The purpose of this study is to assess the effectiveness of defibrillation testing (DT) in patients undergoing implantable cardioverter-defibrillator (ICD) insertion. Although DT is considered a standard procedure during ICD implantation,its usefulness has not been definitively proven. The SAFE-ICD (Safety of Two Strategies of ICD Management at Implantation) study is a prospective observational study designed to evaluate the outcome of 2 strategies:performing defibrillation testing (DT+) versus not performing defibrillation testing (DT−) during de novo ICD implants. No deviation from the centers’current practice was introduced. In all,2,120 consecutive patients (836 DT+ and 1,284 DT−) age ≥18 years were enrolled at 41 Italian centers from April 2008 to May 2009 and followed up for 24 months until June 2011. The primary endpoint was a composite of severe complications at ICD implant and sudden cardiac death or resuscitation at 2 years. The primary endpoint occurred in 34 patients:12 intraoperative complications (8 in DT+ group;4 in DT− group) and 22 during follow-up (10 in DT+ group;12 in DT− group). Overall,the estimated yearly incidence (95% confidence interval) was DT+ 1.15% (0.73 to 1.83) and DT− 0.68% (0.42 to 1.12). The difference between the 2 groups was negligible:0.47% per year (−0.15 to 1.10). Mortality from any cause was similar at 2 years (adjusted hazard ratio:0.97 [0.76 to 1.23],p = 0.80). In this large cohort of new ICD implants,event rates were similar and extremely low in both groups. These data indicate a limited clinical relevance for DT testing,thus supporting a strategy of omitting DT during an ICD implant. (Safety of Two Strategies of ICD Management at Implantation [SAFE-ICD];NCT00661037)
Journal of the American College of Cardiology Current Issue
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