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Balloon dilation of the eustachian tube in a cadaver model: Technical considerations, learning curve, and potential barriers

Authors


  • Support for research facilities and materials provided by Acclarent, Inc., Menlo Park, California. Each coauthor received a one-time honorarium as a consultant to Acclarent, Inc. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

Objectives/Hypothesis:

The surgical management options for eustachian tube dysfunction have historically been limited. The goal of the current study was to evaluate the technical considerations, learning curve, and potential barriers for balloon dilation of the eustachian tube (BDET) as an alternative treatment modality.

Study Design:

Prospective preclinical trial of BDET in a cadaver model.

Methods:

A novel balloon catheter device was used for eustachian tube dilation. Twenty-four BDET procedures were performed by three independent rhinologists with no prior experience with the procedure (eight procedures per surgeon). The duration and number of attempts of the individual steps and overall procedure were recorded. Endoscopic examination of the eustachian tube was performed after each procedure, and the surgeon was asked to rate the subjective difficulty on a five-point scale.

Results:

Successful completion of the procedure occurred in each case. The overall mean duration of the procedure was 284 seconds, and a mean number of 1.15 attempts were necessary to perform the individual steps. The mean subjective procedure difficulty was noted as somewhat easy. Statistically shorter duration and subjectively easier procedure were noted in the second compared to the first half of the series, indicating a favorable learning curve. Linear fissuring within the eustachian tube lumen without submucosal disruption (nine procedures, 37%) and with submucosal disruption (five procedures, 21%) were noted. The significance of these physical findings is unclear.

Conclusions:

Preclinical testing of BDET is associated with favorable duration, learning curve, and overall ease of completion. Clinical trials are necessary to evaluate safety and efficacy. Laryngoscope, 2012

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