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长期跟踪左心室尾排除:V-CLIP多中心营销后研究结果

Elias Zias¹, Katherine G Phillips¹, Marc Gerdisch²

¹Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA.

Journal of clinical medicine

|August 14, 2025

概括

在97%的心脏手术患者中,V形的AtriClip设备实现了完全的左心房附属物排除 (LAAE). 这种上心脏装置在12个月内证明了预防中风风险的安全性和有效性.

科学领域:

心脏病学心脏病学
医疗器械医疗器械
手术创新在外科创新.

背景情况:

心脏手术后的心房会增加血栓栓塞性中风风险,通常与左心房附属体 (LAA) 血栓有关.
完全的外科LAA排除 (LAAE) 对于预防血栓形成至关重要.
脊心器件为LAAE提供了一种最少的侵入性方法.

研究的目的:

为了评估LAAE的上心V形AtriClip装置的长期安全性和性能.
评估12个月内完全LAAE和设备相关不良事件的发生率.

主要方法:

一项前性的多中心后市场研究 (NCT05101993) 涉及155名心脏手术患者.
患者接受了V形AtriClip设备,并接受了12个月的LAA成像随访.
主要终点包括30天内完成LAAE和设备/程序相关的严重不良事件 (SAE).

主要成果:

在97%的患者 (治疗意向人群) 中实现了完整的LAAE.
达到了主要安全性终点,100%的患者在30天内没有预定义的SAE.
一个与设备相关的SAE发生,但在程序内得到解决.

结论:

在心脏手术患者中,V形AtriClip设备证明了安全有效的LAAE.
该设备在12个月的随访期间显示了持续的性能和安全性.
这项研究支持在LAAE治疗上心脏V形AtriClip的使用,以减轻中风风险.

关键词:

这里有AtriClip.心脏外科手术的心脏手术左心房附属体左心房附属体

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