磁悬浮左心室辅助装置在 MOMENTUM 3 试验中的住院模式和影响。
Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial.
机构信息
Division of Cardiology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.
Division of Cardiac, Thoracic, and Vascular Surgery, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York, USA.
出版信息
JACC Heart Fail. 2022 Jul;10(7):470-481. doi: 10.1016/j.jchf.2022.03.007. Epub 2022 Jun 8.
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).
背景
在 MOMENTUM 3（多中心研究磁悬浮技术在接受 HeartMate 3 机械循环支持治疗的患者中的应用）关键性试验中，HeartMate 3（HM3）全磁悬浮左心室辅助装置（LVAD）相较于轴流 HeartMate II（HMII）LVAD 具有优越性。HM3 LVAD 住院的模式和预测因素尚未得到明确。
目的
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。在关键性试验中，将 485 例 HM3 接受者与 471 例 HMII 接受者进行比较。关键性试验的 HM3 组还与试验组合内 949 例 HM3 接受者在批准后阶段进行了比较。对特定原因再住院的预测因素进行了分析。
结果
与 HMII LVAD 相比，HM3 LVAD 在关键性试验中的再住院率较低（225.7 与 246.4 例患者每年每 100 例事件；P<0.05）。总体而言，HM3 批准后阶段和关键性试验中的再住院率和持续时间相似，但延长住院时间（>7 天）的频率较低（率比：0.90 [95%CI：0.80-0.98]；P<0.05）。在 HM3 接受者中，再住院的最常见原因包括感染、心力衰竭（HF）相关事件和出血。首次因 HF 相关事件而导致的再入院与降低的生存率相关（HR：2.2 [95%CI：1.3-3.9]；P=0.0014）。男性、非白人种族、存在心脏再同步治疗/植入式心律转复除颤器、肥胖、较高的右心房压力、较小的左心室大小、较长的住院时间以及指数出院时较低的估计肾小球滤过率均预测 HF 住院。
结论
与之前的泵相比，使用 HM3 全磁悬浮 LVAD 进行当代支持与较低的住院负担相关；然而，感染、HF 和出血再住院仍然是患者治疗进展的重要挑战。（MOMENTUM 3 IDE 临床研究，NCT02224755；MOMENTUM 3 持续准入方案[MOMENTUM 3 CAP]，NCT02892955）。
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