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Tracking Real-World Outcomes

The TVT Registry™ is a new benchmarking tool developed to track patient safety and real-world outcomes related to the newly introduced transcatheter aortic valve replacement (TAVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis.

Employing a first-of-its-kind transcatheter heart valve technology, TAVR provides a new treatment option for patients who are considered to be inoperable for conventional aortic valve replacement surgery.

Through the capture and reporting of patient demographics, procedure details, and facility and physician information, the TVT Registry provides a data repository capable of delivering insight into clinical practice patterns and patient outcomes.

For Participating Hospitals, the TVT Registry Offers:

Quarterly reports containing practice patterns, demographics and outcomes of procedures that compare an institution’s performance with that of the national experience
Standardized, evidence-based data elements and definitions
A web-based data collection tool
A wide range of other quality improvement tools to advance quality improvement initiatives

The TVT Registry Measures:

Patient demographics, provider and facility characteristics
History/risk factors, cardiac status and detailed health status
Well-defined indications for the procedure
Pre, intra and post procedure data points and adverse event rates
Outcomes at 30 days and one year

Providing an Invaluable Data Source

Backed by the registry expertise of the ACC’s NCDR^® and the STS National Database, the TVT Registry serves as the main repository for clinical data related to TAVR and is positioned to incorporate future catheter-based procedures.

A powerful data source, the registry allows 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. In this capacity, it will serve as a tool for conducting research in areas of comparative effectiveness, cost effectiveness and appropriate use criteria.

Analysis of these data will allow the cardiovascular profession and medical community to understand how this new technology will be deployed throughout the U.S., and what impact it will have on patient outcomes as it becomes more prevalent. Data from the TVT Registry will assist the medical device industry and the FDA in surveillance of the quality, safety and efficacy of new medical devices.

Employing the Expertise of Key Leadership

The TVT Registry is governed by a joint Steering Committee with representatives from the STS and ACC selected through each society’s standard selection process. Given the importance and broad function of the registry, it is important that representatives have current relevant clinical background and expertise with large data registries − and be recognized as leaders in their field.

The Steering Committee also includes representation from the Food and Drug Administration and Centers for Medicare and Medicaid Services. A Research and Publications Subcommittee and Stakeholder Advisory Group allow for input from multiple stakeholders, including industry trial sponsors, consumers, researchers, and health plans so that the registry benefits from the wisdom of many constituencies.