CVRN-Risk with ICD Placement and Outcomes in Kidney Disease (CVRN-RISK) Study

描述(由申请人提供)：使用植入式心律转复除颤器(ICD)作为心脏性猝死(SCD)的主要预防策略，极大地降低了选定患者群体的死亡率。随机对照试验表明，在左心室射血分数(LVEF)降低的心力衰竭(HF)患者中，预防性ICD植入通过检测和治疗恶性室性心律失常，与标准药物治疗相比，可提高存活率。然而，由于ICD植入带来了巨大的风险和昂贵的费用，这种疗法在试验参与者之外和高危亚组中的使用和结果是患者、临床医生和政策制定者共同关注的重要问题。慢性肾脏疾病(CKD)，定义为估计的肾小球滤过率(EGFR)和60毫升/分钟/1.73平方米，在美国570万成人心力衰竭(HF)患者中，大约三分之一受到影响。在HF患者中，肾功能低下被证明是SCD最有力的预测因素。尽管心衰患者的高负担和高风险与肾功能下降有关，但大多数先前的一级预防ICD植入的试验和研究都排除了肾功能下降的患者或研究力度不足。因此，与肾功能正常的患者相比，肾功能降低的患者植入一级预防ICD的风险和益处是否有所不同仍不清楚，但对这一高危、不断增长的患者群体具有关键的治疗意义。我们计划在正在进行的NHLBI资助的心血管研究网络(CVRN)中合并两个独特的队列，CVRN是一个全国性的、大型的、具有特殊特征的15个健康系统的患者登记，以解决这些知识上的差距：(1)一组心衰和LVEF&lt；50%的患者(CVRN-HF-REF)和(2)植入性心脏复律除颤器的纵向研究(LSICD)，这是一组接受ICD一级预防的患者。合并这两个重叠的队列，我们将创建CVRN-Risk(CVRN-与ICD的位置和肾脏疾病的结果)队列，以实现以下特定目标。在目标1中，我们将评估肾功能水平与接受ICD一级预防心源性猝死的可能性之间的关系。在目标2中，我们将确定在接受一级预防ICD的患者中，植入前肾功能与植入后感染/血肿和不适当电击的相关性。在目标3中，我们将评估肾功能是否改变了接受一级预防ICD治疗与不接受一级预防ICD治疗对左心室射血分数降低的心衰患者住院和死亡的比较效果。最后，在目标4中，我们将开发一个决策和成本效益模型来评估一级预防ICD在不同水平肾功能的心衰患者中的净收益和危害。

DESCRIPTION (provided by applicant): The use of implantable cardioverter defibrillator (ICD) as a primary prevention strategy for sudden cardiac death (SCD) has dramatically reduced mortality in selected patient populations. Randomized controlled trials have shown that in heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF), prophylactic ICD implantation improves survival compared with standard medical therapy by detection and treatment of malignant ventricular arrhythmias. However because ICD implantation poses significant risk and is costly, the use and outcomes associated with this therapy outside trial participants and in high-risk subgroups is an important focus by patients, clinicians and policy-makers alike. Chronic kidney disease (CKD), defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2, affects approximately one-third of the 5.7 million adults with heart failure (HF) in the U.S. Among HF patients, reduced kidney function has been shown to be the most powerful predictor of SCD. Despite a high burden of and high risk associated with reduced kidney function among HF patients, most previous trials and studies of primary prevention ICD implantation have excluded or have been underpowered to study patients with reduced kidney function. Thus, whether the risks and benefits of primary prevention ICD implantation differs among patients with reduced kidney function compared with those with preserved kidney function remains unclear, but has critical therapeutic implications for this high-risk, growing patient population. We plan to merge two unique cohorts within the ongoing NHLBI-funded Cardiovascular Research Network (CVRN), a national, large, exceptionally-characterized patient registry of 15 health systems to address these gaps in knowledge: (1) a cohort of patients with HF and LVEF<50% (CVRN-HF-REF) and (2) the Longitudinal Study of Implantable Cardioverter-Defibrillators (LSICD), a cohort of patients undergoing primary prevention ICD placement. Merging these two overlapping cohorts, we will create the CVRN-RISK (CVRN-Risks with ICD placement and outcomeS in Kidney disease) cohort to accomplish the following specific aims. In Aim 1, we will evaluate the association between level of kidney function and likelihood of receiving an ICD for primary prevention of sudden cardiac death among patients with HF with reduced LVEF. In Aim 2, we will determine the association of pre-implantation kidney function with post-implantation infections/hematomas and inappropriate shocks among patients receiving a primary prevention ICD. In Aim 3, we will evaluate if kidney function modifies the comparative effectiveness of receipt versus no receipt of a primary prevention ICD on HF hospitalizations and death among HF patients with reduced LVEF. Finally in Aim 4, we will develop a decision and cost-effectiveness model to evaluate the net benefit versus harm associated with primary prevention ICD placement at different levels of kidney function among patients with HF with reduced LVEF.