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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.

Authors
  • Durko, Andras P1
  • Head, Stuart J2
  • Pibarot, Philippe3
  • Atluri, Pavan4
  • Bapat, Vinayak5
  • Cameron, Duke E6
  • Casselman, Filip P A7
  • Chen, Edward P8
  • Dahle, Gry9
  • Ebels, Tjark10
  • Elefteriades, John A11
  • Lancellotti, Patrizio12
  • Prager, Richard L13
  • Rosenhek, Raphael14
  • Speir, Alan15
  • Stijnen, Marco16
  • Tasca, Giordano17
  • Yoganathan, Ajit18
  • Walther, Thomas19
  • De Paulis, Ruggero20
  • 1 Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Cardiac Surgery, Medical and Health Science Centre, University of Debrecen, Debrecen, Hungary. , (Hungary)
  • 2 Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. , (Netherlands)
  • 3 Québec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. , (Canada)
  • 4 Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pa.
  • 5 Department of Cardiovascular Surgery, New York-Presbyterian/Columbia University Medical Center, New York, NY.
  • 6 Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, Mass.
  • 7 Department of Cardiovascular and Thoracic Surgery, OLV Clinic, Aalst, Belgium. , (Belgium)
  • 8 Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga.
  • 9 Department of Cardiothoracic and Thoracic surgery, Rikshospitalet, Oslo University Hospital, Oslo, Norway. , (Norway)
  • 10 Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands. , (Netherlands)
  • 11 Department of Cardiothoracic Surgery, Yale University School of Medicine, New Haven, Conn.
  • 12 Department of Cardiology, GIGA Cardiovascular Sciences, University of Liège Hospital, Liège, Belgium. , (Belgium)
  • 13 Department of Cardiac Surgery, University of Michigan Hospital, Ann Arbor, Mich.
  • 14 Department of Cardiology, Medical University of Vienna, Vienna, Austria. , (Austria)
  • 15 Department of Cardiac Surgery, Inova Heart and Vascular Institute, Falls Church, Va.
  • 16 LifeTec Group, Eindhoven, The Netherlands. , (Netherlands)
  • 17 Cardiovascular Department, Operative Unit of Cardiac Surgery, Hospital A. Manzoni, Lecco, Italy. , (Italy)
  • 18 Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology/Emory School of Medicine, Atlanta, Ga. , (Georgia)
  • 19 Department of Thoracic and Cardiovascular Surgery, University Hospital Frankfurt, Johann Wolfgang Goethe University Frankfurt, Frankfurt, Germany. , (Germany)
  • 20 Department of Cardiac Surgery, European Hospital, Rome, Italy. Electronic address: [email protected] , (Italy)
Type
Published Article
Journal
The Journal of thoracic and cardiovascular surgery
Publication Date
Oct 01, 2019
Volume
158
Issue
4
Pages
1041–1054
Identifiers
DOI: 10.1016/j.jtcvs.2019.04.001
PMID: 31084981
Source
Medline
Keywords
Language
English
License
Unknown

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. Copyright © 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.

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