title: Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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 echocardiography 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).
authors.affiliation: Erasmus MC, Rotterdam, the Netherlands. a.kappetein@erasmusmc.nl
authors.forename: A Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Head
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: van Mieghem
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Brott
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: van Es
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000047:Academies and Institutes; D001024:Aortic Valve Stenosis / Q000601:surgery*; D035843:Biomedical Research; D006328:Cardiac Catheterization / Q000592:standards*; D003245:Consensus Statements as Topic; D019918:Heart Valve Prosthesis Implantation / Q000379:methods / Q000592:standards*; D006801:Humans