DAVID I: INNOVATIVE VALVE-SPARING SURGICAL PROCEDURE NEW YORK-PRESBYTERIAN HOSPITAL WEILL CORNELL MEDICAL CENTER NEW YORK, NY June 12, 2007

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1 DAVID I: INNOVATIVE VALVE-SPARING SURGICAL PROCEDURE NEW YORK-PRESBYTERIAN HOSPITAL WEILL CORNELL MEDICAL CENTER NEW YORK, NY June 12, :00:09 ANNOUNCER: Welcome to New York-Presbyterian Hospital Weill Cornell Medical Center. Over the next hour you'll see experts discuss valve-sparing surgery for patients with aneurysms of the aortic root. If left untreated, an aortic root aneurysm can cause lifethreatening conditions such as aortic rupture or dissection. With dissection, blood flows through a tear in the inner layer of the aorta, causing the layers to separate, potentially triggering the aortic walls to burst. With method being discussed, the aneurysm is repaired while the patient's own aortic valve is preserved. This helps to avoid the use of long-term anti-coagulant medication like Coumadin and may reduce the risk of stroke. 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 join the doctors at New York- Presbyterian Hospital Weill Cornell Medical Center. 00:01:10 O. WAYNE ISOM, MD: Good evening. I'm Dr. Isom. I'm the chairman of the department of cardiothoracic surgery here at Weill Cornell Medical Center, part of New York-Presbyterian Hospital. And we're going to talk about aortic aneurysms today. Now, there's all sorts of aneurysms, everybody knows, and they're all serious. But the aneurysms of the ascending aorta are probably one of the most feared aneurysms and the most dangerous. If they get to a certain size they can rupture or dissect, and if they rupture, even if the doctor is standing right there, there's nothing we can do about it. You're probably going to die. The -- when they get to a certain size, and we've learned over a period of years, if they get to about 5 centimeters, then they've got about a 5% chance a year of rupturing. If they get up to 6 cm, then it's about a 15% chance of rupturing. So we want to take care of them before they get to that chance of rupturing and dissecting or dying. We're going to talk about today a fairly new technique that's done here at Weill Cornell mainly by Dr. Girardi, and we'll introduce him a little bit later and he's going to describe a little bit about this. But in the years past -- for example, when I was a resident I never saw one of these survive. They all bled to death. Over the period of '70s and '80s they got better, but even then you had to replace the valve along with the aneurysm with a tissue valve that might wear out -- we still use those -- or a mechanical valve which lasts a long time but you've got to take Coumadin or a blood thinner for the rest of your life. So one of the newer techniques is to be able to take care of the aneurysm before it gets so big and spare that valve and hopefully prevent it from developing a leakage later on and having to go back in a second time. We've got Dr. Girardi, who's head of the Aneurysm Center here at Weill Cornell, and Dr. Mary Roman, who is a professor of cardiology here at Weill Cornell who will also discuss some of the diagnostic techniques. I'm going to turn it over to Dr. Girardi at this point. Dr. Girardi? 00:03:28 LEONARD N. GIRARDI, MD: Thank you, Dr. Isom. As Dr. Isom described, in the past patients with aneurysms of the aortic root were left with one basic technique for aortic reconstruction, and that was replacing the ascending aorta with a Dacron graft, and under most circumstances, having to replace the aortic valve because the valve was attached at

2 the base of the aorta as it comes out of the heart. We would do it with a one-piece unit called a composite valve graft, as you're seeing here in this slide, where the aortic graft is attached to the valve and then that portion was attached into the heart after removing the aortic valve and cutting out the ascending aorta. As you see in this schematic drawing here, we would then go ahead and put that one-piece unit in and reattach the coronary arteries and then hook it back into the native aorta and that would take care of the problem. Unfortunately, however, in patients who had mechanical valves that mandated lifelong anticoagulation with a drug like Coumadin, a blood thinner that you have to take every day, that you have to monitor at certain levels, and if you get a little too much of it in your system your blood can get too thin and you can have bleeding problems, or if you don't have enough you could get a clot on your valve. Similarly, if you had a tissue valve like a cow valve, a bovine valve, or a porcine valve, those valves would eventually wear out and you'd need another operation. About the late '80s, early '90s, techniques -- surgical techniques were developed that allowed one to replace aortic root aneurysms while preserving the patient's native aortic valve. This left the patient without the need for Coumadin, it allowed them to have native valve function, which allowed better performance of the heart from an efficiency perspective, and hopefully with time we would get improved durability. Now, the initial procedures that were described by one of the surgeons in London did a great job of eliminating the aneurysm and preserving the valve. Unfortunately, it didn t do much to stabilize the root of the heart, and those patients' aortic roots, or the skeleton of the heart, continued to grow, and recurrent aortic insufficiency mandated reoperation in many of those patients. A separate technique was developed by Dr. David in Toronto, and that technique allowed the same things to happen: preservation of the aortic valve, elimination of the aortic aneurysm as well as the risk of rupture or dissection, but his technique allowed us to put the valve inside a graft, put that graft around the skeleton of the heart, thereby preventing further dilatation of the aortic root that would lead to valve failure. That was called the original David I procedure. That has since undergone multiple modifications in an effort to make improvements, but the David I is still the most common procedure performed by surgeons doing this on a routine basis. And that's the kind of procedure we're going to show you tonight. Now, it normally takes about 1.5 to 2 hours, which is more time than allotted this evening. We're going to show you our most recent videotape of this and go over the technique in great detail. Now, the patient in question tonight is a 47-year-old male who incidentally had a very strong family history of thoracic aneurysms -- his father had had a thoracic aneurysm -- and so he went to see his doctor, who found a murmur on him on examination. He otherwise was well: a little bit of hypertension, a little bit of high cholesterol, but no other major medical problems, and he was quite well. His physician fortunately heard his murmur and sent him for an echocardiogram, which showed that he had a little bit of leakiness of his aortic valve, which in and of itself is not a major threat. However, his aortic root, the ascending aorta, was very dilated, and subsequently he performed -- he got an MRA scan, which looked at the aorta in detail from the aortic root on. This is a still photo of that MRA. As you can see in the center of the screen, outlined in white and with a line running right through the middle of it is the ascending aorta. The part that's bulging out is about 5 centimeters in diameter. The upper limit of what's abnormal, which were described here by Dr. Roman a number of years ago, is about 3 to 3.4 cm for an average adult male of about 80 of 90 kg, which this man was. This is a 5 cm aorta, and once the clinician who was taking care of him had this information, he sent him on to us for an evaluation. Once we saw him in our clinic we thought he might be a good candidate for valve-sparing surgery, but we required more information and we wanted to see our own echocardiogram, and so I asked Dr. Roman to perform an echocardiogram here at Cornell. Dr. Roman, would you please go over that for us? 00:08:21 MARY J. ROMAN, MD: Thank you, I'd be happy to. In determining whether a patient is a good candidate for a valve-sparing surgery, there are a number of different aspects that we

3 look for on the transthoracic echocardiogram. One of them is to determine whether the aneurysm is not extremely large. And this gentleman's transthoracic echocardiogram -- why don't we look at the videotape now? -- showed that his sinuses of valsalva measured about 5 cm, confirming the findings on the MRA. And this is a parasternal long-axis view of his heart, and you can see that the enlargement is 5 cm. In addition, another aspect that we look for on the echocardiogram is whether the pump function of the heart is normal, the left ventricular ejection fraction is normal. This person's ejection fraction was normal, meaning that he would probably be able to tolerate the duration of the surgery. We also looked to confirm that the aortic valve was structurally normal, which it appeared to be. And then finally, we looked to see what the degree of aortic regurgitation was. And in this particular gentleman, there was just trivial aortic regurgitation. So in sum, all four things that we look for were in good order for this particular man: minimal aortic regurgitating, not extreme aortic dilatation, normal pump function of the left ventricle, and a morphologically normal aortic valve. 00:09:59 LEONARD N. GIRARDI, MD: Thanks, Dr. Roman. Once we got the final information on his echocardiogram and we saw that his valve leaflets were in good shape and that he had a minimal amount of aortic insufficiency and that his aortic root wasn't terribly dilated, we scheduled him for an operation. Prior to the operation we performed one more test on this individual. Because of his history of high cholesterol and hypertension, we performed a cardiac catheterization, or a cardiac angiogram, as you can see here. And that procedure allows us to identify any potential obstruction or blockages in the patient's coronary arteries. It also gives us an idea of what his coronary anatomy is, because in this operation we have to reconstruct the root in such a way that the coronary arteries have to be taken down while you're reconstructing the aorta and reimplanting the valve, and then have to be reattached. Most of the time that's not a problem and most patients don't have any anomalous origins of their coronary arteries. However, if you're born with a congenital anomaly, where one of your coronaries comes off in an unusual positioning, it can make this operation more challenging than you really want it to be, and that's not necessarily something we want to find out in the operating room. One of the newer techniques that we use here at Cornell also is what's called a '64 slice, or CT angiogram. It allows us to see a patient's coronary anatomy in detail without putting them through an invasive procedure such as a catheterization. Here at New York-Presbyterian we have many of these '64 slice CT scans, and so we're going to be using them more and more and not having to put as many of these patients through this procedure. We do this procedure, the catheterization or the CTA, the day before their surgery, and then the next morning we take them to the operating room for the procedure, which we're going to start now. The patient's brought into the operating room, and after they're put under anesthesia by the anesthesiologist, we have a number of monitoring devices that are placed into the patient to keep track of how they're doing from a blood pressure perspective. We put a heart monitor or a heart catheter in to check the pressures in their heart arteries and inside the main chambers of the heart and also allow us to continuously monitor heart muscle function. After all that is done and the patient is asleep, we then prepare them for surgery. And utilizing a standard median sternotomy incision, expose the heart and all the contents around it. This operation in general is not something that we do through a minimally invasive approach. It requires a lot of exposure in order to get down into the root of the heart, get adequate exposure and visualization of all the vital structures, all of which require a meticulous detail, and you won't want to do this by trying to reach around the corner during a minimally invasive procedure. Once we have opened the sternum and the pericardium, the sac around the heart, we then place them on cardiopulmonary bypass and we stop the heart with a solution of high potassium, and then we open the aorta, as you see we have done there. 00:13:00

4 O. WAYNE ISOM, MD: Let me ask a question, Dr. Girardi. We hear all this new stuff about robotic surgery. Could you do this with a robot? 00:13:07 LEONARD N. GIRARDI, MD: I don't believe you can. 00:13:08 O. WAYNE ISOM, MD: Why -- and why not? 00:13:09 LEONARD N. GIRARDI, MD: In this particular procedure, as you can see, we're working very deep within the root of the heart. And it requires a lot of tactile sensation to figure out what sort of tissue you're going through, when to stop, when to start, and especially what kind of tissue planes you're going through. You need to be able to feel what you're doing, and with a robotic technique you really don't have tactile sensation. You're actually sitting across the room rather than being involved in what you're doing here. This operation also to be done through keyholes. As you can see, the aorta's big, the hearts sometimes are big, and to try to get in there and do this through a small incision would be, I think quite frankly, very, very, very dangerous and quite difficult. Now, once we've opened the aorta, you can see the aortic valve. It's a three-leaflet structure down at the root of the heart. And now we have to start removing the aorta that's diseased. The first step in this particular operation as you're seeing here is once we've opened the aneurysm up and we've looked at the valve leaflets and made sure that they are in fact intact, that they don't have any holes in them or what we call fenestrations, and that we think it'll give the patient a durable result, we then have to remove, or dissect away from the aneurysm the coronary arteries. What you're seeing us doing here is the right coronary artery. This is on the front of the heart. You can see blood trickling out of the mid-portion. The assistant is removing blood from the mid-portion of that coronary artery that keeps trickling out. And we're going to remove this coronary artery away from the aneurysm and prepare it for reattachment later on during this operation. What we're doing when we do this, obviously we have to know the coronary anatomy. You don't want to be in there moving things around and potentially get into a portion of a branch of this artery that you don't want to remove. And then we put it off to the side. The next thing we have to do after we've gotten done with the right coronary artery is we have to go get the left coronary artery, and that's in the back of the heart here. Again, knowing the anatomy, we're very meticulously dissecting the coronary away from the aneurysm and cutting it out on a little island of tissue that we're going to use to reattach it later on. This is a little bit more difficult to see. It's on the back of the heart, and you're not seeing it very well from the camera that we have here. Nonetheless, we're doing the same thing as we did on the front. We're making a little button of tissue and doing our best to stay out of branches that we don't want to divide. The other thing we're doing while we're doing this is getting some exposure down deep in the root of the heart. We're also making sure that we don't cut away too much aortic wall because we do have to use that to reattach the valve inside the Dacron graft that we're going to use to replace the aneurysm after we're done taking things apart in preparation to put them back together. Again, once we've finished moving that coronary artery away from the aneurysm, we put it off to the side on a suture, and every 25 or 30 minutes we'll give a solution into those arteries to sort of keep the heart cool, keep the heart still, and preserve function for the future. Now, in this part here we've removed the coronary arteries, and there's one more -- remember, this is a three-leaflet valve, so there are three what we call sinuses, or dilated portions of the aorta down near the root of the heart, that we have to remove the dilated aortic tissue away from what we're going to preserve. And this part we're finishing off on the patient's right side. This is the non-coronary sinus. As you can see here, we're leaving a small ring of tissue down along the aortic valve, and we're leaving that behind. Now we're going to just -- we have the tissue that we want to remove, and now we've got to begin to get an adequate exposure so that we can perform the reconstructive part of this procedure. 00:17:21

5 O. WAYNE ISOM, MD: Dr. Girardi, while we're going along here and you're working on the valve, we've got some questions that have come in. Are there any symptoms that would indicate to a patient that they have an aortic aneurysm? 00:17:35 LEONARD N. GIRARDI, MD: Certainly patients with aortic aneurysms can have chest pain. If the aorta gets to be a fairly sizable one, in fact the patients can have chest pains that lead them to get some sort of stress test or echocardiogram, and then eventually through imaging techniques they're found to have an aneurysm. The other kind of symptoms they can have are shortness of breath. If in fact their valve is leaking tremendously, that leakiness of the valve makes the heart very efficient and it can dilate it quite significantly. Dr. Roman sees a lot of these patients prior to even I see them, so she sort of is left with figuring it out. And Mary, how do you approach the patient with an aneurysm as far as evaluation and trying to figure out what's symptoms from their cardiac problems or symptoms from an aneurysm. 00:18:21 MARY J. ROMAN, MD: I would say that the overwhelming majority of patients with aortic aneurysms are asymptomatic. Frequently these aneurysms are discovered in the context of evaluating families where aneurysms occur in multiple members of the same family. It's relatively uncommon in the absence of dissection, which obviously is a very symptomatic event, for the aneurysms to cause symptoms, unless as you mentioned, there is coexistent aortic regurgitation. So usually we just need to do an imaging study, and frequently the first is a transthoracic echocardiogram. 00:19:02 O. WAYNE ISOM, MD: So a regular chest x-ray might not pick this up. It's either maybe an echo or a CAT scan. 00:19:06 MARY J. ROMAN, MD: Yes. 00:19:10 O. WAYNE ISOM, MD: Go ahead, Dr. Girardi. Tell us what you're doing now. There's another question or two that we can -- 00:19:13 LEONARD N. GIRARDI, MD: Okay. In this part of the procedure now, after we ve cut away the diseased native aorta that we want to remove, the second part of this operation that's quite important and is different from a traditional reconstruction of the root with composite valve graft is you have to get the tissues around the aortic annulus, or the skeleton of the heart, away from that part of the aorta so that you can then put the graft around this valve and tie it down to sutures that are placed below the level of the valve. And that requires a lot of dissection down to a level that you're normally not going when you're doing a root reconstruction. As you can see here, we're underneath the left coronary artery heading down behind the heart on top of the left atrium and getting down into the muscular portion of the heart into what we call the left ventricular outflow track. That portion is a territory that you really don't want to have to go down to unless you're doing this kind of operation because there's a lot of potential problems down there, and it's the kind of thing that you just need to have a lot of experience doing before you get comfortable working in that area. But it's a vital portion of this operation. That's where you're going to be securing the graft. 00:20:25 O. WAYNE ISOM, MD: I've got another question here, too. Is there any difference in approach to this valve if it's bicuspid or if it's a tricuspid valve like this one? 00:20:36 LEONARD N. GIRARDI, MD: Very good question. Patients with bicuspid valves in a setting of ascending aortic aneurysms, as you know, we're recognizing this as being a very common scenario, and we think that it is more genetically based than just an aneurysm that forms as a result of post-stenotic dilatation or some sort of hemodynamic alterations. We know for a

6 fact that patients with bicuspid valves genetically are predisposed to form ascending aortic aneurysms. And when you come in with a bicuspid valve, we always want to image the ascending aorta to make sure that you don't have an aneurysm. Now, if your aortic valve, regardless of whether it's trileaflet or bicuspid, is soft, is not heavily calcified, and is not leaking too much, we've spared many a bicuspid valve in addition to trileaflet valves, and we sort of expect the same long-term durability from this procedure, whether it's a threeleaflet or a two-leaflet valve. 00:21:32 O. WAYNE ISOM, MD: So we don't miss anything, right now it looks like you're putting those mattress stitches without pledgets down below the origin, or the sinuses of valsalva. How far below them are you? 00:21:49 LEONARD N. GIRARDI, MD: Well, as you can see here, we've done a dissection. And we actually -- there's a spare amount of space around the aortic root at this point that we've created with that dissection that we were doing earlier. And we're going to make use of that by putting the sutures in below the level of the valve, as you see here, and bringing them out underneath the valve through the muscular layer or the skelet-- the fiber skeleton layer of the heart, in this case behind the left coronary leaflet underneath the left main coronary artery, full thickness through the wall of the left ventricular outflow track. And we're catching the fibrous trigone as we place these so that when we hook a graft up with these sutures it'll pull the Dacron graft, which doesn't expand, right down onto that fibrous trigone and solidify the size so that we don't have to worry about it stretching out and pulling the valve apart in the future. 00:22:40 O. WAYNE ISOM, MD: So on that non-coronary side, sinus side, you're going into almost the base of the aortic leaflet of the mitral valve? 00:22:48 LEONARD N. GIRARDI, MD: That's correct, and that's one of the things you have to be particularly careful about. In this area here, we're underneath the right coronary artery and underneath the right coronary leaflet. And as you can see, we're bringing up those sutures, we're checking to make sure that we don't bring it through any part of the valve leaflet itself. And then as we bring it up on the outside, we're taking extra care to make sure we don't bring it into the muscle of the right ventricle, which you see there at the base of the aorta underneath the right coronary artery. Again, we're going to lift up the leaflet. You can see that white sort of fibrous tissue down underneath there, and we're bringing that suture up right at the base of where the muscle of the right ventricle attaches to that fibrous triangle under the heart. You could not get to that area if you hadn't spent all that time dissecting that away as we did earlier. And that's an area where you just have to be very meticulous in your dissection so that you don't make perforations in the right ventricular muscle, and you have to be very meticulous in placing these stitches so that you don't grab part of the aortic valve leaflet. It is also -- you want to put these into a single plane. Remember that the Dacron graft that you're putting on top of this is not a scalloped graft. The scalloped graft reconstruction, or the reimplant -- the remodeling technique -- is a technique that was originally described for valve-sparing surgery but one that we found was not as durable for us in the short or long-term because of the inability to secure the aortic root inside the graft. You can see we're bringing these valve sutures up one right next to one another. When we lift up the valve you can see we're putting them together. In general, we put about three sutures into each sinus underneath the leaflets and then an additional suture under each commissure or post where the valve leaflets are attached. 00:24:27 O. WAYNE ISOM, MD: So there's no pledgets? 00:24:29 LEONARD N. GIRARDI, MD: No pledgets.

7 00:24:29 O. WAYNE ISOM, MD: And how do you size it? How do you know what size to use? 00:24:34 LEONARD N. GIRARDI, MD: We use traditional valve sizers to measure the diameter of the aortic annulus and the root. And in general, we'll take a Dacron graft, as you see here, and we'll increase the diameter by about 4 or 5 mm. So if I measure the aortic annulus at, say, 26 mm, I'll put in a 30 mm graft. And what that allows me to do is size the annulus to the size that I want it without narrowing it too much, but then having the oversize of the graft rather than making the exact size of the annulus allows the sinuses of valsalva to be recreated, which in theory will increase the durability of this reconstruction because the leaflets of the valve during systole will not be coming out and smacking up against the valve graft, a graft that is very stiff and noncompliant. By giving it this extra 2 or 3 mm, that allows the leaflets of the valve more room and makes it more of a native reconstruction. 00:25:34 O. WAYNE ISOM, MD: It looked like when you were doing all this that you had freed up the commissures, and they looked like they were sort of floating in the breeze. What keeps them from turning wrong side out and having insufficiency, because those stitches are below those commissures? 00:25:52 LEONARD N. GIRARDI, MD: They are. As you're going to see, we're going to reattach the commissures up inside this graft. Now, we took those sutures and we brought them through the bottom of this graft, as you see here, and we tied them down. And we tie that down over a metal dilator that is of a certain size, either 26 or 28 mm. And that prevents us from narrowing the aortic root and giving the patient either distorted anatomy that will lead to aortic insufficiency or aortic stenosis. We use that metal dilator -- it's called a Hagar dilator -- to prevent things from narrowing down when we were tying those stitches. So those stitches were brought through the muscle and the fiber skeleton of the heart, subsequently through this graft, and then they were tied down over the dilator. And now what we're doing is addressing exactly what you were talking about. Now this becomes a little more difficult to see because we're working down inside this graft, but what we're doing now is we're taking the commissures -- the posts where the valve leaflets are attached -- and we're resuspending them as high as possible inside this graft with prolene sutures, the blue sutures that you're seeing, which is a monofilament non-absorbable permanent suture, and we're going to resuspend that part of the post of the valve, hooking it up to the Dacron and then securing it there with suture and these Teflon felt pledgets that you're seeing here. There's the post that you see attached from the anterior portion of the graft between the right and the non-coronary sinus. We're now attaching the post on the commissure between the left sinus. And now, after we have the post resuspended, as you see here, now we've got to start sewing up that remainder of the aortic wall up to the Dacron graft, and that's what we're going to do here, and that's going to be the final step of reimplanting the valve inside the graft. 00:27:31 O. WAYNE ISOM, MD: So you're doing that from the inside, then? 00:27:35 LEONARD N. GIRARDI, MD: Yes. We trim this graft down to a size where we can work comfortably, but we don't want to make it too short so that we don't have to use two separate grafts, although there's nothing wrong with that. If you have to trim the graft down to the level of the commissures to get better exposure and make the reconstruction easier, you just do that understanding that you're going to have to attach a second graft to it. In one of the modifications of the David procedures, a number of individuals use two grafts all the time. And so there's nothing wrong with that, it's just not what we prefer to do. 00:28:03

8 O. WAYNE ISOM, MD: Then again, how do you on those commissures when you're reimplanting them, how do you know how high to go? Is it centimeter, two centimeter, is it eyeballing it, or how do you know to do? 00:28:15 LEONARD N. GIRARDI, MD: Basically it is eyeballing it. You basically pull them up as high as they will go because the mode of aortic insufficiency in these patients is that as the post of those commissures are pulled apart by the aortic aneurysm, you'll see central aortic insufficiency. The leaflets just don't coapt. And as they get pulled apart, in addition to that you can sometimes have prolapse of one of the leaflets. And what you do by pulling them up is you're basically restoring the native geometry of the aortic valve. The semilunar shape of the aortic valves rely on the post to be as high as possible to get coaptation in the middle. And when you pull them all together we obviously test them for the height. We just pull them up as high as we can, attach them to the wall. And at that point in time we even test the valve, and without ever having sewn this up it'll be competent, and you can see that it's going to work. 00:29:06 O. WAYNE ISOM, MD: So now, then what size prolene are you using there? 00:29:11 LEONARD N. GIRARDI, MD: This is a 4-0 prolene that we're using down in the root of the heart. 00:29:14 O. WAYNE ISOM, MD: That's on a big needle or a little needle? 00:29:15 LEONARD N. GIRARDI, MD: It's on a little needle. It's on an RB-1 needle. And this schematic drawing that you see here is what we're doing right now. We've taken the valve inside the tube graft, we've put our posts up, as you can see there, with the pledget sutures right there, and we run this suture line, reattaching that 3 or 4 mm remnant of the aortic wall up to the graft itself. And in doing that, because we've oversized the graft, we can recreate the depths of the sinuses of valsalva that will give the aortic valve leaflets room to open and close without smacking up against the Dacron in a forceful fashion. This is a running suture line. As you can see, we're just moving it along, reattaching it, full thickness bites. 00:29:58 O. WAYNE ISOM, MD: So that's not at the edge of the graft, that's just going through the graft up above the original suture line? 00:30:07 LEONARD N. GIRARDI, MD: Yes, sir. That's exactly right. 00:30:09 MARY J. ROMAN, MD: Dr. Girardi, you said that the Dacron graft is very rigid. I would have to say that this looks relatively flexible. Does it become more rigid over time? 00:30:18 LEONARD N. GIRARDI, MD: Well, I think it is a very flexible graft, especially compared to the kind of grafts that Dr. Isom was describing earlier that were very stiff. But compared to the native aorta, which expands and contracts in systole and diastole, this graft does not do that. So when systole comes and the valve leaflets open, they smack up against this graft and we want to have something that recreates it. Now, here we've reattached the sinuses and we've reattached the aortic valve and reimplanted inside this graft, and as you saw, we tested it with water and it was very component. It held very well. And when you look down inside this graft you can see the aortic valve leaflets coapting very nicely. Now what we have to do is after we've tested the valve and we think it all looks like it's going to work, we have to start reattaching the coronary arteries. And this is the left main coronary artery on the back of this graft that we're reattaching. Again, we use a monofilament prolene suture,

9 usually a 5.0 prolene, which is somewhat smaller than what we used to reimplant the valve. And we start by reattaching the inferior portion of it along the back of the graft. 00:31:26 O. WAYNE ISOM, MD: Now, I remember some people use pledgets. Were you using any pledgets in that area? 00:31:31 LEONARD N. GIRARDI, MD: For the coronary reattachment? 00:31:32 O. WAYNE ISOM, MD: Yeah. 00:31:32 LEONARD N. GIRARDI, MD: No, none at all. What we'll do is we'll run this first suture line and just bring it around, just attaching it up to the graft, and then what we'll end up doing is we take a second layer of 5-0 prolene and run it along the outside as a reinforcement and hopefully catch any areas that there might be a gusset so that we don't have a leak. 00:31:50 O. WAYNE ISOM, MD: So it's essentially a double running later of 5-0 prolene? 00:31:553 LEONARD N. GIRARDI, MD: Yes, exactly. 00:31:54 O. WAYNE ISOM, MD: How big are those openings there? 00:31:55 LEONARD N. GIRARDI, MD: They're probably about a centimeter, centimeter-and-a-half in diameter, maybe 2 cm in diameter. We don't have -- we try not to leave a tremendous amount of aortic tissue around the coronary arteries because those potentially could dilate into new aneurysms in the future. That's especially true in patients with known connective tissue disorders like Marfan's syndrome or Ehlers-Danlos syndrome, where we know that whatever aorta you leave behind potentially can dilate in the future. And you have to have a certain amount of aortic tissue to make it a safe procedure when you're reattaching these, but we don't like to leave too much behind. And here we're completing the top row of that suture line. We've reattached the coronary artery there on the back of this Dacron graft. You can see the pledgets on the outside where we resuspended the posts, and you can see how deep that suture line goes down below that reattached coronary down to where the original suture line was with the nonpledgeted sutures through the aortic annulus. Now once we reattach this we're looking inside again. You can see when we put that inside there. Now we're going to test this valve and give another dose of solution to arrest the heart and keep it cold. This is a test that I actually learned from you. Back when we were doing Bentalls, I'd never really seen anybody do this before where we take a Foley catheter, we give cardioplegic solution through it, and blow up a 30cc balloon inside this reconstructive graft, let that solution go down into that left main coronary artery that we've reattached, and that allows the heart to be protected, but what it also does is it allows us to test the competency of the valve. And if we can generate enough blood pressure inside that graft and get good profusion down the coronary, then we know that the valve has to be holding. 00:33:38 O. WAYNE ISOM, MD: Also tells you whether you've got a leak in the coronary anastomosis. 00:33:41 LEONARD N. GIRARDI, MD: Correct. And in this particular operation, it also tells you if you have a leak down at the annulus level. With a composite valve graft it doesn't tell you that, but in this technique it does. Now, once we've reattached that left main coronary artery, now we're going to sew the top of the graft up to the native aorta just underneath the cross-clamp up by the great vessels. Now, there are times when the aorta is dilated all the way up into the aortic arch and we have to reconstruct the arch as well. The presence of an aneurysm that goes up into the arch is not a contraindication of this procedure, it just makes it a little longer and requires the use of circulatory arrest, where we have to protect

10 the brain using profound hypothermia. We take the patients down to 18 degrees Celsius at that level. We don't have to do that too often, but it does happen. This is showing the completion of that anastomosis. We're running the suture line, attaching the Dacron graft up to the top of the aorta, again, with monofilament prolene suture. Now, we use a cautery to create these defects in the graft where we're going to reattach the coronary arteries, and now we're going to start working on the right coronary artery here. And we're going to reattach that as we would for a composite valve graft. 00:34:53 O. WAYNE ISOM, MD: Now, while you're -- while you're doing that, let me -- we've got another question or two. What's the success rate of this procedure? The initial -- the way we assess success rate is mortality. What percentage of the patients live? And then this goes into one of the other questions: What are the long-term results on this? Do they -- we need to have to do more surgery later on or what's been the experience so far? 00:35:22 LEONARD N. GIRARDI, MD: The mortality, or success of the operation, is quite good. At least in our experience -- knock on wood -- we have not had any mortalities related to this procedure, and our mortality for composite valve graft replacement of the aortic root is also less than 1%. And that's an experience of over 500 aortic root reconstructions over the last 9.5 years, and not including approximately 100 valve-sparing procedures where we've had zero mortality. 00:35:54 O. WAYNE ISOM, MD: So out of the 500 root procedures, you've done about 100 this way. 00:35:58 LEONARD N. GIRARDI, MD: About 500 roots and about 100 additional valve-sparing procedures without doing a full root reconstruction. 00:36:06 O. WAYNE ISOM, MD: Now, how many of these have you had to go back in on? 00:36:10 LEONARD N. GIRARDI, MD: We've had four patients out of the 100 or so that we've done that have required reoperation for aortic valve insufficiency. I will say that all of those so far occurred in patients who we did a remodeling procedure on rather than a reimplantation, as you here. The remodeling procedure, we found in those patients we had continued dilatation of the aortic root, and that led to a lot of aortic insufficiency and we had to go back in, take out their native valves, and replace it with either a bovine valve or a mechanical valve. The durability, however, is quite good. I think the freedom from reoperation and multiple experiences over the first five years is in excess of 85%, both in our experiences and that of others who do this procedure on a regular basis. Our freedom from reoperation is approximately 86 to 90% in the first five to seven years. But again, I'd be interested to see long-term how this holds up as compared to a composite valve graft, where it's very rare for a patient to have to come back at all. But again, those patients do have to take Coumadin. There is a certain risk to that as well. 00:37:23 O. WAYNE ISOM, MD: Well, I'd just re-echo what I have taught here for years and what I learned from Frank Spencer. Anything in cardiac surgery and probably a lot of things in medicine, until you see real good five-year data, you consider it possibly experimental. This is not experimental because we're seeing some five-year data now. But I think we have to keep an open mind on all of this. Another question just came in. "What's the current role of this valve-sparing procedure if you're using a homograft aortic root for Marfan patients?" I guess this means it's -- the homograft, the questioner's asking, if you're just using a homograft rather than a Dacron. Seems to be the same to me. 00:38:10 LEONARD N. GIRARDI, MD: Well, the homograft valves have markedly diminished durability compared to any of the bioprosthetic valves that we have available today, so if you're not a

11 candidate for valve-sparing surgery but you wish to avoid anticoagulation and avoid Coumadin, the best thing for you to do is get a bovine pericardial composite valve graft. We know that the bovine valves at 15 years are 87% to 95% free of structural valve deterioration, and at 20 years they're upwards of 80% free of structural valve deterioration. A homograft, or a cadaveric human valve, in the aortic position as a root, at 15 years only 60% are still working well. So in my opinion, unless you have an infectious process in the aortic root where you don't want to put in any prosthetic material whatsoever, either Dacron or a prosthetic valve, that's the indication for a homograft aortic valve root replacement. Other than that, in my opinion, I don't really think that's a viable option, especially in patients with connective tissue disorders. 00:39:11 MARY J. ROMAN, MD: That brings me to another question, Dr. Girardi. I know that there's been some concern that the valve-sparing procedure may not be as durable in Marfan patients as in non-marfan patients. What's your opinion on that? 00:39:26 LEONARD N. GIRARDI, MD: As you know, that's something we're trying to assess with a study that's being run by the National Marfan Foundation. We started out as 17 centers, 17 international centers who perform a lot of aortic surgery looking specifically at Marfan's patients, having root reconstruction with both the valve-sparing and a composite valve graft technique. We've enrolled, I believe, in all the centers nearly 300 patients up to this point in time. And we are just following along, as Dr. Isom said, trying to get 5 and 7 and 10-year data on these patients who had valve-sparing surgery and compare it to those who have had composite valve grafts. I think certainly for of the patients with known connective tissue disorders the jury's still out as to whether this is truly a durable procedure. We like to think we're doing them a service. Certainly they're avoiding Coumadin in the short run, but how many of them are actually going to come back for another operation remains to be seen. I don't think we know the answer to that yet, although again, there are data out there in limited and smaller populations showing that the durability at five years is about 85 to 90%. Beyond five years, no one has a lot of experience with it, and so we're still collecting that data and trying to get a better handle on it. 00:40:42 O. WAYNE ISOM, MD: Well, even so, if you get 5 years, 10 years, or 15 years and this valve becomes dysfunctional, you could always still go back in and put a tissue valve in there. This does not preclude a valve replacement later on, and you've already got the aneurysm taken care of, you've got the coronaries reimplanted, so all you'd need to do is cut the dysfunctional valve out and put another one in. 00:41:10 LEONARD N. GIRARDI, MD: That's correct, and that's exactly what we've done in those patients who've had to come back for reoperations. We've just gone back in. Obviously it's not something we want to do, not something the patient wants, but when the valve becomes markedly insufficient, we're forced to do that. But as you said, all the tough stuff is really done. The aneurysm's been taken care of, the aortic root's been reconstructed, the coronaries have been reattached. You just go back in through the Dacron graft, put whatever valve in they want -- either mechanical or tissue -- and come on back out. And we've had good success with that, and hopefully we'll continue to have good success with that in the future, should the need arise. Dr. Roman, how -- when you're looking at patients and referring them for this type of surgery, when the patients come out with the mechanical valve and they have to be managed with lifelong Coumadin, how difficult is it to manage patients with Coumadin? Do you find it as challenging as some people make it out to be or do most patients find it pretty compliant, fairly reasonable to manage, and safer than maybe advertised? What is your view on Coumadin for these patients with mechanical valves? 00:42:19

12 MARY J. ROMAN, MD: In my experience it's -- it's something that people learn to live with. As you mentioned earlier, it's important that the blood be adequately thinned so that there's not a clot risk and the potential for stroke or blood clot to other parts of the body, but at the same time that the blood not be too thinned such that there might be bleeding complications. And I think it's very important at the outset to sit down with the patient, ideally with their family, significant others, as many people as you can possibly find, and explain to them exactly what they need to be aware of in terms of dietary concerns, changes in their daily activities, exercise restraints, in terms of avoiding contact sports, any sort of activity that has the potential for trauma. And I've found that an educated patient is always the best patient, and once that patient knows exactly what the test is that we perform -- that is the INR, or International Normalized Ratio to determine what the adequate anticoagulation, or level of blood thinning is, and if you repeatedly tell them what their INR is each time their blood test is done, sometimes they can just pretty much be their own doctor in terms of managing their blood thinning medications. Patients become very well attuned to when the blood is potentially too thin or understand that they cannot miss a single dose. A new development that has facilitated ease of anticoagulation is the ability for patients to have home machines. In the same way that they can have home machines to follow their blood pressure, home machines to follow their blood sugar if they're diabetic, there are now home machines where patients can follow their INR or the adequacy of their blood thinning. And I think that particularly for these relatively young people who are working, who have families, have lots of responsibilities, if they don't have to run to the doctor's office or to a neighborhood laboratory all the time but can monitor their INR at home, call in the results to the doctor, it really facilitates the anticoagulation. So although of course one would always rather not be on a medication if it's not absolutely necessary, I think it's something that can easily become integrated into a person's life. So if it seems as if the standard valve conduit procedure with the mechanical prosthesis is the best way to go, then I will certainly make that recommendation. 00:45:12 O. WAYNE ISOM, MD: We've got some other questions here. You know, everybody's scared about all the complications, and you hear all these things about, "Well, can you do off-pump minimally invasive?" Obviously you've got to be on the pump here. You've already mentioned that about minimally invasive, you can't see real well, and there's a lot of work to do. It'd probably take about three times as much. But the complications that can occur -- mention a little bit a the neurological. Everybody's scared to death ever since that Duke study about 10 years ago that showed in the Duke study they had something like -- in coronary bypasses something like a 44% incidence of neurological dysfunction in 5 years. We repeated that study here and didn't see that at all. Mention a little bit about the approach to neurological preservation here. 00:46:12 LEONARD N. GIRARDI, MD: In this operation, since we're doing it on cardiopulmonary bypass, we practiced the same principles for this operation as we do for our other heart operations in our other patients, regardless of whether it's a valve-sparing operation, a composite replacement, a coronary bypass, or a straight valve repair replacement. And what we found in the studies that we did here was that in patients on cardiopulmonary bypass, traditionally it was thought that because the brain has a mechanism to regulate its own pressure within the system that you could run the heart and lung machine at almost any level at all and the brain would maintain the same level of blood pressure within it. And utilizing that technique, it's easy to understand why some centers utilizing that technique would have neurological injury rates that might not be what you would want them to be. And what we've found here was that basically we would run the patient's blood pressure on the heart and lung machine equivalent to what their mean arterial pressure is when they're walking around on the street. And in general, we use a rule where we basically keep their pressure on the heart and lung machine equivalent to their age. So if it's a 75-year-old

13 patient, we'll run their mean arterial pressure on bypass at 75. If it's an 80-year-old patient we run them at 80. And pretty much all the other patients below 70 we run them in the 70s all the time. That did not -- we did not find that that obscured or made the operations any more difficult or any less safe, and we've found that it did not eliminate our protection of the heart nor increase the need to protect the heart more frequently, which would then prolong the operation. But what we did find was that the neurologic injury rate went down to around anywhere between 1 to 2% on most operations. And in our experience, it's actually been less than that over the last 2 to 3 years, where the rate of stroke here is substantially less than 1.5% over approximately 1,200 to 1,400 cases per year for the last decade. And so although everybody worried about neurologic injury with cardiac surgery, our experience using high-pressure cardiopulmonary bypass and using a very aggressive blood conservation program, we can keep the neurologic injury rates down to less than 1 to 1.5%, even for big operations like this. 00:48:29 O. WAYNE ISOM, MD: Well, I think I agree with you. The -- all of those places that had the high neurological injury rates were using that same data that was developed back in the '50s and '60s, and most of that was on little kids. You can take a little kid, a 4 or 5-year-old kid, and run their blood pressure at 60 or 70, and that's fine, but if we dropped your blood pressure to 60 or 70, you'd pass out or if we leave it long enough you'll have a stroke. So that's the real reason for keeping the pressure up. It's sort of simple. Like most things in medicine and surgery, it's common sense. But those are some of the things that scare the dickens out of a lot of people. Another question that came in is, what's the difference between a David I and a David II, and how did David come up with the David II? 00:49:22 LEONARD N. GIRARDI, MD: Well, the differences between the David I up until now, the David V. Pretty much the II, III, and IV have been left behind, so you're either a traditionalist doing a David I, which is a lot of folks do, or you can do the David V, which is the latest modification that actually was probably pioneered most by Craig Miller out at Stanford. The David I, as you saw we did here, there's a lot of ways to do it, but the main thing that allows us to reconstruct the sinuses in a way that's consistent with the native anatomy is oversizing the graft. If you put a graft in the same size as the aortic annulus, you're going to have sinuses of valsalva that are not as big, and potentially when the valve leaflets open they're going to smack up against the graft because there's no space that the normal sinuses of valsalva would normally have. And that potentially will limit your durability. In an effort to increase the size of the sinuses of valsalva further, all these modifications -- one, two, three, four - to try to reconstruct them. And now we're up to the David V, where a very oversized graft is used to reconstruct the aortic root and reimplant the valve up inside that. And then at the top of that graft just above the commissures, things are narrowed down in again with a second graft as we had described earlier that then reconstructs what we call the sinotubular junction, which is the top of where the commissures come in. It allows extra bulging of the sinuses of valsalva to leave more room down in there for the valve leaflets to open without smacking up against the Dacron. So it's really at this point in time, at least in my mind, you're either a David I reconstruction or a David V reconstruction, but the other ones are not terribly important. 00:51:06 O. WAYNE ISOM, MD: Is David still using a David I or did he move on to another one? 00:51:11 LEONARD N. GIRARDI, MD: I'm not real sure exactly where he stands on it. 00:51:13 O. WAYNE ISOM, MD: You know, I learned on the farm a long time ago if something's working, don't fix it. 00:51:19