Medical University of Vienna, Austria (D.Z.).
Oslo University Hospital, Norway (A.E.F.).
Circ Heart Fail. 2020 Mar;13(3):e006252. doi: 10.1161/CIRCHEARTFAILURE.119.006252. Epub 2020 Mar 13.
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.
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.
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%.
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.
可供移植的心脏数量有限，这意味着更多的患者需要长期使用耐用的左心室辅助装置。Registry to Evaluate the HeartWare Left Ventricular Assist System 是一项由研究人员发起的多中心、前瞻性、单臂数据库研究，旨在收集接受 HeartWare 心室辅助装置系统作为移植桥接的患者的上市后临床信息。该注册研究代表了最长的多中心原发性左心室辅助装置结果的随访。
从欧洲 9 个中心（7 个）和澳大利亚 2 个中心收集了 2009 年 2 月至 2012 年 3 月期间进行的 254 例商业植入数据。对患者进行随访至设备取出、心脏移植或死亡。对 2018 年 7 月/8 月之前的患者结果进行了分析。使用汇总统计数据描述了该长期队列患者的人口统计学特征、不良事件、支持时间和结局。
共有 122 名患者的支持时间超过 2 年，34 名患者的支持时间超过 5 年。29 名患者仍在支持下存活（支持时间从 1213 天到 3396 天不等），其中 23 名患者仍在使用原始的 HeartWare 心室辅助装置系统。7 年时的 Kaplan-Meier 生存率为 51%。6 年后，任何中风的无事件生存率为 82%，严重致残性中风的无事件生存率为 89%。
现在心脏移植的低比率要求患者需要更长时间的左心室辅助装置支持。这项分析表明，使用 HeartWare 心室辅助装置系统进行长期支持可实现 7 年时 51%的生存率。
