1. Characteristics of surgical prosthetic heart valves and problems around labelling
- Author
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Durko, Andras, Head, Stuart, Pibarot, P, Atluri, P, Bapat, V, Cameron, DE, Casselman, FPA (Filip), Chen, EP, Dahle, G, Ebels, T, Elefteriades, JA, Lancellotti, P, Prager, RL, Rosenhek, R, Speir, A, Stijnen, M, Tasca, G, Yoganathan, A, Walther, T, De Paulis, R, Kappetein, AP, Hart, J, Di Rienzo, G, McLaren, A, Randall, H, Becker, L, Capps, S, Duncan, B, Green, C, Hay, JC, Ieropoli, O, Jacob, AA, Manasse, E, Marquez, S, Northrup, W, Ryan, T, Smith, W, Cardiothoracic Surgery, ACS - Heart failure & arrhythmias, Cardiovascular Biomechanics, and Cardiovascular Centre (CVC)
- Subjects
Prosthesis–patient mismatch (PPM) ,Standardization ,IMPACT ,Product Labeling/methods ,Heart Valve Prosthesis/standards ,medicine.medical_treatment ,Heart Valve Diseases ,Iso standards ,030204 cardiovascular system & hematology ,RECOMMENDATIONS ,0302 clinical medicine ,Government regulation ,Aortic valve replacement ,International Organization for Standardization (ISO) ,Labelling ,International standard ,Heart Valve Diseases/surgery ,AMERICAN SOCIETY ,Societies, Medical ,media_common ,Prosthetic heart ,Heart Valve Prosthesis Implantation ,Objective performance criteria (OPC) ,Thoracic Surgery ,PATIENT MISMATCH ,Product Labeling/legislation & jurisprudence ,General Medicine ,REPLACEMENT ,DOPPLER ,Europe ,Prosthetic heart valve ,Cardiothoracic surgery ,Heart Valve Prosthesis ,Cardiology and Cardiovascular Medicine ,SUBCLINICAL LEAFLET THROMBOSIS ,Regulation ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Surgical prosthetic heart valve (SHV) ,Advisory Committees ,HEMODYNAMIC PERFORMANCE ,Product Labeling ,Prosthesis Design ,STENOSIS ,03 medical and health sciences ,Medical ,medicine ,media_common.cataloged_instance ,Humans ,European Union ,European union ,Device approval ,Sizing ,BIOPROSTHETIC AORTIC VALVES ,Task force ,business.industry ,General surgery ,Mitral valve replacement ,medicine.disease ,Valve performance ,United States ,030228 respiratory system ,Government Regulation ,Surgery ,business ,Societies - Abstract
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult.To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary. (C) 2019 by The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery
- Published
- 2019
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