Section of Cardiothoracic Surgery, Department of Surgery, Ochsner Clinic Foundation, New Orleans, Louisiana, USA.
Faculty of Medicine, Ochsner Clinical School, The University of Queensland, New Orleans, Louisiana, USA.
J Card Surg. 2022 Jul;37(7):1907-1914. doi: 10.1111/jocs.16452. Epub 2022 Apr 6.
The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval.
This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection.
A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group.
In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
欧洲 CE 标志批准研究和 MOMENTUM 3 试验证明了使用 HeartMate 3（HM3）装置的安全性，并减少了与血液相容性相关的不良事件。这项单中心研究调查了自 FDA 批准以来 HM3 患者的真实世界经验。
这项回顾性观察研究纳入了 2017 年 10 月至 2020 年 3 月期间作为初次植入植入 HM3 LVAD 的患者。患者分为试验组和批准后组。主要终点是 6 个月时的生存率。次要终点是不良事件，包括泵血栓形成（需要更换泵）、中风、肾功能衰竭、急性肢体缺血、因出血而再次探查、胃肠道出血、右心室衰竭和驱动线感染。
在研究期间，共有 189 例患者植入 HM3 装置。174 例符合纳入标准：试验组 82 例，批准后组 92 例。批准后组的患者年龄较小，术前平均国际标准化比值较高，桥接移植（BTT）指征、INTERMACS 评分 1 级和使用机械辅助设备（除 IABP 外）的患者数量多于试验组。两组其他特征相当。批准后组 6 个月的总体生存率为 93.3%，试验组为 93.8%（p=0.88）。与试验组相比，批准后组因出血而再次手术的发生率较低（10.9%对 46.3%，p=0.01）。
在这项单中心研究中，批准后组的 6 个月实际生存率与试验结果相当。需要进一步研究来监测长期结果。
