TY - JOUR
T1 - Updated standardized endpoint definitions for transcatheter aortic valve implantation
T2 - The Valve Academic Research Consortium-2 consensus document
AU - Kappetein, A. Pieter
AU - Head, Stuart J.
AU - Généreux, Philippe
AU - Piazza, Nicolo
AU - Van Mieghem, Nicolas M.
AU - Blackstone, Eugene H.
AU - Brott, Thomas G.
AU - Cohen, David J.
AU - Cutlip, Donald E.
AU - Van Es, Gerrit Anne
AU - Hahn, Rebecca T.
AU - Kirtane, Ajay J.
AU - Krucoff, Mitchell W.
AU - Kodali, Susheel
AU - MacK, Michael J.
AU - Mehran, Roxana
AU - Rodés-Cabau, Josep
AU - Vranckx, Pascal
AU - Webb, John G.
AU - Windecker, Stephan
AU - Serruys, Patrick W.
AU - Leon, Martin B.
N1 - Funding Information:
Disclosures: N. Piazza has received consultancy fees from Medtronic, his institution has received grants/grants pending from Medtronic. E.H. Blackstone has received study support from Edwards Lifesciences consultancy fees from Edwards Lifesciences. D.J. Cohen has received consultancy fees from Medtronic, his institution has received grants/grants pending from Medtronic and Edwards Lifesciences. G.A van Es is an employee of Cardialysis BV, The Netherlands. M.W. Krucoff has received study support from Edwards Lifesciences. S. Kodali is a Board member of St. Jude Medical and Thubrikar Aortic Valve and has received consultancy fees from Medtronic and Edwards Lifesciences. R. Mehran has received consultancy fees from Astra Zeneca, Janssen (Johnson & Johnson), Regado, Abbott Laboratories, Merck Sharpe & Dohme Corp., Maya Medical. Her institution has received grants/grants pending from BMS/Sanofi, The Medicines Company, Lilly/Daiichi Sanko. J. Rodés-Cabau has received consultancy fees from Edwards Lifesciences, St. Jude Medical. J.G. Webb has received consultancy fees from Edwards Lifesciences, his institution has received grants/grants pending from Edwards Lifesciences. S. Windecker has received speakers bureaus fees from Edwards Lifesciences and Medtronic, his institution has received a Swiss National Science Foundation Grant (32003B_135807) and has grants/ grants pending from Edwards Lifesciences and Medtronic. M.B. Leon is on the advi-sory Board for Edwards Lifesciences. The others authors have declared to have no conflict of interests for this paper. The VARC meetings involved members of the Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, USFDA. The opinions or assertions herein are the private views of the authors and are not to be construed as reflect-ing the views of the FDA.
PY - 2013/1
Y1 - 2013/1
N2 - 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).
AB - 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).
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U2 - 10.1016/j.jtcvs.2012.09.002
DO - 10.1016/j.jtcvs.2012.09.002
M3 - Article
C2 - 23084102
AN - SCOPUS:84871211131
SN - 0022-5223
VL - 145
SP - 6
EP - 23
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 1
ER -