Vagus nerve stimulation in pediatric intractable epilepsy: a Korean bicentric study

Kang, Hoon-Chul; Hwang, Yong Soon; Kim, D. S.; Kim, HeungDong

doi:10.1007/978-3-211-35205-2_18

Cited by 33 publications

(26 citation statements)

References 10 publications

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“…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%

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

Révész

Rydenhag

Ben‐Menachem

2016

PED

143

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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.

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Section: Discussionmentioning

confidence: 99%

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

Révész

Rydenhag

Ben‐Menachem

2016

PED

143

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“…Sixteen Class III studies were identified regarding the efficacy of VNS for seizure treatment in children (see table e-1 for study details). [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] This group of studies included 2 reports of patients with tuberous sclerosis 16,17 and one report of patients with Dravet syndrome. 18 Ten of 16 studies included subjects through age 18 18 One study of 11 patients with tuberous sclerosis had a mean age of 14, and the range of ages included was 2-35, with 2 subjects older than 19 (27 and 35).…”

Section: Analysis Of Evidencementioning

confidence: 99%

“…Children should be carefully monitored for site infection after VNS implantation. Neurology® 2013;81: [1][2][3][4][5][6][7] GLOSSARY: AAN = American Academy of Neurology; AE = adverse effect; BDI = Beck Depression Inventory; CI = confidence interval; FDA = US Food and Drug Administration; JME = juvenile myoclonic epilepsy; LGS = Lennox-Gastaut syndrome; SUDEP = sudden unexpected death in epilepsy; VNS = vagus nerve stimulation.…”

mentioning

confidence: 99%

Evidence-Based Guideline Update: Vagus Nerve Stimulation for the Treatment of Epilepsy

et al. 2013

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Epilepsy Resources and UpdatesIn 1997, the US Food and Drug Administration (FDA) approved vagus nerve stimulation (VNS) as adjunctive therapy for reducing the frequency of seizures in patients >12 years with partial-onset seizures refractory to antiepileptic medications. OBJECTIVE: To evaluate the evidence since the 1999 assessment regarding efficacy and safety of vagus nerve stimulation (VNS) for epilepsy, currently approved as adjunctive therapy for partial-onset seizures in patients >12 years. METHODS: We reviewed the literature and identified relevant published studies. We classified these studies according to the American Academy of Neurology evidence-based methodology. RESULTS: VNS is associated with a >50% seizure reduction in 55% (95% confidence interval [CI] 50%-59%) of 470 children with partial or generalized epilepsy (13 Class III studies). VNS is associated with a >50% seizure reduction in 55% (95% CI 46%-64%) of 113 patients with Lennox-Gastaut syndrome (LGS) (4 Class III studies). VNS is associated with an increase in ≥50% seizure frequency reduction rates of ~7% from 1 to 5 years postimplantation (2 Class III studies). VNS is associated with a significant improvement in standard mood scales in 31 adults with epilepsy (2 Class III studies). Infection risk at the VNS implantation site in children is increased relative to that in adults (odds ratio 3.4, 95% CI 1.0-11.2). VNS is possibly effective for seizures (both partial and generalized) in children, for LGS-associated seizures, and for mood problems in adults with epilepsy. VNS may have improved efficacy over time. RECOMMENDATIONS: VNS may be considered for seizures in children, for LGS-associated seizures, and for improving mood in adults with epilepsy (Level C). VNS may be considered to have improved efficacy over time (Level C). Children should be carefully monitored for site infection after VNS implantation. Neurology® 2013;81:1-7 GLOSSARY: AAN = American Academy of Neurology; AE = adverse effect; BDI = Beck Depression Inventory; CI = confidence interval; FDA = US Food and Drug Administration; JME = juvenile myoclonic epilepsy; LGS = Lennox-Gastaut syndrome; SUDEP = sudden unexpected death in epilepsy; VNS = vagus nerve stimulation.

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“…Sixteen Class III studies were identified regarding the efficacy of VNS for seizure treatment in children (see table e-1 for study details). [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] This group of studies included 2 reports of patients with tuberous sclerosis 16,17 and one report of patients with Dravet syndrome. 18 Ten of 16 studies included subjects through age 18 One study of 11 patients with tuberous sclerosis had a mean age of 14, and the range of ages included was 2-35, with 2 subjects older than 19 (27 and 35).…”

mentioning

confidence: 99%

Evidence-based guideline update: Vagus nerve stimulation for the treatment of epilepsy

Morris¹,

Gloss²,

Buchhalter³

et al. 2013

Neurology

353

203

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Objective: To evaluate the evidence since the 1999 assessment regarding efficacy and safety of vagus nerve stimulation (VNS) for epilepsy, currently approved as adjunctive therapy for partial-onset seizures in patients .12 years. Methods:We reviewed the literature and identified relevant published studies. We classified these studies according to the American Academy of Neurology evidence-based methodology.Results: VNS is associated with a .50% seizure reduction in 55% (95% confidence interval [CI] 50%-59%) of 470 children with partial or generalized epilepsy (13 Class III studies). VNS is associated with a .50% seizure reduction in 55% (95% CI 46%-64%) of 113 patients with Lennox-Gastaut syndrome (LGS) (4 Class III studies). VNS is associated with an increase in $50% seizure frequency reduction rates of ;7% from 1 to 5 years postimplantation (2 Class III studies). VNS is associated with a significant improvement in standard mood scales in 31 adults with epilepsy (2 Class III studies). Infection risk at the VNS implantation site in children is increased relative to that in adults (odds ratio 3.4, 95% CI 1.0-11.2). VNS is possibly effective for seizures (both partial and generalized) in children, for LGS-associated seizures, and for mood problems in adults with epilepsy. VNS may have improved efficacy over time.Recommendations: VNS may be considered for seizures in children, for LGS-associated seizures, and for improving mood in adults with epilepsy (Level C). VNS may be considered to have improved efficacy over time (Level C). Children should be carefully monitored for site infection after VNS implantation. Neurology In 1997, the US Food and Drug Administration (FDA) approved vagus nerve stimulation (VNS) as adjunctive therapy for reducing the frequency of seizures in patients .12 years of age with partialonset seizures refractory to antiepileptic medications.1 A 1999 American Academy of Neurology (AAN) technology assessment concluded that VNS is indicated for patients .12 years with medically intractable partial seizures who are not candidates for potentially curative surgical resections such as lesionectomies or mesial temporal lobectomies. The authors also recommended that patients undergo a thorough epilepsy evaluation to rule out nonepileptic conditions or treatable symptomatic epilepsies before implantation of a vagus nerve stimulator. At that time, evidence was insufficient to recommend VNS for epilepsy in young children or for seizures associated with Lennox-Gastaut syndrome (LGS). Since the 1999 AAN assessment, the FDA has approved VNS for the adjunctive long-term treatment of chronic or recurrent depression in patients .18 years who are experiencing a major depressive episode and have not had an adequate response to 4 or more adequate antidepressant treatments.1 Moreover, there are new reports of long-term efficacy and VNS use in pediatric epilepsy and other seizure types and syndromes. We evaluated this evidence using the AAN guideline methodology.

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Vagus nerve stimulation in pediatric intractable epilepsy: a Korean bicentric study

Cited by 33 publications

References 10 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

Evidence-Based Guideline Update: Vagus Nerve Stimulation for the Treatment of Epilepsy

Evidence-based guideline update: Vagus nerve stimulation for the treatment of epilepsy

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