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Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial

Overview of attention for article published in this source, September 2017
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Title
Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial
DOI 10.1002/lary.26827
Pubmed ID
Authors

Dennis Poe, Vijay Anand, Marc Dean, William H. Roberts, Jose Pablo Stolovitzky, Karen Hoffmann, Nathan E. Nachlas, Joshua P. Light, Mark H. Widick, John P. Sugrue, C. Layton Elliott, Seth I. Rosenberg, Paul Guillory, Neil Brown, Charles A. Syms, Christopher W. Hilton, John T. McElveen, Ameet Singh, Raymond L. Weiss, Moises A. Arriaga, John P. Leopold, Poe, Dennis, Anand, Vijay, Dean, Marc, Roberts, William H., Stolovitzky, Jose Pablo, Hoffmann, Karen, Nachlas, Nathan E., Light, Joshua P., Widick, Mark H., Sugrue, John P., Elliott, C. Layton, Rosenberg, Seth I., Guillory, Paul, Brown, Neil, Syms, Charles A., Hilton, Christopher W., McElveen, John T., Singh, Ameet, Weiss, Raymond L., Arriaga, Moises A., Leopold, John P.

Abstract

To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. 1b Laryngoscope, 2017.

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Mendeley readers

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Geographical breakdown

Country Count As %
Unknown 17 100%

Demographic breakdown

Readers by professional status Count As %
Student > Postgraduate 5 29%
Other 4 24%
Student > Doctoral Student 2 12%
Researcher 2 12%
Professor > Associate Professor 2 12%
Other 2 12%
Readers by discipline Count As %
Medicine and Dentistry 17 100%