TY - JOUR
T1 - Characteristics of Surgical Prosthetic Heart Valves and Problems Around Labelling
T2 - 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
AU - EACTS-STS-AATS Valve Labelling Tas
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
PY - 2019/7
Y1 - 2019/7
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 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
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 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
KW - BIOPROSTHETIC AORTIC VALVES
KW - SUBCLINICAL LEAFLET THROMBOSIS
KW - PATIENT MISMATCH
KW - HEMODYNAMIC PERFORMANCE
KW - AMERICAN SOCIETY
KW - REPLACEMENT
KW - IMPACT
KW - RECOMMENDATIONS
KW - STENOSIS
KW - DOPPLER
U2 - 10.1016/j.athoracsur.2019.03.020
DO - 10.1016/j.athoracsur.2019.03.020
M3 - Article
VL - 108
SP - 292
EP - 303
JO - Annals of thoracic surgery
JF - Annals of thoracic surgery
SN - 0003-4975
IS - 1
ER -