title: Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).
abstract: The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Emily P
authors.initials: EP
authors.lastname: Zeitler
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
authors.affiliation: Mercy Health, Chesterfield, MO.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Drozda
authors.affiliation: University of Washington, Seattle, WA.
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: David F
authors.initials: DF
authors.lastname: Kong
authors.affiliation: US Food Drug Administration, Silver Spring, MD.
authors.forename: John
authors.initials: J
authors.lastname: Laschinger
authors.affiliation: US Food Drug Administration, Silver Spring, MD.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: European Cardiovascular Research Center, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: US Food Drug Administration, Silver Spring, MD.
authors.forename: Terrie
authors.initials: T
authors.lastname: Reed
authors.affiliation: Weill Cornell Medical College, New York, NY.
authors.forename: Art
authors.initials: A
authors.lastname: Sedrakyan
authors.affiliation: Boston Scientific, St Paul, MN.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Stein
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: James
authors.initials: J
authors.lastname: Tcheng
authors.affiliation: Duke Clinical Research Institute, Durham, NC. Electronic address: mitchell.krucoff@duke.edu.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D002318:Cardiovascular Diseases / Q000628:therapy*; D003226:Congresses as Topic; D006801:Humans; D007400:Interprofessional Relations; D012042:Registries; D018570:Risk Assessment / Q000379:methods*; D017751:Safety Management / Q000379:methods*; D014481:United States