Balloon dilation of the Eustachian tube with a seeker-based device: A registry of 169 patients
| Autor: | Edward D. McCoul, Robert T. Standring, Joshua B. Greene, Joseph L. Russell, Ellen M O'Malley |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
RD1-811 Eustachian tube business.industry Repeated measures design General Medicine Evidence-based medicine Eustachian tube dysfunction Eustachian tube balloon dilation Comprehensive (General) Otolaryngology medicine.anatomical_structure Otorhinolaryngology RF1-547 Internal medicine ETDQ‐7 medicine Balloon dilation Middle ear In patient Surgery business Adverse effect barochallenge Original Research |
| Zdroj: | Laryngoscope Investigative Otolaryngology Laryngoscope Investigative Otolaryngology, Vol 6, Iss 5, Pp 975-982 (2021) |
| ISSN: | 2378-8038 |
| Popis: | Objective To collect real‐world data on the safety and effectiveness of balloon dilation of the Eustachian tube using a seeker‐based device in patients with persistent/chronic symptoms of Eustachian tube dysfunction. Methods A multicenter, prospective, single‐arm registry was conducted from June 2018 through August 2020 at 10 US centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the 7‐item Eustachian Tube Dysfunction Questionnaire (ETDQ‐7) and the serious related adverse event rate. Secondary endpoints include changes in middle ear assessments, surgical intervention rate, and changes in Sino‐Nasal Outcome Test and Work and Activity Impairment (WPAI) questionnaires. Results A total of 169 participants were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6‐week and 6‐month follow‐ups, respectively. Repeated measures analysis of the change in ETDQ‐7 scores indicated statistically significant improvement (−2.1; 95% CI −2.40, −1.84; P The purpose of this current study was to gather effectiveness and safety data for BDET using a seeker‐based device in real‐world settings. We conclude that balloon dilation of the Eustachian tube with a seeker‐based device is a safe and effective procedure to treat ETD symptoms. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|