* Automatic Implantable Cardiac Defibrillator (Halifax Health Medical Center, Daytona Beach, FL, 2/19/2009)
Automatic Implantable Cardiac Defibrillator
February 19, 2009
Halifax Health Medical Center, Daytona Beach, FL
Welcome to Halifax Health Daytona Beach, Florida. Over the next hour you'll see the implantation of an
automated implantable cardiac defibrillator. The surgery will be performed by Dr. Hanscy Seide and
moderated by Dr. Donald Stoner. In just moments, you'll see how the implantable cardioverter-defibrillator
significantly improves the chances of survival in people at high risk for arrhythmias. You'll also discover
the precision and experience required to successfully use this technology, and Halifax Health’s
commitment to provide quality healthcare for all patients. "OR Live" makes it easy for you to learn more.
Just click on the “Request Information” button on your Webcast screen, and open the door to informed
medical care.
Welcome and thank you for joining us this evening for this very special event. My name is Matt Petkus.
I'm the Director of Cardiology here at Halifax Health. And joining me this evening is Dr. Donald Stoner,
Chief Medical Officer at Halifax Health and cardiologist; as well as Dr. Hanscy Seide, board-certified
electrophysiologist and director of our Electrophysiology Department here at Halifax Health. This evening
we're going to be discussing the implantation of a defibrillator. It’s a battery-powered implantable device
that saves patients from deadly arrhythmias in the heart. If at any point in this discussion and review of
this case, if you have any questions please feel free to send them.
Before we get into the procedure, first I'd like to talk to Dr. Stoner about the current state of cardiac
disease here in the United States. So where are we right now, Dr. Stoner, with heart disease?
Well, Matt, we're going to see tonight the implantation of a very complex, sophisticated device to save
people’s lives. But the question first might come up, why do we need this, what's the purpose, what role
does this serve in the community of health. If we look at the slides that we have here, you'll notice that
deaths from cardiovascular disease have been declining over the last decade or so. And our first thought
would be, well maybe we're all getting healthier and better, and so we just don't have as much heart
disease. Unfortunately, that’s not true.
If we look at the prevalence of heart disease in the community, as you'll see on this next slide, you're
looking at discharges from the hospital for cardiovascular disease, you'll see that although it may have
tapered off a tiny bit towards the last five years or so, it really has stayed extremely high. In fact, over our
lifetimes it’s continued increase. So we have a great deal of cardiovascular disease in the community. If
we look at the next slide we'll also appreciate the volume of cardiac disease compared to other diseases.
If you look at the top bar, represents admissions to the hospital for cardiovascular disease compared to
many other causes of illness. And if you look at the very bottom bar, you'll see neoplasms, that’s cancer.
So we all worry and think and talk about how prevalent cancer is, but if you compare it to heart disease,
there’s an enormous difference. We have much more heart disease to deal with than any other disease.
If we look at the next slide, we'll realize that about 2,400 Americans die of heart disease each year. That's
an average of virtually a person every 30 seconds. Just think about that, every 30 seconds while we're
talking, someone’s dropping dead of heart disease. It claims as many lives as the next causes, including
cancer, chronic obstructive lung disease or emphysema, automobile or accidents of all kind, diabetes --
all combined. You put them all together and we lose more people to heart disease than to all of those
other diseases included. If we talk about to women, if we talk about death from breast cancer, which
women seem to be very concerned about, approximately one in 4-1/2 women dies of breast cancer but
one of every 2-1/2 women dies of heart disease. So heart disease is a very prevalent problem in our
community.
Now when we talk about dying from heart disease, what are we talking about? There are really three
ways that people can die from heart disease. One is that a coronary artery can be occluded, blocked,
that’s a heart attack. The heart just simply ceases to function so well and within a period of hours to a day
or so the heart can cease to function to the point that you simply die. Now we try and treat that very
aggressively here, particularly at this hospital, by getting those vessels open. If somebody comes in with
a heart attack, we try and get it open and we hopefully save their lives and heart muscle. But if that fails,
or someone doesn't come to the hospital, then we end up with part of the muscle dying. And so we have
a heart that just -- just like squeezing a fist, if you were to lose a couple of fingers and try and squeeze
with three fingers instead of five you'd find that you just couldn't squeeze as well. The heart is the same
kind of muscle, so that as we get to the place where the heart becomes weaker, we have the situation
where it doesn't pump well enough to allow a person to live a normal life and eventually will die of heart
failure. That's the second way of dying. And the third way of dying is sudden cardiac death. This is the
proverbial person that was stepping off the curb and fell flat on their face dead. What happens in a case
like that is the heart, usually because of ischemia because of blockage, will begin to beat irregularly. And
so instead of pumping in a sequential fashion so that it pumps blood out it begins to pump so fast that it
doesn't even have time to relax and fill. And if it can't fill with blood, it can't pump blood out. When the
heart begins to beat fast like that, an atrial and ventricular fibrillation or ventricular tachycardia, it becomes
ineffective as a pump. The blood’s not pumped from the heart to the brain, the brain immediately shuts
down. Then you have the impression that someone just falls to the ground.
And that's that we're going to be talking about tonight. As we look at the next slide, we'll see an illustration
of ventricular fibrillation. These are the most common causes of death that we can intervene and have an
effect on. And that’s what we're going to be talking about tonight. Dr. Seide is doing to explain that to us
now.
Don, sudden death is one of the most common cause of death from heart disease. We got over 360,000
people in United State with going to die with heart disease in this year. This a yearly thing. And then 50
percent of them will be sudden death. Sudden death, even you survive to go to the hospital but survive
out of those people to be discharged, going to be a maximum of 10 percent. We see that in the big
Seattle study when the response was less than four minutes, they get the patient in the hospital even
though less than 10 percent going to survive. Is rate -- this is of men. A lot of heart diseased men are
prevalent, more -- it’s just for men to have heart disease, that mean their risk of sudden death is high.
So what are some of the symptoms that someone might feel if they're at risk for sudden cardiac death?
Sudden cardiac death, sometime if give you notice, but 99 percent of the time you don't have notice.
Sometime your first manifestation can be syncope. You have the heart disease, you have coronary artery
disease, you have dilated cardiomyopathy, you have bypass, you have a previous stent or previous MI,
your ejection fraction low, you begin to pass out or fainting. This is one of the manifestation. This is bad
arithmia. This is ventricular fibrillation [inaudible]. Number two, you can have you feel like your heart is
racing. That's a warning. You not always lucky to have those kind of warnings. And the best was to do it is
to talk to our doctor. You see a doctor. My heart is not pumping well, I have coronary artery disease, what
my chance of sudden is very high, one over three. We predict, probably say oh 35 percent going to have
it, 65 percent go to die -- to survive may be under 65. But I will not gamble in this case.
Dr. Seide you mentioned you can sometimes feel your heart pumping fast or having an arrhythmia.
People will say that it felt like my heart turned over. Is there a way that they can tell when you feel your
heart flutter? Is there a way a patient can tell whether this is a risk of sudden cardiac death, or what
should they do at that case?
I don't think they can say this is a risk at that point. If you have any issue, any symptom, go to your doctor.
Your doctor will do a couple of study for you or will refer you to a competent electrophysiologist and then
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we can evaluate. We will decide, okay this gentleman or this lady, if they qualify for those kind of
procedures.
So Dr. Seide, who’s most at risk for sudden cardiac death and who is a candidate to have this type of
defibrillator implanted?
There is a lot of study. We have Dr. Arthur Moss who’s done the mass companion study in MADIT II
around 2001-2002. When they present patient with coronary artery disease, ejection fraction less than
percent. That's the capacity of pump of the heart. The heart pump well around 55 to 65, 75 percent.
Patient with that low is no good, it will quit pumping around 55 to 70 -- to 65 percent. And in those patient
the heart is so weak, so damage, it’s getting scar, therefore below 30 percent. At that level, any tissue of
the heart can provoke this bad arrhythmia. It’s that provoking that can lead you to sudden death. You got
patient who say, “I was sleeping and I get shock, or we get patient that realize they were shock while
they're sleeping. This is the thing we're doing. This is a device there to monitor you. It’s like it’s watching
on you every second of your life. And if you have this palpitation, it shock you. Your ejection fraction is
very important. You have heart disease. You take all the mediations and your ejection fraction is still low,
you are the candidate for this kind of procedures.
Okay, well let’s go ahead and go into the procedure. And Dr. Seide, can you give us a little bit of
background on the patient that you're doing this procedure on?
This is a 64-years-old Caucasian gentleman with coronary artery disease. He’s on all the good
medication: he’s on the statin, he’s on a beta blocker, ace inhibitor, digoxin, and also aldactone, and then
the patient still, when he cannot walk less -- more than half a block. This is what we call (inaudible) class
three. What we going to do with a more advanced defibrillator is a defibrillator and (inaudible) pacer. We
try to coordinate, to synchronize the function of the heart so this patient can do some activity. We don't
expect them to run a marathon but we expect them to go to the mall, walk freely or go to the mailbox or
walk the dog. This is the quality of life we try to restore in those patients.
Okay, let’s go ahead and go into the procedure.
We starting there, the first thing we're doing, we're going to do to get access. We're going to do access on
the left subclavian vein. We don't need to open the chest. We have the monitor. We're going to see the
monitor pretty soon where we're going to advance this wire. Those are the thin wire that’s going from
there and go straight to the right atrium, that the impression of the heart. If you can see on the monitor,
this is where we go by the clavicle and go to the heart. This is minimally invasive. We expect the patient
to walk out of the hospital the next morning, with the blessing of the Lord. And we make a cut around
three centimeters and we going to go over the muscle. Some patients are too thin, they don't have too
much fat, we maybe under the muscle but not in the thoracic cage. We don't open your chest, we just go
over the chest and make it minimally invasive. We create the pocket. This is the place where the
defibrillator going to sit. Or -- there, we put some four by four in the pocket, a sponge. What we looking is
antibiotics so the patient can be sterile and at the same time, look in more stasis for this. And we
threading the wires. Those wires are very important for me. As Dr. Stoner mentioned today was talking is
a railroad to get the lead and the access to the heart. This is that we looking basically. We will thread
them to make them more accessible to us inside the pocket.
Dr. Seide, I think it’s important to realize that those wires, on the tip, are somewhat curved and very, very
soft. And, as you pointed out, this is minimally invasive. We're not cutting into the chest cavity at any point
here. This is just under the skin and the fat tissue. Those wires are inside the blood vessel that leads to
your heart that allows us access, but they're so soft that they can be moved back and forward inside the
vessel without damaging or scraping the vessel wall or causing any harm. And then when they're in the
place you want them, you're able to slide another catheter over top of them that just follows the course of
that wire, just like a monorail, to be put in the position you want it to be in.
Yeah, exactly. They have the tip -- the tip is bent and very soft. You going to see I put a suture allowing
them, is just so it prevent bleeding because we don't want a lot of bleeding in that kind of procedure. I'm
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advancing the introducer. This is a non-friction introducer because the lead we're going to use is an
acceptable size lead and it has to go into the introducer.
So this is like putting a little tunnel into the blood vessel so that now you have that tunnel to be able to put
your lead, or whatever else you want, in or out through that tunnel, is that right?
Exactly. I want access. I want to be able to be navigate it. I'm going to -- this lead has a cut on it so in the
future if we need to remove this lead, it will be easier. Tissue will go around it yes, but it will be easier to
remove. Now that I made this cut, and I'm going to put an introducer there so I can get access easily
without damaging the cut we have already made.
And, as you were just showing, the tip of that has a coil wrapped around it. You an also see it here.
This is the lead going to the heart. We basically in the superior vena cava. We going down, this is the
right atrium, we go there. And then we going to try to navigate through the tricuspid valve and begin to get
the lead into the wire. Before that, usually I remove all the introducer, everything, so I can navigate better.
There’s better traffic there. I'm in the right ventricle but I'm not in a good position. I'm going to try to bend
the lead so the lead flow through the valve. We call this tricuspid valve.
If we stop there for just a moment, perhaps we could look at a heart model and show you what Dr. Seide
is explaining right now. What’s happened is this is a heart. And if we open up the right side of the heart,
the right atrium, the upper chamber and the ventricle, the lower chamber, what Dr. Seide has done is
advanced a write through the blood vessels that come into this chamber and through the tricuspid valve is
what he’s speaking of right now. That's this valve here. And he’s able to advance a little wire and then the
pacemaker device through this tricuspid valve into the right ventricle and be able to put it against the
muscle in this right ventricle. That allows it then to give an impulse that causes this muscle to contract or
squeeze.
Exactly. This is perfectly illustrated. Next -- well the movie -- yes, at this point if you realize, we crossing
the valve. This is the valve I will keep the tip of the lead because we have a lot of trabiculation there.
There is a lot of some kind of wires, some type of bends. It’s not easy to navigate in there. We have to --
why we access it this way because there’s a lot of shadows in the heart, we don't want to get there. We --
dancing, is a ballet, putting this lead the way we want to go. You don't see the monitor, but I'm watching
the monitor. This is what I'm watching. I don't watch the patient, basically. We have an anesthesiologist
doing this job for us.
Dr. Seide, do you want to explain, you're making those leads go in all kinds of different directions. Do you
want to explain a little bit about how you're doing that?
We have -- the lead’s supposed to respond one to one talk with you. I manipulated the tip of the lead, the
back of the lead, and the I'm full aware the lead going. They have a good body, they're designed for that.
They have some braided between silicone and other type of material. That's going to give you a good
body, a good structure and then so we can put the lead where we want to go.
So the lead has a little bit of shape to itself in certain circumstances or you can choose leads that do have
some shape. And by simply twisting them or turning them, you can point the tip in different directions.
Oh, yes.
There are other things you can do as well if that’s not satisfactory.
Oh, yeah, we can shape our own wire because every case is different. Whenever you approach a patient,
you try to see the topography of the heart. Most of my patients, the heart is so enlarged, the ejection
fraction is so low, or the heart is warted. I have to figure out in the next minute or less and I'm in the heart
what need to be done, what -- I do the traditional approach and then I say, okay we have to evaluate this
thing. Let’s see.
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You just put a wire in in this case to help you be able to navigate and manipulate.
I'm looking for support. Right now I believe the lead may be in good place. I'm testing the lead. I have to
figure out couple of thing. If I have a good sensing, if the muscle in there is good because somebody said
that mean on beat. If there is tissue scar, we don't have electrical activity. And also I have to see the
impedance of this lead. This mean if there is a stent, I'm going to freeze. And also if this lead is capture,
what might capture, I have to -- how many voltage I need. I need one volt, so volt. My criteria is only 1.5
volt is acceptable.
So we're talking about little tiny amounts of electricity that if it’s delivered in the right place in good, living
muscle that not only can you sense what the heart muscle is doing, but you can also stimulate it and
cause it to contract and have control over it.
No way, man. I don't think I'm satisfied with the position the lead is in. I'm removing the lead and I'm going
to navigate again until I find the right spot. Sometimes you will -- this take time or you'll -- this what -- the
stylus is there to give you support, because without the stylus I cannot advancing my lead.
So as you say, this is a ballet. You're working, you're working also with a technician who’s standing at
your side to help control these leads. And by manipulating them, moving them backward and forward,
rotating them, turning them, moving the support in and out, you're able to steer. And I can tell you it’s a
true skill to be able to steer these devices into the proper place in the heart. Dr. Seide is very good at this.
Yes, experience is very import -- how many devices you implant, how many cases you did, that’s very
important. So you can have a very true control of it. Right now I'm testing the lead. The pacing look great,
that different from the patient, if you can see. This is the patient right now. This is the (inaudible) of the
patient and this is the pacing coming up after that. And we sutured early because we realize where we
have the lead, it was in good position. Now is the time to secure the lead in the pocket. We put some
sutures around the lead do the lead can I place. And in the future, nature will provide your stability.
You say that, but what happens, Dr. Seide, is that when you first put that lead in, you want to basically put
it in the right position, then sew it so that it doesn't move. But as you're showing there, the tip of the lead
has a somewhat porous structure to it. And that allows -- in fact it encourages -- once it’s up against the
wall of the heart for the tissue of the heart to grow right into those little pores and basically seal over, grow
right over the tip of that lead so that it becomes part of the lining of the heart, the endothelium of the
heart. Once that happens, then it’s not likely to move much at all. But it needs to be in that one position
for a while to heal.
Exactly. Well, as you see, we just put a new lead in the heart. This is the right atrial lead. We're going to
squirt a coat of sugar on it. We have to wait for that to dissolve and then we put the lead in the portion of
the heart and we're going to screw the lead in the heart. It’s like -- and then after that, we're going to put it
safely in the pocket. And in the future we expect in two to our months, tissue will grow, as you mentioned,
around the lead and then will keep the lead in place very safely so a patient can go back to golf after four
to six weeks and can go to nominal activity or lifting weights in four to six weeks.
And as they could see, you were turning, rotating the end, you were in fact rotating the whole shaft of that
device so that a tiny screw, like a wire, extends from the end of it into the tissue of the heart to hold it in
place in the atrium so that it doesn't move until it grows in place there.
Exactly. We have to give the right turn so we can avoid perforation also because the paper-thin tissue
we're working on.
Once again, skill and knowledge of how to do this is incredibly important.
You have to know where you go.
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When you talk about sudden cardiac death, do you mean that the heart just stops all of a sudden?
We talk about sudden cardiac death is a death happen with no warning. There was -- patient was sick but
we don't expect that to happen. Patient fell on the floor. If you're lucky, if you have police by you or you're
in a restaurant, or in Disney, or in Vegas in one of the casino, everybody has a defibrillator and they will
shock you and bring you back.
So generally speaking, it’s patients going into fibrillation, not being able to pump blood, and then they
pass out and then they can die if not rescued.
If blood doesn't go to your brain in five seconds you're out, you pass out.
If we know that the heart simply stopped, which can happen as well, it’s very unusual but can, if that can
be documented, a simple pacemaker will actually fix that so that the heart doesn't stop. Very few people
die suddenly from the heart stopping. They may pass out or have a syncopable episode, well we can fix
that with a pacemaker. It doesn't require a device that’s this complex to get the heart back into rhythm
and then shock it. These are much more sophisticated devices. But sudden cardiac death is almost
always a fast arrhythmia of the heart.
If you see that we're putting the third wire. This is a wire we're going to use. We use a lot of hardware
there. We have a pre-shaped catheter we're putting in the right ventricle so we can access the left side.
We do into the right, there’s a small vein down there. We're going to try to get access to that vein. It’s
called coronary sinus. There’s multiple branch. One, we're looking for the best branch to go into the left
ventricle so that we can get a good access without needed to open the chest of the patient.
Once again, before we started doing bi-ventricular devices, there was always a concern for a long time
we would like to pace both the right and left ventricle to make them work together, but in the old days you
had to actually open the chest and sew a patch over the left side of the heart because there was no way
to get from the right side to the left side of the heart without opening the chest. It’s very invasive. Until
they decided -- the heart is covered over its surface with arteries that carry blood out to the muscle and
veins that go basically alongside the arteries that carry blood back to the right side of the heart. And
someone came up the brilliant idea that, by following the vein, we could go out to the left side of the heart
and be able to put a pacing device on the let side of the heart outside the heart that would be able to
make the left ventricle squeeze, as well as the right ventricle.
Exactly. We tried to coordinate the movement of both sides of the heart. We call that resynchronization.
We have to flush the system. You see, we don't want blood to be stasis there to form clots. We flushing
the system first, we establish a line. There will be continued flow in the cannulation system. This is what
we're setting up. We take bubble out of it
Once again it is an example of the need to have a team that works together. You’ve right now got three
different wires in the heart. You’re flushing a catheter, you're going to be manipulating another and you're
at the same time monitoring all of the effect that’s going on with the patient. Now this requires and
incredible amount of teamwork.
Under the leadership of Mark in the lab and Lee and Steve, we have a great team to work with. It's at the
level of any university studying. We got some great (inaudible) like Dale working with us here in the lab.
And then this is a great place to work. I do most of my procedure here, yeah I love that.
It’s great to have a start quarterback but you have to have a star team around he quarterback. And that's
one of the reason that we get so many of the accolades in terms of outcome that we have received in this
institution.
Oh, yeah.
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Dr. Seide, there's a question from the audience about what are possible complications from the
procedure.
Possible complications, we can perforate the heart. And we can have a bad ventricle tachycardial
fibrillation we cannot get out of it. And patient can die from it. This is a very complex procedure. Mortality
is no that high. Remember we're dealing with -- usually I tell my patient I'm between you and the priests.
We're dealing with a patient with a very, very sick heart. We try to give them another chance in life,
another way to pump the heart. This is what we're doing. Those patients are not candidates for bypass.
They're not candidates for stent. The only thing you can do is just try to do something. Whenever nobody
can do nothing, they call, “Hanscy, can you see this patient?”
Let’s interrupt a second. You've just shown a very sophisticated device for guiding a catheter. Right now
you're shaping a wire.
If you see -- I'm sorry, Dr. Stoner. I get in the coronary sinus. I get a couple of bridge here. I'm using a
wire to get access to the lateral branch of the coronary sinus. This is what I'm using. It’s a wire we use
usually for angioplasty. This angioplasty wire, I'm going to use it and at the end, use the top to manipulate
that and go to the left side of heart. And then over that, after I do all the manipulation, put the lid over. I'm
rinsing the wire, manipulating them. Good luck, we get there. And then we have to dance with it and then
figure out where to put it there. And we're going to address each -- this is a great potion. This is a dream
position but we have the phrenic nerve going by. Dale is putting the lead for me over there so we can
advance it further into the heart. And we have to put it over the wire.
And once again, you're using the wire like a monorail to steer the device where you want it.
Really I want to do it, yes, because the body of the lead doesn't allow me to advance the lead by itself. It’s
a very flaccid structure. We're advancing there. We open the valve and then you will see the lead -- taking
time, you have to be very careful because you can decanulate and this is my lead I'm ready to advance
there. Once the lead get on the coronary sinus, we have to worry about at couple of things. You're going
to see further down the road where we pacing with a big difference, a great difference. But the issue, the
heart is moved so much, we're close to the phrenic nerve. Sometime we move the heart, we can change
configuration. We change a lot of things in the lead. And we still have this chomping of the diaphragma. In
the future patient, we never know if they have hiccup. After that they call us, they say they have hiccup
and then we have to make sure we don't get close to that.
Let’s perhaps illustrate a little better so that people can understand. What we're talking about is we can go
through the veins to get to the right side of the heart. And that was fairly easy, straightforward. In the old
days, there was no way to get across the septum, this muscle in the middle of the heart, to get into the left
side of the heart and take it beat, short of going through an artery, which doesn't work very well, or
opening the chest wall and sewing something over the outside of it. The advancement here came when
the realization was that the arteries and veins that go over the outside of the heart track pretty much
together. And the result is we want to get from the right side of the heart over here to the left side of the
heart over here. Instead of going through the middle of the heart and poking a hole through muscle, we
learned that we can track this vessel on the outside of the heart -- it’s very difficult, it’s like following a
maze -- and come down here and put the lead on the back wall of the heart and make this side of the
heart pace along with this side of the heart so that in fact you can make the two sides of the heart
squeeze together, which is much more effective.
Coordinate the two side of the heart. And this is what we do. We always look for the best spot. We always
look for the best position and depend the amount of voltage we use then. Sometimes we don't have a
choice. We have to use a different branch. And if we realize the branch is not working properly for the
patient, the next step will be an epicardial lead.
Okay, you want to go back to the procedure?
Yes, please.
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We are advancing the lead very well. We put it in the best position. Look at the configuration of the
electrocardiogram, it’s very nice. You see the native -- the one from the patient on the one we're placing
on the bottom. It’s look beautifully well and then this is the patient by himself right now.
Hansi, why do we look at three or four leads? You always seem to have three or four EKG’s running at
the same time.
Because we want to see how the axis, how it’s look like, where the electricity coming from. One lead may
be deceiving but when we have two or three leads, you got the better assessment what you are doing.
So if we're inside the heart, the electrical impulse goes in a direction of the heart. It doesn't spread
everywhere at the same time, it has a direction. So like taking a camera to look at a person’s face, you
can look at the person face-on or to see them really well you ma want them to turn partially to the side or
full profile.
Exactly.
We do the same thing with electricity. We are able to look at it from different directions and put together in
our mind the flow, like a river, of how the electricity is going through the heart.
Exactly, we do that also the fluoroscopic. We have the back plane equipment here and also we have
those, the fluoroscopic imaging. We call it II, image intensifier. And then we go there and we look then
different view. I'm satisfied with the lead at this point. This is a blade, a cutter, whatever you want to call it.
We're going -- this is a fairly stressful part of the procedure too because you have to be careful so you
don't dislodge your blade. Because all the work you spent hour doing, it get lost in a fraction of second
and you have to restart again.
So you’ve been working through this long tunnel and to get that tunnel off, you have to actually cut it, from
one end to the other and peel it off.
Yes. When it goes up the end of it, you cannot make it go through. You have to cut it. And this is the
second axis I got there. I'm going to cut it out. Before we do that we put a stylus inside the lead so it can
give the lead support. Remember, it's a silicone structure, it’s very flimsy, very soft. We have to give it
support.
Matt, do you want to make any comments about the equipment? We have state-of-the-art, really world
class equipment in all of our cath labs here.
Well, one of the thing that’s very important for us here is that the physicians are able to see exactly where
they're going. And so we have one of the first bi-plane flat panel detector systems installed in the state of
Florida and one of six of the first hospitals in the country to have it. So we think it’s very important here
that we have the latest technology available to the physicians to do these procedures.
I'm sorry to interrupt you, we're securing the lead again because it’s a very important process. You can
lose all those work, all this thing can be done and you losing the lead just because you don't secure it
properly. At the beginning we have to do the job, as mentioned before. Nature will do the rest for you at
this point.
And again, you notice there’s very little blood here. The pocket’s very clean. It’s been cleaned with
antibiotics. It will be flushed again as you'll see in a minute. It’s not really very large, as we can show
afterward. But this is part of the good outcome when you have a nice, tight, clean pocket like this, it’s
much less likely to get infected. We were talking about complications. Complications include infection.
That's the most serious one we have, either displacement of the leads, movement of the leads, or
infection. In a good, clean environment, sterile environment, a very clean dry pocket helps get us to that
successful outcome.
8
Our rate of dislodgement is very low. Our rate of infection, the infection really superior. Nationwide, you're
talking about one percent will not even be low -- 0.2, 0.1 percent. [
Would a patient know if their lead had become dislodged?
Sometime they know because -- most of the time they don't know because what they going -- they came
to your office after two weeks and you check it or the next morning you check, there is no capture or you
go to X-ray, you see the lead move. Sometime it’s not big dislodgement, it’s just a micro-dislodgement.
Remember those heart are very safe. You can move from good tissue to bad tissue in less than a
millimeter sometime. And if that happen you have to redo it again.
But again, the complication rate that we've had for years here has been really outstanding. And that
includes not just implantable defibrillators but our complications from catheterizations, our complications
from intervention. Matt, as you and I remember, when the rage in the medical world was stents to open
heart vessels that were impregnated with medicine to keep them open, we had to study whether we really
wanted to use them because our success rate with bare metal stents was actually better than the success
rate that they were boasting about getting with the drug-eluding stents. And we had a cardiology meeting
to discuss how we wanted to use those devices as a result, because they're costly. And even to this day,
we use far fewer drug-eluding stents than many hospitals because of the skill of our cardiologists and the
success of this team of being able to get good results without having to rely on the drug-eluding stents for
the results for us.
Right, and then there were some studies that came out earlier last year that showed that maybe some
caution was the better part of valor with drug-eluding stents.
We were so far ahead of the curve. I'm patting us all on the back a little bit here because we sensed that
we didn't want to jump on this bandwagon, we didn't want to be an early innovator. We wanted to say,
“Let’s be sure this really works because our results are so good to begin with that we can't expect to
make them much better and why should we take a chance on changing something?” And we've always
had that idea here and it’s paid off for us time and time again.
We clean the pocket, we put some (inaudible) fluid there, we clean in there. And that’s a good point.
When you go to implant to somebody, you want to know how -- where you're going, that hospital you're
going, what the rate of infection, how many device, how many experience the implanter has. That's make
a different because every case, you learning from every single case. Every patient different. There is not
a single patient the same. The topographic of their heart is different. Patient right now is very well
educated. They go to the Internet, they do their research, they call their peers and figure out where to go.
This is stationary too, are we going to you. This is a biological pacer and defibrillator that is five port and
I'll show one of them to you after the filming. And got five port. We make sure we tied the lead in the
pocket. And these are electronic system. People will ask about the rate of failure, about recall. You go to
Best Buy, you buy -- I'm not doing a commercial -- you buy an electronic TV or computer, you buy some
insurance on it. And there is risk of failure. Those, the risk of failure is lower than the usual electronic you
buy. You talking about risk also. Aspirin is a medication that save lives. Many penicillin, we have also
used as medicine. But you got every single day people die of anaphylactic reaction from penicillin or
aspirin. And these recall maybe one over 20,000 one offer 21,000 and most of them can be fixed just
reprogramming the software, redo the software, communicate with it; you don't have to reopen the chest,
you don't have to do nothing, just reprogramming. Those are very intelligent machine. They don't stop
because we don't want them to.
They are truly amazing devices because of their complexity, but as you pointed out also, because of their
utter reliability. It’s mind-boggling when you think of the number of heartbeats that go on every day. If
you're 60 beats a minute on an average and you take that through the time of two or three years, these
devices, to be able to function electively over that period of time, are truly amazing. And the outcome on
these devices we know because we've used them not for years, is phenomenal.
9
Oh, yeah. And these devices, like you got angel guardian watching on you every single minute of your
life. I go at patient who call with he get a report to there in the office. He was shocked by the defibrillator --
he has ventricle fibrillation while he was sleeping -- and then he didn’t realize that he was shocked. The
device save his lie while he was sleeping and he’s a gentleman very well functional. We putting the leads
in the pocket and the generator. We have to make sure the leads go under it can, so when the next
doctor or whoever come to replace the battery and then to change the generator, they cannot -- they can
just get to it and not cutting the leads.
I think it’s important to realize we talk about battery life and changing the battery, you don't just open the
pocket, take the generator out, open it up and put a new battery in. You have to change the whole
computer device so that the whole generator comes out and a whole brand new one goes in. And to do
that, I can tell you from reimplanting many of these devices, you really appreciate the surgeon who took
the time to coil the leads in the proper place away from the line you're going to enter again so they're not
damaged. Folding them up underneath the can against the muscle is so important.
At this point we're closing the pocket. The defibrillator was tested. We don't show too much stress, we
don't show the testing of the defibrillator on this show. But the defibrillator was tested and it worked very
well. At this point it’s the time to set -- with testing the leads. That this is the right ventricle lead, the one
on the right side we're testing. The configuration is different. We're testing at this point the left ventricular
lead. You can see what’s going on there. And at this point we're checking the right atrial lead. You see a
blue -- somebody asked maybe not that good of light, but there's a blue spot at the bottom. This is patient
-- this is the left ventricular lead we're testing at this point.
And this is very -- this device that tests is, which is right here behind us, is a very sophisticated device.
And when we first started putting in pacemakers, we would have to program to test each increment that
we wanted to test, do the test and then have to stop and then reset the computer, do another test, reset
the computer -- took hours.
[crosstalk] faster, like a microchip, is like the cell phone you have in the past, it was big thing and right
now you got a smaller cell phone and faster than --
It does everything all at one time.
Exactly, exactly. We program in those defibrillator and later on we'll talk about the way we program them.
I'm trying, the station will be shock at 21 and the first shock will come in at 165 beat per minute. Because I
mention before it’s like to the heart with the maximum predictable heart rate is 220 minus age. And then
we can take 10 from them, depend of the heat, and add 20 or 30. This is where we're going to set all. We
can use -- we doing electrophysiological study, we are do ventricle tachycardia. We notice that here is the
patient now. We don't have to shock them all the time. We elaborate on that further down. We'll elaborate
on that.
So what you're saying is, after you’ve got the device in and it’s functioning the way you think you want it
to, you actually induce the heart to be out of rhythm like it would be in the situation that would kill you.
Yes.
And then you make sure that the device is functioning, that it recognizes it and that it shocks the heart or
paces it out appropriately and then rescues the patient.
Yes, we have a backup defibrillator outside, put on the patient first. And then we induce the ventricle
afibrillation and then you -- the device at this point will recall major signal, analyzing it and shock the
patient. We use -- when you use 200 joules outside, what now use biphasic instead of monophasic 260,
only 20 or 30-20 is your maximum go through the heart. Most of the energy this person will be loss. This
is what we're going to see in most of our patients, will be shocked out of ventricular fibrillation at 10 -- 11
joules. And then we test it at the lowest we can, and than we test it again so we can reprogram the
10
defibrillator. And the patient need it, you will know it’s work because some of the colleagues said if you
cannot test it, don't implant it.
You might point out here there are many ways -- and again, it’s the skill of the cardiologist if we look at
the lead, the skill of the cardiologist -- there are many ways to make the lead function and to shock a
patient. You can actually deliver the shock through the end or through the end to the coil or the coil to the
end or from one lead to another. We'll let Dr. Seide show you that.
This is a triangle of energy we use in basically. We can use -- this is a can -- this is basically -- I don't
know if you can see it -- this is a very -- this is a very small device, basically flat. My finger is thicker than
the device basically. We put under your skin and then we try to create a triangle where we project all the
energy into the distal coil inside the heart. This is when we deliver the 11 joules, the amount of energy we
deliver into the heart so we can rescue the heart.
We've got a lot of great questions from the audience, so I'd like to try to get to some of those now if we
could. First is a question from a person named Larry. He says, “I've been diagnosed with atrial fibrillation
and flutter. I've had a valve replacement and cardioversion.” Is this procedure relevant for his condition?
At this point we have to know how much heart is pumping, the capacity of pumping. You may have atrial
fibrillation, you may atrial flutter, you may have a valve in your heart still pumping over 25 percent. The
key word, how much your heart is pumping. The fibrillation and flutter, yeah that can be managed. That
can be ablate and then that will have the heart pumped by thick -- getting rid of the fibrillation and the
flutter.
Again, I think it’s fair to say that what we're talking about tonight is the most intensive device for
intervention. We could start out with most of this by treating the patient’s general heath and medical care.
You fix the valve if the valve’s not working. You try and fix the person, if they're overweight, try and get
the weight down, control blood pressure, do all the things that help the heart to work better. Then if that's
not sufficient, you use medications. And if medications are not sufficient to keep the heart in rhythm and
pumping well, then you might choose to use different kinds of devices, or as Dr. Seide just said, you
might choose to actually go into the inside of the heart and ablate -- that means just kill -- some of the
little never pathways that can lead to an arrhythmia. The heart is made up, just like a house, it has walls --
the muscles -- it has pipes to carry the blood in and it has electrical wiring. And electrical wiring can short
or develop a short circuit. And if we can identify where that short circuit is, you can go in and basically clip
those wires so that they don't keep shorting out. So there are many different modalities to take care of a
patient who has arrhythmic heart disease. But it’s all a sequence of evaluation in advance of intervention
that requires someone who’s very knowledgeable and skilled. That's why we have the cardiologist and in
some circumstances electrophysiologists. Because it’s important to understand all of your options and
alternatives.
Why does -- can you explain why does delivering a shock to the heat restore the heart rate or restore
somebody’s heart?
Is like we reset it. We got the heat going on. There is some circuit. The scar tissue will create energy, will
make energy, electricity go slow and then shut down the main electrical system of the heart. As Dr.
Stoner said, you have electricity. You have the -- I call it the FPLA meter -- and you’ve got everything
that’s the circuit breaker and you’ve got the wire. This circuit can take over all the electrical system of the
heart and then make the heart go faster. What you do, you shock it, you produce electricity. You get in
collision with the two wave. That give you time for the load to restart again and function as usual.
So can you explain to me again, how does the device know the difference between a rapid heart rate due
to exercise or activity and a rapid heart rate that could be potentially deadly for a patient?
This is why we program. We set up the device. Before we put the computer, we don't let the computer
doing everything by itself. We set up everything. We calculate the maximum predictable heart rate for the
patient is 220 minus age. And then we can pick our 10 and at 20 to set up the defibrillator. At this point,
11
we -- or we do an electrophysiloiod study where we got the true ventricular tachycardia. We know the
cycle length or the speed of the ventricular tachycardia. When we get that, we set up the defibrillator. We
don't want -- you have a 60-years-old gentleman with a bad heart, you don't want them to go over 160
beat per minute. Something wrong if they go there. And the first thing the defibrillator do is not shocking
you. The way we program it today, we try to pace you out of it until 200, 220. If we fail and cannot pace
the patient out, then the shock come.
And it’s more comfortable for a patient if you can pace them out of it because they don't sense any
discomfort for that. They’ll feel their heart maybe fibrillating or fluttering a bit but it doesn't hurt. When you
get a shock, as Dr. Seide said, it really is a kick in the chest. Most people find it is at least uncomfortable
but you have to be reassured then that it really has saved your life. So it’s worth somebody coming up
and taking a slug into your chest to know you're going to walk away from it.
So how often could a patient expect to get or receive shocks from this device?
As I mentioned, this is -- you go on a cruise, most of the people go on a cruise on a boat. There’s a drill at
the beginning. They give you a life jacket. They say, “Okay, if something happen, you go this way, you get
the life jacket and you go to the ocean.” This is the same thing. We got this thing there for you. We don't
expect it to shock you but if you need it, it will be there or you to bring you back in alive. Sometime, as
mentioned before, you get a shock in your sleep or you was doing something and suddenly it bring you
back. Or you feel like you're going to pass out, and you’ll get shock. Is going to be here if you needed it
there. I hope you don't get shock, I hope the ATP, the anti-tachycardia pacing, will bring the patient back.
But if the shock is needed, it’s there for you. We don't expect the patient to be shock all the time.
We got a question from overseas. Actually, this one comes from Egypt. Actually the question is, what are
the indications for the use of a cardiac defibrillator in open heart surgery and what is the risk to the
phrenic nerve?
You don't use cardiac defibrillator in open heart surgery at the moment of the point of that surgery.
Remember the guideline. You have to give the patient 45 days to recuperate post-heart surgery, then
open heart surgery. Then you figure out if the ejection fraction doesn't improve after 45 days, then you put
on the defibrillator. Some patients cannot wear it because they have the bad palpitation couple of day
after surgery.
But it is worth noting that in some circumstances, going into an open heart surgery, for instance, if you
know the patient has a very weak heart. Sometimes because the heart is open and exposed, surgeons
will choose to either sew a lead on the outside of the heart and tunnel it out so that instead of having to
put it in, as Dr. Seide just did, the lead’s on the heart and it’s been tunneled through the skin so that if that
45 days goes by and you find yes, the heart really isn't pumping better, then you're going to need to put a
device in. Now you don't have to go through this whole thing again. It's already sewn on the heart or place
in the heart by the surgeon at the time of surgery. So it can sometimes be used in concert with open heart
surgery appropriately.
We've got so many questions to get to and I hope we get to most of them, if not all of them. How long do
these generators, or these defibrillators, generally last?
Go or it, Hansi.
Depend how you use it. It’s like you have a radio, battery-power radio, or cell phone. How many call you
make on it, how many the batter will be -- the duration of the battery. If you’re pacing a lot, like you're
doing or you get shocked by the defibrillator, it’s going to last two or three years, four years. But the
average life expectancy is between our to six years. With the lithium battery we have there, four to six
years you're going to have acceptable. But if you get shocked, you use a lot of energy and then the
battery even shorter.
12
And we should mention too that it’s important after you have one of these devices that you follow up with
your cardiologist and are put into a pacemaker clinic where these are checked at regular intervals, usually
about three months to begin with and then two months. And these devices, you use a wand, we call it,
that’s held over the device. It’s a telemetry device that can actually talk to the pacemaker. It tells us how
well the pacemaker is working: is it doing what it’s supposed to, how well is the battery functioning, how
much battery life. We can actually tell how long they're going to last and when they need to be replaced.
Exactly. And right now they have wireless. Most of the device. You see there is an antenna there in some
of them, and what the antenna do, you put something in your house, a transmitter and by your phone.
You can be passing by and pick up the information and transmit it to the center.
Through the telephone.
Through the telephone. And there is company right now, this big company, they have a center. When the
pacer realizes something was wrong with the patient, even the patient doesn't realize that, and then they
transmit the information to the doctor office. They make sure to call you or they send an error to your
system and you download, you see what’s going on, what happened to the patient last night. And you call
Mr. Smith. Yes, sir, you got a bad palpation. How you feel? Everything is okay? You get shock yesterday
night during your sleep. You feel okay? And the patient say, “What? I feel good. Nothing happen to me.”
But when you download the information and you see something was happened to it.
So it’s even possible that a patient’s life could be rescued by the device and they wouldn't even know it?
Oh, definitely, definitely.
Before you had mentioned it and when we were talking about complications, you had mentioned
infections. How often do you think people receive an infection from an implant?
They talk about one percent nationwide for a new implant, or around two to four percent generator
replacement. You have to be careful. This is a foreign structure you put into the body. You going to see
the body quarantine this foreign structure and put a layer of connective tissue around it, create its own
pocket, its own seal. You say, okay, you not going to my place, I'm going to quarantine you. Same thing
as a computer. This is the most intelligent machine, human being is. And then at this point, if you have an
infection, your blood flow doesn't go to the defibrillator. Sometime in the pull or in the slice pocket you can
have the infection still there after you cure there. If you have an infection, you have to remove it. This
center, we good at preventing infection. Our rate of infection, I implant more than 400 kit a year, and my
rate of infection is basically very low, maybe we have two or there a year. We got a gentleman who was
in jail and last year who tried to get out and then infect the device. We have a couple of patient, Medicare
patient, live in nursing home or some assisted living. That's not good care, they're very high risk to get
infected, those kind of device.
Are there -- Dr. Stoner, are things, once a patient’s had one of these defibrillators implanted an they go
home, are there things out in the world that could cause trouble for them? We've heard about microwave
ovens disrupting the operation. Are these things true? I mean where are we with it?
I can't shave or I'm afraid to get in front of a microwave oven. In the earliest days, and I was there to
remember some of these, some of that was true because the devices, no one realized some of the risks.
And consequently there were some problems. But they now understand the electronics and they insulate
the devices in such a way that it’s virtually impossible to disturb one of these in your skin. It is not totally
impossible. I've seen two. One was a racecar mechanic here at the track who was leaning across the
alternator of a race car, which is generating a whole lot of electricity. He actually had his chest wall up
against it and it knocked out his pacemaker and he passed out. Another was a gentleman working on a
big lawnmower. But as normal activity using electric tools or what have you, I wouldn’t advise taking a
screwdriver, an electric screwdriver or a drill and holding it right over your pacemaker. It probably wouldn’t
hurt a thing but you still would be careful. But no, by and large these are not at risk for being interfered
with. It takes a lot of external energy to be able to have this impact the cam. Now there are some things
13
you do have to be careful of. You need to make sure all of your physicians know you have a pacemaker
because we don't want to slide you into a magnetic resonance imager because that’s a huge magnet and
these are metal. And we'd hate to see you sort of stuck up against the wall of the magnet. So it does
affect your life to some extent. But by and large, people that have these implanted, after the first few
months and accustoming themselves to it, go about a total normal life, normal activities in virtually every
regard.
Generally speaking, I know we talked about battery life and how long they could last. And you had
mentioned that, you know, it depends on how much the patient needs it or how much it gets used inside
the patient by pacing or shocking the patient, but generally speaking how long could somebody expect a
device like this to last?
Four to six years. We give them a range. They can be lucky and get over that, but actually four to six
years.
You know, we were just talking about also external environments. Can you -- what about, you know, the
airport, going through safety checks at the airport?
Well, you're given a card when you have one of these. And it’s important to keep that card with you for a
host of reasons. And one of them is if you want to fly because then you go, it’s a metal device again. And
when you walk through security you'll set off the security alarms probably. And so somebody wants to
know why you did that. And if you present your card, those cards are recognized and honored very, very
clearly at security checkpoints. And you just present them, explain the situation and it does not constitute
a problem. It does not harm the device to walk through. Your only problem is setting of the alarm. The
other reason for keeping that card with you is if you were to have a medical problem and show up in an
emergency room -- say an automobile accident or something -- and somebody recognizes there’s a
pacemaker working, they may want to know is this working the way it’s supposed to be working. So we
have to know which device it is, whether it’s Boston Scientific or someone else, so that we can pick the
right computers to analyze it and know whether it’s working or not. So keeping that card and knowing
what you’ve had done to yourself is very important just like knowing what medicine you're on.
And how often did you say the patient should get checked with their device?
We usually start off at three-month intervals after they're implanted. And then, depending on the
recommendations for that specific device, eventually that goes over a couple of years down to every two
months. And we watch that until we can see that the battery life is beginning to diminish. And then
sometimes we even have patients come in every month while we're watching to determine at what point
we need to implant a new generator.
Dr. Seide, there's a lot of questions being asked about what’s the difference between a pacemaker and a
defibrillator, and understanding that difference. Some people are asking which is more powerful or which
is stronger. And in fact, is a pacemaker a defibrillator as well?
Yeah, there is a big difference between the pacemaker and defibrillator. The pacemaker, your heart go
too low, you begin to faint, to pass out, or we need to give you medication to control your heart with and
not avoid it going too low. We put a pacemaker. Pacemaker is to prevent your heart to go certain level.
It’s like there is a hurricane, your power is out, you've got to produce power for you. This is pacemaker.
The defibrillator is a more advanced pacemaker, is a combo -- pacemaker and defibrillator. What it does,
it pace your heart if needed and then at the same time monitoring your heart. If your heart go too fast, to
bring you back. This is the difference. And if you can have a pacemaker -- it’s no matter who is more
powerful than another -- is what matter is if you need it and what you need.
So Dr. Stoner, so a pacemaker, just to reiterate what Dr. Seide said, a pacemaker is for too slow?
Generally a pacemaker means you need to speed the heart up. You need to set a pace of the heart.
That's where the term comes from: pace maker, make the pace of the heart. The heat is wondrously
14
made. The good Lord knew what he was doing. We have a sinus node, as Dr. Seide referred to it, as
FPL. It keeps giving us a little jolt of electricity on a regular basis. If it forgets or gets too old or is diseased
or damaged, it may not stimulate the heart the way it’s supposed to and the heart forgets to squeeze the
way it’s supposed to. The pacemaker reminds it, puts that little jolt of electricity in and the heat beats
normally. The defibrillator, on the other hand, recognizes when the heart’s going too fast and says, “I got
to slow it down.” And it does it by literal socking it with a jolt of electricity, stunning it. It’s just like doing a
hard set on your computer. You stop everything and say, “Okay, let’s start this all over again and see if it
will go back to normal.”
You mentioned MRIs and not being able to have MRIs once you've had one of these devices implanted.
Dr. Seide, are there any other procedures a patient couldn't have once they’ve had one of these
implanted?
There is lithotripsy we try -- they try to with sound, try to break some stone in the kidney. And then we
have the stimulator, the never stimulator they use sometime for the brain or for the spinal. Those can
create noise, can create interference with the pacemaker. Before you do all those thing, you should talk to
your doctor. Call your specialist and let them know we going to do that, what should be done.
I’ve managed two patients in the past that had implantable devices in their brain for Parkinson’s Disease
or shaking where we’ve actually been managing two pacemakers at the same time. That’s very possible
that we can coordinate, do that when you work with other physicians. The nerve stimulators are a little
more of a problem sometimes. But often there are ways of working around it, around the problems. They
do make it a more complex issue that has to be dealt with.
One last question before we conclude this evening. And both of you could discuss this a little bit. If an
patient has had a defibrillator implanted, does that mean that they can just stop taking the cardiac
medicines that they've be placed on?
Oh, please don't.
That's not a good idea. No, please you have to take your medication. This is add to your -- this is additive
to what you taking. We want you to take your medication and the defibrillator is there to save your life. I
got patient, after I put it in for them for them say, “I feel so great.” And they travel, they forget to take your
-- they stop taking their medication. They feel so good, they stop taking it at all and then drop into
emergency room with heart failure. It’s something to help that doesn't replace the medication. Please,
after this procedure, don't stop taking your medication.
These all work together and sometimes it is possible to either reduce or stop some medications.
Sometimes it is, but that’s a decision that has to be made by a physician who’s monitoring it carefully and
understands all of the implications of any changes because any change can have an effect, adversely, on
the whole system.
Just want to say thank you to everybody for joining us this evening for this panel discussion and review of
the surgery. I'd also like to say thank you to Dr. Stoner and Dr. Seide for joining us this evening on the
discussion. Thank you for all the great questions out there. If you have any further questions about our
cardiology program here at Halifax, you can go to www.Halifax.org or call us at 1-877-8Halifax. Thank you
and have a great evening.
Thank you for watching this "OR Live" presentation from Halifax Health in Daytona Beach, Florida. "OR
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