Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis
Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis
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DOI：
10.1056/nejmoa1313385
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发表时间：
2014-01-02
影响因子：
158.5
通讯作者：
Smedira, Nicholas G.
中科院分区：
文献类型：
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作者：
Starling, Randall C.;Moazami, Nader;Smedira, Nicholas G.
背景：我们观察到，与批准前的临床试验结果和初始经验相比，使用HeartMate II左心室辅助装置的患者血栓形成率明显增加。我们在一项多机构研究中调查了泵血栓形成和乳酸脱氢酶（LDH）水平升高的发生，LDH水平预示血栓形成（和相关溶血），以及不同管理策略的结果。方法：从2004年到2013年中期，我们获得了来自三家机构的837名患者的数据，其中895个装置被植入；患者的平均（SD）年龄为5514岁。主要终点确定为泵血栓形成。次要终点是确诊和疑似血栓形成、纵向LDH水平和泵血栓形成后的结果。结果66例患者共确诊血栓形成72例；在独特的装置中，另外36例血栓形成被怀疑。大约从2011年3月开始，植入后3个月确诊的泵血栓发生率从2.2%（95%可信区间[CI]， 1.5 - 3.4）增加到2013年1月1日的8.4% （95% CI, 5.0 - 13.9）。2011年3月1日前，从植入到血栓形成的中位时间为18.6个月（95% CI, 0.5 ~ 52.7），从2011年3月起，中位时间为2.7个月（95% CI, 0.0 ~ 18.6）。植入后3个月内LDH水平升高反映了血栓形成。在诊断前几周内，LDH水平从540 IU / l增加到1490 IU / l，增加了一倍以上，预示着血栓形成。11例患者通过心脏移植治疗血栓形成（1例患者在移植后31天死亡），21例患者采用泵置换治疗，死亡率与无血栓形成患者相当；在40例未接受移植或泵置换的血栓患者中，在泵血栓形成后的6个月内，精算死亡率为48.2% （95% CI, 31.6 - 65.2）。结论在我们的中心，与使用心脏伴侣II型瓣膜相关的泵血栓发生率呈上升趋势，并与大量的发病率和死亡率相关。
BackgroundWe observed an apparent increase in the rate of device thrombosis among patients who received the HeartMate II left ventricular assist device, as compared with preapproval clinical-trial results and initial experience. We investigated the occurrence of pump thrombosis and elevated lactate dehydrogenase (LDH) levels, LDH levels presaging thrombosis (and associated hemolysis), and outcomes of different management strategies in a multi-institutional study.MethodsWe obtained data from 837 patients at three institutions, where 895 devices were implanted from 2004 through mid-2013; the mean (SD) age of the patients was 5514 years. The primary end point was confirmed pump thrombosis. Secondary end points were confirmed and suspected thrombosis, longitudinal LDH levels, and outcomes after pump thrombosis.ResultsA total of 72 pump thromboses were confirmed in 66 patients; an additional 36 thromboses in unique devices were suspected. Starting in approximately March 2011, the occurrence of confirmed pump thrombosis at 3 months after implantation increased from 2.2% (95% confidence interval [CI], 1.5 to 3.4) to 8.4% (95% CI, 5.0 to 13.9) by January 1, 2013. Before March 1, 2011, the median time from implantation to thrombosis was 18.6 months (95% CI, 0.5 to 52.7), and from March 2011 onward, it was 2.7 months (95% CI, 0.0 to 18.6). The occurrence of elevated LDH levels within 3 months after implantation mirrored that of thrombosis. Thrombosis was presaged by LDH levels that more than doubled, from 540 IU per liter to 1490 IU per liter, within the weeks before diagnosis. Thrombosis was managed by heart transplantation in 11 patients (1 patient died 31 days after transplantation) and by pump replacement in 21, with mortality equivalent to that among patients without thrombosis; among 40 thromboses in 40 patients who did not undergo transplantation or pump replacement, actuarial mortality was 48.2% (95% CI, 31.6 to 65.2) in the ensuing 6 months after pump thrombosis.ConclusionsThe rate of pump thrombosis related to the use of the HeartMate II has been increasing at our centers and is associated with substantial morbidity and mortality.