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晚期心力衰竭患者接受左心室辅助装置的长期支持:评估HeartWare左心室辅助系统注册研究的随访分析

Long-term support of patients receiving a left ventricular assist device for advanced heart failure: a follow-up analysis of the Registry to Evaluate the HeartWare Left Ventricular Assist System.

作者信息

Schmitto Jan D, Zimpfer Daniel, Fiane Arnt E, Larbalestier Robert, Tsui Steven, Jansz Paul, Simon Andre, Schueler Stephan, Strueber Martin

机构信息

Hannover Medical School, Hannover, Germany

Medical University of Vienna, Vienna, Austria.

出版信息

Eur J Cardiothorac Surg. 2016 Nov;50(5):834-838. doi: 10.1093/ejcts/ezw224. Epub 2016 Jul 13.

Abstract

OBJECTIVES

The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated multicentre, prospective, single-arm database established to collect post-Conformité Européenne Mark clinical information on patients receiving the HeartWare® Ventricular Assist System (HVAD®). The number of patients requiring longer periods of mechanical circulatory support is ever increasing and so further investigation into long-term outcomes in bridge-to-transplant populations is necessary.

METHODS

Data were collected on 254 commercial implants performed between February 2009 and March 2012 from nine centres in Europe (7 centres) and Australia (2 centres). Patients were followed to device explant, heart transplant or death, and the outcomes of patients who remained on support longer than 2 years were analysed. Summary statistics were used to describe patient demographics, adverse events, length of support and outcomes for this long-term cohort.

RESULTS

A total of 124 patients (49% of the original ReVOLVE population) were on support for more than 2 years (range: 731-2108 days), 76 of whom are still alive on support. Overall survival through 5 years was 59%.

CONCLUSIONS

Owing to the low rate of heart transplants, a significant number of patients receiving a left ventricular assist device as a bridge to transplant remain on support for prolonged periods, often exceeding 2, 3 and even 4 years. Real-world use of the HVAD system continues to show excellent outcomes for patients on the device, including those on support beyond 2 years.

摘要

目的

评估HeartWare左心室辅助系统注册研究(ReVOLVE)是一项由研究者发起的多中心、前瞻性、单臂数据库,旨在收集接受HeartWare®心室辅助系统(HVAD®)的患者在获得欧洲合格认证标志后的临床信息。需要更长时间机械循环支持的患者数量不断增加,因此有必要进一步研究桥接移植人群的长期预后。

方法

收集了2009年2月至2012年3月期间在欧洲7个中心和澳大利亚2个中心进行的254例商业植入的数据。对患者进行随访直至装置取出、心脏移植或死亡,并分析了支持时间超过2年的患者的预后。采用汇总统计数据描述该长期队列患者的人口统计学特征、不良事件、支持时间和预后。

结果

共有124例患者(占ReVOLVE原始人群的49%)接受支持超过2年(范围:731 - 2108天),其中76例仍在接受支持且存活。5年总生存率为59%。

结论

由于心脏移植率较低,大量接受左心室辅助装置作为桥接移植的患者需要长期接受支持,时间常常超过2年、3年甚至4年。HVAD系统在实际应用中继续显示出对使用该装置的患者有良好的预后,包括那些支持时间超过2年的患者。

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