BACKGROUND

Stroke is a devastating morbidity associated with left ventricular assist device (LVAD) support. We report a comprehensive analysis of stroke subtypes in the ENDURANCE destination therapy (DT) and ENDURANCE Supplemental (DT2) trials.

METHODS

Patients in the combined HeartWare LVAD (HVAD) cohorts of the DT and DT2 trials were included. Neurologic events included ischemic stroke (ischemic cerebrovascular accident [ICVA]), hemorrhagic stroke (hemorrhagic cerebrovascular accident [HCVA]), and transient ischemic attack (TIA). Peri-operative strokes were defined as occurring within 2 weeks of the implant.

RESULTS

A total of 604 patients received an HVAD in the DT (n = 296) and DT2 (n = 308) trials. Over 2 years, 178 (29.5%) had at least 1 cerebrovascular accident (CVA). Forty-four (7.3%) had HCVAs, 116 (19.2%) had ICVAs, and 44 (7.3%) had TIAs. Thirty (5.0%) had peri-operative stroke. In multivariable analysis, sub-therapeutic international normalized ratio (INR) values were independently associated with peri-operative stroke. Supra- and/or sub-therapeutic INR values, peripheral vascular disease, and presence of left ventricular thrombus were independently associated with ICVA. No aspirin and supra- and/or sub-therapeutic INR values were independently associated with TIA. No aspirin, supra- and/or sub-therapeutic INR values, and prior stroke and/or TIA were associated with HCVA. In further analysis, mean arterial pressure (MAP) was higher in the ICVA (86.8mm Hg, p = 0.002 4) and TIA (88.8mm Hg, p<0.0001) groups, but not in HCVA, than in the No-CVA group (81.4mm Hg). Time in therapeutic range for INR was 65.3% for the No-CVA group, 62.9% (p = 0.59) for HCVA, 65.1% (p = 0.97) for ICVA, and 63.2% (p = 0.62) for TIA.

CONCLUSIONS

Supra- and sub-therapeutic INR values at the time of CVA were associated with all stroke subtypes >14 days post-implant. MAP was higher among those with ICVA and TIA but not with HCVA compared to without CVA. Our study demonstrates the challenges of anti-thrombotic therapy and blood pressure management in LVAD population.

中文翻译：

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在ENDURANCE试验中了解卒中亚型的危险因素和预测因素。

背景

中风是与左心室辅助设备（LVAD）支撑相关的毁灭性疾病。我们在ENDURANCE目的地治疗（DT）和ENDURANCE补充（DT2）试验中报告了卒中亚型的综合分析。

方法

纳入DT和DT2试验的合并HeartWare LVAD（HVAD）队列的患者。神经系统事件包括缺血性中风（缺血性脑血管意外[ICVA]），出血性中风（出血性脑血管意外[HCVA]）和短暂性脑缺血发作（TIA）。围手术期中风定义为在植入后2周内发生。

结果

共有604名患者在DT（n  = 296）和DT2（n = 308）次试用。在2年中，有178（29.5％）发生至少1例脑血管意外（CVA）。HCVA占44（7.3％），ICVA占116（19.2％），TIA占44（7.3％）。30名（5.0％）发生了围手术期中风。在多变量分析中，亚治疗国际标准化比率（INR）值与围手术期卒中独立相关。上和/或亚治疗INR值，周围血管疾病和左心室血栓的存在与ICVA独立相关。没有阿司匹林和治疗上和/或亚治疗INR值与TIA独立相关。HCVA无阿司匹林，治疗上和/或亚治疗INR值以及先前的卒中和/或TIA。在进一步分析中，ICVA中的平均动脉压（MAP）较高（86.8mm Hg，p = 0.002 4）和TIA（88.8mm Hg，p <0.0001）组，但在HCVA中则没有No-CVA组（81.4mm Hg）。No-CVA组的INR治疗时间为65.3％，HCVA为62.9％（p  = 0.59），ICVA为65.1％（p  = 0.97  ），TIA为63.2％（p = 0.62）。

结论

CVA时的超治疗和亚治疗INR值与植入后> 14天的所有卒中亚型相关。与没有CVA的患者相比，有ICVA和TIA的患者的MAP更高，但没有HCVA的患者的MAP更高。我们的研究证明了LVAD人群的抗血栓治疗和血压管理面临的挑战。