Rationale and Design of the Comparative Effectiveness of ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients at a Low Risk for Arrhythmic Death (CONTEMP-ICD) trial.

Background: Current recommendations for a prophylactic (primary prevention) implantable cardioverter defibrillator (ICD) in patients with both ischemic and non-ischemic heart failure with reduced ejection fraction (HFrEF) originate from clinical trials conducted in selected patients over 20 years ago that showed an overall statistically significant survival benefit associated with a primary prevention ICD in the range of 23%-34%. The recent introduction of angiotensin receptor-neprilysin inhibitors [ARNI] and sodium glucose co-transporter 2 inhibitors [SGLT2i]) was shown to further reduce the risk of sudden cardiac death (SCD) in patients with HFrEF. Thus, there is an unmet need appropriately designed comparative effectiveness clinical trials aimed to reassess the survival benefit of a primary prevention ICD in contemporary patients with HFrEF.

Reassessing the need for primary prevention implantable cardioverter-defibrillators in contemporary patients with heart failure.

The main function of the implantable cardioverter-defibrillator (ICD) is to protect against sudden cardiac death (SCD) due to ventricular tachyarrhythmia (VTA). Current guidelines provide a recommendation to implant a prophylactic ICD for the primary prevention of SCD in individuals having heart failure with reduced ejection fraction (HFrEF) who never experienced a previous sustained VTA. However, these recommendations are based on clinical trials conducted more than 20 years ago and may not be applicable to contemporary patients with HFrEF who have a lower arrhythmic risk as a result of advances in heart failure medical therapies.

Reassessing the need for primary prevention implantable cardioverter-defibrillators in contemporary patients with heart failure.

The main function of the implantable cardioverter-defibrillator (ICD) is to protect against sudden cardiac death (SCD) due to ventricular tachyarrhythmia (VTA). Current guidelines provide a recommendation to implant a prophylactic ICD for the primary prevention of SCD in individuals having heart failure with reduced ejection fraction (HFrEF) who never experienced a previous sustained VTA. However, these recommendations are based on clinical trials conducted more than 20 years ago and may not be applicable to contemporary patients with HFrEF who have a lower arrhythmic risk as a result of advances in heart failure medical therapies.