A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up

Ted A Meyer, Ellen M O'Malley, Rodney J Schlosser, Zachary M Soler, Jason Cai, Mark J Hoy, Patrick W Slater, Jeffrey L Cutler, Roger J Simpson, Michael J Clark, Habib G Rizk, Theodore R McRackan, Christopher F D'Esposito, Shaun A Nguyen, Ted A Meyer, Ellen M O'Malley, Rodney J Schlosser, Zachary M Soler, Jason Cai, Mark J Hoy, Patrick W Slater, Jeffrey L Cutler, Roger J Simpson, Michael J Clark, Habib G Rizk, Theodore R McRackan, Christopher F D'Esposito, Shaun A Nguyen

Abstract

Objective: Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD).

Study design: Prospective, multicenter, randomized controlled trial.

Setting: Tertiary care academic center and private practice.

Patients: Diagnosed with medically refractory persistent ETD.

Interventions: 1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted.

Main outcome measures: Primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate.

Results: Sixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was -2.9 (1.4) for balloon dilation compared with -0.6 (1.0) for control: balloon dilation was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation.

Conclusions: Balloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.

Figures

FIG. 1
FIG. 1
Participant flow diagram through 12-month follow-up.
FIG. 2
FIG. 2
Primary efficacy endpoint: change in mean overall ETDQ-7 scores at 6 weeks by randomized treatment arm. P value is based on a one-sided, two-sample Student's t test comparing change from baseline between randomized arms with p < 0.025 indicating statistical significance. The change from baseline (Δ) is presented as the mean ± standard deviation. ETDQ-7 indicates 7-item Eustachian Tube Dysfunction Questionnaire.
FIG. 3
FIG. 3
Mean overall ETDQ-7 scores over time for all participants undergoing Eustachian tube balloon dilation (randomized or crossover). P values are based on the mixed effects model of repeated measures (MMRM) analysis for the comparison between baseline and each follow-up visit. Error bars indicate standard deviations. ETDQ-7 scores of 1 to 2 indicate no to mild symptoms, 3 to 5 indicate moderate symptoms, and 6 to 7 indicate severe symptoms. ETDQ-7 indicates 7-item Eustachian Tube Dysfunction Questionnaire.

References

    1. Poe DS, Hanna BMN. Balloon dilation of the cartilaginous portion of the Eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol 2011; 32:115–123.
    1. Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilation Eustachian tuboplasty: a feasibility study. Otol Neurotol 2010; 31:1100–1103.
    1. McCoul ED, Singh A, Anand VK, Tabaee A. Balloon dilation of the eustachian tube in a cadaver model: technical considerations, learning curve, and potential barriers. Laryngoscope 2012; 122:718–723.
    1. Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff H. Balloon dilatation Eustachian tuboplasty: a clinical study. Laryngoscope 2010; 120:1411–1416.
    1. Poe DS, Silvola J, Pyykko I. Balloon dilation of the cartilaginous Eustachian tube. Otolaryngol Head Neck Surg 2011; 144:563–569.
    1. Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of the Eustachian tube: a preliminary study. Otol Neurol 2012; 35:1549–1552.
    1. McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol 2012; 2:191–198.
    1. Silvola J, Kivekas I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg 2014; 151:125–130.
    1. Wanscher JH, Svane Knudsen V. Promising results after balloon dilatation of the Eustachian tube for obstructive dysfunction. Dan Med J 2014; 61:A4818–A4822.
    1. Bowles PF, Agrawal S, Salam MA. Balloon tuboplasty in patients with Eustachian tube dysfunction: a prospective study in 30 patients (55 ears). Clin Otolaryngol 2017; 42:908–911.
    1. Luukkainen V, Kivekas I, Hammaren-Malmi S, et al. Balloon Eustachian tuboplasty under local anesthesia: is it feasible? Laryngoscope 2017; 127:1021–1025.
    1. Poe D, Anand V, Dean M, et al. Balloon dilation of the Eustachian tube for dilatory dysfunction: a randomized controlled trial. Laryngoscope 2018; 128:1200–1206.
    1. McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of Eustachian tube dysfunction: the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope 2012; 122:1137–1141.
    1. Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol 2013; 3:404–411.
    1. Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope 2016; 126:44–50.

Source: PubMed

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