Safety of responsive neurostimulation in pediatric patients with medically refractory epilepsy.

OBJECTIVE: Approximately 75% of pediatric patients who suffer from epilepsy are successfully treated with antiepileptic drugs, while the disease is drug resistant in the remaining patients, who continue to have seizures. Patients with drug-resistant epilepsy (DRE) may have options to undergo invasive treatment such as resection, laser ablation of the epileptogenic focus, or vagus nerve stimulation. To date, treatment with responsive neurostimulation (RNS) has not been sufficiently studied in the pediatric population because the FDA has not approved the RNS device for patients younger than 18 years of age. Here, the authors sought to investigate the safety of RNS in pediatric patients. METHODS: The authors performed a retrospective single-center study of consecutive patients with DRE who had undergone RNS system implantation from September 2015 to December 2019. Patients were followed up postoperatively to evaluate seizure freedom and complications. RESULTS: Of the 27 patients studied, 3 developed infections and were treated with antibiotics. Of these 3 patients, one required partial removal and salvaging of a functioning system, and one required complete removal of the RNS device. No other complications, such as intracranial hemorrhage, stroke, or device malfunction, were seen. The average follow-up period was 22 months. All patients showed improvement in seizure frequency. CONCLUSIONS: The authors demonstrated the safety and efficacy of RNS in pediatric patients, with infections being the main complication. ABBREVIATIONS: DBS = deep brain stimulation; DRE = drug-resistant epilepsy; MDC = multidisciplinary conference; MER = microelectrode recording; MSHS = Mount Sinai Health System; RNS = responsive neurostimulation; SEEG = stereo-EEG; VNS = vagus nerve stimulation.