TY - JOUR
T1 - ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023
AU - Lorts, Angela
AU - VAnderPluym, Christin A.
AU - Adachi, Lki
AU - Perry, Tanya
AU - AlexAnder, Peta M.A.
AU - Almond, Christo Pher S.
AU - AuerbaCh, Scott R.
AU - Barbaro, Ryan P.
AU - Bhavasar, Sonya
AU - Bourque, Kevin
AU - Conway, Jennifer
AU - Danziger-IsAkov, Laraa
AU - Davies, Ryan R.
AU - Eghtesady, Pirooz
AU - Hirata, Yasutaka
AU - Ichord, Rebecca N.
AU - Kormos, Robert L.
AU - Kroslowitz, Robert
AU - Krucoff, Mitchell
AU - Lantz, Jodie
AU - Mehegan, Mary
AU - Mehran, Roxana
AU - Morales, david L.S.
AU - Murray, Jenna
AU - Niebler, Robert A.
AU - O’Connor, matthew J.
AU - Pagani, Francis D.
AU - Peng, david M.
AU - Rossano, Joseph W.
AU - Spitzer, Ernest
AU - Steiner, Marie E.
AU - Sutcliffe, david L.
AU - Taylor, J. Michael
AU - Villa, Chet R.
AU - Wearden, Peter D.
AU - RosenthAl, David
N1 - Publisher Copyright:
Copyright © ASAIO 2024.
PY - 2024/11/1
Y1 - 2024/11/1
N2 - 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.
AB - 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.
KW - ACTION
KW - Adult Congenital Heart
KW - adverse event definitions
KW - pediatric
KW - ventricular assist device
UR - http://www.scopus.com/inward/record.url?scp=85206439701&partnerID=8YFLogxK
U2 - 10.1097/MAT.0000000000002288
DO - 10.1097/MAT.0000000000002288
M3 - Article
C2 - 39330959
AN - SCOPUS:85206439701
SN - 1058-2916
VL - 70
SP - 911
EP - 919
JO - ASAIO Journal
JF - ASAIO Journal
IS - 11
ER -