The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices

Greg Tsougranis, Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt; Geisel School of Medicine at Dartmouth, Hanover, NH.
Jens Eldrup-Jorgensen, Division of Vascular Surgery, Maine Medical Center, Portland, Me.
Daniel Bertges, Section of Vascular Surgery, University of Vermont Medical Center, Burlington, Vt.
Marc Schermerhorn, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass.
Pablo Morales, Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Scott Williams, Cook Medical, Inc, Bloomington, Ind.
Roberta Bloss, W. L. Gore & Associates, Inc., Flagstaff, Ariz.
Jessica Simons, Division of Vascular Surgery, UMass Memorial Medical Center, Boston, Mass.
Sarah E. Deery, Department of Surgery, Massachusetts General Hospital, Boston, Mass.
Salvatore Scali, Department of Surgery, University of Florida School of Medicine, Gainesville, Fla.
Graham Roche-Nagle, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Leila Mureebe, Division of Vascular Surgery, Duke University School of Medicine, Durham, NC.
Matthew Mell, Division of Surgery at University of California, Davis, NC.
Mahmoud Malas, Vascular and Endovascular Surgery at University of California, San Diego, Calif.
Brian Pullin, Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
David H. Stone, Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt.
Misti Malone, Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Adam W. Beck, Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.
Grace Wang, Vascular and Endovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pa.
Danica Marinac-Dabic, Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Art Sedrakyan, Weill Cornell Medical Center, New York, NY.
Philip P. Goodney, Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt. Electronic address: philip.p.goodney@hitchcock.org.

Abstract

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes. The VISION CRN began in September 2015 and held its first strategic meeting on September 10, 2018, at the FDA headquarters in Silver Spring, Maryland. VISION is a collaboration of the Vascular Quality Initiative (VQI), the FDA, and other stakeholders. At this annual meeting, leaders from the FDA, VQI, industry representatives, population health researchers, and regulatory science experts gathered to discuss strategic goals and opportunities for VISION. One of the key focus areas for VISION is linkage of VQI registry data to Medicare, longitudinal data sources maintained by various states, and other relevant data sources, as a model for efficient, cost-saving, and effectual evidence generation and appraisal. This would provide the means to expand data collection, assess long-term procedural outcomes across the carotid, lower extremity, aortic, and venous intervention datasets, and execute registry-based trials through the CRN structure in an efficient, cost-effective manner. Looking forward, VISION strives to validate long-term outcome data in the VQI using industry datasets, in hopes of using CRNs to make device regulatory decisions. With the guidance of a steering committee, VISION will provide vascular surgeons, industry, and regulators the appropriate data to improve care for patients with vascular disease.