This is an open-label, retrospective, multicenter study to determine the ou
tcome of intermittent stimulation of the left vagal nerve in children with
tuberous sclerosis complex and medically refractory epilepsy. The records o
f all children treated with vagal nerve stimulation were reviewed in five p
ediatric epilepsy centers to locate those with tuberous sclerosis complex w
ho had been treated with vagal nerve stimulation for at least 6 months. The
se patients were compared with (1) a series of patients obtained from the l
iterature, (2) 10 similar control patients with epilepsy obtained from a re
gistry of patients receiving vagal nerve stimulation, and (3) four publishe
d series of tuberous sclerosis complex patients whose epilepsy was surgical
ly managed. Ten tuberous sclerosis complex patients with medically refracto
ry epilepsy treated with vagal nerve stimulation were found. Nine experienc
ed at least a 50% reduction in seizure frequency, and half had a 90% or gre
ater reduction in seizure frequency. No adverse events were encountered. Co
mparison with published and registry patients revealed improved seizure con
trol in the tuberous sclerosis complex patients. Comparison with the group
undergoing seizure surgery demonstrated improved outcomes after surgery. Va
gal nerve stimulation appears to be an effective and well-tolerated adjunct
ive therapy in patients with tuberous sclerosis complex and seizures refrac
tory to medical therapy. Resective surgery has a better prospect for improv
ed seizure control. (C) 2001 by Elsevier Science Inc. All rights reserved.