the change in ETS measured at 2, 6, and 12 months after BDET. Secondary objectives were the evolution of clinical symptoms assessed by the Eustachian Tube Questionnaire (ETDQ-7), audiometry, tympanometry, and otoscopy changes after BDET. RESULTS: Twenty-eight patients were included between May 2014 and December 2017 and were treated with BDET without adverse effects in three different referral centers. Population's median age was 52 (Q25; Q75: 24, 82) years. The median follow-up time was 381 (Q25; Q75: 364; 418) days. The median ETS was 2 (Q25; Q75: 1; 4) before BDET. There was a significant improvement in ETS at 2 and 6 months and 1 year after BDET (score at 1 year: 6 (Q25; Q75: 2; 8) (p < 0.0001)). There was a significant, sustained improvement in the ETDQ-7 with a score of 4.21 (Q25; Q75-3.50; 4.79) before BDET and 3.43 (Q25; Q75-2.43; 4.14) (p = 0.0012) at 1 year. There was a suggestive improvement in tympanometry results at 1 year (p = 0.025). CONCLUSION: BDET provides an improvement in symptoms and objective measures assessed at 1 year in patients with COETD who have failed medical treatment. TRIAL REGISTRATION: NCT02123277 (April 25, 2014).
PURPOSE: Balloon dilatation of the Eustachian tube (BDET) is an option for treating chronic obstructive Eustachian tube dysfunction (COETD). In this prospective multicentric study, the main objective was to evaluate the results of BDET in unilateral COETD refractory to medical treatment. METHODS: Adults with unilateral COETD whose Eustachian Tube Score (ETS) was less than 5 despite medical pressure therapy were included. The primary endpoint was the change in ETS measured at 2, 6, and 12 months after BDET. Secondary objectives were the evolution of clinical symptoms assessed by the Eustachian Tube Questionnaire (ETDQ-7), audiometry, tympanometry, and otoscopy changes after BDET. RESULTS: Twenty-eight patients were included between May 2014 and December 2017 and were treated with BDET without adverse effects in three different referral centers. Population's median age was 52 (Q25; Q75: 24, 82) years. The median follow-up time was 381 (Q25; Q75: 364; 418) days. The median ETS was 2 (Q25; Q75: 1; 4) before BDET. There was a significant improvement in ETS at 2 and 6 months and 1 year after BDET (score at 1 year: 6 (Q25; Q75: 2; 8) (p < 0.0001)). There was a significant, sustained improvement in the ETDQ-7 with a score of 4.21 (Q25; Q75-3.50; 4.79) before BDET and 3.43 (Q25; Q75-2.43; 4.14) (p = 0.0012) at 1 year. There was a suggestive improvement in tympanometry results at 1 year (p = 0.025). CONCLUSION: BDET provides an improvement in symptoms and objective measures assessed at 1 year in patients with COETD who have failed medical treatment. TRIAL REGISTRATION: NCT02123277 (April 25, 2014).
Authors: Harman S Parhar; Robert M Brody; David Shimunov; Karthik Rajasekaran; Christopher H Rassekh; Devraj Basu; Bert W O'Malley; Ara A Chalian; Jason G Newman; Laurie Loevner; Jillian W Lazor; Gregory S Weinstein; Steven B Cannady Journal: Laryngoscope Date: 2020-07-04 Impact factor: 3.325