Dataset related to the article "Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy The DERIVATE–ICM International Registry"

This record contains raw data related to the article “Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy The DERIVATE–ICM International Registry” <strong>BACKGROUND</strong> Implantable cardioverter-defibrillator (ICD) therapy is the most effective prophylactic strategy against sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) and left ventricle ejection fraction (LVEF) #35% as detected by transthoracic echocardiograpgy (TTE). This approach has been recently questioned because of the low rate of ICD interventions in patients who received implantation and the not-negligible percentage of patients who experienced SCD despite not fulfilling criteria for implantation. <strong>OBJECTIVES</strong> The DERIVATE (CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy)-ICM registry (NCT03352648) is an international, multicenter, and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to TTE in patients with ICM. <strong>METHODS</strong> A total of 861 patients with ICM (mean age 65 [1] 11 years, 86% male) with chronic heart failure and TTE-LVEF &lt;50% participated. Major adverse arrhythmic cardiac events (MAACE) were the primary endpoints. RESULTS During a median follow-up of 1,054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007 [95% CI: 1.000-1.011]; P ¼ 0.05), CMR-LVEF (HR: 0.972 [95% CI: 0.945-0.999]; P ¼ 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010 [95% CI: 1.002-1.018]; P ¼ 0.015) were independent predictors of MAACE. A multiparametric CMR weighted predictive derived score identifies subjects at high risk for MAACE compared with TTE-LVEF cutoff of 35% with a NRI of 31.7% (P ¼ 0.007). <strong>CONCLUSIONS</strong> The DERIVATE-ICM registry is a large multicenter registry showing the additional value of CMR to stratify the risk for MAACE in a large cohort of patients with ICM compared with standard of care.本数据集收录与《缺血性心肌病患者心脏磁共振用于预防性植入式心律转复除颤器治疗：DERIVATE–ICM国际注册研究》一文相关的原始数据。 <strong>研究背景</strong> 植入式心律转复除颤器（Implantable cardioverter-defibrillator, ICD）治疗是缺血性心肌病（ischemic cardiomyopathy, ICM）且经胸超声心动图（transthoracic echocardiography, TTE）检测左心室射血分数（left ventricle ejection fraction, LVEF）≤35%患者预防心源性猝死（sudden cardiac death, SCD）最有效的策略。但近期该治疗方案受到质疑，原因在于接受植入术的患者中ICD干预率较低，且部分未达到植入标准的患者仍发生了心源性猝死，该比例不容小觑。 <strong>研究目标</strong> DERIVATE（心脏磁共振用于原发性预防植入式心律转复除颤器治疗）-ICM注册研究（临床试验编号NCT03352648）是一项国际性多中心多厂商协作研究，旨在评估相较于经胸超声心动图，应用心脏磁共振（cardiac magnetic resonance, CMR）指导ICD植入适应证时的净重新分类指数（net reclassification improvement, NRI）。 <strong>研究方法</strong> 本研究共纳入861例缺血性心肌病患者（平均年龄65±11岁，男性占86%），均合并慢性心力衰竭且经胸超声心动图检测LVEF＜50%。主要研究终点为主要不良心律失常心脏事件（major adverse arrhythmic cardiac events, MAACE）。 <strong>研究结果</strong> 中位随访1054天期间，共88例（10.2%）患者发生主要不良心律失常心脏事件。左心室舒张末期容积指数（风险比HR=1.007，95%置信区间CI:1.000~1.011；P=0.05）、心脏磁共振检测左心室射血分数（CMR-LVEF，HR=0.972，95%CI:0.945~0.999；P=0.045）以及晚期钆增强（late gadolinium enhancement, LGE）质量（HR=1.010，95%CI:1.002~1.018；P=0.015）是主要不良心律失常心脏事件的独立预测因素。相较于经胸超声心动图LVEF cutoff值35%的分层标准，基于多参数心脏磁共振加权预测衍生评分可识别出更高危的主要不良心律失常心脏事件人群，净重新分类指数为31.7%（P=0.007）。 <strong>研究结论</strong> DERIVATE-ICM注册研究作为一项大型多中心注册研究，证实相较于标准诊疗手段，心脏磁共振可进一步对缺血性心肌病患者群体的主要不良心律失常心脏事件风险进行分层，展现出额外的临床应用价值。