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

EACTS-STS-AATS Valve Labelling Tas, 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 WaltherRuggero De Paulis*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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 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

Original languageEnglish
Pages (from-to)292-303
Number of pages12
JournalAnnals of thoracic surgery
Volume108
Issue number1
DOIs
Publication statusPublished - Jul-2019
Externally publishedYes

Keywords

  • BIOPROSTHETIC AORTIC VALVES
  • SUBCLINICAL LEAFLET THROMBOSIS
  • PATIENT MISMATCH
  • HEMODYNAMIC PERFORMANCE
  • AMERICAN SOCIETY
  • REPLACEMENT
  • IMPACT
  • RECOMMENDATIONS
  • STENOSIS
  • DOPPLER

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