Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure
Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure
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DOI：
10.1161/circulationaha.117.028303
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发表时间：
2017-05-23
期刊：
影响因子：
37.8
通讯作者：
Mehra, Mandeep R.
中科院分区：
文献类型：
--
作者：
Uriel, Nir;Colombo, Paolo C.;Mehra, Mandeep R.
背景技术背景：HeartMate 3（HM 3）左心室辅助系统（LVAS）（Abbott）是一种离心式、全磁悬浮、连续血泵，旨在增强血液相容性并降低血液成分的剪切应力。MOMENTUM 3试验（MagLev技术在接受HeartMate 3机械循环支持治疗的患者中的多中心研究）比较了HM 3 LVAS与HeartMate II（HMII）LVAS（Abbott）在药物治疗难治性晚期心力衰竭中的疗效，不考虑治疗意图（桥接移植与目的治疗）。该研究报告了短期队列（n=294; 6个月随访）的主要结局，证明了HM 3在试验主要终点（无致残性卒中或因故障更换泵而再次手术的生存率）方面的优效性，这是由于再次手术的需求减少。本分析的目的是评估2个LVAS.METHODS之间的血液相容性相关临床不良事件（HRAE）的汇总：我们进行了短期队列（治疗队列n=289）6个月时HRAE（无任何非手术出血、血栓栓塞事件、泵血栓形成或神经系统事件的生存率）的次要终点评价。HRAE的净负担也通过使用先前描述的血液相容性评分进行评估，该评分使用4个等级严重程度的递增等级来得出每个患者在整个随访期间遇到的事件的总评分。治疗组289例（151例HM 3和138例HM II），HM 3组和HM II组分别有69%和55%的患者实现了无HRAE生存。（风险比，0.62;置信区间，0.42-0.91; P=0.012）。使用血液相容性评分，与对照组HMII LVAS相比，HM 3组显示需要再次手术的泵血栓形成（0与36分，P < 0.001）或药物管理的泵血栓形成（0与5分，P=0.02）较少，非致残性卒中（6与24分，P=0.026）较少。与HMII患者相比，HM 3患者的净血液相容性评分为101（0.67 +/- 1.50分/患者）与137（0.99 +/- 1.79分/患者）（比值比，0.64;可信区间，0.39-1.03; P=0.065）。在MOMENTUM 3试验的次要分析中，与HMII LVAS相比，HM 3 LVAS在6个月时显示出更大的HRAE自由度。
BACKGROUND: The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS.METHODS: We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient.RESULTS: In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P < 0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67 +/- 1.50 points/patient) versus 137 (0.99 +/- 1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065).CONCLUSIONS: In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months.