Key result
A clinical risk score comprising male sex, left ventricular ejection fraction ≤25%, no CRT-D indication, and Black race identified patients with non-ischemic cardiomyopathy at a significantly increased risk for ventricular tachyarrhythmias (HR 3.29 compared to low-risk patients).
Why the study?
Clinical trial data have questioned the benefit of an ICD in patients with HF due to non-ischemic cardiomyopathy.
Can a risk stratification score based on demographic and clinical variables predict ventricular tachyarrhythmias in patients with non-ischemic cardiomyopathy receiving a primary prevention ICD?
Cohort (n=1,515)
Yes
Can a risk stratification score based on demographic and clinical variables predict ventricular tachyarrhythmias in patients with non-ischemic cardiomyopathy receiving a primary prevention ICD?
Hazard Ratio: 3.29 (95% CI 2.3–4.8)
Absolute Event Rate: 42% vs 15%
p-value: p=<0.001
A simple 4-factor clinical risk score can effectively stratify patients with non-ischemic cardiomyopathy into low, intermediate, and high risk for ventricular tachyarrhythmias, aiding in shared decision-making for primary prevention ICD implantation.
May inform shared decision-making for primary prevention ICDs in non-ischemic cardiomyopathy; leaves open prospective validation of outcome benefit.
Background The implantable cardioverter defibrillator reduces mortality among patients with heart failure (HF) due to ischemic heart disease. Clinical trial data have called into question the benefit of an ICD in patients with HF due to non-ischemic cardiomyopathy (NICM). Objective We developed a risk stratification score for ventricular tachyarrhythmia (VTA) among patients with NICM receiving a primary prevention ICD. Methods The study population comprised of 1,515 patients with NICM who were enrolled in the landmark MADIT trials. Fine and Gray analysis was used to develop a model to predict the occurrence of VTAs and ICD therapies while accounting for the competing risk of non-arrhythmic mortality. External validation was carried out in the RAID Trial population. Results Four risk factors associated with increased risk for VTA were identified: male sex, left ventricular ejection fraction ≤25%, no indication for cardiac resynchronization therapy with a defibrillator (CRT-D), and Black race. A score was generated based on this model and patients were stratified into low (N=390), intermediate (N=728), and high-risk (N=387) groups. The five-year cumulative incidences of VTA were 15%, 24%, 42% respectively. Application of score groups for the secondary endpoints of Fast VT or VF and Appropriate ICD Shock revealed similar findings. Recurrent event analysis yielded consistent results. The AUC in the validation cohort for the endpoint of Appropriate ICD Shock was 69.3. Conclusions Our study shows that patients with NICM can be risk stratified using demographic and clinical variables and may be used when evaluating such patients for a primary prevention ICD. CONDENSED ABSTRACT Data regarding the effectiveness of the ICD is lacking in patients with HF and NICM. The purpose of this study was to develop a risk score for ventricular tachyarrhythmia (VTA) among patients with NICM. We included patients from the MADIT trials to generate a risk score. Four risk factors associated with increased risk for VTA were identified and incorporated into the score. Patients were stratified into low, intermediate, and high-risk groups. The five-year cumulative incidences of VTA were 15%, 24%, 42% respectively. Our risk prediction model can support patient-physician shared decision making regarding primary ICD implantation in patients with NICM.
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Younis et al. (2023) conducted a cohort in Non-ischemic cardiomyopathy (n=1,515). High risk score (male sex, LVEF ≤25%, no CRT-D indication, Black race) vs. Low risk score was evaluated on Any ventricular tachycardia (VT) or ventricular fibrillation (VF) defined as ICD recorded, treated, or monitored sustained VT ≥170 bpm or VF (HR 3.29, 95% CI 2.3-4.8, p=<0.001). A clinical risk score comprising male sex, left ventricular ejection fraction ≤25%, no CRT-D indication, and Black race identified patients with non-ischemic cardiomyopathy at a significantly increased risk for ventricular tachyarrhythmias (HR 3.29 compared to low-risk patients).
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