Erasmus University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.
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.
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.
Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional 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.
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 endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).
当前 Valve 学术研究联合会（VARC）-2 计划的目的是重新审视经导管主动脉瓣植入术（TAVI）的临床终点选择和定义，使其更适合临床试验的当前和未来需求。此外，本文件旨在扩展对患者风险分层和病例选择的理解。
最近的一项研究证实，VARC 定义已经被纳入临床和研究实践中，并且代表了一种新的标准，用于报告接受 TAVI 的有症状严重主动脉瓣狭窄（AS）患者的临床结局的一致性。然而，随着该技术的临床经验的成熟和扩展，某些定义变得不合适或模糊。
两次面对面会议（分别于 2011 年 9 月在美国华盛顿特区和 2012 年 2 月在荷兰鹿特丹举行），涉及 VARC 研究小组成员、独立专家（包括外科医生、介入和非介入心脏病专家、影像学专家、神经病学家、老年病学专家和临床研究人员）、美国食品和药物管理局（FDA）和行业代表，提供了大量实质性讨论内容，本 VARC-2 共识文件即源于此。本文提供了一个概述，介绍了需要考虑的风险评估和患者分层，以便准确地将患者纳入研究中。工作组被分配定义以下临床终点：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，以及一个包括以前未分类的相关并发症的杂项类别。此外，还提供了全面的超声心动图评估建议，以评估人工瓣膜（功能）障碍。还报告了生活质量评估的定义。这些终点构成了几个推荐的复合终点的基础。
本 VARC-2 文件进一步规范了评估 TAVI 使用的研究的终点定义，这将提高研究结果的可比性和可解释性，为 TAVI 和/或外科主动脉瓣置换术提供越来越多的证据。这一倡议和文件还可以作为当前将定义应用于其他经导管瓣膜治疗（例如二尖瓣修复）的努力的模型。
