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

EACTS–STS–AATS Valve Labelling Task Force, Andras P. Durko, Stuart J. Head, Philippe Pibarot, Pavan Atluri, Vinayak Bapat, Duke E. Cameron, Filip P.A. Casselman, Edward P. Chen, Gry Dahle, Tjark Ebels, John A. Elefteriades, Patrizio Lancellotti, Richard L. Prager, Raphael Rosenhek, Alan Speir, Marco Stijnen, Giordano Tasca, Ajit Yoganathan, Thomas Walther & 1 andere Ruggero de Paulis

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Uittreksel

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.

TaalEngels
Pagina's1041-1054
Aantal pagina's14
TijdschriftJournal of Thoracic and Cardiovascular Surgery
Volume158
Nummer van het tijdschrift4
DOI's
StatusGepubliceerd - 1 okt 2019

Vingerafdruk

Heart Valves
Advisory Committees
Thoracic Surgery
Thorax
Organizations
Paris
France
Hemodynamics
Surgeons

Trefwoorden

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    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",
    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 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.",
    keywords = "aortic valve replacement, device approval, International standard, 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",
    author = "{EACTS–STS–AATS Valve Labelling Task Force} and Durko, {Andras P.} and Head, {Stuart J.} and Philippe Pibarot and Pavan Atluri and Vinayak Bapat and Cameron, {Duke E.} and Casselman, {Filip P.A.} and Chen, {Edward P.} and Gry Dahle and Tjark Ebels and Elefteriades, {John A.} and Patrizio Lancellotti and Prager, {Richard L.} and Raphael Rosenhek and Alan Speir and Marco Stijnen and Giordano Tasca and Ajit Yoganathan and Thomas Walther and {de Paulis}, Ruggero",
    year = "2019",
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    AU - EACTS–STS–AATS Valve Labelling Task Force

    AU - Durko,Andras P.

    AU - Head,Stuart J.

    AU - Pibarot,Philippe

    AU - Atluri,Pavan

    AU - Bapat,Vinayak

    AU - Cameron,Duke E.

    AU - Casselman,Filip P.A.

    AU - Chen,Edward P.

    AU - Dahle,Gry

    AU - Ebels,Tjark

    AU - Elefteriades,John A.

    AU - Lancellotti,Patrizio

    AU - Prager,Richard L.

    AU - Rosenhek,Raphael

    AU - Speir,Alan

    AU - Stijnen,Marco

    AU - Tasca,Giordano

    AU - Yoganathan,Ajit

    AU - Walther,Thomas

    AU - de Paulis,Ruggero

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    N2 - 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.

    AB - 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.

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    KW - device approval

    KW - International standard

    KW - labeling

    KW - lnternational Organization for Standardization (ISO)

    KW - mitral valve replacement

    KW - objective performance criteria (OPC)

    KW - prosthesis–patient mismatch (PPM)

    KW - prosthetic heart valve

    KW - regulation

    KW - sizing

    KW - surgical prosthetic heart valve (SHV)

    KW - valve performance

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