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韩国植入式心脏复律除颤器的应用及其结果:韩国急性心力衰竭注册研究的数据。

Implantable Cardioverter-defibrillator Utilization and Its Outcomes in Korea: Data from Korean Acute Heart Failure Registry.

机构信息

Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.

Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.

出版信息

J Korean Med Sci. 2020 Nov 30;35(46):e397. doi: 10.3346/jkms.2020.35.e397.

Abstract

BACKGROUND

There are sparse data on the utilization rate of implantable cardioverter-defibrillator (ICD) and its beneficial effects in Korean patients with heart failure with reduced left ventricular ejection fraction (LVEF).

METHODS

Among 5,625 acute heart failure (AHF) patients from 10 tertiary university hospitals across Korea, 485 patients with reassessed LVEF ≤ 35% at least 3 months after the index admission were enrolled in this study. The ICD implantation during the follow-up was evaluated. Mortality was compared between patients with ICDs and age-, sex-, and follow-up duration matched control patients.

RESULTS

Among 485 patients potentially indicated for an ICD for primary prevention, only 56 patients (11.5%) underwent ICD implantation during the follow-up. Patients with ICD showed a significantly lower all-cause mortality compared with their matched control population: adjusted hazard ratio (HR) (95% confidence interval [CI]) = 0.39 (0.16-0.92), = 0.032. The mortality rate was still lower in the ICD group after excluding patients with cardiac resynchronization therapy (adjusted HR [95% CI] = 0.09 [0.01-0.63], = 0.015). According to the subgroup analysis for ischemic heart failure, there was a significantly lower all-cause mortality in the ICD group than in the no-ICD group (HR [95% CI] = 0.20 [0.06-0.72], = 0.013), with a borderline statistical significance (interaction = 0.069).

CONCLUSION

Follow-up data of this large, multicenter registry suggests a significant under-utilization of ICD in Korean heart failure patients with reduced LVEF. Survival analysis implies that previously proven survival benefit of ICD in clinical trials could be extrapolated to Korean patients.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01389843.

摘要

背景

关于韩国射血分数降低的心力衰竭(HFrEF)患者中植入式心脏复律除颤器(ICD)的使用率及其有益效果,相关数据十分有限。

方法

在韩国 10 家三级大学医院的 5625 例急性心力衰竭(AHF)患者中,对至少在指数入院后 3 个月重新评估 LVEF≤35%的 485 例患者进行了本研究。评估了随访期间 ICD 的植入情况。比较了 ICD 组与年龄、性别和随访时间匹配的对照组患者的死亡率。

结果

在 485 例有指征进行 ICD 一级预防的患者中,只有 56 例(11.5%)在随访期间植入了 ICD。与匹配对照组相比,ICD 组的全因死亡率显著降低:校正后的危险比(HR)(95%置信区间 [CI])=0.39(0.16-0.92),P=0.032。在排除心脏再同步治疗(CRT)患者后,ICD 组的死亡率仍较低(校正 HR [95% CI] = 0.09 [0.01-0.63],P=0.015)。根据缺血性心力衰竭的亚组分析,ICD 组的全因死亡率明显低于无 ICD 组(HR [95% CI] = 0.20 [0.06-0.72],P=0.013),具有统计学意义(交互 P=0.069)。

结论

这项大型多中心注册研究的随访数据表明,韩国射血分数降低的心力衰竭患者中 ICD 的使用率明显不足。生存分析表明,临床试验中已证实的 ICD 生存获益可外推至韩国患者。

临床试验注册

ClinicalTrials.gov 标识符:NCT01389843。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16fe/7707927/b75ed405b9e0/jkms-35-e397-g001.jpg

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