ENDOVASCULAR STENT GRAFT REPAIR OF THORACIC AORTIC ANEURYSM BRIGHAM & WOMEN'S HOSPITAL BOSTON, MA

Transcription

1 ENDOVASCULAR STENT GRAFT REPAIR OF THORACIC AORTIC ANEURYSM BRIGHAM & WOMEN'S HOSPITAL BOSTON, MA 00:00:02 ANNOUNCER: Today leading cardiac and vascular surgeons from Brigham and Women's Hospital will demonstrate an endovascular stent graft repair of a thoracic aortic aneurysm performed through the vessels in the groin. Recently developed as an alternative to the conventional open surgical repair, which requires a major operation with a possibility of complications and a long recovery, endovascular stent graft repair offers a new, less invasive alternative for thoracic aneurysm repair with less risk of complications, decreased blood loss, and a faster recovery. Today's program is part of Brigham and Women's ongoing educational efforts to bring the latest information in healthcare to physicians and patients. And now your host. 00:00:51 RALPH MORTON BOLMAN, III, MD: Hello, my name is Ralph Bolman. I'm chief of cardiac surgery at Brigham and Women's Hospital. Welcome to our live web cast of minimally invasive thoracic aortic aneurysm repair. I'm here today with my colleague, Mike Belkin, chief of vascular and endovascular surgery here at the Brigham, and my colleague Mike Davidson in the cardiac surgery division, and Ed Gravereaux, who is director of endovascular surgery in the vascular surgery division. The thoracic aortic center at the Brigham and Women's Hospital brings together specialists and experts with interest in aortic disease. We screen, evaluate, survey, and treat patients with multiple types of aortic disease, and we commit to developing the best therapy for each individual patient. We're also involved in trials to develop better patient -- better treatments for our future patients. An aneurysm is a weakening or a bulge in the artery that can occur in any part of the -- any artery, but we're talking today about the aorta, which is of course the artery's -- the body's main artery. It carries a tremendous amount of blood flow, so the implications of any rupture or leakage from an aneurysm are life-threatening and potentially disastrous. Here we see the thoracic aortic aneurysm. This is defined by the area of the aorta between the left subclavian artery and the diaphragm. This entity is diagnosed in between 15,000 and 25,000 people in the United States every year, and the incidence is increasing because we have an increasing age of our population and also because the screening tests are much more available. These things are caused by degenerative diseases in over four-fifths of patients. About a fifth of patients have what I call an aortic dissection, which is a tear in the lining of the artery which occurs in patients with hypertension and other disorders. The remainder occur because of connective tissue problems or rare infections. This graph nicely shows the impact of treatment on these patients. In the blue dotted line you see what happens to patients with aneurysms who are not treated over time, and you can see that the vast majority of patients don't survive three or four or five years. In contrast, those in the red line, who are treated with surgery, have a far different survival curve, and really they are returned to the survival curve expected for the general population. Risk factors for developing aneurysms are shown here, and they include increasing age, high blood pressure, cigarette smoking, hardening of the arteries, or arterial sclerosis, and of course family history of aneurysms. We screen for these entities by using chest x-ray and a variety of increasingly sophisticated imaging techniques, including magnetic resonance imaging,

2 computed tomography, angiography still has a role, and transesophageal echocardiogram is very useful, especially for the ascending aorta. Repair for these is recommended when they reach a maximal diameter of 5 or 6 cm or when they grow significantly between imaging studies. Certainly when any symptoms develop or a dissection occurs, emergency surgery would be indicated. And smaller aneurysms can be considered for repair, especially if they are demonstrated to grow rapidly. Treatment options occur -- include medical management or monitoring, so-called watchful waiting. If this is going to be chosen for an individual patient, it's important that strict interval surveillance with imaging studies be employed to prevent anybody from getting in a dangerous area with their aneurysm without us knowing it. Open surgical repair is another option. And what we're talking about today is the exciting new therapy of an endovascular stent graft repair. The open repair has with it 50 years of history. It requires a large left chest incision. The aneurysm is replaced with a Dacron tube graft. It does carry significant risk of mortality and significant morbidity. The endovascular repair, by contrast, requires access through an artery in the groin, or the iliac artery. These grafts are deployed using angiographic guidance. They require anchoring of the device in relatively normal areas of the aorta above and below the aneurysm. The principle is that of a tube-shaped stent graft that relines the vessel and diverts the blood through the stent graft and away from the aneurysm. The aneurysm is thus excluded and depressurized and usually shrinks in size or clots off. Shown here are the various types of devices that are designed for this type of repair. Unfortunately, only one is present that is approved at the present time. This is the Gore-Tex prosthesis shown on your left. Other companies are working on similar devices, and hopefully they'll be available for our patients in the near future. I'm going to turn it over to Mike Belkin in the operating room now, who will walk us through the steps of the procedure for today's patient. Mike? 00:05:46 MICHAEL BELKIN, MD: Good afternoon, ladies and gentlemen, and welcome to the Brigham and Women's Hospital endovascular OR suite. We're pleased you can join us today for this live web cast of an endovascular repair of a descending thoracic aortic aneurysm. I'd like to start by introducing you to the team. As you'll see, this does take a team to complete this procedure. I'm Mike Belkin. I'm the chief of vascular and endovascular surgery here at the Brigham. Right in back of me here is Ed Gravereaux, who is the director of endovascular therapy at the Brigham. Mike Davidson is a cardiac surgeon and an endovascular specialist. Over here is Gene [Jijitz], who is the tech and endovascular specialist. Sue Driscoll is the circulating nurse who is the chief operating officer of the operating room. At the head of the table is Dr. Stanley Leeson, who is the chief of vascular anesthesia here at the Brigham. And finally, to the right here is Charles Boswell, who is the radiation tech and runs the imaging here for the case today. So before we get started, I'd like to go through the procedure a little bit so you can see in graphic terms what you -- we'll be showing you with our case. Can I have the next slide, please? So the endovascular approach allows us to introduce the graft through the sheath, which you see on this slide here. It's a flexible sheath, and it usually goes in through the femoral artery. You'll see that today we're going to do a little different approach because this patient has small vessels, necessitating an alternative but still a minimally invasive approach. Next slide. This slide here shows the endovascular graft we're using. This is the W.L. Gore TAG graft, the only commercially available, FDA-approved graft at this time. The lower picture shows the graft in its constrained state on its sheath, and then the upper picture shows the deployed graft as it would be anchored in the aorta. Next slide. And this just shows the deployment process. You see the surgeon pulling the deployment knob, and then the graft opens as the sheath unfurls from the middle outwards. And then at the bottom you see the completely deployed graft as it would be anchored in the aorta. Next slide. Once the graft has been deployed we use this special tri-lobe balloon to touch down and iron out the anchor sites to ensure that the graft is well-opposed to the aortic wall above and below the aneurysm. Next slide. Depending on the size of the patient's native aorta and aneurysm, a variety of grafts are

3 available. The grafts vary in size such that they can accommodate aortas measuring anywhere from 23 mm in diameter all the way up to 37 mm in diameter. Next slide. And there's just some of the anatomic considerations we make when we repair a descending thoracic aorta with the endovascular approach. We need 2 cm of anchor zone above and below the aneurysm, that is, 2 cm of normal aorta that we can sink this graft in so that we're sure that it anchors securely and occludes blood flow. Ideally we'd like to have an iliac artery which is greater than 8 mm to allow these large sheaths to go through. In this case today we have 7-mm iliac arteries, so we're going to show our alternative approach. Next slide. This patient today is a delightful 78-year-old female. Her aneurysm was discovered when she had a CAT scan for another reason, as is often the case. She was found to have a 5.2 cm ascending thoracic aorta and a 5.9 cm descending thoracic aortic aneurysm. Her past history is remarkable for breast cancer and hypertension. Next slide. She had her ascending aortic aneurysm repaired by Dr. Bolman with a traditional open approach. This was completed in March 2007, and she did remarkably well and has recovered nicely and now is returning today for her descending thoracic aneurysm repair. Next slide. The anatomy of this patient is that she has a 31 mm aorta distal to the subclavian artery, which will be our proximal anchor zone -- and I'll show you that graphically in a moment -- and a 28 mm distal thoracic aorta, which will be our distal anchor zone. Her external iliac arteries measure 7 to 8 mm in diameter and her common iliac arteries are 11mm. Next slide. This just shows a CAT scan image of her aorta, and you can see the repaired ascending aorta. That's a normal-sized graft replacing her ascending aorta that was aneurysmal before March. And then on the backside you can see a 59 mm descending thoracic aorta, which is about 2.5 times the normal size. Next slide. And this is just a sagittal reconstruction, coronal reconstruction, showing our anchor zones at 31 mm near the subclavian artery and 28 mm down in the distal chest above the mesenteric vessels. Next slide. And this is just a 3D reconstruction showing the visceral vessels and giving you a better graphic demonstration of the heart and the large thoracic aortic aneurysm. Next slide. And we have a digital 3D reconstruction system here where we take the images from CT and then can do precise measurements along the center line so we can determine exactly the size and length of the grafts that we need and build strategies to optimize the repair. Next slide. And this is the strategy for the case today. We will start by deploying a 31 mm distal graft down low above the celiac vessel, as you see that blue graft in the middle frame. And then we will complete the repair by performing a second graft above that anchoring beyond the subclavian and within the proximal graft. So two grafts will be deployed to complete this repair today. Next slide. I'd like to show a quick animation of the actual deployment, if we can switch to that. So here you see the heart and the aorta. And as the heart turns to the lateral view, you can see a large descending thoracic aneurysm, not unlike the one we're going to repair today. And there's a guidewire passing up, which you'll see later live, and the graft passing through. And now the device is being deployed to complete the repair. Okay, can we cut off that now and come to live at the operating table. So normally we would do the repair through a small incision in the groin down here, but because this patient has a small vessel, we made a small flank incision, much like you'd do for an appendectomy, and we performed a graft to that. I don't know if we can show that very clearly, but we sewed a 10 mm graft down onto her common iliac artery and brought it out through a counterincision here, and we're going to use this as our conduit to introduce the graft today. And let's get started. 00:12:36 EDWIN C. GRAVEREAUX, MD: Here we go. 00:12:38 RALPH MORTON BOLMAN, III, MD: I'd like to remind our viewers, please feel free to respond to this program with questions at livesurgery@partners.org, and we'll try our best to answer any questions you have. 00:12:49

4 MICHAEL BELKIN, MD: So what we're doing now is we're passing a guidewire up the left groin and we're going to pass it all the way up. Now it's going through the abdominal aorta, and we're going to follow it up into the chest. There's the heart. And we're going to pass right around the aortic arch. Or actually, we're going to start with an x-ray picture, so we'll stop there. 00:13:08 RALPH MORTON BOLMAN, III, MD: Mike, we have one viewer who called in and asked, Is there any added danger for other aneurysms forming if a person's had a stent graft repair of an aneurysm? 00:13:16 MICHAEL BELKIN, MD: Well, the -- Yes, the patients who have aneurysms are at higher risk for additional aneurysm formation, and there is certainly about a 10 to 20% incidence of abdominal aortic aneurysms in patients who have these types of aneurysms. The procedure per se does not contribute to aneurysm formation, but patients who have aneurysms are definitely at risk for additional aneurysms and need to be checked thoroughly out for synchronous aneurysms and followed for newly developing aneurysms over time. 00:13:43 RALPH MORTON BOLMAN, III, MD: Great. Thank you. 00:13:47 MICHAEL BELKIN, MD: So there's the -- Why don't you tell us what we're doing here, Ed? 00:13:53 EDWIN C. GRAVEREAUX, MD: Yep. We've put a pigtail catheter -- Boz, we're going to come in left anterior oblique, LAO. Stay up at the arch. We're going to just take an angiogram. Table up, please, as much as you can go. 00:14:03 MICHAEL BELKIN, MD: About 35. We measured it to be 35 before. Let's see what that looks like. And come a little higher if you can. 00:14:12 EDWIN C. GRAVEREAUX, MD: Table up some more if you can do it. Good. 00:14:18 MICHAEL BELKIN, MD: Come a little less. Come back to a full view. Good. Let's slide up a little. 00:14:24 RALPH MORTON BOLMAN, III, MD: Here's another question. What percent of thoracic aneurysms can be repaired with this technique, roughly? 00:14:28 MICHAEL BELKIN, MD: Well, all comers would be about 20%, but we have various procedures that we can do to increase the number of patients by doing sorts of debranching procedures where we'll do bypasses to the mesenteric vessels and the subclavian vessels and carotid vessels, which allows us to pass the graft more far proximally and distally, which then allows us to expand the applicability of this approach. But this case today being a garden variety straightforward case, about 20% of patients fall into this category. Okay, so what we're going to do now is we're going to shoot an initial angiogram just to get the lay of the land and to see where our fixation sites will be proximally and distally. And if we could come over to the -- maybe in a moment once we get the pictures taken, we'll come over to a live shot of the fluoro. 00:15:21 EDWIN C. GRAVEREAUX, MD: Looks good. Yes, sir. 00:15:26 MICHAEL BELKIN, MD: All right. So -- 00:15:29

5 EDWIN C. GRAVEREAUX, MD: This will provide the viewers with a general overview of what the pre-procedural aneurysm looked like, the flow channel, and some of the more important vessels we'll be paying attention to as we deploy the modular stent graft. Dr. Leeson -- 00:15:42 MICHAEL BELKIN, MD: Hold respirations, please. 00:15:43 EDWIN C. GRAVEREAUX, MD: Hold ventilation, please. 00:15:45 MICHAEL BELKIN, MD: Okay. 00:15:46 SUE DRISCOLL, RN: Holding respiration. 00:15:54 MICHAEL BELKIN, MD: Okay. Now, this patient -- this shows us the anatomy very nicely. You don't see a big bulge in the vessel, and the reason you don't see a big bulge in the vessel is because this aneurysm is lined with thrombus. But if we could come over here and if I could have a marking pen. And can you show me this picture live? Let's go to peak opac, if we can, please. That's -- okay. So the outer wall of the aorta would measure -- I'm just going to draw it here. That's what the outer wall of the aorta looks like. So this is all aneurysm, and this is -- this here is thrombus within the aneurysm. So we're going to line our graft -- will be from here to here to complete our repair. We'll line that entire area with a -- with a graft which will exclude that aneurysmal area from the circulation, okay? So Sue, can you give me a clean on that, please? 00:16:56 RALPH MORTON BOLMAN, III, MD: Mike, here's a question from Cleveland for you. Why two grafts instead of one, and are there increased complications or risks working with two grafts? 00:17:02 MICHAEL BELKIN, MD: Oh, that's a good question. You know, the grafts only come in a certain number of sizes. The longest length available is 20 cm, which is not long enough for what we need today, which we have approximated to be 23 cm of coverage. So in that case we will do two grafts, but we will overlap the areas. The minimal overlap is suggested to be 3 cm, but we like much more than that and we really like to have 5 to 10 cm minimal overlap just to ensure there is not a problem with the junction site, which is probably what the person asking the question was driving at. So if you get a good solid overlap, I think it actually can actually strengthen the quality of the repair. Okay, so what we're doing now is we're putting a second wire up, and this wire is going to go all the way around to the -- to the -- to the valve. Are we around yet, or as far as you are? Are you going to pass that? 00:17:58 EDWIN C. GRAVEREAUX, MD: Yeah, we're going to get around. 00:18:00 MICHAEL BELKIN, MD: Okay. 00:18:01 EDWIN C. GRAVEREAUX, MD: Do you like that angle, Mike? Do we want to run that? 00:18:03 MICHAEL BELKIN, MD: I thought the angle was great. 00:18:04 EDWIN C. GRAVEREAUX, MD: Boz, can you run that one more time just to make sure it opened up pretty nicely. 00:18:06 MICHAEL BELKIN, MD: I thought we could see it pretty nicely. So we set up our viewing angle so that we can see the origin of the subclavian vessel. And if we look over here to -- if you can show me over on the screen here for one moment. If you go to peak opac again. Yeah. And by taking this particular view we can see the various great vessels coming off.

6 Here you see the inominant artery, the first one, and then you see the second vessel, which is the left carotid artery. And this third vessel, which is our landmark here for our repair, is the left subclavian artery, and we're going to try to anchor this graft just beyond the subclavian. 00:18:49 EDWIN C. GRAVEREAUX, MD: So now we're exchanging out for a soft wire. We'll put a nice, stiff Lunderquist wire where we can then track the large introducer sheath over. 00:18:59 RALPH MORTON BOLMAN, III, MD: We have a couple questions from physician viewers. One from Detroit asks, "Do you routinely use cerebrospinal fluid drainage to protect the spinal cord in these procedures?" 00:19:09 MICHAEL BELKIN, MD: That's a very good question about CSF drainage. In open surgery we often use drainage of CSF fluid to protect the blood flow to the spinal cord during the procedure because one of the complications of open surgery is an approximately 10 to15% incidence of -- watch that wire, please -- injury to the spinal cord from damaging blood flow to the spinal cord. And CSF drainage can help protect the spinal cord. And we believe in theory that it also can be protective when we do endografts like this. The only patients who we routinely do CSF drainage in are patients who had prior infrarenal angioma repair, because these are the patients who we know from previous studies are the ones who are at most risk for having an injury to their spinal cord. And this patient has not had a previous infrarenal angioma and does not have an angioma at all on the abdominal aorta, and therefore we did not do CSF drainage here today. Okay, so we got this wire in nice position. And can we -- if you can show us up to the -- if we can pan up to the live fluoro again. What this will show -- no, leave it right there -- but can I have a marking pen or a pointer of some sort? 00:20:24 EDWIN C. GRAVEREAUX, MD: Taking an 11 blade and the big sheath 00:20:26 MICHAEL BELKIN, MD: So what we've done now is we've passed the wire all the way around, all the way around the arch down to the aortic valve, and here's where the wire's sitting. And we need that wire all the way around because we need -- we need to have the strength and purchase so we can slide this large sheath and this graft up over the wire and get it in an ideal position. So we like to have that wire all the way around to where it's actually touching the aortic valve. And if we can pan back down to the table here, straight down. And what you're seeing now is this large sheath now is going to be placed through this conduit and we're going to pass it up. And if we can have a live shot of what's going on at the table with a simultaneous fluoro shot. Let's -- Boz, let's come back down to the pelvis. AP, please. And come to AP. And now we'd like to have a simultaneous view of the -- what's going on at the table as well as what's going on with fluoro. And you'll see this large sheath going up. Okay. 00:21:33 EDWIN C. GRAVEREAUX, MD: You got wire, Michael? 00:21:34 MICHAEL J. DAVIDSON, MD: I do. Since this is a big sheath, it's important to watch this on fluoro go up. 00:21:38 MICHAEL BELKIN, MD: Right, exactly. Let's get our main device out, first main device out. Ed, do you want to get the device up -- 00:21:50 EDWIN C. GRAVEREAUX, MD: Well, because of the pre-measured sizing, a lot of our -- a lot of the ballgame's in the preoperative planning. So we've planned that we're having a 31 mm distal diameter modular device, which will be deployed first, and then the larger device will

7 then be telescoped into it and the more proximal device second. So first we're going to move down to the visceral segment, make sure we see the celiac artery, position our distal device first. 00:22:21 MICHAEL BELKIN, MD: Do you want to put the device up before the angio, I think? 00:22:23 EDWIN C. GRAVEREAUX, MD: Yeah, we'll get it all set up. 00:22:27 MICHAEL BELKIN, MD: So now we're going to be -- if you have any other questions this might be a good time because we're prepping the first device. 00:22:31 EDWIN C. GRAVEREAUX, MD: Back to AO, please. 00:22:32 RALPH MORTON BOLMAN, III, MD: There are a couple others. Another physician asks from St. Louis, "What is the incidence of endoleaks, and how are they handled?" 00:22:39 MICHAEL BELKIN, MD: Well, okay. That's another good question. Endoleaks -- what an endoleak is, first of all, is there are branches that come off the aorta and even off aneurysms. These little branches can still persist even after we line the aneurysm with a graft. And these little branches can leak back into the aorta. Any time you have blood flowing into the aneurysm despite the presence of a graft, that's called an endoleak. And there are various types of endoleaks. The most common is the so-called type 2 endoleak, which is a side branch feeding into the aneurysm cavity, and that's usually off a little intercostal branch. And the great majority of those we simply observe. And as long as the aneurysm is not enlarging -- and over time we continue to just monitor them with serial CAT scans. Only about 5% of endoleaks -- 2 to 5% --require any form of intervention. Conversely, an endoleak which occurs at the junction site so that there's flow around the graft into the aneurysm, that's a major problem. That's called a type 1 endoleak, and that is basically an unrepaired aneurysm, which we will -- we take very seriously and must repair in the operating room or take the patient back to the operating room. 00:23:49 EDWIN C. GRAVEREAUX, MD: Mike, do you want to show the preparation of the device here? 00:23:51 MICHAEL BELKIN, MD: Sure. Let's shoot back over to the table here. We're coming over. And we have -- oh, great. So we pull -- there's a stylet that gets pulled out. And then we flush the catheter from below, which Gene is going to do right now. Very important for us to keep -- 00:24:11 RALPH MORTON BOLMAN, III, MD: Not to put any pressure on you guys, but one viewer asks, "What would need to be done if the aneurysm burst during the procedure?" 00:24:17 MICHAEL BELKIN, MD: We'd have to work very quickly. 00:24:19 EDWIN C. GRAVEREAUX, MD: I think an aortic occlusion balloon would be the first thing to put up. Since we have wire positioning, it would not be too difficult to help obtain some control and still put the endograft in. I think moving quickly would be advisable. 00:24:31 MICHAEL BELKIN, MD: Yeah. We would -- you know, at this point, where we are at this point, it would be much quicker for us to deploy the graft and fix it that way than to try to prep the patient's chest and open the chest and do a conventional emergent repair. So this -- we would just carry on, and as Ed mentioned, we would temporarily occlude the aorta with a large balloon.

8 00:24:54 RALPH MORTON BOLMAN, III, MD: You do have some measure of control with your wires in place and sheath and everything. 00:24:56 MICHAEL BELKIN, MD: We sure do. Yeah, we sure do. 00:24:58 RALPH MORTON BOLMAN, III, MD: What is the risk of damage in the aortic valve, Mike, another viewer asks, with your catheters? 00:25:03 MICHAEL BELKIN, MD: A good question. The ends of these wires where they are passed around are very floppy. In fact, we can show one later. They're very soft and floppy. So the stiff portion of the wire does not get anywhere near the aortic valve. But we always manipulate that wire under direct vision and be sure that we see that wire spin back away from the valve in its soft portion so we don't injure. So the instance of aortic valve injury -- in fact, I've never even heard of it. I'm sure it's happened, but I've never even heard of that. 00:25:29 EDWIN C. GRAVEREAUX, MD: This is the 31, correct? 00:25:32 MICHAEL BELKIN, MD: This is a 31x15, correct? 00:25:34 MAN: Yep. 00:25:35 MICHAEL BELKIN, MD: Perfect. All right. 00:25:35 EDWIN C. GRAVEREAUX, MD: Okay. Just making sure. 00:25:41 RALPH MORTON BOLMAN, III, MD: And why do you put the more distal graft in before the proximal? 00:25:43 EDWIN C. GRAVEREAUX, MD: Well, in this case the discrepancy in diameters necessitates us putting the distal, or the lower, device module in first because it's a smaller size. The second one then becomes more telescoped in when we deploy. The 34 into the 31 obviously will taper down. We could not go in the reverse way without an interjunctional device leak. So now we're -- where you see the diaphragm's in motion, this is about the level of the celiac access. We actually are going to be a little bit higher than this, so I'm putting the endograft in. Mike, do you want to point to the endograft markers on the screen? 00:26:17 MICHAEL BELKIN, MD: Sure. So can we have another pointer, a snap or something? 00:26:18 EDWIN C. GRAVEREAUX, MD: Pointing device? 00:26:19 MICHAEL BELKIN, MD: Okay. So let's mag this, if we can, right here and center, get a live fluoro here. If we can. Just give me a live fluoro magged. Okay. So what you see here, and let's center on that graft if we can so I can just show -- Great. Perfect. So right here is the top of the graft, right here, that section. And this is the bottom of the graft. And this catheter with the marks on it is the pigtail catheter, which is going to be -- through which we inject dye. So what we're going to do now is we'll go back off mag and we're going to shoot the angio to see where the optimal deployment site is, and then we're just going to deploy it. 00:26:58 EDWIN C. GRAVEREAUX, MD: To reinsure that we're not near the celiac artery, we're not -- 00:27:01

9 MICHAEL BELKIN, MD: So we're off mag, are we? And let's go -- We're back to 35, that's good. Let's see how we look off mag. I think that's pretty good. Ed, what do you like? Do you like that? 00:27:10 EDWIN C. GRAVEREAUX, MD: That's good for the start. As we'll shoot the arteriogram again, you can point out the celiac access. We might have to go in a little farther with the graft, so let's preemptively do it that way. Okay, Boz, let's go 10 for 20, I think should be sufficient to give us what we need to see right now. 00:27:25 RALPH MORTON BOLMAN, III, MD: Here's another medical viewer asks, "How did the availability of endovascular surgery for thoracic aneurysm change the role of open surgery?" In other words, are there -- are there certain diagnoses that are more amenable to this technique than others? 00:27:39 MICHAEL BELKIN, MD: Well, that's a good question. We're pushing the limits all the time in trying to -- let's just get this angio and see it. That's a great shot. Yeah. Perfect. That's exactly where we want it to be. 00:27:50 EDWIN C. GRAVEREAUX, MD: Breathe. 00:27:52 MICHAEL BELKIN, MD: I'll come back to that question in a moment. Let me just peak opac that. 00:27:57 EDWIN C. GRAVEREAUX, MD: You need to stop it at -- yeah. Make it easy there. 00:28:01 MICHAEL BELKIN, MD: So if we can pan over to the film here. Yep. Okay. Okay, are we live here now? Okay, so this is the -- the major portion in the aneurysm is up here, and I'm just going to draw it in here again so you can have some idea where we are. And we're going to anchor our graft in here. And we know this -- we know from looking at the CT scans that there's a slightly bulbous portion below, but we're going to anchor our graft -- you like that for an anchor site, Ed? 00:28:31 EDWIN C. GRAVEREAUX, MD: It looks good. You can see the celiac and the splenic, so those are sort of our landmarks that we're clearly above the major beginnings of the visceral segment. 00:28:37 MICHAEL BELKIN, MD: Here's the mesenteric vesicle right here coming off. And these little branches here are those intercostals vessels which I mentioned before that could backbleed into the sac. So that's a good picture right there. I think we can work with that. 00:28:49 EDWIN C. GRAVEREAUX, MD: Yep. That's pretty nice. So keeping that mark there, we'll advance or pull back our device just a little bit. I think it's actually pretty well positioned. 00:28:58 MICHAEL BELKIN, MD: Yeah. It's probably a centimeter high, yeah? Do you think? 00:28:59 EDWIN C. GRAVEREAUX, MD: Well, I don't know if you have to get all the way down to that bottom part. We certainly want to make sure we have decent overlap, right? 00:29:05 MICHAEL BELKIN, MD: All right. Good. I'm happy with that. 00:29:08 EDWIN C. GRAVEREAUX, MD: So the flared markers are down to that level. Good. Let's withdraw the pigtail. 00:29:16

10 MICHAEL BELKIN, MD: So let's shoot back onto the table now. 00:29:18 EDWIN C. GRAVEREAUX, MD: Okay. Dr. Davidson will demonstrate the deployment. 00:29:20 MICHAEL BELKIN, MD: We'll have a live fluoro on one screen and a table on the other, if we can. Is that possible to work that? 00:29:26 MICHAEL J. DAVIDSON, MD: Do you have a towel? 00:29:29 MICHAEL BELKIN, MD: Okay. So what we have here -- Mike Davidson's going to explain how he does the deployment. You've got that sheath pulled back? 00:29:35 MICHAEL J. DAVIDSON, MD: So there's -- 00:29:36 MICHAEL BELKIN, MD: It's all the way back. It's fine. It's good. 00:29:37 MICHAEL J. DAVIDSON, MD: Sheath's all the way back. So this is a ripcord here on the device. And as you saw from the animation, there is a Gore-Tex sheath that constrains the device. And this device opens from the middle outwards in both directions, so as we pull this ripcord, it will -- you'll see the device deploy pretty quickly. 00:29:57 EDWIN C. GRAVEREAUX, MD: Should we hold on for a second? 00:29:58 MICHAEL BELKIN, MD: No, no, that's fine. Don't worry about it. We're good. 00:30:00 EDWIN C. GRAVEREAUX, MD: Can we get both of these on a screen? Do you want to see the -- 00:30:03 MICHAEL BELKIN, MD: All right, so let's do this. What Mike's going to do is he's going to pull this, but what I'd like to do, I'd like to focus on the screen, then a live feed. 00:30:14 EDWIN C. GRAVEREAUX, MD: There you go. 00:30:15 MICHAEL BELKIN, MD: All right. And now we're going to show this being deployed, and you'll see this graft opening up as he pulls it. 00:30:19 EDWIN C. GRAVEREAUX, MD: Are you ready to go? 00:30:21 MICHAEL BELKIN, MD: Let's go. 00:30:21 EDWIN C. GRAVEREAUX, MD: Okay. One, two, and three. 00:30:24 MICHAEL BELKIN, MD: There it goes. It fired open. So -- 00:30:28 EDWIN C. GRAVEREAUX, MD: Perfect. 00:30:29 MICHAEL BELKIN, MD: It's perfect. It actually is perfect. Can I have a marking pen again? Now, if we could come over here live to the screen. Can you mag it once? 00:30:39 EDWIN C. GRAVEREAUX, MD: Thanks, yeah, that's great. 00:30:41

11 MICHAEL BELKIN, MD: All right. Live fluoro. All right. And what you can see -- do you see this little hatched area here? That's the actual stent graft. The bottom of the graft is down here near our line. The upper portion's a little -- let's pan up a little bit. 00:30:55 EDWIN C. GRAVEREAUX, MD: Boz, north. 00:30:56 CHARLES BOSWELL: Yep. 00:30:58 MICHAEL BELKIN, MD: And there's the top of the graft. And you can see -- one more light fluoro please -- you can see that line right there. That's the gold wire line in the graft, which demarcates the very top of the graft. And now we're going to start to prepare the second graft, which is going to go through this one and be deployed higher. So Chip, to get back to your question, has this changed the way we use open surgery? And the answer is yes it has. I mean, right now the most complex cases still require open surgery, those that involve the various branches of the ascending aorta or mesenteric vessels. And we still need and value open surgery, which is a big part of what we do. However, we are increasingly employing the endovascular approach, particularly with the sort of adjunctive procedures I described before, such as bypasses that allow us to cross those -- those mesenteric vessels. But I think that, you know, the open -- the open surgery is still a major part of our armatarium. And this woman, I think, is a perfect example of somehow who had a complex ascending aorta aneurysm -- ascending aortic aneurysm and a descending thoracic aneurysm and had an uncomplicated ascending repair and now just two months later is here to have her descending repair via the less invasive endovascular approach. 00:32:21 RALPH MORTON BOLMAN, III, MD: That's great, Mike. 00:32:21 EDWIN C. GRAVEREAUX, MD: Now we're inserting the pigtail catheter back intralumenally. We had pulled it back for the deployment of the first module and repositioned it around the arch. 00:32:31 RALPH MORTON BOLMAN, III, MD: There's a question from Cairo, Egypt, that comes in asking, "What medication should a patient be given before and after the surgery, and what is the prognosis after stent grafting for an individual such as this?" 00:32:40 MICHAEL BELKIN, MD: Okay. Well, there is -- the only medications that the patient needs during this procedure is anticoagulation with Heparin. Andy -- Stanley, do you have any CT check for us? Okay. 00:32:52 EDWIN C. GRAVEREAUX, MD: They're keeping it all good. 00:32:52 MICHAEL BELKIN, MD: And we make sure that the patient is well anticoagulated. But there are no particular medications that a patient needs after surgery for a thoracic aneurysm like this. They -- most of our patients are on antiplatelet agents, and that's pretty routine, but other than that there's no particular medications they need. And the prognosis really -- our goal in treating aneurysms of any type are to restore patients to normal longevity, and so their prognosis is very good. 00:33:21 EDWIN C. GRAVEREAUX, MD: Try a little more, Boz, a little more lateral. 00:33:25 RALPH MORTON BOLMAN, III, MD: Another perceptive question: "You mentioned earlier that there's a large area of the aneurysm that contained thrombus. What are the risks of disturbing that area with the wires and stent, resulting in clots traveling to other parts of the body?"

12 00:33:36 MICHAEL BELKIN, MD: Well, that thrombus that lies in the aneurysm is pretty firm, rubbery type organized thrombus. It doesn't tend to move, thankfully. So as long as we're doing these procedures all over wires -- you notice there's no blind passage of any devices, everything's done over a wire, and a soft wire interiorly -- then the chances of dislodging thrombus and having a significant embolus is very low. Now, when we pass the large devices through diseased vessels, we can damage the iliac vessels. And if there's a lot of plaque there or cholesterol-laden lesions associated with thrombus, those lesions can break off and embolize, and that is a known complication. So -- so we really like it when a patient like this lady has very normal vessels. They may be small, but they're very normal, and it generally results in very smooth passages of the device. Okay, so where are we now? 00:34:29 EDWIN C. GRAVEREAUX, MD: So now we've repositioned the pigtail catheter back intralumenally through the distal-most module, which was deployed. It's back around the arch. And our second module is now ready to be positioned. So I'm going to actually advance this around the arch. You can see the -- on fluoroscopy is probably the more interesting view right now, guys. 00:34:50 MICHAEL BELKIN, MD: Yeah, let's -- do you have live fluoro up now? 00:34:55 EDWIN C. GRAVEREAUX, MD: Live fluoro. So here we go. So this is the -- 00:34:58 MICHAEL BELKIN, MD: Okay. And now you can see the device tracking around. 00:35:00 EDWIN C. GRAVEREAUX, MD: It's moving around the arch. 00:35:02 MICHAEL BELKIN, MD: And we want to get it up by where we saw that subclavian artery before. That's where we want it to be. And now he's shot by, which is good. We like to shoot by and pull back, and that allows it to -- and we'll need to -- yeah, we're -- 00:35:14 EDWIN C. GRAVEREAUX, MD: I actually wanted to pull out. Okay. So at this point -- I understand. That might be something we're -- 00:35:22 MICHAEL BELKIN, MD: I think we'll be -- I think we'll be okay. 00:35:24 EDWIN C. GRAVEREAUX, MD: So I want you to float the wire up. You've got to push it out against the great curvature so we make sure we get around the candy cane. There's a little hook to the initial segment of the arch beyond the lesser clavian, which we have to make sure we land very close to, to get a good seal zone. So Boz, now let's go back to another arteriogram. We can check our positions. Yep. We're all hooked up. We're ready to go. 20 to :35:54 MICHAEL J. DAVIDSON, MD: Again, probably live fluoro would be the best shot to show here. 00:35:56 RALPH MORTON BOLMAN, III, MD: Are there any age restrictions on these procedures? 00:35:58 MICHAEL BELKIN, MD: No, there are no age restrictions. And obviously this is a procedure that we really like to offer elderly patients who have very large aneurysms because it's so much less invasive. And I know you're going to skip to showing some results of the surgery later, and I think it'll be clear to the audience why this is such a preferential technique for elderly and more frail patients. 00:36:25 EDWIN C. GRAVEREAUX, MD: So we have more. Do you have the 34x10?

13 00:36:29 MICHAEL BELKIN, MD: If we need to overlap. 00:36:30 EDWIN C. GRAVEREAUX, MD: Do you have a 34x10 in the room? 00:36:33 MAN: Yeah. 00:36:34 EDWIN C. GRAVEREAUX, MD: Great. 00:36:36 MICHAEL BELKIN, MD: Yeah. I think if we have to, we have to. I would just -- 00:36:39 MAN: Okay, all set. 00:36:40 MICHAEL BELKIN, MD: And we'll explain why we did that. 00:36:41 EDWIN C. GRAVEREAUX, MD: Okay. Dr. Leeson, breath hold, please. 00:36:55 MICHAEL BELKIN, MD: Okay. We're right about -- 00:36:57 EDWIN C. GRAVEREAUX, MD: Good. Breathe. 00:37:00 MICHAEL BELKIN, MD: Can we get a peak opac there? 00:37:04 EDWIN C. GRAVEREAUX, MD: Actually, we don't need a peak. It may block out our -- well, that'll be good. Yeah, you can make a mark. 00:37:08 MICHAEL J. DAVIDSON, MD: We're sitting at our curve. 00:37:09 MICHAEL BELKIN, MD: I think we can see it. So can you -- can you -- 00:37:16 MICHAEL J. DAVIDSON, MD: Yeah. 00:37:18 RALPH MORTON BOLMAN, III, MD: Mike, is there any problem getting these [relatively steady] grafts to lay down around that aortic arch curvature? 00:37:23 MICHAEL BELKIN, MD: I'm sorry? No, the grafts are quite -- are designed to take a curve quite nicely. They're straight when they're deployed on a table, but they have interlocking stents, which allow them to turn around an arch very nicely. So they're designed with this in mind. Okay, so we come up to the screen. So here's our transverse shot of the arch, unwinding it very nicely. This is the subclavian artery right here, which we want to deploy the graft close to. And we're going to have to move it up a little bit farther. And then we'll start the deployment here and deploy distally, and if we have enough overlap between the two grafts, we will stop, but if we don't have enough overlap we'll put an additional graft in between there, a shorter graft, just to make sure that the seal between the two grafts is adequate. Okay, so let's cut to live fluoro, and we're just going to advance that a little bit more. And you -- as you can see, the overlap is not going to be optimal. It's going to be -- 00:38:20 EDWIN C. GRAVEREAUX, MD: We're going to get another graft ready. 34x10. So you see how I'm blowing it up a little bit? Hug the wall, then we're going to eke it back. 00:38:31 RALPH MORTON BOLMAN, III, MD: Mike, could you just reiterate how big of landing zones you like to have and how much overlap you like to have when you have to use more than one graft?

14 00:38:37 MICHAEL BELKIN, MD: Okay, so we like to have a minimum -- I like to have a minimum of 2-3 cm of anchor zone proximally and distally. And I like to have a minimum of, personally, 5 cm of overlap. And we're only going to have a couple of centimeters here, so we're going to put another graft in between to complete the repair. So we're going to get that graft ready and then come right up after this one. And that looks like a pretty good position, I think. We lost a little bit of length, but. 00:39:05 EDWIN C. GRAVEREAUX, MD: We need the 34x10 or 15, whichever one you have, as an interposing graft. Great. So Dr. Belkin, I think in this position, we're hugging the greater curvature, we should get decent apposition down the initial segment. We might have some of the open web impinging on the lesser clavian, which would not be the biggest problem. We want to get really close. So -- there you go -- Mike, why don't you -- 00:39:33 MICHAEL BELKIN, MD: Okay. So we're going to be showing live fluoro again, please, to watch this deployment. We're looking good. 00:39:38 EDWIN C. GRAVEREAUX, MD: We're not ready yet. Live fluoro on the monitor. Good. 00:39:43 MICHAEL BELKIN, MD: Okay. And here comes the deployment. Here we go. And there it is. Jump forward a little bit, but I think it'll be fine. 00:39:49 EDWIN C. GRAVEREAUX, MD: It'll be okay. 00:39:52 MICHAEL BELKIN, MD: Okay. Now we're going to do another -- we're going to do a graft in between because I think -- Now can we slide down a little bit, Boz, and show us this site right here. Right. Perfect. And let's center on this. Yeah. All right. And let's mag it. Okay. So -- and what you can see here is here and here, that's the overlap. So all have is 2 cm of overlap, maybe 3 cm. Three centimeters is what the industry standard is. They want a minimum of 3 cm, but we like to have more, so we're going to put an additional graft in between there to cover, let's say, from here to here. You like that, Ed? 00:40:38 EDWIN C. GRAVEREAUX, MD: Exactly right. 00:40:41 RALPH MORTON BOLMAN, III, MD: What size graft are you going to use there? 00:40:42 MICHAEL BELKIN, MD: We're going to use a 34 because we know that'll -- it'll fit well, it's the same size as the upper graft, and it will sit securely in the lower graft. 00:40:50 EDWIN C. GRAVEREAUX, MD: Where did Susan go? Is she out of the room? 00:40:52 MICHAEL BELKIN, MD: Um. Deb, can you clean the screen for me? 00:41:05 RALPH MORTON BOLMAN, III, MD: How are patients followed after these procedures, Mike, in terms of imaging and medical care in general? 00:41:11 MICHAEL BELKIN, MD: Okay, so the follow-up is a very important aspect of this procedure. And it's safe to say that probably some 10% of patients will require another intervention somewhere down the line, either another graft put in or something done to keep the graft functioning correctly. So we follow the patients closely, and what that usually involves is a CAT scan at one month postoperatively, a CAT scan at six months postoperatively, and then a CAT scan once a year after that. 00:41:40

15 EDWIN C. GRAVEREAUX, MD: Got the balloon ready? Great. Right after this? 00:41:44 MAN: Yes. 00:41:45 EDWIN C. GRAVEREAUX, MD: Good. 00:41:46 MICHAEL BELKIN, MD: So after this deployment we will use our tri-lobe balloon to iron down the anchor sites, and then we'll get a picture of what we have and we'll hopefully have a nice completion angio and can break over to talk about some of the results of this procedure compared to open surgery. 00:42:07 EDWIN C. GRAVEREAUX, MD: I got wire, Jean. Yeah. 00:42:12 MICHAEL BELKIN, MD: Why don't we mag this, if we can. 00:42:14 EDWIN C. GRAVEREAUX, MD: I think we're -- we can probably get a better. 00:42:16 MICHAEL BELKIN, MD: Yeah, that's good right there. 00:42:19 EDWIN C. GRAVEREAUX, MD: Like it? 00:42:20 MICHAEL BELKIN, MD: I like that. 00:42:23 EDWIN C. GRAVEREAUX, MD: We don't need to take this back around the arch. I think it's superfluous, so we'll stay right below. It'll look nice. 00:42:26 MICHAEL BELKIN, MD: No, I think -- yeah, I think that's -- yeah, that's going to give us. Okay, so we're going to do another deployment right between these two, and that will -- let's not let it slip back, though, because it's slipping back a little bit. Okay. 00:42:39 EDWIN C. GRAVEREAUX, MD: Well, there's a situation, too, we don't want this thing to be facing up, so I don't know. Boz, show me a little more north. So it's either below or above, Mike. 00:42:48 MICHAEL BELKIN, MD: I like it right there. It's going to give us five -- 00:42:50 EDWIN C. GRAVEREAUX, MD: I think this is actually -- 00:42:51 MICHAEL BELKIN, MD: Five centimeters. Because there's the lower one right there, so that gives us 5 cm. 00:42:58 EDWIN C. GRAVEREAUX, MD: Why don't you come down a little bit? Still gives us -- you know, we're talking over, we're talking -- see how it's -- you want it right there. 00:43:05 MICHAEL BELKIN, MD: Okay. Great. 00:43:08 EDWIN C. GRAVEREAUX, MD: Second junction. You happy with that? 00:43:10 MICHAEL BELKIN, MD: I'm happy. 00:43:11 EDWIN C. GRAVEREAUX, MD: Or do you want to go around the arch? 00:43:11 MICHAEL BELKIN, MD: I would not go around the arch.

16 00:43:18 EDWIN C. GRAVEREAUX, MD: Good. Why don't you go there, Mike? That's perfect overlap. 00:43:22 MICHAEL J. DAVIDSON, MD: Okay. Ready, fluoro. 00:43:23 MICHAEL BELKIN, MD: And here's our third graft being deployed. 00:43:24 MICHAEL J. DAVIDSON, MD: Third graft being deployed. 00:43:27 MICHAEL BELKIN, MD: Great. Perfect. Okay. Let's get our tri-lobe balloon up. Can we get a wire up in this and pull this down? This is -- I think it's been -- great. So if we pan over to the screen now, I can show you the various grafts. And a marking pen, please. Okay. Great. Tell me when you're live on that. Okay, so here's our proximal graft here, and that graft ends here. And our second graft came up here. First graft was here, second graft came down to there, and the third graft overlapped the whole thing to just complete the repair. So it gives us a nice strong core with good overlaps so these devices can't separate from each other. All right, can you clean that up for me, Boz? 00:44:26 EDWIN C. GRAVEREAUX, MD: Very nice. Boz, we're going to have you come back off magnification. 00:44:30 RALPH MORTON BOLMAN, III, MD: Mike, what kind of an endoleak would you -- could you observe in the operating room that would make you feel that you needed further intervention? 00:44:37 MICHAEL BELKIN, MD: Well, if we saw a leak from either the proximal anchor site or the distal anchor site which was feeding back into the aneurysm, that would be very worrisome. That would be the so-called type 1 endoleak, which means that the aorta -- aortic aneurysm is essentially unrepaired. So we really don't like to leave the operating room with any type 1 endoleaks. Type 2 endoleaks, if we see the aneurysm sac filling late via a side branch, we would make note of it and look for it on the CAT scans, but we wouldn't -- we would not try to treat that now. In fact, it's almost impossible to treat in the operating room. 00:45:11 RALPH MORTON BOLMAN, III, MD: Do the type 1 endoleaks tend to occur early or late, or both? 00:45:14 MICHAEL BELKIN, MD: Well, they can occur in both fashions. The most common manifestation is to see them at the time of surgery and to fix them at that time, but they can occur late if you have a migration of the graft, if the graft slips or moves or anything like that. Then you could be forced to -- to go ahead and fix it. Could we get a live on the screen? Okay, perfect. Now you're -- so that's good. So this is the tri-lobe balloon going up. And we balloon this up to anchor the actual touchdown sites. And I think you could go a little farther down. 00:45:45 EDWIN C. GRAVEREAUX, MD: We will. 00:45:46 MICHAEL BELKIN, MD: Yeah. And this is just to make sure that that graft is well opposed against the aorta so that there's no blood leaking around it getting back into the aneurysm sac. And the way we do this with this balloon is we inflate in one site and then we turn the balloon 60 degrees and inflate again. That way we're sure to get the whole circumference. 00:46:23 EDWIN C. GRAVEREAUX, MD: It's rotated now, so one more here and that'll be sufficient. This looks like a fairly normal segment. We shouldn't have a --