TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of these partnering organizations on the availability, delivery, organization and quality of transcatheter aortic valve replacement (TAVR) cardiovascular care. The document was jointly released from the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS).

The "2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement," was also publish online in the Journal of the American College of Cardiology (JACC).

With the rapid evolution and spread of TAVR technology, the documents states it is imperative that the cardiovascular community work together to identify the

criteria for performing these procedures safely and successfully. Such criteria serve to guide both practitioners and institutions in the development and maintenance of TAVR programs, in the spirit of optimizing quality outcomes. The unique qualifications to participate in this field comprise specific interventional skills, high-tech equipment, collaborative clinical management, evolving approaches for alternative access and multidisciplinary decision making, the authors wrote.

The document includes the sections on the following areas:

• What Is New in the 2018 TAVR Operator and Institutional Requirements
• Structural Program Requirements
• Procedural Volume
• Multidisciplinary Team (MDT)
• Knowledge Base and Skills
• Proceduralist Formalized Training
• Facilities and Institutional Resources
• Process Program Requirements
• Patient Selection Requirements
• MDT Patient Case Conference Requirements
• Operational Details
• Patient Selection Considerations
• Frailty, Cognition, Quality of Life, Immobility and Disability
• Procedural Denial, Futility, QoL, Limited Life Expectancy
• Predictive Risk Models
• SDM Requirements
• Outcome Requirements
• Registry Requirements
• Criteria for Establishing a TAVR Program and Maintenance of Competence
• Requirements and Recommendations for New TAVR Programs
• Requirements and Recommendations for Existing TAVR Programs
• Requirements for SAVR
• SAVR-only Programs
• Compliance with Document Recommendations

Read through a PDF version of the document.

Moving Toward National Coverage for TAVR

In addition to releasing the updated consensus document, the ACC—along with AATS, SCAI and STS, is submitting comments to Ceters for Medicare and Medicaid Services (CMS) in response to its request for public comments on a National Coverage Analysis (NCA) to reconsider the national coverage determination (NCD) for TAVR. The comments will use the document as a framework for supporting an updated NCD. CMS convened a panel July 25, of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. The ACC participated in the meeting.

Lastly, based on the recommendations for external review and accreditation in the Expert Consensus document, as well as the CMS decision to reconsider its current TAVR NCD, the ACC is preparing to offer an external review and accreditation process that would assist hospitals in meeting standards such as multidisciplinary teams, formalized training, shared decision making and registry performance.

For more more information: acc.org

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Recent Advances in Transcatheter Valve Technology

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TAVR Stands Equal to Surgical Valve Replacement

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