Vagus nerve stimulation: Clinical experience in drug-resistant pediatric epileptic patients

Rychlicki, F.; Zamponi, Nelia; Trignani, Roberto; Ricciuti, Riccardo; Iacoangeli, Maurizio; Scerrati, Massimo

doi:10.1016/j.seizure.2006.06.001

Cited by 102 publications

(72 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Others have reported vocal cord paralysis in 1%-5.6% of patients. 7,17,21,23,32,34,37,38,41 The surgical complication rate for all procedures was 8.6%, and 1.4% of the patients experienced vocal cord paralysis and all recovered completely. In a recent study by Robinson and Winston, 33 vocal cord paralysis occurred at almost twice the rate with leads that had a 2-mm inner diameter in comparison with 3-mm inner diameter in patients 18 years of age and older.…”

Section: Discussionmentioning

confidence: 95%

“…Most long-term studies have safety data ranging from 1 to 5 years. 6,14,19,20,34,[37][38][39] Considering that VNS can be a life-long treatment for many patients, it also involves repeated surgeries with multiple (up to 4) battery replacements that we account for in our series.…”

Section: Discussionmentioning

confidence: 99%

“…Most previous studies present frequencies ranging from 2.5% to 12.5%. 2,11,15,18,22,23,34,38,39 It is reasonable to believe that the complication frequency increases with a longer follow-up time, considering the repeated surgeries needed due to depleted batteries and hardware being worn out. Kahlow and Olivecrona 21 recently presented a single-center longitudinal study of 143 patients with a mean follow-up time of 62 months.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies report 0.5% to 20.8%. 11,15,20,21,24,27,34,37,38 Of the 13 lead malfunctions, all but 1 was of the Cyberonics model 300, which suggests that this model is more susceptible to breakage. This product is no longer distributed by Cyberonics, and lead failure has decreased significantly since the introduction of newer models.…”

Section: 42mentioning

confidence: 99%

See 3 more Smart Citations

Complications and safety of vagus nerve stimulation: 25 years of experience at a single center

Révész

Rydenhag

Ben‐Menachem

2016

PED

143

View full text Add to dashboard Cite

OBJECTIVE The goal of this paper was to investigate surgical and hardware complications in a longitudinal retrospective study. METHODS The authors of this registry study analyzed the surgical and hardware complications in 247 patients who underwent the implantation of a vagus nerve stimulation (VNS) device between 1990 and 2014. The mean follow-up time was 12 years. RESULTS In total, 497 procedures were performed for 247 primary VNS implantations. Complications related to surgery occurred in 8.6% of all implantation procedures that were performed. The respective rate for hardware complications was 3.7%. Surgical complications included postoperative hematoma in 1.9%, infection in 2.6%, vocal cord palsy in 1.4%, lower facial weakness in 0.2%, pain and sensory-related complications in 1.4%, aseptic reaction in 0.2%, cable discomfort in 0.2%, surgical cable break in 0.2%, oversized stimulator pocket in 0.2%, and battery displacement in 0.2% of patients. Hardware-related complications included lead fracture/malfunction in 3.0%, spontaneous VNS turn-on in 0.2%, and lead disconnection in 0.2% of patients. CONCLUSIONS VNS implantation is a relatively safe procedure, but it still involves certain risks. The most common complications are postoperative hematoma, infection, and vocal cord palsy. Although their occurrence rates are rather low at about 2%, these complications may cause major suffering and even be life threatening. To reduce complications, it is important to have a long-term perspective. The 25 years of follow-up of this study is of great strength considering that VNS can be a life-long treatment for many patients. Thus, it is important to include repeated surgeries such as battery and lead replacements, given that complications also may occur with these surgeries.

show abstract

Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: 42mentioning

confidence: 99%

See 2 more Smart Citations

Complications and safety of vagus nerve stimulation: 25 years of experience at a single center

Révész

Rydenhag

Ben‐Menachem

2016

PED

143

View full text Add to dashboard Cite

show abstract

“…The power analysis was based on open label studies in children that suggested a larger effect in children compared with the results of the available randomized controlled trials in adults. 4,5 It is conceivable that a significant effect on seizure frequency reduction in the initial treatment phase can only be detected in a larger study population. We therefore sincerely hope that our study will prompt a larger multicenter trial in the near future.…”

mentioning

confidence: 99%

Klinkenberg et al. reply

Klinkenberg

Aalbers

Vles

et al. 2012

Develop Med Child Neuro

View full text Add to dashboard Cite

SIR-Klinkenberg et al.1 are to be congratulated for publishing the first prospective randomized controlled trial on vagal nerve stimulation in children. The design was similar to that of the initial adult studies in which a 'high' (normal) stimulus regime was compared to 'low' stimulus. Like the adult studies, a number of participants appeared to respond to the low stimulus, a result which could be a real effect or one possibly due to chance particularly with the fluctuating nature of their conditions. This result might also be more likely to have arisen with the relatively short time (20wks) of the treatment phase. This, and the underpowered nature of the study -some 100 participants would be needed in each group given their assumptions as to relative efficacy -go some way to explaining the similar results obtained in both groups.A further confounding factor which is not discussed was changes in concomitant antiepileptic drug dosage. Clearly this would have to be held constant during the baseline and treatment periods. It would be reassuring to know that this was in fact the case.The study found a decrease in seizure severity overall. Was this effect irrespective of a decrease in seizure frequency, i.e. seen in both non-responders as well as in responders?The difficulties in carrying out a trial such as this should not be underestimated. Clearly further work needs to be done in order to establish the place for vagal nerve stimulation in children with difficult-to-treat epilepsy. Professor Robinson makes a valid remark by pointing out the possible confounding effect of changing the concomitant antiepileptic drug dosage during the study. For this reason neither the type of drug nor the dosage were altered during the complete study in all participating children. Furthermore, there was the question of whether the effects on seizure severity were dependent on the effects on seizure frequency reduction. This was not the case: vagus nerve stimulation significantly decreased seizure severity in both responders and non-responders.We agree that the positive effects in patients receiving lowoutput stimulation might be due to the fluctuating nature of the disease and the short follow-up. However, we based our study design on the previously published randomized controlled trials in adults, which led to US Food and Drug Administration approval for vagus nerve stimulation for intractable epilepsy. Our treatment phase was at least 1 month longer than the trial of both the VNS study group and Handforth et al.

show abstract

Vagus and trigeminal nerve stimulation

Schachter

2015

The Treatment of Epilepsy

View full text Add to dashboard Cite

Vagus nerve stimulation: Clinical experience in drug-resistant pediatric epileptic patients

Abstract: VNS can be considered an appropriate strategy as an add-on treatment in children affected by drug-resistant partial epilepsy and ineligible for resective epilepsy surgery.

Cited by 102 publications

References 26 publications

Complications and safety of vagus nerve stimulation: 25 years of experience at a single center

Complications and safety of vagus nerve stimulation: 25 years of experience at a single center

Klinkenberg et al. reply

Vagus and trigeminal nerve stimulation

Contact Info

Product

Resources

About