A viewpoint paper appearing in the March issue of JACC: Cardiovascular Interventions looks back at the launch of the STS/ACC TVT Registry with an eye on helping other professional societies and stakeholders anticipate and plan for challenges as they develop similar programs.

John S. Rumsfeld, MD, PhD, FACC, and colleagues, recall significant challenges that arose during the creation of the Registry, established in 2011 to help address the limitations of medical device surveillance and assess outcomes and care delivery. The TVT Registry does share features of the other programs, including the STS National Database and the NCDR, but with important differences, the authors note. In particular, the TVT Registry was conceived and built in a way that allows professional societies to work with the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) to support medical device surveillance and research. Those unique features gave rise to obstacles directly tied to the multiple stakeholders, data collection requirements, and the use of the Registry for pre- and post-market device evaluations that provide specific value to all partners.

“Although it is challenging to balance the perspectives and input from various stakeholders, we believe that the commitment to multi-stakeholder partnerships in the governance of the Registry program is a critical component for long-term success,” the authors wrote. “Stakeholders must be able to see that their input helps shape the strategic vision and goals of the Registry.”

The authors note that the scope of data collection has also proven to be a key challenge for the Registry, and they explain the difficulty in balancing data collection sufficient to support the varied goals of the stakeholders while not imposing an undue burden on the participating sites.  A top priority now is to minimize unnecessary data collection, prompting the Registry to undertake a focused effort to reduce the number of data elements collected.  The trend toward electronic record-keeping should facilitate this goal, they wrote.

Another challenge presented by the collaborative nature of the STS/ACC TVT Registry relates to its use as a device-surveillance system. The authors suggest that improvements be made so the system evolves to be more responsive to the needs and timelines of regulatory and industry partners.

Like most clinical registry programs, the STS/ACC TVT Registry receives data submitted by trained site personnel, a process that enhances data completeness and accuracy but does not constitute real-time surveillance. The authors write that the “TVT Registry will need to enhance device surveillance capabilities to optimally support the FDA’s strategic plan.”

Post-market data analysis has also presented challenges related to the multi-stakeholder nature of the Registry.  As the authors explain, “It is more challenging to operationalize clinical registries to conduct the formal post-approval studies (PASs) that are mandated by the FDA as a condition of device approval and have been traditionally executed by industry.”  The burden is on the TVT Registry to be designed in a way that provides the data that the FDA requires and to ensure that the benefits of conducting PASs using a clinical registry infrastructure are realized, they said. 

The article also describes the “significant” challenges related to pre-market studies and investigation device exemptions (IDEs), noting that the complex regulatory requirements involved in IDE studies present novel issues for a registry. In addition, the device industry has raised reasonable concerns about the ability of clinical registry programs to meet pre-market study requirements for data integrity, monitoring and timeliness.

“In sum, the role of clinical registry programs for IDE and pre-market studies is appealing in concept and will be pursued, but remains uncertain,” Rumsfeld writes. 

Keywords: Centers for Medicare and Medicaid Services, U.S., Cost of Illness, Device Approval, Goals, Medicaid, Medicare, Registries, United States Food and Drug Administration, STS/ACC TVT Registry, National Cardiovascular Data Registries

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