STS News, Winter 2013 -- The STS/ACC TVT Registry recently marked two significant milestones in its growth with the enrollment of the 150th site and the entry of the 2,000th patient record in December.
The Registry, which launched just over a year ago in December 2011, serves as the main repository for clinical data related to transcatheter aortic valve replacement (TAVR).
“We reached 2,000 patient records pretty quickly, so we know this valuable technology is being applied across the country. Perhaps just as important is the fact that cardiothoracic surgeons and cardiologists are working together to report the detailed information that will help us learn from experience and tailor the procedure to the right population,” said Fred H. Edwards, MD, Director of the STS Research Center.
As of December 5, 121 of 154 participating sites had submitted patient data, and the TVT Registry support staff continues to diligently recruit new sites and provide training to Registry site managers. As more manufacturers develop TAVR devices, the Registry is positioned to provide a repository of longitudinal outcomes that will enhance monitoring for the safety and effectiveness of these devices.
“Reaching this milestone solidifies that our new paradigm for clinical data registries is not only feasible but also very functional. Collaboration among professional societies, government agencies, and industry has coalesced to establish a registry meeting the needs of multiple stakeholders,” said Michael J. Mack, MD, STS Immediate Past President and Chair of the TVT Registry Steering Committee.
Engaging in this model of a multi-stakeholder partnership has enabled all parties with a vested interest to identify and define a robust set of data elements and outcomes measures needed to track the safety and effectiveness of these devices. This allows for the development of quality measurement systems for the lifecycle of a device, from market introduction to long-term health outcomes.
“This is an incredible accomplishment and truly reflects an early win for our growing Research Center. The TVT Registry is a wonderful model for the types of research engines envisioned by our Board of Directors when it established the STS Research Center, and it strategically aligns with the mission and vision of our Research Center,” said Robert A. Wynbrandt, STS Executive Director & General Counsel.
For more information on the STS/ACC TVT Registry, contact Hilary Kirk, TVT Registry Project Manager, at hkirk [at] sts [dot] org or (312) 202-5879. You can also learn more at www.tvtregistry.org.