Key result
Quadruple GDMT and device placement linked to lower mortality despite only ~17% utilization.
Why the study?
Limited real-world evidence exists for outcomes with contemporary guideline-directed medical therapy (GDMT) alone or with ICD/CRT-D therapy in patients with HFrEF and LVEF <=35%.
Does the number of GDMT classes prescribed and ICD/CRT-D device therapy reduce mortality risk in patients with HFrEF and LVEF ≤35%?
Observational (n=43,591)
Yes
Does the number of GDMT classes prescribed and ICD/CRT-D device therapy reduce mortality risk in patients with HFrEF and LVEF ≤35%?
In a real-world U.S. cohort of HFrEF patients with LVEF ≤35%, higher numbers of prescribed GDMT classes and ICD/CRT-D device therapy were independently associated with lower mortality risk.
Answers are grounded in this paper and cite their sources.
May support GDMT and device optimization in HFrEF; extends trial data to real-world cohorts but leaves causality open.
Background: Limited real-world evidence exists for outcomes with contemporary guideline-directed medical therapy (GDMT) or GDMT with implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy for patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤35%. Objective: The present study aimed to assess survival associated with GDMT or GDMT with ICD/CRT-D therapy. Methods: This retrospective observational study included real-world de-identified data from January 1, 2016, to December 19, 2023, from 24 U.S. institutions per participating institutional agreements (egnite Database; egnite, Inc.). Patients with a diagnosis of HFrEF and an echocardiographic study documenting LVEF ≤35% were included for analysis. Results: Of 43,591 patients with eligible index event of LVEF ≤35%, prescription history through ≥1 year preindex, and no ICD/CRT-D therapy preindex, mean ± standard deviation age at index was 71.2 ± 13.2 years; 14,805 (34.0%) patients were female. At 24 months, an estimated 99.1% (95% confidence interval [CI] 99.0%-99.2%), 89.9% (95% CI 89.7%-90.1%), 54.8% (95% CI 54.4%-55.2%), and 17.2% (95% CI 16.9%-17.5%), had ≥1, 2, 3, or all 4 GDMT classes prescribed, respectively; an estimated 15.7% (95% CI 15.3%-16.1%) had device placement. Of those without a device, by 24 months, an estimated 45.1% (95% CI 44.4%-45.7%) had a documented LVEF >35%. Counts of GDMT classes prescribed as well as ICD/CRT-D device therapy were associated with lower mortality risk in this population, even after adjustment for patient age, sex, and comorbidities. Conclusion: Both GDMT classes prescribed and device therapy were independently associated with lower mortality risk, even in the presence of more GDMT options for this more contemporary population.
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Mignone et al. (2024) conducted an observational in Heart failure with reduced ejection fraction (HFrEF) (n=43,591). Guideline-directed medical therapy (GDMT) and ICD/CRT-D therapy was evaluated on Mortality risk. At 24 months, 17.2% of patients had all 4 GDMT classes prescribed and 15.7% had device placement; both therapies were independently associated with lower mortality risk.
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