Rigshospitalet, Department of Cardiology, University of Copenhagen 9 Blegdamsvej, Copenhagen, Denmark.
Manchester University NHS Foundation Trust, Southmoor Road, Manchester, UK.
Eur Heart J. 2018 Oct 1;39(37):3454-3460. doi: 10.1093/eurheartj/ehy513.
The ELEVATE registry was planned to study post-approval outcomes with HeartMate 3™ (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD).
A total of 482 patients provided consent to participate in ELEVATE (enrolled cohort). Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. An additional 58 patients were implanted with HM3 during the same period but expired or were explanted prior to consent, and only survival data were collected (anonymized cohort). We report the 6-month outcomes of the patients who received HM3 as their primary implant (n = 463) and the survival of the 540 patients in the full cohort (enrolled + anonymized). Baseline characteristics included a mean age of 55.6 ± 11.7 years, 89% male, 48% ischaemic aetiology, and 70% on inotropes. The majority of patients (66%) were bridge-to-transplantation (BTT) and 32% were INTERMACS profile 1-2. Full cohort survival at 6 months was 82 ± 2%. In the enrolled primary implant patients, there was no incidence of pump thrombosis, major bleeding was 25%, major infection 35%, and any stroke type 5%. Functional capacity improved significantly (Δ6MWD 230 ± 191 m) as did QOL (ΔVAS 31 ± 23). Freedom from unplanned rehospitalizations at 6 months was 68 ± 2%.
The 6-month outcomes of the HM3 LVAD demonstrate a highly reliable, thrombosis free, device with low incidence of stroke and improved functional capacity, and QOL.
CLINICALTRIALS. GOV IDENTIFIER: NCT02497950.
ELEVATE 注册研究旨在研究 HeartMate 3™（HM3）的批准后结果，HM3 是一种完全磁悬浮的连续血流左心室辅助装置（LVAD）。
共有 482 名患者同意参与 ELEVATE（入组队列）。数据收集包括基线人口统计学资料、生存情况、不良事件、生活质量（QOL）[EuroQoL-5 维度视觉模拟量表（VAS）和 6 分钟步行距离（6MWD）]。同期还有 58 名患者植入 HM3，但在同意前死亡或被取出，仅收集生存数据（匿名队列）。我们报告了接受 HM3 作为主要植入物的患者的 6 个月结果（n=463）和全队列（入组+匿名）中 540 名患者的生存情况。基线特征包括平均年龄 55.6±11.7 岁，89%为男性，48%为缺血性病因，70%使用正性肌力药。大多数患者（66%）为桥接移植（BTT），32%为 INTERMACS 1-2 级。全队列 6 个月生存率为 82%±2%。在入组的主要植入患者中，无泵血栓形成，大出血发生率为 25%，严重感染发生率为 35%，任何类型的卒中发生率为 5%。功能能力显著改善（Δ6MWD 230±191m），生活质量（ΔVAS 31±23）也得到改善。6 个月时无计划再住院的比例为 68%±2%。
HM3 LVAD 的 6 个月结果表明，该装置具有高度可靠性、无血栓形成、卒中发生率低、功能能力和生活质量改善。
临床试验。注册号：NCT02497950。
