Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice
Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice
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DOI：
10.1093/ejcts/ezw232
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发表时间：
2016-11-01
影响因子：
3.4
通讯作者：
Schima, Heinrich
中科院分区：
文献类型：
--
作者：
Zimpfer, Daniel;Strueber, Martin;Schima, Heinrich
目的：心室血液淤滞是连续流动机械支持器械的一个问题，可能导致血栓栓塞事件的形成。HeartWare（R）心室辅助系统（HVAD（R））配备了Lavare（TM）循环，这是一种周期性速度调节功能，旨在改变左心室内的流动模式并减少潜在的血液淤积区域。在这里，我们报告在体外和临床研究结果的影响Lavare cycle.METHODS：泵速度的变化对心室内流场的影响进行了研究与体外粒子图像测速模型。通过对ReVOLVE研究的回顾性审查评价了Lavare循环的临床影响，该研究包括在欧洲和澳大利亚的9个中心植入HVAD的248例患者，这些患者均获得了Conformite Europeenne标志。基线特征，不良事件配置文件和Kaplan-Meier生存率估计分层患者使用/不使用Lavare cycle.RESULTS：粒子图像测速显示增加心室冲洗与一个积极的Lavare周期测量的流体速度和角离散参数。随着拉瓦雷循环的开启，与拉瓦雷循环关闭时相比，滞止指数也降低了22%。在ReVOLVE登记研究中，打开Lavare循环的患者（n = 215）获得了497患者年的支持，而未使用速度调制的患者（n = 33）获得了39.3患者年的支持。Lavare周期对患者生存率没有显著影响，因为两组1年后的生存率约为80%。使用Lavare周期的患者卒中发生率显著降低[0.06 vs 0.20起事件/患者年（EPPY），P = 0.0008]，败血症（0.03 vs 0.15 EPPY，P = 0.0003）和右心衰竭（0.03 vs 0.18 EPPY，P < 0.0001），两个队列之间的移植率或恢复率没有差异。Lavare循环有效地产生心室冲洗，并且开启Lavare循环的ReVOLVE患者的不良事件特征优于关闭Lavare循环的患者。需要进行更大规模的研究，以验证Lavare循环的积极效果并优化速度调制设置，从而实现其他临床相关的改进。
OBJECTIVES: Ventricular blood stasis is a concern for continuous flow mechanical support devices and might contribute to the formation of thromboembolic events. The HeartWare (R) Ventricular Assist System (HVAD (R)) is equipped with the Lavare (TM) cycle that is a periodic speed modulation feature designed to alter flow patterns within the left ventricle and reduce areas of potential blood stasis. Here, we report in vitro and clinical findings on the effects of the Lavare cycle.METHODS: The effect of pump speed changes on the intraventricular flow field was examined with an in vitro particle image velocimetry model. The clinical impact of the Lavare cycle was evaluated through a retrospective review of the ReVOLVE study which includes 248 patients implanted with the HVAD following Conformite Europeenne Mark in nine centres in Europe and Australia. Baseline characteristics, adverse event profiles and Kaplan-Meier survival estimates were stratified by patients using/not using the Lavare cycle.RESULTS: Particle image velocimetry showed increased ventricular washout with an active Lavare cycle as measured by the fluid velocities and angular dispersion parameters. With the Lavare cycle on, there was also a 22% decrease in the stagnation index compared with when the Lavare cycle was off. In the ReVOLVE registry, patients with the Lavare cycle turned on (n = 215) were supported for 497 patient-years, whereas patients who did not use the speed modulation (n = 33) were supported for 39.3 patient-years. The Lavare cycle did not significantly affect patient survival as both groups had approximately an 80% survival after 1 year. Patients using the Lavare cycle had significantly fewer rates of stroke [0.06 vs 0.20 events per patient-year (EPPY), P = 0.0008], sepsis (0.03 vs 0.15 EPPY, P = 0.0003) and right heart failure (0.03 vs 0.18 EPPY, P < 0.0001) with no difference in the transplant or recovery rates among the two cohorts.CONCLUSIONS: The Lavare cycle effectively generates ventricular washout and the adverse event profiles of ReVOLVE patients with the Lavare cycle on were better than those with the Lavare cycle off. Larger studies are warranted to verify the positive effect of the Lavare cycle and to optimize speed modulation settings, so additional clinically relevant improvements can be realized.