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接受心脏再同步治疗(有或无除颤器)患者的生存情况:RESET-CRT 项目。

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project.

机构信息

Institute of Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany.

Department of Electrophysiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

出版信息

Eur Heart J. 2022 Jul 14;43(27):2591-2599. doi: 10.1093/eurheartj/ehac053.

Abstract

AIMS

Cardiac resynchronization therapy (CRT) is an established treatment for heart failure. There is contradictory evidence whether defibrillator capability improves prognosis in patients receiving CRT. We compared the survival of patients undergoing de novo implantation of a CRT with defibrillator (CRT-D) option and CRT with pacemaker (CRT-P) in a large health claims database.

METHODS AND RESULTS

Using health claims data of a major German statutory health insurance, we analysed patients with de novo CRT implantation from 2014 to 2019 without indication for defibrillator implantation for secondary prevention of sudden cardiac death. We performed age-adjusted Cox proportional hazard regression and entropy balancing to calculate weights to control for baseline imbalances. The analysis comprised 847 CRT-P and 2722 CRT-D patients. Overall, 714 deaths were recorded during a median follow-up of 2.35 years. A higher cumulative incidence of all-cause death was observed in the initial unadjusted Kaplan-Meier time-to-event analysis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92]. After adjustment for age, HR was 1.13 (95% CI: 0.95-1.35) and after entropy balancing 0.99 (95% CI: 0.81-1.20). No survival differences were found in different age groups. The results were robust in sensitivity analyses.

CONCLUSION

In a large health claims database of CRT implantations performed in a contemporary setting, CRT-P treatment was not associated with inferior survival compared with CRT-D. Age differences accounted for the greatest part of the survival difference that was observed in the initial unadjusted analysis.

摘要

目的

心脏再同步治疗(CRT)是心力衰竭的一种既定治疗方法。关于在接受 CRT 的患者中,除颤器功能是否能改善预后,目前存在相互矛盾的证据。我们在一个大型健康索赔数据库中比较了初次植入 CRT 并带有除颤器(CRT-D)选项和带有起搏器(CRT-P)的患者的生存率。

方法和结果

使用一家主要德国法定健康保险公司的健康索赔数据,我们分析了 2014 年至 2019 年期间初次植入 CRT 且无植入除颤器以预防心脏性猝死二级预防指征的患者。我们进行了年龄调整 Cox 比例风险回归和熵平衡,以计算权重来控制基线不平衡。该分析包括 847 例 CRT-P 和 2722 例 CRT-D 患者。在中位随访 2.35 年期间,共记录了 714 例死亡。在初始未调整的 Kaplan-Meier 时间事件分析中,观察到全因死亡的累积发生率更高[风险比(HR):1.63,95%置信区间(CI):1.38-1.92]。调整年龄后,HR 为 1.13(95%CI:0.95-1.35),熵平衡后为 0.99(95%CI:0.81-1.20)。在不同年龄组中未发现生存差异。敏感性分析结果稳健。

结论

在一个在当代背景下进行 CRT 植入的大型健康索赔数据库中,与 CRT-D 相比,CRT-P 治疗并未导致生存率降低。在初始未调整分析中观察到的生存差异主要归因于年龄差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e246/9279111/7942a49625d5/ehac053ga1.jpg

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