On March 1 the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS), released a Multisociety Expert Consensus Statement for Operator and Institutional requirements for Transcatheter Valve Repair and Replacement.
Transcatheter Aortic Valve Replacement (TAVR) is a technology for patients with severe aortic valvular stenosis who are either high-risk candidates or inoperable for surgical aortic valve replacement. Since its approval by the Food and Drug Administration (FDA) in November 2011, interest in the procedure has quickly grown among cardiologists and heart surgeons as well as patients, prompting efforts by professional medical societies to identify institutional and physician credentialing criteria for performing the procedure.
“As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care,” said Carl Tommaso, M.D., chair of the document writing committee and medical director of the cardiac catheterization lab, Skokie Hospital, NorthShore HealthSystem, Chicago. “TAVR is a complex procedure that has potential to serve many patients, and it is up to us to deliver the highest standard of care available.”
The recommendations in the statement classify operating requirements for both existing TAVR centers and those that intend to develop a TAVR program, credentialing requirements for cardiac surgeons and interventional cardiologists who perform the procedure, and guidance for maintaining approval to perform TAVR. Requirements include:
- Annual heart (aortic valve) surgery and interventional procedural volume requirements for institutions
- Board certification and procedural requirements for both surgeons and interventional cardiologists
- Participation in FDA-approved clinical trials post-approval studies
- Monitoring of complication rates and institutional follow up
- Participation in national databases for continued tracking of outcomes
- Commitment to a heart team concept that is led by the surgeon and interventional cardiologist and made up of a formal collaborative effort among all medical team members. In all aortic procedures, the interventional cardiologist and surgeon must both be present during the entire procedure ensuring joint participation and optimal patient-centered care.
These recommendations follow last month’s release of an Expert Consensus Document which facilitates the integration of TAVR and enables responsible adaption and diffusion of the new technology.
ACC will also be submitting comments to the Centers for Medicare and Medicaid Services (CMS) on its National Coverage Determination (NCD) request for TAVR. The ACC and STS requested the NCD analysis in late 2011.
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.