STS and ACC Launch New Transcatheter Valve Therapy Registry
STS News, Winter 2012 -- Following FDA approval of new trancatheter valve therapy (TVT) technology for the treatment of aortic stenosis, STS and the American College of Cardiology launched, on Dec. 1, the STS/ACC TVT Registry, a new benchmarking tool, to track real-world outcomes related to new and emerging TVT procedures. The STS/ACC TVT Registry is the first national program to evaluate the safety and efficacy of a transcatheter aortic valve replacement (TAVR) option for patients who are otherwise considered to be non-operable for conventional valve replacement surgery.
Backed by the registry expertise of the ACC’s NCDR® and the STS National Database, the TVT Registry will serve as the main repository for clinical data related to TAVR and is positioned to capture outcomes data for expanded indications, as well as additional devices and procedures that will likely emerge in the future. The goal of the registry is to link clinical and administrative claims data and assess early and long-term outcomes. The registry forms the basis of a new platform that can be used for FDA post-approval studies in future generations of transcatheter valve devices.
The registry was developed in collaboration with the FDA and CMS, with input from other professional societies, including the Society for Cardiovascular Angiography and Interventions and the American Association for Thoracic Surgery, as well as industry trial sponsors.
A working group, composed of experts from both the STS National Database and ACC’s NCDR®, developed the TVT data module to harmonize with both databases. Ultimately the TVT Registry was designed to link with the Social Security Death Master File and CMS administrative databases, providing longterm outcomes data on all patients receiving TAVR.
STS President Michael J. Mack, MD and ACC President David R. Holmes, Jr., MD authored a Commentary column in the Nov. 16 issue of the Journal of the American Medical Association, titled “Rational Dispersion for the Introduction of Transcatheter Valve Therapy.” The editorial outlines details of the rollout of this new technology and the implications for postmarket surveillance studies and patient safety issues. (See related article below.)
The STS/ACC TVT Registry is governed by a joint Steering Committee with representatives from STS and ACC selected through each organization’s standard selection process. Representing the Society are Dr. Mack, serving as its chair, as well as Fred H. Edwards, MD, Frederick L. Grover, MD, and David M. Shahian, MD. The Steering Committee also includes representation from the FDA and CMS. A Research and Publications Subcommittee and a Stakeholder Advisory Group allow for input from multiple stakeholders, including industry trial sponsors, consumers, researchers, and health plans so that the TVT Registry benefits from the wisdom of many constituencies.
The TVT Registry also marks the first phase in the process of building a Research Engine as part of the STS Research Center. Plans are already underway to add a new registry dealing with the treatment of atrial fibrillation, and there is a long-term goal to create a suite of STS Research Center registries, linking STS data with ACC data so that meaningful national studies of comparative effectiveness, device surveillance, and appropriateness of care can be carried out.
For more information about the STS/ACC TVT Registry or the STS Research Center, please visit www.sts.org or contact Cynthia M. Shewan, PhD, STS Director of Quality, Research and Patient Safety at cshewan [at] sts [dot] org or (312) 202-5812.