{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T05:21:28Z","timestamp":1792300888646,"version":"4.4.0"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T00:00:00Z","timestamp":1604102400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T00:00:00Z","timestamp":1604102400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Universit\u00e4tsklinikum Hamburg-Eppendorf (UKE)"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Res Cardiol"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Objective<\/jats:title>\n                <jats:p>This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud\u00ae\u00a0L\u00ea\u00a0VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8\u00a0mm.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud\u00ae\u00a0L\u00ea\u00a0VSD.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2\u201365) years and a median body weight of 26.7\u00a0(10\u2013109)\u00a0kg. A complete closure of the defects was achieved in 85.4% 2\u00a0weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3\/85 patients) and a major adverse event rate of 5.9% (5\/85 patients).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The Nit-Occlud\u00ae\u00a0L\u00ea\u00a0VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00392-020-01750-6","type":"journal-article","created":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T07:03:01Z","timestamp":1604127781000},"page":"382-390","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Long-term outcome of perimembranous VSD closure using the Nit-Occlud\u00ae L\u00ea VSD coil system"],"prefix":"10.1007","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6222-2683","authenticated-orcid":false,"given":"Rainer","family":"Kozlik-Feldmann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avraham","family":"Lorber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horst","family":"Sievert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Ewert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Jux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00f6tz C.","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Dalla Pozza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustafa","family":"Yigitbasi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dietmar","family":"Schranz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelika","family":"Lindinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Galal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Meinertz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,31]]},"reference":[{"issue":"238","key":"1750_CR1","doi-asserted-by":"publisher","first-page":"245","DOI":"10.1002\/ccd.10406","volume":"58","author":"JL Bass","year":"2003","unstructured":"Bass JL, Kalra GS, Arora R, Masura J, Gavora P, Thanopoulos BD, Torres W, Sievert H, Carminati M, Fischer G, Ewert P (2003) Initial human experience with the Amplatzer perimembranous ventricular septal occluder device. 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On behalf of all authors, the corresponding author states that there is no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The clinical investigators were responsible for obtaining their local Ethics Committee's approval. No patient was allowed to be included in this clinical investigation before this approval had been received.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}]}}