Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description.
Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description.
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DOI：
10.1161/jaha.112.000083
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发表时间：
2013-02-22
影响因子：
5.4
通讯作者：
Tomaselli GF
中科院分区：
文献类型：
--
作者：
Cheng A;Dalal D;Butcher B;Norgard S;Zhang Y;Dickfeld T;Eldadah ZA;Ellenbogen KA;Guallar E;Tomaselli GF
一级预防植入式心律转复器（ICD）可降低左心室收缩功能严重患者的总死亡率。然而，只有少数患者受益于这些设备。我们设计了植入式心律转复除颤器（PROSE-ICD）的前瞻性观察性研究，以确定风险因素，并加深我们对接受ICD植入作为猝死一级预防的患者中易发生猝死的生物学机制的理解。这是一项多中心前瞻性队列研究，目标入组1200例患者。主要终点是裁定的室性快速性心律失常的ICD电击。次要终点是总死亡率。所有患者均接受全面评估，包括病史和体格检查、信号平均心电图以及用于基因组学、蛋白质组学和代谢组学分析的血样采集。患者每6个月进行一次评估，并在每次已知的ICD电击后进行额外的心电图和血液采样。截至2011年12月，共入组了1177例患者，与既往随机试验相比，非白人和女性患者更多。共有143例患者达到主要终点，而在平均59个月的随访期内，共有260例患者死亡。PROSE-ICD研究代表了接受一级预防ICD的收缩性心力衰竭患者的真实的队列。广泛的电生理学和结构表型分析以及连续DNA和血清样本的可用性将是评估风险分层和识别处于药物性猝死风险中的患者的新指标的重要资源。URL：http://clinicaltrials.gov/唯一标识符：NCT 00733590。
Primary‐prevention implantable cardioverter‐defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter‐Defibrillators (PROSE‐ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal‐averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow‐up of 59 months. The PROSE‐ICD study represents a real‐world cohort of individuals with systolic heart failure receiving primary‐prevention ICDs. Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590.