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 haemodynamic 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.
| Language | English |
|---|---|
| Pages | 1025-1036 |
| Number of pages | 12 |
| Journal | European Journal of Cardio-Thoracic Surgery |
| Volume | 55 |
| Issue number | 6 |
| DOIs | |
| State | Published - 1 Jun 2019 |
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Keywords
- Aortic valve replacement
- Device approval
- International Organization for Standardization (ISO)
- International standard
- Labelling
- Mitral valve replacement
- Objective performance criteria (OPC)
- Prosthesis–patient mismatch (PPM)
- Prosthetic heart valve
- Regulation
- Sizing
- Surgical prosthetic heart valve (SHV)
- Valve performance
Cite this
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Characteristics of surgical prosthetic heart valves and problems around labelling : 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; Atluri, Pavan; Bapat, Vinayak; Cameron, Duke E.; Casselman, Filip P.A.; Chen, Edward P.; Dahle, Gry; Ebels, Tjark; Elefteriades, John A.; Lancellotti, Patrizio; Prager, Richard L.; Rosenhek, Raphael; Speir, Alan; Stijnen, Marco; Tasca, Giordano; Yoganathan, Ajit; Walther, Thomas; de Paulis, Ruggero (Corresponding author).
In: European Journal of Cardio-Thoracic Surgery, Vol. 55, No. 6, 01.06.2019, p. 1025-1036.Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Characteristics of surgical prosthetic heart valves and problems around labelling
T2 - European Journal of Cardio-Thoracic Surgery
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 - 2019/6/1
Y1 - 2019/6/1
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 haemodynamic 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.
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 haemodynamic 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.
KW - Aortic valve replacement
KW - Device approval
KW - International Organization for Standardization (ISO)
KW - International standard
KW - Labelling
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
UR - http://www.scopus.com/inward/record.url?scp=85066419133&partnerID=8YFLogxK
U2 - 10.1093/ejcts/ezz034
DO - 10.1093/ejcts/ezz034
M3 - Article
VL - 55
SP - 1025
EP - 1036
JO - European Journal of Cardio-Thoracic Surgery
JF - European Journal of Cardio-Thoracic Surgery
SN - 1010-7940
IS - 6
ER -