Electrical storm in patients with an implantable defibrillator: incidence, features, and preventive therapy: insights from a randomized trial.

The purpose of this study was to assess the incidence, features, and clinical sequelae of 'electrical storm' (ES). This study is a prospectively designed secondary analysis of SHIELD; a randomized trial of azimilide for suppression of ventricular tachycardia/fibrillation (VT/VF) leading to implanted cardioverter defibrillator (ICD) therapies. Systematic and rigorous follow-up and blinded adjudication of ICD therapy allowed identification of all ESs (>/=3 separate VT/VF episodes leading to ICD therapies within 24 h). Of 633 ICD recipients, 148 (23%) experienced at least one ES over 1-year follow-up. No clinical predictors of ES were identified. Frequent VT episodes accounted for 91% of all ESs, with the remaining being VF alone or both VT plus VF. ES led to a 3.1-fold increase in arrhythmia-related hospitalization (95% CI 2.3-4.3; P<0.0001) compared with patients with isolated VT/VF, and to a 10.2-fold increase (95% CI 6.4-16.3; P<0.0001) compared with patients without VT/VF. Compared with placebo, azimilide (75 and 125 mg/day) reduced the risk of recurrent ES by 37% (HR=0.63, 95% CI 0.35-1.11, P=0.11) and 55% (HR=0.45, 95% CI 0.23-0.87, P=0.018), respectively. However, the reduction in time-to-first ES did not reach statistical significance by both doses (75 and 125 mg) of azimilide (HR=0.82, 95% CI 0.56-1.19, P=0.29 and HR=0.69, 95% CI 0.46-1.04, P=0.07), respectively. ES is common and unpredictable in ICD recipients and it is a strong predictor of hospitalization.