■左心室辅助装置(LVAD)的植入是选择的终末期心力衰竭患者的关键治疗选择。然而,大出血(MB)并发症是一个重要的问题。
■我们评估了LVAD接受者MB的当前风险评分预测准确性。
■我们进行了观察,荷兰LVAD接受者(HeartWare或HeartMate-3,2010年11月至2022年12月)的单中心研究。主要结果是LVAD后的第一个MB(根据国际血栓形成和止血协会[ISTH]和机构间注册机构机械辅助循环支持[INTERMACS],和INTERMACS结合颅内出血[INTERMACS+]标准)。MB之前的死亡率被认为是竞争性事件。辨别(C统计量)和校准被评估为高血压,肾/肝功能异常,Stroke,出血史或倾向,INR,老年人,药物/酒精伴随评分,肝脏或肾脏疾病,乙醇滥用,恶性肿瘤,年龄较大,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)。
■纳入了104名患者(中位年龄,64岁;女性,20.2%;心术,90.4%;HeartMate-3,9.6%)。根据ISTH和INTERMACS标准,累积MB发生率为75.7%(95%CI65.5%-85.9%),根据INTERMACS标准,累积MB发生率为67.0%(95%CI56.0%-78.0%),中位无事件随访时间为1916天(范围,59-4521)。所有分数在预期的预测时间范围内的辨别能力都很差。根据ISTH和INTERMACS+标准,接收操作者特征曲线下的累积面积范围为0.49(95%CI0.35-0.63,静脉血栓栓塞-BLEED)至0.56(95%CI0.47-0.65,UBRS),以及0.48(95%CI0.40-0.56,心房颤动中的抗凝和危险因素)至0.56(95%CI0.47-0.65)。所有模型显示校准不良,大大低估了MB风险。
■目前的出血风险评分对LVAD受者的预测准确性不足。需要准确的风险评分来识别可能受益于患者定制的抗血栓治疗的MB高风险的LVAD患者。
UNASSIGNED: 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.
UNASSIGNED: We evaluated current risk scores\' predictive accuracy for MB in LVAD recipients.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.