美国哈佛医学院Mandeep R. Mehra团队研究了接受全磁悬浮离心式与轴式左心室辅助装置患者的五年结局。这一研究成果于2022年9月8日发表在《美国医学会杂志》上。

尽管耐久性左心室辅助装置（LVAD）治疗已成为对药物支持无效的晚期心力衰竭患者的重要治疗选择，但2年后的结局（包括生存率）仍缺乏特征。

研究组选择在MOMENTUM 3随机试验中接受了全磁悬浮离心式HeartMate 3或轴式HeartMate II LVAD，并在2年随访时仍在接受LVAD治疗的患者，该研究旨在报道这些患者在植入后5年内移植存活、恢复或无衰弱性中风（改良Rankin评分>3）的LVAD支持或再次手术以更换泵的复合终点。

这项观察性研究是MOMENTUM 3试验的5年随访，该试验在美国69个中心进行，证明了离心式LVAD在移植存活、恢复或无衰弱性中风的LVAD支持或2年后再次手术更换泵方面优于轴式泵。2019年6月至2021年4月，共有295名患者被纳入延长期研究，2021年9月完成了5年随访。

在1020名研究器械豁免患者中，有536名患者在2年后仍在接受LVAD支持，其中289名接受离心式泵，247名接受轴式泵。在按方案人群中，研究组在5年内评估了10个终点，包括离心式泵和轴式泵组之间移植存活、恢复或无衰弱性中风的LVAD支持或再次手术以更换泵以及两组之间的总体存活率。

共有477名患者（295名入选，182名提供有限数据）参与了扩展期分析，其中536名患者在2年时仍接受LVAD支持（中位年龄为62岁；86[18%]名为女性）。离心式泵组中移植存活、恢复或无衰弱性中风的LVAD支持或再次手术以更换泵的5年Kaplan-Meier估计存活率为54.0%，轴式泵组为29.7%，组间差异显著。离心式泵组的总Kaplan-Meier生存率为58.4%，显著高于轴式组的43.7%，危险比为0.72。离心式泵组中风、出血和泵血栓形成的严重不良事件发生率较低。

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，接受全磁悬浮离心式LVAD与轴式LVAD相比，可能具有更好的综合结局和更高的5年总生存率。这些发现支持使用全磁悬浮LVAD。

附：英文原文

Title: Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

Author: Mandeep R. Mehra, Daniel J. Goldstein, Joseph C. Cleveland, Jennifer A. Cowger, Shelley Hall, Christopher T. Salerno, Yoshifumi Naka, Douglas Horstmanshof, Joyce Chuang, AiJia Wang, Nir Uriel

Issue&Volume: 2022-09-08

Abstract:

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 2021 in 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]; 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.

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.

DOI: 10.1001/jama.2022.16197

Source: https://jamanetwork.com/journals/jama/fullarticle/2796306