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Related Experiment Videos

DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE).

Andi Schaechter1, Alan H Kadish,

  • 1Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, IL, USA.

Cardiac Electrophysiology Review
|April 9, 2004
PubMed
Summary
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Implantable cardioverter-defibrillators in heart failure patients with reduced ejection fraction and diabetes.

European journal of heart failure·2018

The DEFINITE trial evaluated implantable cardioverter defibrillators (ICDs) for non-ischemic cardiomyopathy. ICDs are expected to significantly reduce mortality in high-risk heart failure patients.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Medical Devices

Background:

  • Non-ischemic cardiomyopathy (NICM) with reduced ejection fraction (
  • Standard medical therapy for heart failure may not sufficiently mitigate sudden cardiac death risk in these patients.

Purpose of the Study:

  • To evaluate the efficacy of implantable cardioverter defibrillators (ICDs) in reducing total mortality in patients with NICM.
  • To assess the impact of ICDs on quality of life and healthcare costs in this population.

Main Methods:

  • The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial was a multi-center, randomized study.
  • Patients with NICM, symptomatic heart failure, and documented arrhythmias were randomized to ICD or no ICD, alongside standard medical therapy.

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  • Follow-up was for 2-3 years, with total mortality as the primary endpoint.

    • Main Results:

    • An estimated annual mortality of 15% at 2 years was projected for the no-ICD arm.
    • ICDs were anticipated to reduce mortality by 50% in the target population.
    • The study required approximately 229 patients per group for adequate statistical power.

    Conclusions:

    • ICDs represent a potential life-saving intervention for select patients with non-ischemic cardiomyopathy and high-risk arrhythmias.
    • Further analysis of quality of life and pharmacoeconomics is crucial for comprehensive treatment evaluation.