Exploring the lasting legacy of the STS/ACC TVT Registry
The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry, part of the National Cardiovascular Data Registry (NCDR), has become a cornerstone of structural heart care, reshaping the heart team approach and setting new standards for patient-centered outcomes.
"We're constantly trying to keep our fingers on the pulse of what's happening in the real world. This is not a trial, this is real-world experience. And what comes with that is getting the real world to follow what you'd like them to do so we can achieve the best outcomes for patients," Joan Michaels, RN, director of the ACC’s TVT and IMPACT congenital heart registries, said in an interview with Cardiovascular Business.
She said the registry’s impact also extends well beyond data collection. By systematically incorporating patient-reported outcomes, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ), the registry has helped define how success is measured in transcatheter aortic valve replacement (TAVR), mitral interventions, and more recently, tricuspid therapies. Early on after the market approval of TAVR, the coverage decision approved by the Centers for Medicare and Medicaid Services (CMS) asked for quality of life to be one of the endpoints that is documented, Micheals explained. This measure has also been extended for documenting transcatheter mitral and tricuspid valve repair and replacement devices.
"Many hospitals try to impress upon the patient and the family that this is a program, not a procedure, and that you agree to not only to a baseline procedural workup, but then at 30 days and one year follow-up workups, because we want to make sure that that quality of life is captured," Michaels explained.
She said the quality of life measurements have been branded into the heart team as a key metric, but it is also really important for the patients and the family. Lately this metric has also gained even more prominence in the tricuspid space, where quality of life is a primary driver for transcatheter therapies because therapies often do not cure the patient, but do make them feel much better so they can do things they enjoy in life. This was the primary reason the U.S. Food and Drug Administration (FDA) cleared Abbott's TriClip.
"We really wanted to manage that and to educate and make everyone a part of the importance of doing the one-year KCCQ on the tricuspid patients as well," Michaels said.
Data from more than 850 participating TVT sites, with roughly 560 of which now perform mitral interventions, show that the greatest improvements in quality of life typically occur between baseline and 30 days post-procedure. Sustained one-year follow-up ensures that progress is maintained and has become a hallmark of the program.
TVT has helped craft the heart team approach
Equally transformative has been the collaborative structure of the registry. Launched more than a decade ago as a joint venture between the ACC and the Society of Thoracic Surgeons (STS), TVT was built on a 50/50 partnership between cardiologists and cardiac surgeons.
"Collaboration has proved to be very helpful with more people at the table. I won't say it was easy at the beginning. I'm a nurse and everybody has their cardiologists, cardiac surgeons, different professionals work differently. This has been an art of having everyone dance to the same tune. And that's a shout out to the leadership that we've had both on the STS side and the ACC side ... it's been a real team effort with many different factions," Michaels said.
Public outcomes data aids cardiology program transparency
Another TVT milestone has been the launch of public reporting. Nearly half of TVT sites have voluntarily adopted transparency measures that include a composite morbidity and mortality risk model based on five endpoints: mortality, stroke, bleeding, kidney injury and paravalvular leak.
"It's really the gold standard, and we operate on a three star rating, just like STS. In our short tenure of launching public reporting, we now have between 45 and 46% of the sites adopting it. It's voluntary and it promotes the transparency," Michaels said.
Over the past decade, she said TVT has improved outcomes in real-world practice and influenced how new cardiovascular technologies are evaluated, monitored and adopted. Its collaborative, transparent structure has become a model other specialties now seek to emulate.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]