Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial

被引:34
|
作者
Vidula, Himabindu
Takeda, Koji [1 ]
Estep, Jerry D. [2 ,3 ]
Silvestry, Scott C. [4 ]
Milano, Carmelo [5 ]
Cleveland, Joseph C. [6 ]
Goldstein, Daniel J. [7 ]
Uriel, Nir [8 ]
Kormos, Robert L. [3 ,9 ]
Dirckx, Nicholas [10 ]
Mehra, Mandeep R. [11 ,12 ,13 ,14 ]
机构
[1] Univ Rochester, Sch Med & Dent, Div Cardiol, Rochester, NY USA
[2] Columbia Univ, Div Cardiac Thorac & Vasc Surg, Coll Phys & Surg, New York, NY USA
[3] New York Presbyterian Hosp, New York, NY USA
[4] Cleveland Clin Fdn, Kaufman Ctr Heart Failure & Recovery, Cleveland Hts, OH USA
[5] AdventHlth Transplant Inst, Thorac Transplant Thorac & Cardiovasc Surg Progra, Orlando, FL USA
[6] Duke Univ Med Ctr, Div Cardiothorac Surg, Durham, NC USA
[7] Univ Colorado, Sch Med, Div Cardiothorac Surg, Aurora, CO USA
[8] Monte fiore Einstein Ctr Heart & Vasc Care, Dept Cardiothorac Surg, New York, NY USA
[9] Columbia Univ, Coll Phys & Surg, Div Cardiol, New York, NY USA
[10] Med Affairs, Austin, TX USA
[11] Global Biometr, Plymouth, MN USA
[12] Ctr Adv Heart Brigham, Boston, MA USA
[13] Brigham & Womens Hosp Heart, Ctr Adv Heart Dis, 75 Francis St, Boston, MA 02115 USA
[14] Vasc Ctr Ctr, Ctr Adv Heart Dis, 75 Francis St, Boston, MA 02115 USA
基金
美国国家卫生研究院;
关键词
heart failure; hospitalizations; left ventricular assist device (LVAD); HEMOCOMPATIBILITY-RELATED OUTCOMES; IMPLANTATION; PUMP;
D O I
10.1016/j.jchf.2022.03.007
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 1/4 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. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
引用
收藏
页码:470 / 481
页数:12
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