在5年后的随访中,无心脏起器:Micra跨导管起系统在审批后登记
Mikhael F El-Chami1, Christophe Garweg2, Nicolas Clementy3
1Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, Georgia.
European heart journal
|March 1, 2024
概括
迈克拉无心脏起器显示出卓越的长期安全性和有效性. 这项研究发现,与传统的透静脉起器相比,在五年内,主要并发症和系统修订率显著降低.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 电子生理学 电子生理学
背景情况:
- 迈克拉无心脏起器提供了有利的中期安全性和有效性概况.
- 之前,Micra VR无心脏起器的长期现实世界结果是未知的.
研究的目的:
- 通过五年评估Micra VR无心脏起器的更新性能.
- 在现实环境中评估长期的安全性和有效性.
主要方法:
- 全球Micra后审批注册表 (PAR) 的分析,包括1809名患者.
- 评估与系统或程序相关的重大并发症和系统修订率在植入后的60个月内.
- 与使用细灰竞争风险模型的跨静脉心脏起器参考数据集进行比较.
主要成果:
- 在60个月后,主要并发症率为4.5%,明显低于输血系统 (8.5%).
- 60个月后全因系统修订率为4.9%,修订通常是为了升级或提高值.
- 在随访期间,没有报告由于感染而导致的Micra去除.
结论:
- 长期的结果证实了Micra无心脏起器的严重并发症和系统修改率较低.
- 该设备的感染率极低,增强了其安全性.
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