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Long-Term Survival of Patients With Advanced Heart Failure Receiving an Left Ventricular Assist Device Intended as a Bridge to Transplantation: The Registry to Evaluate the HeartWare Left Ventricular Assist System.
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2020-03-13 , DOI: 10.1161/circheartfailure.119.006252
Daniel Zimpfer 1 , Arnt E Fiane 2 , Robert Larbalestier 3 , Steven Tsui 4 , Paul Jansz 5 , Andre Simon 6 , Stephan Schueler 7 , Martin Strueber 8 , Jan D Schmitto 9
Affiliation  

Background:The paucity of available hearts for transplantation means that more patients remain on durable left ventricular support for longer periods of time. The Registry to Evaluate the HeartWare Left Ventricular Assist System was an investigator-initiated multicenter, prospective, single-arm database established to collect post-Conformité Européene mark clinical information on patients receiving the HeartWare ventricular assist device system as a bridge to transplantation. This registry represents the longest multicenter follow-up of primary left ventricular assist device outcomes.Methods:Data were collected on 254 commercial implants performed between February 2009 and March 2012 from 9 centers in Europe (7) and Australia (2). Patients were followed to device explant, heart transplantation, or death. The outcomes of patients through July/August 2018 were analyzed. Summary statistics were used to describe patient demographics, adverse events, length of support, and outcomes for this extended-term cohort.Results:A total of 122 patients were on support for >2 years, and 34 patients were on support for >5 years. Twenty nine patients are still alive on support (support ranging from 1213 to 3396 days), and 23 of those are on their original HeartWare ventricular assist device system. Kaplan–Meier survival through 7 years was 51%. Through 6 years, freedom from any stroke was 82%, while freedom from severely disabling stroke was 89%.Conclusions:Low rates of heart transplant now require longer periods of left ventricular assist device support in patients. This analysis demonstrates that long-term support using a HeartWare ventricular assist device system offers survival of 51% through 7 years.

中文翻译:

晚期心力衰竭患者接受左心室辅助装置作为移植桥梁的长期生存:评估HeartWare左心室辅助系统的注册表。

背景:可用于移植的心脏很少,这意味着更多的患者会在较长的时间里停留在持久的左心室支持上。评价HeartWare左心室辅助系统的注册表是由研究人员发起的多中心,前瞻性,单臂数据库,其建立目的是收集关于接受HeartWare心室辅助设备系统作为移植桥梁的患者的欧洲合格标记后临床信息。该方法代表了最长的多中心随访,主要随访左心室辅助装置的结果。方法:从欧洲(7)和澳大利亚(2)的9个中心收集了2009年2月至2012年3月之间进行的254例商业植入物的数据。对患者进行器械外植,心脏移植或死亡。分析了截至2018年7月/ 8月的患者结局。摘要统计数据用于描述此长期队列的患者人口统计学,不良事件,支持时间长短和结果。结果:共有122名患者获得了2年以上的支持,有34位患者获得了5年以上的支持。 。29名患者仍在生存中(支持时间为1213至3396天),其中23名患者在其最初的HeartWare心室辅助设备系统上。Kaplan–Meier的7年生存率为51%。在过去的6年中,无任何中风的发生率为82%,而患有严重致残性中风的发生率为89%。结论:低心脏移植术现在需要更长的患者左心室辅助装置支持时间。
更新日期:2020-03-19
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