Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California.
Division of Cardiothoracic Surgery, Department of Surgery, University of Colorado, Aurora, Colorado.
Ann Thorac Surg. 2020 Mar;109(3):649-660. doi: 10.1016/j.athoracsur.2019.12.005.
The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system.
Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices.
Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001).
Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.
新型连续血流左心室辅助装置（LVAD）的获批和美国心脏分配系统的改变，对机械循环支持领域产生了影响。
评估 2014 年 1 月至 2019 年 9 月期间胸外科医师学会（STS）Intermacs 注册中心中接受单纯连续血流 LVAD 植入术的患者。比较轴流、混合磁悬浮离心流（CF-HL）和全磁悬浮离心流（CF-FML）LVAD 之间的生存率和重大不良事件发生率。
2014 年共植入 2603 台设备，其中 1824 台（70.1%）为轴流，1213 台（46.6%）为终末期心力衰竭治疗；截至 2019 年 9 月，共植入 1752 台设备，但只有 37 台（2.1%）为轴流，1230 台（70.2%）为终末期心力衰竭治疗。2014 年至 2018 年期间，共有 13016 名患者接受了植入术。与 2014-2016 年相比，2017-2018 年接受植入术的患者更有可能处于 Intermacs 1 期（17.1%比 14.3%，P<0.001），并且更有可能在植入前使用临时机械循环支持（34.8%比 29.3%，P<0.001）。CF-FML 设备的总体生存率和重大不良事件发生率更高。在 CF-HL 与 CF-FML 之间的生存多变量分析中，设备类型并不是早期死亡的显著危险因素，但 CF-HL 设备的使用具有晚期死亡风险比 3.01（P<0.001）。
在过去的 5 年中，离心流 LVAD 已成为主要技术，终末期心力衰竭治疗成为最常见的植入策略。虽然 CF-FML 设备的结果很有前景，但与其他非随机注册研究中的设备进行比较时应谨慎。
