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Safety of responsive neurostimulation in pediatric patients with medically refractory epilepsy
Fedor Panov1, Sara Ganaha1, Jennifer Haskell1
11Department of Neurosurgery, Mount Sinai West; and.
Insights
Responsive neurostimulation (RNS) shows promise for pediatric drug-resistant epilepsy (DRE). This study found RNS to be safe and effective in young patients, with infections as the primary complication, improving seizure frequency.
Area of Science:
- Pediatric Neurology
- Neurosurgery
- Epilepsy Research
Background:
- Drug-resistant epilepsy (DRE) affects a significant portion of pediatric patients, necessitating alternative treatments beyond antiepileptic drugs.
- Current invasive options for DRE include resection, laser ablation, and vagus nerve stimulation.
- Responsive neurostimulation (RNS) has shown efficacy in adults but is not FDA-approved for pediatric use, limiting its study in this population.
Purpose of the Study:
- To investigate the safety and efficacy of responsive neurostimulation (RNS) in pediatric patients with drug-resistant epilepsy (DRE).
Main Methods:
- A retrospective, single-center study was conducted involving pediatric patients with DRE who received RNS system implantation.
- Data were collected from September 2015 to December 2019.
- Postoperative follow-up assessed seizure freedom and complications.
Main Results:
- Twenty-seven pediatric patients with DRE underwent RNS implantation.
- Three patients developed infections, with one requiring partial device removal and another complete removal.
- No other serious complications like hemorrhage or stroke were observed. All patients experienced reduced seizure frequency.
- The average follow-up period was 22 months.
Conclusions:
- Responsive neurostimulation (RNS) is a safe and effective treatment option for pediatric patients with drug-resistant epilepsy (DRE).
- Infections represent the main complication associated with RNS in this pediatric cohort.
- RNS demonstrates potential for improving seizure control in young individuals with 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.
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