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Evaluating vagus nerve stimulation treatment with heart rate monitoring in pediatric patients with intractable epilepsy

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Abstract

Purpose

Vagus nerve stimulators (VNS) have emerged as an effective treatment modality for pediatric patients suffering from intractable, drug-resistant epilepsy. Newer devices, AspireSR™ Model 106 and the SenTiva™ Model 1000 (VNS TherapyⓇ, LivaNova™), contain an “auto-stimulation” feature that detects ictal tachycardia and transmits pulsations to attenuate seizures. However, the exact benefits of auto-stimulation compared to its risks still merit further exploration. This study evaluates the utility of these specific devices in a heterogeneous population of pediatric and young adult patients with intractable epilepsy.

Methods

This is a retrospective chart review of 55 patients who underwent either VNS insertion with or without an auto-stimulation-enabled VNS device at a single level four epilepsy center. Seizure frequency, seizure subtype, side effects, and change in anti-seizure medication load both before and after VNS implantations were collected from patient self-reporting at the time of VNS insertion and 12 months following implantation. Information regarding output current, auto-stimulation current, duty cycling, and auto-stimulation threshold of the device was obtained from documented VNS interrogation for patients with auto-stimulation-enabled VNS devices.

Results

Patients with auto-stimulation-enabled VNS devices had a mean 56.0% (SD = 0.414) seizure frequency reduction 12 months post-VNS insertion, while patients without auto-stimulation-enabled VNS devices had a mean 41.6% (SD = 0.456) seizure frequency reduction during the same interval. The mean seizure frequency reduction 12 months post-VNS insertion for patients with a SenTiva™ 1000 model was 66.0% (SD = 0.426). For patients with auto-stimulation-enabled VNS devices, post-treatment seizure reduction was significantly correlated with daily auto-stimulation activation (R = 0.432, p = 0.025).

Conclusion

This study supports the clinical safety and utility of auto-stimulation-enabled VNS models, specifically the SenTiva™ 1000, in treating pediatric patients with intractable epilepsy of various subtypes and etiologies. Further research is needed to evaluate the sustained impact of auto-stimulation on long-term outcomes (≥ 2 years follow-up post-VNS).

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Availability of data and material

All data generated in this study are included in this published article.

Change history

  • 08 December 2021

    Springer Nature’s version of this paper was updated to present the cut-off Table 5 caption in Springerlink.

Notes

  1. FDA Summary of Safety and Effectiveness Data: https://www.accessdata.fda.gov/cdrh_docs/pdf/p970003s207b.pdf

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Funding

BS received a stipend from the Zucker School of Medicine at Hofstra/Northwell Office of Medical Student Research. No other external funding was received for the work.

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Authors and Affiliations

  1. Division of Pediatric Neurosurgery, Cohen Children’s Medical Center, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, New Hyde Park, NY, USA

    Brandon Santhumayor & Shaun Rodgers

  2. Division of Pediatric Neurology, Cohen Children’s Medical Center, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, New Hyde Park, NY, USA

    Shefali Karkare & Sanjeev Kothare

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  1. Brandon Santhumayor
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  2. Shefali Karkare
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  3. Sanjeev Kothare
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  4. Shaun Rodgers
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Contributions

Conceptualization: BS, SR: recording, analysis, writing: BS, writing—reviewing and editing: SK, SK, SR: Supervision: SR.

Corresponding author

Correspondence to Brandon Santhumayor.

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IRB exempt form obtained from the institutional department.

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Not applicable—this is a retrospective review and did not involve patient participation.

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Not applicable—there are no publications of identifiable patient information.

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The authors have no conflicts of interest to report. The authors are not affiliated with LivaNova™ or Cyberonics™.

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Santhumayor, B., Karkare, S., Kothare, S. et al. Evaluating vagus nerve stimulation treatment with heart rate monitoring in pediatric patients with intractable epilepsy. Childs Nerv Syst 38, 547–556 (2022). https://doi.org/10.1007/s00381-021-05416-0

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