研究动态
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风险评分在预测左心室辅助装置接受者大出血方面的表现:比较外部验证。

Performance of risk scores in predicting major bleeding in left ventricular assist device recipients: a comparative external validation.

发表日期:2024 May
作者: S F B van der Horst, Y de Jong, N van Rein, J W Jukema, M Palmen, E Janssen, E F Bonneville, F A Klok, M V Huisman, L F Tops, P L den Exter
来源: Disease Models & Mechanisms

摘要:

植入左心室辅助装置(LVAD)是选定的终末期心力衰竭患者的重要治疗选择。然而,植入后大出血 (MB) 并发症是一个值得关注的问题。我们评估了 LVAD 受者当前风险评分对 MB 的预测准确性。我们对 LVAD 受者进行了一项观察性、单中心研究(HeartWare 或 HeartMate-3,2010 年 11 月- 2022 年 12 月)在荷兰。主要结局是第一个 LVAD 后 MB(根据国际血栓和止血学会 [ISTH] 和机械辅助循环支持机构间登记处 [INTERMACS],以及 INTERMACS 结合颅内出血 [INTERMACS] 标准)。 MB 之前的死亡率被认为是一个竞争事件。对高血压、肾/肝功能异常、中风、出血史或易感性、不稳定的 INR、老年人、药物/酒精伴随评分、肝病或肾病、乙醇滥用、恶性肿瘤、老年进行鉴别(C 统计)和校准评估、血小板计数或功能减少、再出血、高血压、贫血、遗传因素、过度跌倒风险和中风评分、心房颤动评分中的抗凝和危险因素、门诊出血风险指数、静脉血栓栓塞评分、心房颤动评分和犹他州出血风险评分 (UBRS)。纳入 104 名患者(中位年龄 64 岁;女性,20.2%;HeartWare,90.4%;HeartMate-3,9.6%)。在 1916 年的中位无事件随访时间内,根据 ISTH 和 INTERMACS 标准,MB 累积发生率为 75.7%(95% CI 65.5%-85.9%),根据 INTERMACS 标准,累积 MB 发生率为 67.0%(95% CI 56.0%-78.0%)天(范围,59-4521)。所有分数在其预期预测时间范围内的辨别能力都很差。根据 ISTH 和 INTERMACS 标准,接收操作员特征曲线下的累积面积范围为 0.49(95% CI 0.35-0.63,静脉血栓栓塞-BLEED)至 0.56(95% CI 0.47-0.65,UBRS),以及 0.48(95% CI 0.40)根据 INTERMACS 标准,-0.56,抗凝和心房颤动的危险因素)至 0.56(95% CI 0.47-0.65,UBRS)。所有模型的校准结果都很差,很大程度上低估了 MB 风险。当前的出血风险评分对 LVAD 接受者的预测准确性不足。需要准确的风险评分来识别具有 MB 高风险的 LVAD 患者,这些患者可能会受益于患者定制的抗血栓治疗。© 2024 作者。
Implantation of a left ventricular assist device (LVAD) is a crucial therapeutic option for selected end-stage heart failure patients. However, major bleeding (MB) complications postimplantation are a significant concern.We evaluated current risk scores' predictive accuracy for MB in LVAD recipients.We conducted an observational, single-center study of LVAD recipients (HeartWare or HeartMate-3, November 2010-December 2022) in the Netherlands. The primary outcome was the first post-LVAD MB (according to the International Society on Thrombosis and Haemostasis [ISTH] and Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and INTERMACS combined with intracranial bleeding [INTERMACS+] criteria). Mortality prior to MB was considered a competing event. Discrimination (C-statistic) and calibration were evaluated for the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly score, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke score, Anticoagulation and Risk Factors in Atrial Fibrillation score, Outpatient Bleeding Risk Index, venous thromboembolism score, atrial fibrillation score, and Utah Bleeding Risk Score (UBRS).One hundred four patients were included (median age, 64 years; female, 20.2%; HeartWare, 90.4%; HeartMate-3, 9.6%). The cumulative MB incidence was 75.7% (95% CI 65.5%-85.9%) by ISTH and INTERMACS+ criteria and 67.0% (95% CI 56.0%-78.0%) per INTERMACS criteria over a median event-free follow-up time of 1916 days (range, 59-4521). All scores had poor discriminative ability on their intended prediction timeframe. Cumulative area under the receiving operator characteristic curve ranged from 0.49 (95% CI 0.35-0.63, venous thromboembolism-BLEED) to 0.56 (95% CI 0.47-0.65, UBRS) according to ISTH and INTERMACS+ criteria and from 0.48 (95% CI 0.40-0.56, Anticoagulation and Risk Factors in Atrial Fibrillation) to 0.56 (95% CI 0.47-0.65, UBRS) per INTERMACS criteria. All models showed poor calibration, largely underestimating MB risk.Current bleeding risk scores exhibit inadequate predictive accuracy for LVAD recipients. There is a need for an accurate risk score to identify LVAD patients at high risk of MB who may benefit from patient-tailored antithrombotic therapy.© 2024 The Author(s).