Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability

E Ben-Menachem, D Revesz, B J Simon, S Silberstein, E Ben-Menachem, D Revesz, B J Simon, S Silberstein

Abstract

Vagus nerve stimulation (VNS) is effective in refractory epilepsy and depression and is being investigated in heart failure, headache, gastric motility disorders and asthma. The first VNS device required surgical implantation of electrodes and a stimulator. Adverse events (AEs) are generally associated with implantation or continuous on-off stimulation. Infection is the most serious implantation-associated AE. Bradycardia and asystole have also been described during implantation, as has vocal cord paresis, which can last up to 6 months and depends on surgical skill and experience. The most frequent stimulation-associated AEs include voice alteration, paresthesia, cough, headache, dyspnea, pharyngitis and pain, which may require a decrease in stimulation strength or intermittent or permanent device deactivation. Newer non-invasive VNS delivery systems do not require surgery and permit patient-administered stimulation on demand. These non-invasive VNS systems improve the safety and tolerability of VNS, making it more accessible and facilitating further investigations across a wider range of uses.

Keywords: depression; epilepsy; headache; implantable; migraine; safety; transcutaneous; vagus nerve stimulation.

© 2015 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

Figures

Figure 1
Figure 1
Vagus nerve innervation. (Reprinted with permission from Massey 9).
Figure 2
Figure 2
Implantable VNS systems: (a) VNS Therapy system and (b) CardioFit. (Reprinted with permission from (a) Cyberonics, Houston, TX, USA, and (b) BioControl Medical, Yehud, Israel).
Figure 3
Figure 3
Non‐implantable VNS systems: (a) NEMOS (tVNS) and (b) gammaCore (nVNS). (Reprinted with permission from (a) Cerbomed, Erlangen, Germany, and (b) electroCore, Basking Ridge, NJ, USA).

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