Author + information
- Received January 18, 2019
- Revision received June 5, 2019
- Accepted June 10, 2019
- Published online August 12, 2019.
- Takekazu Miyoshi, MDa,
- Yasuki Maeno, MDb,∗∗ (, )@YMaeno2,
- Toshimitsu Hamasaki, PhDc,
- Noboru Inamura, MDd,
- Satoshi Yasukochi, MDe,
- Motoyoshi Kawataki, MDf,
- Hitoshi Horigome, MDg,
- Hitoshi Yoda, MDh,
- Mio Taketazu, MDi,
- Masaki Nii, MDj,
- Akiko Hagiwara, MDk,
- Hitoshi Kato, MDl,
- Wataru Shimizu, MDm,
- Isao Shiraishi, MDn,
- Heima Sakaguchi, MDn,
- Keiko Ueda, MDa,
- Shinji Katsuragi, MDa,
- Haruko Yamamoto, MDo,
- Haruhiko Sago, MDp,
- Tomoaki Ikeda, MDq,∗,
- on behalf of the Japan Fetal Arrhythmia Group
- aDepartment of Perinatology and Gynecology, National Cerebral and Cardiovascular Center, Suita, Japan
- bDepartment of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan
- cDepartment of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan
- dDepartment of Pediatric Cardiology, Osaka Women’s and Children’s Hospital, Izumi, Japan
- eDepartment of Cardiology, Nagano Children’s Hospital, Azumino, Japan
- fDepartment of Gynecology and Obstetrics, Tohoku University Graduate School of Medicine, Sendai, Japan
- gDepartment of Pediatrics, University of Tsukuba, Tsukuba, Japan
- hDepartment of Neonatology, Toho University Omori Medical Center, Tokyo, Japan
- iDepartment of Pediatric Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan
- jDepartment of Cardiology, Shizuoka Children’s Hospital, Shizuoka, Japan
- kDepartment of Internal Medicine, Kanagawa Children’s Medical Center, Yokohama, Japan
- lDepartment of Pediatric Cardiology, National Center for Child Health and Development, Tokyo, Japan
- mDepartment of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan
- nDepartment of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita, Japan
- oDepartment of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Suita, Japan
- pCenter for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan
- qDepartment of Obstetrics and Gynecology, Mie University, Tsu, Japan
- ↵∗Address for correspondence:
Dr. Yasuki Maeno, Department of Pediatrics and Child Health, Kurume University School of Medicine, 67 Asahi-machi, Kurume 830-0011, Japan.
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.
- adverse event
- atrial flutter
- fetal echocardiography
- fetal tachyarrhythmia
- supraventricular tachycardia
- transplacental treatment
↵∗ Drs. Maeno and Ikeda contributed equally to this work.
This work was supported by the Agency for Medical Research and Development of the Ministry of Education, Culture, Sports, Science, and Technology of Japan (JP15lk0201001). The funding organization had no role in the trial design; data collection, analysis, or interpretation; or manuscript preparation. All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received January 18, 2019.
- Revision received June 5, 2019.
- Accepted June 10, 2019.
- 2019 American College of Cardiology Foundation
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