Lb-456090-1 contemporary outcomes of non-ischemic cardiomyopathy patients with an implanted defibrillator or cardiac resynchronization therapy (bio-libra)

The implantable cardioverter defibrillator (ICD) has been shown to improve survival in patients with non-ischemic cardiomyopathy (NICM). However, recent studies challenged the benefit of the ICD in this cohort, especially when optimal guideline-directed medical therapy (GDMT) is applied. Therefore, contemporary data on outcomes of non-ischemic cardiomyopathy patients with ICD or CRT-D on GDMT are warranted. The role of sex in this cohort remains largely unexplored due to the historical low enrollment of women in device trials (16-28%). The objective of the BIO-LIBRA study was to prospectively assess outcomes of device-treated ventricular tachyarrhythmias (VT/VF) and mortality in NICM patients with primary prevention ICD or CRT-D, with a focus on sex-differences. A study-wide minimum of 40% female enrollment was promoted during enrollment. The BIO-LIBRA study is a multi-center, prospective, observational study to enroll 1000 patients at 50 enrolling sites in the United States (Figure). Patients were implanted with BIOTRONIK ICD or CRT-Ds with Home Monitoring® to be uniformly assessed for the primary endpoint of device-treated VT or VF. Standard of care follow-up visits included 6-month follow-up visits via phone and remote monitoring, and annual in-clinic visits. Secondary endpoints included the all-cause mortality, VT or VF, cardiac death, and sudden cardiac death by sex, and by device type. Tertiary endpoints included assessment of cardiovascular and diabetes medication use and dosages, changes in medications, left ventricular reverse remodeling, inappropriate ICD therapies, and device complications. The study successfully enrolled 1000 subjects between May, 2019 and October, 2021, and recruited 475 of 1000 (47.5%) female patients, exceeding our enrollment goal of 40% women. Importantly, 30% of the enrolled subjects in BIO-LIBRA were non-white, and 9% of the subjects self-reported their ethnicity to be Hispanic/Latino, highlighting the diversity of the cohort. One-third of the patients had diabetes, and 24% reported atrial fibrillation (12% paroxysmal). We have completed one-year of follow-up for all subjects, and comprehensive data on VT, VF or death events by sex, and by device type will be presented at HRS, along with the secondary and tertiary endpoints. BIO-LIBRA enrolled a diverse cohort of patients with non-ischemic cardiomyopathy with an ICD or CRT-D, assessing VT/VF outcomes. Long-term, 3-year follow-up of the enrolled subjects is currently underway.