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

Morris, George L.; Gloss, David; Buchhalter, Jeffrey; Mack, Kenneth J.; Nickels, Katherine; Harden, Cynthia L.

doi:10.5698/1535-7597-13.6.297

Cited by 100 publications

(34 citation statements)

References 38 publications

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“…Using the VNS Therapy Device Tracking Database, they analyzed patients implanted with a VNS over a 24-year period for deaths and SUDEP, yielding a standardized mortality rate due to any cause of 13.3 per 1000 PY and a SUDEP rate during the first 2 years of 2.47 per 1000 PY and 1.68 per 1000 PY in years 3 to 10. These findings were previously noted in the American Academy of Neurology evidence-based guideline update on VNS in epilepsy (9). Similarly, the recent article by Devinsky and colleagues demonstrates that the standardized mortality rate due to SUDEP for patients with brain-responsive neurostimulation was 2.0 per 1000 PY over 2036 patient stimulation years.…”

Section: Long-term Surveillance Of Sudep In Drug-resistant Epilepsy Psupporting

confidence: 60%

SUDEP: When the Nightmare Becomes the Reality

Nickels¹

2018

Epilepsy Curr

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To study the incidence and clinical features of sudden unexpected death in epilepsy (SUDEP) in patients treated with direct brain-responsive stimulation with the RNS System. METHODS: All deaths in patients treated in clinical trials (N = 256) or following U.S. Food and Drug Administration (FDA) approval (N = 451) through May 5, 2016, were adjudicated for SUDEP. RESULTS: There were 14 deaths among 707 patients (2208 postimplantation years), including 2 possible, 1 probable, and 4 definite SUDEP events. The rate of probable or definite SUDEP was 2.0/1000 (95% confidence interval [CI] 0.7-5.2) over 2036 patient stimulation years and 2.3/1000 (95% CI 0.9-5.4) over 2208 patient implant years. Stored electrocorticograms around the time of death were available for 4 patients with probable/definite SUDEP and revealed the following: frequent epileptiform activity ending abruptly (n = 2), no epileptiform activity or seizures (n = 1), and an electrographic and witnessed seizure with cessation of postictal electrocorticography (ECoG) activity associated with apnea and pulselessness (n = 1). SIGNIFICANCe: The SUDEP rate of 2.0/1000 patient stimulation years among patients treated with the RNS System is favorable relative to treatment-resistant epilepsy patients randomized to the placebo arm of add-on drug studies or with seizures after resective surgery. Our findings support that treatments that reduce seizures reduce SUDEP risk and that not all SUDEPs follow seizures. The Incidence and Significance of Periictal Apnea in Epileptic Seizures.

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Section: Long-term Surveillance Of Sudep In Drug-resistant Epilepsy Psupporting

confidence: 60%

SUDEP: When the Nightmare Becomes the Reality

Nickels¹

2018

Epilepsy Curr

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“…The intermittent reduction of glottal space, which occurs during VNS activation in Ib and II laryngeal patterns, is supposed to determine obstructive respiratory events during sleep. Universally accepted VNS settings are lacking, and the mechanism of action of the VNS remains unclear …”

Section: Discussionmentioning

confidence: 99%

“…Universally accepted VNS settings are lacking, and the mechanism of action of the VNS remains unclear. 11 VNS is known to cause side effects related to laryngeal function. 9 VNS may also cause a new-onset SBD or an increase in apneic events during stimulation.…”

Section: Discussionmentioning

confidence: 99%

Laryngeal motility alteration: A missing link between sleep apnea and vagus nerve stimulation for epilepsy

et al. 2015

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SUMMARYThis study aimed to evaluate the prevalence and the relationship of sleep breathing disorders (SBDs) and laryngeal motility alterations in patients with drug-resistant epilepsy after vagus nerve stimulator (VNS) implantation. Twenty-three consecutive patients with medically refractory epilepsy underwent out-of-center sleep testing before and after VNS implantation. Eighteen eligible subjects underwent endoscopic laryngeal examination post-VNS implantation. Statistical analysis was carried out to assess an association between laryngeal motility alterations and the onset/worsening of SBDs. After VNS implantation, 11 patients showed a new-onset mild/moderate SBD. Half of the patients already affected by obstructive sleep apnea (OSA) showed worsening of SBD. All of the patients with a new-onset OSA had a laryngeal pattern with left vocal cord adduction (LVCA) during VNS stimulation. The association between VNS-induced LVCA and SBD was statistically significant. This study suggests an association between VNS and SBD, hinting to a pivotal role of laryngeal motility alterations. The relationship between SBD and VNS-induced LVCA supports the need to routinely investigate sleep respiratory and laryngeal motility patterns before and after VNS implantation. KEY WORDS: Sleep breathing disorders, Drug-resistant epilepsy, Vocal cord dysfunction.Sleep breathing disorder (SBD) appearance in patients with epilepsy who are treated with vagus nerve stimulator (VNS) was first reported by Malow and colleagues and confirmed by other authors. [1][2][3][4][5][6][7][8] The mechanisms by which VNS can induce SBD are not clearly understood. A possible explanation is based on the effects on laryngeal muscles related to VNS. 9 The aim of this study is to evaluate the prevalence of SBD and laryngeal functional obstruction after VNS implantation in order to ascertain the correlation between these two clinical issues. Materials and Methods PatientsTwenty-three consecutive patients (16 female) were recruited from the Regional Epilepsy Centre of San Paolo Hospital, University of Milan, Italy. All of the patients were affected by drug-resistant epilepsy and were taking antiepileptic polytherapy. Patients' demographics and clinical characteristics are summarized in Table S1.All patients underwent an out-of-center sleep testing (OCST) before and after VNS implantation. All patients with sufficient collaboration (18 patients) underwent postimplantation awake endoscopic laryngeal examination.VNS stimulation parameters, body mass index (BMI), and epileptologic data for each patient are reported in Table S2. OCSTAll 23 patients underwent an OCST with a portable device, Embletta (Embla, Broomfield, CO, U.S.A.), which allows measurement of thoracic and abdominal respiratory 10 Respiratory events index (REI) was used to describe obstructive sleep apnea (OSA). REI equals the ratio between apnea and hypopnea events to reported total sleep time. An REI ≥5 was chosen to define clinically significant OSA.In addition, we analyzed variation of REI in the...

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“…In a recent analysis of VNS for epilepsy treatment, several aspects of the therapy are analyzed and recommendations for it use are stated based on evidence levels of its potential benefits. 33 Data from 14 class III studies including 481 children with medication-resistant epilepsy showed that the responder rate in patients using VNS was 55%. Taking into account the data from 4 class III studies analyzing 113 patients with LGS using VNS, the responder rate was 55%.…”

Section: Vagus Nerve Stimulation (Vns)mentioning

confidence: 99%

Dietary therapy is not the best option for refractory nonsurgical epilepsy

Vaccarezza

Silva

2015

Epilepsia

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SUMMARYThe ketogenic diet (KD) is currently a well-established treatment for patients with medically refractory, nonsurgical epilepsy. However, despite its efficacy, the KD is highly restrictive and constitutes a treatment with serious potential adverse effects, and often with difficulties in its implementation and compliance. Patients on the KD require strict follow-up and constant supervision by a medical team highly experienced in its management in order to prevent complications. Other alternative treatments for patients with refractory epilepsy include vagus nerve stimulation (VNS), new-generation antiepileptic drugs (AEDs), corpus callosotomy (CC), and responsive focal cortical stimulation (RNS). In this review, we explain not only the difficulties of the KD as a therapeutic option for refractory epilepsy but also the benefits of other therapeutic strategies, which, in many cases, have proven to have better efficacy than the KD itself.

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

Cited by 100 publications

References 38 publications

SUDEP: When the Nightmare Becomes the Reality

SUDEP: When the Nightmare Becomes the Reality

Laryngeal motility alteration: A missing link between sleep apnea and vagus nerve stimulation for epilepsy

Dietary therapy is not the best option for refractory nonsurgical epilepsy

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