Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium

By M. Leon, N. Piazza, E. Nikolsky, Eugene H. Blackstone, D. Cutlip, A. Kappetein, M. Krucoff, M. Mack, R. Mehran, Craig Miller and 10 more. European Heart Journal, 2010

1,258 citations recorded by the source corpus.

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Conclusion Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.

Subfields: Cardiology and Cardiovascular Medicine, Pulmonary and Respiratory Medicine, Surgery

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Citations in the corpus

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. (2014, methodology): “Prosthetic valve dysfunction and periprocedural aortic regurgitation were determined using VARC-1 criteria (16).”
Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. (2012, background): “ite clinical endpoints, for transcatheter aortic valve implantation (TAVI) clinical trials [1, 2].”
Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). (2012, positive): “The recent Valve Academic Research Consortium statement provides a standardized definition for end points after TAVI, which will enable a more accurate comparison between devices and approaches.(109)”
Third universal definition of myocardial infarction. (2012, methodology): “Modified criteria have been proposed for the diagnosis of periprocedural MI 72 h after aortic valve implantation (85).”
Computed Tomography Imaging in the Context of Transcatheter Aortic Valve Implantation (TAVI)/Transcatheter Aortic Valve Replacement (TAVR): An Expert Consensus Document of the Society of Cardiovascular Computed Tomography. (2019, neutral): “Echocardiography is the test for evaluation of transcatheter heart valve function and durability (87,88).”
2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. (2012, methodology): “Howver, patient selection criteria varied amongst the different egistries; standardized definitions for clinical events such as hose described by the Valve Academic Research Consortium VARC) (96) were not used; and endpoints were not prospecively adjudicated using a blinded clinical event committee.”
Third universal definition of myocardial infarction. (2012, methodology): “Modified criteria have been proposed for the diagnosis of peri- procedural MI 72 h after aortic valve implantation [85].”
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design (2012, methodology): “Stroke diagnostic criteria [734] Rapid onset of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other n”