ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023

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.

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Publication Details

Journal
ASAIO Journal
Published
2024-09-27
DOI
https://doi.org/10.1097/mat.0000000000002288
Citations
5
Primary Topic
Mechanical Circulatory Support Devices
Type
article
Field-Weighted Citation Impact
0.92
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article

ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023

Jenna Murray, Christopher S. Almond, Robert Kroslowitz, Roxana Mehran et al.
5 citations
ASAIO Journal
Mechanical Circulatory Support Devices
0.92
article

ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023

Jenna Murray, Christopher S. Almond, Robert Kroslowitz, Roxana Mehran, Tanya Perry, Scott R. Auerbach, Iki Adachi, Chet Villa, Rebecca Ichord, Kevin Bourque, Joseph William Rossano, David M. Peng, Yasutaka Hirata, Matthew J. O’Connor, Pirooz Eghtesady, J. Michael Taylor, Francis D. Pagani, Peter D. Wearden, David L.S. Morales, Christina VanderPluym, Jennifer Conway, Robert L. Kormos, Ryan P. Barbaro, Angela Lorts, David N. Rosenthal, Ryan R. Davies, Robert A. Niebler, Lara Danziger‐Isakov, Peta M. A. Alexander, Ernest Spitzer, Sonya S. Bhavsar, David Sutcliffe, Marie E. Steiner, Mary Mehegan, Mitchell W. Krucoff, J. Lantz
article en
5 citations

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.

ASAIO JournalVol. 70(11)
Children's Hospital of Wisconsin (US), Cincinnati Children's Hospital Medical Center (US), Boston Children's Hospital (US), University of Minnesota (US), St. Louis Children's Hospital (US), Children's Mercy Hospital (US), Johnson & Johnson (United States) (US), Children's Hospital of Philadelphia (US), University of Alberta (CA), University of Michigan (US), Abbott (United States) (US), Children's Hospital Colorado (US), University of Tokyo Hospital (JP), Duke Medical Center (US), Abbott Fund (US), Texas Children's Hospital (US), C. S. Mott Children's Hospital (US), Abiomed (United States) (US), Stollery Children's Hospital (CA), Cardialysis (Netherlands) (NL), The University of Texas Southwestern Medical Center (US), University of Colorado Denver (US), Stanford University (US), Icahn School of Medicine at Mount Sinai (US)
Partnerships for the goals
Openalex Percentile: Top 28%
Mechanical Circulatory Support Devices
0.92
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