一个皮下植入式心脏转换器-除器系统的后审批研究
Michael R Gold1, Mikhael F El-Chami2, Martin C Burke3
1Medical University of South Carolina, Charleston, South Carolina, USA.
Journal of the American College of Cardiology
|July 26, 2023
概括
皮下植入式心脏转换器-除器 (S-ICD) 是安全有效的长期使用. 这项研究证实了在五年内,在多样化的患者群体中,高冲击疗效和低并发症率.
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:
- 皮下植入式心脏转换器-除器 (S-ICD) 系统是为了减轻与静脉输送相关的风险而开发的.
- 之前的研究表明,S-ICD在选择的患者群体或有限的随访中具有安全性和有效性.
研究的目的:
- 评估S-ICD系统在广泛多样化的患者群体中长期的安全性和有效性.
- 通过现实世界注册机构,评估美国众多植入中心的设备性能.
主要方法:
- 预计将在86个美国中心招募1643名患者,满足标准S-ICD适应症.
- 观察时间长达5年,评估冲击疗效和系统相关并发症的初级终点.
- 利用预先规定的绩效目标来评估安全性和疗效的终点.
主要成果:
- 在心室节律失常方面获得高冲击效率 (98.4%),在整个随访期间保持一致.
- 报告的并发症率较低:93.4%与S-ICD相关,99.3%与电极相关.
- 只有1.6%的患者需要转换为输血植入式心脏转换器-除器 (TV-ICD),以满足节奏需求.
结论:
- 该S-ICD系统审批后研究 (PAS) 满足了所有预先规定的终点,证实了5年的安全性和有效性.
- 在一个庞大,多样化的伴随病症患者队列中,证明了低并发症率和高冲击疗效.
- 支持S-ICD作为一种可行的长期治疗选择,用于广泛的患者.
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