Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research

被引:52
作者
Genereux, Philippe [1 ]
Piazza, Nicolo [2 ]
Alu, Maria C. [3 ,4 ]
Nazif, Tamim [3 ,4 ]
Hahn, Rebecca T. [3 ,4 ]
Pibarot, Philippe [5 ]
Bax, Jeroen J. [6 ]
Leipsic, Jonathon A. [7 ,8 ]
Blanke, Philipp [7 ,8 ]
Blackstone, Eugene H. [9 ,10 ]
Finn, Matthew T. [3 ,4 ]
Kapadia, Samir [11 ]
Linke, Axel [12 ]
Mack, Michael J. [13 ]
Makkar, Raj [14 ]
Mehran, Roxana [15 ]
Popma, Jeffrey J. [16 ]
Reardon, Michael [17 ]
Rodes-Cabau, Josep [5 ]
Van Mieghem, Nicolas M. [18 ]
Webb, John G. [8 ,19 ]
Cohen, David J. [20 ]
Leon, Martin B. [3 ,4 ]
机构
[1] Morristown Med Ctr, Gagnon Cardiovasc Inst, Morristown, NJ USA
[2] McGill Univ Hlth Ctr, Montreal, PQ, Canada
[3] Columbia Univ, Irving Med Ctr, NewYork Presbyterian Hosp, New York, NY 10032 USA
[4] Cardiovasc Res Fdn, New York, NY 10019 USA
[5] Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
[6] Leiden Univ, Dept Cardiol, Med Ctr, Leiden, Netherlands
[7] St Pauls Hosp, Dept Radiol, Vancouver, BC, Canada
[8] Univ British Columbia, Vancouver, BC, Canada
[9] Cleveland Clin, Dept Thorac & Cardiovasc Surg, Cleveland, OH 44106 USA
[10] Cleveland Clin, Dept Quantitat Hlth Sci, Res Inst, Cleveland, OH 44106 USA
[11] Cleveland Clin, Dept Cardiovasc Med, Cleveland, OH 44106 USA
[12] Herzzentrum Dresden, Dresden, Germany
[13] Baylor Scott & White Heart Hosp Plano, Plano, TX USA
[14] Cedars Sinai Med Ctr, Smidt Heart Inst, Los Angeles, CA 90048 USA
[15] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA
[16] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
[17] Methodist DeBakey Heart & Vasc Ctr, Houston, TX USA
[18] Erasmus MC, Thoraxctr, Rotterdam, Netherlands
[19] St Pauls Hosp, Dept Cardiol, Vancouver, BC, Canada
[20] Univ Missouri, Sch Med, Kansas City, MO 64108 USA
关键词
Valve Academic Research Consortium; Transcatheter aortic valve replacement; Transcatheter aortic valve implantation; Surgical aortic valve replacement; Endpoints; Definitions; BUNDLE-BRANCH BLOCK; ACUTE KIDNEY INJURY; HIGH-RISK PATIENTS; PERMANENT PACEMAKER IMPLANTATION; QUALITY-OF-LIFE; CITY CARDIOMYOPATHY QUESTIONNAIRE; SUBCLINICAL LEAFLET THROMBOSIS; AMERICAN-HEART-ASSOCIATION; EXPERT CONSENSUS DOCUMENT; EMBOLIC DEFLECTION DEVICE;
D O I
10.1093/eurheartj/ehaa799
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Methods and results Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Conclusions Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
引用
收藏
页码:1825 / 1857
页数:33
相关论文
共 248 条
[1]   Neurological damage after transcatheter aortic valve implantation compared with surgical aortic valve replacement in intermediate risk patients [J].
Abdul-Jawad Altisent, Omar ;
Ferreira-Gonzalez, Ignacio ;
Marsal, Josep R. ;
Ribera, Aida ;
Auger, Cristina ;
Ortega, Gemma ;
Cascant, Purificacion ;
Urena, Marina ;
Garcia Del Blanco, Bruno ;
Serra, Vicenc ;
Sureda, Carlos ;
Igual, Albert ;
Rovira, Alex ;
Teresa Gonzalez-Alujas, Maria ;
Gonzalez, Anna ;
Puri, Rishi ;
Cuellar, Hug ;
Tornos, Pilar ;
Rodes-Cabau, Josep ;
Garcia-Dorado, David .
CLINICAL RESEARCH IN CARDIOLOGY, 2016, 105 (06) :508-517
[2]   Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis [J].
Adams, David H. ;
Popma, Jeffrey J. ;
Reardon, Michael J. ;
Yakubov, Steven J. ;
Coselli, Joseph S. ;
Deeb, G. Michael ;
Gleason, Thomas G. ;
Buchbinder, Maurice ;
Hermiller, James, Jr. ;
Kleiman, Neal S. ;
Chetcuti, Stan ;
Heiser, John ;
Merhi, William ;
Zorn, George ;
Tadros, Peter ;
Robinson, Newell ;
Petrossian, George ;
Hughes, G. Chad ;
Harrison, J. Kevin ;
Conte, John ;
Maini, Brijeshwar ;
Mumtaz, Mubashir ;
Chenoweth, Sharla ;
Oh, Jae K. .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (19) :1790-1798
[3]   Epidemiology of acute heart failure syndromes [J].
Alla, Francois ;
Zannad, Faiez ;
Filippatos, Gerasimos .
HEART FAILURE REVIEWS, 2007, 12 (02) :91-95
[4]   Impact of the Use of Transradial Versus Transfemoral Approach as Secondary Access in Transcatheter Aortic Valve Implantation Procedures [J].
Allende, Ricardo ;
Urena, Marina ;
Cordoba, Juan G. ;
Ribeiro, Henrique Barbosa ;
Amat-Santos, Ignacio ;
DeLarochelliere, Robert ;
Paradis, Jean-Michel ;
Doyle, Daniel ;
Mohammadi, Siamak ;
Cote, Melanie ;
Abdul-Jawad, Omar ;
del Trigo, Maria ;
Ortas, Maria Rosario ;
Laflamme, Louis ;
Laflamme, Jerome ;
DeLarochelliere, Hugo ;
Dumont, Eric ;
Rodes-Cabau, Josep .
AMERICAN JOURNAL OF CARDIOLOGY, 2014, 114 (11) :1729-1734
[5]   Warfarin and Antiplatelet Therapy Versus Warfarin Alone for Treating Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement [J].
Altisent, Omar Abdul-Jawad ;
Durand, Eric ;
Munoz-Garcia, Antonio J. ;
Nombela-Franco, Luis ;
Cheema, Asim ;
Kefer, Joelle ;
Gutierrez, Enrique ;
Benitez, Luis M. ;
Amat-Santos, Ignacio J. ;
Serra, Vicenc ;
Eltchaninoff, Helene ;
Alnasser, Sami M. ;
Elizaga, Jaime ;
Dager, Antonio ;
del Blanco, Bruno Garcia ;
del Rosario Ortas-Nadal, Maria ;
Ramon Marsal, Josep ;
Campelo-Parada, Francisco ;
Regueiro, Ander ;
del Trigo, Maria ;
Dumont, Eric ;
Puri, Rishi ;
Rodes-Cabau, Josep .
JACC-CARDIOVASCULAR INTERVENTIONS, 2016, 9 (16) :1706-1717
[6]   Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral [J].
Amat-Santos, Ignacio J. ;
Rojas, Paol ;
Gutierrez, Hipolito ;
Vera, Silvio ;
Castrodeza, Javier ;
Tobar, Javier ;
Goncalves-Ramirez, L. Renier ;
Carrasco, Manuel ;
Catala, Pablo ;
San Roman, Jose A. .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2018, 92 (05) :935-944
[7]   Incidence, Predictive Factors, and Prognostic Value of New-Onset Atrial Fibrillation Following Transcatheter Aortic Valve Implantation [J].
Amat-Santos, Ignacio J. ;
Rodes-Cabau, Josep ;
Urena, Marina ;
DeLarochelliere, Robert ;
Doyle, Daniel ;
Bagur, Rodrigo ;
Villeneuve, Jacques ;
Cote, Melanie ;
Nombela-Franco, Luis ;
Philippon, Francois ;
Pibarot, Philippe ;
Dumont, Eric .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2012, 59 (02) :178-188
[8]   Trends in Vascular Complications in High-Risk Patients Following Transcatheter Aortic Valve Replacement in the United States [J].
Ando, Tomo ;
Akintoye, Emmanuel ;
Telila, Tesfaye ;
Briasoulis, Alexandros ;
Takagi, Hisato ;
Grines, Cindy L. ;
Afonso, Luis .
AMERICAN JOURNAL OF CARDIOLOGY, 2017, 119 (09) :1433-1437
[9]  
[Anonymous], 2018, CIRC-CARDIOVASC INTE, DOI DOI 10.1161/CIRCINTERVENTIONS.118.007415
[10]  
[Anonymous], J AM SOC ECHOCARDIOG, DOI DOI 10.1016/j.echo.2019.01.003