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Publication of high\u2010quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi\u2010disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO\/stroke program, with emphasis on shared decision making and patient\u2010centered care.<\/jats:p>","DOI":"10.1002\/ccd.28111","type":"journal-article","created":{"date-parts":[[2019,3,21]],"date-time":"2019-03-21T13:08:35Z","timestamp":1553173715000},"page":"859-874","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke"],"prefix":"10.1002","volume":"93","author":[{"given":"Eric","family":"Horlick","sequence":"first","affiliation":[{"name":"Institute of Medical Science University Health Network  Toronto Ontario"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clifford J.","family":"Kavinsky","sequence":"additional","affiliation":[{"name":"Section of Structural and Interventional Cardiology Rush University Medical Center  Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahid","family":"Amin","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Augusta University  Augusta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantinos Dean","family":"Boudoulas","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine The Ohio State University Wexner Medical Center  Columbus Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Carroll","sequence":"additional","affiliation":[{"name":"Department of Medicine\u2010Cardiology University of Colorado  Denver Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziyad M.","family":"Hijazi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Sidra Medicine  Doha Qatar"},{"name":"Department of Pediatrics Weill Cornell Medicine  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Leifer","sequence":"additional","affiliation":[{"name":"Department of Neurology Weill Cornell Medicine  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helmi L.","family":"Lutsep","sequence":"additional","affiliation":[{"name":"Department of Neurology Oregon Health and Science University  Portland Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2928-6316","authenticated-orcid":false,"given":"John F.","family":"Rhodes","sequence":"additional","affiliation":[{"name":"Congenital Heart Center Medical University of South Carolina  Charleston South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan M.","family":"Tobis","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California  Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,3,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000485"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(01)01427-9"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.09.002"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002961"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.12.023"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1610057"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707404"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705915"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.02.046"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1301440"},{"key":"e_1_2_10_12_1","unstructured":"FDA Executive Summary Prepared for the May 24 2016 meeting of the Circulatory System Devices Panel. 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