Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: Long-term outcomes and predictors of response

The goal of this study was to assess the efficacy and safety of vagus nerve stimulation in a consecutive series of adults and children with treatment-resistant epilepsy (TRE). In this retrospective review of a prospectively created database of 436 consecutive patients who underwent vagus nerve stimulator implantation for TRE between November 1997 and April 2008, there were 220 (50.5%) females and 216 (49.5%) males ranging in age from 1 to 76   years at the time of implantation (mean: 29.0   ±   16.5). Thirty-three patients (7.6%) in the primary implantation group had inadequate follow-up (<   3   months from implantation) and three patients had early device removal because of infection and were excluded from seizure control outcome analyses. Duration of vagus nerve stimulation treatment varied from 10   days to 11   years (mean: 4.94   years). Mean seizure frequency significantly improved following implantation (mean reduction: 55.8%, P   <   0.0001). Seizure control ≥   90% was achieved in 90 patients (22.5%), ≥   75% seizure control in 162 patients (40.5%), ≥   50% improvement in 255 patients (63.75%), and <   50% improvement in 145 patients (36.25%). Permanent injury to the vagus nerve occurred in 2.8% of patients. Vagus nerve stimulation is a safe and effective palliative treatment option for focal and generalized TRE in adults and children. When used in conjunction with a multidisciplinary and multimodality treatment regimen including aggressive antiepileptic drug regimens and epilepsy surgery when appropriate, more than 60% of patients with TRE experienced at least a 50% reduction in seizure burden. Good results were seen in patients with non-U.S. Food and Drug Administration-approved indications. Prospective, randomized trials are needed for patients with generalized epilepsies and for younger children to potentially expand the number of patients who may benefit from this palliative treatment.