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胸外科医生协会 Intermacs 2019 年度报告:设备和适应证的变化格局。

The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications.

机构信息

Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California.

Division of Cardiothoracic Surgery, Department of Surgery, University of Colorado, Aurora, Colorado.

出版信息

Ann Thorac Surg. 2020 Mar;109(3):649-660. doi: 10.1016/j.athoracsur.2019.12.005.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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)。

结论

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。

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