Angela Lorts, Christina VanderPluym, Iki Adachi, Tanya Perry, Peta M A Alexander, Christopher S Almond, Scott R Auerbach, Ryan P Barbaro, Sonya Bhavsar, Kevin Bourque, Jennifer Conway, Lara A Danziger-Isakov, Ryan R Davies, Pirooz Eghtesady, Yasutaka Hirata, Rebecca N Ichord, Robert L Kormos, Robert Kroslowitz, Mitchell Krucoff, Jodie Lantz, Mary Mehegan, Roxana Mehran, David L S Morales, Jenna Murray, Robert A Niebler, Matthew J O'Connor, Francis D Pagani, David M Peng, Joseph W Rossano, Ernest Spitzer, Marie E Steiner, David L Sutcliffe, J Michael Taylor, Chet R Villa, Peter D Wearden, David Rosenthal
{"title":"ACTION-ARC 儿童和成人先天性心脏病心室辅助装置不良事件定义--2023。","authors":"Angela Lorts, Christina VanderPluym, Iki Adachi, Tanya Perry, Peta M A Alexander, Christopher S Almond, Scott R Auerbach, Ryan P Barbaro, Sonya Bhavsar, Kevin Bourque, Jennifer Conway, Lara A Danziger-Isakov, Ryan R Davies, Pirooz Eghtesady, Yasutaka Hirata, Rebecca N Ichord, Robert L Kormos, Robert Kroslowitz, Mitchell Krucoff, Jodie Lantz, Mary Mehegan, Roxana Mehran, David L S Morales, Jenna Murray, Robert A Niebler, Matthew J O'Connor, Francis D Pagani, David M Peng, Joseph W Rossano, Ernest Spitzer, Marie E Steiner, David L Sutcliffe, J Michael Taylor, Chet R Villa, Peter D Wearden, David Rosenthal","doi":"10.1097/MAT.0000000000002288","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8844,"journal":{"name":"ASAIO Journal","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023.\",\"authors\":\"Angela Lorts, Christina VanderPluym, Iki Adachi, Tanya Perry, Peta M A Alexander, Christopher S Almond, Scott R Auerbach, Ryan P Barbaro, Sonya Bhavsar, Kevin Bourque, Jennifer Conway, Lara A Danziger-Isakov, Ryan R Davies, Pirooz Eghtesady, Yasutaka Hirata, Rebecca N Ichord, Robert L Kormos, Robert Kroslowitz, Mitchell Krucoff, Jodie Lantz, Mary Mehegan, Roxana Mehran, David L S Morales, Jenna Murray, Robert A Niebler, Matthew J O'Connor, Francis D Pagani, David M Peng, Joseph W Rossano, Ernest Spitzer, Marie E Steiner, David L Sutcliffe, J Michael Taylor, Chet R Villa, Peter D Wearden, David Rosenthal\",\"doi\":\"10.1097/MAT.0000000000002288\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":8844,\"journal\":{\"name\":\"ASAIO Journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ASAIO Journal\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1097/MAT.0000000000002288\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ASAIO Journal","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1097/MAT.0000000000002288","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/27 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
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.
期刊介绍:
ASAIO Journal is in the forefront of artificial organ research and development. On the cutting edge of innovative technology, it features peer-reviewed articles of the highest quality that describe research, development, the most recent advances in the design of artificial organ devices and findings from initial testing. Bimonthly, the ASAIO Journal features state-of-the-art investigations, laboratory and clinical trials, and discussions and opinions from experts around the world.
The official publication of the American Society for Artificial Internal Organs.