Department of Psychiatry, Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, USA.
J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012.
The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support.
Data were collected in a sub-study from 96 HeartMate II continuous-flow and 30 HeartMate XVE pulsatile-flow LVAD patients from 12 of the 35 trial sites that followed the same serial neurocognitive (NC) testing protocol at 1, 3, 6, 12, and 24 months after LVAD implantation. Spatial perception, memory, language, executive functions, and processing speed were the domains assessed with 10 standard cognitive measures. Differences over time and between LVAD type were evaluated with linear mixed-effects modeling.
From 1 to 24 months after LVAD implantation, changes in NC functions were stable or showed improvement in all domains, and there were no differences between the continuous-flow and pulsatile-flow groups. Data at 24 months were only available from patients with the continuous-flow LVAD due to the limited durability of the HeartMate XVE device. There was no decline in any NC domain over the time of LVAD support. Missing data not collected from patients who died could have resulted in a bias toward inflated study results.
The NC performance of advanced heart failure patients supported with continuous-flow and pulsatile-flow LVADs shows stabilization or improvement during support for up to 24 months.
在一项随机试验中，与脉动流左心室辅助装置（LVAD）相比，Thoratec 公司的 HeartMate II 连续流 LVAD 提高了终末期心力衰竭患者的生存率。本研究记录了该试验中 DT 患者认知功能的变化，以确定连续流和脉动流支持之间是否存在差异。
该研究从该试验的 35 个试验点中的 12 个收集了来自 96 例 HeartMate II 连续流和 30 例 HeartMate XVE 脉动流 LVAD 患者的数据，这些患者在 LVAD 植入后 1、3、6、12 和 24 个月遵循相同的连续神经认知（NC）测试方案进行了测试。空间感知、记忆、语言、执行功能和处理速度是通过 10 项标准认知测试来评估的。使用线性混合效应模型评估随时间的变化和 LVAD 类型之间的差异。
从 LVAD 植入后 1 到 24 个月，NC 功能的变化在所有领域都保持稳定或有所改善，并且在连续流和脉动流组之间没有差异。由于 HeartMate XVE 装置的耐用性有限，只有连续流 LVAD 的患者才有 24 个月的数据。在 LVAD 支持期间，没有任何 NC 领域出现下降。由于患者死亡导致未从患者那里收集到的缺失数据可能导致研究结果膨胀。
在长达 24 个月的时间内，使用连续流和脉动流 LVAD 支持的晚期心力衰竭患者的 NC 表现显示出稳定或改善。
