{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T22:48:28Z","timestamp":1770504508859,"version":"3.49.0"},"reference-count":12,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2012,3,15]],"date-time":"2012-03-15T00:00:00Z","timestamp":1331769600000},"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":[[2012,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:styled-content>Objectives<\/jats:styled-content>: To determine the incidence of device fractures (DF) after implantation of a Solysafe\u00ae Septal Occluder (iSSO) and to assess the spectrum of associated problems. <jats:styled-content>Background<\/jats:styled-content>: In August 2010, after initial unpublished reports on DF, the manufacturer issued an \u201curgent field safety notice,\u201d prompting all medical care providers to re\u2010examine all patients after iSSO. <jats:styled-content>Methods<\/jats:styled-content>: Prospective single center study. Extended follow\u2010up examination, including standardized fluoroscopy (sF), was performed in all patients after iSSO. <jats:styled-content>Results<\/jats:styled-content>: A total of 111 patients had undergone iSSO at our institution between June 2005 and July 2010. Median age and body weight were 50 years (9.3\u201379.6) and 75 kg (29\u2013122), respectively. Indications for iSSO were (1) patent foramen ovale in patients with a history of cryptogenic stroke (<jats:italic>n<\/jats:italic> = 84; 76%) and (2) hemodynamically significant atrial septal defect of the secundum type (<jats:italic>n<\/jats:italic> = 27; 24%). A total of 113 devices were implanted. Complete follow\u2010up was available in 103 patients (92.8%). Median follow\u2010up was 1.9 years (0\u20135.2). There were no postimplantation neurological events or symptoms. The closure rate was 97.1%. DF was suspected on a chest X\u2010ray in one patient and documented in 10 patients by sF. The overall probability of freedom from DF was 82.3% after 5 years. One patient had embolization of a device fragment to the right pulmonary artery. So far, all patients with DF have been managed conservatively. <jats:styled-content>Conclusions<\/jats:styled-content>: The incidence of DF after iSSO is unacceptably high. sF is imperative for accurate diagnosis of DF. Further, follow\u2010up is needed to determine the risk of clinical complications and to optimize management. \u00a9 2012 Wiley Periodicals, Inc.<\/jats:p>","DOI":"10.1002\/ccd.23399","type":"journal-article","created":{"date-parts":[[2011,11,22]],"date-time":"2011-11-22T06:46:10Z","timestamp":1321944370000},"page":"1161-1168","source":"Crossref","is-referenced-by-count":12,"title":["Wire fractures in Solysafe\u00ae septal occluders: A single center experience"],"prefix":"10.1002","volume":"79","author":[{"given":"Stephen","family":"Gielen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank T.","family":"Riede","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerhard","family":"Schuler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingo","family":"D\u00e4hnert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,3,15]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21963"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8175.2010.01174.x"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21929"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22320"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2003.07.018"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0300-8932(10)70093-2"},{"key":"e_1_2_7_8_2","first-page":"E247","article-title":"Late presentation of CardioSEAL PFO closure device fracture and thrombus formation three years after device implantation","volume":"20","author":"Narayan V","year":"2008","journal-title":"J Invasive Cardiol"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22081"},{"key":"e_1_2_7_10_2","article-title":"Nitinol wire mesh fracture and traumatic left atrial thrombus in a patient with atrial septal defect Amplatzer Occluder","author":"Rezaian GR","journal-title":"J Card Surg."},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2001.tb00745.x"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21360"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2009.03.086"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.23399","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.23399","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T09:47:20Z","timestamp":1700560040000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.23399"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,15]]},"references-count":12,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2012,6]]}},"alternative-id":["10.1002\/ccd.23399"],"URL":"https:\/\/doi.org\/10.1002\/ccd.23399","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,3,15]]}}}