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多病情患者队列中皮下与经静脉植入式心脏除颤器治疗的临床结果

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort.

作者信息

Kattih Badder, Operhalski Felix, Boeckling Felicitas, Hecker Florian, Michael Felix, Vamos Mate, Hohnloser Stefan H, Erath Julia W

机构信息

Division of Clinical Electrophysiology, Department of Cardiology, University Hospital Frankfurt, J. W. Goethe University, Frankfurt am Main, Germany.

Department of Cardiac Surgery, University Hospital Frankfurt, J. W. Goethe University, Frankfurt am Main, Germany.

出版信息

Front Cardiovasc Med. 2022 Oct 18;9:1008311. doi: 10.3389/fcvm.2022.1008311. eCollection 2022.

Abstract

BACKGROUND

The subcutaneous implantable cardioverter-defibrillator (S-ICD) has been designed to overcome lead-related complications and device endocarditis. Lacking the ability for pacing or resynchronization therapy its usage is limited to selected patients at risk for sudden cardiac death (SCD).

OBJECTIVE

The aim of this single-center study was to assess clinical outcomes of S-ICD and single-chamber transvenous (TV)-ICD in an all-comers population.

METHODS

The study cohort comprised a total of 119 ICD patients who underwent either S-ICD ( = 35) or TV-ICD ( = 84) implantation at the University Hospital Frankfurt from 2009 to 2017. By applying an inverse probability-weighting (IPW) analysis based on the propensity score including the Charlson Comorbidity Index (CCI) to adjust for potential extracardiac comorbidities, we aimed for head-to-head comparison on the study composite endpoint: overall survival, hospitalization, and device-associated events (including appropriate and inappropriate shocks or system-related complications).

RESULTS

The median age of the study population was 66.0 years, 22.7% of the patients were female. The underlying heart disease was ischemic cardiomyopathy (61.4%) with a median LVEF of 30%. Only 52.9% had received an ICD for primary prevention, most of the patients (67.3%) had advanced heart failure (NYHA class II-III) and 16.8% were in atrial fibrillation. CCI was 5 points in TV-ICD patients vs. 4 points for patients with S-ICD ( = 0.209) indicating increased morbidity. The composite endpoint occurred in 38 patients (31.9 %), revealing no significant difference between patients implanted with an S-ICD or TV-ICD (unweighted HR 1.50, 95 % confidence interval (CI) 0.78-2.90; = 0.229, weighted HR 0.94, 95% CI, 0.61-1.50, = 0.777). Furthermore, we observed no difference in any single clinical endpoint or device-associated outcome, neither in the unweighted cohort nor following inverse probability-weighting.

CONCLUSION

Clinical outcomes of the S-ICD and TV-ICD revealed no differences in the composite endpoint including survival, freedom of hospitalization and device-associated events, even after careful adjustment for potential confounders. Moreover, the CCI was evaluated in a S-ICD cohort demonstrating higher survival rates than predicted by the CCI in young, polymorbid (S-)ICD patients.

摘要

背景

皮下植入式心律转复除颤器(S-ICD)旨在克服与导线相关的并发症和装置性心内膜炎。由于缺乏起搏或再同步治疗能力,其应用仅限于有心脏性猝死(SCD)风险的特定患者。

目的

本单中心研究的目的是评估S-ICD和单腔经静脉(TV)-ICD在所有患者群体中的临床结局。

方法

研究队列共纳入119例接受ICD植入的患者,这些患者于2009年至2017年在法兰克福大学医院接受了S-ICD(n = 35)或TV-ICD(n = 84)植入。通过应用基于倾向评分的逆概率加权(IPW)分析,包括Charlson合并症指数(CCI)以调整潜在的心外合并症,我们旨在对研究复合终点进行直接比较:总生存、住院和与装置相关的事件(包括恰当和不恰当电击或系统相关并发症)。

结果

研究人群的中位年龄为66.0岁,22.7%的患者为女性。潜在的心脏病为缺血性心肌病(61.4%),中位左心室射血分数(LVEF)为30%。仅52.9%的患者因一级预防接受ICD,大多数患者(67.3%)有晚期心力衰竭(纽约心脏协会II-III级),16.8%的患者为心房颤动。TV-ICD患者的CCI为5分,而S-ICD患者为4分(P = 0.209),表明发病率增加。38例患者(3%)发生了复合终点事件,植入S-ICD或TV-ICD的患者之间无显著差异(未加权风险比1.50,95%置信区间(CI)0.78 - 2.90;P = 0.229,加权风险比0.94,95%CI,0.61 - 1.50,P = 0.777)。此外,我们在任何单个临床终点或与装置相关的结局方面均未观察到差异,无论是在未加权队列中还是在逆概率加权后。

结论

S-ICD和TV-ICD的临床结局在包括生存、住院率和与装置相关事件的复合终点方面没有差异,即使在仔细调整潜在混杂因素之后。此外,在S-ICD队列中评估了CCI,结果显示年轻的、患有多种疾病的(S-)ICD患者的生存率高于CCI预测值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d340/9624387/fe191ac5c35b/fcvm-09-1008311-g0001.jpg

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