Author + information
- David R. Holmes Jr, MD, FACC, ACC President⁎ ()
- ↵⁎Address correspondence to:
David R. Holmes, Jr., MD, FACC, American College of Cardiology, 2400 N Street NW, Washington, DC 20037
- Michael J. Mack, MD, FACC, President of the Society of Thoracic Surgeons
Irrespective of the field, be it religion (the 3 main Abrahamic religions, Hinduism, or Buddhism), philosophy (Hegel's dialectic), physics (baryon), chemistry (atomic constituents), or anatomy (human light perception), the underlying structure of 3's has been accorded considerable attention.
This underlying structure of 3's has great relevance right now to the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) as 3 occurrences converge, each of which is transformational. Such alignment brings with it tremendous opportunities.
The continued drive towards less invasive strategies of care has led to the development, testing, and, more recently the approval of transcatheter or transvascular aortic valve replacement (TAVR). This is truly transformational technology in that it finally offers an alternative for patients with severe aortic stenosis who are too high risk for surgical aortic valve replacement. Now evaluated in a single pivotal randomized clinical trial, and the subject of another ongoing randomized clinical trial, this technology has been used worldwide in more than 45,000 patients in more than 40 countries and is transforming the care of ill, debilitated, and elderly patients who previously had no option.
There has always been a natural tension between interventional cardiology and cardiovascular surgery. At times this has become manifest in strident debates and at other times in a polarization of attitudes and approaches that confuse patients' families and referring physicians alike. Beginning with the SYNTAX trial, and the novel concept of heart teams, the chasm is beginning to be bridged. With the advent of TAVR and the ever-expanding relationship between the STS and the ACC, heart teams are gaining even further traction. Both the STS and the ACC bring different strengths (and, it is even possible, different weaknesses) to the table. Working in close collaboration, we are forging a future for heart teams that will only be enhanced by this partnership.
TAVR has also provided a unique opportunity for the STS and the ACC to work more closely with industry, as well as the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). This novel, multi-stakeholder collaboration of professional societies, industry, and governmental agencies is a first of its kind. As these relationships grow ever deeper and more robust, they too will change the landscape and hopefully serve as a new paradigm for future innovative technologies and therapies.
The third part of the troika is the development of transformational approaches. An example of this is the collaboration among the ACC, STS, FDA, CMS, and industry to develop the STS/ACC TVT Registry™. This unique registry, which was imagined, discussed, and implemented in 3 short months (yet another 3), serves as the main repository for clinical data related to TAVR. It will allow the cardiovascular profession to monitor important safety information, detect infrequent complications, and build the robust clinical research infrastructure necessary to advance the science surrounding the TAVR procedure.
The TVT Registry™ is the pilot for a new approach to post-approval studies and post-market surveillance and is intended to be the poster child for new device development, approval, and reimbursement strategies. By linking the NCDR and STS databases, it will subsequently become a robust research engine for comparative effectiveness and cost-effectiveness research. The governance of this registry includes representatives from the STS, ACC, FDA, and CMS. A Research and Publications Subcommittee and Stakeholder Advisory Group also allow for input from industry trial sponsors, consumers, researchers, and health plans so that the registry benefits from the wisdom of many constituencies.
The concept of 3 is central to religion, philosophy, physics, and chemistry. This concept now comes to the field of cardiovascular disease, where the troika of transformation made up of transformational technology (TAVR), transformational relationships, and transformational approaches will change our world. Amazingly it has all happened in the past 3 months.
From your ACC and STS to you!
For more information on the TVT Registry™, go to www.ncdr.com/tvt.
- American College of Cardiology Foundation