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Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.

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

Author information

1
Boston Children's Hospital, Boston, Massachusetts.
2
Weill Cornell Medical College, Department of Otolaryngology and Head and Neck Surgery, New York, New York.
3
Texas Healthcare, Fort Worth, Texas.
4
Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.
5
ENT of Georgia, Atlanta, Georgia.
6
Piedmont Ear, Nose and Throat and Related Allergy, Atlanta, Georgia.
7
Nose and Sinus Institute of Boca Raton, Boca Raton, Florida.
8
ENT Associates of South Florida, P.A., Boynton Beach, Florida.
9
ENT Associates of South Florida, Boca Raton, Florida.
10
ENT and Allergy Associates, LLP Department of Otolaryngology, Port Jefferson, New York.
11
Witham Health Services/Memorial Hospital ENT Department, Lebanon, Indiana.
12
Silverstein Institute, Sarasota, Florida.
13
Red River ENT Associates, Alexandria, Louisiana.
14
Meriter/UnityPoint Heathcare, Madison, Wisconsin.
15
University of Texas Health, San Antonio, Department of Otolaryngology, San Antonio, Texas.
16
HealthPartners Medical Group, Department of Otolaryngology Head and Neck Surgery, St. Paul, Minnesota.
17
Carolina Ear and Hearing Clinic, P.C., Department of Otology/ Neurotology, Raleigh, North Carolina.
18
George Washington University Medical Center, Division of Otolaryngology, Department of Surgery, Washington, DC.
19
Sinus Center of the South, Ocean Springs, Mississippi.
20
Louisiana State University, School of Medicine, Department of Otolaryngology and Neurosurgery, New Orleans, Louisiana.
21
Depuy Synthes, Johnson & Johnson Medical Devices Companies, Raynham, Massachusetts, U.S.A.

Abstract

OBJECTIVES/HYPOTHESIS:

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.

STUDY DESIGN:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

LEVEL OF EVIDENCE:

1b. Laryngoscope, 128:1200-1206, 2018.

KEYWORDS:

Eustachian tube dysfunction; balloon catheter; normalization of tympanogram

PMID:
28940574
DOI:
10.1002/lary.26827
[Indexed for MEDLINE]

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