@article{41521d5a52a648f3ab7b462e20b4bc4e,
title = "Maternal and fetal outcomes associated with vagus nerve stimulation during pregnancy",
abstract = "Objective To access the effect of vagus nerve stimulation (VNS) on the outcome of pregnancy. Methods We used the International Registry of Antiepileptic Drugs and Pregnancy (EURAP) and its network to search for women receiving adjunctive VNS during pregnancy. Data on maternal and fetal outcomes were extracted from the registry databases and outcomes were evaluated. Results Twenty-six pregnancies were identified in 25 women. All women were exposed to a relative high VNS stimulation level (mean duty cycle 18%, range 5%–51%). Most women had seizures during pregnancy and almost 70% were on antiepileptic drug (AED) polytherapy. The proportion of women with obstetrical interventions was 53.9% (95% confidence interval [CI] 33.4%–73.4%) which was higher compared to the EURAP average (48.2%; 95% CI 47.2%–49.1%). One infant (3.9%; 95% CI 0.1%–19.6%) was born with a major malformation (unilateral congenital glaucoma), which is within the range expected among offspring of AED-treated women. Conclusion Although the present series of VNS-exposed pregnancies is the largest reported to date, the sample size is insufficient to draw any firm conclusions on the safety of VNS in pregnancy but the findings suggest an increased rate of obstetrical interventions, and no clear signal of VNS-related teratogenicity.",
keywords = "Epilepsy, Obstetrical interventions, Pregnancy, Teratogenicity, Vagus nerve stimulation",
author = "Anne Sabers and Dina Battino and Erminio Bonizzoni and John Craig and Dick Lindhout and Emilio Perucca and Thomas, {Sanjeev V.} and Torbj{\"o}rn Tomson and Frank Vajda",
note = "Funding Information: EURAP has received financial support from the following pharmaceutical companies: Bial, Eisai, GlaxoSmithKline, Janssen-Cilag, Novartis, Pfizer, Sanofi-Aventis, and UCB, from Netherlands Epilepsy Foundation (NEF) grant 03-18 (DL) and from Stockholm County Council, ALF (TT). The sponsors had no influence on the conduct of the study, analysis, interpretation, writing of the manuscript or the decision to publish the results. Funding Information: AS received consultancy or lecture fees, and has received travel support from Eisai Denmark, GSK, and UCB Nordic. DB has received honoraria for advisory boards from Sanofi-Aventis. EB has received consultancy fees from Italfarmaco, Zambon, Polichem, Roche and Sanofi-Aventis. JC received research grants and speaker{\textquoteright}s fees from UCB Pharma, Eisai, GSK, Sanofi-Aventis, Pfizer, and Janssen-Cilag. DL received research grants from Janssen-Cilag, GSK, Pfizer, and Netherlands Epilepsy Foundation. EP received research funds from the European Union, the Italian Ministry of Health, the Italian Ministry for Education and University, and the Italian Medicines Agency. He also received speaker{\textquoteright}s or consultancy fees and/or research grants from Eisai, Biopharm Solutions, GW Pharma, Sanofi, Sun Pharma, Takeda, and UCB Pharma. TT has received speaker{\textquoteright}s honoraria to his institution from Eisai, UCB, BMJ India, and Actavis, honoraria to his institution for advisory boards from UCB and Eisai, and received research support from Stockholm County Council, CURE, and GSK. FV and SVT report no disclosure. Publisher Copyright: {\textcopyright} 2017 Elsevier B.V.",
year = "2017",
month = nov,
doi = "10.1016/j.eplepsyres.2017.05.013",
language = "English",
volume = "137",
pages = "159--162",
journal = "Epilepsy Research",
issn = "0920-1211",
publisher = "Elsevier",
}