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Multicenter Study
. 2024 Mar 1;143(3):440-448.
doi: 10.1097/AOG.0000000000005491. Epub 2023 Dec 21.

Fetoscopic Endoluminal Tracheal Occlusion for Severe, Left-Sided Congenital Diaphragmatic Hernia: The North American Fetal Therapy Network Fetoscopic Endoluminal Tracheal Occlusion Consortium Experience

Affiliations
Multicenter Study

Fetoscopic Endoluminal Tracheal Occlusion for Severe, Left-Sided Congenital Diaphragmatic Hernia: The North American Fetal Therapy Network Fetoscopic Endoluminal Tracheal Occlusion Consortium Experience

Eric Bergh et al. Obstet Gynecol. .

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).

Conclusion: 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%).

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Conflict of interest statement

Financial Disclosure Eric Bergh disclosed that the NFocus Goldvalve balloon is no longer commercially available, and he receives royalties from UpToDate. Dr. Cromblehome disclosed that the Balt GOLDBAL2 balloon and catheter and Storz fetoscope are used under an investigational device exemption from the Food and Drug Administration, which are not otherwise available for use in the United States. Ahmet A. Baschat disclosed that the instrumentation was provided in-kind by Karl Storz, and he receives royalties from UpToDate. Holly Hedrick receives royalties from UpToDate. The other authors did not report any potential conflicts of interest.

Figures

Fig. 1.
Fig. 1.. Flowchart demonstrating patient inclusion and exclusion for the comparative analysis. *Patients for whom procedural data for entire cohort is included (data presented in Table 1). Patients included for comparative analysis (data presented in Table 2). Two patients had balloon placement after 30 weeks of gestation (31 3/7 and 30 2/7 weeks). §Five patients had initial evaluation after 30 weeks of gestation (31 6/7, 32 1/7, 32 3/7, 32 4/7, and 34 3/7 weeks). CDH, congenital diaphragmatic hernia; O/E LHR, observed-to-expected lung area/head circumference ratio; FETO, fetoscopic endoluminal tracheal occlusion; CMA, chromosomal microarray.
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