The International Consortium of Cardiovascular Registries (ICCR) is focused on two major initiatives:
- The International Consortium of Transcatheter Valve Registries (ICTVR) and
- The International Consortium of Vascular Registries (ICVR).
These two initiatives provide a collaborative platform through which registries and other stakeholders around the world can start a dialog, discuss data/methodology issues, and use aggregate level innovative analytic methods for conducting worldwide studies. An additional goal is to work with stakeholders such as manufacturers and regulators to improve their understanding of the safety and effectiveness of aortic valves and vascular devices designed to be implanted percutaneously. In order to promote this collaborative platform, the ICTVR and ICVR initiatives are creating one of the largest networks in the world, one that includes registries and academic centers with the research and clinical capability needed to tackle even the biggest obstacles related to cardiovascular device surveillance. Several papers are in preparation outlining the vision and research.
As surgical treatment options for valve disease are replaced by newer, less invasive procedures such as transcatheter valve replacement, questions about specific device performance, safety, and effectiveness remain unanswered in real-world settings. The implementation of International Consortium of Transcatheter Valve Registries (ICTVR) means development of an innovative framework for post-market surveillance of cardiovascular devices. This initiative establishes a collaborative global network among transcatheter valve registries to conduct analytic projects within the consortium. The governance model and research projects are innovative and we have built from the experience gained from ICOR. The registries participating in this network will identify gaps in evidence, harmonize relevant data and create innovative methodologies to analyze data in a distributed way. ICTVR has several aims:
- Develop a multi-national distributive transcatheter aortic valve replacement (TAVR) research network, including creating a governance structure whose leadership will oversee the creation of new methodological approaches for research and the establishment of public-private partnerships that will address stakeholder’s needs and sustainability.
- Align TAVR registry rare endpoints and other key variable definitions that support distributive research by reviewing current date fields in registries; then summarizing, defining, and prioritizing data elements in order to reach consensus on those definitions among registry leads around the world.
Conduct analytic ICTVR projects using distributive research methods through the description of the variation in international practice patterns, the evaluation of the association between specific patient and procedural characteristics, and rare procedure-related adverse outcomes, and determine the association between specific device attributes and in-hospital and mid-term outcomes.
The mission of the International Consortium of Vascular Registries (ICVR) is to provide a collaborative platform through which registries and other stakeholders around the world can share data to improve vascular healthcare. The ICVR was launched in November 2014 at Cornell University as another collaboration of FDA and the MDEpiNet’s Science and Infrastructure Center with participation of over 12 national registries, FDA, manufacturers, and other stakeholders. The ultimate goal is to more rapidly generate evidence through worldwide registries related to vascular devices and procedures. An important component is working with manufacturers and regulators to improve the safety and effectiveness of vascular devices, to define optimal patient and pathology selection for devices, and to identify potential device problems as soon as possible.
In order to create this collaborative platform, the ICVR is leveraging existing national registries, including the Society for Vascular Surgery’s Vascular Quality Initiative (VQI) and a history of collaboration in Vascunet, a “sub-committee of the European Society of Vascular Surgery which aims to increase knowledge and understanding of vascular disease, and to promote excellence in vascular surgery, by means of international vascular audit”. The primary focus of ICVR relates to vascular device evaluation; the leadership board has discussed several potential projects including infrarenal abdominal aortic aneurysm (AAA) treatment, pararenal AAA treatment, and thoracic endovascular aortic repair (TEVAR) of aortic dissection. There are two projects in parallel:
- A registry of endovascular aneurysm repair (EVAR) devices used for treatment of AAAs. The registry will involve long term (up to 5 year) follow-up of limited outcomes (death, re-intervention), and would be compared with open surgical treatment during the same time period.
- Analytic projects to evaluate international variation in device use and procedure type in different patient subgroups. Existing registry data will be used, and information will be combined whenever relevant using distributed analysis methodology.