Long-Term Preclinical Evaluation of a Permanent Stent Developed for the Human Eustachian Tube

Autor: Katharina Schmitt, Malena Timm, Philipp Krüger, Niels Oppel, Alexandra Napp, Friederike Pohl, Robert Schuon, Andreas Kampmann, Lisa Kötter, Marion Bankstahl, Thomas Lenarz, Tobias Stein, Gerrit Paasche
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Bioengineering, Vol 11, Iss 8, p 755 (2024)
Druh dokumentu: article
ISSN: 2306-5354
DOI: 10.3390/bioengineering11080755
Popis: The Eustachian tube (ET) is a bottleneck when it comes to middle ear (ME) health. If its function is impaired, this can lead to serious consequences for the patient, such as hearing problems or deafness. Therefore, this study investigated a tapered nitinol stent (3–5 mm × 14 mm) for the human ET as a potential new permanent treatment for chronic Eustachian tube dysfunction (ETD) and thus ME ventilation disorders. The self-expanding stent was inserted unilaterally into the ET of 24 sheep with observation periods of 3, 6, and 12 months. Local tissue effects and the safety of the stent insertion were analyzed based on regular endoscopic checks, weekly tympanometry measurements, final imaging, and histological examinations. The animals showed no stent-related health restrictions. However, the individual anatomy and stenting procedure had an influence on the results. The tissue reaction in the endoscopic examinations was mild even though no concomitant antibiotics were administered. After all three monitoring periods, stented ETs had a significantly larger ET lumen than the non-stented contralateral ETs. However, tissue growth was detected in the stent. Overall, the first long-term study on an ET stent showed that the tapered ET stent could be a promising treatment option for ETD.
Databáze: Directory of Open Access Journals
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