ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL, NEW BRUNSWICK, NJ BROADCAST OCTOBER 20, 2004

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1 ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL, NEW BRUNSWICK, NJ BROADCAST OCTOBER 20, 2004 NARRATOR Welcome to the live webcast from Robert Wood Johnson University Hospital in New Brunswick, New Jersey. During this live webcast, surgeons from the Vascular Center of New Jersey at Robert Wood Johnson University Hospital will demonstrate a lesson based surgery for patients with an abdominal aortic aneurysm. The procedure is known as endovascular stent grafting. Patients only have small groin incision with relatively little pain after the operation and a short hospital stay. Most return to normal activity within a few weeks. Today s program is part of the Vascular Center of New Jersey s on-going educational efforts to bring the latest information in health care to patients and physicians. During this program, you may send your questions to the OR surgeons at any time. Just click the MDirect access button on the screen. Hi, good afternoon everyone and welcome to Robert Wood Johnson University Hospital here in New Brunswick, New Jersey where we will be watching a live webcast broadcast of the repair of an abdominal aortic aneurysm here in New Brunswick. I m Mark Adelman, I m from New York University and I m joined here with Dr. Lucy Brevetti, who is an attending vascular surgeon here at Robert Wood Johnson here in New Brunswick. She ll be assisting Dr. Alan Graham who is the Chief of Vascular Surgery and professor of surgery as well as the Vice Chairman of the Department of Surgery as he attempts to repair an abdominal aortic aneurysm using endovascular techniques. He ll be using a device that looks just like this, it s a Gore excluder. We use this device to seal the aneurysm away from the circulation, exclude the aneurysm away from the circulation. I d like to invite all of you to hit the MDirect button on your screens if you have any questions for us and we will be glad to try to answer them here during the webcast, but for now, we are going to go on over to Dr. Alan Graham and get an update in the operating room. Good afternoon, we are here at Robert Wood Johnson University Hospital. My name is Alan Graham, we are going to repair an abdominal aortic aneurysm today with an endovascular stent

2 craft by W.L. Gore. Before I start I just want to introduce some of the people that are in the on the team that allowed the this thing to occur, so easily. Uh, Dr. D Angelos is our Chief of Vascular Anesthesiologist, he is at the head of the table. He is with my 99% of the time. Mark is the Vascular Radiology Technologist who is with us and runs all the equipment so that we can find out where we are inside the body. Chris Abbot is out fellow with us along with Sei Hom, who is our fellow over by the x-ray box. And then we have three nurses with us, Rochelle, Tennille and Randy who as a team all coordinate the effort that I am about to put together here. Clearly we hope today s case to go smoothly. We should be able to get this done in a very short period of time. This is a gentleman who had a small abdominal aortic aneurysm, was followed up properly by his cardiologist and found to have an enlarged aneurysm, which has almost gone from 3 sonometers to almost 5 sonometers in less than 6 months. And it s quite tender on palpation. We have some x-rays of the patient s aneurysm and we are going to be able to show them to you in a second here. Dr. Hom was going to point out the aneurysm here. We just get the camera over there, make it clear for everybody. Here is George, he is doing a great job. George is going to show Dr. Hom is showing the aneurysm, he is pointing to the sac, this bulging sac in the main aorta, which is your main artery in your body, feeding the kidney s, the intestines and your legs. And this is a bulge, it s like a balloon that spreads out, gets thin and as it enlarges can burst. If it bursts, 50% of the people who have this will die acutely. Can you actually point out the aneurysm? And now Dr. Hom is going to point out here on the renal arteries, you can see the arteries to the kidneys. And just below that there is a fairly normal piece of aorta, that is where we are going to land our endograft and below that is the bulge in the aorta which is the weak weakness. And we are going to line that weakness with an endograft. So that gives you an idea of what we are doing with this patient. And I think we are going to get started here. We ve already made some incisions about 15 minutes ago. We have made 2 incisions in the groins. This is the patient s abdomen, to my left, these are the groins. We made an inch about 2 inch cuts in these in the regions of the inguinal ligament. Have dissected out the femoral arteries and you can we have wires in the femoral arteries and these wires go up through the aorta, up into the chest. And along this wire we are going to place an endograft and line the graft itself. The first thing we are going to do right now is an angiogram to identify the site of those renal vessels in order for us to know where to land the device. So, we will do that first. And we are going to inject 8 cc s of dye. There it is. It is very nicely we can see the renal vessels, we can see the neck of the aneurysm, which is the normal aorta, and we are going to land our device in that zone, please. First I need to put a sheath you can mark that for me, Mark. First I need to put a sheath in the femoral artery up into the aorta and that is a larger plastic sheath that will place the device inside of Hey, Alan, we are just getting a look now at the at the video, the angiogram, can you just point out the renal arteries again? Yeah, I sure can. I don t I don t know if I can get over there before that alright there you go, okay, well you can see the pigtail, which is that round, curly thing where the dye came out and

3 about an inch below that and as you are looking at it to your left, which is the patient s right, you see the right renal artery. That is the artery going to the right kidney. And opposite of that a little lower is the left renal artery going to the left kidney. So, clearly the left renal is lower than the right so we have to land a device just below the left renal artery. So, we will put a sheath in here right now, which is a plastic hollow tube inside which inside which, uh, can I have a just don t move a second please. Inside which we will place the device. We ve just got to put a towel here. You want us to talk about the aneurysm while you are getting those sheaths up or do you want to keep going here? We re gonna keep going unless I have a problem, Mark. I think we are in good shape here. Uh, here is the sheath going up and can I have that please, Chris? We need to staple that down, please. You see on the fluoro, I ll be advancing the sheath up into the aorta, that went very nicely. We take the inner lining of the sheath out and now we have complete control and access to the aorta. Can we have the device, please? The device, which is the endograft that we are talking about is a bifurcated(?) device that I think you saw on the video. We haven t shown that yet, Dr. Graham. Why don t you go to the video then, that would be good right now. So we actually have a video here of the device that we are going to show you and we will have a cartoon of the device and a cartoon of the patient. Uh, this is the Gore excluder endograft and it is a cartoon of a patient. And the patient s aorta is right here with the kidney s just above the aortic aneurysm and the iliac artery is below. There is the wire that Dr. Graham described going up through the iliac artery. And here is that sheath that he just advanced up on that live video feed of the angiogram. And now that sheath will be withdrawn to allow the exposure of the device. The device is all constrained and constricted until it s positioned properly and then it will be opened up or deployed. So you will see Dr. Graham go ahead and move this device side to side to gain his orientation. He ll see an image like this in the operating room with a fluoroscopy. He wants perfect position up and down below the renal arteries and right and left. And there is the deployment of the device and it actually will you will see it deploy that quickly in the operating room. The delivery system is moved from the device, you ll see that pop out here. And then a balloon catheter is advanced over that same wire, never losing wire access. The balloon is used to seat, or smash the device up against the inside of the aorta and there are little anchors that will hold the device in place. The balloon is removed and now we need to go ahead and finish the delivery with the wire up the contralateral side of the other side. The limb going to the left patient s left leg will be positioned and unsheathed and again deployment is the same as the trunk deployment. Again, the delivery system is removed and the balloon catheters are used to iron out the device and to seat all of the connections to the patient s normal aorta and to seat the device to itself. And with that cartoon animation, you should be able

4 to see a live case now with Dr. Graham. You have sheaths in place, we will go back to you, Dr. Graham. And Dr. Graham, did you get your sheath up there and you are well positioned? Yeah, we are in good shape here. We ve we ve orientated the graft and you can see us down here placing the graft inside the sheath. And I ll just show you here is the graft that is going to line the inside of the aorta. And now we place it inside the sheath. And now that is inside. Did you orient it already, Dr. Graham? Yes, I did, while you guys were showing that video I orientated it to about 130 in turns of the handle. So we are going to place this up, you see on the video, where we are. I checked the blood pressure and it is pretty good, could be a little lower. He said, quietly. Do you have to take another picture of the renals before you deploy, or? I m not going to yeah, I m going to do one more 30 for 8 and just bring this back. So we see the top of the graft that is right next to the pigtail catheter. And you can see the marks near the below the pigtail. Now I m going to shoot an angio, another 38-8cc angio. Hold breaths How much contrast do you like to use, Dr. Adelman? Usually use 20 cc for these renal shots. So you can see that we are with the 8 cc s shot here with you can see the cath, the device is probably just a little high. If I were to open it there it might be okay, but then again it might cover the left renal artery, which is not what you want. So we will pull it down a little bit. We have a pretty good length neck. So it is not 1, 2 millimeters is not critical. It looks like you are perfectly oriented. The long line is on the left side of the body there. So I need to take so my colleague will hold everything very steady for me. Your sheath is back there.

5 And before we do that we just want to bring the can I have the wire for the pig please? Oh maybe it will come down, hang on please. Did you withdraw your sheath already? The sheath is withdrawn. We just pulled the marking catheter out of the site that we are going to deploy. I d like that position pretty well. Hold that there. So this is about the only thing that you can have a problem with. I think everybody agrees we are in pretty good shape. That s the deployment string you just pulled there, so we should be able see that device open. So, we ve opened the device We ve got a lot at the angio the fluoroscopy? Yeah, can we see it on the angiogram there? On the The fluoroscopy? If I can have a balloon now, please. We can take it off a meg. So we should be able to see those 4 markers we see 4 markers on the screen, I know there are more than that in the patient, but we see it well opened up and in good position, according to that [unintelligible] and the audience should now see I guess you are going to advance your aortic balloon and try to see That s exactly right. We are going to put the balloon in now. This is a malleable balloon that starts off very small. Tennille and Rochelle are mounting it on the this wire that we have that sits up through the aneurysm. So the device has been deployed over the wire so the wire is still inside the device. We put the we put the balloon up here. And the balloon is used to seal that the neck of the graft, the endograft, inside that aorta. We use a nice malleable balloon. Is that what you use Dr? Yeah, we use a latex complied balloon. So now now I m just inflating this balloon. If you can see on the screen fluoroscopy screen.

6 Yeah, we can see it well. You like that, Don? And we are just pushing the hooks. Pushing the hooks into the into the aortic wall. The small hooks attach to this device. Yeah, excluder graft is nice, it has hooks on the top and preventing it from migrating which is I like that. Tell me how you leave the blood pressure, Alan. I know you like to drop the blood pressure for deployment and then you let it come up right about now? In reality, unless he has cardiac disease I don t. I just leave it steady so that I don t have any trouble with my migration until I get some longitudinal stability, so it can come up now, yeah, but we don t really worry about it too much. So now all we need to do, we can back this off. This tends to be a tricky part coming up, trying to get up the other leg and get that wire up into the grafts. So, some times we this part now so, basically we have the device with one leg lower, deployed. Lower So, I have this marking catheter in the aortic aneurysm, but it s the catheter is not in the device. I have to try and get this wire to go through the device. Yeah, while you cannulate that contralateral gate, can we talk to the audience about aneurismal disease? Yeah, I think that would be great right now and come back in a few minutes, we ll show you what we are doing. So, I m here again with Dr. Brevetti and while Dr. Graham he s got a very nice deployment of that first part of the device the trunk, now he s got to get a wire up through a gate where that hole in the contralateral side going to the left leg to be able to deploy the second part of the device. That usually takes a few minutes, so we ll try to go over to Dr. Brevetti, where she will talk to the audience about abdominal aortic aneurysms and if we have some time after that we will start to answer some questions. Dr. Lucy Brevette. Just a little bit about aneurysmic disease. What I have here is a picture of or cartoon of a person with the heart and aorta. Now, this picture is the normal aorta and you see here are the renal arteries that Dr. Graham had pointed out on the angiogram of the patient that he is

7 operating on currently. And then there is a picture of the bulge, or the aneurysm itself. Now the aorta is the largest blood vessel that carries blood away from the heart and supplies the legs and the abdomen and as Dr. Adelman had talked about, the iliac vessels, and that s the vessels where the bottom part, or the pant leg part of the graphed seals as well. An aneurysm is a dilated portion of the blood vessel and the reason why we fix them is because if they grow to be a certain size, then they can rupture or burst and that would be very life-threatening. As far as celebrities or people that you might now or have heard of that had aneurysm disease, the picture here Lucille Ball and Albert Einstein both died of ruptured aneurysms. And people that were treated successfully with aneurysms- Rodney Dangerfield was treated successfully a few years ago, unfortunately he died of his cardiac disease. And Senator Bob Dole also had an abdominal aortic aneurysm, which was repaired with the endovascular graft and that was successful as well. Just a little bit about who gets abdominal aortic aneurysms. AAA, also abdominal aortic aneurysms are the 15 th leading cause of death in the United States and approximately 200,000 Americans were diagnosed with abdominal aortic aneurysms per year. And 15,000 Americans will die yearly of abdominal aortic aneurysm ruptures. As far as what symptoms people might experience with AAA, or aneurysms, most people really don t have any symptoms at all. The smaller aneurysms and even some large aneurysms have no symptoms. Some patients do complain of abdominal or back pain or tenderness on exam or when people are examining or pushing on their abdomen. Like I said earlier, smaller aneurysms can be observed safely if they are not tender or painful. And then the larger aneurysms are the ones that we prefer to repair, such as this patient that Dr. Graham is operating on now, had an increase in size on his aneurysm and that is why he is at slightly increased risk of rupture. Here is a picture of the traditional approach for repairing an aneurysm. Once again, the top picture is showing the aneurysm itself and then the bottom picture is showing how we sew in a graft the old fashioned way. A long incision on the abdomen is made and the blood vessel, the aorta is actually clamped above and then there are clamps here on the blood vessels that supply the leg. And this is the graft that is sewn in place. Normally patients that require this stay in the hospital about 5 to 7 days at the minimum and sometimes stay in the intensive care unit for one to two days. And generally patients don t feel back to normal until a couple of months, even. As far as the endovascular repair, there has been a tremendous improvement in patient morbidity and comfort. And I think Dr. Adelman will take over here in explaining the endovascular repair. Well, it s a much less invasive repair, Dr. Brevetti, I think is going to go check on things in the operating room. It s a much less invasive repair, one to three days in the hospital as Dr. Brevetti mentioned. And a full recovery and back to work really within a week, typically. The device we are going to be using today is the excluder device, as we mentioned earlier. And this comes in two pieces really, with anchors which are well seen at the top of the device right in this area, the junction point is right in here and you ll see soon Dr. Graham cannulate that contralateral gate. And prepare to deploy the contralateral limb. Okay, so we have some s coming in now, some questions, and we will try to get through those right now. We ve got Elmer from the United Kingdom, writes, I m about to undergo this procedure, how long has this method been in use and what is the follow-up immortality? Well, actually in the United Kingdom, in Europe, this device these devices, endovascular devices, have been going on now for almost 15 years. The first device was placed in Argentina about 14 years years ago and the European experience has been quite good. It became FDA approved in the United States in 1999 and we ve got follow-up data on patients who are in trial going back to So the follow-up data now is up to 10 years old, with excellent long term results. We don t yet have 20 year data and

8 so we are continuing to follow these patients annually. Sheryl asks, What is the main cause of aneurysm? And is there any way to avoid having them? We really don t know what causes aneurismal disease. We do know that it tends to run in families. It tends to be inherited from one generation to the next and when women have an aneurysm, they pass it on to their first degree male relatives, their sons have a very high incidence of aneurysm disease and brothers of women with aneurysms have a very high incidence of aneurysm disease. So it is expressed very potently when it is expressed in a woman, although most aneurysms do occur in men. We really don t know of any way of avoiding these aneurysms, we do know that they grow more slowly if we keep the blood pressure controlled. Cessation of smoking, all those good things, but no, we really don t have a good way of preventing the growth of these aneurysms. A kid asks, What are the symptoms of an abdominal aortic aneurysm? And, she indicates, her kid indicates, I had two uncles and my grandmother die of aneurysm ruptures, are there hereditary factors? We touched on that a bit. Again, with the grandmother, it is a very strong expression of the gene in this family, you can see that there were ruptures in this family as well. Symptoms are tough. Symptoms most patients do not have symptoms prior to the point of rupture. Which is important in terms of screening. If aneurysms run in your family, the best way to look for an aneurysm is with an ultrasound. Ask you mention to your physician that you have aneurysms that run in your family and an abdominal ultrasound will make the diagnosis. Physical examination is also sometimes good although half of aneurysms can be missed by even an experienced surgeon manually, looking for aneurysms. In terms of symptoms, they typically don t become symptomatic until the time of rupture and that can be an acute onset of very severe back pain or abdominal pain, low blood pressure, loss of consciousness. This usually represents an emergency, of course and requires a direct contact with an emergency room. So chronic back pain is often times not a sign of an aneurysm because many people do have back pain. But if you have aneurysms that run in your family, these ought to be checked with a you ought to be checked with an ultrasound to make sure you don t have an aneurysm in your belly. Carl asks about other treatment options instead of surgery. For the abdominal aneurysms, no. There is nothing besides endovascular repair or open repair, conventional repair of the abdominal aortic aneurysm. Once it becomes large enough, the size of aneurysms that require treatment typically about 5 centimeters, depending on cormorbidies of the patient maybe 5.5 if they have other serious medical problems. If patients are very sick and very poor surgical candidates, we may go on to 6 or 6 ½ centimeters. But there are currently no other treatment options. Dr. Brevetti mentioned Albert Einstein, who died of a ruptured aneurysm. The diagnosis was made some three days prior to his death and surgeons from all over the world were flown in to consult on this and suggest treatment for it and there really was no good treatment for Dr. Einstein s aneurysm. So surgery really is the way to go once it is necessary to treat this aneurysm. Mindy asks, What is calcification of the aorta. What can be done about it? All blood vessels in the human body ultimately become calcified, if you live long enough. Some people calcify earlier than others. And calcification in and of itself is not dangerous. It can be a sign that there is some blockage in the arteries. It can be a sign that there is an aneurysm in the area, but also it is normal to have some calcification in all arteries of elderly patients, so that calcification that you would see on an x-ray is not necessarily a bad thing. John asks, What patients what should patients or referring physicians look for in a hospital that performs these procedures? I think he is referring to the endovascular procedure. As I mentioned, this procedure was first FDA approved in 1999, there were many centers that were involved in trials leading up to FDA approval beginning in 1993 and Results in these procedures are very much depended upon the volume that that hospital does, because as Dr. Graham mentioned, it s not just the surgeon, it s the entire hospital. It s the ICU, it s the OR nurses, it s the house staff, it s the fellows. And

9 all of the support staff in the hospital that help get you sort of endovascular procedures done. So, results typically do correlate directly with volume, so you ought to be looking for a surgeon and a hospital that do high volume of endovascular repairs. That will give you the best results typically. Jerry asks, My mom has an aneurysm that is 5.5 centimeters, she has been told she can t have the less invasive surgery because of the location of the aneurysm. What are her expectations after more invasive surgery? She is 79 years old and had two siblings die from ruptured aneurysm. Well, Jerry, as Dr. Graham was indicating to us earlier, we need to have good, normal aortal anatomy by and below the aneurysm to be able to attach the device, so I think probably what is going on with your mother is that the anatomy is inappropriate. The most common reason for that is that there is not enough space between the renal arteries or the kidney arteries and the aneurysm itself. We like to have 15 millimeters of normal aorta before the aneurysm starts up. So, she probably had her aneurysm and it went up higher. At 5.5 centimeters, it probably does deserve to be repaired. Especially if she is in relatively good health and she has a strong family history. The more invasive surgery typically involves about two to four hours of operating room time, about one to two days in the intensive care unit, about a week 7,8, maybe even 10 days in the hospital. And then patients typically do not feel themselves for about 6 to 8 weeks after the aneurysm surgery. So it is quite a bit ordeal. It is similar to open heart surgery in terms of the recovery from this major surgery. The good news is once they are repaired, it tends to be a very durable surgery that lasts for the rest of the patients life. Hedrick in Belgium writes in and he says, I am 67 years old and my aneurysm is 54 millimeters in diameter, or 5.4 centimeters. My family doctor told me that I could wait with hospitalization until the aneurysm has reached 60 millimeters or 6.0 centimeters. Ten years ago my father passed away from a ruptured aorta. What do you suggest I do? This goes back to the sizing that I was talking about earlier. We start to consider patients for repair of an aneurysm as they approach 5 centimeters or 50 millimeters in diameter. Depending on the patient s co morbidity, if patients are more sick or have a higher surgical risk, they ll tend to wait longer. Because we don t want to subject the patients to a very high surgical risk if the rate of rupture is low. So, at 54 millimeter, Hendricks, I would think that your risk of rupture runs about seven percent per year. And probably is something that we here in the United States would consider for repair. There are some other trials, they ve been published out of Europe, talking about waiting until 55 or 60 millimeters. And, I think that is also a valid choice. But, I think there in the United States most surgeons would tend to repair a 54 millimeter aneurism, especially with a strong family history. Janie writes in, and she says she s 48 years old with a four centimeter aneurysm. This is interesting, one doctor indicates that the newer, less invasive way should be done at this time. One says that you re too young to have the repair because the long term outcome is not known, I guess. Um, well that s true, that the long term outcome is not known. We only have ten year data on a few patients. And, this is, we don t know what is going to happen 20 years out. At age 48, I m sure you hope to live another 40 or 50 years. And, we don t know what is going on. I think for younger patients, many surgeons are recommending open repair if the anatomy is appropriate for an open repair, just because we don t know what is going to happen 40 years down the road. We do know that the ten year data looks very promising. We expect to have great 20 year data. We don t know what is going to happen 40 years down the road. Jerry asks about what influences are the choice of the Gore Excluder over other stints? Well, Jerry, there are three now FDA approved devices for repairing abdominally aortic aneurysms. There were four, one of them was removed from the market. The Gore Excluder is one device,

10 there s a device called the Cook/Zenith graft, and the Aneurex Graft by Metronics. All of these devices have their own attributes and are better suited for individual patients. So, much of this has to do with the individual patient s anatomy as well as the surgeon s experience with the devices. This patient seems extremely well suited for the Gore Excluder, and that tends to be my graft of choice when the aorta will fit all three devices. Ron asks, which company produces the best stint graft? And, again, I guess we answered that question ago shortly. There is not best stint graft right now. Each stint graft has its own application, and each stint graft has its own problems. All surgical procedures and all devices have their own Achilles heels. And, each device has its own little things that tend to be bothersome to us as surgeons. But, they re all excellent devices. As I mentioned, I tend to try to use the Gore Excluder. It s just a very easy device to use when it will fit all three devices. Darren asks, does the graft line the entire aorta where the inflammation is, or is there a gap where the bulge is? Darren, the graft will line the entire aneurismal segment. So, we re actually trying to seal the device. Let me see if I can pull a slide up here. Yeah, I ve got a slide showing now, if you could get that on your website. And, you can see that there s normal aorta above the graft, and normal iliac arteries below the graft. And, the stint graft, or the excluder in this case, will line just the segment that is diseased, attaching to the normal arteries above and below the aneurysm. You don t want to line the entire aorta because there are important blood vessels that come off of the aorta to the intestines, the kidneys, the spinal chord, the legs and higher up the carotid arteries to the brain. So, you certainly don t want to line the entire aorta, but you do want to line the entire segment of diseased aorta. Maggie asks about latex. She asks, instead of latex, are there any types of balloon materials? And, the answer is yes. I think of what you re probably referring to, Maggie, is that you may have a latex allergy or know someone that has a latex allergy. There are many other balloons out there, and we certainly have latex free operating rooms for patients that have latex allergies; That does not pose a problem at all. Here s Chris from Ohio. And, he s an EMT intermediate. And, in his training, he s been strictly taught that gentle handling, blood pressure control, and oxygen are the keys for prehospital care. Are there any other things you would emphasize in the management of these patients. Well, this is actually a very interesting question, and you make a good point, Chris. In the old days, with ruptured aneurysms, we used to talk about trying to get the blood pressure back to normal. And, actually, Stanley Crawford, in Houston, did a family study and this and wrote a paper describing the fact that when we get the blood pressure back to normal, it actually causes a rupture to occur again. So, the rupture may seal off temporarily. As the patient s blood pressure drops, blood clots will form, and the blood pressure drops and the patients do well. And, then as we raise the blood pressure, this may cause more bleeding. So, the current teaching is as you are, as you ve been taught, you generally want to keep the blood pressure maybe in the 60 to 80 systolic range, which is hypertensive, it s very below normal blood pressure so that we don t cause more bleeding. And, as long as we keep the patient alive like that, we re happy to see them with a ruptured aneurysm with that low blood pressure. Ellen writes, an ultrasound showed several small aneurysms two years ago. Recent tests show no aneurysm. Can they just disappear? And, the answer, Ellen, is no, they cannot just disappear. Two possibilities there. The ultrasound might have been wrong. Meaning that if we

11 are able to look at the aneurysm well with the ultrasound, we typically get a very good look at it and we can size them very nicely. However, if it s an abdominal ultrasound, typically the bowel acids can get in the way and we don t always get a good look. So, they might not have seen the aneurysms before. The best test at whether you have an aneurysm is probably a non-contrast cat scan. A cat scan without intravenous contrast will show the aneurysms. An ultrasound is a great screening system. It picks up most aneurysms. But, if there s a discrepancy between your prior reports and your current report, a non-contrast scan is going to tell us whether or not you have aneurysms there. My brother died from an aneurysm. This is Maureen, and she writes, My brother died from an aneurysm three years ago. That s when I had my first ultrasound, and they found an aneurysm that was 3.1 centimeters. I have ultrasounds every six months, and my doctor told me not to worry until it reaches 5 centimeters. It s now grown to 3.7, and grew just 0.5, or half a centimeter in the past six months. Should I be concerned, and should it be operated on earlier than five? Well, the typical rate of growth of all aneurysms is about 0.5 centimeters per year. So, you re growing at a normal rate, it would not be considered a rapidly expanding aneurysm. The fact that it s 3.7 now is probably not a cause for concern. The reason we pick five centimeters is that there are many studies out there that show that aneurysms that are small than five or 5.5 centimeters do now rupture. And, that has to do with the intention on the aneurysm wall. It s a physics equation. So, at 3.7 we are really not concerned with rupture. And, at the growth of 0.5 centimeters, actually at six months, that is a little faster than normal, it may be considered rapid growth. I would probably start to repair aneurysms that are growing that speed as they approach 4.5 centimeters. But, that s a judgment call and depends very much upon your other health conditions. I m going to break here and get an update from Dr. Graham, who can show us what he s been doing there and, how does it look in there, Alan? Camera two, we re still trying to get the wire inside that blind gate. And, so that s what the hesitation s been a little bit, here. We can t get, the aorta s got a lot of calcium in the distal part of it, and we can t get the wire through. So, we re going to snare this thing, so we ll be a few more minutes and then we ll get this thing up and we ll get back to you. So, we ll got back to Dr. Adelman for a few more s. Ok. Great, so just to explain to the audience what s going on, we talked about the most difficult part of this procedure was going to be trying to get the wire up into that contralateral gate. If you remember from the video that we showed you earlier, there s, I m going to see if I can find a slide of that. Well, there s the device, you can see that it looks like an upside down Y in this position. But, it actually comes in two pieces. And, Dr. Graham has deployed the first piece, which is the trunk going down into the patients right leg. And, the needs to get a wire from the left leg into the device. So, he s got to drive that wire up and hit a little tiny target with very little control of the wire as it passes through these very torturous, or twisted arteries. After several attempts at trying to do that, he was unable to do it, so he s actually going to up and what we call, Over the top. Meaning he s going to come from the patient s right side where the device has already been deployed. He ll come up to the stump of that Y or the bigger part of that device and over the top and down into the patient s left leg. And, snare that wire and bring it

12 out, it s a pretty nifty move, and it just takes a little bit longer, and we should be with him shortly. So, we ll go back to some questions, now. Norma writes, My husband has an abdominal aortic aneurysm, and he has a blockage in both legs. The doctor suggests an aortic bypass to include both legs. This seems very risky, how safe is this procedure? Well, if the blockages in the iliac arteries are significant, then it is not very easy to bring one of these devices up. The device deployment delivery system tends to be about as thick as a pencil. So, if your access sites are smaller than the thickness of a pencil, meaning there s severe blockage in the arteries, we typically have a very difficult time trying to get the device in. That is coupled with the idea that the same time as an open repair, the surgeon can also repair the iliac arteries and fix the circulation going to the legs. So, it s really not a very more involved procedure than an open abdominal aortic aneurysm repair. That is a somewhat risky procedure. The open repairs tend to carry around a mortality rate of about two percent. So, we take these things very seriously, where it is not much different than an open aneurysm repair, and if the blockages in the legs are quite severe in the iliac arteries, I would tend to believe, after seeing the films directly, that an open repair is probably more appropriate. Jason asks, Is this less invasive procedure available in most hospitals? I think that probably not. This is, as I mentioned, was only FDA approved in 1999 and takes a very sophisticated staff of radiologists to make the diagnosis. Imaging techniques to make the diagnosis. Surgeons to be able to perform these procedures. Radiation technicians to be able to operate the x-ray equipment. ICU staff and anesthesiologists who are familiar with this. So, it s only been FDA approved now for five years. I think it has not made it into the smaller community hospitals. And, as I mentioned earlier, results are best when going to a hospital that does a high volume of these like the two hospitals that Dr. Graham and I represent. Mary asks, Is abdominal aortic aneurysm likely to rupture if it is currently 5.1 centimeters. I have a repair scheduled for early November. Well, good luck with you surgery, Mary. It is probably not dangerous to wait until early November, we re probably talking two, three weeks down the road. The risk or rupture at five centimeters probably runs somewhere in the range of five to seven percent per year. So, waiting two or three more weeks is probably not a dangerous thing, and we certainly wish you well in your surgery. Janie writes in, and she says that, no we ve been through that one. Shannon asks, Can this procedure be done on a person that had three hundred percent blockages in an aneurysm in the main aorta? I think Shannon s probably referring to blockages in the coronary arteries, or in the heart when a patient has three total occlusions of the coronary vessels. The answer there, Shannon, is yes, this procedure can be done. Any time a patient has severe heart disease like that, of course the complication rate goes up significantly. So, we tend to wait until those aneurysms are larger than five or six centimeters. You know, a patient with three blockages, I might wait until the aneurysm is seven centimeters. When the risk of rupture of the aneurysm or the risk of leaving it alone gets very high. As that risk of rupture comes up to 20, 30, 40 percent per year, we have to accept a little bit of cardiac risk to go forth with this endovascular procedure. But, this has been a great procedure for patients who have severe coronary disease or severe heart disease because it is not very stressful on the heart or the lungs to go through a procedure like this. And, in fact, we have done several of these procedure under local anesthesia. Not my preference, but it can be done.

13 Laura is asking about symptoms. She says that she has sweats and nausea, a faint feeling running down the left side of her stomach. Is this symptomatic of the problem? Well, pain in the abdomen can be a symptom of an abdominal aortic aneurysm if it s rapidly expanding or trying to rupture. But, the sweats, nausea, typically are not symptomatic of an aneurysm. Faint feeling can happen any time there s low blood pressure. So, if you re worried about an aneurysm my advice to you would be to go see your doctor. If he s worried about the aneurysm he can always get an ultrasound to make the diagnosis or to figure out what exactly is going on I there. How s it going in there Alan, are you getting over the top? Well, we re over the top but we can t get through the piece of calcified iliac. So, we re still struggling a little bit. That s fine, Dr. Graham, I ll let him work a bit. So, what he s describing in there is that this patient does have a little bit of blockage in their artery. There s a little piece of calcium in the artery and he s able to get the wire over the top of the Y device, and he s now trying to bring the wire back down and he s run into a little bit of blockage in the artery. This may be something that he needs to open up with a balloon. But, it sounds like it s going to be a little bit more challenging than Dr. Graham was hoping. Darren asks, What causes an aneurysm to grow or form? Does the aorta wall just get weak over time? And, that speaks probably back to that hereditary component that we talked about. Uh, it does tend to run in families. We don t know exactly what causes them to grow. There have been some protein abnormalities defined by several scientists in the aortic wall in some family groups so that the protein tends to not be as strong. Or there tends to be different enzymes in the aortic walls. So, this can cause them to grow more quickly. We also know that the aneurysm are more likely to rupture or grow in patients that have high blood pressure and patients who smoke. And that probably has to do with the blood pressure, which is obvious. There s higher pressure in the aneurysm. The smoking probably has to do with turning on certain enzymes in the aortic wall. Allison wants to know, What is the recovery time for this type of surgery? And, it s quite good. The patient will typically leave the operating room awake, talking, feeling comfortable, with two small groin incisions. The patient will then go to a monitored setting, either an ICU or a step down unit. And, will spend one day there, maybe two days, and go home the next day. The patient will feel very well, and typically is hopeful to return to work or their daily living activities within one week. So, patients they literally walk right out of the hospital when all goes well. It s quite remarkable given the severe complicated course that some patients have run after an open surgery. Christina asks, We are a high school biology class, and one of the student would like to know if this surgery can disrupt a pregnancy? Ok, well, we ll get back to Christina s question in just a moment. Dr. Graham has done what he needs to do here. Dr. Graham, go ahead. I m glad you stayed with us, we had a little difficulty in order to get the wire up the contralateral limb. We ve been able to do that, we re quite happy now. This is, as Dr. Adelman said, it can

14 take ten seconds or it can take 20 minutes. It depends on the morphology. We re up now, so now we re in the position to complete the procedure. How did you get past that block, Alan? We tried, we finally put a soft somny around the corner, there was a big calcified ridge around the bottom of the aneurysm. So, we had the calcified ridge there, and we had trouble getting underneath it and over to the left side of the aorta. But, we got the wire in, we re ok now. Is that going to require something down the road in the procedure? A balloon or No, I don t think so, Mark. I think it s just some calcium in the bottom part of the aneurysm shell. The access vessels are ok, so it s just one of those things that happens. Live TV or whatever, live internet. So, now we re in a position now to place my contralateral sheath, please. We re going to check the pig first. So, do we have a pig there? Alright, so what we do here, we re pretty certain that we re in the contralateral limb, but what we re going to do to be certain, is put a catheter in and form it. And, we actually take the catheter and we twirl it around. You see it twirling inside aorta. That means that we re inside that limb. You can make the mistake of after struggling, think that you get through the aorta, forget that step, and find that you wire went not through the graft, but the back of the device. And, when you deploy your contralateral limb, it s not in the right spot and you end up having to invert to an open procedure. May I have the big sheath, please? Have you looked at you length on that side yet, in terms of not covering that hypogastric? Yeah, we re going to do that. We re just getting organized here. 10 for 15 on an REO projection, please. So, now we re going to look and see where the left internal iliac artery is. This is the vessel that feeds the pelvis, the rectum, the muscles in the buttocks. And, we don t want to cover that vessel. So, we do an go to fluoral, if you go to fluoral you ll see an angiogram being performed by the die is coming down. We re going up, we re actually profuging up the sheath, we re going up the iliac artery. And, then we ll mark that. And, we get the right lengths for us. So, what we do is we measure from where the device is in the aorta. And, down to the internal iliac arteries. Do we have a 95 or something? What do we got? Ten to the So we ten centimeters of the vessel to cover. Thank you. So, we have that device.

15 That s a nice looking angiogram. You d never know from looking at that that you had run into some trouble. Well, the trouble is in the very distal aorta, just past, just before the origin of the iliac artery. We need to change this sheath out. DR. BREVETTI Glide catheter. And, then the amplats. So, now we re just changing wires to get a stiffer wire, a stiffer wire into the aorta. We need a stiff wire to track the device. If you have a soft wire when you track in the device, instead of carrying on the wire, it will push the wire out of the aorta, and that will take us the other 20 minutes that we spent trying to find that hole there, again. So, we don t want to do that. So, we re going to make sure we re ok here. Are you going to use an amplats wire? We re going to put an amplats wire, yes, up into the aorta. That s nice, ok, can I have the amplats, please. So, we ve put this sheath into the aorta. So, all we re doing, we just leave the sheath in there to change wires. So, the wire now we re putting is so much stiffer. And, we ll use that to track the device. We measure how long it is so we don t place the vessels in the neck. Now, we re ready to place a larger sheath. Can we have the contra sheath, please. Wire. This, this thank you. We take the smaller sheath out, and we have a larger sheath, please. This is the same as we did on the other side, only this sheath is smaller because this limb that we put in is only, is about half the size of the main device. So, we re just, as you can see we actually don t watch the patient when we operate. We actually watch the television monitor or the fluoroscopy monitor. And, that goes there. And, now I watch this sheath, you can see it moving up. Watch fluoroscopy now, and you see the sheath goes right into the device very nicely. You can feel the little bit of irregularity as it went past that calcified ridge on the distal aorta below where the device is. We ll have the contralateral limb placement, now. How did you orient that contra limb? Was it anterior? It is anterior, left anterior. The limb, it comes down deeply into the aorta. And, that s a calcified ridge, and we had to kind of go around it and then if the where is George? Where is my main man, George? so basically we re going off the limb and then we had to go around this calcified ridge and back up into that limb. And, so that S shaped curve was complex. You lose all of your mechanical advantage.

16 Yeah, it becomes a little difficult. How are we doing here? Good. So, Dr. Bravetti, now, is placing the contralateral limb. Can we sharpen up that image on the fluoroscopy? Here we go, now if we see the large, if you go to fluoroscopy, you see the large mark on the patient s left, your right as you re watching it. That s the bottom of the contralateral stump. And, there s a mark a long ways down by the pelvis, which is the distal end of the device. And, I think that s a pretty good spot there, you could bring it down just a hair. And, the sheath is ok? So, ok, now what we do, George, what I d like you to do is have a close up of Dr. Bravetti unsheathing the device. I m going to hold everything here, and all it is, is like a lawn mower chord. All she does is pull and, that looks pretty good right there, Lou. And, bingo, that thing s open, now. And, we can remove the device and put the balloon back up, and the balloon, where that contralateral limb now is attached to the main body. All those years of training and all it takes is to pull that string. It s impressive to have to go school for 13 or 14 years and learn how to pull a lawn mower chord. DR. LUCY BRAVETTI Sometimes you pull it too fast. It s probably tough for the audience to see. We re getting a very nice image there, actually, but unless you know what you re looking at. It looks beautiful from my standpoint. The shadows are a little difficult probably for the Well, he s got a little ball gas going right now, but you know that 20 minutes of fluoroscopy, you get some bowel gas, and you don t see it quite as well as you d like to. We re going to show you a nice picture here in a minute. I know it s difficult. But, I think if the audience goes back in their minds to the, to the animation in fact, it might not be a bad time at one point just to switch to the animation one more time. You ve got time for us to watch that while you re ballooning. Just watch the balloon, we re ballooning the contralateral limb. We re just squeezing that limb against the main body. And, then we ll balloon it down at the bottom part. And, I think you could, right now you could go to an animation and show them what we ve done so far so they can get a feel for what s going on here. That s great, can we, yeah, ok. Great, so actually, we re going show that movie again. We showed it s a few minutes ago, for those of you that missed it, we re going to go through the video presentation of the cartoon of what Dr. Graham just did with the Gore Excluder device. Here s the cartoon of the body again, and the aneurysm sits below the kidneys, below the renal arteries. The wire goes up, just as Dr. Graham did. And, a sheath will go up over that wire, and underneath that sheath sits the aortic excluder device. The sheath will be moved now to show the device, but the device is still constrained. The device is then going to be oriented, right, left, and up and down. We want to keep it below the renal arteries, and we want to make sure that