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Characteristics of Surgical Prosthetic Heart Valves and Problems Around Labelling: A Document From the European
Andras P Durko1, Stuart J Head2, Philippe Pibarot3
1Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands; Department of Cardiac Surgery, Medical and Health Science Centre, University of Debrecen, Debrecen, Hungary.
Insights
Standardizing surgical prosthetic heart valve (SHV) sizing and labelling is crucial for better surgical outcomes. A joint task force identified key areas for improvement in SHV reporting and testing.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Regulatory Science
Background:
- Surgical prosthetic heart valve (SHV) selection impacts surgical success and patient outcomes.
- Current controversies in SHV sizing and labelling hinder valve comparison and optimal choice.
- An expert Valve Labelling Task Force was formed by EACTS, STS, and AATS to address these issues.
Purpose of the Study:
- To identify critical areas for standardization in SHV sizing and labelling.
- To improve the information provided to cardiac surgeons for optimal SHV selection.
- To foster collaboration among stakeholders for enhanced SHV characterization.
Main Methods:
- Convened a multidisciplinary task force including surgeons, cardiologists, engineers, regulators, and industry representatives.
- Analyzed current practices and identified challenges in SHV reporting, sizing, and testing.
- Reviewed the regulatory landscape and relevant International Organization for Standardization (ISO) standards.
Main Results:
- Identified needs for improved reporting of SHV physical dimensions and characteristics.
- Highlighted the necessity for standardized methods in determining and labelling SHV size.
- Emphasized the importance of consistent in vivo and in vitro testing for hemodynamic performance and thrombogenicity.
Conclusions:
- Standardization in SHV sizing, labelling, and performance reporting is essential.
- Enhanced cooperation between stakeholders, including regulatory bodies and manufacturers, is required.
- Clearer information and standardized practices will empower surgeons to make optimal SHV choices.
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.
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