Predictors of an Inadequate Defibrillation Safety Margin at ICD Implantation Insights From the National Cardiovascular Data Registry

BACKGROUND Defibrillation testing is often performed to establish effective arrhythmia termination, but predictors and consequences of an inadequate defibrillation safety margin (DSM) remain largely unknown. OBJECTIVES The aims of this study were to develop a simple risk score predictive of an inadequate DSM at implantable cardioverter-defibrillator (ICD) implantation and to examine the association of an inadequate DSM with adverse events. METHODS A total of 132,477 ICD Registry implantations between 2010 and 2012 were analyzed. Using logistic regression models, factors most predictive of an inadequate DSM (defined as the lowest successful energy tested < 10 J from maximal device output) were identified, and the association of an inadequate DSM with adverse events was evaluated. RESULTS Inadequate DSMs occurred in 12,397 patients (9.4%). A simple risk score composed of 8 easily identifiable variables characterized patients at high and low risk for an inadequate DSM, including (with assigned points) age < 70 years (1 point); male sex (1 point); race: black (4 points), Hispanic (2 points), or other (1 point); New York Heart Association functional class III (1 point) or IV (3 points); no ischemic heart disease (2 points); renal dialysis (3 points); secondary prevention indication (1 point); and ICD type: single-chamber (2 points) or biventricular (1 point) device. An inadequate DSM was associated with greater odds of complications (odds ratio: 1.22; 95% confidence interval: 1.09 to 1.37; p 0.0006), hospital stay > 3 days (odds ratio: 1.24; 95% confidence interval: 1.19 to 1.30; p < 0.0001), and in-hospital mortality (odds ratio: 1.96; 95% confidence interval: 1.63 to 2.36; p < 0.0001). CONCLUSIONS A simple risk score identified ICD recipients at risk for an inadequate DSM. An inadequate DSM was associated with an increased risk for in-hospital adverse events. (C) 2014 by the American College of Cardiology Foundation.