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February 29, 2012
Cardiovascular Societies Issue Recommendations for Credentialing and Maintaining TAVR Programs
March 1, 2012—Initial recommendations for creating and maintaining transcatheter aortic valve replacement (TAVR) programs were jointly issued by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons.
Carl Tommaso, MD, served as Chair of writing committee for the recommendations, which were copublished online ahead of print in each society's respective publications, including the Journal of the American College of Cardiology, Catheterization and Cardiovascular Interventions, The Journal of Thoracic and Cardiovascular Surgery, and The Annals of Thoracic Surgery.
According to the societies, the recommendations are aimed at ensuring optimal care for patients with aortic stenosis, as use of the new TAVR procedure grows, and represent a joint collaboration of the 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,” commented Dr. Tommaso. “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 societies stated that because of the complexity of the TAVR procedure and the rapid rate at which the technology is evolving, defining operator and institutional requirements is a vital step in ensuring optimal program implementation. The recommendations emphasize a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone for establishing a successful program, noting that a program without both specialties would be fundamentally deficient. Other factors on which success is based include ensuring patient safety and a demonstrated commitment to excellence by the institution.
The recommendations classify operating requirements for those that intend to develop a TAVR program, including credentialing requirements for cardiothoracic surgeons and interventional cardiologists who intend to perform the procedure, as well as guidance for maintaining approval to perform TAVR. These requirements include annual aortic valve surgery and percutaneous coronary intervention volume requirements for institutions, board certification and procedural requirements for both surgeons and interventional cardiologists, monitoring of complication rates and institutional follow-up, participation in a national registry that will include enrollment of all patients undergoing TAVR with continued tracking of outcomes, and 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 TAVR procedures, the interventional cardiologist and surgeon must both be present during the entire procedure, ensuring joint participation and optimal patient-centered care.
SCAI President Christopher J. White, MD, commented on the document, “It recommends high standards for the delivery of this new technology to patients who have few, if any, other therapeutic options. As always, patient safety is our top priority.” He further noted that, “These recommendations developed collaboratively by the four leading cardiovascular organizations may be helpful to CMS as it completes the national coverage analysis for TAVR.”
Dr. White commended the writing committee for finalizing the recommendations within significant time constraints and advised that because there are currently few data available to guide decision making, “SCAI views these credentialing recommendations as a work in progress that may be modified as we learn more about performing TAVR and achieving optimal outcomes outside of clinical trials.” He also stated, “Like many of the practice guidelines and other documents that support our mission of quality care, this document is stronger because it was a collaborative effort by cardiovascular societies.“
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