Abstracts

Rationale: Vagus nerve stimulation (VNS) is an accepted therapy for the treatment of drug-resistant epilepsy (DRE). The VNS Aspire SR® model 106 detects the increase of pre-ictal heart rate through the AutoStim mode and automatically stimulates VN avoiding seizures. The aim of this study is to assess the overall efficacy on seizures of VNS model 106 for the DRE in children and adult patients in Centro Médico Docente la Trinidad (CMDLT), Caracas, Venezuela. Methods: This single-center, prospective and cross-sectional study, through the follow-up of patients with this VNS system for 3-6-12-18-24 and 36 months post-implanted from June 2017 to January 2019. The response rate (greater than 50% reduction of the seizure frequency), adverse effects, complications, number of hospitalizations, frequency of status epilepticus, overall quality of life and caregiver overload were also evaluated. The Zarit test evaluated caregiver overload. Results: 34 patients, 12 (35%) women; mean age was 17,5yr (3,7 to 43); 11p (32%) <14yo and 23(68%) ≥14yo. Daily life activities: Total Dependent: 21 (62%); total independent: 7 (21%) and partially independent: 6 (17%) patients. Mean time with Epilepsy: 26,8yr (3,1 to 42). 25 (74%) subjects with neurodevelopmental delay. Epileptic encephalopathy in 14p. Mean previous AED´s: 5(3 to 8) and post-VNS: 3 (1 to 5). Mean age at the time of VNS implantation was 17,5yr (3.9 to 42.1). Follow-up time 6m in 6p; 12m in 15p; 18m in 6p, 24m in 5p and 1p for 36m. Mean seizure frequency per month pre-VNS: 450. Seizures reduction post-VNS activation: ≥50%: 24p (70%) at 3m, 5p at 6m, 2 at 12m and 1p at 18m, all of them with shorter seizures and response rate stable at about 80% to the complete follow time. 2p seizure-free at 3m and 1p at 6m. 13p had a reduction in status epilepticus (SE) after VNS from multiple SE per month to no-one in 3m and all of them were free in 6m. 29p (85%) improved behavior, alertness and reactivity. Adverse effects in 29p, cough and transient hoarseness in 15p (44%), 6p (18%) hiccups. 4p had an infectious complication, the device had to be removed in 2p (6%) one of them because of broken leads with successful reimplantation and the other one by healing troubles.. Caregiver overload: 38% No overload, 15% mild and 47% intense overload, related to the degree of dependency. Conclusions: • Auto stim and parameters. such as threshold and sensitivity, in this VNS therapy allow more precise and targeted adjustments to each patient, which gives to the caregiver and to the patient itself greater independence due to a lower requirement of magneto use to avoid a seizure.• The positive impact of the VNS model 106 by decreasing the frequency and duration of the seizures, the time in the postictal confusional period, number of epileptic status and a lower amount of antiepileptic drugs (effects evidenced from the first 3 months post-implant and activation).• Summative effects: Improvement in alertness, behavior, and reactivity with the environment.• VNS Aspire SR® model 106 demonstrates a significant reduction of seizure frequency throughout follow up and is a safe and effective treatment option in patients with DRE who are not candidates for surgery.• This is the first report in Venezuela showing that the VNS Aspire SR® model 106 is an effective treatment controlling seizure for DRE in children and adult patients. Funding: No funding