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Revision and removal of vagus nerve stimulation systems: twenty-five years’ experience

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Abstract

Background

Epilepsy, a disease characterized by recurrent seizures, is a common chronic neurologic condition. Antiepileptic drugs (AED) are the mainstay of treatment for epilepsy. Vagus nerve stimulation (VNS) surgery is an adjuvant therapy for the treatment of drug refractory epilepsy (DRE). VNS revision and implant removal surgeries remain common.

Methods

Using a single neurosurgeon data registry for epilepsy surgery, we retrospectively analyzed a total of 824 VNS surgeries. Patients were referred to two Level IV Comprehensive Epilepsy centers (from 08/1997 to 08/2022) for evaluation. Patients were divided into four groups: new device placement, revision surgery, removal surgery, and battery replacement for end-of-life of the generator. The primary endpoint was to analyze the reasons that led patients to undergo revision and removal surgeries. The time period from the index surgery to the removal surgery was also calculated.

Results

The median age of patients undergoing any type of surgery was 34 years. The primary reason for revision surgeries was device malfunction, followed by patients’ cosmetic dissatisfaction. There was no statistical sex-difference in revision surgeries. The median age and body mass index (BMI) of patients who underwent revision surgery were 38 years and 26, respectively. On the other hand, the primary reason for removal was lack of efficacy, followed again by cosmetic dissatisfaction. The survival analysis showed that 43% of VNS device remained in place for 5 years and 50% of the VNS devices were kept for 1533 days or 4.2 years.

Conclusions

VNS therapy is safe and well-tolerated. VNS revision and removal surgeries occur in less than 5% of cases. More importantly, attention to detail and good surgical technique at the time of the index surgery can increase patient satisfaction, minimize the need for further surgeries, and improve acceptance of the VNS technology.

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Data availability

Data and material are available upon request from the corresponding author.

Code availability

Code is available upon request from the corresponding author.

Abbreviations

AED:

Antiepileptic drugs

VNS:

Vagus nerve stimulation

DRE:

Drug refractory epilepsy

BMI:

Body mass index

FDA:

Food and Drug Administration

MRI:

Magnetic Resonance Imaging

PNES:

Psychogenic non-epileptic seizures

EEG:

Electroencephalogram

IQR:

Interquartile range

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Author information

Authors and Affiliations

  1. Department of Neurosurgery, Medical College of Georgia, Augusta University (MCG-AU), Augusta, GA, USA

    Lydia Kaoutzani, Liam V. Goldman, Manish Kumar & Fernando L. Vale

  2. Department of Neurosurgery, University of South Florida (USF), Tampa, USA

    Keaton Piper

  3. Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA

    Manish Kumar

Authors
  1. Lydia Kaoutzani
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  2. Liam V. Goldman
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  3. Keaton Piper
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  4. Manish Kumar
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  5. Fernando L. Vale
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Contributions

LK: writing original paper, methodology, and writing—review and editing. LVG: investigation and writing—review and editing. KP: investigation and writing—review and editing. MK: data curation and writing—review and editing. FLV: conceptualization, investigation, methodology, writing—review and editing, and supervision.

Corresponding author

Correspondence to Fernando L. Vale.

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This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Human Investigation Committee (IRB) of Medical College of Georgia, Augusta University (MCG-AU), and the University of South Florida (USF) approved this study.

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The authors declare no competing interests.

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Kaoutzani, L., Goldman, L.V., Piper, K. et al. Revision and removal of vagus nerve stimulation systems: twenty-five years’ experience. Acta Neurochir 165, 3913–3920 (2023). https://doi.org/10.1007/s00701-023-05875-1

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