An analysis of pump thrombus events in patients in the Heart Ware ADVANCE bridge to transplant and continued access protocol trial
An analysis of pump thrombus events in patients in the Heart Ware ADVANCE bridge to transplant and continued access protocol trial
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DOI：
10.1016/j.healun.2013.12.001
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发表时间：
2014-01-01
影响因子：
8.9
通讯作者：
Boyce, Steven W.
中科院分区：
文献类型：
--
作者：
Najjar, Samer S.;Slaughter, Mark S.;Boyce, Steven W.
背景技术背景：HeartWare左心室辅助装置（HVAD，HeartWare Inc，Frawillon，MA）是第一个被批准用作移植桥梁的植入式离心连续泵。LVAD支持的一种罕见但严重的不良事件是泵内血栓摄入或形成。在这项研究中，我们分析了泵血栓的发病率，评估各种治疗策略的比较有效性，并检查因素易患的发展pump thrombosis.METHODS：该分析包括382例患者接受植入HVAD的一部分的HeartWare桥移植（BTT）和随后的持续访问协议（CAP）试验。生成描述性统计量和组比较，以分析基线特征、泵血栓发生率和治疗结局。进行多变量分析，以评估显着的危险因素，发展泵thrombosis.RESULTS：有34泵血栓事件观察到31例（8.1%的队列）为0.08事件每患者年的速率。泵血栓的发生率在BTT和CAP之间没有差异。30例患者尝试了泵血栓的药物治疗，15例（50%）成功。16例患者接受了泵更换，2例患者接受了紧急移植。5例泵血栓患者在药物治疗失败后死亡，其中4例还进行了泵更换。有和无泵血栓患者的1年生存率分别为69.4%和85.5%（p = 0.21）。多变量分析显示，泵血栓的重要危险因素包括平均动脉压> 90 mm Hg，阿司匹林剂量
BACKGROUND: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus.METHODS: The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus.RESULTS: There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose