Children and adolescents with drug-resistant epilepsy who underwent brain surgery — extent and location of seizure foci dictating the particular type — were more likely to be seizure-free a year later compared with adolescents who received medical therapy alone in a randomized trial.
An intention-to-treat analysis found a significantly higher portion of children in the brain surgery group reported freedom from seizures at 12 months compared to those in the medical therapy group (77% versus 7%, P<0.001), reported Rekha Dwivedi, PhD, of the All India Institute of Medical Sciences in New Delhi, and colleagues.
Children in the brain surgery group also had significantly better seizure severity, behavior, and quality of life scores, the authors wrote in the New England Journal of Medicine.
They noted that children and adolescents with drug-resistant epilepsy are at increased risk for “poor long-term intellectual and psychosocial outcomes, along with a poor health-related quality of life.”
However, other randomized trials of temporal lobectomy for this condition included only adults, they said. Two other studies looked at seizure outcomes in children with brain lesions and presence of seizures in children who underwent surgery for drug-resistant epilepsy. Dwivedi’s group said their study was done “to follow up on these results.”
They randomized 116 patients with drug-resistant epilepsy, ages ≤18 years, into two groups — 57 patients received “brain surgery appropriate to the underlying cause of the epilepsy” along with appropriate medical therapy, and 59 patients received medical therapy alone, and placed on a waiting list for surgery. Drug-resistant epilepsy was defined as “failure of adequate trials of two appropriately chosen antiepileptic drug schedules with acceptable side effects.” Mean age of patients in both groups was between ages 9 and 10 years, and around 20% of each group were girls.
Freedom from seizures, the primary outcome of the trial, was defined as “class 1 on the International League Against Epilepsy Scale,” or no seizures or auras at 12 months.
Procedures in the surgery group were hemispherotomy (15 patients), temporal lobe resection (14), resection of lesion in other lobe than temporal (12), corpus callosotomy (10), and disconnection or resection of hypothalamic hamartoma (6).
Overall, the relative risk of seizure recurrence in the medical therapy group was more than four-fold of that in the surgery group (RR 4.09, 95% CI 2.52-6.62). Dwivedi’s group said that at the last follow-up, all patients who underwent temporal lobectomy or hypothalmic hamartoma surgeries, along with the large majority of those who had extratemporal resection or hemispherotomy, were seizure-free.
But in the medical therapy group, only two of 15 patients on the waiting list for a temporal lobectomy, one of 19 patients waiting for an extratemporal resection and one of 16 patients waiting for a corpus callosotomy were seizure-free.
Examining secondary outcomes, the surgery group had significantly better scores on several seizure and behavioral scales versus the medical therapy group:
Though the difference trended towards significance, there was no significant between-group difference in the Binet-Kamat intelligence quotient, the authors noted (difference 2.5, 95% CI -0.1 to 5.1, P=0.06).
There were serious adverse events in 19 patients in the surgery group, and none in the medical therapy group. Fifteen patients had hemiparesis, or weakness on one side of the body, and two patients had monoparesis, where one limb is weak but not completely paralyzed. Of these 17 patients, 15 were able to “move all major joints against gravity or better at 12 months,” the authors said.
In the medical therapy group, there were 10 patients with physical injuries related to seizures, along with one with an adverse reaction to an antiepileptic drug and one who developed “autistic features.”
Patients underwent many types of epilepsy surgeries directed at the cause of their seizures, which was a study limitation. In addition, there was an overrepresentation of hypothalamic hamartomas in the study, the authors noted.
The study was supported by the the Indian Council of Medical Research, the Center of Excellence for Epilepsy and Magnetoencephalography, and the Department of Biotechnology, Government of India.
Dwivedi and co-authors disclosed no relevant relationships with industry.
F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner