Contemporary Berlin Heart EXCOR Outcomes in North America: Report from the ACTION Registry

PURPOSE: Berlin Heart EXCOR was introduced in North America almost two decades ago. Field of pediatric ventricular assist device, as it relates to available devices, anticoagulation strategies and patient population, has changed since then. This study reports the outcomes of most recent cohort of EXCOR patients. METHODS: Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a learning collaborative of over 40 pediatric heart failure programs worldwide, which collects data for all ventricular assist device (VAD) implants as one of its initiatives. All EXCOR implants reported to ACTION (n=52) from April 2018 - Sep 2019 in North America were included in the analysis and compared to previously reported EXCOR study (IDE and Post Approval - n=187) and database (also include compassionate use patients at non-IDE sites - n=320) cohorts (2007-2015). RESULTS: ACTION cohort was younger, smaller in weight/BSA, more likely to have congenital heart disease (CHD) diagnosis and less likely to receive a BiVAD compared to EXCOR study and database cohorts. [Table1] Patients in the ACTION cohort were less likely to be in INTERMACS profile 1 and were supported for longer duration. Of the total, 89% (46) of the ACTION cohort was on Bivalirudin for anticoagulation. Success, defined as transplant, weaned or alive on device was 83% for the ACTION cohort. Incidence of stroke reduced by 51% and pump thrombosis reduced by 65% in the ACTION cohort compared to the EXCOR study cohort. Similarly, all other adverse events including major bleeding reduced significantly in the ACTION cohort. CONCLUSION: Use and outcome of Berlin Heart EXCOR has also evolved over time. EXCOR has experienced early implantation, more utilization in CHD, longer support duration and more importantly, improved outcomes.