Takekazu Miyoshi1, Yasuki Maeno2, Toshimitsu Hamasaki3, Noboru Inamura4, Satoshi Yasukochi5, Motoyoshi Kawataki6, Hitoshi Horigome7, Hitoshi Yoda8, Mio Taketazu9, Masaki Nii10, Akiko Hagiwara11, Hitoshi Kato12, Wataru Shimizu13, Isao Shiraishi14, Heima Sakaguchi14, Keiko Ueda1, Shinji Katsuragi1, Haruko Yamamoto15, Haruhiko Sago16, Tomoaki Ikeda17. 1. Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center, Suita, Japan. 2. Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan. Electronic address: yasukim@med.kurume-u.ac.jp. 3. Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan. 4. Department of Pediatric Cardiology, Osaka Women's and Children's Hospital, Izumi, Japan. 5. Department of Cardiology, Nagano Children's Hospital, Azumino, Japan. 6. Department of Gynecology and Obstetrics, Tohoku University Graduate School of Medicine, Sendai, Japan. 7. Department of Pediatrics, University of Tsukuba, Tsukuba, Japan. 8. Department of Neonatology, Toho University Omori Medical Center, Tokyo, Japan. 9. Department of Pediatric Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan. 10. Department of Cardiology, Shizuoka Children's Hospital, Shizuoka, Japan. 11. Department of Internal Medicine, Kanagawa Children's Medical Center, Yokohama, Japan. 12. Department of Pediatric Cardiology, National Center for Child Health and Development, Tokyo, Japan. 13. Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan. 14. Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita, Japan. 15. Department of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Suita, Japan. 16. Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan. 17. Department of Obstetrics and Gynecology, Mie University, Tsu, Japan.
Abstract
BACKGROUND: Standardized treatment of fetal tachyarrhythmia has not been established. OBJECTIVES: This study sought to evaluate the safety and efficacy of protocol-defined transplacental treatment for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL). METHODS: In this multicenter, single-arm trial, protocol-defined transplacental treatment using digoxin, sotalol, and flecainide was performed for singleton pregnancies from 22 to <37 weeks of gestation with sustained fetal SVT or AFL ≥180 beats/min. The primary endpoint was resolution of fetal tachyarrhythmia. Secondary endpoints were fetal death, pre-term birth, and neonatal arrhythmia. Adverse events (AEs) were also assessed. RESULTS: A total of 50 patients were enrolled at 15 institutions in Japan from 2010 to 2017; short ventriculoatrial (VA) SVT (n = 17), long VA SVT (n = 4), and AFL (n = 29). One patient with AFL was excluded because of withdrawal of consent. Fetal tachyarrhythmia resolved in 89.8% (44 of 49) of cases overall and in 75.0% (3 of 4) of cases of fetal hydrops. Pre-term births occurred in 20.4% (10 of 49) of patients. Maternal AEs were observed in 78.0% (39 of 50) of patients. Serious AEs occurred in 1 mother and 4 fetuses, thus resulting in discontinuation of protocol treatment in 4 patients. Two fetal deaths occurred, mainly caused by heart failure. Neonatal tachyarrhythmia was observed in 31.9% (15 of 47) of neonates within 2 weeks after birth. CONCLUSIONS: Protocol-defined transplacental treatment for fetal SVT and AFL was effective and tolerable in 90% of patients. However, it should be kept in mind that serious AEs may take place in fetuses and that tachyarrhythmias may recur within the first 2 weeks after birth.
BACKGROUND: Standardized treatment of fetal tachyarrhythmia has not been established. OBJECTIVES: This study sought to evaluate the safety and efficacy of protocol-defined transplacental treatment for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL). METHODS: In this multicenter, single-arm trial, protocol-defined transplacental treatment using digoxin, sotalol, and flecainide was performed for singleton pregnancies from 22 to <37 weeks of gestation with sustained fetal SVT or AFL ≥180 beats/min. The primary endpoint was resolution of fetal tachyarrhythmia. Secondary endpoints were fetal death, pre-term birth, and neonatal arrhythmia. Adverse events (AEs) were also assessed. RESULTS: A total of 50 patients were enrolled at 15 institutions in Japan from 2010 to 2017; short ventriculoatrial (VA) SVT (n = 17), long VA SVT (n = 4), and AFL (n = 29). One patient with AFL was excluded because of withdrawal of consent. Fetal tachyarrhythmia resolved in 89.8% (44 of 49) of cases overall and in 75.0% (3 of 4) of cases of fetal hydrops. Pre-term births occurred in 20.4% (10 of 49) of patients. Maternal AEs were observed in 78.0% (39 of 50) of patients. Serious AEs occurred in 1 mother and 4 fetuses, thus resulting in discontinuation of protocol treatment in 4 patients. Two fetal deaths occurred, mainly caused by heart failure. Neonatal tachyarrhythmia was observed in 31.9% (15 of 47) of neonates within 2 weeks after birth. CONCLUSIONS: Protocol-defined transplacental treatment for fetal SVT and AFL was effective and tolerable in 90% of patients. However, it should be kept in mind that serious AEs may take place in fetuses and that tachyarrhythmias may recur within the first 2 weeks after birth.
Authors: Sutopa Purkayastha; Michael Weinreich; Joao D Fontes; Joe F Lau; Diana S Wolfe; Anna E Bortnick Journal: Cardiol Rev Date: 2022 Jan-Feb 01 Impact factor: 2.644