Updated standardized endpoint definitions for transcatheter aortic valve implantation

The valve academic research consortium-2 consensus document (varc-2)

Arie Pieter Kappetein, Stuart J. Head, Philippe Genereux, Nicolo Piazza, Nicolas M. Van Mieghem, Eugene H. Blackstone, Thomas G. Brott, David J. Cohen, Donald E. Cutlip, Gerrit Anne Van Es, Rebecca T. Hahn, Ajay J. Kirtane, Mitchell W. Krucoff, Susheel Kodali, Michael J. Mack, Roxana Mehran, Josep Rodés-Cabau, Pascal Vranckx, John G. Webb, Stephan Windecker & 2 others Patrick W. Serruys, Martin B. Leon

Research output: Contribution to journalArticle

294 Citations (Scopus)

Abstract

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, USA, and in February 2012 in Rotterdam, 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. 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 endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved.

Original languageEnglish (US)
JournalEuropean Journal of Cardio-thoracic Surgery
Volume42
Issue number5
DOIs
StatePublished - Jan 1 2012
Externally publishedYes

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Research
Manuscripts
Aortic Valve Stenosis
Drug Industry
Aortic Valve
Mitral Valve
Acute Kidney Injury
Surgical Instruments
Geriatrics
Netherlands
Thoracic Surgery
Blood Vessels
Transcatheter Aortic Valve Replacement
Cardiac Arrhythmias
Stroke
Myocardial Infarction
Quality of Life
Clinical Trials
Hemorrhage
Technology

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Kappetein, Arie Pieter ; Head, Stuart J. ; Genereux, Philippe ; Piazza, Nicolo ; Van Mieghem, Nicolas M. ; Blackstone, Eugene H. ; Brott, Thomas G. ; Cohen, David J. ; Cutlip, Donald E. ; Van Es, Gerrit Anne ; Hahn, Rebecca T. ; Kirtane, Ajay J. ; Krucoff, Mitchell W. ; Kodali, Susheel ; Mack, Michael J. ; Mehran, Roxana ; Rodés-Cabau, Josep ; Vranckx, Pascal ; Webb, John G. ; Windecker, Stephan ; Serruys, Patrick W. ; Leon, Martin B. / Updated standardized endpoint definitions for transcatheter aortic valve implantation : The valve academic research consortium-2 consensus document (varc-2). In: European Journal of Cardio-thoracic Surgery. 2012 ; Vol. 42, No. 5.
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abstract = "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, USA, and in February 2012 in Rotterdam, 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. 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 endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved.",
author = "Kappetein, {Arie Pieter} and Head, {Stuart J.} and Philippe Genereux and Nicolo Piazza and {Van Mieghem}, {Nicolas M.} and Blackstone, {Eugene H.} and Brott, {Thomas G.} and Cohen, {David J.} and Cutlip, {Donald E.} and {Van Es}, {Gerrit Anne} and Hahn, {Rebecca T.} and Kirtane, {Ajay J.} and Krucoff, {Mitchell W.} and Susheel Kodali and Mack, {Michael J.} and Roxana Mehran and Josep Rod{\'e}s-Cabau and Pascal Vranckx and Webb, {John G.} and Stephan Windecker and Serruys, {Patrick W.} and Leon, {Martin B.}",
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Kappetein, AP, Head, SJ, Genereux, P, Piazza, N, Van Mieghem, NM, Blackstone, EH, Brott, TG, Cohen, DJ, Cutlip, DE, Van Es, GA, Hahn, RT, Kirtane, AJ, Krucoff, MW, Kodali, S, Mack, MJ, Mehran, R, Rodés-Cabau, J, Vranckx, P, Webb, JG, Windecker, S, Serruys, PW & Leon, MB 2012, 'Updated standardized endpoint definitions for transcatheter aortic valve implantation: The valve academic research consortium-2 consensus document (varc-2)', European Journal of Cardio-thoracic Surgery, vol. 42, no. 5. https://doi.org/10.1093/ejcts/ezs533

Updated standardized endpoint definitions for transcatheter aortic valve implantation : The valve academic research consortium-2 consensus document (varc-2). / Kappetein, Arie Pieter; Head, Stuart J.; Genereux, Philippe; Piazza, Nicolo; Van Mieghem, Nicolas M.; Blackstone, Eugene H.; Brott, Thomas G.; Cohen, David J.; Cutlip, Donald E.; Van Es, Gerrit Anne; Hahn, Rebecca T.; Kirtane, Ajay J.; Krucoff, Mitchell W.; Kodali, Susheel; Mack, Michael J.; Mehran, Roxana; Rodés-Cabau, Josep; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.; Leon, Martin B.

In: European Journal of Cardio-thoracic Surgery, Vol. 42, No. 5, 01.01.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Updated standardized endpoint definitions for transcatheter aortic valve implantation

T2 - The valve academic research consortium-2 consensus document (varc-2)

AU - Kappetein, Arie Pieter

AU - Head, Stuart J.

AU - Genereux, 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.

PY - 2012/1/1

Y1 - 2012/1/1

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, USA, and in February 2012 in Rotterdam, 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. 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 endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved.

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, USA, and in February 2012 in Rotterdam, 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. 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 endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved.

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