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March 17, 2020European Heart Journal158 citationsOpen Access

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

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MZMarkus ZabelRWRik WillemsALAndrzej Lubiński

Key Result

Primary prophylactic ICD implantation was associated with lower all-cause mortality compared to no ICD (5.6% vs 9.2% annualized mortality; HR 0.682; 95% CI 0.537-0.865; P=0.0016).

Study Design

Type

Cohort (n=2,247)

Multicenter

Yes

Structured PICO

Does primary prevention ICD therapy reduce all-cause mortality in patients with ischaemic or dilated cardiomyopathy and guideline indications?

P
Population
2,247 patients with ischaemic or dilated cardiomyopathy and guideline indications for prophylactic ICD implantation, followed for a mean of 2.4 years.
E
Exposure
Primary prevention implantable cardioverter-defibrillator (ICD) therapy
C
Comparator
No ICD therapy (controls)
O
Outcome
All-cause mortalityhard clinical

Primary prevention ICD therapy is associated with a significant reduction in all-cause mortality in patients with ischaemic or dilated cardiomyopathy in a contemporary European cohort.

Main Result

Hazard Ratio: 0.682 (95% CI 0.537–0.865)

Absolute Event Rate: 5.6% vs 9.2%

p-value: p=0.0016

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

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Cite This Study

Zabel et al. (2020) conducted a cohort in Ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) (n=2,247). Primary prophylactic implantable cardioverter-defibrillator (ICD) vs. No ICD was evaluated on all-cause mortality (HR 0.682, 95% CI 0.537-0.865, p=0.0016). Primary prophylactic ICD implantation was associated with lower all-cause mortality compared to no ICD (5.6% vs 9.2% annualized mortality; HR 0.682; 95% CI 0.537-0.865; P=0.0016).

synapsesocial.com/papers/6a958c4750ceddc3e5f577a8https://doi.org/10.1093/eurheartj/ehaa226
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