THE FRAIL-D STUDY: ASSESSING FRAILTY AS A RISK FACTOR FOR OUTCOMES IN PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS FOR PRIMARY PREVENTION

Abstract

Frailty is a biological syndrome characterized by decreased physiological reserve and vulnerability to stressors. The prevalence in community dwelling individuals aged ≥ 65 years ranges from 10 to 60%, depending on comorbidities. In the peri-operative setting, the frail patient is at increased risk of mortality and morbidity when compared to the non-frail patient. While frailty assessments have been utilized in many cardiovascular conditions, there are no studies applying frailty assessments in patients undergoing an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT). To determine the prevalence of frailty in patients whom underwent ICD or CRT-D for primary prevention of sudden cardiac death (SCD), and to analyze the impact of frailty on mortality, emergency room presentations, hospitalization, appropriate and inappropriate shocks and device therapy. The FRAIL-D study is a prospective cohort study of consecutive patients aged 65 or older, who were accepted for ICD or CRT-D for primary prevention of SCD between December 2014 and December 2016. Frailty assessment was determined at baseline using the Fried Frailty Score. Follow up assessments are performed at 1, 6, 12, and 24 months post device implantation. Of 77 patients included, 12 (15.6%) met criteria for frailty at baseline. Characteristics of frail and non-frail patients are presented in table 1. Six month follow up outcome data is available for 63 patients. Seventeen patients presented to emergency, 50% in the frail group vs 20% of non-frail patients (p=0.07), 10 were hospitalized, 25% in the frail group and 12% in the non-frail group (p=0.19). There was one death in the frail group. Device therapy rates were low, but a larger proportion of frail patients received both appropriate and inappropriate therapy. The prevalence of frailty among patients receiving a primary prevention ICD or CRT-D is comparable to that of the community-dwelling elderly population. Six month follow-up results suggest a trend towards frailty as a risk factor for mortality and morbidity post ICD or CRT-D insertion. Longer term follow up is planned.