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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, The Netherlands.
Insights
Standardized Valve Charts are recommended to improve surgical heart valve (SHV) selection and performance assessment. This aims to ensure clinicians have uniform, transparent information for better patient outcomes.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Regulatory Science
Background:
- Optimal selection and assessment of surgical heart valves (SHVs) require comprehensive characteristic information.
- Current SHV sizing and labeling present challenges in obtaining uniform data across different models.
- Existing regulatory frameworks do not fully address the need for standardized SHV information.
Purpose of the Study:
- To formulate recommendations for transparent and uniform reporting of SHV physical dimensions, implant position, and hemodynamic performance.
- To advocate for a standardized chart to assess prosthesis-patient mismatch probability.
- To call upon valve manufacturers to provide essential SHV selection information on standardized Valve Charts.
Main Methods:
- Formation of a multidisciplinary Task Force by EACTS, STS, and AATS, including surgeons, cardiologists, engineers, and manufacturers.
- Review of existing challenges in SHV sizing and labeling.
- Development of recommendations for standardized information dissemination.
Main Results:
- Identification of key problems in SHV sizing and labeling.
- Formulation of recommendations for uniform SHV data presentation.
- Advocacy for standardized Valve Charts and prosthesis-patient mismatch assessment tools.
Conclusions:
- Standardized Valve Charts are crucial for informed SHV selection and improved clinical decision-making.
- Transparent and uniform information on SHV characteristics can enhance post-replacement function assessment.
- Collaboration between professional societies, manufacturers, and regulatory bodies is essential for implementing these standards.
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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