International Consortium of Vascular Registries

1. International Consortium of Vascular Registries Jack L. Cronenwett, M.D. Medical Director Society for Vascular Surgery Patient Safety Organization

2. Launched by Society for Vascular Surgery in 2011 • Mission: To improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information. • History: Based on the Vascular Study Group of New England, a regional quality improvement group using a common registry, organized in 2002. • Organization: • 16 Regional Quality ImprovementGroups • 12 National Registries in a Patient Safety Organization

3. Current Status 300 Centers, 45 States + Ontario as of 10/8/2014

4. Rwgistries and Devices Captured

5. Progress to Date • Multiple national and regional QI projects • Optimizing medical management to improve survival • Changing specific operative techniques to improve outcomes • Regional and national research projects • De-identified datasets available to VQI members • More than 50 scientific publications • Opportunity for device evaluation with existing data • Efficiency, existing network of sites, infrastructure • Real world data, both academic and community hospitals

6. 2 Post-Approval Surveillance Projects • Thoracic aortic stent grafts for aortic dissection • Gore Conformable TAG, Medtronic Valiant Captiva • Infra-renal aortic aneurysm stent graft • Lombard Aorfix • Use modification of existing VQI TEVAR/EVAR Registries • Expanded data elements and follow-up • Same data serve multiple purposes: • Quality improvement in PSO, device improvement by industry and device monitoring for FDA

7. Steps in Process • SVS PSO recruited 55 participating sites in 2 months • Simple addendum to current site-PSO contract • IRB approval, patient consent not required to collect data regarding standard of care practice in QI project • PSO provides line-by-line data to each industry for their device so they can create required reports for FDA • PSO provides summary, aggregate reports of all devices to industry and FDA in anonymous fashion for all pre-defined endpoints

8. VQI VASCUNET Vascular Study Group of New England 16 Regional Quality Improvement Groups Society for Vascular Surgery Vascular Quality Initiative

9. VQI VASCUNET Vascular Study Group of New England 11 Other National Vascular Surgery Registries UK, Sweden, Norway, Finland, Denmark, Germany, Hungary, Spain, Italy, Australia, New Zealand 16 Regional Quality Improvement Groups Society for Vascular Surgery Vascular Quality Initiative European Society for Vascular Surgery VASCUNET

10. VASCUNET • Committee of European Society for Vascular Surgery • Mission: Promote excellence and increase knowledge in vascular surgery with an international audit. • Organized in 1997, first combined data report in 2007 • 13 Current Members: • United Kingdom, Sweden, Norway, Finland, Denmark, Iceland, Germany, Switzerland, Hungary, Italy, Spain, Australia, New Zealand • Focused on abdominal aortic aneurysm, carotid endarterectomy and lower extremity bypass • 5 Combined data reports and multiple publications from individual national registries

11. VQI and VASCUNET Vascular Study Group of New England 11 European National Vascular Registries UK, Sweden, Norway, Finland, Denmark, Germany, Hungary, Spain, Italy, Australia, New Zealand 16 Regional Quality Improvement Groups Society for Vascular Surgery Vascular Quality Initiative European Society for Vascular Surgery VASCUNET International Consortium of Vascular Registries Including Quality of Vascular Devices

12. International Consortium of Vascular Registries • MDEpiNet Task Force Meeting, June, 2014 • International Consortium of Orthopedic Registries • Discussion of potential ICOR analog for Vascular • SVS Annual Meeting, June, 2014 • VQI and VASCUNET discussion of collaboration • ESVS Annual Meeting, September 25 • Commitment of VASCUNET members to the concept of international device evaluation

13. Agenda: • Learn from ICOR and ICTVR • Experience of current national vascular registries • Perspective of manufacturers and funding agencies • Select first project, core dataset requirements • Minimal registry requirements, follow-up, validation • Mechanisms for data sharing • Governance, financial support

14. International Consortium of Vascular Registries Summary • International vascular surgery registries are sufficiently developed to support a consortium patterned after ICOR for device evaluation • First ICVR meeting in November • Much work to be done regarding core data set, late follow-up, registry requirements • Hope is to hold a public meeting in Spring, 2015 • Thanks to Danica Marinac-Dabic and Art Sedrakyan for continued support