New Expert Consensus Document Includes Updated TAVR Operator, Institutional Requirements
The ACC, along with 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 TAVR. The original document was published in 2011.
The updated document is intended to provide guidance and support for centers throughout the U.S. 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 first document.
Of note, the document focuses on treating all patients with aortic valve disease and therefore all forms of treatment, including TAVR, SAVR, medical care, and palliative care. It also recommends that sites incorporate shared decision-making methods and processes. Like the original document, 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.
A prologue included at the start of document points out that there are no recommendations that sites failing to meet all requirements should close their TAVR-SAVR programs. “It is important to patient access that TAVR sites serving low-population dense areas remain active even if they don’t meet volume requirements but can document acceptable quality,” it states. However, the document does recommend that all sites review their quarterly outcome reports and assess if they are within national benchmarks of acceptable quality of care. “An accreditation process is one means to help ensure quality, while also providing external review of programs,” according to the document.
Meanwhile, the next few weeks are expected to busy for TAVR. The ACC – along with AATS, SCAI and STS – will submit comments to the Centers for Medicare and Medicaid Service (CMS) in response to its request for public comments on an national coverage analysis to reconsider the national coverage determination (NCD) for TAVR. The comments will use the document as a framework for supporting an updated NCD and are due by July 27.
On July 25, CMS is convening a panel 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. Expert consensus document co-chairs, Joseph E. Bavaria, MD, FACC, and Carl L. Tommaso, MD, FACC, will be summarizing the recommendations from the Expert Consensus document, while John D. Carroll, MD, FACC, will represent the College in discussing lessons from the STS/ACC TVT Registry.
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.
More information on these activities will be posted to ACC.org and promoted via ACC’s email newsletters, including the ACC Update, ACC Advocate and NCDR News & Views. For the latest updates via social media, follow @ACCinTouch and @Cardiology.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging
Keywords: Aortic Valve Stenosis, Aortic Valve, Cardiovascular Surgical Procedures, Clinical Competence, Decision Making, Diagnostic Imaging, Frail Elderly, Heart Valve Diseases, Outcome Assessment, Health Care, Patient Care Team, Palliative Care, Patient Care Team, Quality of Health Care, Quality of Life, Registries, Research, Risk Assessment, Safety, Transcatheter Aortic Valve Replacement, Accreditation, Advisory Committees, Angiography, Benchmarking, Centers for Medicare and Medicaid Services, U.S., Cost-Benefit Analysis, Medicaid, Medicare, Surgeons, Thoracic Surgery
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