Updated Expert Consensus Document Addresses Operator and Institutional Requirements for TAVR
July 23, 2018—The American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) have released an updated Expert Consensus Systems of Care document regarding operator and institutional recommendations and requirements for transcatheter aortic valve replacement (TAVR). The document is available online in Journal of the American College of Cardiology.
According to the ACC, the updated document is intended to provide guidance and support for centers throughout the United States and offer a “rational balance between patient access to TAVR and quality outcomes.” It also includes additional quality metrics that complement requirements included in the original consensus document, which was published in 2011.
The ACC noted that the document focuses on treating all patients with aortic valve disease and therefore all forms of treatment, including TAVR, surgical aortic valve replacement (SAVR), medical care, and palliative care. It also recommends that sites incorporate shared decision-making methods and processes. The updated version continues to place a strong emphasis on a team-based approach for patient management.
The writing group also included a multimodal approach to quality measurement that allows the recommendations and requirements to evolve in anticipation of newer treatment modalities, expansion to younger and lower-risk populations, and emerging evidence regarding patient outcomes, cost, cost-effectiveness, and durability.
As highlighted by the ACC, the document does not recommend that sites failing to meet all requirements should close their TAVR/SAVR programs because of the need to continue to serve low-density population areas, while documenting acceptable quality.
The document does recommend that all sites review their quarterly outcome reports and assess whether they are within national benchmarks of acceptable quality of care and advises that an accreditation process is one means to help ensure quality, while also providing external review of programs.
In related news, the four societies will submit comments to the Centers for Medicare & Medicaid Services (CMS) by July 27 in response to the agency's request for public comments on a national coverage analysis to reconsider the national coverage determination (NCD) for TAVR. The comments will use the expert consensus document as a framework for supporting an updated NCD.
On July 25, CMS will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee to seek the panel's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. At the CMS meeting, the Expert Consensus Document Co-Chairs, Joseph E. Bavaria, MD, and Carl L. Tommaso, MD, will be summarizing the recommendations from the document. John D. Carroll, MD, will represent the ACC in discussing lessons from the STS/ACC TVT Registry.
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.