Yesterday the ACC in partnership with the American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS), released an Expert Consensus Document (ECD) on Transcatheter Aortic Valve Replacement (TAVR), a new technology for patients with severe aortic valvular stenosis who are either high-risk candidates or inoperable for surgical aortic valve replacement.

The document elaborates on the previously published joint ACCF/STS societal overview of transcatheter valve therapy (read my previous blog post here) and assesses the current state of evidence available for TAVR. It is also intended to inform practitioners, payers, and other interested parties of how TAVR should be introduced into the practice community.

The consensus document outlines key recommendations for the successful roll out of this new therapy and provides detailed criteria on:

• Careful patient selection
• Team-based approach given the complexity of procedure coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management
• Specialized heart centers and physician expertise in treating valve disorders; this includes use of proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified cath labs)
• TAVR screening tests to inform treatment decisions
• Enhanced patient and family education in the risk and benefits of this procedure
• Ongoing evaluation and participation in national TAVR registry to assess real world outcomes

An estimated 45,000 patients have received TAVR worldwide. Clinical use of TAVR, its continued evolution, and outcomes will be evaluated in the recently launched STS/ACC TVT Registry^TM which will further inform future recommendations on application of this transformational technology. The ACC is currently awaiting the Centers for Medicare and Medicaid Services’ (CMS) decision regarding a request for a National Coverage Determination.

The consensus document was also developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Society of Cardiovascular Anesthesiologists, Society of Cardiac Computed Tomography, and Society of Cardiac Magnetic Resonance. The writing committee also comprised of a consumer perspective from Mended Hearts due to the sensitive issues related to this procedure.  Since these are very sick patients facing dire consequences, the College acknowledges the importance of valuing the patient not just in the day-to-day doctor-patient relationship, but also in development of policy statements that affect those daily situations.

The ACC is continuing to work closely with the other stakeholders on the development of future clinical documents and educational programming. Overall, the College welcomes opportunities to provide clinical guidance to the Food and Drug Administration, CMS, payers, and others to roll out new devices and therapies and help provide a balanced clinical viewpoint.  This is a new, transformational technology for our patients, and by working together we can effectively and appropriately introduce new therapies with clear recommendations and guidance for its use.

Don’t miss the TAVR sessions at ACC.12 in Chicago. Advance registration closes soon!

UPDATE (2/3): CMS Releases Proposed NCD for TAVR