The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic
Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated,
controlled cohort study, was conducted in 44 centres and 15 European countries. It
aimed to assess current clinical effectiveness of primary prevention ICD therapy.We
recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy
(DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint
was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead
Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and
follow-up (FU) data from 2247 patients were analysable, 1516 patients before first
ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable
models and propensity scoring for adjustment were used to compare the two groups for
mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized
mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD
treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537-0.865,
P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection
fraction (LVEF), New York Heart Association class
