STS News, Winter 2012 -- The Nov. 16 issue of the Journal of the American Medical Association features a Commentary column, authored by STS President Michael J. Mack, MD and ACC President David R. Holmes, Jr., MD, on transcatheter valve therapy (TVT).
Highlighting both organizations’ efforts to safeguard patient safety in the introduction of transcatheter aortic valve replacement technology in the United States, the editorial advocates for the rational dispersion of TVT and assesses important issues about the use of this new approach to the treatment of aortic stenosis.
From designing proper training and credentialing of operators to developing integrated educational programs that focus on a heart-team approach and tracking long-term patient outcomes through the STS/ACC TVT Registry, Dr. Mack and Dr. Holmes detail the collaborative approach that STS and ACC have taken together and with both the FDA and CMS. The shared goal is to strike a balance that allows the U.S. population access to this innovative therapy, while at the same time preventing “indication creep.”
While cardiac surgeons and interventional cardiologists may not have always agreed on the appropriate use of medical device therapy in the past, this feature editorial showcases how STS and ACC’s collaboration on TAVR has set a new standard in professional society cooperation. As the editorial notes, “The introduction of new medical devices into clinical use is a complex process with multiple stakeholders involved.”
Beyond offering expertise and commentary in the premarket FDA approval of TVT, STS and ACC collaborated on the joint submission of a National Coverage Determination request to CMS and will remain active partners with the establishment of the STS/ACC TVT Registry. The JAMA Commentary can be found at jama.ama-assn.org; click on Nov. 16 in the Past Issues section (note: subscriber user ID and password may be required).