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1. Changes over 24 years in a pregnancy register - Teratogenicity and epileptic seizure control

Author

Vajda, F, O'Brien, T, Graham, J, Hitchcock, A, Perucca, P, Lander, C, Eadie, M, Vajda, F, O'Brien, T, Graham, J, Hitchcock, A, Perucca, P, Lander, C, and Eadie, M

Abstract

OBJECTIVES: To trace (i) changes in Australian Pregnancy Register (APR) records concerning antiseizure medications (ASMs) prescribed for women with epilepsy (WWE) over the course of 24 years and correlate the changes with (ii) rates of occurrence of pregnancies involving foetal malformations, (iii) the body organs involved in the malformations, and (iv) freedom from epileptic seizures. RESULTS: Use of valproate and carbamazepine decreased progressively, use of lamotrigine remained relatively static, and the use of levetiracetam increased progressively, whereas the use of topiramate first increased and then fell again, associated with a temporary increase in malformation-associated pregnancy rate. More serious malformations, such as spina bifida, became less frequent, whereas more trivial ones tended to increase, whereas epileptic seizure freedom rates improved. CONCLUSIONS: The increasing use of newer ASMs in pregnant women has been associated with overall advantages in relation to the frequency and severity of foetal malformation and with advantages in relation to freedom from epileptic seizures.

Published
2023

2. Specific fetal malformations following intrauterine exposure to antiseizure medication

Author

Vajda, F, O'Brien, T, Graham, J, Hitchcock, A, Perucca, P, Lander, C, Eadie, M, Vajda, F, O'Brien, T, Graham, J, Hitchcock, A, Perucca, P, Lander, C, and Eadie, M

Abstract

OBJECTIVE: To investigate in the Australian Pregnancy Register of Antiepileptic Drugs patterns of fetal malformation associated with intrauterine exposure to particular currently available antiseizure medications taken by women with epilepsy. RESULTS: There was statistically significant evidence (P < 0.05) of an increased hazard of fetal malformation associated with exposure to valproate, carbamazepine, topiramate, zonisamide, and with conception after assisted fertilization, but a reduced hazard in the offspring of women who continued to smoke during pregnancy. Valproate exposure was associated with malformations in a wide range of organs and organ systems, carbamazepine and topiramate with hydronephrosis, topiramate also with hypospadias, zonisamide with spina bifida and assisted fertilization with heart and great vessel maldevelopment. CONCLUSIONS: Prenatal valproate exposure appears to interfere with the development of many if not all, fetal tissues. It seems likely that prenatal exposure to carbamazepine and topiramate, and possibly exposure to zonisamide, but also some process related to in vitro fertilization, may more selectively affect the normal development of particular fetal tissues or organs.

Published
2023

7. Gabapentin

Author

Vajda, F. J. E., Eadie, Mervyn J., editor, and Vajda, Frank J. E., editor

Published
1999
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14. Declining malformation rates with changed antiepileptic drug prescribing: An observational study

Author

Tomson T., Battino D., Bonizzoni E., Craig J., Lindhout D., Perucca E., Sabers A., Thomas S. V., Vajda F., Bisulli F., Tinuper P., for the EURAP Study Group, Tomson T., Battino D., Bonizzoni E., Craig J., Lindhout D., Perucca E., Sabers A., Thomas S.V., Vajda F., Bisulli F., Tinuper P., and for the EURAP Study Group

Subjects
Pediatrics, medicine.medical_specialty, CIENCIAS MÉDICAS Y DE LA SALUD, Medicina Clínica, EURAP, Lamotrigine, Epilepsia, 03 medical and health sciences, Epilepsy, Neurologia, 0302 clinical medicine, AED, purl.org/becyt/ford/3.2 [https], medicine, 030212 general & internal medicine, Medical prescription, Prospective cohort study, Valproic Acid, Pregnancy, business.industry, Neurología Clínica, Carbamazepine, medicine.disease, epilepsy, purl.org/becyt/ford/3 [https], sense organs, pregnancy, Neurology (clinical), Levetiracetam, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Objective Changes in prescribing patterns of antiepileptic drugs (AEDs) in pregnant women with epilepsy would be expected to affect the risk of major congenital malformations (MCMs). To test this hypothesis, we analyzed data from an international pregnancy registry (EURAP). Methods EURAP is an observational prospective cohort study designed to determine the risk of MCMs after prenatal exposure to AEDs. The Cochrane-Armitage linear trend analysis was used to assess changes in AED treatment, prevalence of MCMs, and occurrence of generalized tonic-clonic seizures (GTCs) over 3 time periods: 2000–2005 (n = 4,760), 2006–2009 (n = 3,599), and 2010–2013 (n = 2,949). Results There were pronounced changes in the use of specific AEDs over time, with a decrease in the use of valproic acid and carbamazepine and an increase in the use of lamotrigine and levetiracetam. The prevalence of MCMs with monotherapy exposure decreased from 6.0% in 2000–2005 to 4.4% in 2010–2013. The change over time in MCM frequency after monotherapy exposure showed a significant linear trend in the crude analysis (p = 0.0087), which was no longer present after adjustment for changes in AED treatment (p = 0.9923). There was no indication of an increase over time in occurrence of GTCs during pregnancy. Conclusions There have been major changes in AED prescription patterns over the years covered by the study. In parallel, we observed a significant 27% decrease in the prevalence of MCMs. The results of adjusting the trend analysis for MCMs for changes in AED treatment suggest that changes in prescription patterns played a major role in the reduction of teratogenic events. Fil: Tomson, Torbjörn. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Battino, Dina. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Thomas, Sanjeev V.. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Vajda, Frank. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Kochen, Sara Silvia. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic; Argentina. Universidad Nacional Arturo Jauretche. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos; Argentina Fil: Craig, John. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Binozzoni, Erminio. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Lindhout, Dick. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Perucca, Emilio. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia Fil: Sabers, Anne. Karolinska Huddinge Hospital. Karolinska Institutet; Suecia

Published
2019

15. Antiepileptic Drug Teratogenicity and De Novo Genetic Variation Load

Author

Perucca, P., Anderson, A., Jazayeri, D., Hitchcock, A., Graham, J., Todaro, M., Tomson, T., Battino, D., Perucca, E., Ferri, M. M., Rochtus, A., Lagae, L., Canevini, M. P., Zambrelli, E., Campbell, E., Koeleman, B. P. C., Scheffer, I. E., Berkovic, S. F., Kwan, P., Sisodiya, S. M., Goldstein, D. B., Petrovski, S., Craig, J., Vajda, F. J. E., O'Brien, T. J., Leu, C., Wolking, S., Peter, S., Weber, Y. G., Weckhuysen, S., Moller, R. S., Nikanorova, M., Muhle, H., Avbersek, A., Heggeli, K., Striano, P., Gambardella, A., Langley, S. R., Krenn, M., Klein, K. M., Mccormack, M., Borghei, M., Willis, J., Berghuis, B., Jorgensen, A., Auce, P., Francis, B., Srivastava, P., Sonsma, A. C. M., Sander, Jw., Zimprich, F., Depondt, C., Johnson, M. M., Marson, A. G., Sills, G. J., Kunz, W. S., Cavalleri, G. L., Delanty, N., Zara, F., Krause, R., Lerche, H., Andrade, D., Sen, A., Bazil, C. W., Boland, M., Cavalleri, G., Choi, H., Colombo, S., Costello, D., Devinsky, O., Doherty, C. P., Dugan, P., Frankel, W., Heinzen, E., Johnson, M., Marson, T., Mikati, M., Ottman, R., Pandolfo, M., Radtke, R., Rees, M., Sadoway, T., Valley, N., Walley, N., Wood, N., and Zuberi, S.

Subjects
Adult, Male, 0301 basic medicine, Pediatrics, medicine.medical_specialty, DNA Copy Number Variations, Polymorphism, Single Nucleotide, Paternal Age, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, Pregnancy, Polymorphism (computer science), medicine, Humans, Exome, Copy-number variation, Indel, business.industry, Confounding, Infant, Newborn, Abnormalities, Drug-Induced, Genetic Variation, DNA, medicine.disease, Genetic load, Exact test, Teratogens, 030104 developmental biology, Neurology, Anticonvulsants, Female, Neurology (clinical), Genetic Load, business, 030217 neurology & neurosurgery
Abstract

OBJECTIVE: The mechanisms by which antiepileptic drugs (AEDs) cause birth defects (BDs) are unknown. Data suggest that AED-induced BDs may result from a genome-wide increase of de novo variants in the embryo, a mechanism which we investigated. METHODS: Whole-exome sequencing data from child-parent trios were interrogated for de novo single-nucleotide variants/indels (dnSNVs/indels) and copy number variants (dnCNVs). Generalized linear models were applied to assess de novo variant burdens in: children exposed prenatally to AEDs (AED-exposed children) vs children without BDs not exposed prenatally to AEDs (AED-unexposed unaffected children), and AED-exposed children with BDs vs those without BDs, adjusting for confounders. Fisher's exact test was used to compare categorical data. RESULTS: 67 child-parent trios were included: 10 with AED-exposed children with BDs; 46 with AED-exposed unaffected children; 11 with AED-unexposed unaffected children. The dnSNV/indel burden did not differ between AED-exposed children and AED-unexposed unaffected children [median dnSNV/indel number/child (range): 3 (0-7) vs 3 (1-5), p = 0.50]. Among AED-exposed children, there were no significant differences between those with BDs and those unaffected. Likely deleterious dnSNVs/indels were detected in 9/67 (13%) children, none of whom had BDs. The proportion of cases harbouring likely deleterious dnSNVs/indels did not differ significantly between AED-unexposed and AED-exposed children. The dnCNV burden was not associated with AED exposure or birth outcome. INTERPRETATION: Our study indicates that prenatal AED exposure does not increase the burden of de novo variants, and that this mechanism is not a major contributor to AED-induced BDs. These results can be incorporated in routine patient counselling. This article is protected by copyright. All rights reserved.

Published
2020

24. Update from EURAP

Author

Battino, D., Bonizzoni, E., Craig, J., Lindhout, D., Perucca, E., Sabers, A., Tomson, T., and Vajda, F.

Published
2005

29. Vacuum ultra-violet damage and damage mitigation for plasma processing of highly porous organosilicate glass dielectrics.

Author

de Marneffe, J.-F., Zhang, L., Heyne, M., Lukaszewicz, M., Porter, S. B., Vajda, F., Rutigliani, V., el Otell, Z., Krishtab, M., Goodyear, A., Cooke, M., Verdonck, P., and Baklanov, M. R.

Subjects
VACUUM ultraviolet spectroscopy, PLASMA materials processing, FAR ultraviolet radiation, PLASMA flow, PLASMA-enhanced chemical vapor deposition
Abstract

Porous organosilicate glass thin films, with k-value 2.0, were exposed to 147 nm vacuum ultra-violet (VUV) photons emitted in a Xenon capacitive coupled plasma discharge. Strong methyl bond depletion was observed, concomitant with a significant increase of the bulk dielectric constant. This indicates that, besides reactive radical diffusion, photons emitted during plasma processing do impede dielectric properties and therefore need to be tackled appropriately during patterning and integration. The detrimental effect of VUV irradiation can be partly suppressed by stuffing the low-k porous matrix with proper sacrificial polymers showing high VUV absorption together with good thermal and VUV stability. In addition, the choice of an appropriate hard-mask, showing high VUV absorption, can minimize VUV damage. Particular processing conditions allow to minimize the fluence of photons to the substrate and lead to negligible VUV damage. For patterned structures, in order to reduce VUV damage in the bulk and on feature sidewalls, the combination of both pore stuffing/material densification and absorbing hard-mask is recommended, and/or the use of low VUV-emitting plasma discharge. [ABSTRACT FROM AUTHOR]

Published
2015
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33. Development of EpiRisk: An online clinical tool for estimating the risk of major congenital malformations in pregnant women treated for epilepsy.

Author

Davis Jones, G, Hitchcock, A, Vajda, F, Craig, J, O'Brien, TJ, Sen, A, Davis Jones, G, Hitchcock, A, Vajda, F, Craig, J, O'Brien, TJ, and Sen, A

Abstract

Antiepileptic drugs (AEDs) are known to associate with an increased risk of major congenital malformations (MCMs) in children born to women who become pregnant while taking them. As the indications for AEDs continue to diversify, novel AEDs emerge, and polytherapy becomes more prevalent, the volume and complexity of the information relating to teratogenic risk can become unmanageable for the clinician. This in turn makes accurate education of pregnant women treated with AEDs regarding the risk of MCMs challenging. To enable clinicians to provide better information regarding the potential teratogenic risk of AEDs, we outline here the method we have employed to underpin a new system of real-time risk analysis, "EpiRisk." When launched, EpiRisk will offer a user-friendly, online clinical tool, compatible with all modern Internet browsers, smart phones, and personal computers. Using the most current published data, as well as "real world" data from the UK and the Australian Pregnancy Registers, EpiRisk will enable clinicians to quickly and accurately assess the teratogenic risk of AEDs in mono- and polytherapy. EpiRisk may thus provide a future-proof central hub for empowering patients, clinicians, and registries by delivering evidence-based information on the teratogenic risk of the AEDs in pregnant women with epilepsy through an easily accessible platform.

Published
2018

34. Saved to Remember : Raoul Wallenberg, Budapest 1944 and After

Author

Vajda, F. J. E. and Vajda, F. J. E.

Subjects
Holocaust survivors--Hungary, Jews--Hungary--History--20th century, Holocaust, Jewish (1939-1945)--Hungary
Abstract

Frank Vajda, a major figure in Australian neurology, was a boy in Budapest, Hungary, during the Second World War. He witnessed the attempt by Hitler's Nazis and a fascist Hungarian militia to murder him, his family and the rest of the Jews of this nation. Frank survived in the care of his courageous and ever-resourceful mother. In Saved to Remember Vajda vividly and matter-of-factly conveys what life was like for Jews trying to stay alive in a world where the law of the land, backed up by brute soldierly force, suddenly determined that they were to be killed, and how they hid, bluffed, and fought to avoid that fate. Vajda pays tribute to those who did not survive, including his father, and to those who did their best to save them, amongst whom the name of Raoul Wallenberg, Swedish diplomat, shines most brightly. Saved to Remember is also an account of Vajda's ongoing campaign, within the journey of his life, to publicly recognise and honour those, particularly Wallenberg, who risked their own lives in the attempt to save Jewish life. At a time when the memory of this period of Hungarian history is increasingly contested, Vajda's memoir is important both for what it reveals of what happened and for what it says of how these happenings should be remembered. About the author: Frank Vajda AM, Officer 1st.cl. Royal Order of Polar Star (Sweden), MD FRCP FRACP, is a consultant neurologist, Professorial Fellow, University of Melbourne, Director of the Australian Pregnancy Register of Antiepileptic Drugs, Past President of Epilepsy Society of Australia, International Ambassador for Epilepsy, Member of the International Pregnancy Register Board, Head of the Free Wallenberg Australian Committee and Founder of Raoul Wallenberg Centre of Clinical Neuropharmacology. [Subject: Jewish Studies, History]

Published
2016

40. Withdrawal of valproic acid treatment during pregnancy and seizure outcome: Observations from EURAP

Author

Tomson, T, Battino, D, Bonizzoni, E, Craig, J, Lindhout, D, Perucca, E, Sabers, A, Thomas, SV, Vajda, F, Tomson, T, Battino, D, Bonizzoni, E, Craig, J, Lindhout, D, Perucca, E, Sabers, A, Thomas, SV, and Vajda, F

Abstract

Based on data from the EURAP observational International registry of antiepileptic drugs (AEDs) and pregnancy, we assessed changes in seizure control and subsequent AED changes in women who underwent attempts to withdraw valproic acid (VPA) during the first trimester of pregnancy. Applying Bayesian statistics, we compared seizure control in pregnancies where VPA was withdrawn (withdrawal group, n = 93), switched to another AED (switch group, n = 38), or maintained (maintained-therapy group, n = 1,588) during the first trimester. The probability of primarily or secondarily generalized tonic-clonic seizures (GTCS) was lower in the maintained-therapy group compared with the other two groups, both in the first trimester and for the entire duration of pregnancy. GTCS were twice as common during pregnancy in the withdrawal (33%) and switch groups (29%) compared with the maintained-treatment group (16%). Limitations in the data and study design do not allow to establish a cause-effect relationship between treatment changes and seizure outcome, but these observations provide a signal that withdrawal of, or switch from, VPA during the first trimester could lead to loss of seizure control, and highlight the need for a specifically designed prospective observational study.

Published
2016

46. Implementation Framework for Artificial Neural Networks on FPGA

Author

Škoda, P., Tomislav Lipic, Srp, A., Rogina, B. M., Skala, K., Vajda, F., Biljanović, Petar, and Skala, Karolj

Subjects
Computer Science::Hardware Architecture, field programmable gate array, neural network, Computer Science::Neural and Evolutionary Computation, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

In an Artificial Neural Network (ANN) a large number of highly interconnected simple nonlinear processing units work in parallel to solve a specific problem. Parallelism, modularity and dynamic adaptation are three characteristics typically associated with ANNs. Field Programmable Gate Array (FPGA) based reconfigurable computing architectures are well suited to implement ANNs as one can exploit concurrency and rapidly reconfigure to adapt the weights and topologies of an ANN. ANNs are suitable for and widely used in various real-life applications. A large portion of these applications are realized as embedded computer systems. With continuous advancements in VLSI technology FPGAs have become more powerful and power efficient, enabling the FPGA implementation of ANNs in embedded systems. This paper proposes an FPGA ANN framework which facilitates implementation in embedded systems. A case study of an ANN implementation in an embedded fall detection system is presented to demonstrate the advantages of the proposed framework.

Published
2011

48. Altered cortical thickness following prenatal sodium valproate exposure

Author

Wood, AG, Chen, J, Barton, S, Nadebaum, C, Anderson, VA, Catroppa, C, Reutens, DC, O'Brien, TJ, Vajda, F, Wood, AG, Chen, J, Barton, S, Nadebaum, C, Anderson, VA, Catroppa, C, Reutens, DC, O'Brien, TJ, and Vajda, F

Abstract

Prenatal exposure to sodium valproate (VPA) is associated with neurodevelopmental impairments. Cortical thickness was measured in 16 children exposed prenatally to VPA and 16 controls. We found increased left inferior frontal gyrus (IFG; BA45) and left pericalcarine sulcus (BA18) thickness, an association between VPA dose and right IFG thickness, and a close relationship between verbal skills and left IFG thickness. A significant interaction between group and hemispheric IFG thickness showed absence of the normal asymmetry in the IFG region of VPA-exposed children. These data provide preliminary insights into the putative neural basis of difficulties experienced by some VPA-exposed children.

Published
2014

49. Utilization of antiepileptic drugs during pregnancy: comparative patterns in 38 countries based on data from the EURAP registry

Author

Battino, D, Bonizzoni, E, Craig, J, Lindhout, D, Perucca, E, Sabers, A, Vajda, F, Tomson, T, Eurap Study Group, Rocchi, Raffaele, Tinuper P., Bisulli F., EURAP Study Group., and University of Groningen

Subjects
Drug Utilization, Adult, Cross-Cultural Comparison, Pediatrics, medicine.medical_specialty, Antiepileptic drugs, Drug utilization, Epilepsy, Pregnancy, Lamotrigine, Global Health, Drug Prescriptions, Risk Assessment, Risk Factors, medicine, MAJOR MALFORMATIONS, Humans, Prospective Studies, Registries, Medical prescription, Prospective cohort study, Psychiatry, Child, FETAL, business.industry, Triazines, SEIZURE CONTROL, Pregnancy Outcome, WOMEN, International Agencies, medicine.disease, Obstetric labor complication, Obstetric Labor Complications, Pregnancy Complications, Neurology, Anticonvulsants, Drug Therapy, Combination, Female, Neurology (clinical), Risk assessment, business, medicine.drug
Abstract

P>We assessed the utilization of antiepileptic drugs (AEDs), 1999-2005, in 4,798 prospective epilepsy pregnancies from 38 countries participating in EURAP, an international AED and pregnancy registry. Prominent differences in utilization patterns were observed across the various countries. Exposure to second-generation AEDs ranged from 3.5% in India and 7.3% in Italy to 75% in Denmark. Even wider variation was recorded in exposure to individual AEDs. The utilization of second-generation AEDs increased over time (for lamotrigine, from 9.9% of all pregnancies before 2001 to 29.6% after 2003). The differences in use of individual AEDs across countries probably reflect lack of evidence concerning the optimal treatment of epilepsy in women of childbearing age, as well as variation in country-specific traditions, medication costs, and drug promotion. Our observations underscore the need for comparative studies to investigate the factors influencing the prescription of AEDs during pregnancy, as well as their influence on pregnancy outcome.

Published
2009

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