Article (Scientific journals)
Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
Durko, Andras P.; Head, Stuart J.; Pibarot, Philippe et al.
2019In The Journal of thoracic and cardiovascular surgery, 158 (4), p. 1041-1054
Peer reviewed
 

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Keywords :
International standard; aortic valve replacement; device approval; labeling; lnternational Organization for Standardization (ISO); mitral valve replacement; objective performance criteria (OPC); prosthesis-patient mismatch (PPM); prosthetic heart valve; regulation; sizing; surgical prosthetic heart valve (SHV); valve performance
Abstract :
[en] 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 labeling 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 labeling 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 labeling and identifies the most important elements where further standardization is necessary.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Durko, Andras P.
Head, Stuart J.
Pibarot, Philippe
Atluri, Pavan
Bapat, Vinayak
Cameron, Duke E.
Casselman, Filip P. A.
Chen, Edward P.
Dahle, Gry
Ebels, Tjark
Elefteriades, John A.
Lancellotti, Patrizio  ;  Université de Liège - ULiège > Département des sciences cliniques > Cardiologie - Pathologie spéciale et réhabilitation
Prager, Richard L.
Rosenhek, Raphael
Speir, Alan
Stijnen, Marco
Tasca, Giordano
Yoganathan, Ajit
Walther, Thomas
De Paulis, Ruggero
More authors (10 more) Less
Language :
English
Title :
Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
Publication date :
October 2019
Journal title :
The Journal of thoracic and cardiovascular surgery
ISSN :
0022-5223
eISSN :
1097-685X
Volume :
158
Issue :
4
Pages :
1041-1054
Peer reviewed :
Peer reviewed
Commentary :
Copyright (c) 2019 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Available on ORBi :
since 08 June 2020

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