Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the Heart Mate II left ventricular assist device
Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the Heart Mate II left ventricular assist device
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DOI：
10.1016/j.healun.2013.11.001
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发表时间：
2014-01-01
影响因子：
8.9
通讯作者：
Miller, Marissa A.
中科院分区：
文献类型：
--
作者：
Kirklin, James K.;Naftel, David C.;Miller, Marissa A.
背景技术背景：泵血栓形成仍然是一种罕见的，但潜在的灾难性并发症的持久的连续流动左心室辅助装置（LVAD）。临床医生认为HeartMate II（HMII）LVAD（Thoratec，普莱森顿，CA）中泵血栓形成的发生率增加，促使对机械辅助循环支持机构间登记（INTERMACS）数据库进行分析。方法：在2006年至2013年6月期间，8，988名年龄超过18岁的美国患者接受了耐用LVAD。其中，6,910例成人患者从132个机构谁收到了HMII LVAD进入INTERMACS数据库，并构成本analysis.Results的研究组：总生存率（在移植或取出恢复删失）与HMII LVAD是80%，在1年和69%，在2年，并没有显着差异时，分层的植入时代。无器械更换或因血栓形成死亡的比率从2009年6个月时的99%降至2012年的94%（p < 0.0001）。多变量风险函数分析显示泵血栓形成的风险因素包括植入年份晚（p < 0.0001），年轻（p < 0.0001），肌酐较高（p = 0.002），体重指数较大（p = 0.004）、白色人种（p = 0.0004）、左心室射血分数高于20%（p = 0.02）和1个月时较高的乳酸脱氢酶水平（p < 0.0001）。泵更换后的生存率（p < 0.0001）、无感染率（p = 0.008）和脑血管意外率（p < 0.0001）均低于初次植入后。结论：2011年和2012年期间，泵更换或因泵血栓形成导致的死亡率增加，但增加幅度仍然相对较小。HVBI LVAD的生存率仍然很高（1年时80%）。风险因素分析表明，许多患者相关因素导致血栓形成的风险。第一个月乳酸脱氢酶显著升高是泵血栓形成的预测因子。该分析无法检查植入过程中技术因素的潜在作用，例如次优泵或移植物定位、患者管理模式与泵速设置的变化、泵更换阈值的改进识别和变化，或泵的设计或生产变化，这些因素是泵血栓形成风险的促成因素。(C)2014年国际心肺移植学会。All rights reserved.
BACKGROUND: Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database.METHODS: Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis.RESULTS: Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant.CONCLUSIONS: Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HVBI LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis. (C) 2014 International Society for Heart and Lung Transplantation. All rights reserved.