Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study

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.

Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study

“…The primary endpoint all-cause mortality was visualized by Kaplan-Meier curves and analysed by Cox proportional hazards models stratified by region, which was scrutinized using standard model diagnostics including visual checks of the proportionality assumption. In order to consider possible differences in baseline variables, the primary analyses were adjusted for potential confounders which were selected based on a stepwise procedure using a p-value criterion with a two-sided level of 10% as threshold for entry and stay [13] . This resulted in a list of covariates including age, gender, NYHA class, body mass index, LVEF, diastolic blood pressure, QTc interval duration, creatinine, haemoglobin, and history or presence of atrial fibrillation, COPD or diabetes mellitus.…”

The year in cardiovascular medicine 2020: arrhythmias

“…Dva registra primarne prevencije ICD-a koja primjenjuju bodovanje sklonosti pokazali su korisne učinke, ali su se razlikovali u pogledu učinkovitosti ICD-a u žena i starijih osoba. 56,57 Radi predviđanja iznenadne aritmijske smrti (SAD) kod koronarne bolesti srca, istraživači su u studiji PRE-DETERMINE integrirali EKG ocjenu rizika s konvencionalnim kardiovaskularnim parametrima. EKG ocjena visokog rizika koja uključuje susjedne Q-valove, hipertrofiju lijeve klijetke, trajanje QRS-a, i produljenje JTc bilo je jače povezano sa SAD-om nego s ne-SAD-om (prilagođeni HR 2,87 prema 1,38) i udio smrtnih slučajeva zbog SAD-a bio je veći u skupinama s visokim u odnosu prema niskom riziku (24,9 % prema 16,5 %).…”

“…Two primary prevention ICD registries applying propensity scoring showed beneficial effects but differed concerning efficacy of ICD in women and elderly. 56,57 To predict sudden arrhythmic death (SAD) in coronary artery disease, the PRE-DETERMINE investigators integrated an ECG risk score with conventional cardiovascular parameters. A high-risk ECG score incorporating contiguous Q waves, LV hypertrophy, QRS duration, and JTc prolongation was more strongly associated with SAD than non-SAD (adjusted hazard ratios 2.87 vs. 1.38) and the proportion of deaths due to SAD was greater in the high vs. low risk groups (24.9% vs. 16.5%).…”

Jahresbericht 2018 des Deutschen Herzschrittmacher- und Defibrillator-Registers – Teil 2: Implantierbare Kardioverter-Defibrillatoren (ICD)

“…11). Ob dies ausschließlich auf die Ergebnisse der DANISH-Studie [10] zurückzuführen ist, die inzwischen überdies auch nicht unwidersprochen geblieben ist [11], sei dahingestellt. Bei der ICD-Systemauswahl (.…”