Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model.

FETO congenital diaphragmatic hernia efficacy lamb magnetic resonance prenatal therapy safety sheep trachea unplug

Journal

Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology
ISSN: 1469-0705
Titre abrégé: Ultrasound Obstet Gynecol
Pays: England
ID NLM: 9108340

Informations de publication

Date de publication:
01 2021
Historique:
received: 22 07 2020
revised: 15 09 2020
accepted: 18 09 2020
pubmed: 5 10 2020
medline: 15 12 2021
entrez: 4 10 2020
Statut: ppublish

Résumé

To investigate the efficacy and safety of the 'smart' tracheal occlusion (Smart-TO) device in fetal lambs with diaphragmatic hernia (DH). DH was created in fetal lambs on gestational day 70 (term, 145 days). Fetuses were allocated to either pregnancy continuation until term (DH group) or fetoscopic endoluminal tracheal occlusion (TO), performed using the Smart-TO balloon on gestational day 97 (DH + TO group). On gestational day 116, the presence of the balloon was confirmed on ultrasound, then the ewe was walked around a 3.0-Tesla magnetic resonance scanner for balloon deflation, which was confirmed by ultrasound immediately afterwards. At term, euthanasia was performed and the fetus retrieved. Efficacy of occlusion was assessed by the lung-to-body-weight ratio (LBWR) and lung morphometry. Safety parameters included tracheal side effects assessed by morphometry and balloon location after deflation. The unoccluded DH lambs served as a comparator. Six fetuses were included in the DH group and seven in the DH + TO group. All balloons deflated successfully and were expelled spontaneously from the airways. In the DH + TO group, in comparison to controls, the LBWR at birth was significantly higher (1.90 (interquartile range (IQR), 1.43-2.55) vs 1.07 (IQR, 0.93-1.46); P = 0.005), while on lung morphometry, the alveolar size was significantly increased (mean linear intercept, 47.5 (IQR, 45.6-48.1) vs 41.9 (IQR, 38.8-46.1) μm; P = 0.03); whereas airway complexity was lower (mean terminal bronchiolar density, 1.56 (IQR, 1.0-1.81) vs 2.23 (IQR, 2.14-2.40) br/mm In fetal lambs with DH, TO using the Smart-TO balloon is effective and safe. Occlusion can be reversed non-invasively and the deflated intact balloon expelled spontaneously from the fetal upper airways. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Identifiants

pubmed: 33012007
doi: 10.1002/uog.23135
pmc: PMC7613565
mid: EMS152838
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

105-112

Subventions

Organisme : European Union's Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant
ID : 765274
Organisme : Great Ormond Street Hospital Charity Fund
Organisme : Wellcome Trust
ID : 101957
Pays : United Kingdom
Organisme : Society for Anesthesia and Resuscitation of Belgium (SARB) and by the Obstetric Anaesthetists' Association (OAA) International
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : KU Leuven (Internal Funds)
ID : Post-Doctoral Mandate 18/215
Organisme : TBM-FWO
Organisme : Engineering and Physical Sciences Research Council (EPSRC)
ID : NS/A000027/1
Organisme : Erasmus + Programme of the European Union
ID : 2013-0040
Organisme : Innovative Engineering for Health award by the Wellcome Trust
ID : WT101957

Informations de copyright

© 2020 International Society of Ultrasound in Obstetrics and Gynecology.

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Auteurs

D Basurto (D)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.

N Sananès (N)

INSERM 1121 Biomaterials and Bioengineering, Strasbourg University, Strasbourg, France.
Department of Maternal-Fetal Medicine, Strasbourg University Hospital, Strasbourg, France.

T Bleeser (T)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.

I Valenzuela (I)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.

N De Leon (N)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.

L Joyeux (L)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.

E Verbeken (E)

Department of Pathology, University Hospitals Leuven, Leuven, Belgium.

S Vergote (S)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
Clinical Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

L Van der Veeken (L)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
Clinical Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

F M Russo (FM)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
Clinical Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

J Deprest (J)

Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
Clinical Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.
Institute for Women's Health, University College London, London, UK.

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