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

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, Ruggero de Paulis (Corresponding author)

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1025-1036
Number of pages12
JournalEuropean Journal of Cardio-Thoracic Surgery
Volume55
Issue number6
DOIs
Publication statusPublished - 1 Jun 2019

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
  • Heart Valve Prosthesis Implantation
  • United States
  • Europe
  • Heart Valve Prosthesis
  • Humans
  • Product Labeling/methods
  • Thoracic Surgery
  • Prosthesis Design
  • Societies, Medical
  • Heart Valve Diseases/surgery

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