{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:24:46Z","timestamp":1790097886898,"version":"4.0.1"},"reference-count":40,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Quality and Outcomes"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>Following regulatory approval, medical devices may be used \u201coff-label.\u201d Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with \u22652 years of preprocedure coverage to establish indications, classified hierarchically as stroke\/systemic embolism, migraine, transient ischemia attack, or other.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%\u226560 years old), which increased from 4.75 per 100\u2005000 person-years in 2006 to 6.60 per 100\u2005000 person-years in 2019. Patients aged \u226560 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke\/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged \u226560 years and male were less likely to undergo closure for migraine than stroke\/systemic embolism.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circoutcomes.123.010200","type":"journal-article","created":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T10:00:33Z","timestamp":1704708033000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Approval, Evidence, and \u201cOff-Label\u201d Device Utilization: The Patent Foramen Ovale Closure Story"],"prefix":"10.1161","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2952-7837","authenticated-orcid":true,"given":"Andrew M.","family":"Goldsweig","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Medicine, Baystate Medical Center, Springfield, MA (A.M.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yihong","family":"Deng","sequence":"additional","affiliation":[{"name":"Kern Center for the Science of Health Care Delivery and Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (Y.D., X.Y., S.T.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9906-7106","authenticated-orcid":true,"given":"Xiaoxi","family":"Yao","sequence":"additional","affiliation":[{"name":"Kern Center for the Science of Health Care Delivery and Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (Y.D., X.Y., S.T.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2384-2545","authenticated-orcid":true,"given":"Nihar R.","family":"Desai","sequence":"additional","affiliation":[{"name":"Section of Cardiovascular Medicine, Yale University, New Haven, CT (N.R.D., A.J.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9163-724X","authenticated-orcid":true,"given":"David J.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Cardiovascular Research Foundation, New York, NY (D.J.C.)."},{"name":"St. Francis Hospital and Heart Center, Roslyn, NY (D.J.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9061-7893","authenticated-orcid":true,"given":"Herbert D.","family":"Aronow","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Henry Ford Health System, Detroit, MI (H.D.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3108-5441","authenticated-orcid":true,"given":"Steven R.","family":"Mess\u00e9","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia (S.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9218-3320","authenticated-orcid":true,"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[{"name":"Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT (J.S.R.)."},{"name":"Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (J.S.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8002-7497","authenticated-orcid":true,"given":"Alexandra J.","family":"Lansky","sequence":"additional","affiliation":[{"name":"Section of Cardiovascular Medicine, Yale University, New Haven, CT (N.R.D., A.J.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3190-7740","authenticated-orcid":true,"given":"Samuel T.","family":"Savitz","sequence":"additional","affiliation":[{"name":"Kern Center for the Science of Health Care Delivery and Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (Y.D., X.Y., S.T.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","unstructured":"U.S. Food and Drug Administration. 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