Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus 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
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Published on: August 27, 2019
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. These charts will provide uniform data on SHV dimensions, implant position, and performance, aiding clinicians and reducing mismatch.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Regulatory Science
Background:
- Optimal selection and assessment of surgical heart valves (SHVs) require comprehensive, uniform data.
- Current SHV sizing and labeling present challenges for consistent information retrieval.
- A joint Task Force was established by EACTS, STS, and AATS to address these issues.
Purpose of the Study:
- To develop recommendations for transparent and uniform presentation of SHV characteristics.
- To advocate for standardized Valve Charts for SHV selection and prosthesis-patient mismatch assessment.
- To ensure clinicians have adequate information for informed SHV choice.
Main Methods:
- Expert consensus development by a multidisciplinary Task Force.
- Review of existing challenges in SHV sizing and labeling.
- Formulation of recommendations for data presentation and assessment tools.
Main Results:
- Recommendations for uniform reporting of SHV physical dimensions, intended implant position, and hemodynamic performance.
- Advocacy for a standardized chart to assess prosthesis-patient mismatch probability.
- Call for valve manufacturers to adopt standardized Valve Charts.
Conclusions:
- Standardized Valve Charts are crucial for improving SHV selection and patient outcomes.
- Uniform data presentation will enhance clinical decision-making and reduce prosthesis-patient mismatch.
- Collaboration between professional societies and manufacturers is key to 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 haemodynamic 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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