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离心血流左心室辅助装置患者的脑血管事件:来自 Intermacs 注册中心的倾向评分匹配分析。

Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score-Matched Analysis From the Intermacs Registry.

机构信息

Neuroscience Critical Care Division, Departments of Neurology, Neurosurgery, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD (S.-M.C.).

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Virginia, Charlottesville (J.H.M., J.K., L.T.Y.).

出版信息

Circulation. 2021 Sep 7;144(10):763-772. doi: 10.1161/CIRCULATIONAHA.121.055716D.

Abstract

BACKGROUND

Ischemic and hemorrhagic cerebrovascular accidents remain common among patients with centrifugal-flow left ventricular assist devices, despite improvements in survival and device longevity. We compared the incidence of neurologic adverse events (NAEs) associated with 2 contemporary centrifugal-flow left ventricular assist devices: the Abbott HeartMate3 (HM3) and the Medtronic HeartWare HVAD (HVAD).

METHODS

Using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), we collected data on adult patients who received a centrifugal-flow left ventricular assist device as a primary isolated implant between January 1, 2017, and September 30, 2019. Major NAEs were defined as transient ischemic attack, ischemic cerebrovascular accident, or hemorrhagic cerebrovascular accident. The association of HVAD with risk of NAE in the first year after implant was evaluated using propensity score matching to balance for preimplant risk factors. After matching, freedom from first major NAE in the HM3 and HVAD cohorts was compared with Kaplan-Meier curves. A secondary analysis using multivariable multiphase hazard models was used to identify predictors of NAE, which uses a data-driven parametric fit of the early declining and constant phase hazards and the associations of risk factor with either phase.

RESULTS

Of 6205 included patients, 3129 (50.4%) received the HM3 and 3076 (49.6%) received the HVAD. Median follow-up was 9 and 12 months (HM3 and HVAD, respectively). Patients receiving HVAD had more major NAEs (16.4% versus 6.4%, <0.001) as well as each subtype (transient ischemic attack: 3.3% versus 1.0%, <0.001; ischemic cerebrovascular accident: 7.7% versus 3.4%, <0.001; hemorrhagic cerebrovascular accident: 7.2% versus 2.0%, <0.001) than did patients receiving HM3. A propensity-matched cohort balanced for preimplant risk factors showed that HVAD was associated with higher probabilities of major NAEs (% freedom from NAE 82% versus 92%, <0.001). Device type was not significantly associated with NAEs in the early hazard phase, but HVAD was associated with higher incidence of major NAEs during the constant hazard phase (hazard ratio, 5.71 [CI, 3.90-8.36]).

CONCLUSIONS

HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early postimplantation period and during the constant hazard phase. Defining the explanation for this observation will inform device selection for individual patients.

摘要

背景

尽管生存和设备寿命都有所改善,但离心流左心室辅助装置的患者仍常发生缺血性和出血性脑血管意外。我们比较了两种当代离心流左心室辅助装置(雅培 HeartMate3 [HM3] 和美敦力 HeartWare HVAD [HVAD])相关的神经不良事件(NAE)发生率。

方法

利用胸外科医生协会机械循环支持机构间注册(Intermacs),我们收集了 2017 年 1 月 1 日至 2019 年 9 月 30 日期间接受离心流左心室辅助装置作为原发性单纯植入术的成年患者的数据。主要 NAE 定义为短暂性脑缺血发作、缺血性脑血管意外或出血性脑血管意外。使用倾向评分匹配来平衡植入前的风险因素,评估 HVAD 与植入后第一年 NAE 风险的关联。匹配后,使用 Kaplan-Meier 曲线比较 HM3 和 HVAD 队列中首次主要 NAE 的无事件生存率。使用多变量多阶段风险模型的二次分析用于确定 NAE 的预测因素,该模型使用早期下降和恒定阶段风险的基于数据的参数拟合,以及风险因素与任一阶段的关联。

结果

在纳入的 6205 例患者中,3129 例(50.4%)接受了 HM3,3076 例(49.6%)接受了 HVAD。中位随访时间分别为 9 个月和 12 个月(HM3 和 HVAD)。接受 HVAD 的患者发生更多的主要 NAE(16.4%比 6.4%,<0.001)和每种亚型(短暂性脑缺血发作:3.3%比 1.0%,<0.001;缺血性脑血管意外:7.7%比 3.4%,<0.001;出血性脑血管意外:7.2%比 2.0%,<0.001)。与接受 HM3 的患者相比。在平衡了植入前风险因素的倾向匹配队列中,HVAD 与更高的主要 NAE 概率相关(%无 NAE 生存率 82%比 92%,<0.001)。在早期危险阶段,设备类型与 NAE 无显著关联,但在恒定危险阶段,HVAD 与主要 NAE 发生率较高相关(风险比,5.71 [CI,3.90-8.36])。

结论

HM3 与 HVAD 相比,在植入后早期和恒定危险阶段发生主要 NAE 的风险较低。确定这一观察结果的解释将为个体患者的设备选择提供信息。

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