The American College of Cardiology Foundation (ACCF), in partnership with the American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS), recently 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, which was co-published online on Jan. 31 and will appear in the March 27 issue of the Journal of the American College of Cardiology, is intended to inform practitioners, payers, and other interested parties of the opinions concerning how TAVR should be introduced into the practice community.
“The Expert Consensus Document elaborates on the previously published joint ACCF/STS societal overview of transcatheter valve therapy (TVT) and assesses the current state of evidence available for TAVR,” said David R. Holmes, Jr., MD, FACC, president of the ACC and co-author of the document.
The ECD also facilitates the integration of TAVR and enables responsible adaption and diffusion of the new technology. The authors note that “although the technique and equipment continue to evolve, TAVR is a complex procedure with many interlocking steps which require meticulous attention to achieve optimal results and minimize complications.” They also emphasize a team-based approach as a foundational requirement of TAVR given the high-risk profile of patients as well as the technical complexity of the procedure involved.
The ECD also answers several of the questions previously raised about patient selection, TAVR screening, site selection, center and physician experience, procedural performance, post-procedural care, and registries.
The ECD 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, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiac Computed Tomography, and Society of Cardiac Magnetic Resonance.
This past November, the ACC and STS launched the STS/ACC TVT RegistryTM, a new benchmarking tool developed to track patient safety and real-world outcomes related to new and emerging TVT procedures. The Registry was developed in collaboration with the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS) with input from other professional societies including SCAI and AATS. The ACC is currently awaiting CMS’ decision regarding a request for a National Coverage Determination (NCD).
The ACC is continuing to work closely with these stakeholders on the development of future clinical documents and educational programming to ensure appropriate use of this new therapy.