The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial.

OBJECTIVE: To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS + BMP) is superior to BMP alone in improving long-term health-related quality of life (HRQoL). METHODS: PuLsE (Open Prospective Randomized Long-term Effectiveness) was a prospective, randomized, parallel-group, open-label, and long-term effectiveness study (conducted at 28 sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n = 112) received VNS + BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary endpoints included changes in seizure frequency, responder rate (≥50% decrease in seizure frequency), Centre for Epidemiologic Studies Depression scale (CES-D), Neurological Disorders Depression Inventory-Epilepsy scale (NDDI-E), Clinical Global Impression-Improvement scale (CGI-I), Adverse Event Profile (AEP), and antiepileptic drug (AED) load. The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n = 362. Results for n = 96 who had baseline and at least one follow-up QOLIE-89 assessment (from months 3-12) were included in this analysis. Mixed model repeated measures (MMRM) analysis of variance was performed on change from baseline for the primary and secondary endpoints. RESULTS: Significant between-group differences in favor of VNS + BMP were observed regarding improvement in HRQoL, seizure frequency, and CGI-I score (respective p-values < 0.05, 0.03, and 0.01). More patients in the VNS + BMP group (43%) reported adverse events (AEs) versus BMP group (21%) (p = 0.01), a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation. No significant difference between treatment groups was observed for changes in CES-D, NDDI-E, AEP, and AED load. SIGNIFICANCE: VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone. A PowerPoint slide summarizing this article is available for download in the Supporting Information section here.

Discontinuation of antiepileptic drugs after successful epilepsy surgery. a Canadian survey.

INTRODUCTION: To identify the perceived practice among Canadian epileptologists regarding discontinuation of antiepileptic drugs (AEDs) following successful resective surgery for temporal and extratemporal surgery. METHODS: We performed a survey of pediatric and adult epileptologists in Canada, using a 77-item questionnaire to explore attitudes, timing, rate of withdrawal, and factors contributing to the decision to withdraw AEDs after successful epilepsy surgery. Surveys were mailed with a postage-paid return envelope. Two subsequent surveys were mailed to non-respondents at 15 days intervals. All procedures received institutional review board approval. RESULTS: Surveys were sent to 82 epileptologists in all the Canadian provinces. Sixty-six physicians answered the survey (80.5%), representing all epilepsy centers across Canada. The minimum seizure free period required after epilepsy surgery before withdrawing AEDs, varied substantially among responders: <6 months in 10%, 6-11 months in 21%, >1 year in 50%, >2 years in 12%, >2 years in 3% after. The most important factors influencing the decision to withdraw AEDs a negative EEG before discontinuation (71%), patients' preferences (78%) and the presence of unilateral mesial temporal sclerosis (70%). The most important factors against reduction were the following: patients' wishes to resume driving (67%), focal (65%) or generalized (78%) epileptiform activity on EEG after surgery, persistent isolated auras (78%), any seizures after hospital discharge (81%), and presurgical multifocal/bilateral/diffuse findings (78%). DISCUSSION: Canadian epileptologists indicated that AED levels, EEG and MRI are typically done before discontinuing AEDs. Generally, a good candidate for stopping AEDs has focal pathology, is completely seizure free, had an anterior temporal lobe resection, complete resection of seizure focus, and has no epileptiform discharges on postoperative EEG. The data pertaining to self-reported practice styles, and actual practice may differ.

Electroencephalographic features of temporal lobe epilepsy.

Electroencephalography (EEG) is an important tool for diagnosing, lateralizing and localizing temporal lobe seizures. In this paper, we review the EEG characteristics of temporal lobe epilepsy (TLE). Several "non-standard" electrodes may be needed to further evaluate the EEG localization, Ictal EEG recording is a major component of preoperative protocols for surgical consideration. Various ictal rhythms have been described including background attenuation, start-stop-start phenomenon, irregular 2-5 Hz lateralized activity, and 5-10 Hz sinusoidal waves or repetitive epileptiform discharges. The postictal EEG can also provide valuable lateralizing information. Postictal delta can be lateralized in 60% of patients with TLE and is concordant with the side of seizure onset in most patients. When patients are being considered for resective surgery, invasive EEG recordings may be needed. Accurate localization of the seizure onset in these patients is required for successful surgical management.

Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor?

We assessed the impact of vagus nerve stimulation on a cohort of patients with intractable epilepsy. A 1-year prospective trial of vagus nerve stimulation for intractable epilepsy was done in 26 patients. Seizure frequency, anti-epileptic drugs, and quality of life were assessed using QOLIE-89, ELDQOL, and a Likert scale of impact of treatment. Seizures were reduced by more than 50% in 19% of the patients, by less than 50% in 46%, and were unchanged in 35% of them. Antiepileptic drugs were reduced in 43% of the patients. There was a significant improvement in the mean overall QOLIE-89 score and other measures of quality of life, but these did not correlate with changes in seizure frequency. Subjective improvement occurred in 84% of the patients. The quality of life improves in some patients following vagus nerve stimulation for intractable epilepsy. The favorable effects of this treatment may be attributable to additional factors besides seizure control which in this study was modest.