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.
| Original language | English |
|---|---|
| Pages (from-to) | 292-303 |
| Number of pages | 12 |
| Journal | The Annals of Thoracic Surgery |
| Volume | 108 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 1 Jul 2019 |
Funding
This joint EACTS–STS–AATS Labelling Task Force has identified several issues related to SHV sizing and labelling. These issues should be addressed to ensure that surgeons are provided with sufficient, appropriate and standardized information required for optimal SHV choice. This work was supported by the European Association for Cardio-Thoracic Surgery (EACTS). We acknowledge the financial support from the Netherlands Cardio Vascular Research Initiative : the Dutch Heart Foundation , Dutch Federation of University Medical Centres , the Netherlands Organisation for Health Research and Development and the Royal Netherlands Academy of Sciences . Dr Pibarot has received research grant support from Edwards Lifesciences and Medtronic for echocardiography core laboratory analyses in transcatheter heart valves. The authors would like to acknowledge the help of Rianne Kalkman (EACTS Office) in coordinating the Task Force activities.
Keywords
- Advisory Committees
- European Union
- Government Regulation
- Heart Valve Prosthesis/standards
- Humans
- Product Labeling/legislation & jurisprudence
- Prosthesis Design
- Societies, Medical
- Thoracic Surgery
- United States