F irst introduced to clinical practice in 1980,1 the implantable cardioverter-defibrillator (ICD) improves survival in patients at high risk for sudden cardiac death. [2][3][4][5] Randomized, multicenter studies have shown a relative risk reduction in total mortality of up to 54% and an arrhythmic mortality reduction of 50% to 70%. Offsetting this mortality benefit, however, are significant acute and chronic morbidities associated with the use of transvenous leads.6-9 Procedure-related transvenous lead complications include major events such as lead dislodgement, pneumothorax, cardiac perforation, pericardial effusion, and cardiac tamponade. Chronic transvenous lead complications include systemic infections as well as insulation breaches and conductor coil breaks, which can cause inappropriate shocks and physical trauma to the heart and may render ICD therapy unavailable. The lead is the most common failure mechanism for a transvenous ICD system, and patients often outlive the useful life of the lead.
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Editorial see p 938 Clinical Perspective on p 953The long-term complications associated with the transvenous ICD leads have been a rationale to develop a totally subcutaneous ICD (S-ICD). The S-ICD System (Cameron Health/Boston Scientific) senses, detects, and treats malignant ventricular tachycardia (VT)/ventricular fibrillation (VF) but leaves the heart and vasculature untouched. The subcutaneous pulse generator and electrode are placed extrathoracically, and no part of the system is exposed to most of the risks associated Background-The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results-This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: Th...