RESUMO
OBJECTIVE: Short-term outcomes of deep brain stimulation of the anterior nucleus of the thalamus (ANT-DBS) were reported for people with drug-resistant focal epilepsy (PwE). Because long-term data are still scarce, the Medtronic Registry for Epilepsy (MORE) evaluated clinical routine application of ANT-DBS. METHODS: In this multicenter registry, PwE with ANT-DBS were followed up for safety, efficacy, and battery longevity. Follow-up ended after 5 years or upon study closure. Clinical characteristics and stimulation settings were compared between PwE with no benefit, improvers, and responders, that is, PwE with average monthly seizure frequency reduction rates of ≥50%. RESULTS: Of 170 eligible PwE, 104, 62, and 49 completed the 3-, 4-, and 5-year follow-up, respectively. Most discontinuations (68%) were due to planned study closure as follow-up beyond 2 years was optional. The 5-year follow-up cohort had a median seizure frequency reduction from 16 per month at baseline to 7.9 per month at 5-year follow-up (p < .001), with most-pronounced effects on focal-to-bilateral tonic-clonic seizures (n = 15, 77% reduction, p = .008). At last follow-up (median 3.5 years), 41% (69/170) of PwE were responders. Unifocal epilepsy (p = .035) and a negative history of epilepsy surgery (p = .002) were associated with larger average monthly seizure frequency reductions. Stimulation settings did not differ between response groups. In 179 implanted PwE, DBS-related adverse events (AEs, n = 225) and serious AEs (n = 75) included deterioration in epilepsy or seizure frequency/severity/type (33; 14 serious), memory/cognitive impairment (29; 3 serious), and depression (13; 4 serious). Five deaths occurred (none were ANT-DBS related). Most AEs (76.3%) manifested within the first 2 years after implantation. Activa PC depletion (n = 37) occurred on average after 45 months. SIGNIFICANCE: MORE provides further evidence for the long-term application of ANT-DBS in clinical routine practice. Although clinical benefits increased over time, side effects occurred mainly during the first 2 years. Identified outcome modifiers can help inform PwE selection and management.
Assuntos
Núcleos Anteriores do Tálamo , Estimulação Encefálica Profunda , Epilepsia Resistente a Medicamentos , Sistema de Registros , Humanos , Estimulação Encefálica Profunda/métodos , Estimulação Encefálica Profunda/efeitos adversos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Epilepsia Resistente a Medicamentos/terapia , Resultado do Tratamento , Europa (Continente)/epidemiologia , Adulto Jovem , Seguimentos , Adolescente , IdosoRESUMO
More than half of adults with epilepsy undergoing resective epilepsy surgery achieve long-term seizure freedom and might consider withdrawing antiseizure medications. We aimed to identify predictors of seizure recurrence after starting postoperative antiseizure medication withdrawal and develop and validate predictive models. We performed an international multicentre observational cohort study in nine tertiary epilepsy referral centres. We included 850 adults who started antiseizure medication withdrawal following resective epilepsy surgery and were free of seizures other than focal non-motor aware seizures before starting antiseizure medication withdrawal. We developed a model predicting recurrent seizures, other than focal non-motor aware seizures, using Cox proportional hazards regression in a derivation cohort (n = 231). Independent predictors of seizure recurrence, other than focal non-motor aware seizures, following the start of antiseizure medication withdrawal were focal non-motor aware seizures after surgery and before withdrawal [adjusted hazard ratio (aHR) 5.5, 95% confidence interval (CI) 2.7-11.1], history of focal to bilateral tonic-clonic seizures before surgery (aHR 1.6, 95% CI 0.9-2.8), time from surgery to the start of antiseizure medication withdrawal (aHR 0.9, 95% CI 0.8-0.9) and number of antiseizure medications at time of surgery (aHR 1.2, 95% CI 0.9-1.6). Model discrimination showed a concordance statistic of 0.67 (95% CI 0.63-0.71) in the external validation cohorts (n = 500). A secondary model predicting recurrence of any seizures (including focal non-motor aware seizures) was developed and validated in a subgroup that did not have focal non-motor aware seizures before withdrawal (n = 639), showing a concordance statistic of 0.68 (95% CI 0.64-0.72). Calibration plots indicated high agreement of predicted and observed outcomes for both models. We show that simple algorithms, available as graphical nomograms and online tools (predictepilepsy.github.io), can provide probabilities of seizure outcomes after starting postoperative antiseizure medication withdrawal. These multicentre-validated models may assist clinicians when discussing antiseizure medication withdrawal after surgery with their patients.
Assuntos
Epilepsias Parciais , Epilepsia Generalizada , Epilepsia , Humanos , Adulto , Anticonvulsivantes/efeitos adversos , Recidiva Local de Neoplasia/tratamento farmacológico , Epilepsia/tratamento farmacológico , Epilepsia/cirurgia , Convulsões/tratamento farmacológico , Epilepsia Generalizada/tratamento farmacológicoRESUMO
INTRODUCTION/OBJECTIVES: The authors make the balance of the first five years of teaching Anatomy to the Licensure in Health Sciences, of Lisbon University. MATERIALS AND METHODS: Were studied 408 students, enrolled in the Curricular Unit of Anatomy (mandatory subject of the 1st semester) and 29 in the Curricular Unit of Neuroanatomy (optional subject of the 6th semester). It was performed the statistical analysis by Anova and t Student test. RESULTS AND DISCUSSION: There was an annual growing influx of students enrolled in Curricular Unit of Anatomy, a stable number in Neuroanatomy and clear predominance of female students; ratio teacher / student variable between 1/9 and 1/17 in Anatomy and 1/8 in Neuroanatomy; high number of initial dropouts (15.69%) in Anatomy; approval levels of 95.93% in Anatomy and Neuroanatomy 100%; trend of improvement in the last two years, with statistical significance in the Curricular Unit of Anatomy (p = 0.0001) and equal academic performance of students of both genders; satisfaction scores of students of Anatomy, Good = 71% and Very Good = 8%; in Neuroanatomy, unanimous classification by students = Very Good. CONCLUSIONS: It was a very positive learning experience. The authors propose: the study of the causes and prevention of early dropout of incoming students, improving the ratio teacher / student, possible extension to a 2nd semester of the Curricular Unit of Anatomy and improving facilities that are already underway and includes the refurbishment and modernization of the anatomical theater of the Institute of Anatomy, Faculty of Medicine, University of Lisbon.
Introdução/Objectivos: Os autores fazem o balanço dos primeiros cinco anos de ensino de Anatomia da Licenciatura em Ciências da Saúde da Universidade de Lisboa.Material e Métodos: Estudaram o desempenho de 408 alunos inscritos na Unidade Curricular de Anatomia (disciplina obrigatória do primeiro semestre) e 29 na Unidade Curricular de Neuroanatomia (disciplina opcional do sexto semestre). Realizaram a análise estatística pelos testes Anova e t de Student.Resultados e Discussão: Houve um afluxo crescente anual de alunos inscritos na Unidade Curricular de Anatomia, um número estável em Neuroanatomia, predomínio claro de alunos do sexo feminino, ratio docente/aluno variável entre 1/9 e 1/17 na Unidade Curricular de Anatomia e 1/8 na Unidade Curricular de Neuroanatomia; elevado número de desistências iniciais (15,69%) em Anatomia; níveis de aprovação de 95,93% na Unidade Curricular de Anatomia e de 100% em Neuroanatomia; tendência de melhoria verificada nos últimos dois anos, com significado estatístico na Unidade Curricular de Anatomia (p = 0,0001) e igual desempenho escolar de alunos de ambos os sexos; índices de satisfação dos alunos de Anatomia, Bom = 71% e Muito Bom = 8%; Neuroanatomia, classificaçãounânime pelos alunos = Muito Bom.Conclusões: Foi uma experiência pedagógica muito positiva. Os autores propõem: o estudo e a prevenção das causas da desistência inicial dos alunos que acedem ao curso, melhoria do ratio docente/discente, possível extensão a um segundo semestre da Unidade Curricular de Anatomia e melhoria das instalações que já estão em curso e que inclui a remodelação e a modernização do teatro anatómico do Instituto de Anatomia da Faculdade de Medicina da Universidade de Lisboa.