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欧斯塔基管气球扩张:对不良事件的全面分析

Tyler B Merrill¹, Vijay A Patel², Christopher Pool³

¹Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.

American journal of rhinology & allergy

|August 28, 2023

概括

欧斯塔基管气球扩张 (ETBD) 通常是安全的,但可能会发生严重的不良事件,如皮下肺气和中风. 意识到这些并发症可以改善患者的咨询和手术决策.

科学领域:

耳鼻喉科耳鼻喉科耳鼻喉科
医疗器械安全医疗器械安全
医疗信息学医疗信息学

背景情况:

尤斯塔基管气球扩张 (ETBD) 在2016年获得FDA批准,用于耐火尤斯塔基管功能障碍.
虽然通常被认为是安全的,但ETBD的并发症概况需要进一步定义.

研究的目的:

使用FDA MAUDE数据库分析与ETBD相关的不良事件 (AE).
为了更好地了解安全概况,并识别ETBD的潜在风险.

主要方法:

对FDA的MAUDE数据库进行了回顾性分析.
与ETBD相关的医疗器械报告 (MDR) 从2012年1月到2022年11月被查询.
16个独特的MDR满足了分析的纳入标准.

主要成果:

大多数报告的事件 (81.3%) 是与患者相关的副作用,而18.8% 是与设备相关的无副作用.
最常见的AE是术后皮下肺 (46.2%).
一种罕见但严重的AE包括手术后中风,这是动脉剖析的次要原因 (6.3%).

结论:

ETBD与有关不良事件有关,包括皮下肺气和中风.
提高对ETBD并发症的认识对于知情的患者同意和手术决策至关重要.
对于未来的研究,建议对ETBD进行标准化报告和中央注册.

关键词:

马德数据库的数据库是什么不良事件是不良事件.气球扩张膨胀气球扩张尤斯塔希安管的功能障碍风险概况风险概况

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