皮下植入式心脏复律除颤器系统的上市后研究。

Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System.

机构信息

Medical University of South Carolina, Charleston, South Carolina, USA.

Emory University School of Medicine, Atlanta, Georgia, USA.

出版信息

J Am Coll Cardiol. 2023 Aug 1;82(5):383-397. doi: 10.1016/j.jacc.2023.05.034.

DOI:10.1016/j.jacc.2023.05.034

PMID:37495274

Abstract

BACKGROUND

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to avoid complications related to transvenous implantable cardioverter-defibrillator (TV-ICD) leads. Device safety and efficacy were demonstrated previously with atypical clinical patients or limited follow-up.

OBJECTIVES

The S-ICD PAS (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study) is a real-world, multicenter, registry of U.S. centers that was designed to assess long-term S-ICD safety and efficacy in a diverse group of patients and implantation centers.

METHODS

Patients were enrolled in 86 U.S. centers with standard S-ICD indications and were observed for up to 5 years. Efficacy endpoints were first and final shock efficacy. Safety endpoints were complications directly related to the S-ICD system or implantation procedure. Endpoints were assessed using prespecified performance goals.

RESULTS

A total of 1,643 patients were prospectively enrolled, with a median follow-up of 4.2 years. All prespecified safety and efficacy endpoint goals were met. Shock efficacy rates for discrete episodes of ventricular tachycardia or ventricular fibrillation were 98.4%, and they did not differ significantly across follow-up years (P = 0.68). S-ICD-related and electrode-related complication-free rates were 93.4% and 99.3%, respectively. Only 1.6% of patients had their devices replaced by a TV-ICD for a pacing need. Cumulative all-cause mortality was 21.7%.

CONCLUSIONS

In the largest prospective study of the S-ICD to date, all study endpoints were met, despite a cohort with more comorbidities than in most previous trials. Complication rates were low and shock efficacy was high. These results demonstrate the 5-year S-ICD safety and efficacy for a large, diverse cohort of S-ICD recipients. (Subcutaneous Implantable Cardioverter-Defibrillator [S-ICD] System Post Approval Study [PAS]; NCT01736618).

摘要

背景

皮下植入式心律转复除颤器（S-ICD）的研发旨在避免与经静脉植入式心律转复除颤器（TV-ICD）导线相关的并发症。此前已有研究证明该设备的安全性和有效性，但这些研究纳入的是临床特征不典型的患者或随访时间有限的患者。

目的

S-ICD PAS（皮下植入式心律转复除颤器系统上市后研究）是一项在美国多个中心开展的真实世界、多中心注册研究，旨在评估 S-ICD 在一组不同患者和植入中心中的长期安全性和有效性。

方法

符合标准 S-ICD 适应证的患者入组 86 家美国中心，观察时间最长达 5 年。有效性终点为首次和最终电击有效性。安全性终点为与 S-ICD 系统或植入程序直接相关的并发症。使用预设的性能目标评估终点。

结果

共前瞻性纳入 1643 例患者，中位随访时间为 4.2 年。所有预设的安全性和有效性终点目标均达到。离散性室性心动过速或心室颤动发作的电击有效性率为 98.4%，且随随访年限的不同无显著差异（P=0.68）。S-ICD 相关和电极相关无并发症率分别为 93.4%和 99.3%。仅有 1.6%的患者因起搏需求更换为 TV-ICD。累积全因死亡率为 21.7%。

结论

在迄今为止最大规模的 S-ICD 前瞻性研究中，尽管患者的合并症较大多数既往试验更多，但所有研究终点均达到。并发症发生率低，电击有效性高。这些结果表明，在一个大型、多样化的 S-ICD 患者队列中，S-ICD 可实现 5 年的安全性和有效性。（皮下植入式心律转复除颤器[S-ICD]系统上市后研究[PAS]；NCT01736618）。