全磁离心左心室辅助装置和长期结果:ELEVATE注册表
Jan D Schmitto1, Steven Shaw2, Jens Garbade3
1Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, OE 6210, Carl-Neuberg-Str. 1, Hannover 30625, Germany.
European heart journal
|November 30, 2023
概括
在初级植入物患者中,ELEVATE注册表显示HeartMate 3 (HM3) 连续流动左心室辅助器件的存活率为63.3%. 现实数据显示,5年后生活质量和功能能力有所改善.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 心脏衰竭管理的管理
背景情况:
- 心脏Mate 3 (HM3) 是一个完全磁悬浮的连续流动左心室辅助装置.
- ELEVATE注册表的建立是为了收集2015年CE标志批准后对HM3设备结果的现实数据.
研究的目的:
- 为了评估用HeartMate 3设备治疗的患者的现实世界结果.
- 评估接受HM3.3的患者的生存率,不良事件,生活质量和功能能力.
主要方法:
- 在2015年3月至2017年2月期间植入HM3的540名患者的注册表.
- 分析包括463名患者的初级植入组 (PIC),交换队列 (19名患者) 和匿名队列 (58名患者) 的生存数据.
- 收集的数据包括人口统计,生存率,不良事件,生活质量 (EuroQoL-5维度-5级视觉模拟尺度) 和功能能力 (6分钟步行距离).
主要成果:
- 主要植入组 (PIC) 患者的平均年龄为56岁,主要是男性 (89%),其中48%患有缺血病.
- 在基线,PIC患者表现出功能能力低下 (104 ± 140 m) 和生活质量受损 (35 ± 19 分).
- 在5年后,PIC的整体生存率为63.3%,无中风生存率为58.1%. 功能能力 (301 ± 131 m) 和生活质量 (64 ± 20 分) 的显著改善被观察到并持续.
结论:
- 来自ELEVATE注册表的现实数据显示,HeartMate 3设备的初级植入物总生存率为63.3%.
- 该研究观察到,在接受HM3.3治疗的晚期心力衰竭患者中,在5年内减少了不良事件,改善了生活质量和功能能力.
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