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Abstract：
OBJECTIVE: To report the outcomes of fetoscopic endoluminal tracheal occlusion in a multicenter North American cohort of patients with isolated, left-sided congenital diaphragmatic hernia (CDH) and to compare neonatal mortality and morbidity in patients with severe left-sided congenital diaphragmatic hernia who underwent fetoscopic endoluminal tracheal occlusion with those expectantly managed.
METHODS: We analyzed data from 10 centers in the NAFTNet (North American Fetal Therapy Network) FETO (Fetoscopic Endoluminal Tracheal Occlusion) Consortium registry, collected between November 1, 2008, and December 31, 2020. In addition to reporting procedure-related surgical outcomes of fetoscopic endoluminal tracheal occlusion, we performed a comparative analysis of fetoscopic endoluminal tracheal occlusion compared with contemporaneous expectantly managed patients.
RESULTS: Fetoscopic endoluminal tracheal occlusion was successfully performed in 87 of 89 patients (97.8%). Six-month survival in patients with severe left-sided congenital diaphragmatic hernia did not differ significantly between patients who underwent fetoscopic endoluminal tracheal occlusion and those managed expectantly (69.8% vs 58.1%, P =.30). Patients who underwent fetoscopic endoluminal tracheal occlusion had higher rates of preterm prelabor rupture of membranes (54.0% vs 14.3%, P <.001), earlier gestational age at delivery (median 35.0 weeks vs 38.3 weeks, P <.001), and lower birth weights (mean 2,487 g vs 2,857 g, P =.001). On subanalysis, in patients for whom all recorded observed-to-expected lung/head ratio measurements were below 25%, patients with fetoscopic endoluminal tracheal occlusion required fewer days of extracorporeal membrane oxygenation (ECMO) (median 9.0 days vs 17.0 days, P =.014).
CONCLUSIONS: In this cohort, fetoscopic endoluminal tracheal occlusion was successfully implemented across several North American fetal therapy centers. Although survival was similar among patients undergoing fetoscopic endoluminal tracheal occlusion and those expectantly managed, fetoscopic endoluminal tracheal occlusion in North American centers may reduce morbidity, as suggested by fewer days of ECMO in those patients with persistently reduced lung volumes (observed-to-expected lung/head ratio below 25%).
METHODS: We analyzed data from 10 centers in the NAFTNet (North American Fetal Therapy Network) FETO (Fetoscopic Endoluminal Tracheal Occlusion) Consortium registry, collected between November 1, 2008, and December 31, 2020. In addition to reporting procedure-related surgical outcomes of fetoscopic endoluminal tracheal occlusion, we performed a comparative analysis of fetoscopic endoluminal tracheal occlusion compared with contemporaneous expectantly managed patients.
RESULTS: Fetoscopic endoluminal tracheal occlusion was successfully performed in 87 of 89 patients (97.8%). Six-month survival in patients with severe left-sided congenital diaphragmatic hernia did not differ significantly between patients who underwent fetoscopic endoluminal tracheal occlusion and those managed expectantly (69.8% vs 58.1%, P =.30). Patients who underwent fetoscopic endoluminal tracheal occlusion had higher rates of preterm prelabor rupture of membranes (54.0% vs 14.3%, P <.001), earlier gestational age at delivery (median 35.0 weeks vs 38.3 weeks, P <.001), and lower birth weights (mean 2,487 g vs 2,857 g, P =.001). On subanalysis, in patients for whom all recorded observed-to-expected lung/head ratio measurements were below 25%, patients with fetoscopic endoluminal tracheal occlusion required fewer days of extracorporeal membrane oxygenation (ECMO) (median 9.0 days vs 17.0 days, P =.014).
CONCLUSIONS: In this cohort, fetoscopic endoluminal tracheal occlusion was successfully implemented across several North American fetal therapy centers. Although survival was similar among patients undergoing fetoscopic endoluminal tracheal occlusion and those expectantly managed, fetoscopic endoluminal tracheal occlusion in North American centers may reduce morbidity, as suggested by fewer days of ECMO in those patients with persistently reduced lung volumes (observed-to-expected lung/head ratio below 25%).
摘要：
目的：报告在北美多中心队列患者中进行胎儿镜腔内气管封堵的结果，左侧先天性膈疝（CDH），并比较严重的左侧先天性膈疝患者的新生儿死亡率和发病率。
方法：我们分析了NAFTNet（北美胎儿治疗网络）FETO（胎儿镜腔内气管阻塞）协会注册的10个中心的数据，在2008年11月1日至2020年12月31日之间收集。除了报告与手术相关的手术结果外，胎儿镜下腔内气管封堵，我们对胎儿镜下腔内气管封堵术与同期预期治疗患者进行了比较分析.
结果：89例患者中有87例（97.8%）成功行了腹腔镜下气管腔内封堵术。严重左侧先天性膈疝患者的6个月生存率在接受胎儿镜下腔内气管阻塞的患者和预期治疗的患者之间没有显着差异（69.8％vs58.1％，P=.30）。行胎儿镜下腔内气管封堵术的患者早产胎膜破裂的发生率较高（54.0％vs14.3％，P<.001),分娩时孕龄较早(中位数为35.0周vs38.3周，P<.001),和较低的出生体重(平均2,487克vs2,857克，P=.001)。关于子分析，在所有记录的观察到的肺/头比率测量值低于25%的患者中，腹腔镜下气管腔内闭塞患者需要的体外膜氧合（ECMO）天数较少（中位数9.0天vs17.0天，P=.014）。
结论：在这个队列中，在北美几个胎儿治疗中心成功实施了胎儿镜下腔内气管封堵术.尽管接受胎儿镜下腔内气管阻塞的患者和预期治疗的患者的生存率相似，北美中心的胎儿镜下腔内气管阻塞可能会降低发病率，在肺容积持续减少的患者中,ECMO治疗天数较少(观察到的肺/头比低于25%)。
方法：我们分析了NAFTNet（北美胎儿治疗网络）FETO（胎儿镜腔内气管阻塞）协会注册的10个中心的数据，在2008年11月1日至2020年12月31日之间收集。除了报告与手术相关的手术结果外，胎儿镜下腔内气管封堵，我们对胎儿镜下腔内气管封堵术与同期预期治疗患者进行了比较分析.
结果：89例患者中有87例（97.8%）成功行了腹腔镜下气管腔内封堵术。严重左侧先天性膈疝患者的6个月生存率在接受胎儿镜下腔内气管阻塞的患者和预期治疗的患者之间没有显着差异（69.8％vs58.1％，P=.30）。行胎儿镜下腔内气管封堵术的患者早产胎膜破裂的发生率较高（54.0％vs14.3％，P<.001),分娩时孕龄较早(中位数为35.0周vs38.3周，P<.001),和较低的出生体重(平均2,487克vs2,857克，P=.001)。关于子分析，在所有记录的观察到的肺/头比率测量值低于25%的患者中，腹腔镜下气管腔内闭塞患者需要的体外膜氧合（ECMO）天数较少（中位数9.0天vs17.0天，P=.014）。
结论：在这个队列中，在北美几个胎儿治疗中心成功实施了胎儿镜下腔内气管封堵术.尽管接受胎儿镜下腔内气管阻塞的患者和预期治疗的患者的生存率相似，北美中心的胎儿镜下腔内气管阻塞可能会降低发病率，在肺容积持续减少的患者中,ECMO治疗天数较少(观察到的肺/头比低于25%)。
