Seiji Wada1, Katsusuke Ozawa1, Rika Sugibayashi1, Fumio Suyama1, Shoichiro Amari1, Yushi Ito1, Yutaka Kanamori2, Hiroomi Okuyama3, Noriaki Usui4, Jun Sasahara5, Tomomi Kotani6, Masahiro Hayakawa7, Kiyoko Kato8, Tomoaki Taguchi9, Masayuki Endo10, Haruhiko Sago1. 1. Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan. 2. Division of Surgery, Department of Surgical Specialties, National Center for Child Health and Development, Tokyo, Japan. 3. Department of Pediatric Surgery, Osaka University Graduate School of Medicine, Suita, Japan. 4. Department of Pediatric Surgery, Osaka Women's and Children's Hospital, Izumi, Japan. 5. Department of Maternal Fetal Medicine, Osaka Women's and Children's Hospital, Izumi, Japan. 6. Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya, Japan. 7. Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan. 8. Department of Obstetrics and Gynecology, Kyushu University School of Medicine, Fukuoka, Japan. 9. Department of Pediatric Surgery, Kyushu University School of Medicine, Fukuoka, Japan. 10. Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Japan.
Abstract
AIM: To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH). METHODS: This was a single-arm clinical trial of FETO for isolated left-sided CDH with liver herniation and Kitano Grade 3 stomach position (>50% stomach herniation into the right chest). FETO was performed at 27-29 weeks of gestation for cases with observed/expected lung to head ratio (o/e LHR) <25% and at 30-31 weeks for cases with o/e LHR ≥25%. RESULTS: Eleven cases were enrolled between March 2014 and March 2016, and balloon insertion was successful in all cases. The median o/e LHR at entry was 27% (range, 20-33%). The median gestational age at FETO was 30.9 (range, 27.1-31.7) weeks. There were no severe maternal adverse events. One fetus died unexpectedly at 33 weeks of gestation due to cord strangulation by the detached amniotic membrane. There were 3 cases (27%) of preterm premature rupture of membranes. In all 10 cases, balloon removal at 34-35 weeks of gestation was successful. The median gestational age at delivery was 36.5 (range, 34.2-38.3) weeks. The median duration of occlusion and the median interval between balloon insertion and delivery were 26 days (range: 17-49 days) and 43 days (range, 21-66 days), respectively. Both the survival rate at 90 days of age and the rate of survival to discharge were 45% (5/11). CONCLUSION: The FETO is feasible without maternal morbidity in Japan and could be offered to women whose fetuses show severe isolated left-sided CDH to accelerate fetal lung growth.
AIM: To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH). METHODS: This was a single-arm clinical trial of FETO for isolated left-sided CDH with liver herniation and Kitano Grade 3 stomach position (>50% stomach herniation into the right chest). FETO was performed at 27-29 weeks of gestation for cases with observed/expected lung to head ratio (o/e LHR) <25% and at 30-31 weeks for cases with o/e LHR ≥25%. RESULTS: Eleven cases were enrolled between March 2014 and March 2016, and balloon insertion was successful in all cases. The median o/e LHR at entry was 27% (range, 20-33%). The median gestational age at FETO was 30.9 (range, 27.1-31.7) weeks. There were no severe maternal adverse events. One fetus died unexpectedly at 33 weeks of gestation due to cord strangulation by the detached amniotic membrane. There were 3 cases (27%) of preterm premature rupture of membranes. In all 10 cases, balloon removal at 34-35 weeks of gestation was successful. The median gestational age at delivery was 36.5 (range, 34.2-38.3) weeks. The median duration of occlusion and the median interval between balloon insertion and delivery were 26 days (range: 17-49 days) and 43 days (range, 21-66 days), respectively. Both the survival rate at 90 days of age and the rate of survival to discharge were 45% (5/11). CONCLUSION: The FETO is feasible without maternal morbidity in Japan and could be offered to women whose fetuses show severe isolated left-sided CDH to accelerate fetal lung growth.
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