Arrhythmia risk stratification with regard to prophylactic implantable defibrillator therapy in patients with dilated cardiomyopathy. Results of MACAS, DEFINITE, and SCD-HeFT.

To date, generally accepted indications for prophylactic defibrillator implantation in patients with dilated cardiomyopathy do not exist. Recently, the Marburg Cardiomyopathy Study (MACAS) revealed left ventricular ejection fraction to be the only significant arrhythmia risk predictor in a relatively large patient population with dilated cardiomyopathy. Meanwhile, the preliminary results of two prospective randomized trials evaluating prophylactic defibrillator therapy in dilated cardiomyopathy have been reported. The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study (DEFINITE) randomized 458 patients with a history of symptomatic heart failure, a left ventricular ejection fraction < or = 35% and arrhythmias on Holter to an ICD versus no ICD. As a result, ICD therapy was associated with a significant reduction of arrhythmic deaths, which failed to result in a significant decrease in total mortality due to an insufficient number of patients in DEFINITE. The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) was a three-arm study comparing placebo to amiodarone to prophylactic ICD therapy in a total of 2,521 patients with ischemic cardiomyopathy (51%) or nonischemic dilated cardiomyopathy (49%). All patients in SCD-HeFT had a left ventricular ejection fraction inverted exclamation mark U 35% despite optimized medical heart failure therapy. SCD-HeFT showed a significant reduction of total mortality in the ICD group, whereas amiodarone did not improve survival.

RCT Entities:   Population Interventions Outcomes