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Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert
Andras P Durko1, Philippe Pibarot2, Pavan Atluri3
1Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
Insights
Standardized Valve Charts are recommended to improve surgical heart valve (SHV) selection and assessment. This aims to ensure uniform information for clinicians and reduce prosthesis-patient mismatch.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Regulatory Science
Background:
- Optimal selection and post-operative assessment of surgical heart valves (SHVs) require comprehensive characteristic data.
- Current methods for obtaining uniform SHV information are challenging despite existing regulatory frameworks.
Framework:
- Established by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS), and American Association for Thoracic Surgery (AATS).
- Comprised of multidisciplinary experts including surgeons, cardiologists, engineers, and regulatory representatives.
Implementation:
- Formulates recommendations for transparent and uniform presentation of SHV physical dimensions, implant position, and hemodynamic performance.
- Advocates for a standardized chart to assess the probability of prosthesis-patient mismatch.
- Calls for valve manufacturers to provide essential SHV choice information on standardized Valve Charts.
Implications:
- Enhances clinician understanding and decision-making in SHV selection.
- Aims to improve patient outcomes by minimizing prosthesis-patient mismatch.
- Promotes consistency and transparency in the surgical heart valve market.
Abstract:
Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
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