Navigating the Gray: The Complex Story of PFO Closure Utilization

HomeCirculation: Cardiovascular Quality and OutcomesVol. 17, No. 1Navigating the Gray: The Complex Story of PFO Closure Utilization No AccessEditorialRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessEditorialRequest AccessFull TextNavigating the Gray: The Complex Story of PFO Closure Utilization Karen D. Orjuela, Michelle H. Leppert and John D. Carroll Karen D. OrjuelaKaren D. Orjuela Correspondence to: Karen D. Orjuela, MD, MSCR, University of Colorado School of Medicine, 12401 E. 17th Avenue, Aurora, CO 80045. Email E-mail Address: [email protected] https://orcid.org/0000-0002-7807-7003 Neurology Department (K.D.O., M.H.L.), University of Colorado School of Medicine, Aurora. , Michelle H. LeppertMichelle H. Leppert https://orcid.org/0000-0002-0679-7634 Neurology Department (K.D.O., M.H.L.), University of Colorado School of Medicine, Aurora. and John D. CarrollJohn D. Carroll https://orcid.org/0000-0001-8423-0169 Division of Cardiology (J.D.C.), University of Colorado School of Medicine, Aurora. Originally published8 Jan 2024https://doi.org/10.1161/CIRCOUTCOMES.123.010581Circulation: Cardiovascular Quality and Outcomes. 2024;17This article is a commentary on the followingApproval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure StoryFootnotesFor Disclosures, see page 29.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to: Karen D. Orjuela, MD, MSCR, University of Colorado School of Medicine, 12401 E. 17th Avenue, Aurora, CO 80045. Email karen.orjuela@cuanschutz.eduREFERENCES1. Goldsweig AM, Deng Y, Yao X, Desai NR, Cohen DJ, Aronow HD, Messé S, Ross JS, Lansky AJ, Savitz ST. Approval, evidence, and "off-label" device utilization: the patent foramen ovale closure story.Circ Cardiovasc Qual Outcomes. 2024; 17:18–27. doi: 10.1161/CIRCOUTCOMES.123.010200LinkGoogle Scholar2. Kavinsky CJ, Szerlip M, Goldsweig AM, Amin Z, Boudoulas KD, Carroll JD, Coylewright M, Elmariah S, MacDonald LA, Shah AP, et al. SCAI guidelines for the management of patent foramen ovale.JACC Cardiovasc Interv. 2022; 1:100039. doi: 10.1016/j.jscai.2022.100039CrossrefGoogle Scholar3. Kent DM, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, Derumeaux G, Furlan AJ, Herrmann HC, Jüni P, et al. Heterogeneity of treatment effects in an analysis of pooled individual patient data from randomized trials of device closure of patent foramen ovale after stroke.JAMA. 2021; 326:2277–2286. doi: 10.1001/jama.2021.20956CrossrefMedlineGoogle Scholar4. Carroll JD, Shuren J, Jensen TS, Hernandez J, Holmes D, Marinac-Dabic D, Edwards FH, Zuckerman BD, Wood LL, Kuntz RE, et al. Transcatheter valve therapy registry is a model for medical device innovation and surveillance.Health Aff (Millwood). 2015; 34:328–334. doi: 10.1377/hlthaff.2014.1010CrossrefMedlineGoogle Scholar5. Brida M, Chessa M, Celermajer D, Li W, Geva T, Khairy P, Griselli M, Baumgartner H, Gatzoulis MA. Atrial septal defect in adulthood: a new paradigm for congenital heart disease.Eur Heart J. 2022; 43:2660–2671. doi: 10.1093/eurheartj/ehab646CrossrefMedlineGoogle Scholar6. Skibsted CV, Korsholm K, Pedersen L, Bonnesen K, Nielsen-Kudsk JE, Schmidt M. Long-term risk of atrial fibrillation or flutter after transcatheter patent foramen ovale closure: a nationwide Danish study.Eur Heart J. 2023; 44:3469–3477. doi: 10.1093/eurheartj/ehad305CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesApproval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure StoryAndrew M. Goldsweig, et al. Circulation: Cardiovascular Quality and Outcomes. 2024;17 January 2024Vol 17, Issue 1 Advertisement Article InformationMetrics © 2024 American Heart Association, Inc.https://doi.org/10.1161/CIRCOUTCOMES.123.010581PMID: 38189124 Originally publishedJanuary 8, 2024 Keywordsatrial fibrillationconsensusdata warehousingdevice approvalforamen ovalepatentPDF download Advertisement SubjectsCerebrovascular Disease/StrokeTreatment