Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document
Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document
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DOI：
10.1016/j.jtcvs.2012.09.002
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发表时间：
2013-01-01
影响因子：
6
通讯作者：
Leon, Martin B.
中科院分区：
文献类型：
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作者：
Kappetein, A. Pieter;Head, Stuart J.;Leon, Martin B.
目的：当前瓣膜学术研究联盟（VARC）-2倡议的目的是重新审视经导管主动脉瓣植入术（TAVI）临床终点的选择和定义，使其更适合当前和未来的临床试验需求。此外，本文件旨在扩大对患者风险分层和病例选择的理解。背景：最近的一项研究证实，VARC定义已被纳入临床和研究实践，并代表了一个新的标准，用于报告接受TAVI的症状性重度主动脉瓣狭窄（AS）患者的临床结局的一致性。然而，随着这项技术的临床经验的成熟和扩展，某些定义已经变得不合适或模糊。方法和结果：两次面对面会议（2011年9月在哥伦比亚特区华盛顿和2012年2月在荷兰鹿特丹举行）（包括外科医生、介入和非介入心脏病专家、影像学专家、神经科医生、老年病专家和临床试验专家）、美国食品药品监督管理局（FDA）和行业代表，提供了大量的实质性讨论，VARC-2共识手稿就是从这些讨论中得出的。本文件提供了风险评估和患者分层的概述，需要考虑这些风险评估和患者分层，以便准确地将患者纳入研究。分配工作组以定义以下临床终点：死亡率、卒中、心肌梗死、出血并发症、急性肾损伤、血管并发症、传导障碍和心律失常，以及包括先前未分类的相关并发症的其他类别。此外，提供了评价人工瓣膜（dys）功能的全面超声心动图建议。还报告了生活质量评估的定义。这些终点形成了几个建议的复合endpoints.Conclusions的基础上：这VARC-2文件提供了进一步的标准化终点定义的研究评估使用TAVI，这将导致提高可比性和可解释性的研究结果，提供了越来越多的证据方面TAVI和/或手术主动脉瓣置换术。此外，在当前将定义应用于其他经导管瓣膜治疗（例如，二尖瓣修复）的努力中，该倡议和文件可用作模型。（《胸血管外科杂志》2013;145：6-23）
Objectives: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection.Background: A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous.Methods and Results: Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys) function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints.Conclusions: This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). (J Thorac Cardiovasc Surg 2013;145:6-23)