Abstract:VNS is an effective treatment of refractory epilepsy and remains effective during long-term follow-up. Cost-benefit analysis suggests that the cost of VNS is saved within two years following implantation.
“…Approximately 25%-30% of patients who are deemed surgical candidates at our center undergo VNS instead of intracranial epilepsy surgery. We agree with authors from other centers 12,41 and stress that VNS-despite its apparent simplicity and safety-should be considered as a palliative treatment option for children with treatment-resistant epilepsy but only after thorough evaluation to exclude those children who may benefit from intracranial surgery.…”
Section: Study Limitationssupporting
confidence: 70%
“…6,11,12,32 Authors reported significant decreases in hospital admissions, length of stay, intensive care unit admissions, and emergency room visits and estimated that the cost of the device and implantation (roughly $10,000) can be recovered within 2-3 years after initiation of VNS therapy. 6,11,12,32 Given the long life expectancy of children, these results may translate into a significant cost savings over time.…”
ObjectThe authors undertook this study to analyze the efficacy of vagus nerve stimulation (VNS) in a large consecutive series of children 18 years of age and younger with treatment-resistant epilepsy and compare the safety and efficacy in children under 12 years of age with the outcomes in older children.MethodsThe authors retrospectively reviewed 141 consecutive cases involving children (75 girls and 66 boys) with treatment-resistant epilepsy in whom primary VNS implantation was performed by the senior author between November 1997 and April 2008 and who had at least 1 year of follow-up since implantation. The patients' mean age at vagus nerve stimulator insertion was 11.1 years (range 1–18 years). Eighty-six children (61.0%) were younger than 12 years at time of VNS insertion (which constitutes off-label usage of this device).ResultsFollow-up was complete for 91.8% of patients and the mean duration of VNS therapy in these patients was 5.2 years (range 25 days–11.4 years). Seizure frequency significantly improved with VNS therapy (mean reduction 58.9%, p < 0.0001) without a significant reduction in antiepileptic medication burden (median number of antiepileptic drugs taken 3, unchanged). Reduction in seizure frequency of at least 50% occurred in 64.8% of patients and 41.4% of patients experienced at least a 75% reduction. Major (3) and minor (6) complications occurred in 9 patients (6.4%) and included 1 deep infection requiring device removal, 1 pneumothorax, 2 superficial infections treated with antibiotics, 1 seroma/hematoma treated with aspiration, persistent cough in 1 patient, severe but transient neck pain in 1 patient, and hoarseness in 2 patients. There was no difference in efficacy or complications between children 12 years of age and older (FDA-approved indication) and those younger than 12 years of age (off-label usage). Linear regression analyses did not identify any demographic and clinical variables that predicted response to VNS.ConclusionsVagus nerve stimulation is a safe and effective treatment for treatment-resistant epilepsy in young adults and children. Over 50% of patients experienced at least 50% reduction in seizure burden. Children younger than 12 years had a response similar to that of older children with no increase in complications. Given the efficacy of this device and the devastating effects of persistent epilepsy during critical developmental epochs, randomized trials are needed to potentially expand the indications for VNS to include younger children.
“…Approximately 25%-30% of patients who are deemed surgical candidates at our center undergo VNS instead of intracranial epilepsy surgery. We agree with authors from other centers 12,41 and stress that VNS-despite its apparent simplicity and safety-should be considered as a palliative treatment option for children with treatment-resistant epilepsy but only after thorough evaluation to exclude those children who may benefit from intracranial surgery.…”
Section: Study Limitationssupporting
confidence: 70%
“…6,11,12,32 Authors reported significant decreases in hospital admissions, length of stay, intensive care unit admissions, and emergency room visits and estimated that the cost of the device and implantation (roughly $10,000) can be recovered within 2-3 years after initiation of VNS therapy. 6,11,12,32 Given the long life expectancy of children, these results may translate into a significant cost savings over time.…”
ObjectThe authors undertook this study to analyze the efficacy of vagus nerve stimulation (VNS) in a large consecutive series of children 18 years of age and younger with treatment-resistant epilepsy and compare the safety and efficacy in children under 12 years of age with the outcomes in older children.MethodsThe authors retrospectively reviewed 141 consecutive cases involving children (75 girls and 66 boys) with treatment-resistant epilepsy in whom primary VNS implantation was performed by the senior author between November 1997 and April 2008 and who had at least 1 year of follow-up since implantation. The patients' mean age at vagus nerve stimulator insertion was 11.1 years (range 1–18 years). Eighty-six children (61.0%) were younger than 12 years at time of VNS insertion (which constitutes off-label usage of this device).ResultsFollow-up was complete for 91.8% of patients and the mean duration of VNS therapy in these patients was 5.2 years (range 25 days–11.4 years). Seizure frequency significantly improved with VNS therapy (mean reduction 58.9%, p < 0.0001) without a significant reduction in antiepileptic medication burden (median number of antiepileptic drugs taken 3, unchanged). Reduction in seizure frequency of at least 50% occurred in 64.8% of patients and 41.4% of patients experienced at least a 75% reduction. Major (3) and minor (6) complications occurred in 9 patients (6.4%) and included 1 deep infection requiring device removal, 1 pneumothorax, 2 superficial infections treated with antibiotics, 1 seroma/hematoma treated with aspiration, persistent cough in 1 patient, severe but transient neck pain in 1 patient, and hoarseness in 2 patients. There was no difference in efficacy or complications between children 12 years of age and older (FDA-approved indication) and those younger than 12 years of age (off-label usage). Linear regression analyses did not identify any demographic and clinical variables that predicted response to VNS.ConclusionsVagus nerve stimulation is a safe and effective treatment for treatment-resistant epilepsy in young adults and children. Over 50% of patients experienced at least 50% reduction in seizure burden. Children younger than 12 years had a response similar to that of older children with no increase in complications. Given the efficacy of this device and the devastating effects of persistent epilepsy during critical developmental epochs, randomized trials are needed to potentially expand the indications for VNS to include younger children.
“…42 VNS may also decrease the annual number of hospital admissions required per year, as well as epilepsy-related direct medical costs. 43 These open-label pilot studies led to the onset of multicenter, double-blind, randomized control trials for VNS in medically refractory epilepsy. 8,16,44,45 Results from these trials revealed a mean or median seizure frequency reduction of 24 -31% over 3 months of follow-up in patients receiving the high VNS treatment paradigm (i.e., VNS at therapeutic stimulatory parameters, such as 30 Hz, 30 s on, 5 min off, 500-ks pulse width).…”
Summary: Many patients with epilepsy suffer from persistent seizures despite maximal antiepileptic drug (AED) therapy. Chronic, intermittent vagus nerve stimulation (VNS) has proven to be a safe, effective option for patients suffering from refractory seizures who are not candidates for surgical resection. Although only a small minority of patients will be entirely seizure-free, VNS as an adjunct to medical therapy does appear to provide a significant amount of improvement in quality of life. Reports of antidepressant effects independent of seizure control, along with the use of multiple AEDs in the treatment of depression, has led to the investigation of VNS as a potential adjunctive treatment for major depressive disorder. Both the number of severely depressed patients refractory to available pharmacologic options and the need for repeated treatments and significant side effects associated with electroconvulsive therapy have heightened the interest in VNS for this patient population. Pilot studies of VNS for depression have shown impressive response rates; however, the effect appears to be gradual in onset, as demonstrated by the lack of a favorable response in a short-term, randomized controlled study. Investigation is thus needed to establish the potential role of VNS as an adjunctive treatment for severe depression.
“…The cost of VNS was saved within 2 years following implantation of the device in drug resistant epilepsy (Boon et al, 1999). In the same way, the treatment of IBD is estimated to be reduced with VNS.…”
Section: Questions-future For Vagus Nerve Stimulation In Inflammatorymentioning
The vagus nerve (VN), the longest nerve of the organism that innervates the gastrointestinal tract, is a mixed nerve composed of 80% of afferent and 20% of efferent fibers. The VN has anti-inflammatory properties, in particular an anti-TNFα effect through the cholinergic anti-inflammatory pathway. The VN is a key component of the autonomic nervous system, i.e. the parasympathetic nervous system. An imbalance of the autonomic nervous system, as represented by a low vagal tone, is described in many diseases and has a pro-inflammatory role. Inflammatory bowel diseases (IBD) are chronic disorders of the gastro-intestinal tract where TNFα is a key cytokine. VN stimulation (VNS), classically used for the treatment of drug resistant epilepsy and depression, would be of interest in the treatment of IBD. We have recently reported in a 6 month follow-up pilot study that VNS improves active Crohn's disease. Preliminary data of another pilot study confirm this interest. Similarly, VNS has recently been reported to improve rheumatoid arthritis, another TNFα mediated disease. Bioelectronic Medicine, as represented by VNS, opens new therapeutic avenues in the treatment of such chronic inflammatory disorders. In the present manuscript, we will focus on the interest of VNS in IBD.
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