Neurostimulator devices have gained traction in 2017, evidenced by regulatory developments and compelling new data highlighting their utility in the management of epilepsy.
In June, the FDA approved LivaNova’s Vagus Nerve Stimulation (VNS) Therapy Programming System, a minimally invasive treatment designed to prevent seizures before they start, in patients as young as four years of age with partial-onset refractory seizures. Several months later, the company received approval for its next-generation VNS device for drug-resistant epilepsy and its SenTiva implantable device, allowing for guided and scheduled programming.
Brain-responsive neurostimulation has also earned wider recognition for the reduction of seizures. Studies presented at the American Academy of Neurology (AAN) Annual Meeting in April offered long-term perspective on the efficacy and safety of brain-responsive neuromodulation in patients with medically intractable mesial temporal lobe epilepsy1 and in patients with medically intractable seizures arising from eloquent and other neocortical areas.2
In the October edition of Practical Neurology® magazine, Barbara C. Jobst, MD, Professor of Neurology at Darmouth-Hitchcock Medical Center in Lebanon, NH, noted that these recent advances are making surgery less daunting from the standpoint of invasiveness. She emphasized that the onus is on physicians to ensure that patients receive optimal treatment. “Given the high proportion of patients with refractory epilepsy for whom adequate care is too often delayed, it is our duty to direct patients to the appropriate providers if we cannot offer the level of care required,” Dr. Jobst wrote.
Expanded Indications for Numerous Anti-Epileptic Drugs
The therapeutic armamentarium for epilepsy was given a boost with new approvals and indications for several drugs.
Briviact (briveracetam, UCB) was approved as a monotherapy in patient’s ages 16 years and older. It is the newest antiepileptic drug in the racetam class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A in the brain.
Qudexy XR (topiramate, Upsher-Smith) Extended-Release Capsules received two new supplemental indications, for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older.
Aptiom (eslicarbazepine acetate, Sunovion) was approved in patients between the ages of four and 17 based on FDA guidance that permits the extrapolation of adult data to support pediatric use.
SUDEP in Focus
The AAN and the American Epilepsy Society have released a new joint guideline for sudden unexpected death in epilepsy (SUDEP), recommending that health professionals tell people with epilepsy that controlling epileptic seizures and seizures in general may reduce the risk of SUDEP.3 Also endorsed by the International Child Neurology Association, the guidelines were the result of a review of all available evidence showing that general tonic-clonic seizures represent a major risk factor for SUDEP.
According to Michelle Dougherty, MD, Assistant Professor of Neurology and Director of the neurology residency program at the Drexel Neuroscience Institute in Philadelphia, significant knowledge gaps remain when it comes to SUDEP and physicians should take the opportunity to educate patients and families. “Ideally, a discussion of SUDEP risk and factors that influence risk could help patients and families take appropriate steps to lower that risk wherever possible, such as adherence to prescribed anti-epileptic drugs, continuing to pursue further treatments, and avoiding known seizure triggers,” she wrote in the July/August edition of Practical Neurology® magazine.