Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.
Dr. Joseph E. Bavaria
U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).
“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.
Dr. Carl T. Tommaso
The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.
“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.
The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.