The STS National Database and Research and Analytic Center can help address industry's business research needs.
Information from the STS National Database can be used to:
- Answer questions about cardiothoracic surgery procedures and device performance;
- Investigate opportunities to enhance quality of care and improve patient outcomes;
- Confirm market trends and obtain clinical data to support new product innovations; and
- Save time and reduce costs on clinical trials, as well as post-approval, continued access, and investigational device exemption studies.
Whether you are in the early stages of planning a new product, designing clinical trials, or understanding device performance and procedural outcomes, the STS National Database can be a valuable resource for your company.
The STS National Database was established in 1989 as an initiative for quality improvement and patient safety among cardiothoracic surgeons. The Database has since grown exponentially and has become the gold standard for clinical outcomes registries.
The Database has participants in 11 countries, including the United States (all 50 states), Canada, Argentina, Australia, Brazil, Cayman Islands, Israel, Italy, Singapore, Turkey, and the United Arab Emirates.
The STS National Database has four components, each focusing on a different area of cardiothoracic surgery—adult cardiac surgery, congenital heart surgery, general thoracic surgery, and mechanical circulatory support devices.
Adult Cardiac Surgery Database
The STS Adult Cardiac Surgery Database (ACSD) is the world’s premier clinical outcomes registry for adult cardiac surgery. Launched in 1989, the Database contains more than 6.5 million cardiac surgery procedure records and currently has more than 3,700 participating physicians, including surgeons and anesthesiologists. It captures up to 1,000 individual data points on each patient and represents more than 90% of all adult cardiac surgeries in the United States. Participants continuously add new patient data to the registry, thereby providing a highly dynamic, up-to-date overview of cardiothoracic surgical practice.
Congenital Heart Surgery Database
The STS Congenital Heart Surgery Database (CHSD) is the largest registry in North America dealing with congenital cardiac malformations. The CHSD contains more than 450,000 congenital heart surgery procedure records and currently has more than 900 participating physicians, including surgeons and anesthesiologists.
General Thoracic Surgery Database
The STS General Thoracic Surgery Database (GTSD) is the largest and most robust clinical thoracic surgical database in North America. The GTSD contains more than 530,000 general thoracic surgery procedure records and currently has more than 950 participating surgeons.
Intermacs, along with its Pedimacs component, is a North American registry for the clinical outcomes of patients who receive an FDA-approved mechanical circulatory support (MCS) device to treat advanced heart failure. It was established in 2005 at the University of Alabama at Birmingham as a joint effort among the National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and others.
The Intermacs Database includes longitudinal data for the life of a patient with an MCS device. Approximately 36,000 patients currently are enrolled at more than 200 sites.
Medical device, pharmaceutical, biotechnology, and insurance companies, as well as a variety of other health care organizations can benefit by leveraging highly accurate, real-world clinical data collected over three decades.
Examples of STS Data Use by Industry
Company A wants to know if the volume of a certain clinical procedure performed by cardiothoracic surgeons has increased or decreased over time and then compare those data with its product’s sales history. Is the product use keeping pace with the increasing procedure volume? Given certain clinical outcomes, is there opportunity for product innovation to
increase market share? The STS National Database can provide detailed clinical and device-related data to answer important questions like this.
Company B is planning a clinical trial to test a new valve and needs to accrue patients quickly. The STS National Database can help identify the appropriate high-volume institutions as potential trial sites. Moreover, the STS Research and Analytic Center can facilitate a “trial within a registry” as a proven, high-quality and cost-effective data collection approach that is increasingly advocated by the FDA.
- Complete an STS Data Request Form for Industry
The Data Request Form will provide STS with a project summary and plan for data usage. You will need to submit sample tables showing how the extracted data should be presented.
- Execute a Data Sharing and Licensing Agreement
Following STS approval of the data request and the requestor’s approval of STS estimated royalty fees, a completed Data Sharing and Licensing Agreement will be required.
For more information contact Robert Habib, Vice President, STS Research and Analytic Center.