ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023.
Publication/Presentation Date
11-1-2024
Abstract
Adverse events (AEs) experienced by children and adults with congenital heart disease (CHD) on ventricular assist devices (VADs) are sometimes unique to these populations. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation. Data from the ACTION registry and adjudication committee were used to adapt general mechanical circulatory support ARC definitions. This ACTION-ARC international expert panel of trialists, clinicians, patients, families, statisticians, biomedical engineers, device developers, and regulatory agencies drafted and iterated definitions harmonized to ACTION data and existing literature during sessions conducted between December 2022 and May 2023, followed by dissemination across clinical/research audiences and professional organizations and further revision. Both email-linked, internet-based surveys and in-person discussions were used as a modified Delphi process. Nineteen AE types were identified and defined, including seven new event types and six event types that were deleted and will no longer be collected, achieving consensus. ACTION-ARC paired rigorous development with methodical stakeholder involvement and dissemination to define pediatric VAD AEs to facilitate assimilation of data across future clinical trials and evaluation of devices for VAD-supported children and adults with CHD.
Volume
70
Issue
11
First Page
911
Last Page
919
ISSN
1538-943X
Published In/Presented At
Lorts, A., VanderPluym, C., Adachi, I., Perry, T., Alexander, P. M. A., Almond, C. S., Auerbach, S. R., Barbaro, R. P., Bhavsar, S., Bourque, K., Conway, J., Danziger-Isakov, L. A., Davies, R. R., Eghtesady, P., Hirata, Y., Ichord, R. N., Kormos, R. L., Kroslowitz, R., Krucoff, M., Lantz, J., … Rosenthal, D. (2024). ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023. ASAIO journal (American Society for Artificial Internal Organs : 1992), 70(11), 911–919. https://doi.org/10.1097/MAT.0000000000002288
Disciplines
Medicine and Health Sciences | Pediatrics
PubMedID
39330959
Department(s)
Department of Pediatrics
Document Type
Article