Frailty and Risk of Death Without Device Therapy Among Patients with Primary Prophylaxis Implantable Cardioverter-Defibrillators: The CERTITUDE Registry.
Academic Article
Overview
abstract
BACKGROUND: Frailty is common among patients with heart failure and is associated with non-arrhythmic morbidity and mortality. Whether frailty assessment can be used to improve risk stratification among patients undergoing primary prevention implantable cardioverter-defibrillator (ICD) placement is unknown. OBJECTIVE: This study examined the association between frailty and death without ICD therapy following ICD implantation among patients with heart failure. METHODS: We used data from the Biotronik CERTITUDE Registry linked to Medicare claims to identify adults aged ≥66 years with heart failure who underwent primary prevention ICD implantation between 1/1/2015 and 12/22/2022. Frailty was assessed using the validated Claims-Based Frailty Index (CFI) and stratified into robust (CFI <0.15), pre-frail (CFI 0.15-0.25), and frail (CFI ≥0.25) groups. RESULTS: Among 1060 adults with heart failure who underwent primary prevention ICD implantation, 12.1% (128) were identified as frail. The primary outcome of death without ICD therapy for up to 5-years increased stepwise across frailty groups (16.5% in robust, 26.3% in pre-frail, 45.3% in frail; p<0.001), with a similar pattern observed for all-cause mortality (26.3%, 37.3%, 55.5%, respectively; p<0.001). After adjusting for age, sex, and comorbidities, frailty remained associated with death without ICD therapy (frail vs. robust; HR 1.92, 95% CI 1.12-3.29) and mortality (frail vs. robust; HR 1.66, 95% CI 1.07-2.58). The frailty threshold (CFI=0.20) identified the point where predicted 5-year risk of death without ICD therapy exceeded risk of ICD therapy. CONCLUSION: Frailty is associated with higher risks of death without ICD therapy and all-cause mortality among patients undergoing primary prevention ICD.
