The procedure to placethe device, which is usually performed under general anesthesia on anoutpatient basis, takes about an hour. Two small incisions arerequired: one on the upper chest area for the pulse generator and oneon the left neck for the thin, flexible wires that connect the pulsegenerator to the vagus nerve. The incisions heal in one to two weeks,and the scars fade over time. The neck scar is usually located within anatural crease of the neck and is therefore not very visible.
"Thepulse generator, which is like a pacemaker, is implanted in the chestarea and sends mild pulses to the brain via the vagus nerve in theneck. A thin, thread-like wire attached to the generator, runs underthe skin to the left vagus nerve. The vagus nerve, one of the 12cranial nerves, serves as the body's 'information highway' connectingthe brain to many major organs," said Zajecka.
The devicedelivers very mild, intermittent, brief pulses to the left vagus nerve.The pulses are then transmitted via the nerve to the central nervoussystem, to specific areas in the central nervous system that controlmood, motivation, sleep, appetite, and other symptoms that are relevantto depression. Several studies have shown that VNS Therapy may modulateneurotransmitters such as serotonin and norepinephrine thought to beinvolved in mood regulation, according to Zajecka.
VNS Therapy isapproved by the Food and Drug Administration as a long-term adjunctive(add-on) treatment for patients 18 years of age and older who areexperiencing a major depressive episode and have not had an adequateresponse to four or more antidepressant treatments. VNS Therapy wasapproved for the treatment for some patients with epilepsy in 1997, andis now the first treatment specifically studied and approved fortreatment-resistant depression.
Major depressive disorder is oneof the most prevalent and serious illnesses in the U.S., affectingnearly 19 million Americans every year. Of those, 20 percent, orapproximately four million people, experience depression that does notrespond to multiple antidepressant treatments. For these people,treatment may attempts may have included psychotherapy, antidepressantmedications and sometimes electro-convulsive therapy, but they areeffective for a short while and stop working over time.
"Patientswith TRD need additional options," said Zajecka. "The availability ofVNS Therapy is an important treatment option for millions of peoplewho, until now, have not had access to a proven long-term option tocontrol depressive symptoms. It is especially important to know thatclinical study results have shown that patients achieve increasingbenefits from VNS Therapy over time and experience sustained results.Additionally, VNS Therapy is very tolerable, and side effects typicallydiminish over time." Three percent of patients in the clinical trialexperienced side effects of incision pain; voice alteration; incisionsite redness/itching, pain around the device and swelling andtenderness.
Zajecka says that in clinical studies of VNS Therapy,more than half of the patients who had experienced an average of 25years of major depressive disorder and multiple treatment trialsrealized some clinical benefit, one third of the patients had at leasta 50 percent improvement in their depression. One out of six patientswere depression-free after one to two years of treatment with VNSTherapy. Patients also reported significant improvements inquality-of-life areas, such as vitality, mental health, emotionalwell-being and social functioning.
Patients seeking more information should call (888) 352-RUSH(7874).
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