Abstract
Chronic eustachian tube dysfunction is a condition that affects a large number of adults every year. While many cases can be managed pharmacologically, there is a significant portion that does not respond to medical treatment alone. Invasive methods from the aural side like grommet or tympanic tube insertion have complications associated with it and often cannot address the underlying condition of the nasopharyngeal side of the eustachian tube. Balloon eustachian tuboplasty (BET) is a minimally invasive intervention that has been used successfully in countries like Germany and USA in the past decade. This paper presents the experience of a new clinical user of BET in India by retrospectively looking at the outcomes of the first 10 patients on which the procedure was performed. A marketed product EustaCare was used for the cases. There was a 90% procedural success rate within 4 weeks with one patient showing no improvement in symptoms even after 8 weeks. There were no adverse events associated with the procedure nor technical issues with the product. The product is easy to learn and use. Further study is needed to draw any conclusions on long term safety and efficacy, though historical records and preliminary results for this procedure described in this paper seem promising.
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Acknowledgements
The authors acknowledge the support from InnAccel for this study in the form of supply of the device. InnAccel is the manufacturer of the BET device EustaCare. However, the company had no involvement or funding from the company for study execution or any influence on the presented results.
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This is not a sponsored study.
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One author, Pooja Kadambi is employed by the company that makes the product used in this study. However, she did not have anything to do with device usage or data collection, thus there is no conflict of interest.
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This study was conducted as an independent retrospective study. This does constitute as human subject research to the extent that the treating physician and author Dr. Narendran Ramakrishnan had access to patient records. The second author only had access to de-identified patient data.
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Informed consent was gathered from all patients undergoing the procedure including consent to use data towards scientific research and publications.
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Ramakrishnan, N., Kadambi, P. The Use of Balloon Eustachian Tuboplasty in Patients with Eustachian Tube Dysfunction: A Retrospective Pilot Usage Experience. Indian J Otolaryngol Head Neck Surg 72, 392–394 (2020). https://doi.org/10.1007/s12070-020-01822-z
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DOI: https://doi.org/10.1007/s12070-020-01822-z