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Aortic-valve-disease

Aortic Valve Disease

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.

The VARC-3 update is concordant with the initial ARC initiative and the VARC mission to provide clinically meaningful and standardized definitions which would be useful across the spectrum of clinical research related to aortic valve disease therapy. Acknowledging the dynamic and evolving nature of these definitions, the adoption of these VARC updated endpoints and criteria will ensure homogenous reporting, adjudication, and comparison between devices and therapeutic strategies.

Note: paragraphs extracted from VARC-3, available through the link below.

ARC Publications

Valve Academic Research Consortium 1 (VARC-1)

• Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A Consensus Report From the Valve Academic Research Consortium.
Reference: European Heart Journal 2011 Jan; 32(2): 205-217.

 

• Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A Consensus Report From the Valve Academic Research Consortium.
Reference: J Am Coll Cardiol. 2011 Jan 18;57(3):253-69.

 

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Valve Academic Research Consortium 2 (VARC-2)

• Updated Standardized Endpoint Definitions for transcatheter Aortic Valve Implantation: the Valve Academic Research Consortium-2 consensus document.
Reference: Eur Heart J. 2012 Oct;33(19):2403-18

 

• Updated Standardized Endpoint Definitions for transcatheter Aortic Valve Implantation: the Valve Academic Research Consortium-2 consensus document.
Reference: J Am Coll Cardiol. 2012 Oct 9;60(15):1438-54

 

• Updated Standardized Endpoint Definitions for transcatheter Aortic Valve Implantation: the Valve Academic Research Consortium-2 consensus document.
Reference: Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60

 

• Updated Standardized Endpoint Definitions for transcatheter Aortic Valve Implantation: the Valve Academic Research Consortium-2 consensus document.
Reference: EuroIntervention. 2012 Nov 22;8(7):782-95

 

• Updated Standardized Endpoint Definitions for transcatheter Aortic Valve Implantation: the Valve Academic Research Consortium-2 consensus document.
Reference: J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23.

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Valve Academic Research Consortium 3 (VARC-3)

• Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.
Reference: Eur Heart J. 2021 May 14;42(19):1825-1857.

 

• Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.
Reference: J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746.

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Other relevant references

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria.

Reference: JTCVS Open. 2022 May 29;11:72-80.

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Focusing on the Long Game: Updates on Aortic Valve Research From the Valve Academic Research Consortium.

Reference: J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3467-3471.

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The Deployment of Valve Academic Research Consortium 3 (VARC-3): New Endpoints, Broader Definitions, and Plenty of Unanswered Questions.

Reference: J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3463-3466.

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Hemodynamic durability of transcatheter aortic valves using the updated Valve Academic Research Consortium-2 criteria.

Reference: Catheter Cardiovasc Interv. 2019 Mar 1;93(4):729-738.

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Independent Risk Factors Contributing to Acute Kidney Injury According to Updated Valve Academic Research Consortium-2 Criteria After Transcatheter Aortic Valve Implantation: A Meta-analysis and Meta-regression of 13 Studies.

Reference: J Cardiothorac Vasc Anesth. 2017 Jun;31(3):816-826.

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Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes.

Reference: Singapore Med J. 2017 Sep;58(9):543-550.

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Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Reference: J Am Heart Assoc. 2015 Sep 25;4(10):e002135.

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Evaluation of the Valve Academic Research Consortium-2 Criteria for Myocardial Infarction in Transcatheter Aortic Valve Implantation: A Prospective Observational Study.

Reference: PLoS One. 2015 Jun 12;10(6):e0130423.

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Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions.

Reference: Am J Cardiol. 2015 Jan 1;115(1):100-6.

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Impact of chronic obstructive pulmonary disease on Valve Academic Research Consortium-defined outcomes after transcatheter aortic valve implantation (from the FRANCE 2 Registry).

Reference: Am J Cardiol. 2014 May 1;113(9):1543-9.

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Usefulness of updated valve academic research consortium-2 criteria for acute kidney injury following transcatheter aortic valve implantation.

Reference: Am J Cardiol. 2013 Dec 1;112(11):1807-11.

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Transcatheter aortic valve implantation and bleeding: focus on Valve Academic Research Consortium-2 classification.

Reference: Int J Cardiol. 2013 Oct 12;168(5):5001-3.

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Incidence, predictors, and prognosis of acute kidney injury after transcatheter aortic valve implantation: a summary of contemporary studies using Valve Academic Research Consortium definitions.

Reference: Int J Cardiol. 2013 Sep 30;168(2):1631-5.

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A meta-analysis comparing observed 30-day all-cause mortality with the Society of Thoracic Surgeons Predicted Risk of Mortality in contemporary studies using Valve Academic Research Consortium definitions.

Reference: Int J Cardiol. 2013 Sep 30;168(2):1598-602.

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Predictors and outcomes after transcatheter aortic valve implantation using different approaches according to the valve academic research consortium definitions.

Reference: Catheter Cardiovasc Interv. 2013 Oct 1;82(4):640-52.

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Incidence and effect of acute kidney injury after transcatheter aortic valve replacement using the new valve academic research consortium criteria.

Reference: Am J Cardiol. 2013 Jan 1;111(1):100-5.

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Building on the shoulders of giants: the Valve Academic Research Consortium (VARC) initiative towards a global framework to guide valvular heart disease trials.

Reference: EuroIntervention. 2012 Sep;8 Suppl Q:Q12-4.

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Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies.

Reference: J Am Coll Cardiol. 2012 Jun 19;59(25):2317-26.

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Transcatheter aortic valve implantation (TAVI) outcome according to standardized endpoint definitions by the Valve Academic Research Consortium (VARC).

Reference: J Invasive Cardiol. 2011 Aug;23(8):307-12.

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Valve Academic Research Consortium Consensus report: the pharmaceutical and medical devices agency perspective.

Reference: J Am Coll Cardiol. 2011 Aug 9;58(7):777.

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In-hospital complications after transcatheter aortic valve implantation revisited according to the Valve Academic Research Consortium definitions.

Reference: Catheter Cardiovasc Interv. 2011 Sep 1;78(3):457-67.

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Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines.

Reference: EuroIntervention. 2011 May;7(1):41-8.

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Clinical endpoints in transcatheter aortic valve implantation: a call to ARC for standardised definitions.

Reference: EuroIntervention. 2009 May;5(1):29-31.

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