在心脏病学中穿皮穿微轴流量支持
Enzo Lüsebrink1, Antonia Kellnar1, Kathrin Krieg1
1Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.
Circulation
|April 18, 2022
概括
这种装置有助于心脏功能, 但带有出血和中风等风险. 需要进行大规模试验来证实其在各种心脏疾病中的益处和安全性.
科学领域:
- 心脏病学
- 医疗器械
- 干预心脏病学
背景情况:
- 该装置是一种微轴流,用于心脏性休克,左心室卸载,高风险的PCI,静脉切除和RV失效.
- 虽然观察性研究表明Impella可以改善血液动力学参数,但并发症 (出血,缺血,血液溶解,中风) 的发生率很高.
- 目前的大型随机对照试验 (RCT) 对Impella对结局和并发症的影响的证据不足.
研究的目的:
- 审查Impella设备的当前应用,好处和并发症.
- 突出需要从正在进行和计划的大规模RCT中获得更强有力的临床证据.
主要方法:
- 对Impella设备使用现有文献的审查,包括观察性研究和较小的RCT.
- 确定正在进行和计划的大型RCT,以各种临床场景来研究Impella.
主要成果:
- 使用Impella与平均动脉压,心脏输出和组织 perfusion 的增加有关.
- 报告高出血率 (高达44%),缺血并发症 (高达18%),血液溶解 (高达32%) 和中风 (高达13%).
- 与输入大动脉气球相比,在心脏性休克中进行的小型试验并未证明Impela的死亡率有所改善.
结论:
- 尽管Impella的使用越来越多,但从大型RCT中缺乏可靠的数据来确定其有效性和安全性.
- 目前正在进行或计划进行几项大型RCT,以解决心脏性休克,左心室卸载和高风险PCI方面的证据缺口.
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