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Abstract
Conclusion: The middle ear pressure changes detected during BET can be directly attributed to the balloon inflation and may represent a second, immediate, mechanism of action of BET. BET seems to be safe with respect to the risk of a barotrauma. Further human studies are now necessary to confirm the results and gain more insight into the mechanism of action of BET.
Objective: Since the introduction of Balloon Eustachian Tuboplasty (BET) as a treatment of chronic Eustachian tube dysfunction, the precise mechanism of action is unknown. Long-term effects of BET may be related to observed microfractures of the Eustachian tube cartilage. However, clinical observations indicate a second, immediate mode of action. Therefore, this study investigated and characterized middle ear pressure changes occurring directly during BET procedure.
Methods: Using a micro-optical pressure sensor, pressure changes during BET were monitored transtympanically in a cadaveric animal study using heathland sheep.
Results: Middle ear pressure amplitudes during BET are dependent on the speed of balloon inflation as well as the maximum inflation pressure. A 10-bar inflation pressure yielded a mean middle ear pressure of 5.34 mmHg (71.0 daPA). Negative pressure amplitudes occurring on withdrawal of the balloon catheter are influenced by the speed of withdrawal. No pressure amplitudes capable of causing barotrauma to membranous ear structures could be detected.
Disclosure statement
Martin Lehmann, Jörg Ebmeyer, and Holger Sudhoff received speaker honoraria as well as financial support for research purposes from Spiggle & Theis GmbH, Overath, Germany. The remaining authors report no conflicts of interest.