与角结相关的急性临床不良结果
Konmal Ali1, Syed Shaheer Ali1, Sara Sakowitz1
1Cardiovascular Outcomes Research Laboratories (CORELAB), University of California, Los Angeles, California.
Annals of thoracic surgery short reports
|March 18, 2025
概括
用于心脏外科手术的Cor-Knot设备报告了一些不良事件,包括功能障碍,膜缺陷和出血. 建议增加设备训练,以尽量减少并发症.
科学领域:
- 心血管外科心血管外科
- 医疗器械安全 医疗器械安全
背景情况:
- 在心脏门手术中,手动绑结与手术时间和成本的增加有关.
- 科尔纽特装置提供了使用自动紧固件系统的替代方案.
- 与Cor-Knot设备相关的不良结果以前没有被描述.
研究的目的:
- 为了描述与Cor-Knot设备相关的不良事件.
- 为了确定与Cor-Knot使用相关的并发症的类型和频率.
- 分析导致与Cor-Knot有关的不良事件的因素.
主要方法:
- 通过使用制造商和用户设施设备体验数据库分析了2015-2023年全国代表性的不良事件队列.
- 报告被选,以确定事件类型和并发症.
- 设备和患者并发症被分类并以比例报告.
主要成果:
- 从2015年到2023年,报告的不良事件的增加趋势被观察到.
- 故障 (63.5%) 是最常见的设备事故,通常是由于失火或使用问题.
- 患者的并发症包括膜缺陷 (10.8%),异物存在 (8.1%) 和出血 (2.7%).
结论:
- 功能故障,特别是失火和使用问题,是Cor-Knot设备的主要问题.
- 患者的并发症,如门缺陷,异物存在和出血需要注意.
- 增强的设备训练对于尽量减少不良事件至关重要,因为COR-KNOT的利用量越来越大.
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