BACKGROUND: The Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device (VAD) was introduced in North America nearly 2 decades ago. The EXCOR was approved under Humanitarian Device Exemption status in 2011 and received post-market approval (PMA) in 2017 from Food and Drug Administration. Since the initial approval, the field of pediatric mechanical circulatory support has changed, specifically with regard to available devices, anticoagulation strategies, and the types of patients supported. This report summarizes the outcomes of patients supported with EXCOR from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. These data were part of the PMA surveillance study (PSS) required by the Food and Drug Administration. METHODS: ACTION is a learning collaborative of over 40 pediatric heart failure programs worldwide, which collects data for all VAD implantations as one of its initiatives. All patients in North America with EXCOR implants reported to ACTION from 2018 to 2020 (n = 72) who had met an outcome were included in the EXCOR PSS group. This was compared with a historical, previously reported Berlin Heart EXCOR study group (Berlin Heart study [BHS] group, n = 320, 2007‒2014). RESULTS: Patients in the PSS group were younger, were smaller in weight/body surface area, were more likely to have congenital heart disease, and were less likely to receive a bi-VAD than those in the BHS group. Patients in the PSS group were less likely to be in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 and were supported for a longer duration. The primary anticoagulation therapy for 92% of patients in the PSS group was bivalirudin. Success, defined as being transplanted, being weaned for recovery, or being alive on a device at 180 days after implantation, was 86% in the PSS group compared with 76% in the BHS group. Incidence of stroke was reduced by 44% and the frequency of pump exchange by 40% in the PSS group compared with those in the BHS group. Similarly, all other adverse events, including major bleeding, were reduced in the PSS group. CONCLUSIONS: The PSS data, collected through ACTION, highlight the improvement in outcomes for patients supported with EXCOR compared with the outcomes in a historical cohort. These findings may be the result of changes in patient care practices over time and collaborative learning.
Bibliographical noteFunding Information:
F.Z. is a consultant for SynCardia Systems and leads the Data Coordinating Center for the ACTION learning network. J.C. received an unrestricted educational grant from Abbott Laboratories and was a medical monitor for the PumpKIN trial. K.M. is a consultant for Berlin Heart, Heartare, Abbott Laboratories, and Abiomed. D.L.S.M. is a consultant for Abbott Laboratories, Berlin Heart, Comatrix/Azyio, Medtronic, and SynCardia Systems. A.L. reports receiving grants from Berlin Heart and grants and personal fees from Abbott Laboratories and Medtronic. H.B. is a consultant for Abbott Laboratories. D.M.P. received travel expenses from Abbott Laboratories. R.A.N. received travel expenses from Abbott Laboratories and Berlin Heart. The remaining authors have no conflicts of interest to disclose.
ACTION has received funding from Medtronic, Abbott Laboratories, SynCardia, and Berlin Heart.
© 2021 International Society for Heart and Lung Transplantation
- ACTION Learning Network
- Berlin Heart EXCOR
- pediatric mechanical circulatory support
- post-approval surveillance
- real-world data