Background and Aims HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. Methods A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. Results Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1–3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). Conclusions Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

中文翻译：

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全磁力离心左心室辅助装置和长期结果：ELEVATE 登记处

背景和目标 HeartMate 3 (HM3) 是一种全磁悬浮连续流左心室辅助装置，于 2015 年获得 CE 标志。ELEVATE 注册旨在收集 CE 标志批准后接受 HM3 治疗的患者的真实结果。方法 2015 年 3 月至 2017 年 2 月期间，在 26 个中心总共植入了 540 名受试者。其中，463 名患者接受了该装置作为主要植入物（主要植入物队列，PIC），19 名患者作为泵交换（泵交换队列），而在 58 名患者中，仅收集了匿名生存数据（匿名队列，AC）。PIC 中的患者参与基线人口统计、生存、不良事件、生活质量 (QoL)（EuroQoL-5 维度-5 水平视觉模拟量表）和功能能力（6 分钟步行距离）评估，而 AC 中的患者则参与评估只为生存做出贡献。结果 主要种植体队列患者的平均年龄为 56 岁，主要为男性 (89%)，其中 48% 为缺血性病因。大多数受试者被指定为移植过渡者 (66%)，并且具有 INTERMACS 概况 1-3 (70%)。基线时，受试者的功能能力较差（104 ± 140 m），生活质量受损（35 ± 19 分）。5 年 PIC 总生存率为 63.3%，无卒中生存率为 58.1%。观察到功能能力和生活质量的显着改善并维持了 5 年（分别为 301 ± 131 m 和 64 ± 20 分）。结论 ELEVATE 登记处的真实数据表明，初次种植体的总体存活率为 63.3%。在 PIC 中，在长期随访中，在晚期心力衰竭患者群体中，5 年观察到患者不良事件的减少以及生活质量和功能能力的改善。