Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study
Open Access
- 6 May 2020
- journal article
- research article
- Published by Oxford University Press (OUP) in European Heart Journal
- Vol. 41 (36), 3437-3447
- https://doi.org/10.1093/eurheartj/ehaa226
Abstract
Aims: 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. Methods and results: 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 <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902). Conclusion: In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.Keywords
Funding Information
- European Community's Seventh Framework Programme (FP7/2007-2013, HEALTH-F2-2009-602299)
This publication has 38 references indexed in Scilit:
- Reduction in Inappropriate Therapy and Mortality through ICD ProgrammingThe New England Journal of Medicine, 2012
- Prediction of Mortality in Clinical Practice for Medicare Patients Undergoing Defibrillator Implantation for Primary Prevention of Sudden Cardiac DeathJournal of the American College of Cardiology, 2012
- An overview of the objectives of and the approaches to propensity score analysesEuropean Heart Journal, 2011
- Maximizing Survival Benefit With Primary Prevention Implantable Cardioverter-Defibrillator Therapy in a Heart Failure PopulationCirculation, 2009
- Death Without Prior Appropriate Implantable Cardioverter-Defibrillator TherapyCirculation, 2008
- The Seattle Heart Failure ModelCirculation, 2006
- Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated CardiomyopathyThe New England Journal of Medicine, 2004
- Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practiceand problemsStatistics in Medicine, 2002
- Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection FractionThe New England Journal of Medicine, 2002