{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T12:43:30Z","timestamp":1740141810675,"version":"3.37.3"},"reference-count":15,"publisher":"Cambridge University Press (CUP)","issue":"5","license":[{"start":{"date-parts":[[2018,2,27]],"date-time":"2018-02-27T00:00:00Z","timestamp":1519689600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"content-domain":{"domain":["www.cambridge.org"],"crossmark-restriction":true},"short-container-title":["Cardiol Young"],"published-print":{"date-parts":[[2018,5]]},"abstract":"Abstract<\/jats:title>Objectives<\/jats:title>The objective of this study was to demonstrate the safety and feasibility of using the new Cardia Ultrasept II\u2122 device with interposed Goretex patch referring to the perforation of polyvinyl alcohol membrane.<\/jats:p><\/jats:sec>Background<\/jats:title>Great advances have been made in the development of devices for closure of atrial septal defect. The Cardia Ultrasept II\u2122 with interposed Goretex patch is the modified last generation of Cardia devices, having the advantage of a super-low profile within the atria and an integral locking delivery-retrieval mechanism that ensures safe deployment. In addition, with the interposition of the Goretex, it has been possible to abolish perforation of Ivalon\u2019s membrane as a complication.<\/jats:p><\/jats:sec>Methods and results<\/jats:title>Patients with ostium secundum atrial septal defect with surrounding rims with a minimum length of 5 mm and who underwent atrial septal defect closure with the new Ultrasept II\u2122 with Goretex patch were included from two paediatric cardiac centres. Primary end point was to determine perforation of the Goretex membrane at follow-up; secondary end point included right ventricular diastolic diameter. In total, 30 patients underwent atrial septal defect closure at a median age of 6 (1\u201329) years. At follow-up for 6 (range, 1\u201315) months, freedom from perforations was 100%. A continuous decrease in right ventricular diastolic diameter was found with an initial median of 30 (25\u201349) mm and after catheterisation of 27.5 (18\u201333) mm, p=0.01, and Z-score of 2.6 (1.7\u20133.6) versus 1.9 (1\u20132.9) after procedure, p=0.01.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>The new modified generation of the Ultrasept II\u2122 device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s1047951118000100","type":"journal-article","created":{"date-parts":[[2018,2,27]],"date-time":"2018-02-27T04:12:11Z","timestamp":1519704731000},"page":"709-714","update-policy":"https:\/\/doi.org\/10.1017\/policypage","source":"Crossref","is-referenced-by-count":4,"title":["Atrial septal defect closure with the new Cardia Ultrasept II\u2122 device with interposed Goretex patch: Mexican experience \u2013 has the perforation of Ivalon\u2019s membrane been solved?"],"prefix":"10.1017","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0817-3139","authenticated-orcid":false,"given":"Roberto","family":"Mijangos-V\u00e1zquez","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio J.","family":"Garc\u00eda-Montes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena M.","family":"Soto-L\u00f3pez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ver\u00f3nica","family":"Guarner-Lans","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Zabal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2018,2,27]]},"reference":[{"key":"S1047951118000100_ref15","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01711-4"},{"key":"S1047951118000100_ref1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01862-4"},{"key":"S1047951118000100_ref10","doi-asserted-by":"crossref","first-page":"E141","DOI":"10.1002\/ccd.26704","article-title":"Delayed spontaneous perforation of polyvinyl alcohol membrane \u2013 covered atrial septal defect closure devices","volume":"89","author":"Labombarda","year":"2016","journal-title":"Catheter Cardiovasc Interv"},{"key":"S1047951118000100_ref8","first-page":"1153","article-title":"Disintegration of polyvinyl alcohol membrane covering atrial septal defect closure device","author":"Bhattacharyya","year":"2015","journal-title":"Eur Heart J"},{"key":"S1047951118000100_ref7","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.114.001429"},{"key":"S1047951118000100_ref11","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1002\/ccd.26456","article-title":"Device-in-device: a transcatheter alternative to surgical explantation of a failing atrial septal defect intracardiac prosthesis","volume":"88","author":"Chamie","year":"2016","journal-title":"Catheter Cardiovasc Interv"},{"key":"S1047951118000100_ref2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.100.suppl_2.II-145"},{"key":"S1047951118000100_ref14","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.82.3.300"},{"key":"S1047951118000100_ref5","unstructured":"Turner DR , Forbes TJ . Cardia devices. In: Hijazi Z, Feldman T, Abdullah Al-Qbandi MH, et al (eds). Transcatheter Closure of ASDs and PFOs: A Comprehensive Assessment. Cardiotext, Minneapolis, MN, 2010: 407\u2013416."},{"key":"S1047951118000100_ref13","first-page":"377","article-title":"Percutaneous versus surgical closure of secundum atrial septal defects: a systematic review and meta-analysis of currently available clinical evidence","volume":"7","author":"Butera","year":"2011","journal-title":"Euro Intervention"},{"key":"S1047951118000100_ref3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1976.03260490024013"},{"key":"S1047951118000100_ref4","first-page":"103","volume-title":"Catheter Based Devices for the Treatment of Non-Coronary Cardiovascular Disease in Adults and Children","author":"Schraeder","year":"2003"},{"key":"S1047951118000100_ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.actbio.2013.12.003"},{"key":"S1047951118000100_ref9","doi-asserted-by":"crossref","first-page":"E151","DOI":"10.1002\/ccd.26057","article-title":"Early malfunction of polyvinyl alcohol membrane of septal occluder","volume":"87","author":"Ramoglu","year":"2016","journal-title":"Cathet Cardiovasc Intervent"},{"key":"S1047951118000100_ref12","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31821b1f10"}],"container-title":["Cardiology in the Young"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1047951118000100","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,4,14]],"date-time":"2019-04-14T17:40:09Z","timestamp":1555263609000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1047951118000100\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,2,27]]},"references-count":15,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2018,5]]}},"alternative-id":["S1047951118000100"],"URL":"https:\/\/doi.org\/10.1017\/s1047951118000100","relation":{},"ISSN":["1047-9511","1467-1107"],"issn-type":[{"type":"print","value":"1047-9511"},{"type":"electronic","value":"1467-1107"}],"subject":[],"published":{"date-parts":[[2018,2,27]]},"assertion":[{"value":"\u00a9 Cambridge University Press 2018\u00a0","name":"license","label":"License","group":{"name":"copyright_and_licensing","label":"Copyright and Licensing"}}]}}