The U.S. Food and Drug Administration (FDA) brought together various stakeholders from across the globe on April 22 to establish the International Consortium of Cardiovascular Registries (ICCR). The ground-breaking initiative, comprised of the ACC, the Society of Thoracic Surgeons (STS), industry and others, aims to enhance the way device registries are used across the practice of cardiology and around the world. Efforts to develop the ICCR follow the model of the International Consortium of Orthopedic Registries.

Additional Resources FDA Notice STS/ACC TVT Registry™

"The cooperation that ACC and STS have been successful in developing with U.S. government agencies and with each other is now expanding internationally," said Michael J. Mack, MD, FACC, Chief Science Officer and chair of the STS/ACC TVT Registry™ Steering Committee. "This is a first opportunity for dialogue on international cooperation between representatives of Canada, the United Kingdom, Germany, the Netherlands and the U.S. on key initiatives in medical device use and surveillance." While registries have become important tools for assessing the performance of cardiovascular procedures in real-world settings, limitations and variation across regions open doors for global collaboration.

"New concepts, new technology and new relationships increase the pace of information innovation exponentially, and today's meeting provided a platform to share how far we've come and where we can go," reflected ACC Past President and TVT Registry vice chair David R. Holmes, Jr., MD, MACC. "Expansive opportunities and exciting challenges lie ahead as we leverage global expertise to build a framework and infrastructure for capturing data and answering questions going forward."

The effort will initially focus on registries that track the transcatheter aortic valve replacement (TAVR) procedure with plans to expand to additional cardiovascular registries in the future. The TVT Registry has tracked patient safety and real-world outcomes for the TAVR procedure from the beginning. Part of the ACC’s National Cardiovascular Data Registry (NCDR^®) and the STS National Database, the TVT Registry provides invaluable data and 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. It also serves as a tool for conducting research in areas of comparative effectiveness, cost effectiveness and appropriate use criteria.

Analysis of data from the TVT Registry will allow the cardiovascular profession and medical community to understand how to deploy this new technology, and what impact it will have on patient outcomes as it becomes more prevalent. The registry also aims to use the data to assist the medical device industry and the FDA in surveillance of the quality, safety and efficacy of new medical devices.

"What is probably most remarkable is the shared vision for clinical registries going forward, shared by all the stakeholders, including quality of care measurement and feedback, device surveillance, pre- and post-market approval studies, and measuring patient-centered outcomes," noted John S. Rumsfeld, MD, PhD, FACC, chair of the NCDR Management Board. "It's clear that international collaboration can facilitate this vision."

Registry collaboration has been in the spotlight recently. Earlier in April, ACC Past President Ralph G. Brindis, MD, MPH, MACC, and NCDR's Chief Medical Officer Frederick A. Masoudi, MD, MSPH, FACC, shared ACC's vast experience in developing registries at the China Outcomes, Research and Evidence Based Medicine (CORE) Summit in Shanghai. The Summit—the only meeting in China solely dedicated to outcomes and comparative effectiveness research— brought together key players from the U.S. and Chinese governments, the medical community, industry, and academic and research organizations.

Keywords: Cost-Benefit Analysis, International Cooperation, Comparative Effectiveness Research, Patient Safety, Government Agencies, Evidence-Based Medicine, United States, Research

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