{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T10:20:50Z","timestamp":1782296450551,"version":"3.54.5"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,9,11]],"date-time":"2020-09-11T00:00:00Z","timestamp":1599782400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004040","name":"KU Leuven","doi-asserted-by":"publisher","award":["Internal Funds KU Leuven, Post\u2010Doctoral Mandate 18"],"award-info":[{"award-number":["Internal Funds KU Leuven, Post\u2010Doctoral Mandate 18"]}],"id":[{"id":"10.13039\/501100004040","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ultrasound in Obstet &amp; Gyne"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>One of the drawbacks of fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia is the need for a second invasive intervention to re\u2010establish airway patency. The \u2018Smart\u2010TO\u2019 device is a new balloon for FETO that deflates spontaneously when placed in a strong magnetic field, therefore overcoming the need for a second procedure. The safety and efficacy of this device have not yet been demonstrated. The aim of this study was to investigate the reversibility, local side effects and occlusiveness of the Smart\u2010TO balloon, both in a simulated <jats:italic>in\u2010utero<\/jats:italic> environment and in the fetal lamb model.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>First, the reversibility of tracheal occlusion by the Smart\u2010TO balloon was tested in a high\u2010fidelity simulator. Following videoscopic tracheoscopic balloon insertion, the fetal mannequin was placed within a 1\u2010L water\u2010filled balloon to mimic the amniotic cavity. This was held by an operator in front of their abdomen, and different fetal and maternal positions were simulated to mimic the most common clinical scenarios. Following exposure to the magnetic field generated by a 1.5\u2010T magnetic resonance (MR) machine, deflation of the Smart\u2010TO balloon was assessed by tracheoscopy. In cases of failed deflation, the mannequin was reinserted into a water\u2010filled balloon for additional MR exposure, up to a maximum of three times. Secondly, reversibility, occlusiveness and local effects of the Smart\u2010TO balloon were tested <jats:italic>in vivo<\/jats:italic> in fetal lambs. Tracheal occlusion was performed in fetal lambs on gestational day 95 (term, 145\u2009days), either using the balloon currently used in clinical practice (Goldbal2) (<jats:italic>n<\/jats:italic>\u2009=\u20095) or the Smart\u2010TO balloon (<jats:italic>n<\/jats:italic>\u2009=\u20095). On gestational day 116, the presence of the balloon was assessed by tracheoscopy. Deflation was performed by puncture (Goldbal2) or MR exposure (Smart\u2010TO). Six unoccluded fetal lambs served as controls. Following euthanasia, the lung\u2010to\u2010body\u2010weight ratio (LBWR), lung morphometry and tracheal circumference were assessed. Local tracheal changes were measured using a hierarchical histologic scoring system.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p><jats:italic>Ex vivo<\/jats:italic>, Smart\u2010TO balloon deflation occurred after a single MR exposure in 100% of cases in a maternal standing position with the mannequin at a height of 95\u2009cm (<jats:italic>n<\/jats:italic>\u2009=\u200932), 55\u2009cm (<jats:italic>n<\/jats:italic>\u2009=\u20098) or 125\u2009cm (<jats:italic>n<\/jats:italic>\u2009=\u20098), as well as when the maternal position was \u2018lying on a stretcher\u2019 (<jats:italic>n<\/jats:italic>\u2009=\u20098). Three out of eight (37.5%) balloons failed to deflate at first exposure when the maternal position was \u2018sitting in a wheelchair\u2019. Of these, two balloons deflated after a second MR exposure, but one balloon remained inflated after a third exposure. <jats:italic>In vivo<\/jats:italic>, all Smart\u2010TO balloons deflated successfully. The LBWR in fetal lambs with tracheal occlusion by a Smart\u2010TO balloon was significantly higher than that in unoccluded controls, and was comparable with that in the Goldbal2 group. There were no differences in lung morphometry and tracheal circumference between the two balloon types. Tracheal histology showed minimal changes for both balloons.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In a simulated <jats:italic>in\u2010utero<\/jats:italic> environment, the Smart\u2010TO balloon was effectively deflated by exposure of the fetus in different positions to the magnetic field of a 1.5\u2010T MR system. There was only one failure, which occurred when the mother was sitting in a wheelchair. In healthy fetal lambs, the Smart\u2010TO balloon is as occlusive as the clinical standard Goldbal2 system and has only limited local side effects. \u00a9 2020 International Society of Ultrasound in Obstetrics and Gynecology<\/jats:p><\/jats:sec>","DOI":"10.1002\/uog.22132","type":"journal-article","created":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T13:18:58Z","timestamp":1593523138000},"page":"522-531","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["New device permitting non\u2010invasive reversal of fetal endoscopic tracheal occlusion: <i>ex\u2010vivo<\/i> and <i>in\u2010vivo<\/i> study"],"prefix":"10.1002","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2022-9027","authenticated-orcid":false,"given":"D.","family":"Basurto","sequence":"first","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Sanan\u00e8s","sequence":"additional","affiliation":[{"name":"INSERM 1121 \u2018Biomaterials and Bioengineering\u2019 Strasbourg University  Strasbourg France"},{"name":"Department of Maternal Fetal Medicine Strasbourg University Hospital  Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Verbeken","sequence":"additional","affiliation":[{"name":"Department of Pathology University Hospitals Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Sharma","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Corno","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Valenzuela","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Van der Veeken","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"},{"name":"Clinical Department of Obstetrics and Gynaecology University Hospitals Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Favre","sequence":"additional","affiliation":[{"name":"Department of Maternal Fetal Medicine Strasbourg University Hospital  Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. M.","family":"Russo","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"},{"name":"Clinical Department of Obstetrics and Gynaecology University Hospitals Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-945X","authenticated-orcid":false,"given":"J.","family":"Deprest","sequence":"additional","affiliation":[{"name":"My FetUZ Department of Development and Regeneration Cluster Woman and Child, Biomedical Sciences, KU Leuven  Leuven Belgium"},{"name":"Clinical Department of Obstetrics and Gynaecology University Hospitals Leuven  Leuven Belgium"},{"name":"Institute for Women's Health University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,11]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.sempedsurg.2017.04.011"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.2571"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.4052"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.13065"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.12445"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.16000"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000001675"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0036-1587331"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2017.02.041"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5445"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3468(97)90314-6"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.4284"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10397-018-1041-9"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0301-2115(98)00183-3"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0301-2115(00)00435-8"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.4915"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1259\/bjr\/30146162"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpedsurg.2009.08.014"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1067\/mob.2000.108871"}],"container-title":["Ultrasound in Obstetrics &amp; Gynecology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fuog.22132","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/uog.22132","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/uog.22132","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/uog.22132","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T09:20:49Z","timestamp":1693732849000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/uog.22132"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,11]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["10.1002\/uog.22132"],"URL":"https:\/\/doi.org\/10.1002\/uog.22132","archive":["Portico"],"relation":{},"ISSN":["0960-7692","1469-0705"],"issn-type":[{"value":"0960-7692","type":"print"},{"value":"1469-0705","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,11]]},"assertion":[{"value":"2020-05-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}