Temporary fetoscopic endoluminal tracheal occlusion (FETO) promotes lung growth and increases survival in selected fetuses with congenital diaphragmatic hernia (CDH). FETO is performed percutaneously by inserting into the trachea a balloon designed for vascular occlusion. However, reports on the potential postnatal side-effects of the balloon are scarce. This study aimed to evaluate the prevalence of tracheomalacia in infants with CDH managed with and without FETO and other consequences related to the use of the balloon. In this multicentre, retrospective cohort study, we included infants who were live born with CDH, either with FETO or without, who were managed postnatally at four centres (UZ Leuven, Leuven, Belgium; Antoine Béclère, Clamart, France; BCNatal, Barcelona, Spain; and HCor-Heart Hospital, São Paulo, Brazil) between April 5, 2002, and June 2, 2021. We primarily assessed the prevalence of all (symptomatic and asymptomatic) tracheomalacia as reported in medical records among infants with and without FETO. Secondarily we assessed the prevalence of symptomatic tracheomalacia and its resolution as reported in medical records, and compared tracheal diameters as measured on postnatal x-rays. Crude and adjusted risk ratios (aRRs) and 95% CIs were calculated via modified Poisson regression models with robust error variances for potential association between FETO and tracheomalacia. Variables included in the adjusted model were the side of the hernia, observed-to-expected lung-to-head ratio, and gestational age at birth. Crude and adjusted mean differences and 95% CIs were calculated via linear regression models to assess the presence and magnitude of association between FETO and tracheal diameters. In infants who had undergone FETO we also assessed the localisation of balloon remnants on x-rays, and the methods used for reversal of occlusion and potential complications associated with balloon remnants as documented in clinical records. Finally we investigated whether the presence of balloon remnants was influenced by the interval between balloon removal and delivery. 505 neonates were included in the study, of whom 287 had undergone FETO and 218 had not. Tracheomalacia was reported in 18 (6%) infants who had undergone FETO and in three (1%) who had not (aRR 6·17 [95% CI 1·83–20·75]; p=0·0030). Tracheomalacia was first reported in the FETO group at a median of 5·0 months (IQR 0·8–13·0). Symptomatic tracheomalacia was reported in 13 (5%) infants who had undergone FETO, which resolved in ten (77%) children by 55·0 months (IQR 14·0–83·0). On average, infants who had undergone FETO had a 31·3% wider trachea (with FETO tracheal diameter 7·43 mm [SD 1·24], without FETO tracheal diameter 5·10 mm [SD 0·84]; crude mean difference 2·32 [95% CI 2·11–2·54]; p<0·0001; adjusted mean difference 2·62 [95% CI 2·35–2·89]; p<0·0001). At birth, the metallic component was visible within the body in 75 (37%) of 205 infants with available thoraco-abdominal x-rays: it was located in the gastrointestinal tract in 60 (80%) and in the lung in 15 (20%). No side-effects were reported for any of the infants during follow-up. The metallic component was more likely to be in the lung than either outside the body or the gastrointestinal tract when the interval between occlusion reversal and birth was less than 24 h. Although FETO was associated with an increased tracheal diameter and an increased probability of tracheomalacia, symptomatic tracheomalacia typically resolved over time. There is a higher risk of retention of metallic balloon components if reversal of the occlusion occurs less than 24 h before delivery. Finally, there were no reported side-effects of the metallic component of the balloon persisting in the body during follow-up. Longer-term follow-up is needed to ensure that no tracheal problems arise later in life. None.

中文翻译：

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患有先天性膈疝的婴儿和儿童的气管软化和气管肿大，采用或不采用胎儿镜腔内气管闭塞（FETO）治疗：一项多中心回顾性队列研究


临时胎儿镜腔内气管阻塞（FETO）可促进先天性膈疝（CDH）胎儿的肺生长并提高其存活率。 FETO 是通过将专为血管闭塞设计的球囊插入气管来经皮进行的。然而，关于球囊潜在的产后副作用的报道却很少。本研究旨在评估接受或不接受 FETO 治疗的 CDH 婴儿气管软化症的患病率以及与使用球囊相关的其他后果。在这项多中心、回顾性队列研究中，我们纳入了患有 CDH 的活产婴儿，无论是否使用 FETO，均在四个中心（比利时鲁汶 UZ Leuven；法国克拉马尔 Antoine Béclère；法国巴塞罗那 BCNatal）进行产后管理。西班牙；和巴西圣保罗 HCor-Heart 医院）于 2002 年 4 月 5 日至 2021 年 6 月 2 日期间进行。我们主要评估了医疗记录中报告的有或没有 FETO 的所有（有症状和无症状）气管软化症的患病率。其次，我们评估了病历中报告的症状性气管软化症的患病率及其缓解情况，并比较了产后 X 射线测量的气管直径。通过改进的泊松回归模型计算粗略风险比和调整后风险比 (aRR) 以及 95% CI，该模型具有稳健的误差方差，可表明 FETO 与气管软化症之间的潜在关联。调整后的模型中包含的变量包括疝气的一侧、观察到的肺与头的预期比率以及出生时的孕龄。通过线性回归模型计算粗略和调整后的平均差以及 95% CI，以评估 FETO 和气管直径之间是否存在关联以及关联程度。 在接受 FETO 的婴儿中，我们还评估了 X 射线上球囊残余物的定位，以及用于逆转闭塞的方法以及临床记录中记录的与球囊残余物相关的潜在并发症。最后，我们研究了球囊残留的存在是否受到球囊移除和递送之间的间隔的影响。该研究纳入了 505 名新生儿，其中 287 名接受过 FETO，218 名未接受过 FETO。据报告，18 名（6%）接受 FETO 的婴儿出现气管软化症，3 名（1%）未接受 FETO 的婴儿出现气管软化（aRR 6·17 [95% CI 1·83–20·75]；p=0·0030）。气管软化症首次在 FETO 组中报告，中位时间为 5·0 个月（IQR 0·8–13·0）。据报道，13 名 (5%) 接受 FETO 的婴儿出现了症状性气管软化症，其中 10 名 (77%) 儿童在 55·0 个月时痊愈了 (IQR 14·0–83·0)。平均而言，接受 FETO 的婴儿气管宽 31·3%（FETO 气管直径 7·43 mm [SD 1·24]，未接受 FETO 气管直径 5·10 mm [SD 0·84]；粗平均差2·32 [95% CI 2·11–2·54]；p<0·0001；调整后的平均差 2·62 [95% CI 2·35–2·89]；p<0·0001）。出生时，在 205 名婴儿中，有 75 名 (37%) 的胸腹部 X 光检查显示金属成分在体内可见：60 名婴儿 (80%) 位于胃肠道，15 名婴儿 (80%) 位于肺部，15 名婴儿 (20 %）。在随访期间，没有报告任何婴儿出现副作用。当闭塞逆转与出生之间的间隔小于 24 小时时，金属成分更有可能位于肺部，而不是体外或胃肠道。尽管 FETO 与气管直径增加和气管软化可能性增加有关，但症状性气管软化通常会随着时间的推移而消失。 如果在分娩前 24 小时内发生闭塞逆转，则金属球囊组件滞留的风险较高。最后，在随访期间没有报告气球的金属成分在体内持续存在的副作用。需要更长期的随访以确保晚年不会出现气管问题。没有任何。