Background

In the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) pivotal trial, the HeartMate 3 (HM3) fully magnetically levitated left ventricular assist device (LVAD) demonstrated superiority over the axial-flow HeartMate II (HMII) LVAD. The patterns and predictors of hospitalizations with the HM3 LVAD have not been characterized.

Objectives

This study sought to determine causes, predictors, and impact of hospitalizations during LVAD support.

Methods

Patients discharged after LVAD implantation were analyzed. In the pivotal trial, 485 recipients of HM3 were compared with 471 recipients of HMII. The pivotal trial HM3 group was also compared to 949 recipients of HM3 in the postapproval phase within the trial portfolio. Predictors of cause-specific rehospitalization were analyzed.

Results

The rates of rehospitalization were lower with HM3 LVAD than with HMII LVAD in the pivotal trial (225.7 vs 246.4 events per 100 patient-years; P < 0.05). Overall, rehospitalization rates and duration were similar in the HM3 postapproval phase and pivotal trial but prolonged hospitalizations (>7 days) were less frequent (rate ratio: 0.90 [95% CI: 0.80-0.98]; P < 0.05). In HM3 recipients, the most frequent causes of rehospitalization included infection, heart failure (HF)-related events, and bleeding. First rehospitalization caused by HF-related event versus other causes was associated with reduced survival (HR: 2.2 [95% CI: 1.3-3.9]; P = 0.0014). Male sex, non-White race, presence of cardiac resynchronization therapy/implantable cardioverter-defibrillator, obesity, higher right atrial pressure, smaller LV size, longer duration of index hospitalization, and lower estimated glomerular filtration rate at index discharge predicted HF hospitalizations.

Conclusions

Contemporary support with the HM3 fully magnetically levitated LVAD is associated with a lower hospitalization burden than with prior pumps; however, rehospitalizations for infection, HF, and bleeding remain important challenges for progress in the patient journey. (MOMENTUM 3 IDE Clinical Study, NCT02224755; MOMENTUM 3 Continued Access Protocol [MOMENTUM 3 CAP], NCT02892955)

中文翻译：

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MOMENTUM 3 试验中磁悬浮左心室辅助装置的住院模式和影响

背景

在 MOMENTUM 3（MagLev 技术在使用 HeartMate 3 进行机械循环支持治疗的患者中的多中心研究）关键试验中，HeartMate 3 (HM3) 全磁悬浮左心室辅助装置 (LVAD) 表现出优于轴流式 HeartMate II ( HMII) LVAD。HM3 LVAD 住院的模式和预测因素尚未确定。

目标

本研究旨在确定 LVAD 支持期间住院的原因、预测因素和影响。

方法

对 LVAD 植入后出院的患者进行分析。在关键试验中，将 485 名 HM3 接受者与 471 名 HMII 接受者进行了比较。关键试验 HM3 组也与试验组合内批准后阶段的 949 名 HM3 接受者进行了比较。分析了特定原因再住院的预测因素。

结果

在关键试验中，HM3 LVAD 的再住院率低于 HMII LVAD（225.7 对 246.4 事件/100 患者年；P < 0.05）。总体而言，在 HM3 批准后阶段和关键试验中，再住院率和持续时间相似，但长期住院（> 7 天）的频率较低（比率：0.90 [95% CI：0.80-0.98]；P < 0.05）。在 HM3 受者中，最常见的再住院原因包括感染、心力衰竭 (HF) 相关事件和出血。与其他原因相比，由 HF 相关事件引起的首次再住院与生存率降低相关（HR：2.2 [95% CI：1.3-3.9]；P =0.0014)。男性、非白人、存在心脏再同步化治疗/植入式心脏复律除颤器、肥胖、右心房压力较高、左心室尺寸较小、住院时间较长以及首次出院时估计的肾小球滤过率较低，这些都是心衰住院的预测指标。

结论

与以前的泵相比，HM3 全磁悬浮 LVAD 的现代支持与较低的住院负担相关；然而，因感染、心衰和出血而再次住院仍然是患者旅程中取得进展的重要挑战。（MOMENTUM 3 IDE 临床研究，NCT02224755；MOMENTUM 3 持续访问协议 [MOMENTUM 3 CAP]，NCT02892955）