{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T04:44:16Z","timestamp":1773031456225,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,11,20]],"date-time":"2018-11-20T00:00:00Z","timestamp":1542672000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long\u2010term follow\u2010up (FU).<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The Occlutech device has been proven safe and effective six\u2010months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient\u2010years of FU.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right\u2010to\u2010left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 250 patients (mean age 53.5\u2009\u00b1\u200910.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9\u2009\u00b1\u20091.8 years, a total of 1,345 patient\u2010years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one\u2010year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1\u2010year FU (four TIA, one stroke) and in 7.4% at long\u2010term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient\u2010year of FU, with a stroke rate of 0.01%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Occlutech device appears to be safe at long\u2010term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1\u2010year FU.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27984","type":"journal-article","created":{"date-parts":[[2018,11,21]],"date-time":"2018-11-21T08:42:25Z","timestamp":1542789745000},"page":"1080-1084","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient\u2010years of follow up"],"prefix":"10.1002","volume":"93","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2246-0617","authenticated-orcid":false,"given":"Roel J. R.","family":"Snijder","sequence":"first","affiliation":[{"name":"Department of Cardiology St. Antonius Hospital  Nieuwegein The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura E.","family":"Renes","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine St. Antonius Hospital  Nieuwegein The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maarten Jan","family":"Suttorp","sequence":"additional","affiliation":[{"name":"Department of Cardiology St. Antonius Hospital  Nieuwegein The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jurrien M.","family":"ten Berg","sequence":"additional","affiliation":[{"name":"Department of Cardiology St. Antonius Hospital  Nieuwegein The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martijn C.","family":"Post","sequence":"additional","affiliation":[{"name":"Department of Cardiology St. Antonius Hospital  Nieuwegein The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,11,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.8.1172"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2012.00734.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2010.00619.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707404"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705915"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1610057"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00392-008-0699-9"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22737"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705915"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707404"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/chd.12057"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.05.026"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ehj.2003.10.021"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.10.043"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2017.07.058"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.03.008"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/joic.12255"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.27984","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.27984","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.27984","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.27984","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T02:02:47Z","timestamp":1694138567000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.27984"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,20]]},"references-count":17,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2019,5]]}},"alternative-id":["10.1002\/ccd.27984"],"URL":"https:\/\/doi.org\/10.1002\/ccd.27984","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,20]]},"assertion":[{"value":"2018-08-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}