Safety of Sports for Patients with Subcutaneous Implantable Cardioverter Defibrillator (SPORT S-ICD): study rationale and protocol

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Heart Rhythm O2 Pub Date : 2024-03-01 DOI:10.1016/j.hroo.2024.01.007

Ehud Chorin MD, PhD , Rachel Lampert MD , Nick R. Bijsterveld MD, PhD , Reinoud E. Knops MD, PhD , Arthur A.M. Wilde MD , Hein Heidbuchel MD, PhD, FEHRA, FESC , Andrew Krahn MD , Ilan Goldenberg MD , Raphael Rosso MD , Dana Viskin MD , Shir Frydman MD , Lior Lupu MD , Sami Viskin MD

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Abstract

Background

Recent studies suggest that participation in recreational and even competitive sports is generally safe for patients with implantable cardioverter-defibrillators (ICDs). However, these studies included only patients with implanted transvenous ICD (TV-ICD). Nowadays, subcutaneous ICD (S-ICD) is a safe and effective alternative and is increasingly implanted in younger ICD candidates. Data on the safety of sport participation for patients with implanted S-ICD systems is urgently needed.

Objectives

The goal of the study is to quantify the risks (or determine the safety) of sports participation for athletes with an S-ICD, which will guide shared decision making for athletes requiring an ICD and/or wishing to return to sports after implantation.

Methods

The SPORT S-ICD (Sports for Patients with Subcutaneous Implantable Cardioverter Defibrillator) study is an international, multicenter, prospective, noninterventional, observational study, designed specifically to collect data on the safety of sports participation among patients with implanted S-ICD systems who regularly engage in sports activities.

Results

A total of 450 patients will undergo baseline assessment including baseline characteristics, indication for S-ICD implantation, arrhythmic history, S-ICD data and programming, and data regarding sports activities. LATITUDE Home Monitoring information will be regularly transferred to the study coordinator for analysis.

Conclusion

The results of the study will aid in shaping clinical decision making, and if the tested hypothesis will be proven, it will allow the safe continuation of sports for patients with an implanted S-ICD

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皮下植入式心律转复除颤器（SPORT S-ICD）患者的运动安全性：研究原理和方案

背景最近的研究表明，对于植入式心律转复除颤器（ICD）的患者来说，参加娱乐性甚至竞技性体育运动一般都是安全的。然而，这些研究只包括植入经静脉 ICD（TV-ICD）的患者。如今，皮下 ICD（S-ICD）是一种安全有效的替代方法，越来越多的年轻 ICD 候选者开始使用这种方法。本研究的目的是量化植入 S-ICD 的运动员参加体育运动的风险（或确定其安全性），从而为需要 ICD 和/或植入后希望重返赛场的运动员共同决策提供指导。方法 SPORT S-ICD（皮下植入式心律转复除颤器患者的体育运动）研究是一项国际性、多中心、前瞻性、非介入、观察性研究，旨在收集定期参加体育活动的植入 S-ICD 系统的患者参加体育运动的安全性数据。结果共有 450 名患者将接受基线评估，包括基线特征、S-ICD 植入指征、心律失常病史、S-ICD 数据和编程以及体育活动相关数据。LATITUDE 家庭监测信息将定期传送给研究协调员进行分析。结论这项研究的结果将有助于临床决策的制定，如果测试假设得到证实，将允许植入 S-ICD 的患者安全地继续进行体育运动。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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