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Safety and Efficacy of the Subcutaneous Implantable Defibrillator. Multiple randomized, multicenter trials have established the role of the implantable cardioverter-defibrillator (ICD) in the treatment and prevention of sudden cardiac death. However, transvenous ICD leads have significant short- and long-term complications, offsetting some of the benefit of this therapy. This has led to the development of the entirely subcutaneous ICD. This system is safe and effective, avoiding the need for intravascular leads. It is best suited for patients at low risk for pacing and increased risk for transvenous lead complications. Ongoing randomized and long-term registries will help identify the optimal role of this device in clinical practice.