Safety of vagus nerve stimulation and responsive neurostimulation used in combination for multifocal and generalized onset epilepsy in pediatric patients

Cameron P. BeaudreaultNew York Medical College, Valhalla;

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Eris SpirollariNew York Medical College, Valhalla;

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Alexandria F. NaftchiNew York Medical College, Valhalla;

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Vishad SukulNew York Medical College, Valhalla;
Department of Neurosurgery, Westchester Medical Center, Valhalla;

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Ankita DasNew York Medical College, Valhalla;

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Sima VazquezNew York Medical College, Valhalla;

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Steven M. WolfNew York Medical College, Valhalla;
Department of Pediatrics, Division of Pediatric Neurology, Maria Fareri Children’s Hospital, Valhalla; and
Boston Children’s Hospital Physicians, Hawthorne, New York

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Patricia E. McGoldrickDepartment of Pediatrics, Division of Pediatric Neurology, Maria Fareri Children’s Hospital, Valhalla; and
Boston Children’s Hospital Physicians, Hawthorne, New York

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Carrie R. MuhNew York Medical College, Valhalla;
Department of Neurosurgery, Westchester Medical Center, Valhalla;

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OBJECTIVE

The aim of this study was to assess the safety and efficacy of combined active responsive neurostimulation (RNS) and vagus nerve stimulation (VNS) therapies in pediatric patients with drug-resistant epilepsy.

METHODS

A single-center retrospective chart review was conducted on pediatric patients implanted with the RNS System with a concomitant active VNS System (VNS+RNS) between 2015 and 2021. Patients with at least 1 month of overlapping concomitant VNS and RNS treatment were included. Patients who had an RNS device implanted after 21 years of age, those who had responsive neurostimulators implanted after their VNS was inactivated, or those in whom the VNS battery died and was not replaced before RNS System implantation were excluded.

RESULTS

Seven pediatric VNS+RNS patients were identified, and their courses of treatment were evaluated. All patients tolerated concurrent VNS and RNS treatment well, no device-device interactions were identified, and no major treatment-related adverse effects were noted. The median follow-up after RNS System implantation was 1.2 years. By electroclinical criteria, all 7 patients achieved 75%–99% reductions in the frequency of disabling seizures after RNS System implantation. By patient and caregiver report, 2 patients (28.6%) had 75%–99% reductions in the frequency of their disabling seizures, 2 patients (28.6%) achieved 50%–74% reductions, 2 patients achieved 1%–24% reduction in frequency of disabling seizures, and 1 patient (14.3%) experienced a 1%–24% increase in seizure frequency. The available VNS magnet swipe data identified 2 patients with 75%–99% reductions in seizure frequency as measured by magnet swipes, one with 25%–49% reductions and the other with 1%–24% increases in seizure frequency as measured by magnet swipes.

CONCLUSIONS

This study demonstrated that RNS and VNS therapies can safely be used simultaneously in pediatric patients. RNS may potentially augment the therapeutic effects of VNS treatment. Patients in whom a response to VNS has been suboptimal should still be considered for RNS therapy.

ABBREVIATIONS

ANT = anterior thalamic nucleus; CMT = centromedian thalamic nucleus; DRE = drug-resistant epilepsy; iEEG = intracranial electroencephalography; LGS = Lennox-Gastaut syndrome; PDMS = Patient Data Management System; RNS = responsive neurostimulation; VNS = vagus nerve stimulation.

Supplementary Materials

    • Supplementary Tables 1-3 (PDF 709 KB)
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