Adverse Events in Children Receiving Intermittent Left Vagal Nerve Stimulation

Murphy, Jerome V.; Hornig, Gregory W.; Schallert, Gloria; Tilton, Christie L.

doi:10.1016/s0887-8994(98)00013-7

Cited by 56 publications

(32 citation statements)

References 6 publications

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“…Children tolerate VNS, but may experience technical complications requiring repair or replacement of the device. 20 The available data support the use of the vagus nerve stimulator in patients 13 years and older. Insufficient data are available at this time to permit definitive statements regarding the relative risks and benefits of this technique in children younger than 13 years of age.…”

mentioning

confidence: 87%

Reassessment: Vagus nerve stimulation for epilepsy [RETIRED]

1999

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A July 1997 assessment of the American Academy of Neurology (AAN) Therapeutics and Technology Subcommittee reviewed vagus nerve stimulation (VNS) for epilepsy, and concluded that it was promising, but not yet established.1 Subsequent to that review, a second multicenter, randomized, controlled clinical trial has shown safety and efficacy of VNS for treatment of intractable partial seizures. Given the importance of this novel therapy for epilepsy, and the new information provided by a second major study, the Therapeutics and Technology Subcommittee requested an update on VNS. Use of VNS in epilepsy has recently been reviewed. [2][3][4] VNS uses intermittent stimulation of the left vagus nerve in the neck to reduce the frequency and intensity of seizures. Mechanism of action of VNS remains uncertain, but stimulation does not induce grossly visible alterations in the human EEG. 5 Recent studies suggest that metabolic activation of certain thalamic, brainstem, and limbic structures may be important in mediating the effect of VNS.6,7 Depletion of norepinephrine in the locus coeruleus attenuates the antiseizure affect of VNS. 8 After open-label studies, 9,10 sponsors of VNS engaged in a multicenter randomized study, named E03, 11 details of which were reviewed in the previous assessment.1 Results of the trial were positive, and the technology was considered promising, but the number of patients receiving VNS was insufficient to achieve Food and Drug Administration approval. Therefore, a second randomized, controlled, multicenter clinical trial, called E05, was undertaken. 12Update on controlled studies. The E05 study 12 of VNS evaluated 254 patients, ages 13 to 60 years, with intractable partial seizures. To be eligible, subjects had to have at least six complex partial, visible partial motor, or secondarily generalized seizures in the month before entry, and to be free from other complicating neurologic, psychiatric, or medical conditions. Individuals with prior VNS were excluded. After a 12-to 16-week baseline, the vagus nerve stimulator electrode was implanted around the left vagus nerve and connected subcutaneously to the subclavicular stimulator device. Two weeks after implantation, patients were randomly assigned to high-or lowstimulation groups. Current was increased over 2 weeks, and maintained for 3 months of treatment. The highstimulation group received stimulation with 500-µsec pulses at 30 pulses per second, on for 30 seconds and off for 5 minutes. Current was increased as tolerated over the next 16 weeks to a maximum of 3.5 mA. Patients receiving low stimulation as an active control received 130-µsec pulses at one per second, on for 30 seconds and off for 3 hours, with mA set to the point of patient perception. All patients were told that they could activate the stimulator with a hand-held magnet to produce a 30-second stimulation train at the start of a perceived seizure; however, only patients in the high-stimulation group actually received magnet-induced stimulation.The 94 patients receiving high ...

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mentioning

confidence: 87%

Reassessment: Vagus nerve stimulation for epilepsy [RETIRED]

1999

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“…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%

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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“…Murphy et al 15 reported on adverse events in 24 children treated with VNS for a total of 61 patient-years. Fracture of the stimulating lead (requiring surgical replacement) occurred in four, and malfunction of the stimulating generator module (also requiring replacement) occurred in one.…”

Section: Side Effects Of Vnsmentioning

confidence: 99%

Vagus nerve stimulation for intractable epilepsy in children

Labar

2000

Develop Med Child Neuro

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Adverse Events in Children Receiving Intermittent Left Vagal Nerve Stimulation

Cited by 56 publications

References 6 publications

Reassessment: Vagus nerve stimulation for epilepsy [RETIRED]

Reassessment: Vagus nerve stimulation for epilepsy [RETIRED]

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

Vagus nerve stimulation for intractable epilepsy in children

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