What does this research mean for the field?

ICD therapy reduces all-cause mortality by 21% and sudden cardiac death by 56% in patients with non-ischemic cardiomyopathy. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the survival benefit of ICDs in non-ischemic cardiomyopathy across different treatment eras, considering the impact of contemporary therapies.

February 13, 2026Open Access

Time to rethink ICD indications in nonishemic cardiomyopathy? Evidence from a meta-analysis across therapeutic eras

Resultado clave

Primary-prevention ICDs in NICM reduce all-cause mortality (HR 0.79) and sudden cardiac death (HR 0.44), with 5-year ARR 4.4%-5.9%; projected ARR with full GDMT is 2.31%.

Puntos clave

To assess the survival benefit of ICDs in non-ischemic cardiomyopathy across different treatment eras, considering the impact of contemporary therapies.
Conducted a meta-analysis of randomized controlled trials of ICDs versus control in NICM
Included trials with patients having LVEF ≤35%
Searched MEDLINE, Embase, and CENTRAL databases for relevant studies
ICDs reduced all-cause mortality with a pooled hazard ratio of 0.79
ICDs significantly lowered sudden cardiac death risk (HR 0.44)
Five-year absolute risk reduction was 5.9% in one trial and 4.4% in another under guideline-directed therapy scenarios

PICO estructurado

Does prophylactic ICD implantation reduce all-cause mortality and sudden cardiac death in patients with non-ischemic cardiomyopathy and LVEF ≤35%?

Población

Patients with non-ischemic cardiomyopathy (NICM) and LVEF ≤35% pooled from 3 RCTs (DEFINITE, SCD-HeFT NICM subgroup, and DANISH).

Intervención

Prophylactic implantable cardioverter-defibrillator (ICD) implantation.

Comparador

Control (no ICD).

Resultado

All-cause mortality and sudden cardiac death (SCD).hard clinical

While historical trials show ICDs reduce mortality in non-ischemic cardiomyopathy, scenario-based modeling suggests the absolute benefit is substantially attenuated (projected NNT 43) in the era of contemporary comprehensive guideline-directed medical therapy.

Resultado numérico

Tasa de eventos absoluta: 0% vs 0%

Resumen

Abstract Aims Implantable cardioverter–defibrillators (ICDs) reduce sudden cardiac death (SCD) in non-ischemic cardiomyopathy (NICM), but most evidence predates comprehensive guideline-directed medical therapy (GDMT). We quantified the relative and absolute survival benefit of primary-prevention ICDs in NICM across therapeutic eras and explored how contemporary GDMT modifies absolute benefit. Methods and results We searched MEDLINE, Embase, and CENTRAL through March 2025 and included randomized controlled trials comparing prophylactic ICD implantation versus control in NICM with LVEF ≤35%. Three trials (DEFINITE, SCD-HeFT NICM subgroup, and DANISH) contributed to the quantitative synthesis. ICD therapy reduced all-cause mortality (pooled HR 0.79, 95% CI 0.66–0.95) and sudden cardiac death (HR 0.44, 95% CI 0.28–0.70). Five-year absolute risk reduction (ARR) was 5.9% (NNT 17) in SCD-HeFT NICM and 4.4% (NNT 23) in DANISH. Under a full-GDMT scenario parameterized from pharmacological RCTs, projected baseline risk was ∼11%, yielding ARR 2.31% (NNT 43). Conclusions All contemporary “GDMT-era” absolute benefit estimates are scenario-based modeling outputs. No randomized trial has evaluated ICDs on top of full modern GDMT in NICM; therefore, these results represent illustrative ranges rather than empirical estimates.

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