现代皮下植入式除颤器治疗心肌病和通道病患者：来自大型多中心注册研究的数据。

Modern subcutaneous implantable defibrillator therapy in patients with cardiomyopathies and channelopathies: data from a large multicentre registry.

机构信息

Department of Cardiac, Thoracic Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy.

出版信息

Europace. 2023 Aug 2;25(9). doi: 10.1093/europace/euad239.

AIMS

Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation.

METHODS AND RESULTS

We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8-6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1-3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45-1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1-4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6-5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3-2.3) and 3.2% (95% CI: 1.2-6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients.

CONCLUSION

Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS.

CLINICAL TRIAL REGISTRATION

URL: http://clinicaltrials.gov/Identifier: NCT02275637.

目的

患有心肌病和通道病的患者通常更年轻，且主要具有与心律失常相关的预后；由于植入式心脏复律除颤器（ICD）能防止心源性猝死，他们的预期寿命几乎接近正常。皮下 ICD（S-ICD）是经静脉 ICD 的有效替代方法，并且多年来一直在不断发展。本研究旨在评估在接受现代 S-ICD 植入的患有心肌病和通道病的患者中，无感知电击（IS）、适当治疗和器械相关并发症的发生率。

方法和结果

我们连续纳入了 2016 年 1 月至 2020 年 12 月期间接受现代 S-ICD 植入且随访至 2022 年 12 月的患有心肌病和通道病的患者。在观察期内共进行了 1338 例 S-ICD 植入。其中 628 例患者患有心肌病或通道病。在 12 个月时，患有心肌病的患者的 IS 发生率为 4.6%（95%置信区间：2.8-6.9），患有通道病的患者为 1.1%（95%置信区间：0.1-3.8）（P=0.032）。在中位随访 43 个月时，未观察到显著差异[风险比（HR）：0.76；95%置信区间：0.45-1.31；P=0.351]。在 12 个月时，患有心肌病的患者的适当电击发生率为 2.3%（95%置信区间：1.1-4.1），患有通道病的患者为 2.1%（95%置信区间：0.6-5.3）（P=1.0）。器械相关并发症的发生率分别为 0.9%（95%置信区间：0.3-2.3）和 3.2%（95%置信区间：1.2-6.8）（P=0.074）。在整个随访期间，未观察到显著差异。需要起搏的患者比例较低，为 0.8%。