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

作者：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 Jr; Arriaga Moises A; Leopold John P

来源：Laryngoscope, 2018, 128(5): 1200-1206.

DOI：10.1002/lary.26827

• Eustachian tube dysfunction
• balloon catheter
• normalization of tympanogram

Objectives/HypothesisTo assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study DesignIn 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.
MethodsThe 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.
ResultsPrimary 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.
ConclusionsThis 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.
Level of Evidence1b. Laryngoscope, 128:1200-1206, 2018

• 出版日期2018-5