{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T17:58:56Z","timestamp":1792605536039,"version":"4.5.0"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T00:00:00Z","timestamp":1702425600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Balloon atrial septostomy (BAS)\u00a0is an emergent and essential cardiac intervention to enhance intercirculatory mixing at atrial level in deoxygenated patients diagnosed with transposition of the great arteries (TGA)\u00a0and restrictive foramen ovale. The recent recall of several BAS catheters and the changes in the European legal framework for medical devices (MDR\u00a02017\/745), has led to an overall scarcity of BAS catheters and raised questions about the use, safety, and experience of the remaining NuMED Z\u20105 BAS catheter.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>To evaluate and describe the practice and safety of the Z\u20105 BAS catheter, and to compare it to the performance of other BAS catheters.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A retrospective single\u2010center cohort encompassing all BAS procedures performed with the Z\u20105 BAS catheter in TGA patients between 1999 and 2022.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 182 BAS procedures were performed in 179 TGA\u2010newborns at Day 1 (IQR\u00a00\u20135) days after birth, with median weight of 3.4 (IQR\u00a01.2\u20135.7) kg. The need for BAS was urgent in 90% of patients. The percentage of BAS procedures performed at bedside increased over time from 9.8% (before 2010) to 67% (2017\u20132022). Major complication rate was 2.2%, consisting of cerebral infarction (1.6%) and hypovolemic shock (0.5%). The rate of minor complications was 9.3%, including temporary periprocedural AV\u2010block (3.8%), femoral vein thrombosis (2.7%), transient intracardiac thrombus (0.5%), and atrial flutter (2.2%). BAS procedures performed at bedside and in the cardiac catheterization laboratory had similar complication rates.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>BAS\u00a0using the Z\u20105 BAS catheter is both feasible and safe at bedside and at the cardiac catheterization laboratory with minimal major complications.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30932","type":"journal-article","created":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T19:27:18Z","timestamp":1702495638000},"page":"308-316","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Balloon atrial septostomy for transposition of the great arteries: Safety and experience with the Z\u20105 balloon catheter"],"prefix":"10.1002","volume":"103","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-4262-1808","authenticated-orcid":false,"given":"Jesse A.","family":"Weeda","sequence":"first","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Department of Pediatrics,\u00a0Division of Neonatology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina","family":"Bokenkamp\u2010Gramann","sequence":"additional","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart B.","family":"Straver","sequence":"additional","affiliation":[{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"},{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Emma Children's Hospital, Amsterdam University Medical Center (Amsterdam UMC) Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lukas","family":"Rammeloo","sequence":"additional","affiliation":[{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"},{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Emma Children's Hospital, Amsterdam University Medical Center (Amsterdam UMC) Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan D.","family":"Hahurij","sequence":"additional","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin A.","family":"Bertels","sequence":"additional","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique C.","family":"Haak","sequence":"additional","affiliation":[{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"},{"name":"Department of Obstetrics and Fetal Medicine Leiden University Medical Center (LUMC) Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arjan B.","family":"te Pas","sequence":"additional","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Neonatology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark G.","family":"Hazekamp","sequence":"additional","affiliation":[{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), Departments of Pediatrics, Divisions of Pediatric Cardiology, Departments of Obstetrics and Fetal Medicine, Departments of Cardiothoracic Surgery Amsterdam University Medical Center (Amsterdam UMC) and Leiden University Medical Center (LUMC) Amsterdam and Leiden The Netherlands"},{"name":"Department of Cardiothoracic Surgery Leiden University Medical Center (LUMC) Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nico A.","family":"Blom","sequence":"additional","affiliation":[{"name":"Department of Pediatrics,\u00a0Division of Pediatric Cardiology Willem\u2010Alexander Children's Hospital, Leiden University Medical Center (LUMC) Leiden The Netherlands"},{"name":"Center for Congenital Heart Disease Amsterdam\u2010Leiden (CAHAL), 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