Key result
Prospective observational study evaluates sex and device differences in ICD and CRT outcomes for NICM.
Why the study?
Outcomes in patients with nonischemic cardiomyopathy and low ejection fraction receiving an ICD or CRT-D, particularly differences by sex in contemporary real-life cohorts, are not fully understood.
How do sex and device type affect the combined risk of all-cause mortality and treated VT/VF in patients with nonischemic cardiomyopathy receiving an ICD or CRT-D?
Observational (n=1,000)
Yes
How do sex and device type affect the combined risk of all-cause mortality and treated VT/VF in patients with nonischemic cardiomyopathy receiving an ICD or CRT-D?
The BIO-LIBRA study is designed to prospectively evaluate sex- and device-specific differences in mortality and ventricular tachyarrhythmias among patients with nonischemic cardiomyopathy receiving an ICD or CRT-D.
BACKGROUND: Outcomes of patients with nonischemic cardiomyopathy and low ejection fraction implanted with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with a defibrillator (CRT-D), especially in contemporary, real-life cohorts, are not fully understood. OBJECTIVE: We aimed to better characterize outcomes of death and ventricular tachyarrhythmias in patients with nonischemic cardiomyopathy, implanted with an ICD or CRT-D, and specifically assess differences by sex. METHODS: The AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy (BIO-LIBRA) study was designed to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality events in nonischemic cardiomyopathy patients, indicated for an ICD or CRT-D implantation for the primary prevention of sudden cardiac death (SCD), with a specific focus on sex differences. We will enroll a total of 1000 subjects across 50 U.S. sites and follow patients for up to 3 years. RESULTS: The primary objective of BIO-LIBRA is to evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type. We will also assess all-cause mortality, VT or VF alone, cardiac death, and SCD in the total cohort, as well as by subject sex and by the implanted device type. In addition, the previously validated Seattle Proportional Risk Model (SPRM) will be used to compare the SPRM predicted incidence of SCD to the observed incidence. CONCLUSIONS: The BIO-LIBRA study will provide novel and contemporary information regarding outcomes in patients with a NICM who receive a defibrillator.
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Kutyifa et al. (2020) conducted an observational in nonischemic cardiomyopathy (n=1,000). ICD or CRT-D was evaluated on combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events. Implantable cardioverter-defibrillator and cardiac resynchronization therapy outcomes will be prospectively evaluated for sex and device differences in 1000 patients with nonischemic cardiomyopathy.
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