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Although Vagus Nerve Stimulation (VNS) Therapy has been approved to treat people with focal seizures (also known as partial seizures) since 19974, there are still many common myths about how the implanted device works. For those who are interested in VNS Therapy for refractory epilepsy (seizures that don’t respond to medication) but have questions, these myths and truths shed light on the subject.
Myth: You need brain surgery to have VNS Therapy.
Truth: The VNS Therapy device is not implanted in your brain — or even in your head. The generator for the VNS Therapy device is implanted in the left side of your chest. The lead wires, which send electrical stimulation from the generator, are attached to the vagus nerve in your neck. The vagus nerve carries the impulse from the generator to areas of the brain associated with seizures. Surgery to implant a VNS Therapy device is usually done as an outpatient procedure, although some surgeons require people to stay one night in the hospital for observation following the procedure.1
Myth: You don’t need to take antiepileptic drugs (AEDs) after having a VNS Therapy device implanted.
Truth: Some people become seizure-free with VNS Therapy.5 However, VNS Therapy is an add-on or adjunct treatment for epilepsy, not a replacement for your AEDs.3 While some people are able to reduce the number and dosage of AEDs they take, you and your doctor will determine the right treatment plan for you.1
Studies have shown one in five people achieved at least 90 percent reduction in seizures after receiving VNS Therapy.6,7 In another study, half to two-thirds of participants achieved at least 50 percent reduction in seizures.6,7,8,9,10 VNS Therapy also led to fewer and shorter seizures and better recovery1 as well as significant improvements in mood and quality of life.11 Individual results will vary.
Myth: VNS Therapy works right away or not at all.
Truth: The VNS Therapy device is typically turned on two weeks after the implant procedure. During a follow-up appointment with your neurologist, they will begin the programming process to determine the right level of stimulation to help control your seizures. There is often a period of adjustment while you and your doctor work together to find the right settings for you.1
Studies show the benefits of VNS Therapy continue to improve over time. People should expect to take a few months to a year or two to experience the full benefits of VNS Therapy.1 Results will vary.
Myth: I don’t have any way to control the VNS Therapy device.
Truth: VNS Therapy works in three ways. Throughout each day, the VNS Therapy device automatically sends mild electrical pulses from the generator to the brain to help control your seizures. VNS Therapy devices equipped with the latest technology are designed to detect a rapid increase in heart rate and automatically deliver an extra dose of therapy to stop or shorten an oncoming seizure. As an optional feature to provide additional seizure control, the VNS Therapy device also comes with a small magnet you can use to manually deliver a dose of therapy if you feel a seizure coming on. You can carry the magnet in a pocket or purse, or wear it on your wrist. The magnet is used by swiping it over the area where the device is implanted.3
If you experience side effects such as hoarseness or other voice changes, sore throat, coughing, or shortness of breath, your neurologist can make adjustments to the frequency and duration of VNS Therapy, as well as its strength.12
Myth: If VNS Therapy doesn’t work for me, or if I don’t want it anymore, I have to get another surgery to remove it.
Truth: If you and your doctor decide the VNS Therapy device is not working for you, and you don’t want to use it anymore, your doctor can switch it off. If you decide you want the inactive device removed, you can opt for a minor surgical procedure to remove it.1 The most common side effects of VNS Therapy include hoarseness, shortness of breath, sore throat and coughing.1 These side effects generally only occur during stimulation and usually decrease over time.12,13 Infection is the most common side effect of the procedure.1 For full safety information, visit VNSTherapy.com/safety.
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Ready to talk to your doctor about whether VNS Therapy might be right for you? Download and print our doctor discussion guide to help facilitate the conversation about treatment options.
INTENDED USE/INDICATIONS—UNITED STATES
Epilepsy-The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.
The VNS Therapy System should not be used in people who have had the left vagus nerve cut (a left vagotomy). Anyone implanted with the VNS Therapy system CANNOT have any shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. Injury or damage can occur during diathermy treatment whether the VNS Therapy system is turned “ON” or “OFF.” Note: Diagnostic ultrasound is not included in this contraindication.
VNS Therapy carries some risks. Physicians should inform patients about the warnings, precautions, side effects, and hazards associated with VNS Therapy, including information that VNS Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients should consult with a physician before engaging in unsupervised activities, such as driving, swimming, and bathing, or in strenuous sports that could harm them or others. The safety and efficacy of VNS Therapy has not been established for uses outside of its approved indications. A malfunction of the VNS Therapy system could cause painful or direct current stimulation, which could result in nerve damage. Patients should use the magnet to stop stimulation if they suspect a malfunction, and contact their physician immediately for further evaluation. Removal or replacement of the VNS Therapy system requires an additional surgical procedure.
Patients who have pre-existing swallowing, cardiac, or respiratory difficulties (including, but not limited to, obstructive sleep apnea and chronic pulmonary disease) should discuss with their physicians whether VNS Therapy is appropriate for them since there is the possibility that stimulation might worsen their condition. VNS Therapy may also cause new onset sleep apnea in patients who have not previously been diagnosed with this disorder. MRI can be safely performed provided specific guidelines are followed. Patients should contact their physician before scheduling an MRI.
Postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias.
(AspireSR® and SenTiva® only) Physicians should be informed of any existing heart condition or active treatment for a heart condition (such as beta adrenergic blocker medications). The physician will determine if the Automatic Stimulation feature (also known as AutoStim and Detect & Respond) is appropriate for each patient.
The safety and efficacy of VNS Therapy has not been established for use during pregnancy. Patients who smoke may have an increased risk of laryngeal irritation. There is a risk of infection with the implantation surgery that may require the use of antibiotics to treat or removal of the device. The VNS Therapy system may affect the operation of other implanted devices, such as cardiac pacemakers and implanted defibrillators.
Possible effects include sensing problems and inappropriate device responses. If the patient requires concurrent implantable devices, careful programming of each system may be necessary to optimize the patient's benefit from each device. (AspireSR® and SenTiva® only) Situations, including but not limited to exercise or physical activity, that cause rapid increases in heart rate may trigger AutoStim if the feature is ON. If this is a concern, patients can talk to their physician about ways to stop stimulation during these situations. Use of the AutoStim Mode (Detect & Respond feature) and/or additional features such as prone position detection and low heart rate detection will result in reduced battery life, which may require more frequent generator replacements. (SenTiva® only) Optional time-based features do not automatically adjust for Daylight Savings Time or differing time zones.
The most commonly reported side effects are hoarseness, sore throat, shortness of breath, and coughing. Other adverse events reported during clinical studies as statistically significant are ataxia (loss of the ability to coordinate muscular movement); dyspepsia (indigestion); hypoesthesia (impaired sense of touch); insomnia (inability to sleep); laryngismus (throat, larynx spasms); nausea; pain; prickling of the skin (paresthesia); pharyngitis (inflammation of the pharynx, throat); and vomiting. These typically occur only during stimulation, are well tolerated and noticed less as time goes on. The most commonly reported side effect from the implant procedure is infection. *THE INFORMATION CONTAINED IN THIS SUMMARY REPRESENTS PARTIAL EXCERPTS OF IMPORTANT PRESCRIBING INFORMATION TAKEN FROM THE PRODUCT LABELING. THE INFORMATION IS NOT INTENDED TO SERVE AS A SUBSTITUTE FOR A COMPLETE AND THOROUGH UNDERSTANDING OF THE VNS THERAPY SYSTEM NOR DOES THIS INFORMATION REPRESENT FULL DISCLOSURE OF ALL PERTINENT INFORMATION CONCERNING THE USE OF THIS PRODUCT. PATIENTS SHOULD DISCUSS THE RISKS AND BENEFITS OF VNS THERAPY WITH THEIR HEALTHCARE PROVIDER. PRESCRIPTION ONLY DEVICE RESTRICTED TO USE BY OR ON THE ORDER OF A PHYSICIAN. Not approved in all geographies. Consult your labeling. VNS Therapy is manufactured by LivaNova USA, Inc., 100 Cyberonics Blvd, Houston, Texas, 77058. +1-800-332-1375