Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial
Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial
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DOI：
10.1001/jama.2022.16197
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发表时间：
2022-09-08
影响因子：
120.7
通讯作者：
Uriel, Nir
中科院分区：
文献类型：
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作者：
Mehra, Mandeep R.;Goldstein, Daniel J.;Uriel, Nir
尽管持久的左心辅助装置(LVAD)治疗已经成为药物支持无效的晚期心力衰竭患者的重要治疗选择，但超过2年的结果，包括生存，仍然没有很好的特征。目的报告移植、康复或无衰弱卒中的LVAD支持的综合生存终点(改良Rankin量表评分和GT；3)或在Momentum 3随机试验中接受完全磁悬浮的离心流HeartMate 3或轴流HeartMate II LVAD的参与者在植入后5年再次手术更换泵，并在2年后仍在接受LVAD治疗。设计、设置和参与者这项观察性研究是对Momentum 3试验的5年随访，在69个美国中心进行，证明了离心流LVAD在移植、恢复或在2年时支持无衰弱卒中或再次手术以更换泵的LVAD方面优于轴流泵。在2019年6月至2021年4月期间，共有295名患者参加了这项扩展阶段的研究，并于2021年9月完成了5年的随访。在1020名患者中，536名患者在两年后仍在接受LVAD支持，其中289名接受了离心泵，247名接受了轴流泵。MAIN结果和测量在每项计划的人群中有10个终点在5年时进行评估，包括移植、恢复、结果在536名在2年仍接受LVAD支持的患者中，共有477名患者(295名入选，182名提供有限数据)进入了扩展阶段分析(中位年龄，62岁；86[18%]妇女)。在离心流和轴流组中，无衰弱卒中或再次手术更换泵的移植、恢复或LVAD支持的5年Kaplan-Meier估计为54.0%比29.7%(风险比，0.55[95%CI，0.45-0.67]；A<；.001)。离心流组的总体Kaplan-Meier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)。在这项对Momentum 3随机试验患者的观察性随访研究中，按方案分析发现，接受完全磁悬浮的离心式LVAD与轴流式LVAD相比，接受完全磁悬浮的离心式LVAD与轴流式LVAD相比，接受完全磁悬浮的离心式LVAD与轴流式LVAD相比，卒中、出血和泵血栓形成的严重不良事件的发生率较低。结论在这项对Momentum 3随机试验患者的观察性随访研究中，接受完全磁悬浮的离心式LVAD与轴流式LVAD相比，具有更好的综合预后和更高的5年总存活率。这些发现支持使用完全磁悬浮的LVAD。
IMPORTANCE 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.OBJECTIVE 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 2021in the extended-phase study, with 5-year follow-up completed in September 2021.EXPOSURES 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.MAIN OUTCOMES AND MEASURES 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.RESULTS 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]; A < .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.CONCLUSIONS AND RELEVANCE 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.