Join Venkat Iyer, M.D., Electrophysiologist at Sentara Health, as he performs a WATCHMAN procedure and describes the step-by-step process as he guides the left atrial appendage closure device into the heart. The session is moderated by Erich Kiehl, M.D., Electrophysiologist at Sentara Health, with Q&A and overview of the program. The minimally invasive WATCHMAN procedure is available at Sentara, designed to reduce the risk of strokes that originate in the left atrial appendage (LAA).
So welcome to everyone who's joining for our uh live Watchman case today. Uh My name's Eric Keel. I'm one of the electrophysiologists at uh centric cardiology specialists in Norfolk, Virginia. Um And I'm gonna be moderating this case today uh performed by one of my partners, Vanke Eer, who's at the center heart Hospital. Um We're in the process of getting the patient prepped and ready. And so before we go through the procedure, um we're gonna go through a couple slides about Watchmen. Um and, and really more left atrial appendage elision or closure uh in at more length. Um That's agnostic to the types of uh other devices that are available. Um And so we'll just go through those slides uh quickly. Here, there is a chat feature that you can use. So if you have any questions, um I will look through the chat uh questions as the case goes along and, and, and I will try and answer them. So, um from a disclosure perspective, uh neither Doctor Iyer nor myself have any disclosures related to uh Watchman or any other left L appendage closure devices that would be relevant to this presentation. So, in terms of why a left atrial appendage inclusion or we may say L A A O just for uh for abbreviation perspective is, is an important thing. Um atrial fibrillation is the leading cause of uh arrhythmia care is the leading cause of increased Medicare expenditures if you look at it over the last couple of years and if you just look at prevalence, um this is a 2018 study, it's estimated that uh a fib prevalence will nearly double um in the next decade. Um What we know is as patients age atrial fibrillation becomes more common and patients are living longer and and to be fair, this these estimates may actually be underestimates. So, atrial fibrillation is a common condition. The risk of stroke in patients with atrial fibrillation is five times the risk of those patients that don't have atrial fibrillation. And another way of looking at it is that one in six patients who have strokes have atrial fibrillation. And so, if we can identify atrial fibrillation patients who are at increased risk for stroke, we can therefore uh reduce their risk of stroke, which is a significant morbidity and mortality improvement for patients. Um If we look at what the guidelines are in terms of who we should treat for patients, um not necessarily with closure devices, but with some sort of stroke prevention strategy, it's patients who have a chance to bask or greater than two in men or three in women and for those of you that don't know what a chad two asks or C stands for congestive heart failure. H for hypertension A is age and there's two cutoffs at 65 75. Each one gets you a point D is diabetes. Um uh S is stroke. Uh You get two points for stroke. V is vascular disease or peripheral vascular disease, coronary artery disease. And then S C is basically uh corrected for gender. So what that means is that women are at more risk for stroke than men if they have other risk factors. Um But if they don't have other risk factors, actually at a score of uh zero and one, the risks are the same. Um And so stroke risk, depending on how high your chad's fat score is worse. Uh The higher the score is can range between 2 to 5% a 2 to 15%. Those may seem like small numbers perhaps at a per year basis. But another way to think about it is that every year that you don't have a stroke, um There is this number of people left. So what a 15% annual risk means that that if you cloned yourself 99 times and you started with 100 of you at year zero, uh you would have 85 left after year one, roughly 70 after year two and so on and so forth. So pretty quickly you can get to a 50 50 risk of stroke. So, in those patients, oral anticoagulant, oral anticoagulant, so eloquent Xarelto Pera cumin are recommended. Uh You'll hear the term do act. That's basically just a uh a directoral antic coagulant that doesn't require um uh I N R monitoring. So, so why does the left atrial appendage matter? Well, for patients with atrial fibrillation, it's the origin of about 95% of all cardiac throm by. And here's just a, a video if you can see my my pointer of the left atrial appendage. This is the pulmonary vein coming in here and this is an area. This is an example of a nice clean uh appendage without any blood clot. On the other hand, what you can see here is a is actually a organized thrombo or blood clot down in this, in, in this left atrial appendage. And so this is what we're trying to prevent the blood thinners. Uh if blood thinners don't allow us. Uh and a good alternative because of risk, then what left atrial appendage inclusion is to basically exclude this whole chamber uh with a device so that we can reduce the risk of stroke. So the live case you're gonna see today is a 72 year old female who has a chat to a score of three. So it's in the moderate range and certainly qualifies for watchmen. She has high blood pressure, she's had gastrointestinal bleeding after starting a direct oral anticoagulant and she's had work up thus far, including endoscopy and colonoscopy that have been unremarkable. And this is a common scenario, you'll see patients that have kind of occult bleeding that we can't uh determine a source even after even capsule endoscopies. It's a very common uh in good case to go through. So, what are the, what are the criteria for left atrial appendage closure? So you have to have nonvalvular atrial fibrillation. What that means is that you can't have um basically a surgical valve or a mitotic valve or rheumatic heart disease. That that's the cause of the atrial fibrillation because those patients have increased risk of stroke just from their rim themselves. They have to be a higher risk candidate for oral anticoagulants. And so that means uh we'll go through some examples in a second, but um they have to be able to take short term oral anticoagulants. And actually, this has been well studied. Um but even in patients who have in intercranial bleeds, uh they can do quite well with uh you know, between a month and six months of anticoagulants and then um see if we can advance the next slide. Sorry. There we go. All right. So, reasons to consider closure. So, um bleeding issues like our patient with G I bleeding, severe bruising, um history of falls. So somebody who walks with the walker is a higher fall risk. Um concerns about not being able to take the drug uh if they have dementia, um occupational lifestyle reasons. I think this is an increasing um uh area of, of, of interest. So, um you know, patients who um are, you know, ski patrol instructors, probably not a great idea, you know, somebody who solo boats in a sailboat, those are probably not works in a machine shop, probably not great ideas for those patients to be on blood thinners. Um There's also, you know, arthritis, I think is an a a growing indication to patients who cannot be on um nsaids uh for quality of life reasons because of a blood thinner. Um Those patients can benefit pretty significantly from a quality of life perspective by Watchmen and then in patients who have stents um or, or other sorts of transcatheter valves that would require them to be on what's called triple therapy, which is something like aspirin Plavix and a blood thinner. Um Watchman can reduce the bleeding risk in those patients. So how can we screen for who's a candidate for Watchman? What you'll see today is a live screening of a transesophageal echo at four different views and we'll go through those with you and we're measuring the basically the width of the appendage and the depth of the appendage to size or device appropriately. Um You can also pre image with that, we've kind of moved away from that or you can get AC T scan um to look at this uh which which actually gives quite nice images and that's gonna be helpful for planning the procedure as well. This is just an example. You'll go through a live case here in a, in a second, but of how we would measure the width and the depth. So if in this left example, you'll see the width is a 1.92 centimeters and the depth is roughly three centimeters. And so based on compression ratios you want to hit with the device. This is certainly a suitable uh target our devices uh range from uh uh 20 millimeters or two centimeters up to uh 3.5 centimeters. This is kind of like a mid-range uh to smallish appendage. This one on this side, what you can see is quite a lot, quite a larger appendage. And this is in the 1 35 view uh which will focus a lot during the case. Um So this would require a bigger Watchman device. This is at 45 days how we assess if the watchman is well sealed. So this is the watchman after it's been deployed. This is a transverse sinus here. And what you can see is there's no leak around this watchman. You can also do C T at 45 days. So in terms of what we use now, we use a device called Watchman Flex, which is um not the first generation of watchmen, but it's, it's a remarkable device and was released a couple of years ago now and pretty much every patient is in a registry. And so for about two years worth of data, we now have uh descriptions of who these patients are getting watchmen. So average age of 77 with a confidence interval going up to 84 is that this is a safe procedure for older patients, pretty high risk patients. So chat you has scores of five, has blood scores of uh 2.5 to 3.5. Uh very representative of both, both women and men. 40 to 60 about 60% of patients. It was for patients that had already had clinically relevant bleeding, 98% procedural success, meaning that we very rarely can't get a watchman in that that meets an efficacy goal. Uh And probably most importantly, any time we're talking about a procedure that we have low risk. So a total 0.5 MA E rate uh with a basically one in 300 chance of stroke and a one in 200 chance of pericardial fusion. After we talked about how you need to be on uh therapy for some period of time. There's different ways of doing it. Um These are both approved uh methods. So you can use an or antic regulant and aspirin for 45 days and then switch to dual antipla for six months and then end up with just 81 mg of aspirin long term. Or you can just go straight to dual antiplatelet for six months and then go to Aspirin. I think you'll see a variety of different approaches that we all use. These are operators uh that, that perform Watchmen at Centra Heart Hospital. Um So it's a mix of structural heart physicians and electrophysiologists. And so there's a wealth of people you can refer to, we've done over 1000 cases at Centra. Uh And so, um you know, there's plenty of people to help in this space and I think we'll talk a little bit more during the case. This is a watchman case, but there are other types of left at appendage potion devices, amulet, which is an avid device. And then there's a newer uh device, I think bank will talk more about that's in uh clinical trials. So I think those are the slides we have for you if you want to switch over to the a live case, uh If the cat's ready to go, we can, we can start going through the case. Uh give me 30 seconds. Sure. So I I'll kind of talk through what, what we're doing here beforehand and everyone's got a different approach on how they do this. I think uh Doctor Ier has got a nice, nice approach here. So we're gonna be putting a pretty large sheet in the right femoral vein to implant the watchman uh device. And so, um, you can uh close that sheet um before pre close, which is what Doctor Ier is. Um, setting up to do right now. Um You can uh use a figure of eight suture uh at the end of the proceeding in you can um you can uh just hold pressure that I think that's kind of fallen out of fear or you can downsize to something called the bascay device. So, what he's doing is basically allowing this patient to operate. I go home the same day, um which is um which is, which is somewhat novel and still, still kind of an emerging uh approach. Uh But I think one that most of us take at this, um what he's doing is basically pre closing the, the watchman site here. Um I'm gonna go to the moderator tab just for a second and see if anyone has questions thus far. And let's give our leg line here and then we'll be ready to go like line here. Gabby. Yeah, I don't see any questions thus far. So at this point, we'll just kind of wait, then wait on doctor. I already get ready to go. Flora can be turned on. I need flora pals. Thank you. Excellent. We can go live, we can go live. Yep, you're live. Excellent. Good morning. Actually, good afternoon to everybody uh on the live stream. My name is Ben Ka Eer. Uh I'm one of the cardiac electrophysiologists at Center Heart Hospital. And you guys just heard from one of my colleagues, Eric Keel uh in the room. We have Emily Gold right here. Emily Wave with the camera. Excellent. Uh She's one of the uh cardiovascular technologists that we have. We have Joe, who is one of our nurses there. Uh We have Doctor Matson uh in the back there who is our anesthesiologist, who's also going to be our echocardiographer today. Uh She's gonna help us get some of those images of the uh left atrial appendage. Uh Some of the images that you guys saw on our initial presentation uh done by Doctor Keel. So she's not only gonna be managing the anesthesia part of the uh portion of the case, but also is gonna be our echo echocardiographer. Today. The patient has been intubated. Uh She's on general anesthesia with an endo tracheal tube. Uh She already has a radial arterial uh line which measures her uh blood pressure on a beat to debate basis. And in her right groin here, I have two sheets uh in the right femoral vein. And that will give me access to her uh to her right atrium and then subsequently to her left upper chamber of her left atrium so that we can go ahead and uh and place the uh uh washing device. Uh The other thing that we've already done so far in the case is we've placed a transesophageal echocardiogram cardiogram uh probe, which is basically a probe that Doctor Matson was able to put into our esophagus into our me esophagus. And we get some ultrasound images. And the ultrasound images basically show us the size of the left atrial appendage. And uh it'll help us size the Watchman flex implant as well. What we also wanted to be able to do uh during this is make sure there are no existing blood clots in the left uteral appendage. If there is a blood clot in the left uteral appendage, then unfortunately, we cannot do today's procedure. And based on the initial images that we're seeing so far, uh there are no blood clots in the left uteral appendage. So we're good to go as far as this procedure is concerned. Um So the next thing we're gonna do here is uh I'm gonna put a wire uh into the sheet and we're gonna go across from the right upper chamber of the right atrium to the left upper chamber of the left atrium so that we can access the appendage. So that's what we're gonna do next. So while that's doing that, I'll, I'll kind of direct you to the um ultrasound images that I think are being obtained live by Doctor Matson. And what we're doing is we're looking at four different angles, 0 45 90 and 1 35 to see the width and the depth of the appendage. And that's gonna allow us to choose the size of the watch device. You can see Doctor Ire's wire now going up the growing up into the superior being a cava and that's where his sheet is gonna go over and you can see the T E E probe that's getting the live images right there in the middle of the screen. One of the advantages to the new Watchman Flex device is that it is uh kind of less deep than the prior uh device. And so you basically need half as much depth as you have width. So in the past, we struggled to kind of close these short kind of wide appendages. And now we've got better options for that. So it looks like in the early uh uh dimensions, we've got, this is gonna be kind of a moderate sized device, but it's important to get all them used as far as preparation for this case is concerned. Uh other than talking to the patient and consenting them in the office for a procedure like this, one of the things I do for these patients, uh when they're about to get an implant is I do something called pre implant screening. So the pre implant screening involves uh them talking to another cardiologist in the office to do something called shared decision making. So they wanna make sure that uh the cardiologist is, uh the cardiologist makes sure that they understand the procedure. Uh and uh they understand the risks and benefits of the procedure before they go ahead and do this case. Um they, they consent to do these cases. So every patient will usually see a second cardiologist in the office to make sure that they understand what they're, what they're, what they're signing up to do. Uh, in addition to talking to us. Uh, and then the other thing that I do is, uh, um, I, I, I do C T scans on everybody. C T s of the chest, uh, cat scans of the chest to make sure that the left appendage is of appropriate size. It, uh, We've, we had initially sort of started doing that as we as, as Watchmen became commercial. And uh and then we went away from doing that because the number of patients that came on the table that could not get a watchman was so small that we stop doing that. But now we've sort of restarted doing that only because there's multiple, there's at least two commercial devices on the market, both Watchman and Amulet. And so there are certain anatomies of electro appendix that may be amenable to one or the other. And so it's important for me to determine well, in advance who's going to be helping us doing the case, whether it's going to be Boston scientific reps or it's gonna be Abbi reps. And so I want to make sure that I pick the correct device for the, for the for, for the patient. And so I'll do C T scans for all of them. So this lady has had AC T scan and she had a, a pretty standard size appendage. And so, uh and so that's why we brought her in here today to do this live case. OK. I'll be ready for concept a little bit here. So what you can see on the T now is Doctor Matson is actually showing doctor I the um kind of thin part of the connection between the top left and top right chambers. And that's where he's gonna basically get his, his wire to try and poke across and get the sheath across. Um And so it's important to it not be too anterior because the, the order sit anterior, not too posterior because you can basically puncture through the back of the heart if you're too posture and then not too high or too low. So this is probably I'd say one of the most important parts of the procedure. Can you see me anywhere? Gavin? OK. I may need the other little wire back again. Yeah. Bye. The wire that, that we're using there is uh something called the versa cross wire, which is a um it's a, a wire that basically has a tip that you can provide electric Cotter on um to try and basically get across the septum. But then the minute it crosses, it becomes a floppy, uh we call it pigtail wire. And what that allows you to do is to be able to advance and, and exchange sheets without uh without having to different angle sheet through the back part of the heart. This is a a tool that most of us like to use these days. Yeah, you see me there. Ok, perfect right there. So let me pull the wire back just a little bit here and I think I'm tenting there with the sheet. Ok. Thanks the pending there. Yeah, looks like I am. Yeah, I'm gonna try to go clock here a little bit. Come down just to touch. Yeah, try a different angle there. I think we should take that. Yeah. OK. You can buzz there. Please did not go across. Let's try again. A different angle here. Gabby, I'm gonna come L A O. Here it is. Your uh key probe is sort of in my way, but that's OK. You just move the uh there we go. So I can see there's already a bit of uh questions on the chat feature. Once we get trans, I'll start answering some of those questions for you. OK. We can buzz there. So 11 question somebody asked is, what is the size of the Venus sheet? Um The watchman. She I think is a 15 French uh sheath. Uh So that's the sheath. We're doing the procedure. Um Through I someone has asked, is anyone using more C T versus T E for the 90 day check to assess for leaks and positioning? I, I think most of us tend to use C T. Um Some of us still will use T E E. Um I think C T is, it's non invasive. So, even though T is a pretty low risk procedure, you are still introducing, you know, a stiff probe buzz. He doesn't want to go through there. Huh? Um, in terms of how long does the procedure last? That's another question. Um, it's variable. Right. I always tell patients procedures take as long as they take to do a good job. So safe and effectiveness is what we're always going through. Can I have a uh B R K extra sharp one needle, please? We're just gonna change gears a little bit here. We're just gonna go in with an actual needle rather than the R F device here. Sometimes when the septum is a little bit aneurysmal, it can just kind of the wire can and not be our best tool. So we have sharper tools uh that actually are are physical needles we can use. So, going back to the chat questions. Uh So how long does the procedure take? You know, I I said safe and effective is the most important thing. Um Oftentimes our in room time is about an hour. Uh I think times can sometimes be, you know, 30 minutes or so. Um This case will be obviously a little bit longer because we're, we're annotating through things, but it's a pretty safe and, and, and, and quick procedure a question. Can you use this when the patient has had more than one ablation or may have an, an aortic aneurysm present which does not require surgery. Um, yeah, you can do this if patients have had ablations. Um, you can do this if patients have aortic aneurysms. Um, this, uh, because we're not going near the aorta and, um, because we are, uh, just basically including the left atrial appendage, the mutation part, I wouldn't say it's not relevant but it, but it, it doesn't affect our ability to successfully implant a watchman. There are certain scenarios where if you ablated the atrium significantly enough in areas other than you normally would, then perhaps the atrium could develop myopathy and you might not want to consider a watchman. But in general, yes, you can, uh is the trans seal puncture closed at the end. Uh in general, it's not, it will close off. And when we do our repeat T E or C T E, you'll see if there's any flow. But uh in general, these will, will close off fine without leaving a, a uh hemodynamically significant. Uh A S D. Uh What kind of sedation is used for the procedure? Generally? General anesthesia is our approach. Uh because of the need for the T E E and um you know, kind of patient comfort and, and then stability why two sheets, um everyone does things differently. I actually use two sheets I use in inter cardiac and esop to, to do my um to do my imaging, you can have a dedicated sheet for resuscitation or for drawing labs. Um Yeah, you can do it with one sheet. There's just a, there's a variety of how we approach things. I think that's all the questions for now. So go back to the case. I'm hoping to go trans here so we can start this case. Yeah, I know sometimes it's good to see it. Not straightforward one almost there there. Huh? Yeah. Yeah. That's a nice tent there. OK. Yeah, we just want to cross there. I think let's go ahead and give some fluid there. Flash, flash forward. So one of the things, one of the things you'll see us do is once we uh across the septum, we'll give Heparin, which is um and often times I'll actually give it beforehand, which is a uh an intravenous blood thinner used to make sure that we don't have any clots form on our device while we're doing the procedure. OK. But can you just confirm the Yeah. Yeah. OK. On the ultrasound. Now you can see that nice sheet across uh across the septum on a hard set to do? OK. Yeah. No, I'll do the uh the contract. Yeah. So we can give. So once we go across to the left atrium, since we're in systemic circulation there, which means that systemic means that basically the left atrium and the left ventricle, which is the left sided chambers of the heart are essentially connected to the brain. We want to be able to give, uh he uh to prevent any blood clots from happening, uh from, from emanating in the, in the left atrium or on the wires on the sheets that we use. And so we use an activated clotting time, which is a measure of how thin your blood is. We wanna make sure that the activated clotting time is about 300 seconds. And again, uh, Doctor Matson is about to give an uh give up, give uh heparin right now and uh, we will in a few minutes, we'll check an activated clotting time and make sure that that's about 300. So that's, that's what we're about to do. Uh, right now. So what I'm gonna do here is I'm uh, as you see on the floral screen, on the fluoroscopic screen, I just put another curly uh wire in the left atrium there and I'm gonna remove this sheet that we have that was used to go trans and I'm gonna, I'm gonna actually put in the Watchman delivery sheet. Uh The Watchman delivery sheet is a bigger sheet than the sheet that we have here. Uh, because it has to be able to accommodate the size of the device. And so, uh, the next thing we're gonna do is put that sheet in and then we'll be ready to uh will be ready to implant the device. Thank you. So, so did somebody ask why? So, go ahead. Oh, go ahead. Somebody asked why we have two growing sheets here. Uh I usually don't do two growing sheets, but uh but this is a high profile case. And so, uh if we were to have an issue or something else that we, and we need some, we need resuscitative efforts, is always have good to have multiple uh uh lines in the groin, uh to be able to give fluids if we, if we need to do that. Uh We, the patient also has an a line, so um an arterial line. So uh we can measure sort of real time blood pressures, but having multiple Venus lines in the is, is usually not a bad, not a bad, not a bad idea. And when I get access, access is usually uh obtained using ultrasound guidance now. And so we're not sticking blindly into the vein of the artery. We do that all do using ultrasound guidance and it's essentially made our procedure significantly safer and we've been doing that for the last 10 years in this hospital. So I like this technique that, that doctor Iyer is using of going across with a smaller sheet, you know, a lot of the sheets will use to get across um or, you know, in the 8 to 9 French size and the watch is a 15 French catheter and uh and sheets. So sometimes it doesn't go across the septum easily. And so you kind of pre dilating and switching to this uh floppy pigtail wire and then going with the bigger sheet often lets you get across easier without compromising the sheets. That's, that's what I do too. Um There is a sheet where you can go directly across that, that Boston Scientific makes, which is, which is fine. There's again, different ways of doing the same procedure. But I, I like this approach. So I'm just gonna answer a couple more questions and then Ben interrupt me when you uh are on to your next step. But um somebody asked, how accepted is this procedure among doctors across the nation? Um As we showed you in the registry data, uh over the last couple of years have been like 70,000 cases done. So it's, it's, it's really becoming, wouldn't say first line therapy, you know, because you still have to qualify for it, but it's a much, much more prevalent procedure than it used to be. I think it's, it's not on the fringes, it's in the mainstream. There are new trials coming out that are gonna look even more. So at whether there's an additive benefit to blood thinners, whether um it should be used at the same time of ablation. So the more to come on that, could you use the Da Vinci machine for this procedure? Um I uh it's a great question. I, I probably, I guess you could but um, I don't know of anyone that does come up uh risk factors to determine if there an ice is used. Um Yeah, so, so in terms of it's used, I would say for most of us infrequently, I'm probably the uh the, the outlier that uses it. I just, I find ice gives me a better, better view at trans axis, but where it's being used more and the future is actually uh hopefully to, to be able to use something called the 40 ice to do this without transesophageal acos, that's more of the future I lay pressure here. Those are great questions, by the way, um I think uh that I was gonna say you want to talk through the importance of L A pressure. Yeah. So the left atrial pressure is a pressure that we measure from the PTA cathode that you see in the left atrium, it's connected to a transducer right here and it measures the left atrial pressure. The left atrial pressure we would like to that in a normal left press, a normal, right atrial pressure is, is above five uh and a normal left at pressure would like to be above 10 for the wash procedure or any left atrial appendage closure or procedure we'd like for the L A pressure to be a little bit higher than that. So sort of in the 10 to 15 range. And if, if someone, if someone is, is uh is has a low left atrial pressure, it essentially means that their intravascularly volume depleted or what we call dry. And so we want to give them fluids. And that's because if they're dry and they're like, pressures are lower than the watchman. The left at size may be smaller than we think that it is. So we, the shape, the size of the device that we pick for that appendage may be undersized for when they have, you know, when they're, when they're not dry anymore. And so we want to make sure that we give them enough fluid so that the left at pressures are, are higher so that we can size the device correctly. So what, what are you seeing for this case? 12? So this L A pressure is 12 right now. So we're, we're right in range and we're gonna go ahead and try to get on, get into the appendage and, and start our case here. So the doctor I point with the, with the L A pressure of 12, you don't need to worry that the size you're measuring on the T E E is. So this is, this is uh our, our measurements, we can feel they have there's good fidelity there. But what I'm trying to do here is I'm trying to put this pigtail wire into the uh into the left lateral appendage. And uh and that should be in there that should be in there. And you know, these, these procedures are are sort of fluoroscopically driven. But I really think that trans transesophageal echo or even ice will offers us such a beautiful view of the appendage that whenever now we do implants, I think a lot of us uh are starting to use a lot of pe guidance and a lot of ice guidance to implant these devices. And so, and so, um I, I really think that's, that's, that's, that's, it's very important to sort of be for, for the anesthesiologist to be very versatile in getting us good images. Uh And if we're gonna start doing this using ice, then for us to have a very, very good, good understanding of uh of ultrasound physics uh as well as cardiac anatomy. So the next thing we're gonna do here is we're gonna basically shoot a little bit of contrast through the pigtail. We're in the appendage. And what we want to be able to do is op pacify the appendage so that we can see uh what the appendage shape is, what the appendages size is and whether or not that matches with our trans echo measurements at the beginning of the case. So that's the next thing we're gonna do here and you'll see that live on my floral image, the garden now. Yeah, go ahead and inject. OK. We're gonna, we're gonna do this again. I'm not sure that this was a an optimal uh angiogram. So let's do this again. Just want you guys to be able to see this nice. OK. Go for it. So that's a little bit better. And I guess what you there you could see is you could see sort of the outlines of the electrical appendage there. And, um, uh, will they be able to see the markings on the, on the, uh, perhaps if you freeze it, when you freeze it, it'll, it'll, uh, at least be able to show, go back a little bit on that there. Yep. So, what we're doing now here is, uh, if you guys can see us on the, on the screen here, we're making sort of a uh we're, we're tracing an outline of the left Atal appendage here and then we'll take a pretty quick sort of measurement of the ostium or the entrance into the left atrial appendage so that we can determine what, what device size we want to use here the same. OK. So we'll use it 27. OK. So the maximum osteal diameter here both by pe E and on this ang gra image is about 22 millimeters. And so we want to upsize the device size. So we're gonna use a 27 millimeter device. The reason to go bigger uh is so that the left Aral appendage. So the device tries to expand itself to the left atrial appendage and the left atrial appendage architecture sort of whole prevents that from happening. But what that does is it keeps the device in place. If the left Aral appendage diameter was 22 we chose a 22 device, it would be it would be perfect in terms of sizing into the appendage. But you could see how that would embolize that device would embolize. So what we wanna do is upsize the device compared to the ostium of the appendage. So this is a 22 millimeter ostium, we're gonna choose a 27 millimeter diameter device in this case. And so you'll hear, you'll hear us talking about compression ratios at the end of the case. But essentially we're looking in that 10 to 30% compression range and so 27 is perfect for a 22 device. You're gonna end up in the high teens, low twenties for compression. Th this uh leads in well to a question that was asked about uh how often do these uh devices just lodge? Uh they just lodge very, very infrequently. So, um uh that's in the registry but much, much, much less than 1%. Um I actually can't think of one uh that's just lodged recently. Um Just trying to get through some of the questions. Yes, MRI compatible for Watchman. Uh Yes, you can have a watchman if you already have a stent, most common complications, probably just uh growing bruising. I wouldn't really say it's a complication but it is a big chief in the growing um things like pericardial fusion stroke, things that are, that are more serious, that's very uncommon. Um ages of patients is this procedure is performed. So it's, it's approved for adults um as we showed in the, the registry data of the average patient and the registry is 77 years old with a, a range of about 10 years. So 67 to, to, you know, 87. But um I have had patients in their nineties patients in their fifties, um precautions for con uh contrast allergy or just pretreatment as you would for any contrast allergies, usually steroids, uh Benadryl, uh Tylenol. Um and, and as we showed, it is possible to do the case without contrast, it's just better to, to have it. If you, if you do uh we hand inject um for the person who had a, a question about that, no need to injection. Um Which appendages do not qualify for the procedure. So, if the appendage is too large to accommodate a device, uh So if we had an appendage, that would say 37 millimeters in oum, it would not qualify. Um And then I think we're caught up on questions. OK. Excellent. So, uh so what we initially did was uh uh we got the 27 millimeter device out on the table here and uh we made, we checked the device, we made sure the device was was OK. And then the next thing we wanna do is we did was we connected the manifold to a pressure line and we connected that to the device. And uh um what we do there is we want to make sure that there are no bubbles in the uh in the uh in the delivery sheet and the device. And so by doing that, what we're trying to do is prevent bubbles from entering systemic circulation. So that has been done. And I've already introduced the uh the device into the sheet and it's all the way into the appendage there. So the next thing to do would be for all of us to focus on the fluoroscopic image because we're gonna go ahead and uh and uh and deploy this device here, the fluoroscopic image there is live. And the first thing we're gonna do is we're just gonna push the device out till it becomes a ball. So we call it a flex ball. And right about there is where the flex ball is. I'm just gonna take a sitting image there and then I'm gonna pull the sheet back just a little bit there. Michelle. I'm just gonna go ahead and push forward here. Yep. So I'm gonna go ahead and slowly deploy this. I'm gonna send this the entire way here. There we go. And we hold 10 seconds of forward pressure. The device is deployed as you saw on the floral image that's playing on your computers and you can see the um on the bottom, right? Also the, the live transesophageal uh image uh of the watchman as well. So we're gonna look at it now in both fluoroscopy and so on that image on that trans echo image. You can clearly see, you can see the device at about a four o'clock position over there. And, and that device looks like it is completely opposed to the walls of the appendage and it is perfectly placed on the ostium uh at the, at the entrance of the, at the entrance of the appendage there. So we'll take a couple of quick measurements here. And after that, what I'm gonna do is a tug test, which is what I do is I just back the sheet dot And I just pull the device and I wanna make sure that the device has sort of does not dislodge what the device has is. It has a bunch of barbs on the, on the sides of the device and those barbs help sort of attach to, to appendage tissue. And so when I pull back on the device, I'm hoping for the barbs to be attached. If the device dislodges at that point, I know that the device was not in a good position and we have to redeploy uh the uh the Watchman device. So that's the next thing we're going to be, be doing right now, try and keep your guys' eyes on the flu and then on the E E to see if you, you think the device moves or not cardiac structure puncture rate um that would be mostly pericardial fusion um and as shown in the registry at very low, uh much less than 1% tug here. OK. So we're gonna do a tug test here. And if you guys wanna look at both the floral image and the, and the T image, maybe the T image is actually significantly better than the floral image. So I'm gonna go sit in here and I'm just gonna pull back and you can see pull, pull, third, pull here, the fourth pull here. And I'm, I'm, I, I, I, I pull pretty aggressively on this. I want to make sure that the device is, is sitting in place. And as you can see over there, the device is in good position over there. It really didn't move at all as we, as we sort of popped on the device uh with, with a lot of force and, and what we'll do now is make some compression measurements. I think, I think Doctor Keel talked about some compression ratios. What we're basically trying to do with compression ratios is we're measuring the diameter of the device right now. Like I already said, we upsize the device uh uh for, for the, for the uh for the left adage measurement, we upsized it. So we want to see what the final device uh measures now and we want to divide that by the device uh diameter. So right now, if we get a measurement of 21 millimeters, let's say, and if we had picked a 28 device, we don't have a 28 device just to make the math easy, 21 divided by 28 would give us, would give us uh a compression ratio or one minus 21/28 would give us a compression ratio and that percentage would be about 15% which would be uh uh uh sorry, that would be 25% and that would be a pretty good compression ratio there. So what we're looking for is now in the same pe images at zero degrees, at 45 degrees, at 90 degrees at 1 35. We're gonna take compression ratios and we're gonna make sure that the compression ratios are good. Uh So we've done as far as confirmation uh confirmatory tests. Uh compression ratios is number one, the tug test is always number two. And the third thing that we'll do after they've taken compression ratio is we'll do an angiogram. So what we want to be able to do is we want to make sure that there's a complete seal of the device on the appendage. So we'll shoot some contrast through the sheet. And what we want to do is we want to see contrast go through the device and not around the device. If you see that as, as doctor, he talked about the electrical appendage is a very complex structure with multiple lobes. You know, we we talk about appendages being either wind sock or broccoli or cauliflower or chicken wing. Those are the different types of uh left appendages that you have. And so it's very important for us to make sure that the entire appendage is sealed. So most people will have an anterior lobe and a posterior lobe. And so we don't want to deploy the appendage into one lobe or the other and leave another lobe uncovered. So the, so the reason to do the um the angiogram is to make sure that we haven't missed any lobes that are uncovered. If you leave a lobe uncovered, essentially, you've done nothing at all because now you still have a lobe where blood can get in there, blood can pull and cause you to have clots and you can have embolic strokes from that. So that's the, that's the reason why we want to do a, a very, very nice angiogram at the end of the case. So again, what we want to see on the angiogram is, is blood going through the device into the appendage rather than sneak in through a lobe around the device or something else like that. Um In addition to compression ratios over here that they're measuring, they're also putting some color as you see on the, on the on the echo images, you'll see all this color going. And what we're essentially trying to do essentially again here is we're trying to make sure that the color flow, which is blood flow, uh color means blood blood flow, the blood flow is not around the device. And that the device is completely opposed to, to appendage tissue and there is no leakage of uh of blood around the device. Uh Sometimes we see leaks and they're unavoidable because you know, the device may be a round device and and the appendage may be an oval, oval appendage. And so it's tough to like sort of have the device conform to the uh to the appendage anatomy. And so you may have leaks that form and usually we want leaks to be less than five millimeters. And so what we can do is put an ultrasound image on, on echo and we can actually measure the jet and we can make sure that that jet is less than five millimeters. And there's some data out there, not strong data, but there's some, there's some data out there that says that anything above five millimeters is prothrombotic. And so that's why we want to keep the jet to be less than five millimeters if possible. That, that, that dovetails nicely. Uh The last question we had most recently was um does the device thrombose. And so one of the reasons we keep patients on blood thinners after the procedure for a short period of time, whether it be or antic regulant plus aspirin or dual anti platelet is uh to, to make sure the device doesn't early thrombose. And then usually the device endothelial realizes basically meaning forming its own tissue over the over the device. And that's why we can get away with, with the baby aspirin long term. But, but we are interested in looking into what the right duration of time is and what the right duration of imaging is uh for something called device related thrombosis. And I think that's an emerging area of interest. Do you have any comments on that be? Uh yeah, I think, I think uh I think there's a lot of studies that are out there that are sort of studying what the optimal uh regimen is gonna be. Post up uh post implant of a left atrial appendage closure device. I don't think we have all the right answers right now. Obviously, the device uh uh companies are most interested in keeping it as simple as possible. Our protocol uh differs here amongst, amongst our own partners. We, we all differ in what anti coagulation protocols are. So like I like I, I'm sure you saw the slides where we had an option A, an option B where the option A was 45 days of anticoagulation. And then uh and then do AC T or a pe at 45 days and then going, going with, with, with sort of dual antiplatelet therapy thereafter or now both the commercial devices on the market watchman and Amulet have a dual antiplatelet uh indication for the first six months or so. So if you have somebody that you really think is gonna bleed within the 1st 45 days on or antic coagulation. Uh then, then they would be candidates for going on dual antipla therapy. But, but again, I think this is sort of a very evolving field. Uh My personal feeling is that I would like to keep patients on anticoagulation for at least 90 days because the risk of, of thrombus coming on top of the devices in the 1st 90 days is a real thing. We have seen it. Uh We all see TV, people at 45 days or 90 days. So we do see trauma, trauma on, on devices. And so my personal preference would be to keep somebody on orlan coagulation for 90 days. And the only reason not to do that is if I really think it knows 90 days, they're gonna have a pretty significant bleed. Did I answer that question, Eric? Yeah, that was great. Um I don't know if you guys saw, but earlier we got some nice 3d images of the, of T E E and you can actually see the, the still the attached uh you know, device tether right there kind of going into the, into the watchman and you don't see any leaks around it. So nice imaging for Doctor Matson there. Yeah. The next thing we're gonna do here is now uh as promised, we're gonna do the angiogram. Uh the sheet has already been filled with uh with contrast and so I'm gonna step on floral again now and we're gonna see a an image of contrast flowing sort of through the device into the appendage. The compression ratios have already been measured. They're between 21 23% which is perfect for us. So we're gonna do the angiogram next as our final confirmatory test here, inject perfect. And so if you could see that right there, you could see that the appendage is a pretty complex structure there. You can see the see the device on there and you can see uh that the contrast is sort of going through the device and a pacifying the rest of the appendage there. But that the, but that there's no leaks either on top of the device or or below the device. Most of the all of the contracts is sort of going through the device there. So this is our final confirmatory test here. So we've done three things tug test which is pull hard, make sure it doesn't dislodge second compression ratios, which are perfect. And the last thing is your ang gra uh your angiogram here. And that's sort of our past criteria. So now we know that this is a good device here. We've passed all the tests here. We can go ahead and deploy the device at this point, release it from the delivery sheet and we're good to go. Then at that point, the other thing I would add VCAT is um if you look at the contrast shot um and the transesophageal echo this is a good view at looking to see if you have something called the shoulder, which is basically the device sticking out too much. And in the contrast shot when you played it, you could see the contrast kind of empties out into the body of the left atrium, right flush with the device. And you can see that on the T E. So there's no shoulder here and you don't want to have more than a third of shoulder because that's a risk for that this lodging. Uh So this is a perfect, ok. So I'm gonna go ahead and just pull the sheet back here a little bit. And then we have a mechanism here uh to go ahead and release the device, which I'm gonna go ahead and do now and perfect and the device is released and we're back with the sheet into the inferior Vena cava into the vein. And essentially, can we show a T image of the device again, please? Without the 3D, can we just show a two D image? And you can see there that now that the device has been, the device has been released from the tether uh that it's staying in a perfect spot there and it hadn't, it hasn't moved at all. Sometimes you can get something called wire bias where sometimes the wire that's attached to the uh to the, to the device can, can sort of help, can sort of keep the device in a certain way so that once you release the wire, the wire bias goes away. And now all of a sudden the device moves as you can see on this trans gela image here, the device didn't move at all and it looks like it's in a perfect position. So we'll just make sure right now that we don't have a car diffusion, which is a blood collection around the heart, we're gonna make sure that we don't have a parac fusion and, and then I'll go ahead and close the drawings with the sutures that we have done uh that we've already put in there. And uh essentially, that's the end of the case uh from my standpoint. And then doctor Matson will uh wake the patient up and she will go to the recovery room and spend the night tonight at her request. Most of our patients go home the same day. I'd say more than 95% of our patients go home the same day. And uh in her case, post anti coagulation protocol, uh will not be her blood thinner. It'll actually be aspirin and Plavix that will start tomorrow. And it's because I fear, I fear that if I put her back on, on eloquent, which is an or antic coagulant, I fear that she will have another G I bleed again. Just because when she was in Orlan coagulation, she had a G I bleed and we found no cause. And so I feel I fear that she'll have that again. So she'll go home on Aspirin and Plavix for the first six months. At six months, I'll do a cat scan and at the end of that cat scan, if everything looks good, she'll go on just aspirin baby aspirin alone. OK? There's no fusion on the, on the echo. So I'm gonna go ahead and uh, and put the sutures in here and I think we'll be done with the, with the case at that point. OK. Yeah. So just any questions. Yeah, I was just say for, for the person who asked earlier in the, in, in the video stream, you know, how long does the procedure take? And I said, you know, it could be a half hour procedure. Remember, this is a teaching case. We talked through parts of the case. The trans puncture was, was not the easiest and it's 12 50 I believe. And uh 12 54 and we started around 12 15. So even a kind of more complicated case where we were teaching was a 40 minute case. So, um it very can be done very efficiently. I'm checking to see if there's any more questions. Let me see. We can give protamine, please whenever you get a chance signs and symptoms of judgment. Well, um, it, it depends where it would get dislodged, but usually you, it would be absent on imaging and if it got dislodged in a location that would impede cardiac flow or impede vault function. You would have probably symptoms of heart failure. It'd be very unlikely the device fully deployed would be able to dislodge and leave the left ventricular chamber. But I suppose it is possible any other questions online. So just from a, I guess from in closing, uh I'll obviously give the floor to doctor Ier as the procedural, but I'd say as the moderator, I'd say good job by the whole team. I'd also say uh kudos to our watchman rep, Michelle Beko who's over there. Um She, she's wonderful. Uh We also, um you know, we'll have the, the slides I think shared on the website if you ever want to know who to send patients to. Again, we have a big team that spans all the way from Virginia Beach to Chesapeake to Williamsburg. Um But even if the patients from farther away, um any of us be happy to see them at any point, I think uh bank had any other thoughts you have. Uh Thank you all for, for, for helping us with the case, the production team. Uh Doctor Matson, our E P lab team here. Thank you all for that. Uh As, as a center, we're sort of nationally recognized in, in, in, in, in La Leage Closure, two commercial devices that we offer here, both Watchman and Amulet. We're about to start a trial with another company called Conformal, which is a phone based device. Doctor and I are gonna be uh investigators on that device, uh that we're gonna start in about a couple of weeks. There are many such devices on the uh that are being investigated right now that are being trialed right now, uh that are being studied right now. And I think this is very exciting for our field. Uh where one of the things that we're gonna start, uh one of the other trials that we're gonna do is is looking at patients who uh don't want to take anti coagulation at all, randomizing them to receive uh a left appendage closure device called amulet versus just taking a blood thinner. Uh These are people who've never had a bleeding issue before and we want to see how the device performs with a head to head against a blood that so that's another trial that we're gonna be starting at the center of heart hospital. It's a very exciting time for us. A very exciting time for us in this field with regards to la appendage closure. So there's more to come. I I hope in a year or so we'll have more data from the Watchman device from the ambulance device that we can share with you. I'm sure at that point we'll have to have some additional data regarding some other newer devices on the market. But thank you all for your attention today. This has been a great hour. Yeah, and I've, I've been given the, the final save from Amy Ross who helped set all this up. So thank you, Amy. Um to say thank you to everyone for watching. Thanks for the team doing the case. Thanks particularly to Doctor Ier for letting us uh see one of his patients into his patient for letting us record it and um we'll sign off for now and if you have any other questions, I'm sure you can reach out to us and be happy to answer them.
BROADCASTMED