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New Findings Regarding the Diagnosis and Management of Epilepsy

The 8th European Congress of Epileptology (ECE) was held in Berlin,Germany from September 21-25, 2008. This is one of the largest gatherings in the world of doctors focused on epilepsy, new epilepsy treatments and new research in the field of epilepsy. There were several main programs:

• Immune processes in epilepsy: basic and clinical issues
• Pharmacogenetics and pharmacogenomics in epilepsy
• Predicting the response to AEDs ( anti-epileptic drugs)
• Synaptopathies in epilepsy

Vagus nerve stimulation therapy was also discussed at this important Congress.

Dr. Paul Boon ( of Belgium) reported registry results showing that vagus nerve stimulation may be beneficial for treating generalized seizures. No details were provided in the registry on seizure syndromes; however, 50% had > 50% seizure reduction and 21% had > 90% reduction. The largest improvements in quality of life were increased alertness, decreased postictal impairment, decreases in seizure clusters, and improved mood.

These uncontrolled data are promising, although the natural course of epilepsy in these patients is uncertain in registry monitoring. The study shows, however, that vagus nerve stimulation provides a nonsedating alternative to additional AEDs for treating generalized seizures.

Cyberonics is unable to get partner for its depression therapy; vagus nerve stimulation ( VNS).

Today Cyberonics Inc., the manufacturer of the vagus nerve stimulator,  announced some very disappointing, but not surprising news:

Medical device maker Cyberonics Inc. said Wednesday it still has not found a partner for its depression system and reaffirmed its position that it will not conduct additional studies until it has found a collaborator. The company said it is now evaluating alternative actions that could help maintain regulatory approval while lowering its investment in the product.

We are in the fourth-year of FDA approval of vagus nerve stimulation therapy to treat major depressive disorder. In May of 2007, The Centers for Medicare and Medicaid Services  concluded that vagus nerve stimulation was not necessary to treat resistant depression, issued a final and binding National Coverage Decision of no coverage.

Vincent van Gogh's 1890 painting: On the Threshold of Eternity

For current VNS patients, the Company did announce "we remain committed to supporting patients and clinical partners." That is the good news. If you or a loved one currently has  the implant for depression, please do not worry. The President and Chief Executive of Cyberonics Inc.,  Daniel Moore,  has made it clear that you will continue to receive appropriate medical and clinical support.

It is also important to remember that Cyberonics is fully committed to its very profitable epilepsy business. The procedure for depression is identical to that of the procedure for epilepsy. The device is identical,  the surgery is identical and the programming of the device is identical.

Cyberonics employs over 440 people, has implanted 52,000 patients( epilepsy and depression) nationwide and has relationships with doctors in all fifty states. In the short term, this news is not really news. In the very long term, this news may ultimately be the catalyst for a much larger Company to conduct another trial for treatment-resistant depression--- a large, very well designed, double-blind, placebo-controlled with a long acute( blinded) period. Ideally I think the "blinded" portion of any future trial should be nine months.

For many patients( including me), there is a dramatic improvement in mood and depression that "kicks-in" after six months of stimulation. The design of the original trial had only an eight week fixed dosage of VNS, which apparently was one of the reasons for the  less than stellar results reported during the acute( short-term) portion of the trial. Secondly, scientists are currently researching dosing strategies as well as methods to determine appropriate patients for VNS Therapy(TM).

More on this tomorrow.

How does the new diet treatment of vagal bloc for obesity control or VBLOC may help you lose weight.

Many depression patients also suffer from obesity and are at higher risk of developing Type II diabetes. There is a new investigational  treatment for obesity called VBLOC or vagal block for obesity control.  It is a pacemaker-like device that potentially may help obese Americans drop pounds.The obesity problem in America has led to countless new weight loss strategies from low-calorie diets to drastic surgery; but now a new device falls somewhere in the middle.

(Above picture) Course and distribution of the glossopharyngeal, vagus, and accessory nerves.

The  experimental weight loss device works by slowing down digestion. Doctors first implant a device about the size of a pacemaker inside the abdomen. It sends electrical signals to block the vagus nerve, which normally helps the stomach expand to take in a meal and contract to digest it. According to Dr. James Maher, a surgeon at Virginia Commonwealth University: 

"If we're right about what the vagus nerves do, then if you can't accommodate a large meal, you get full more quickly," "If your stomach's not emptying as quickly, you don't get hungry again as quickly."

Patients wear a belt with a coil over the implanted device to turn it on. "When they take the coil off at night," Maher adds, "they're no longer treating themselves and so the nerve completely recovers during that period of time."

Doctors first implant a device about the size of a pacemaker inside the abdomen. It sends electrical signals to block the vagus nerve, which normally helps the stomach expand to take in a meal and contract to digest it.

                            

"If we're right about what the vagus nerves do, then if you can't accommodate a large meal, you get full more quickly," Dr. Maher explains. "If your stomach's not emptying as quickly, you don't get hungry again as quickly."

Patients wear a belt with a coil over the implanted device to turn it on. "When they take the coil off at night," Maher adds, "they're no longer treating themselves and so the nerve completely recovers during that period of time."

If approved by the FDA this would be a major medical breakthrough for millions of obese Americans. I will have more posts about this very important topic.

Depression, obesity and gastric-bypass surgery.

Many depession patients also are obese, a potentially life threatening illness. Currently vagus nerve stimulation is under investigation for obesity.

What is gastric-by pass surgery?

Gastric bypass surgery, sometimes referred to as a “Roux-en-Y gastric bypass surgery” or simply as a “Roux-en-Y” (pronounced Roo-en-y), is the most common type of restrictive and malabsorptive surgical procedure.

Gastric bypass surgery permanently reduces the stomach to approximately the size of a golf ball and restricts the outlet of the stomach into the small intestine. Gastric bypass surgery also involves “bypassing” a significant portion of the small intestine. The portion of small intestine used to create the bypass is referred to as the “Roux limb.” When the length of the small intestine is reduced, the absorption of calories and nutrients is also reduced, making gastric bypass surgery both restrictive and malabsorptive.

Even when performed laparoscopically, gastric bypass surgery is very invasive and has significant risks. Mortality rates vary greatly and appear to be lowest at centers with higher surgical volumes and very experienced surgeons. Gastric bypass surgery reduces the digestive system's ability to absorb calories as well as vitamins and other micro-nutrients critical to health. Individuals who undergo gastric bypass surgery have a life-long need for nutritional supplements that may include, for example, vitamin B12 injections following surgery.

The causes and mechanisms of obesity are very complex. As with most interventions, bariatric weight loss surgery should be considered as one part of the obesity solution, complemented by increased activity and wise choices regarding diet and nutrition, as advised by each individual's medical provider. New potential treatments, such as VBLOC Therapy, are currently under investigation.

Johns Hopkins surgeon threatens to withhold VNS Therapy from epilepsy patients due to potentially lower reimbursement rates for lead replacement procedure. It is pitiful.

As most people already know,  Cyberonics  markets the Vagus Nerve Stimulation system, a pacemaker-shaped device that is implanted in the chest and sends electrical signals( via leads) to nerves in the neck. The government's Medicare program, which provides health care coverage to 44 million seniors, pays for the device when it is used to treat epilepsy. Vagus nerve stimulation therapy has improved the quality of life for many epilepsy patients.

On Wednesday The Centers for Medicare and Medicaid Sercives (CMS) held a meeting regarding reducing reimbursement rates to physicians for lead replacement surgery( not the initial surgery). The surgeon is compensated quite handsomely for the implant, a 90-minute out-patient procedure.

Apparently a surgeon  from Johns Hopkins Medical said at the meeting that, if the proposed cut becomes final, he would no longer insert the VNS Therapy System in patients. In other words he would deliberately withhold a treatment that improves the quality of a patient's life. I would like to know his name and contact information. It was a pitiful and indefensible remark. If anyone knows his name, please e-mail me. This type of inexcusable behavior must be arrested as soon as possible.

We live in a wonderful world. I would recommend that this doctor re-read the Hippocratic Oath. This is my favorite part of the Oath sworn by the surgeon:

To keep the good of the patient as the highest priority. There may be other conflicting 'good purposes,' such as community welfare, conserving economic resources, supporting the criminal justice system, or simply making money for the physician or his employer that provide recurring challenges to physicians.
 

What is the priority of this surgeon from Johns Hopkins?

Epilepsy in the United States: more than 1.5% of Americans have epilepsy and suffer other illnesses such as depresssion and obesity. The number is expected to increase.

According to a report released last week by The Centers for Disease Control and Prevention (CDC), more than 1.5% of Americans have beed diagnosed with epilepsy. This  number  is likely to increase as the population ages, according to a new study published in the CDC's Morbidity and Mortality Weekly Report:

The study, the first of its kind, reports that 1.65% of non-institutionalized adults surveyed from across the country have been told by a doctor they have epilepsy or a history of epilepsy. The study looked at responses from 19 states and found 2,027 adults aged 18 years or older reported ever being told they had epilepsy.

The researchers found that adults with a history of epilepsy and active epilepsy are more likely to have other health problems, such as obesity, depression,  arthritis, and strokes; they are also are more likely to be unemployed and live in homes with low household incomes. These people are more likely to be current smokers.

According to the rsearchers, "Population-based epidemiological studies of epilepsy are important for policymakers and health-care providers to plan and provide prevention programs and appropriate care and services for those affected,"

COMMENT: I think that the above observation should apply to all chronic illnesses, especially depression. Of note, vagus nerve stimulation therapy is FDA approved for both epilepsy and major depression.

What are the components of vagus nerve stimulation surgery, a 90 minute procedure?

Vagus nerve stimulation is an FDA approved treatment for both epilepsy and major depression. But just what are the components of the implant procedure:

• A generator to provide the appropriate stimulation to the vagus nerve;
• A lead that is attached to both the generator and the vagus nerve;
• Associated equipment to assist with necessary implantation surgery;
• Equipment to assist with setting the stimulation parameters particular to the patient;
• Appropriate instruction manuals; and
• Magnets to suspend or induce stimulation manually

The implantation of the generator and lead into patients is generally performed on an outpatient basis. The battery contained in this generator has a finite life, which varies according to the model, the stimulation parameters and settings used for each patient. At or near the end of the useful life of a battery, a patient may, with the advice of a physician, choose to implant a new generator, with or without replacing the original lead.

Pulse Generator.   The pulse generator is an implantable, programmable signal generator designed to be coupled with the bipolar lead ( see below ) to deliver electrical signals to the vagus nerve. The pulse generator is a battery powered device. Shortly before or upon depletion of the battery, the pulse generator may be removed and a new generator implanted in a short, outpatient procedure.

Above picture: vagus nerve in neck, the glossopharyngeal, vagus, and accessory nerves.

1. The Model 102, 102R, DemiPulse™  and DemiPulse™ Duo VNS Therapy pulse generators, the only pulse generators the manufacturer ( Cyberonics ) currently offers in the U.S., are similar in design and manufacture to a cardiac pacemaker. The generators are comprised of one printed circuit board and a battery hermetically sealed in a titanium case. Standard components are assembled on printed circuit boards using surface-mount technology. The assembled circuit boards are then tested and mounted with the battery in the titanium case, which is laser welded. A header to which the bipolar lead connects is added and each unit is subject to final release testing prior to being sterilized.
2. Bipolar Lead.   The bipolar lead conveys the electrical signal from the pulse generator to the vagus nerve. The lead incorporates electrodes, which are self-sizing and flexible, minimizing mechanical trauma to the nerve and allowing body fluid interchange within the nerve structure. The lead’s two electrodes and anchor tether wrap around the vagus nerve and the connector end is tunneled subcutaneously ( under the skin) to the chest where it attaches to the pulse generator. The leads are available in two sizes of inner spiral diameter to ensure optimal electrode placement on different size nerves.
3. Programming Wand and Software.  The Cyberonics programming wand and proprietary software are used to interrogate the device and to transmit programming information from a handheld computer  to the pulse generator via electromagnetic signals. Programming capabilities include modification of the pulse generator’s programmable parameters (pulse width, amplitude, frequency and ON and OFF intervals) and storage and retrieval of telemetry data.
4. Tunneling Tool.   The tunneling tool is a single use, sterile, disposable surgical tool designed to be used during surgical placement of the bipolar lead. The tool is used for subcutaneous tunneling of the lead assembly between the nerve site in the neck and the pulse generator site in the chest.
5. Accessory Pack.   The accessory pack includes two resistor assemblies used to test the function of the device prior to implantation, the bipolar lead tie-downs and one hex screwdriver.

COMMENT: It all sounds very complicated for a 90-minute out-patient procedure, but it is not considered a risky or complicated surgery. For more information, I would visit VagusNerveStimulation.com

New epilepsy treatments such as vagus nerve stimulation can help treat epileptic seizures and clinical depession.

Epilepsy patients often suffer from depression. Epilepsy can affect those key areas of the brain responsible for mood and depression. Vagus nerve stimulation can help alleviate both diseases.

The main treatment options for people with epilepsy are medications, surgery and vagus nerve stimulation. The ketogenic diet is a treatment option for some children and, increasingly, for some adults. The same treatment does not work for every patient because the type and severity of epilepsy varies. Some patients can manage their epilepsy well with medication. Others may need surgery or vagus nerve stimulation.

Vagus nerve stimulation (VNS) is FDA approved to treat partial seizures in patients 12 and older. VNS can reduce seizure frequency and intensity in some patients. Approximately 30 to 50 percent of patients can be expected to have less seizure activity with VNS.

The vagus nerve stimulator is surgically implanted under the skin in the chest. The surgery requires a one-night stay only for most patients. The device is attached to a wire that is tunneled under the skin and attached to the vagus nerve in the left side of the neck (see picture).***

Picture Source: Cyberonics

The vagus nerve is part of the autonomic nervous system, which controls functions of the body that are not under voluntary control, such as the heart rate. The vagus nerve passes through the neck as it travels between the chest and abdomen and the lower part of the brain.

Vagus nerve stimulation is also FDA approved for chronic or major depression.

***Source: The Mayo Clinic

"Honey, I shrunk the Depression Business division."

We are now entering the fourth year of FDA’s final approval of vagus nerve stimulation to treat major depressive disorder.

Cyberonics continues to execute on its previously announced plan to focus primarily on the epilepsy market. From February 22^nd 2008 to April 25^th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy System™ for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.

Unfortunately, I think that universal reimbursement for non-pharmacological based treatments for mental health conditions (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away.

Only twenty-seven patients were implanted with the VNS Therapy System(TM) for TRD during the past 90-days.

We are now entering the fourth year of FDA's final approval of vagus nerve stimulation to treat major depressive disorder. Cyberonics, the manufacturer of the vagus nerve stimulator continues to execute on its previously announced plan to focus primarily on the epilepsy market.

From February 22nd 2008 to April 25th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy System^TM for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.

Unfortunately, I think that universal reimbursement for non-pharmacological based treatments (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away. Below is a painful reminder of Medicare's National Coverage Determination for vagus nerve stimulation (VNS):

"CMS (Centers for Medicare and Medicaid Services) believes almost all correctly identified depressed patients can be successfully treated for depression" [HELLO?]

"CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination:

Vagus nerve stimulation is not covered for treatment resistant depression."*