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

IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL ASAIO Journal Pub Date : 2024-11-01 Epub Date: 2024-09-27 DOI:10.1097/MAT.0000000000002288
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
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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.

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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。
患有先天性心脏病(CHD)的儿童和成人在使用心室辅助装置(VAD)时发生的不良事件(AEs)有时是这些人群特有的。高级心脏治疗改善结果网络(ACTION)和学术研究联盟(ARC)旨在统一儿科和先天性心脏病 AE 的定义,以便用于临床试验、登记和监管评估。来自 ACTION 登记处和评审委员会的数据被用于调整 ARC 的一般机械循环支持定义。由试验专家、临床医生、患者、家属、统计学家、生物医学工程师、设备开发商和监管机构组成的 ACTION-ARC 国际专家小组在 2022 年 12 月至 2023 年 5 月期间举行的会议上起草并反复修改了与 ACTION 数据和现有文献相一致的定义,随后在临床/研究受众和专业组织中进行传播并进一步修订。作为一种改良的德尔菲流程,我们采用了电子邮件链接、基于互联网的调查和面对面讨论两种方式。确定并定义了 19 种 AE 类型,其中包括 7 种新事件类型和 6 种已删除且不再收集的事件类型,并达成了共识。ACTION-ARC 将严格的开发与有条不紊的利益相关者参与和传播结合起来,对儿科 VAD AE 进行定义,以促进未来临床试验数据的吸收,并对 VAD 支持的儿童和成人先天性心脏病患者的设备进行评估。
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来源期刊
ASAIO Journal
ASAIO Journal 医学-工程:生物医学
CiteScore
6.60
自引率
7.10%
发文量
651
审稿时长
4-8 weeks
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.
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