Brigham and Women's Hospital, Boston, Massachusetts.
Montefiore Einstein Center for Heart and Vascular Care, New York, New York.
JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197.
Although durable left ventricular assist device (LVAD) therapy has emerged as an important treatment option for patients with advanced heart failure refractory to pharmacological support, outcomes, including survival, beyond 2 years remain poorly characterized.
To report the composite end point of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Scale score >3) or reoperation to replace the pump 5 years after the implant in participants who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.
DESIGN, SETTING, AND PARTICIPANTS: This observational study was a 5-year follow-up of the MOMENTUM 3 trial, conducted in 69 US centers, that demonstrated superiority of the centrifugal-flow LVAD to the axial-flow pump with respect to survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump at 2 years. A total of 295 patients were enrolled between June 2019 to April 2021 in the extended-phase study, with 5-year follow-up completed in September 2021.
Of 1020 patients in the investigational device exemption per-protocol population, 536 were still receiving LVAD support at 2 years, of whom 289 received the centrifugal-flow pump and 247 received the axial-flow pump.
There were 10 end points evaluated at 5 years in the per-protocol population, including a composite of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump between the centrifugal-flow and axial-flow pump groups and overall survival between the 2 groups.
A total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis (median age, 62 y; 86 [18%] women). The 5-year Kaplan-Meier estimate of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs axial-flow group was 54.0% vs 29.7% (hazard ratio, 0.55 [95% CI, 0.45-0.67]; P < .001). Overall Kaplan-Meier survival was 58.4% in the centrifugal-flow group vs 43.7% in the axial-flow group (hazard ratio, 0.72 [95% CI, 0.58-0.89]; P = .003). Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.
In this observational follow-up study of patients from the MOMENTUM 3 randomized trial, per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD vs axial-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years. These findings support the use of the fully magnetically levitated LVAD.
ClinicalTrials.gov Identifier: NCT02224755 and NCT03982979.
虽然耐用的左心室辅助装置（LVAD）治疗已经成为治疗对药物支持有抗性的晚期心力衰竭患者的重要治疗选择，但 2 年以上的生存等结果仍描述不佳。
报告在接受完全磁悬浮离心流 HeartMate 3 或轴流 HeartMate II LVAD 的 MOMENTUM 3 随机试验中，在 2 年随访时仍接受 LVAD 治疗的参与者，在植入后 5 年内，移植、恢复或无致残性中风（改良 Rankin 量表评分>3）或更换泵的复发性操作的复合终点存活、无复发性操作或更换泵的生存结果，该研究参与者为接受完全磁悬浮离心流 HeartMate 3 或轴流 HeartMate II LVAD 的患者。
设计、地点和参与者：这是 MOMENTUM 3 试验的 5 年随访研究，在 69 个美国中心进行，该研究表明，与轴流泵相比，离心流 LVAD 在移植、恢复或无致残性中风或更换泵的复发性操作的生存方面具有优越性，2 年时。共有 295 名患者于 2019 年 6 月至 2021 年 4 月期间在延长阶段研究中入组，2021 年 9 月完成了 5 年随访。
在符合研究设备豁免方案的 1020 名患者中，有 536 名患者在 2 年内仍接受 LVAD 支持，其中 289 名患者接受了离心流泵，247 名患者接受了轴流泵。
在符合方案人群中，有 10 个终点在 5 年内进行了评估，包括离心流和轴流泵组之间无致残性中风或更换泵的移植、恢复或 LVAD 支持的复合结果以及两组之间的总生存率。
在 2 年内仍接受 LVAD 支持的 536 名患者中（中位年龄 62 岁；86 [18%] 名女性），共有 295 名入组患者（289 名接受离心流泵，247 名接受轴流泵）为延长阶段分析提供了数据。在离心流组与轴流组中，移植、恢复或无致残性中风或更换泵的复发性操作的 5 年 Kaplan-Meier 估计存活率为 54.0%与 29.7%（风险比，0.55 [95%CI，0.45-0.67]；P<0.001）。离心流组的总生存率为 58.4%，轴流组为 43.7%（风险比，0.72 [95%CI，0.58-0.89]；P=0.003）。在离心流泵组中，中风、出血和泵血栓形成等严重不良事件的发生率较低。
在这项来自 MOMENTUM 3 随机试验的患者的观察性随访研究中，符合方案的分析发现，与接受轴流 LVAD 相比，接受完全磁悬浮离心流 LVAD 与更好的复合结果和更高的总体生存率相关，在 5 年内。这些发现支持使用完全磁悬浮 LVAD。
ClinicalTrials.gov 标识符：NCT02224755 和 NCT03982979。
