Department of Otolaryngology-Head and Neck Surgery, Sunnybrook Research Institute.
Department of Otolaryngology-Head and Neck Surgery, University of Toronto.
Otol Neurotol. 2022 Feb 1;43(2):256-262. doi: 10.1097/MAO.0000000000003404.
Balloon dilation of the eustachian tube is a new therapeutic option for eustachian tube dysfunction. One of the limiting factors of wider adoption of this technique in many parts of the world is the high cost of the devices, in spite of regulatory approval of safety.
Evaluate the performance and usability of standard less-expensive endovascular balloons for eustachian tube dilation in comparison to an approved device in a preclinical study.
Comparative cadaver feasibility study.
University tertiary care facility.
Ten eustachian tube dilations were performed with an approved eustachian tube dilation device. Ten other procedures were carried out with an endovascular balloon of similar dimensions. Cone beam computerized tomography was performed to evaluate the extent of dilation and possible damages. The lumen and mucosal lining were inspected endoscopically post-dilation. Volume measurements were compared before and after the procedure in both groups using contrast enhancement.
All 20 eustachian tube dilations were carried out successfully. No tissue damages could be identified on cone-beam computerized tomography or via endoscopic examination. There was a statistically significant difference of eustachian tube volumes between pre- and post-dilations, with no statistically significant difference between the devices.
Eustachian tube dilation with a less costly endovascular balloon achieved similar results to an approved eustachian tube dilation device. No damages or any other safety concerns were identified in a cadaver study.
球囊扩张咽鼓管是治疗咽鼓管功能障碍的一种新的治疗选择。尽管该技术已获得监管部门批准安全性，但在世界许多地区，由于设备成本高昂，该技术的广泛应用受到限制。
在临床前研究中，评估标准、较廉价的血管内球囊用于咽鼓管扩张的性能和可用性，并与已批准的设备进行比较。
比较尸体可行性研究。
大学三级保健设施。
使用已批准的咽鼓管扩张装置进行 10 次咽鼓管扩张。另外 10 次操作使用具有相似尺寸的血管内球囊进行。进行锥形束计算机断层扫描，以评估扩张的程度和可能的损伤。扩张后通过内窥镜检查检查管腔和黏膜衬里。在两组中均使用对比增强来比较手术前后的容积测量值。
所有 20 次咽鼓管扩张均成功完成。在锥形束计算机断层扫描或内窥镜检查中均未发现组织损伤。与扩张前相比，扩张后咽鼓管的容积有统计学显著差异，但两种设备之间无统计学显著差异。
使用成本较低的血管内球囊进行咽鼓管扩张，可获得与已批准的咽鼓管扩张装置相似的结果。在尸体研究中未发现任何损伤或其他安全问题。
