{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T14:45:38Z","timestamp":1785509138049,"version":"3.56.0"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,1,14]],"date-time":"2018-01-14T00:00:00Z","timestamp":1515888000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2018,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Stroke remains the leading cause of serious long\u2010term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet\u2010based sources from January 2003 to September 2017. Randomized controlled trails (RCTs) comparing percutaneous PFO closure to medical therapy alone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Five RCTs (CLOSURE I, PC Trial, REDUCE, RESPECT, and CLOSE) with 1,829 patients in the device group and 1,611 patients in the medical group met inclusion criteria. The cumulative incidence of recurrent stroke was 2.02% in the PFO closure arm and 4.4% in the medical therapy group (RR 0.42, 95%CI 0.20, 0.91; <jats:italic>P<\/jats:italic>\u2009=\u20090.03). There was no difference in the incidence of death [0.7% vs. 0.9%; RR 0.76 (95% CI 0.35, 1.64), <jats:italic>P<\/jats:italic>\u2009=\u20090.49] or adverse events during the follow\u2010up period [24.6% vs. 23.7% (RR 1.03; 95% CI 0.91, 1.16), <jats:italic>P<\/jats:italic>\u2009=\u20090.65] between the closure and medical therapy groups. Incidence of atrial fibrillation was significantly higher in closure group compared to medical therapy [4% vs. 0.6% (RR 4.73; 95% CI 2.09, 10.70), <jats:italic>P<\/jats:italic>\u2009=\u20090.0002]. The comparative effectiveness of PFO closure (compared to medical therapy) was significantly more pronounced in those younger than 45 years, males, larger shunts and disc design platforms (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27487","type":"journal-article","created":{"date-parts":[[2018,1,14]],"date-time":"2018-01-14T09:32:39Z","timestamp":1515922359000},"page":"1153-1160","source":"Crossref","is-referenced-by-count":11,"title":["Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0099-2866","authenticated-orcid":false,"given":"Abdul","family":"Hakeem","sequence":"first","affiliation":[{"name":"Robert Wood Johnson Hospital, Rutgers University New Brunswick New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3795-8645","authenticated-orcid":false,"given":"Mehmet","family":"Cilingiroglu","sequence":"additional","affiliation":[{"name":"School of Medicine Arkansas Heart Hospital, Little Rock, AR and Koc University Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelos","family":"Katramados","sequence":"additional","affiliation":[{"name":"Department of Neurology Henry Ford Health Sciences Center Detroit Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantinos Dean","family":"Boudoulas","sequence":"additional","affiliation":[{"name":"The Ohio State University Columbus Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8817-4579","authenticated-orcid":false,"given":"Cezar","family":"Iliescu","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betul","family":"Gundogdu","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Arkansas for Medical Sciences Little Rock Arkansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9620-7142","authenticated-orcid":false,"given":"Konstantinos","family":"Marmagkiolis","sequence":"additional","affiliation":[{"name":"Florida Hospital Pepin Heart Institute Tampa Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,1,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000485"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(13)70310-7"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.24.12.1865"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011503"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.04.001"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/2046-4053-2-4"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60903-8"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b2535"},{"key":"e_1_2_9_10_1","doi-asserted-by":"crossref","unstructured":"Higgins JPT Green S. 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