CARDIAC CATHETERIZATION WITH ANGIOPLASTY AND STENT PLACEMENT DEAN & ST. MARY'S CARDIAC CENTER, ST. MARY'S HOSPITAL MADISON, WISCONSIN June 14, 2007

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1 CARDIAC CATHETERIZATION WITH ANGIOPLASTY AND STENT PLACEMENT DEAN & ST. MARY'S CARDIAC CENTER, ST. MARY'S HOSPITAL MADISON, WISCONSIN June 14, :00:12 ANNOUNCER: Welcome to the Dean & St. Mary's Cardiac Center at St. Mary's Hospital in Madison, Wisconsin. Over the next hour, you'll see a cardiac catheterization with angioplasty and stent placement. When doctors need to evaluate the condition in the heart, a cardiac catheterization can provide the information they need. 00:00:30 ALAN H. SINGER, MD: The heart catheterization procedure, we take catheters, or thin hollow tubes, and we insert those via blood vessel into the heart to look at the heart muscle, the heart chambers, the valves, and the arteries to the heart. 00:00:42 ANNOUNCER: From there, doctors can measure blood pressure within the heart and get information about the pumping ability of the heart muscle. It can then be determined what further action is necessary. 00:00:52 JOHN M. PHELAN, MD: If there's blockage and people have symptoms, then we try therapies, often medical therapy or if needed, place stents to open up arteries. And if they're not a candidate for a stent because of their anatomy, then they would get a bypass operation. 00:01:08 ANNOUNCER: 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. Now let's go live to the cathlab. 00:01:24 DON LOGAN, MD: Good afternoon and welcome to the Dean & St. Mary's Cardiac Center. I am here today with my colleagues, Dr. Dan Danahy and Dr. Jane Pearson. We're going to be watching Dr. John Phelan doing a procedure in the cardiac laboratory. We hope to be joined later by Dr. Alan Singer, who is actually involved in an urgent procedure as we speak. We hope he joins us later. We are very pleased that you have chosen to join us for this -- what we hope to be an exciting program. And first a couple of little housekeeping comments. First, we will be attempting to answer all of your questions which you submit by , which you can do by clicking the MDirectAccess button on your screen. Please do so and submit your questions by . We'll hope to answer as many as we can through the time today. Second, an archive of this program will be available and posted on the evening -- this evening on the same website and will be available at a later time. So please feel free to invite family and friends to revisit this tape if you find it interesting and of value. Now let's turn things over to Dr. Phelan, who is in the cardiac laboratory with a patient. And perhaps he can bring us up to date on his process with the procedure. 00:02:40

2 JOHN M. PHELAN, MD: Thank you very much. Thank you all for joining us today, and welcome to the St. Mary's cardiac catheterization laboratory. I'm John Phelan, one of the Dean & St. Mary's interventional cardiologists. I first want to say thank you to our patient, Richard, who was gracious enough to share this experience with all of you today. We hope to make this interactive, we hope to answer your questions. I'd first like to introduce my team today. I have Angela, she's scrubbing with me, and she will be working to manipulate equipment and help organize the table as we pass equipment to the patient. One of Angela's other roles is to monitor the progress with our computerized injection system. This allows us to program the amount of -- volume of contrast that we give and the flow rate of that contrast as we deliver it to our catheters into the heart. Next, I'd like to step over here for a moment and introduce you to Ryan. Ryan is one of our cardiovascular technicians, and today he is the role of monitoring and operating our intracoronary ultrasound equipment. This is actually a very fine ultrasound catheter that's passed inside to the artery and lets us look inside the artery. We show the structure of the artery as well as the accuracy of the stents that we are going to deploy for you here today. Ryan will also be circulating and getting us equipment off of our shelves. Over here in this corner of the room, we have our stent angioplasty equipment: guidewires, balloons, and stents. We have our guiding catheters. These are long catheters that come from outside the patient and travel up the groin into the heart, and through those catheters, we can inject contrast, we can then image, that is see the blockages under our x-ray equipment. And through those blockages, then -- through defining those blockages then, we decide whether to perform a stent or a bypass. In today's procedure, you will see us performing a stent. Next, I'd like to introduce Sean. Sean is one of our nurses here in the cathlab. His role today will be to help keep Richard comfortable. Sean delivers our medicine: sedation, blood-thinning medicines that are important to keep clots from forming while we're putting the stent in. Sean also helps us monitor the vital signs during the procedure. To my right here, you can see that we have a bank of monitors. The first monitor monitors the EKG and the blood pressure, and then next to that we have some x-ray images that we'll be looking at as we perform the procedure today. And these x-ray images are the guideposts, if you will, to help us decide where to deploy the stent. And finally, I'd like to walk into our control room and introduce Todd to you today. This is Todd. Todd is our monitoring technician today, and he will be looking at our monitors for our blood pressure and EKG. He'll be updating the documentation record for the procedure, as well as monitoring the function of our x-ray equipment. Let me just say a little bit about our patient today. Richard is a 69-year-old gentleman. He had bypass surgery nearly eight years ago, and he's now having some symptoms of angina. He also has significant blockage in his legs. Richard has a blockage in one of his arterial grafts to the bottom of the heart. We'll be showing you that on our x-ray equipment here very shortly and then showing you how we plan to deal with that with a balloon and a stent. So with that, I'm going to go back to Don and the panel in the control room there, and we'll be back with you shortly to show you how this procedure gets underway. Thank you. 00:06:46 DON LOGAN, MD: Thank you, John. As you can all tell watching the picture's and Dr. Phelan's introduction, this is not a simple procedure. It is complex with a great deal of equipment necessary, but the patient should be comfortable throughout the procedure and has great support from the staff that work with Dr. Phelan. One of the events that is very exciting but not necessarily fortunate that occurs in people with artery blockages as our patient has today is a heart attack. That is, when an artery closes and a -- by one of these blockages. And that artery closure causes damage to begin to occur to a heart artery. This heart attack is a critical and life-threatening

3 event, and one of the things that our team here has developed is a Level 1 cardiac program. We'd like to first start with some information from Dr. Frank Byrne, president of St. Mary's Hospital, regarding the program, and then perhaps some follow-up comments from Dr. Danahy, who's been actively involved in the development of this program. 00:07:47 FRANK BYRNE, MD: Hello. I'm Dr. Frank Byrne, president of St. Mary's Hospital. I'm pleased to tell you about our Dean & St. Mary's Level 1 Heart Attack Program. When a person is having a certain type of heart attack, it's imperative that he or she is treated in a cathlab as quickly as possible. Our Level 1 program allows us to do just that. We're partnering with emergency medical services and regional hospitals to get heart attack patients transported to St. Mary's in record times. As the largest cardiac program in south central Wisconsin, we're well-positioned to lead this effort. The following segment will tell you all about it. 00:08:32 JOHN M. PHELAN, MD: A Level 1 heart attack program is a fully integrated care delivery system that allows us to bring the most efficient clinical resources to care for patients with acute heart attacks, specifically those patients that have an acute ST-segment elevation heart attack. We now know that time equals muscle, meaning the faster that we get them to the cathlab, the better they do. Studies have proven over and over again, the longer you wait after the onset of symptoms, the more damage there is to the heart muscle, therefore if we can identify patients faster and treat them more quickly by opening their artery, we limit the damage to their heart muscle, we improve their heart muscle function, we reduce the risk of heart failure, we reduce arrhythmias, and we improve their functional outcomes. 00:09:18 LISA BARMANN, RN: Recently, our Dane County EMS have been equipped with the ability to transmit their EKGs back into the hospitals, so what this means is that if a patient is at home having a heart attack and there is an EKG done, it can be faxed to one of the hospitals ahead of time so we know this patient's coming in and we can start preparing for him before they even get here. 00:09:38 DENISE MITTON: One call activates our team. We have a dedicated line that, once they access this line, they have direct communication with our interventional cardiologists, and then at the touch of a button, everybody is paged and notified that we have this patient coming in, so it allows us all to be doing our work ahead of time to get this patient prepared for the catheterization. 00:10:02 JOHN M. PHELAN, MD: We've had numerous patients now that have come from local Dane County or Madison Fire and Rescue who have come directly from the ambulance to the cathlab without stopping in the emergency room, and we've had door to balloon times as low as 20 minutes, meaning that from the minute that the ambulance hits the brakes outside the hospital to the time we have them instrumented in our cathlab and their artery opened, it's 20 minutes. The goal is to have door to balloon times under 90 minutes, so we've actually made tremendous strides in improving efficiency and compressing the care for these patients, and we've actually traveled to a number of community hospitals, and what we try to emphasize to those providers there is that this is a continuum of care that starts even when their paramedic personnel bring those patients in to those regional hospitals. 00:10:54 DENISE MITTON: Although we've always had relationships with other community hospitals, what this does is -- this program itself have removed all the barriers in

4 getting that patient transported to our hospital. Many times, that patient, when they would present to an outlying area, would be treated in their emergency room and would typically stay in their emergency room up to three hours. 00:11:15 LISA BARMANN, RN: Now, since we've gone to these outlying hospitals and made this importance known, they're transferring their patients sometimes in the door out the door within 20 to 30 minutes, and we're saving their heart muscle because of it. 00:11:27 JOHN M. PHELAN, MD: And many of them have nearly normal heart muscle function, so that's a very, very tremendous result. I mean, this care has revolutionized the ability of patients to return to a fully functional and active lifestyle, which is our goal. That's really our goal. 00:11:49 DON LOGAN, MD: That's a very extensive program, and it certainly is a dramatic change over the years of managing heart attacks. Dr. Danahy, you have comments or experiences with the Level 1 program, certainly being involved in its development. Can you give us any more information? 00:12:02 DANIEL T. DANAHY, MD: Well, we're really very excited about the Level 1 program because it's brought together concepts that we've been aware of for a long time but really not well organized to execute to the current level. And so with the team approach with the Level 1s, we've gotten everybody involved in the process on board and we've streamlined it, and we're now able to get people in very rapidly. And we've learned that that's the key to salvaging heart muscle is to get early treatment, get the artery open, and this allows us to do it in an effective manner. As you know, since we go back a long time in our careers, but in the early days with heart attacks, we used to bring people in the hospital and just watch them. There was nothing we could do except to treat complications. Now we can really intervene early in the process and prevent a large amount of heart muscle damage from ever occurring. So that's a great advantage. 00:12:52 DON LOGAN, MD: Early intervention really seems to be the key. The quicker the patient lets their doctor know about problems and the quicker we can see them, then the better it is for that patient. Sounds like a real system event, where many people are involved, not just a doctor and a patient. 00:13:07 DANIEL T. DANAHY, MD: It's a very gratifying experience, actually, to be able to bring somebody in who's having severe chest pain, marked abnormalities on the electrocardiogram, open the artery, and see everything go away: the pain goes away, the cardiogram gets better, the patient does better. It's just exciting to be able to do that. 00:13:21 DON LOGAN, MD: It's very exciting. Maybe we'll have an opportunity to show some of those experiences as the show goes on today. That would be very interesting. We have some information now, and for those of you who have asked questions, and some have, both in my practice and about this procedure is: how do we get from where we start -- that is, outside of the body -- into the body, and the first step is gaining access as we call it by puncturing the artery and getting a catheter into the body. We have a video of Dr. Phelan obtaining access into the arterial system. Perhaps Dr. Danahy -- and we've now been joined by Dr. Singer, who has finished the procedure he had started earlier. And maybe you could make some comments about the process of access that we see. 00:14:10

5 DANIEL T. DANAHY, MD: So this is a procedure that we're doing from the groin, which is typically the point of access simply because there's a large, readily accessible artery there. It's also possible to do these procedures from the arm, but in most instances, they're done from the groin area. We start off by just prepping the area to make it sterile and then using a local anesthetic. It's just a small area that's numbed. And that stings for a few seconds, but after that, it really doesn't cause discomfort. Once the skin has been numbed, you can puncture the artery with a small needle. Sometimes that's very easy to do if the artery is easily accessible: thinner patients, bigger arteries. Sometimes it's a little more challenging if the artery is very small or the patient very large, but once the artery has been punctured with the needle, which is what Dr. Phelan just did, we can advance a little guidewire through the needle into the artery. And then the needle can be removed, and using the guidewire, it's possible to advance a sheath -- what we call a dilator and a sheath in. And then we have complete access to the artery with any other equipment we need. 00:15:19 DON LOGAN, MD: I'll be pointing here at the screen -- I don't know if people can see this, but this is the wire going into the artery through the needle. 00:15:35 DANIEL T. DANAHY, MD: And we have the dilator and sheath there that they're going to put in in just a moment. 00:15:40 DON LOGAN, MD: Many people have worried about how much bleeding goes on in this process of entering their body. Do you have a comment on that? It's visible that there is a certain amount of blood, but estimates of the amount? 00:15:52 DANIEL T. DANAHY, MD: It's a very small amount. The other end of the procedure, we do have to be cautious when we take the sheath out to make sure that there isn't any bleeding. 00:16:04 DON LOGAN, MD: And so we have access now into the body with a -- a hollow tube within the artery wall that will be an access point to enter with other catheters and wire to move up through the vascular system. I think Dr. Phelan has made progress in the catheterization laboratory and would like to bring us up to date on the activities in the lab, so perhaps we could move to Dr. Phelan in the lab and see how progress is going. How are things going, John? 00:16:30 JOHN M. PHELAN, MD: Things are going great, Don. Thanks for getting back to us here. We've had access. We did the access off camera; this is a little more complicated in this gentleman because he has some narrowings in the arteries in the legs. They don't need to be fixed right now, but we thought it would be better to do that off camera today. And what I'm showing you in my hand here is a guiding catheter. This catheter's designed to find one of the bypass grafts, the graft that we're going to be working on today, and we're going to be passing that up through our sheath, which is placed in the patient's groin. And then once the catheter's in the sheath here, Angela's going to be advancing the guidewire and will be watching this up on her fluoroscopic image. So let's get started. The sheath goes in like this, and then Angela passes the wire up. And then we go over to the x-ray fluoro image, and hopefully that's on your screen, and you can see us follow the guidewire up through the aorta. And now we're just above the heart with our guiding catheter, and we take our guidewire out and we hook up our guiding catheter to a valve that allows us to introduce angioplasty equipment. This valve is called the Tuohy, and we then clear the guiding catheter by getting rid of all the blood, we flush out the guiding catheter

6 with some saline. Next, we'll be filling the catheter with contrast, and we'll be able to do this through injecting through our computerized control system here, our sys device. And then I'm going to ask Angela to rotate the x-ray camera around to the arial position. This will be the most favorable for engaging this bypass graft. This bypass graft is not a typical vein graft. That is, it's not harvested from the leg. The surgeon wisely, I think, chose to use a radial artery graft -- that's a graft from the arm -- and we believe that that's a much more durable conduit for patients undergoing bypass surgery. And part of this graft -- this graft comes down and touches down on two arteries, and we'll show you that shortly. And part of this graft has some narrowing that we plan to fix here today. So you want to puff on that for me, please, Angie? There we go, found the graft. Why don't we come AP caudal and see if we can get a good picture of it? 00:19:09 DANIEL T. DANAHY, MD: John, can you hear me? 00:19:10 JOHN M. PHELAN, MD: Yes, I can, Dan. 00:19:11 DANIEL T. DANAHY, MD: You might point out the defibrillator device because that kind of stands out on the x-ray. 00:19:16 JOHN M. PHELAN, MD: Sure, that's the -- that's a great observation. There's a long, thick black wire there. This patient had significant heart muscle dysfunction shortly after his operation, meaning his ability to efficiently pump blood out was less than 35%. The way we like to explain that is if the heart receives 100 units of blood with every pumping cycle, it should normally pump out around 60 units. In Richard's case, he was pumping less than 35, and the criteria tell us that people who have weakened heart muscles like that should really have this defibrillator. It's like the ultimate life-insurance policy. It's like a paramedic standing inside your chest, and it can treat any arrhythmias that may cause you to die suddenly. And I don't think Richard's actually had to use the device. In fact, the way Richard's procedure was delayed this week a little bit was the device has been in so long, the battery had to be replaced here earlier in the week, and that was done by one of our partners, and now we're off doing the angioplasty. So we're first going to start by taking a picture of the bypass graft and the narrowing, and then we'll show you what we find. And I hope people can see on the screen here the narrowing in this bypass graft. The graft comes down and touches on a branch of the circumflex artery and then it continues on and touches on the right coronary artery. And we're going to fix that today by putting in a stent. So for the next step of the procedure, Angela's going to hand me a 14/1000 th inch guidewire and an introducer, and we're going to put all that together for you here. And we're going to then put that down -- down into the artery under -- 00:21:30 DANIEL T. DANAHY, MD: People who aren't used to looking at this may be confused about all the black lines, but that's the catheter going up from the leg. This is the bypass graft as it fills down. This is the connection into that first branch, and that continues on down here and there's an overlap with the branch itself, but the narrowed area in the graft is right there, and then it connects down into another coronary branch more distally. So there's unobstructed flow down the graft to this branch, but then as it continues in a segment down here, that narrowing restricts the flow further down. 00:22:04 JOHN M. PHELAN, MD: I don't know, Dan, if you have a sample of a guidewire there that you may want to show the audience, that may show better in the room there

7 than it does here for us, and then I can show them how we're going to introduce this into the patient. 00:22:16 DANIEL T. DANAHY, MD: Actually, we don't have a guidewire. We have a balloon catheter we can show. 00:22:19 DON LOGAN, MD: We have some samples of catheters and balloons and stents we can do now or later as we go forward, John, whichever works best for your procedure. 00:22:27 JOHN M. PHELAN, MD: Well, actually, right now, I've introduced the guidewire into the Tuohy. It's now traveling through the guiding catheter. And at the back end of this, Angela is placing a torque device, that is a device that lets us turn the guidewire as it -- can you give me a little pump of contrast there? This lets us manipulate the guidewire as it goes down into the bypass graft. 00:23:05 DON LOGAN, MD: This dark line is what we'll be following in its pathway. 00:23:34 DANIEL T. DANAHY, MD: Now, this is a guidewire that we can show. It's a very long, thin, very flexible wire, and that's the pathfinder down the vessel. So if we can first get the guidewire down, then we can advance other things such as the balloon and the stent. So this has a very flexible tip, it can be shaped with a correct bend to negotiate more complicated turns. It's very flexible but very supportive for advancing balloon catheters and stents over it. 00:24:00 DON LOGAN, MD: Did Dr. Phelan say 14/1000ths of an inch? 00:24:03 DANIEL T. DANAHY, MD: That's correct. 00:24:04 DON LOGAN, MD: That would be a pretty small, skinny wire that people would be using. It's very flexible at the tip. As you bent it, I think it would be important for people to know that that flexibility allows you to pass through the -- the catheter and then through the artery without tearing holes in the devices as you go through them. 00:24:21 DANIEL T. DANAHY, MD: Right. 00:24:22 DON LOGAN, MD: And I think we can see it moving on the screen here now. The darkened part is a different metal to allow that tip to be visible on x-ray so Dr. Phelan can follow this, and it will seek many channels, and it's up to the person driving the -- if you will -- this catheter through the blockage and on down through the rest of the artery to reach ultimately a point beyond the blockage so that there is stability of the wire. If you recall, the blockage would be in the mid-portion. So we drive it beyond the blockage to get stability for the catheter passing through the blockage. I say "we" very bravely; it's Dr. Phelan who's doing the driving and the catheter manipulation at this time. 00:25:12 JOHN M. PHELAN, MD: One of the things we learned about doing this procedure already is is that the guiding catheter, even though it's the best fit for this patient, is often a little bit of an angle from the origin of this bypass graft, and that will make this a little bit more of a challenge than we expected, but you can see that we now have the wire down beyond the blockage, and our next step will be to take a balloon catheter and put that balloon over this guidewire, and the balloon will then go and

8 dilate the narrowed segment. So Angie's going to take and put the balloon on the guidewire for us, and then we're going to drive that down to the area of blockage. 00:25:55 DANIEL T. DANAHY, MD: So we can show you a balloon here. So it's a long, hollow tube. There's a little sausage-shaped balloon at the end of it. This rides over the guidewire, so the guidewire is the pathfinder, and we can advance this across the segment of the vessel that's narrowed. And then the balloon can be inflated, which Dr. Phelan will be doing. And we do have one here that has already been inflated. So this one's kind of wound up, but if you look at the tip of this, it's a sausage-shaped balloon from there to there, and these come in different sizes, so we try to match the diameter of the inflated balloon to the diameter of the vessel that we're working in to the desired diameter, which is always bigger than the narrowed segment that we're trying to open up. 00:26:44 JOHN M. PHELAN, MD: So here we are going to -- if I could just interrupt for a second, we now have our balloon on the guidewire, and if you focus on my hands for just a moment, you can see what we're going to do is enter in that balloon into that valve. The wire stays in place, and we pass the balloon down over the wire. Fortunately, these balloons have markers, so it saves us a little bit of x-ray exposure. We don't have to have the x-ray equipment continuously on until the balloon gets down here to the narrowed segment. And you can see the two markers on the balloon. Can you give me a little puff there, Angie? Those two markers are getting down towards the narrowed segment of the artery, and I think we're just about to the point of wanting to dilate. In fact, I think this is pretty good right here. So we've taken a balloon that's 2.5 millimeters, and we're going to inflate it to 8 atmospheres, and we're going to do that for about 10 seconds. Why don't you go ahead, Angie, and do that? 00:28:00 DON LOGAN, MD: Dr. Danahy, you want to comment on "atmosphere"? What is he talking about? 00:28:04 DANIEL T. DANAHY, MD: Well, that's the pressure inside the balloon. And sometimes these narrowed segments are calcified and quite sclerotic, quite rigid. And it may take a fairly high pressure inflation on the balloon to actually get it to open up. 00:28:21 DON LOGAN, MD: So one atmosphere is a certain number of pounds per square inch. The pressure of air on our skin would be one atmosphere? 00:28:28 DANIEL T. DANAHY, MD: Correct. 00:28:30 JOHN M. PHELAN, MD: And you can see what the balloon did there. the balloon basically just opened up that tightly narrowed segment, and this allows us an adequate channel so we can place a stent. And after looking at this artery today, I've decided that actually what I'd like to use is a 3mm by 24mm drug-coated stent, so we're going to get that off the shelf and that'll be the next part of the procedure. 00:29:00 DON LOGAN, MD: While you're doing that, John, we do have our -- one of our first questions from our internet observers, and one is -- perhaps I can direct it to the -- your colleagues here is: how dangerous is it to have stents implanted or even a catheterization performed if you have kidney disease? You have a brief comment about that? Dr. Singer perhaps, who joined us from just having done a procedure. 00:29:22

9 ALAN H. SINGER, MD: Yeah, to do the heart catheterization, as you can see, we need to give a dye, a contrast agent, and that's what makes the arteries look black so that we can see that. And the contrast agent has a little bit of kidney toxicity, especially in a diabetic whose kidneys aren't good, so we really try and minimize the amount of contrast. Currently, we have newer contrast agents that have come over the last decade which make it much safer for the kidney, so the risk is there, but it's quite small, on the order of a couple percent. 00:29:49 DON LOGAN, MD: All right, so it can be done in almost all people, even with kidney disease, if done carefully with the right preparation, pre-medication, and management. 00:29:56 ALAN H. SINGER, MD: Even diabetics. 00:29:57 DON LOGAN, MD: All right. Dr. Danahy, Dr. Phelan said 3mm by 24 mm; could you explain what he's talking about for that catheter size? 00:30:06 DANIEL T. DANAHY, MD: All right, the 3mm refers to the diameter of the stent when it's deployed, and the 24mm refers to the length of the stent. And obviously, we try to match both to the vessel that we're treating, so on a -- for a segment that's narrow over a very short area, we can use a shorter stent. We want to cover completely the narrowed area. And in matching the diameter to the size of the vessel, we want to make it as big as it should be. We don't want to over-expand it and make it -- balloon it out. So we have to individualize in each lesion in terms of deciding both length and diameter. 00:30:43 DON LOGAN, MD: So this is not a "one size fits all" process of identifying the artery size and length of lesion and so forth. 00:30:49 DANIEL T. DANAHY, MD: Correct. 00:30:50 JOHN M. PHELAN, MD: Actually, I can show you now the stent. We have it and just introduced it over the guidewire here. I don't know if you can see this on camera, but my guidewire is through the end of the stent, and I'm advancing the guidewire. The stent is coming over the -- the guidewire here, and the stent is now being introduced into that valve, the Tuohy valve, and we will be placing this down through our guiding catheter and into the narrowed artery. And you know, our audience may want to know a little bit about the difference between this procedure and a Level 1. Certainly, I think we all take the most pride in the Level 1 work we do because that obviously gives us -- gives our patients the greatest impact. This procedure is obviously more elective. You can't schedule a Level 1 heart attack for a presentation like this, and so we will show you some differences here today about the anatomy, if you will, between this procedure and a Level 1. You can see, my stent now is on the screen on the x-ray image, making it down the artery. And in a moment, Angela and I will be taking pictures just to prove that our stent is in the right place. And we could probably -- I don't know if we could come maybe AP caudal just a little bit and just look at this a little bit differently. I want to try a different image just to see if I can identify a better landing zone for the stent. That looks pretty good. Maybe another millimeter or so forward. Any comments from Dan or Alan about that? I'm pretty happy. 00:32:43 DANIEL T. DANAHY, MD: Yeah, I agree. 00:32:44

10 JOHN M. PHELAN, MD: I think that's pretty good there, actually. 00:32:46 DON LOGAN, MD: You're looking to cover the area that looks most abnormal from the area you dilated the balloon before, is that right? 00:32:51 JOHN M. PHELAN, MD: That's correct. And -- 00:32:56 DON LOGAN, MD: And when you said a different view, you meant you moved the camera to a different angle, much as you would look at the backside of a tree by walking behind it to look at the branches from a different angle. 00:33:04 JOHN M. PHELAN, MD: That's exactly right, Don. Maybe just right there. I think we should be okay. Why don't we take and inflate this stent -- we're going to inflate this to 18 atmospheres for 15 seconds, and Angela's going to do that for us now. 00:33:21 DON LOGAN, MD: That inflated very quickly. With what do you inflate it, Dr. Phelan, so we can see it so clearly? 00:33:29 JOHN M. PHELAN, MD: Why don't we show the camera on Angela's hands so we can see the inflation? Why don't you come on down there, Angela, and show that? And then you can deflate the balloon now, I think, is enough time. And... 00:33:50 DON LOGAN, MD: It looks like there's x-ray dye within that balloon. Is that what you use to fill it? 00:33:53 JOHN M. PHELAN, MD: Yes, we do fill the balloon with x-ray dye, and the reason for that is so that we can see it when it's inflated. It -- it's really a nice marker for us to have. And now we're going to -- we've removed our balloon, our guidewire is still down, so we still have access to this artery, and so the next phase of this will be to take a picture to see what our result has been. And I think you can see the area there that we put the stent in, it looks very nice, very widely open, and I think the next part of this, we're going to set up for our ultrasound catheter, and we're going to show you what an ultrasound inside the artery looks like. So at this point, I'm very happy with how the stent is deployed. I don't know what Alan or Dan or the rest of the panel might think about this, but I'm fairly satisfied. 00:34:57 DANIEL T. DANAHY, MD: Yeah, it's wide open at the stent site. There's -- sometimes there's a little constriction in the artery above and below that, and that may -- those segments may open up more with -- with time and with nitro. But the IVUS is a good way to look at it and make sure you've got the job done the way you want to. 00:35:17 DON LOGAN, MD: We have a couple of questions while you're getting set up there. One is -- the first question, which is a very good physiologic question: it seems like inflating the balloon -- this is from Ashley -- inflating the area only compacts the obstruction against the wall of the vessel. Doesn't this actually cause damage? And it may be propped open, if you will, by the stent, but doesn't the stent and the compacted material make a site more likely to be blocked again? Do you have a comment about what actually happens at the site of a stent placement or an angioplasty? Either of you or both? 00:35:48 DANIEL T. DANAHY, MD: Well, I think it's a good observation, that we're not actually removing the material when we do this. There are some procedures that have been developed and we use sometimes that actually remove plaque. In fact, early on, that

11 would -- it was thought that would be the ideal. But actually, it turns out that just compacting it typically works better. And initially it was done just with the balloon, we didn't have the stent, so we would make it as good as we could with the balloon. The stents really give us a better result, though. We can get a better opening, more durable opening that really scaffolds the artery and holds it open. And so most of the time, that is a good, durable result, although it is possible -- and I don't know if we should talk about it now or down the road -- about problems with stents, where potential problems -- 00:36:30 DON LOGAN, MD: Well, that's the good point, because Matt just had a question saying: could you explain the difference between a coated and a non-coated stent? And Dr. Phelan has inserted a coated stent, I think he told us. Maybe Dr. Singer, your comment about the difference between the two and some of the concerns of that? 00:36:46 ALAN H. SINGER, MD: Sure, we could talk about that as well as the difference between balloon angioplasty and stents. We saw that Dr. Phelan, the first thing he did is open it up with a balloon. And before 1994, when the first good stent came out, that's what we did; we just ballooned it open. And that improves it, but it doesn't give a perfect result. The problem with just doing a balloon is twofold. Number one, there's more chance of it closing right away, so before we had stents, you'd get tears in the vessel. And that would lead to the vessel closing down about 2-4% of the time, and people would need urgent bypass surgery. So a very, very serious problem. When the first metal stents came out, they held the vessel open, so those little tears in the vessel, little layers that would obstruct the vessel, you could easily hold open with a stent. So they almost got rid of that need for urgent bypass surgery. So that very awful thing that would happen, the vessel closing down and needing urgent bypass surgery, is almost unheard of nowadays, or very, very rare. The second problem with the just plain balloon is that a third of them would come back after about three months; you'd develop scar tissue in there and the vessel would constrict down so that the vessel -- so that after three months, in a third of the people, it was narrowed just like it was before you started the procedure. In 1994, when we -- when the first stent came out, that stent, that metal support structure that you saw Dr. Phelan put in, would hold the vessel open so that it wouldn't constrict down. And after that, only about 10-20% would need to come back. But in that 10-20% of the time, you'd get scar tissue. Now, with the coated stents, there's a drug to prevent that scar tissue from forming, and so now the incidence of them coming back after three months is in the 5% range, much better. So 95% chance of good, long-term good result. 00:38:29 DON LOGAN, MD: That certainly sounds like an improvement. And having been one of the geezers that started that a long time ago, it was a great day when we could put the stents in place. Dr. Danahy, comments about the drub-eluting stents? I know that one of the questions that we get repeatedly is: what about this news of the drug-eluting stents perhaps being more dangerous than we thought? 00:38:48 DANIEL T. DANAHY, MD: Well, there are -- the stents have been a great advance, as Alan said, and first the bare metal stents and now the drug-eluting, or coated, stents is again, another step forward. There are still two potential problems, and even though neither happens that much, it's still a possible complication to have scar tissue form within a drug-eluting stent. That's pretty unusual, less than 5%. And we can do another stent if that happens. The other problem is it's possible to have stent thrombosis. And what happens there is not a gradual scarring but a sudden clot

12 formation. And we've recognized that from the first days of stents that we had to be careful, we had to make sure the stent was well-deployed, fully positioned against the wall of the vessel, good blood flow. And we use anti-clotting drugs, intravenous medications, during the procedure, but then Plavix and aspirin afterwards. 00:39:39 DON LOGAN, MD: Good. We can talk about that more in a little bit. Dr. Phelan may have something to show us in the lab now, I think. 00:39:46 JOHN M. PHELAN, MD: Thanks, Don. Thanks, Dan and Alan. We're back live. What I've done is I've introduced a catheter with an ultrasound. It's basically constructed similarly to the balloon and stent catheter that we showed you before, although this has a very fine ultrasound probe. This probe will go inside the artery and will let us look at the stent result we have. It's a different way -- different than the angiogram, different than what you see up here with the x-ray picture -- in looking at our stent result. And we know that getting the stent fully compressed against the wall of the artery is very important for making sure we have the best long-term outcome. In many cases, this is valuable, but I would emphasize that not everybody needs to have an intracoronary ultrasound after we've put the stents in. So I'm going to pass the catheter down into the artery similar to what I did before. And you can see on screen the catheter with two markers on it. The more proximal marker, the one that's further back, actually is the one with the ultrasound on it. And actually, I'm just getting down to the distal stent there. and now we're going to turn the ultrasound catheter on and start acquiring our image, and I don't know if maybe Ryan can show this to our audience with the camera here, but you can actually look at our ultrasound pictures. And I hope that -- yeah, you can see that right there on the screen. And maybe Alan or Dan might comment for the audience what we're looking at here. Basically you can see the probe is going to pull back across the inside of this artery and show us how our stent is deployed. So we start just down distal to where the stent is and we pull the catheter back through the stent, and that's all automated here. 00:41:56 DON LOGAN, MD: John, we're going to point at the screen and show a couple things to the audience. 00:41:59 DANIEL T. DANAHY, MD: This is the wall of the artery, and the device is this thing in the center, so you're really looking at the vessel from inside out. So this is in the middle of the vessel, the ultrasound beam gets reflected off the wall of the vessel and it allows you to look. So these very bright spots are actually the stent struts. And you can see that those are well-positioned against the wall of the vessel. 00:42:25 DON LOGAN, MD: And ultrasound is an extremely high-frequency sound wave that actually bounces like an echo would bounce in sound waves in a canyon from the catheter in the center out to the middle and back, and by the use of a complex formula and a computer, it calculates this distance and re-draws, if you will, this picture of the stent and the artery wall by the use of this micros-- really tiny ultrasound emitter in the middle of the artery. 00:42:53 DANIEL T. DANAHY, MD: So this gives us a different way to look at vessels compared to the angiogram, which has been the standard way to look at them in the cathlab. It does give us a lot of good information that in some cases is very, very useful. 00:43:07 DON LOGAN, MD: One of the questions that we've gotten fits right in there, from John, the question: do stents ever move? And where does ultrasound fit in in that?

13 00:43:15 DANIEL T. DANAHY, MD: Well, stents are usually deployed against the wall of the vessel, and they're usually pretty well fixed, so we don't have problems with them migrating. In fact, people have asked about: do we ever take them out? And the answer is no. it's not worth the trouble. 00:43:30 DON LOGAN, MD: Probably not really possible to do that without a major surgical procedure. So once they're embedded, which Dr. Phelan is attempting to prove, in effect, that the size is right and that it would stay in place. If it was a very tiny stent in a big artery, it might move, but if it's a properly deployed stent, which it's compressed firmly against the wall of the artery, then it should stay in place. 00:43:49 DANIEL T. DANAHY, MD: Correct. 00:43:52 JOHN M. PHELAN, MD: So we -- I'm satisfied with his ultrasound image. I don't know if Alan and Dan had any concerns about what we saw as the ultrasound pulled back through the stented segment, but to me it looked very good. there is actually, I think, a little narrowing just very proximal to the stent as we pull out, but I don t think it's bad enough that we'll need to do any further intervention. So I think, from my perspective, my next part of this procedure would be to take some more pictures with the x-ray, and if it all looks good, we probably would -- would be finished here for the day. Alan, Dan, do you like the way the stent looks? Do you think we have anything more to do here? 00:44:41 DANIEL T. DANAHY, MD: No, I think you did a good job, John. 00:44:45 ALAN H. SINGER, MD: The ultrasound shows that each part of the stent is wellembedded into the artery and none of it's hanging in the middle of the -- in the middle of the artery, in the middle of the lumen, which would be a poor result and a place where you could get blood clots forming. 00:44:58 DON LOGAN, MD: Looking for spaces that shouldn't be there, and this is really tightly squeezed in. I think we've talked a little bit about the other half of this question that we received, about: do these -- are stents ever blocked up? And the answer is they have in the past more than they do recently, and now the question is really about fresh clots in the drug-eluting stents when we stop the medications at inappropriate times. And one question for Dr. Pearson: this patient is now fixed, is that right, so we fixed the problem of arterial sclerosis. Dr. Pearson is an expert on preventive cardiology, that is treating medically the process of arterial sclerosis and other disease entities. Is this fixed? 00:45:43 JANE PEARSON, MD: Atherosclerosis is actually a chronic disease, Don, and it needs a lot of attention for the rest of the patient's life. And what I mean by that is risk factors that perhaps led this patient to develop coronary disease will be present for the rest of his life, and fortunately, we have excellent medical treatments that will improve his outcome. And we ask patients to take a fair number of medications that will give them improved function and improved outcome, but sometimes that's a challenge for patients because many of the risk factors that can lead to this problem don't have any symptoms. So we end up having patients to take a fair number of medications for problems that they don't have any symptoms for, and I'm speaking of hypertension, high cholesterol, diabetes. 00:46:25

14 DON LOGAN, MD: It's a very difficult process even sometimes getting their attention, I'm sure, and Dr. Pearson and I discussed -- being an old farm boy -- the Missouri mule technique of getting somebody's attention, in which you use a two-by-four to get their attention. It would seem for our patient, Richard, that this would be the two-by-four. And so after this procedure, he needs it, and it should be pretty evident. What about the person walking down the street age 35 who feels fine? How would they know what to do? 00:46:51 JANE PEARSON, MD: The most important thing is for younger patients to recognize any risk factors they may harbor and be unaware of. There's really nothing you can do to change your family history -- you can't choose your parents -- and this disease does increase as a person ages, but other things that people might be unaware of, especially in their 20s and 30s, they may have hypertension. High blood pressure has no symptoms and is something that needs to be tested for by frequently having a physical exam. Same with cholesterol. High cholesterol has no symptoms that would prompt a person to visit the physician, and it's very important for every individual over the age of 20 to be aware of his or her numbers. Everyone should know his or her blood pressure, everyone should know his or her cholesterol value, and everyone should be screened periodically with a blood sugar for diabetes. 00:47:38 DON LOGAN, MD: That certainly sounds like a suggestion that not only should the highly specialized folks here at the Dean & St. Mary's Cardiac Center be involved with the disease but we need real doctors out there in the primary care world helping us get this done for our patients as well, so that's the importance of the relationship to the primary doctors in not only Level 1 but taking care of patients. Dr. Danahy, one question from Madison here: does the patient need to take medication after the stent is inserted? That'd be worth repeating, the need for that medication and what they might be, pretty vital from the stent point of view. 00:48:10 DANIEL T. DANAHY, MD: Yeah, well, I would second what Jane said. I think putting the stent in, we feel great, the artery's open, it's wonderful, high fives, but it's not the end of the problem, and people have to work on the risk factors, so the cholesterol, the blood pressure, and the sugar, those are all things that still need to be treated. In addition, with the stent, we want to use these anti-platelet drugs, namely aspirin and Plavix, which minimize the risk of a clot forming in a stent. And for bare metal stents, we typically use Plavix for just a month. With drug-eluting stents, which inhibit buildup of scar tissue but may also inhibit the normal healing in that area, we are going much longer with Plavix. In fact, we're -- went from six months to now a year, and in many instances, we're even going longer than that. I think the -- the best time to stop Plavix is not entirely clear, but for drug-eluting stents, we're going now for at least a year, and I usually tell people, "I don't want you to stop this drug on your own, only if we approve it." 00:49:10 DON LOGAN, MD: And the "we" would be a communication between you and the primary care physician so that neither of you stops it without the other person being involved, part of the system of taking care of patients rather than one individual doctor or another, I think, would be an important issue. One other question has come in that is a common question from Phillip, and that is about calcification in the wall of the arteries. Dr. Phelan mentioned it and we talked about it. He said: is there a risk or damage to the artery from the calcium when the artery is expanded and what happens to that? And also, Phillip, I'm glad we did answer one of your questions about the defibrillator. We hope we answer a lot of questions today. Calcium?

15 00:49:46 DANIEL T. DANAHY, MD: Alan, do you want to... 00:49:49 ALAN H. SINGER, MD: When people develop atherosclerosis, these fatty blockages in the arteries, often calcium builds up in that area, and we can see that under the x- rays, they'll look very dense, almost like bone marrow. And usually that calcium doesn't pose a problem for putting in the balloon and stents. We bring these balloons up to high pressure, sometimes quite a few times the pressure in your car tire, and that will open up the vessel, and then we can put our stent in. Sometimes so much calcium builds up, especially in people with kidney disease and kidney failure, that we need to remove the calcium. The way we do that is with a roto-blader, a little diamond-studded burr which will break up the calcium into tiny little pieces. 00:50:25 DON LOGAN, MD: So it can be a problem, but we do have means that we can generally deal with that as -- as a part of the process of the catheterization and angioplasty. 00:50:32 ALAN H. SINGER, MD: Right. There's newer devices that help us get rid of that calcium and make the vessel soft, and then we can use our balloon and metal stent to get it fully open. 00:50:40 DON LOGAN, MD: Okay. That's good. We -- we've seen some of the instruments here; the catheter for taking pictures and the stent. Many people are asking about stents, and I hope the size has been helpful as a perspective. We also have some additional pictures; I think we have time to show one of the catheterization studies of a Level 1 heart attack patient so people can see what it looks like to have an artery that's completely occluded. And this is a person who would be having a heart attack. So while we're getting that set up on the image to come in -- 00:51:14 JOHN M. PHELAN, MD: Maybe while you're doing that, Don, I could show you a couple final pictures here. 00:51:16 DON LOGAN, MD: Oh, great, that'll be perfect, John. Thanks for letting us know you're moving along. 00:51:20 JOHN M. PHELAN, MD: So we're just going to take a final quick couple of pictures here. I didn't have a view in this angle before, but -- and I didn't show you this. There -- it looked like there was still a little narrowing above my stent, so I extended the stent field with a short stent, and now you can see the final picture there. It looks quite nice. This actually runs from about noon on the screen down to around nine o'clock. I don't know if Dan or somebody can point that out. And then we're going to take another picture in the AP caudal projection where we're moving our camera around again, and we will confirm that we have a nice result. So you'll be able to see here, it's really, I think, a very good-looking result from the stent. And we go back one shot -- always at the end here we pause for a few moments just to make sure that we have a result that we're proud of, and I think given the situation, I'm very happy to be finished here today. So I think what we'll do, Don, is maybe go back to you, and if we have some cases to play, some images up on the screen, we could go through those and show our audience what it's like to have an intervention in a Level 1 heart attack situation. 00:52:53 DON LOGAN, MD: Great. We can show perhaps one of the Level 1 heart attacks, and I think this is a patient that Dr. Phelan described for us a little bit earlier. Dr. Danahy