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与Impella 5.0相比,Impella 5.5在当代心源性休克和心力衰竭患者中具有更好的临床结局。

Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients.

作者信息

Ramzy Danny, Soltesz Edward G, Silvestry Scott, Daneshmand Mani, Kanwar Manreet, D'Alessandro David A

机构信息

Department of Cardiac Surgery, UTHealth McGovern School of Medicine Houston, Texas.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.

出版信息

J Heart Lung Transplant. 2023 May;42(5):553-557. doi: 10.1016/j.healun.2023.01.011. Epub 2023 Feb 1.

Abstract

A redesigned surgically implanted heart pump incorporates several design changes from the prior device generation, but no published comparative data demonstrate if these changes translate to improved outcomes. We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-mandated QA database, for contemporary patients treated with the Impella 5.5 or Impella 5.0 for acute myocardial infarction complicated by cardiogenic shock (AMICS), cardiomyopathy, or postcardiotomy cardiogenic shock (PCCS). A total of 1238 patients at 290 US sites were included for analysis. Patients receiving the Impella 5.5 had significantly higher survival through explant (i.e., successfully weaned or bridged to heart replacement therapy) than those receiving the Impella 5.0 in all 3 settings: AMICS (70.5% vs 56.8%; p = 0.005), cardiomyopathy (88.1% vs 76.9%; p = 0.001), and PCCS (76.1% vs 55.7%; p = 0.003). Duration of support was significantly longer for Impella 5.5 patients with AMICS (9.2 vs 6.1 days; p = 0.008) and cardiomyopathy (10.7 vs 8.1 days; p < 0.001).

摘要

一种重新设计的外科植入式心脏泵在设计上与前一代设备有多项改变,但尚无已发表的比较数据表明这些改变是否能转化为更好的治疗效果。我们从美国食品药品监督管理局(FDA)要求的质量保证数据库中,回顾性比较了当代使用Impella 5.5或Impella 5.0治疗急性心肌梗死合并心源性休克(AMICS)、心肌病或心脏手术后心源性休克(PCCS)患者的临床特征和治疗效果。共纳入了美国290个地点的1238例患者进行分析。在所有三种情况下,接受Impella 5.5治疗的患者通过植入物取出(即成功撤机或过渡到心脏替代治疗)的生存率显著高于接受Impella 5.0治疗的患者:AMICS(70.5%对56.8%;p = 0.005)、心肌病(88.1%对76.9%;p = 0.001)和PCCS(76.1%对55.7%;p = 0.003)。Impella 5.5治疗的AMICS患者(9.2天对6.1天;p = 0.008)和心肌病患者(10.7天对8.1天;p < 0.001)的支持时间明显更长。

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