Representatives from the FDA, medical societies, registries and industry met April 22 in Silver Spring, Md., to discuss creation of an international registry for transcatheter aortic valve replacement (TAVR). The collaboration is the first step in an effort to develop a consortium of cardiovascular registries for broad-based analysis and surveillance of medical devices and clinical outcomes.
“Our goal is not to create additional burden for the societies and industries,” said Danica Marinac-Dabic, MD, PhD, of the FDA’s Center for Devices and Radiological Health. Instead, the program is designed to harness the collective power of registries worldwide to improve reporting on cardiovascular devices, starting with TAVR. To be successful, collaborators will need to identify and resolve potential problems that could derail the program.
“We can’t do it alone,” emphasized Marinac-Dabic.
Numerous elements need to be developed to build a robust registry for post-market analyses and surveillance, according to presenters. Those elements include modernizing processes; data mining, including the use of EHRs and automated tools to identify patterns and signals of adverse events; and methodologies.
Panelists shared experiences and insights from registries in the U.S., Germany, the Netherlands, Canada and the U.K. Using the International Consortium of Orthopedic Registries (ICOR) as a model, they discussed the opportunities to improve patient care using international collaboration. ICOR, for or instance, has been instrumental in identifying metal-on-metal wear in hip replacement devices and the patient subgroups most affected.
Panelists used the gathering to outline the steps to building databases, characteristics of their individual registries and the possible challenges of uniting disparate registries. Those include:
- Infrastructure issues;
- Incentives for participation;
- Streamlining registries;
- Costs and economics;
- Harmonizing terms and data fields;
- Data quality;
- Burden associated with participation;
- Protocols for dealing with industry; and
- Access to data.
Panelists pointed out the importance of broad participation, including bringing in collaborators from Asia. They also pointed out the importance of careful planning and integration and discussed the “must have” and “want to have” elements of the registry.