智能气管阻塞器在膈疝羔羊模型中的安全性和有效性。
Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model.
机构信息
Academic Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
INSERM 1121 Biomaterials and Bioengineering, Strasbourg University, Strasbourg, France.
出版信息
Ultrasound Obstet Gynecol. 2021 Jan;57(1):105-112. doi: 10.1002/uog.23135.
OBJECTIVE
To investigate the efficacy and safety of the 'smart' tracheal occlusion (Smart-TO) device in fetal lambs with diaphragmatic hernia (DH).
METHODS
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.
RESULTS
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 ; P = 0.005). Tracheal changes on histology were minimal in both groups, but more noticeable in fetal lambs that underwent TO than in unoccluded lambs (tracheal score, 2 (IQR, 1-3) vs 0 (0-1); P = 0.03).
CONCLUSIONS
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.
目的
探讨智能气管封堵（Smart-TO）装置在先天性膈疝（DH）胎儿中的疗效和安全性。
方法
在妊娠第 70 天（足月，145 天）的胎儿羊膜腔内建立 DH。胎儿被分配为继续妊娠至足月（DH 组）或在妊娠第 97 天行胎儿内窥镜腔内气管封堵（TO）（DH+TO 组）。在妊娠第 116 天，通过超声确认球囊的存在，然后将母羊在 3.0T 磁共振扫描仪周围走动以进行球囊放气，随后通过超声立即确认。在足月时，进行安乐死并取回胎儿。通过肺与体重比（LBWR）和肺形态计量学评估封堵的效果。安全性参数包括通过形态计量学评估的气管副作用和放气后的球囊位置。未封堵的 DH 羔羊作为对照。
结果
DH 组纳入 6 例胎儿，DH+TO 组纳入 7 例。所有球囊均成功放气并自发从气道排出。与对照组相比，DH+TO 组出生时的 LBWR 显著升高（1.90（四分位距（IQR），1.43-2.55）比 1.07（IQR，0.93-1.46）；P=0.005），而在肺形态计量学上，肺泡大小显著增加（平均线性截距，47.5（IQR，45.6-48.1）μm 比 41.9（IQR，38.8-46.1）μm；P=0.03）；而气道复杂性降低（平均终末细支气管密度，1.56（IQR，1.0-1.81）比 2.23（IQR，2.14-2.40）br/mm；P=0.005）。两组的组织学变化都很小，但在接受 TO 的胎儿中比在未封堵的羔羊中更明显（气管评分，2（IQR，1-3）比 0（0-1）；P=0.03）。
结论
在 DH 胎儿中，使用 Smart-TO 球囊进行 TO 是有效和安全的。封堵可以非侵入性地逆转，放气后的完整球囊会自发从胎儿上呼吸道排出。© 2020 年国际妇产科超声学会。
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