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

Fedor Panov,Patricia Mcgoldrick,Jennifer Haskell,Maite La Vega-Talbott,Saadi Ghatan,Steven Wolf,Sara Ganaha,Madeline Fields,Lara Marcuse

doi:10.3171/2020.5.peds20118

Abstract

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. 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. 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. The authors demonstrated the safety and efficacy of RNS in pediatric patients, with infections being the main complication. 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.

Highlights

These limitations have led to the development of neuromodulatory treatments, such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS).[13]
We conducted a retrospective review of the electronic medical records (EMRs) with approval from the IRB of the Mount Sinai Health System (MSHS) to investigate surgical complications and postoperative seizure frequency
Complications No postoperative hematoma, stroke, or responsive neurostimulation (RNS) system malfunction was seen in our cohort

Summary

OBJECTIVE

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. Laser interstitial thermal therapy is an established, minimally invasive alternative to traditional resection with comparable clinical efficacy.[7,8,9] Neither resection nor ablation is recommended in cases of multiple seizure foci, a focus in an eloquent area, or poor delineation of the network, a frequent occurrence in pediatric epilepsy.[10,11,12] These limitations have led to the development of neuromodulatory treatments, such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS).[13] In 2013, the FDA approved the closed-loop responsive neurostimulation (RNS) system (NeuroPace Inc.) as an adjunctive therapy for adults with drug-resistant partial-onset seizures with no more than two epileptogenic foci.[14,15,16]. (age < 18 years) with DRE that had undergone adjunctive treatment with RNS at our institution in the period from September 2015 to December 2019

Methods

Results

Discussion

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Disclosures