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

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.