Transcript of the Surgical Procedure

NARRATOR
Approximately 1% of children in the United States have some form of epilepsy. You are
about to see a vagus nerve stimulation, a safe and effective treatment for children with
uncontrollable seizures who do not response to medication.

FREDERICK BOOP, M.D.
It works for all different types of seizures and particularly the kids who have bad
seizures, like what we call status epilepticus, the seizures that go on and on and end up
causing kids to be admitted to the hospital and so forth.

NARRATOR
Today’s procedure will be performed by neurosurgeons at LeBonheur Children’s Medical
Center in Memphis, TN. During this webcast you may email questions to the OR by
clicking the MDirectAccess button on the screen.

STEPHANIE EINHAUS, M.D.
Good afternoon. Welcome to a live internet broadcast from LeBonheur Children’s
Medical Center in Memphis, TN. You are going to be watching a live surgical procedure
performed on a young child for the implantation of a vagus nerve stimulator for epilepsy.
My name is Dr. Stephanie Einhaus and I am a pediatric neurosurgeon with Semmes
Murphy Clinic. I will be your moderator and explain the procedure as we go, and taking
internet questions which you can email to us during the procedure and we will answer
them. If you look on the website, there’s a link there to email questions in. Our surgeon is
Dr. Frederick Boop, who is Chief of Pediatric Neurosurgeon at LeBonheur Children’s
Medical Center and also a member of Semmes Murphy Neurologic and Spine Institute.
Dr. Boop, would you like to introduce the staff?

FREDERICK BOOP, M.D.
Good afternoon. With us is Scott Waddell and Mark Arcarus, with anesthesia. We have
Leroy Woods here, surgical tech. Nicki Friedman. This is a young 9-year-old who has a
history of a genetic disorder called tuberous sclerosis or what was formerly called
Bourneville’s disease. This is a disorder that we think he inherited from his father. It’s a
disorder that’s associated with severe seizure disorder. He has had seizures for a number
of years. Now, despite being on three different medicines, he’s having daily staring spells
and his parents also recognize some spells during sleep at night, where he probably has
some seizures while he’s asleep. Since his seizures haven’t been controlled medically,
we’ve recommended this vagus nerve stimulator to try to improve his seizure control. So
what you’ll see here is there will be two incisions. One is an incision on the skin of the
chest, where we’ll make a pocket under the skin for the stimulator, which is about the
same size as a pacemaker for the heart. We’ll also have another incision here, to the left
of the midline in the neck, where we can dissect down to the vagus nerve and wrap these
electrodes around the nerve and then connect them underneath the skin to the pacemaker,
where it can then stimulate the nerve.  I’m going to go scrub while we get ready.
 
STEPHANIE EINHAUS, M.D.
We’ll give you a little information about LeBonheur. LeBonheur is a children’s hospital
in Memphis, TN, that treats about 130,000 children every year. We have 42 pediatric
specialties here at LeBonheur and there are more than 500 physicians on the medical
staff. Children are referred to us from all over the United States and many foreign
countries. We have an excellent neuroscience center. We treat approximately 1,500
children here every year. We have a brand new 20-bed neuroscience unit with a 4-bed
step-down unit. Our nursing staff is excellent and the care is world class here. We have a
5-bed epilepsy monitoring unit also at the hospital, with advanced monitoring equipment.
We also have one of the largest brain tumor programs in the world. I’d like to mention
that we also have a comprehensive epilepsy center here that this child is participating in
its program and this is one of the procedures that we do, which is vagus nerve
stimulation. I’d like to explain that to you just a little bit while we’re getting the patient
ready. What vagus nerve therapy is, which is abbreviated VNS therapy, is a small
pacemaker device that gets implanted into a patient and it’s sort of like a pacemaker. It
has a little battery that constantly delivers small electrical impulses to a nerve that is in
the neck. That’s what the vagus nerve is. It’s a big nerve in the neck and it delivers
impulses toward the brain on a continuous basis. The frequency of the impulses, the
strength of the impulses, can be all programmed by the neurosurgeon or neurologist
taking care of the patient and it all can be controlled. It’s very effective therapy and it’s
been a real breakthrough for the treatment of epilepsy. It’s been on the market since 1997
and over 30,000 patients have been implanted, worldwide, with vagus nerve stimulators
now. There’s been probably 4,800 patients that have been treated under the age of 12.
One of the benefits of this type of therapy is that the patient or the patient’s caregivers
have some control over the device. It does automatically fire however the surgeon or the
neurologist sets it, so it’s not that it senses a seizure and then goes off. It’s automatically
delivering impulses however the surgeon sets it, or the neurologist, whether it’s once an
hour, once every 30 minutes, etc., but the nice thing is that the patient or the caregiver has
a magnet that they can swipe across the device. If, for example, the patient knows or can
feel the seizure coming on, then they can use this magnet, swipe it across the device
that’s underneath the skin, and it will automatically cause the device to trigger. This is
very powerful. It can sometimes stop the seizure from actually occurring. It can shorten
the seizure duration or sometimes it can make the recovery time a lot faster after the
seizure, so this is very powerful that the patient or the patient’s caregiver has some
control over the device. It’s very easy to program. It’s done in the office and you’ll see
the programming being done in surgery. There’s a special device that the doctor will hold
over where the magnet is, underneath the skin, and then it electronically sends signals
back and forth to program the device. Another benefit of vagus nerve stimulation is its
lack of side effects. Patients who are getting this are patients who are already refractory
to other drugs. If you can see here on the screen, at least 36%, so it’s in the green here,
the dark green, 36% of patients who have epilepsy are what we call pharmacoresistant or
they’re medically refractory to multiple drugs, so they have tried several different drugs
on the patient and they’re still having seizures. The seizures can be very disabling,
particularly to a developing child. We like to treat children early at LeBonheur, rather
than letting them have seizures for years and not doing well in school and becoming
impaired as adults, to treat them as early as possible. There’s a big trend in the United
States to do that.

At least 36% of all patients with epilepsy are not well controlled and would be in this
category of patients who would be eligible to be considered for this type of therapy. Now,
the nice thing is that, in contradistinction to medication, there are no side effects that are
cognitive. A lot of the epilepsy medications make children sleepy or they have trouble
concentrating. This does not do that, which is a big benefit of vagus nerve stimulation, so
it’s a great alternative. Sometimes it allows a child or an adult to decrease the amount of
medications that they’re on.

The efficacy rate of vagus nerve stimulation is probably about 50% of patients that try
this have at least a 50% or better reduction in the amount of seizures. It’s not curative. In
a small percentage of patients, maybe 5%, it does cure their seizures, but in most patients
what we feel is that they can get at least a 50% or better reduction in their seizures
without the negative side effects of medications and that’s a big benefit to this. Any
improvement for patients in this category, where they’re resistant to multiple
medications, any benefit is certainly advantageous.

Now, here at our comprehensive epilepsy center, there are other procedures that we can
offer that can be curative, so patients that would be considered for vagus nerve
stimulation are patients that we do not feel are candidates for other procedures that may
have a higher rate of cure for their epilepsy.

It looks like they’re getting ready to start here in just a moment. On your screen now is a
picture of the device. You can see that the device, it’s hard to tell, but it’s actually pretty
small. It’s not very noticeable once it’s implanted. You can see there’s a little battery
there and then there’s a long wire that will get tunneled underneath the skin. You can see
some real small helical wires that will actually be wrapped around the nerve itself.
Here’s a close-up of what you’re going to see later, where the tiny electrodes are actually
wrapped around this nerve. Now, here’s a picture of another patient, showing a little
bigger close-up of the incisions that Dr. Boop is going to make on this child. He’ll make
a smaller incision than what’s seen here at the neck and then a small incision also that’s
just in front of the shoulder on the left hand side. The procedure is always done on the
left hand side.

It looks like Dr. Boop is getting ready to begin. I’ll go over some questions that we’ve
already received that some individuals have emailed in to us. One of the questions was
does the implant have to be replaced after a period of time? That’s an excellent question.
This is a battery. It’s really hard to say how long it’s going to last. The company says it
may last 6-8 years. Our experience here at LeBonheur is that children tend to have higher
settings. It’s usually set by the neurologist to fire more frequently, so the battery gets
used up faster, so it can last probably an average of anywhere from 3-4 years, maybe 5
years, but then, when it does run out, it’s a simple procedure to replace the battery. The
incision that he’s making now is in the neck, but all you have to do when you replace the
battery is open up the incision that’s in front of the arm and it’s a quick 20-minute
procedure to do that.

FREDERICK BOOP, M.D.
What we’re doing here is developing a pocket to put the stimulator in. This pocket sits
underneath the fatty tissue but on top of the chest muscle called the pectoralis muscle.

STEPHANIE EINHAUS, M.D.
This pocket that he’s making is where the generator or the battery is going to sit in the
patient. Again, the latest model that’s out is very thing and, really, wearing normal
clothes, you can’t see it. Now, if the patient had their shirt off or very tight-fitting
clothing, then you might see just the slightest elevation there, but it’s very cosmetic and
most people would not even know that there was anything there.

Another email question that we received, which is also a great question, is is there a spot
where the magnet has to stop a seizure? Can you swipe anywhere? Well, the magnet,
which is about 2-3” in diameter, has to be pretty much swiped where this generator is.
You just simply move it across. If the magnet is held over the device, over the generator,
and left there for several minutes, then the device actually is turned off, but the minute
you move it away from there, it’s the motion that makes the generator fire.
Now he’s making the neck incision. There’s a very thin muscle in the neck, called the
platysma, that he’s going to divide and separate before he gets to the next muscle. He will
be dissecting down to get to where the nerve is.

Another question that has been emailed in previously was do small electrical appliances,
cellular phones, or metal detectors affect vagus nerve stimulation? The answer to that is
no.

Someone has asked are there hazards of other kinds of medical treatment or tests when
someone has a vagus nerve stimulator implant? That’s also a very good question. The
answer to that is yes and no. The company recommends that a patient not undergo MRI
scanning with the device, but actually we have done that and it’s okay. We’ve turned the
device off and had the patient get an MRI scan. It does not damage it. Then we simply
reprogram it after the MRI is completed. Also, if a patient is going to have another
surgical procedure with the device in place, it is recommended that the device be turned
off for the surgical procedure and then restarted and reprogrammed once the surgical
procedure is over. That would be surgery for something else.

What he’s preparing to do now is basically dissect through tissue planes in the neck to
find the area where the nerve is. It lies right next to an artery and a vein, which makes it
very easy to identify.

We’ve also been asked does vagus nerve stimulator therapy cause sleep disturbances?
The answer to that question is no, it does not. I can sometimes affect a patient’s speech,
particularly if the amplitude or strength of the signal is a little bit on the high side. Again,
the patient has control over that, so let’s say you have this device and you want to give a
speech or you have to sing in church or something and you know that when the device
triggers, you can feel a little tingling or it makes your voice quiver, which can happen,
the great thing is that you can place the magnet and just tape it over the generator and
actually turn the device off if you feel that’s necessary. You can give the speech or sing
and then turn it back on again and it automatically goes back to the mode that it was set
in.

Remember, this is a live broadcast and if you would like to email questions, there is a
link that you can click onto to send us questions. Please feel free to do that.

FREDERICK BOOP, M.D.
What we’re doing here is we’ve opened the neck and this is the sternocleidomastoid
muscle, which is one of the neck muscles, here. Leroy is holding the fascia over the
trachea and we’re dissecting down between these two to what’s called the carotid sheath.
The vagus nerve runs right between the carotid artery and the jugular vein, so that’s
where we’re going to look for it and try to dissect it out, but we need 3-4 cm of that nerve
in order to be able to have our electrodes wrapped around it. This is where we just have
to take our time and go slowly and try to use meticulous hemostasis so we can see
everything we need to.

STEPHANIE EINHAUS, M.D.
Another question that has been asked is what happens after the surgery? The patient will
go to the recovery room and spend 45-60 minutes there. Once the patient is fully awake,
he’ll go back to his room. Sometimes this can be done as an outpatient procedure,
particularly in adults. They can go home in a few hours. Our children we tend to keep
overnight, again just as a precaution, and they can go home the first thing the next
morning.

I believe that Dr. Boop is going to turn the stimulator on during surgery. Sometimes the
surgeon elects not to turn it on and to have a neurologist turn it on 1-2 weeks later. Then
they will go through what’s called a ramp-up period with the treating doctor with the
stimulator. They’ll first set the stimulator on a very low setting, that it will go off and you
can’t detect it, can’t really feel it in the neck. It’s a very low setting. Then, over several
months or even years, they will continue to try and adjust the settings so they get the
maximum seizure control, so it’s just like a medication. They’ll make a small adjustment
and then wait and see how it affects the patient. The really great thing about this is we
now have long-term outcome data for patients with vagus nerve stimulators, that have
had them for over 10 years. The really neat thing we’ve seen is that patients still get
benefit, even 10 years later. I think people were nervous that what would happen is that
the device and the electrodes would become scarred and you’d lose efficacy over time,
but that’s not what’s been shown in the studies. It still can work years later. In fact, it can
continue to give increasing benefit with time.

In general, this is a fairly straightforward, low risk procedure. Probably the biggest risk of
the procedure is infection, which again is very small. We take a lot of precautions to
make our infection rate very low.

Another question that I’m frequently asked by parents is what kind of sporting events and
activities can the child or adult do later? Probably most of us recommend that the patient
should not participate in contact sports, but other than that, they’re allowed to do
whatever they like. This would include soccer. Soccer is really not a contact sport. The
only thing we’d probably really restrict is football. They can lead pretty normal lives with
the device.

Again, you’re watching a live internet broadcast of a surgical procedure of a vagus nerve
stimulator implant on a child at LeBonheur Children’s Medical Center, being performed
by Dr. Rick Boop. Looks like you’re getting close to the carotid sheath. Is that correct?

FREDERICK BOOP, M.D.
Yes. We’re dissecting over the jugular vein and we can see the carotid artery underneath.
In just a moment, our vagus nerve should start to come into view.

STEPHANIE EINHAUS, M.D.
This will be what you’ll be seeing fairly shortly, with the vein and the artery next to each
other and the nerve close by.

Another question that parents always ask is how does this thing work, as far as what
effect is it having on the brain? We know a lot, but the truth is we don’t know exactly
how it works. We know that it delivers impulses to an area of the brain called the brain
stem, which is kind of the control center for the brain. From there, it delivers impulses to
many other parts of the brain that we know can affect seizure activity, so we know that
the vagus nerve normally has connections with wide areas of the brain, so when we send
signals back toward the brain with this device, then it can affect wide areas of the brain.
The most the person is going to feel is maybe a little tingling in their neck, if the settings
are turned up a little high, but it doesn’t change their thinking. They don’t stop talking
when it works. So it kind of continuously fires, every few minutes or once an hour or
however it’s set and the patient really doesn’t sense it at all, so it basically works silently.
The device has proven to be very reliable and safe. Again, there’s been over 4,800
children implanted in the United States with this device under the age of 12. This device,
though, can be placed in anyone, both adults and children.

Again, feel free to click on the link and email us any questions that you might have
during this live procedure.

Another question that’s frequently asked is if you have this done, does this preclude you
from having another surgical procedure for epilepsy, like a resection of the brain? The
answer to that is no.

One of the questions that we have been emailed in is are there any side effects after
surgery in girls? The answer is no. This is done above where breast tissue is, so it doesn’t
affect their breasts at all. Again, cosmetically it’s not really noticeable. Body image is
important in children and certainly in adolescent females and males too. Again, it’s not
disfiguring to have this implanted, so there’s no special side effects that occur in girls.
There’s been no evidence that this affects hormone levels, so it should not affect puberty
or anything like that. One thing I should mention that has been beneficial in children,
particularly a lot of these children have learning disabilities. Because they’re having so
many seizures, it’s hard for them to concentrate and do well in school. Because the
device is effective and it lowers their seizures, they do better in school, their behavior
improves, and again you don’t have the negative side effects that a lot of the medications
can have and it allows them to get off, sometimes, some of the medications that were
negatively affecting them as far as side effects.

Dr. Boop, would you like to explain what you’re doing now?

FREDERICK BOOP, M.D.
This is the jugular vein here and Leroy is right next to the carotid artery. What we’re
looking at is the vagus nerve right here. We’re trying to dissect enough of it out that we
can get a little vessel loop around it so that we can hold it up and put the electrodes
around it.

STEPHANIE EINHAUS, M.D.
Dr. Boop, someone has emailed us a question about treating infantile spasms. Do you
have any experience doing that with this?

FREDERICK BOOP, M.D.
With the vagus nerve stimulator?

STEPHANIE EINHAUS, M.D.
Right.

FREDERICK BOOP, M.D.
That’s not a front line therapy for infantile spasms, but that’s a very effective treatment in
the long run for those children. Those children will often go through a number of
medications. In times past, we used to do a surgery called a corpus callosotomy for those
children, particularly if they had what we call drop attacks, which is a real ugly type of
seizure where they fall and hurt themselves frequently. I think nowadays a lot of those
kids get the vagus nerve stimulator instead or in addition to the callosotomy if they come
to surgery because that seems to afford them the best long-term function.

STEPHANIE EINHAUS, M.D.
So I think the answer to that question is yes, although again, for infantile spasms, there’s
good medical therapy that works very frequently, so if that patient becomes medically
refractory, where they’ve done everything they can with standard treatment, then yes,
they should be considered for vagus nerve stimulation.

Someone has emailed us a question, does vagus nerve stimulation help prevent seizures?
We would only do it in a patient who is having epilepsy now, having seizures, but the
answer to that is yes because what we’re talking about is how you judge whether it’s
effective or not is looking at the reduction in the number of seizures that a patient has, so
again, in our experience, the seizure reduction rate is probably at least half the patients
who get this, at least 50% or better will have a 50% or better reduction in their seizures.
Some patients have an even greater reduction in the amount of seizures that they’re
currently having. Some patients don’t have as big an effect. It is extraordinarily rare to
make a patient worse with this procedure and then there always are a few patients, maybe
5% -- that’s a small number, but it’s not 0 – who actually are made seizure-free, but
again, this is generally not considered a curative procedure. There are other procedures
out there that sometimes can be curative. I know Dr. Boop and myself both see patients
through our comprehensive epilepsy center and we always evaluate the patients to see if
they are candidates for a curative procedure.

It looks like he’s getting ready to actually put the electrodes around the nerve itself. He
has the nerve with a small red piece of tubing around the nerve. He’s holding it up out of
the wound now so you can actually see, that is the vagus nerve itself.

FREDERICK BOOP, M.D.
Our electrodes have a little spring-like device that wraps around the nerve in 3 places.
This is the hardest part of the operation, getting the electrodes around the nerve, believe it
or not.

STEPHANIE EINHAUS, M.D.
This part is actually harder than it looks. This is what I call the fiddle factor of the case.
It’s very important that these tiny electrodes, which are very small, the inner diameter of
these electrodes, which you can see on the other screen there, on that schematic, are 2 and
3 mm, depending on the size of the patient, so 2 or 3 mm, so these are very tiny. In fact,
Dr. Boop is using special glasses that actually magnify what he’s doing. He’s got one
electrode on there.

So he’s already got the first 2 electrodes on there. The last one he’s putting on there, it
looks like is the anchor, which you can see on the schematic on the other side of your
screen.

FREDERICK BOOP, M.D.
We’ve got the electrodes in place, wrapped around the vagus nerve. What we’ll do next is
anchor them there so that if he should have a violent seizure, something more than a
staring spell, we have a way to prevent them from coming loose.

STEPHANIE EINHAUS, M.D.
In a moment here, he’s got the tiny electrodes, tiny wires wrapped around the nerve. The
nerve itself, if you can see it, is only about 3 mm thick, so it’s fairly small. That nerve has
a lot of different functions. It has to do with stomach function, mobility of your intestines,
although remember that the impulses are not going down that way, so it does not affect
the stomach acid or function. It also, on the other side of the body, has some fibers that
go to the heart. That’s why we stay on the left hand side. So what you’re seeing him do
now is this is a small piece of Teflon that he’s going to use to anchor the electrodes to
this area. He’s going to put a little loop in the electrodes, so when the patient turns their
head, it will not pull on the nerve. So we have a little loop in there and this will anchor it
to that so that with activity it doesn’t slide around or move. It will kind of scar in place,
but this little loop, called a strain relief loop, is something he’s putting in there right now.
You can see that on the other screen here, a picture of the little loop and little piece of
Teflon he’s using to actually anchor it to the tissue. Again, all of this is underneath the
skin and it cannot be felt by the patient.

We’ve had another email question about the magnet. The device itself, the generator, is
where the magnet needs to be swiped over. So that’s in front of the shoulder. So you just
basically move it around there and it will only fire however you program it, so if you
keep putting it back and forth, it’s only going to fire one time. If it’s been programmed
that the magnet is only effective once an hour, then that’s all it’s going to be effective for,
is to make it trigger and fire an impulse once an hour. When it’s moved across the skin
over where the generator is, and the patient can feel the generator, if you push hard
enough, underneath the skin. So could a family member or friend. So the magnet just
needs to come basically over that and there’s an electronic switch in the generator that
gets triggered by the magnet because there’s only a small amount of skin between the
magnet and the generator. Okay, now he’s getting ready to make a tunnel between the
two incisions. He’s going to be bringing the wires from the neck incision to the incision
in front of the shoulder. Again, patients who are felt to be candidate for this procedure are
patients who have had medically refractory epilepsy. That generally means that patients
who have had epilepsy for at least a year or two, have tried several medications, have had
good drug levels, adequate trial, they’ve been compliant and they still don’t have
adequate control of their seizures, so again, we like to look at each patient and see if they
are a candidate for maybe another procedure that might be curative. If we don’t feel that
they are a candidate for anything else, then we would recommend vagus nerve
stimulation.

We’ve had some more email questions. Does the implant affect heart rate? The answer to
that is no. As you see, he brought it through the tunnel now and it’s coming out the
wound that’s in front of the shoulder. He’s getting ready to hook it up to the generator
battery.

FREDERICK BOOP, M.D.
This is our stimulator and we’ve programmed it on the back field with this programming
computer to contain the patient’s initials and date of surgery, so any time anyone needs to
interrogate it, that information will be stored. It also stores how often the patient uses the
device with the magnet. All that is kept as a record inside the device. So what we’ve done
is we’ve attached the electrodes out of the chest wall here. You can see there’s a little bit
of extra length here, which will allow him to grow. This fits up underneath here in this
pocket and that’s all there is to that. So we’ve got it in place here. We’ve got it anchored
with these plastic tabs. We’ve got it connected to the stimulator. Before we close, we’re
going to perform a computer test on it to make sure the connection is good and that it’s
functioning properly.

STEPHANIE EINHAUS, M.D.
The nurse is going to be helping Dr. Boop perform a test on the lead and she’s using a
very small computer. It’s kind of like a Palm Pilot that’s hooked up to an electronic
device that Dr. Boop is holding that delivers the signals to the generator to test it, so you
can see how small the little computer is now that we have. So now the device is being
tested to see if everything is hooked up properly and that the connections between the
wires and the nerves are good.

FREDERICK BOOP, M.D.
Everything’s working fine. If you’ll hit Menu for me, Nicki, then hit Exit Diagnostics and
hit Interrogate Device and hit Start Interrogation, we’ll make sure it’s taking all of the
information that we’ve programmed into it properly.

STEPHANIE EINHAUS, M.D.
Again, back to that heart rate question, that’s why we put the device in the left hand side,
because there are not really any fibers that go to the heart on the left hand side, so it does
not affect the heart at all. That’s why we never put it on the right hand side, because there
are more fibers to the heart on the other side, so it does not affect heart rate at all in
patients.

Dr. Boop, someone has asked us how old this child is and how many seizures this child
has been having. Can you comment about how old this child is and how many seizures?

FREDERICK BOOP, M.D.
He’s 9 years old. He has staring spells every day and his family says they hear him make
noises at night oftentimes that make them think he’s having some seizures during his
sleep at night, but he’s not had any of the bad grand mal seizures, if you would, since
he’s been on three different medications, but the medications make him tired a lot, make
it hard for him to concentrate at school and that sort of thing.

STEPHANIE EINHAUS, M.D.
So now he’s pretty much done. He’s going to be closing the incision now. Basically he
closes the skin on the front of the shoulder, which he’s working on now, the incision in
the neck. He’ll close the muscle that he had divided earlier, the platysma, and then he will
close the skin there. Here’s a close-up of what you saw some of when he actually
wrapped the small wires around the nerve itself.

Someone has asked us what kind of anesthesia is being used. This procedure is being
done under general anesthesia, so the patient is completely asleep. He’s not feeling any
pain and will have no memory at all of the procedure.

Another question is what is the risk of nerve damage from the procedure? That’s a very
good question. It’s actually very small. This procedure is primarily performed by
neurosurgeons, so this is an area that we work in all the time and are very familiar with
the anatomy and the nerves. We are used to handling the tissues and the nerves and so
forth very delicately, so the risk of actually cutting the nerve is extraordinarily small,
particularly in the hands of a neurosurgeon. If there’s any effect at all on the nerve, very
occasionally a patient can have a little bit of hoarseness after the procedure, but that
generally will go away within a few days to a few weeks. Again, that is very uncommon.
The chances of there being some more permanent damage are very small and what that
would be would be the nerve...there’s one nerve on each side of your neck and another
function of this nerve, a branch of it, has to go to one of the vocal cords, so if the nerve
were damaged, it could affect your vocal cord and give you permanent hoarseness, but
again, that is an exceptionally rare event after this procedure.

Someone has asked what is the cost of the procedure and does private health insurance
and/or Medicaid generally pay for the charges? It is a very expensive procedure, but both
private health insurance and Medicaid do pay for the procedure. It frequently takes
several letters back and forth between the surgeon or the neurologist and the insurance
company, but because this is an FDA-approved procedure, we almost always get it
approved for patients and it gets paid for by the insurance company, whether it’s private
or Medicaid.

One of the things that we sometimes have to remind the insurance company is that the
patients who we are doing this on is patients that are having frequent seizures. It’s
affecting their life negatively and often these patients are people who end up coming back
and forth to the emergency room a lot. Of course, that’s very expensive, when they have
seizures that are out of control, so if we can do anything to bring their seizures under
control and give them a better quality of life, again in the long run that’s actually
beneficial in a cost way to the insurance company and they realize that.
So he is closing the skin now of the skin incision.

FREDERICK BOOP, M.D.
All of our stitches are going to be dissolving stitches underneath the skin so he doesn’t
have to worry about coming back to have stitches removed, which in a child is a
traumatic experience.

STEPHANIE EINHAUS, M.D.
If you’re wondering what other procedures are available for epilepsy, I think we can talk
a little bit about that. At the beginning of the program I mentioned that we have a
monitoring unit as part of our neuroscience center. What that is is that we have rooms
that are dedicated to monitoring patients with epilepsy. They come in, they may stay here
overnight or for 2-3 days, and the first stage would be to connect them to an EEG
monitor, which monitors their brain waves. Then we also have a video camera in the
room and there’s somebody that’s monitoring this 24 hours a day. So we capture,
electronically, what’s going on with the patient’s brain for the brain waves and then what
they are doing when they have a seizure. They have a little button that they can press or a
family member can press when the patient has a seizure and that can help us identify
what kind of syndrome they have, perhaps, what kind of seizures. There are many
different kinds of seizures. He mentioned staring spells, like this child has. There are
seizures that are drop seizures, where the patient actually falls down and can injure
themselves. There are grand mal seizures where patients jerk both sides of their body.
There are partial seizures where maybe just one side of their body jerks but they are
actually still conscious. There are complex partial seizures, where the patient has some
staring spells and they lick their lips or pull at their clothing and may or may not go
further into a grand mal seizure, so in categorizing their seizures, it is very important to
choose what kind of medication to use, for example. Then, if we find that the medications
are not working, we would do some imaging of the patient’s brain. That’s usually done
already, beforehand, to look and see if we can find something that might be wrong with
the brain, either developmentally or a tumor, to see if there’s something surgical that we
can do in the beginning to try and cure them from their seizures. There’s a particular kind
of seizure that’s called temporal lobe epilepsy that’s fairly common. We see that in
children as well. It’s very common in adults. That’s what’s called a focal epilepsy. That
means the seizures are being generated from a particular area of the brain and that’s the
whole goal of what we do as epilepsy surgeons is to try to look for that area in the brain
that is generating the seizures. Now, some patients don’t have just one area; it’s coming
from multiple areas. Again, they would be a candidate for a different procedure,
including vagus nerve stimulation, but if we can find a patient with a seizure coming
from just one area, for example a place like the temporal lobe, then they would go to
further testing. We can identify what part of the temporal lobe it’s coming from and then
we do further testing to find out would the patient have side effects if we removed that
area of tissue in the brain. It could be temporal lobe or could be other parts of the brain,
frontal lobe, etc. We can actually test what function is present there and predict fairly
reliably if the patient can actually have that section of brain cut out without any side
effects and actually give them seizure cure. That’s always our goal, to try and cure a
patient whenever we can.

Someone emailed us a question. What is the distance between the two incisions? Dr.
Boop, could you answer that?

FREDERICK BOOP, M.D.
Probably 5 inches, if I had to guess.

STEPHANIE EINHAUS, M.D.
Probably about 5 inches. Another question has been what effect will this implant have on
everyday activities, shaving, showering? After the incisions are healed, which is really in
about a week, patients can do pretty much whatever they want. Most of us recommend
not to do contact sports, but other than that, they can shower, drive, play basketball, go to
school, continue at work and do pretty much whatever they want, so it doesn’t limit the
patient in any way, particularly once the incisions are healed.

Someone has asked how do you know that the electrodes are being placed properly?
There’s an orientation that’s how you know the electrodes are being placed. It’s pretty
easy to do that. The top electrode is the one that goes closest to the head and that is the
one that’s furthest away from the tail of wires that go down into the device, into the
generator, so hopefully that answers your question.

Someone is asking how often will the child need follow-up visits after this procedure and
what is the greatest risk for this specific procedure? Well, the follow-up visits are a little
frequent at first. Usually the patients get seen by the surgeon within 2 weeks and then,
depending if the surgeon or the neurologist is going to manage the patient afterwards,
they’ll be seen maybe every month or 2-3 months in between. We can’t make
adjustments real fast, just like a medication, because it kind of takes time to see what the
effect of that adjustment is going to be, so every 2-3 months during the first year and then
the visits continue to get spaced out with time.

Someone has also asked if they can drive when it’s implanted. The answer to that is it
depends on if they become seizure-free. Most states have laws that you cannot drive if
you have had a seizure within the last 6 months to a year. That varies from state to state.
We’re about at the end of our broadcast here. I’d like to just wrap up and remind you that
on the website there is an action link which you can click onto if you would like to make
a referral to our neuroscience center and if you would like to have more information
about vagus nerve stimulation or other epilepsy procedures that we perform here at
LeBonheur. You can click on that link and send us an email and we will get back with
you. You will have access to this live internet broadcast for one year, so if you have
family or friends that might be interested in this procedure, you can still have access to
seeing this entire broadcast, unedited, for one year.

We want to thank you for joining us this afternoon for this live internet broadcast of Dr.
Boop performing an implantation of a vagus nerve stimulator. My name is Dr. Stephanie
Einhaus and we’ve enjoyed having you with us today. Thanks a lot.

NARRATOR
This has been a live webcast of vagus nerve stimulation therapy performed at LeBonheur
Children’s Medical Center in Memphis, Tennessee. For more information, to make a
referral, or make an appointment, click the buttons below.