Po-686-08 characteristics and outcomes of patients with non-ischemic cardiomyopathy in a contemporary us cohort

Contemporary data on sex-specific outcomes in non-ischemic cardiomyopathy with ICD or CRT-D are scarce, limited by low enrollment of women in device clinical studies. The objective of the Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy (BIO-LIBRA) study was to prospectively assess outcomes of device-treated ventricular tachyarrhythmias (VT/VF) and mortality in 1000 non-ischemic cardiomyopathy patients with primary prevention ICD or CRT-D, with a specific focus on sex-differences. In order to ensure sufficient sample size to evaluate sex-specific outcomes, a study-wide minimum of 40% female enrollment was promoted. In the first interim analysis of this multi-center, prospective, observational registry, we are reporting on characteristics and outcomes of 500 subjects, enrolled at 48 U.S. centers, implanted with BIOTRONIK ICD or CRT-D with Home Monitoring.® Patients were enrolled between May 7, 2019 and August 25, 2020. Follow-up visits included 6-month remote follow-up visits, and annual in-clinic visits. The primary endpoint was VT/VF or death. In BIO-LIBRA, we enrolled 233 of 500 (47%) female patients, exceeding our enrollment goal of 40%. The mean age was 62 years, LVEF was 30%, and 37% of the patients were non-white. Beta-blockers were prescribed in 92%, while ACE-Inhibitor and/or Angiotensin Receptor Blockers were only prescribed in 80% at the time of device implantation. There was a significantly lower rate of one-year probability of VT/VF/death with a 7% rate in women and a 13% rate in men (Z-test p-value=0.024) (Figure 1). The one-year probability of VT/VF/death was 12% in patients with an implanted ICD and 8% in those with CRT-D (Z-test p-value=0.208). This is the first prospective study evaluating VT/VF/death rates in a large cohort of contemporary patients with non-ischemic cardiomyopathy from the United States since the DANISH study, implanted with an ICD or CRT-D, enrolling almost 50% of women. Guideline-directed ACE-Inhibitor/Angiotensin Receptor Blocker use at the time of device implantation was lower than expected. Significant differences were observed in the one-year VT/VF/death rate by sex but not by the implanted device type.