Chapters Transcript Video Advances in Left Atrial Appendage Occlusion Technologies for Atrial Fibrillation Dr. Venkat Iyer describes the design features of left atrial appendage closures. Good morning. Uh As Phil said, uh my name is Ben Carreer. I'm a cardiac electrophysiologist with Centa. I want to start by thanking DP A and the steering committee for putting together such a fantastic list of speakers and topics. I want to thank our clinical chief, Ron Stein, who's sort of the engine behind our cardiology department. It's been phenomenal over 30 years. Uh uh being a cardiologist, I don't know how you do it. Um I don't have any disclosures related to this talk. Uh But I'm willing and able when, uh when Dak asked me to speak at the conference, uh I gave him a list of my demands, uh and he fulfilled all of them except ones that are related to my, how I would enter today. And then, and this is, this is how I wanted to enter today. Uh Let's see if this works. This is Sai and uh so, so DPA, I think, I think if you, if you look at this podium, for example, I think, I think we could put a trapdoor here and have me enter like this next year. All right. So, uh he's, he's, he's assured me that this is gonna happen next year. Uh And just, just to, just to, just to clarify in that video, I am cy and you guys are K pop fans. So just, just making that clear. So um this is gonna be a very practical talk on left la panic closure and uh how best to start the talk then. Um then with some quick slides on on atrial fibrillation, which is sort of the nus behind left atrial appendage uh um clot. So as we know that atrial fibrillation is sort of associated with a 4 to 5 fold, increased risk of ischemic stroke. Oral anticoagulation has been the standard of care for over 30 40 years. But there are many barriers that limit O ac us and there's sort of an unmet clinical need that we want to gap with left atrial appendage closure devices. These are the 2014 guidelines with the 2019 focused update that clearly says that Orland coagulation is recommended in men who have AC A DS VA score above two or women with ach A DS va score greater than equal to three. The left A appendage um is a definitely a cause for stroke and over 90% of thrombi that's observed on tee or an autopsy comes from the left atrial appendage. It has a highly variable anatomy and these findings that sort of led to the development of procedures to exclude the left atrial appendage like endovascular procedures, surgical suturing, surgical amputation and surgical stapling. Uh This uh I'm just going to use this uh panel here to um because we have 22 display screens here. I'm just going to use this one on the left. Uh This is uh the left atrial appendage here. That's the left atrium just to orient everybody else. And this is a picture of a Doppler uh uh flow through the left atrial appendage showing very, very sort of nice velocities and sharp signals here. And this is an example of a left atrial appendage with thrombus uh at the apex of the appendage there with very diminished flows here. So it's this diminished flow during atrial fibrillation that causes the development of of uh of thrombus here. And so when you look at the left atrial appendage, like I said, it's a, it's a, there's different types of L A anatomy. It's a highly variable structure and somebody painstaking, you went ahead and categorize this into sort of a chicken wing, which is probably the most difficult anatomy for us in order to put a uh a left atrial appendage closure device, wind sock, which appears to be the easiest and then you have cauliflower and cactus. So you have sort of highly variable anatomy of left atrial appendages here. So what's in our tool bag? We have five devices here, three commer uh two commercial and three that are sort of in trial and development at various stages panel A refers to the device that we use currently, which is Watchman Flex, which is the most widely used device now in the, in the, in the United States and the world. Uh Panel B is the Amulet device that's made by Abbot um Panel C is the Lamprey device which is under investigation. D is uh uh the, the uh the wavelet and ease conformal, which is a brand new device that we are studying. Currently at Centa, I just did the first case on on Friday and it's an absolutely beautiful device. So all this came to fruition sort of in in 2015 where Watchmen got FDA approval for left atrial appendage closure. And it actually took a long time. It sort of underwent a lengthy sort of multi step approval process that included two randomized clinical trials, two continued access registries and an unprecedented three FDA hearings over the course of two decades before this, this device was was approved. So it took a long time and this was really because of safety concerns that surrounded the device. So in the two Protect A F and the prevail trials where Watchman is compared against Warfarin, you saw that there was definitely non inferiority in terms of reduction of stroke and systemic embolism, but the concerns were really safety concerns. So you had a 8% total complication rate. You had a 5% per car e fusion rate, air embolism device embolization, inter procedural stroke rates were about 1%. And then you al always, always had vascular side issues. So that's the reason why, why this took so long. The newest device on the market right now is the Watchman Flex. We'll have another one soon available at Centa, but this is the device that we use currently. Um It's a night and all frame. It's got active fixation anchors that help engage it with LA A tissue and there are different sizes for, for varying appendage uh sizes as well. And compared to initial trial data, this is the current safety data from Watchmen surpass trial, 16,000 implants. Your key safety end point was 0.37%. And that's a combination of death, ischemic stroke and any events requiring intervention. So where you saw in the, in the, in the, in the in the initial trials, your risk of serious complications with 8%. Now with commercialization, your your serious uh complication rate and your key CFP end point is about 0.3% which is, which is incredible. Our experience as Watchman has been tremendous. So uh since commercialization, um 1300 commercial cases that we've done at SA we've got seven implant or sort of a combination of structural heart interventional cardiology and ep our procedural success has been about 95%. Our uh major intra op or post procedural complications have been very low. Our stroke rates at one year have been about 1% and our prec car effusion or tamp and our rates have been less than 1%. And again, we've done about 1300 commercial cases. This is the next uh device that we have at Xero. Now, it was approved by the FDA in 2021. It's the Amplatzer Amulet LA A occluder implant. Um I've done about 15 patients now uh in the last couple of months, um of those patients that have hit 45 days, we've had 100% LA A seal rate uh as evidenced by tee and CT scan. And the advantage of this device when it initially came out was it had a label for using aspirin and Plavix uh for six months after implant rather than Orland coagulation. This is the newest device uh that we were involved in in the conformal trial. Uh And uh the device is called class. It's basically a foam based device that is supported by a compliant uh endoskeleton. It has a Aptfe uh cover that uh uh reduces thrombogenic and then it's got no metal on the outside. So they say that the risk of thrombus formation on the device is lower because there's no actual metal that's uh that's that's exposed to the left atrium. It comes in two different sizes. One is a regular and one is large and very early data. This is very, very early data. So uh more to come on this but very early data for class seal data compared to amulet versus Watchman 2.5. Is that again, when you look at seal rates of the left atrial appendage here, you can see here that uh class does very favorably in terms of minimizing your, your seal rates of the left atrial appendage compared to the other commercial devices on the market. So, so three devices that were sort of involved with at Centa two commercial and one on trial. So this is the AC C A HR S focused update uh from uh 2019. Uh This is still a class two B indication. But as Eric said, we're hoping that this will get updated and the strength of the recommendation will change based on all this available data. So next, let's go to who is eligible for something like this. Obviously, you want patients who have nonvalvular atrial atrial fibrillation um um to, to get something like this, they have to have either AC A T score two or higher or C A DS VA of three or higher. Uh They should not be a suitable candidate for long term anticoagulation. They should be able to tolerate either short term anticoagulation or short term dual antiplatelet therapy, you have to have a quality of life benefit. So if they're going to die in the next three or four months, probably not a good candidate uh for a left aal appendage implant. Um and you have to have a good patient provider discussion with regards to shared decision making and sort of, that's one of the sort of uh essential parts of, of, uh, of sort of getting approved, uh through C MS and other insurance companies, uh to be able to be eligible for something like this. Uh, again, when it comes to patient selection here, um, all patients have to have sort of an increased bleeding risk as, as evidenced by, by their has bled scores. They have to be either prior bleeders or future bleeders. Um They can be patients who have already been on concomitant DAPT um non compliant or unable to be compliant. There could be some occupational or lifestyle issues. I've had a couple of uh patients who are sort of deep sea fishermen that don't want to take anticoagulation. A couple of people who like hike in remote areas and they don't want to be an anticoagulation either. There's always the issue of drug intolerances and drug interactions. And as with an aging population, you're going to have increased percentage of patients with significant fall risk when you look at the N CD R data. Now, this is a registry data. Uh 70% of clinical bleeding was uh was sort of the indication for for left atrial appendage closure in some of these patients. And uh uh 12% of patients that got a left atrial appendix closure device had intracranial hemorrhages and uh patients with intracranial hemorrhages was was were essentially excluded from uh from the original trials. This is a patient of mine who got a watchman implant about a year ago or a year or two ago. And she has significant skin bruising and she did really well after she got the uh the watchman implant, we were able to get her off Eliquis and all of this sort of cleared up uh pretty easily. So what do we do in terms of left atrial appendage imaging? Uh We have three types of imaging, preprocedural imaging, which we don't do much of. But if you wanted to do preprocedural imaging, you can either do a tee and get measurements of the LA A at different angles. You can do ac T of the pul veins, inter procedural imaging, we have to choices uh tee which sort of gold standard right now. But two D and 3D ice is coming up. The only issue with ice is it has to be in the left atrial appendage and you're already, it has to be in the left atrium and you're already trying to put a left atrial appendage, closure of ice in there. So it can kind of be bulky to sort of move things around there and then post procedural imaging which either is tee or um or CT as well. Uh We don't usually do preprocedural imaging generally unless it's part of a trial, inter procedural imaging for us, the standard care is tee after general anesthesia in the lab. And the number of screen fails that we have is incredibly low. I can't remember the last time one of us had a screen failure uh after getting general anesthesia. So most patients that come in will end up getting an implant. This is uh examples of uh uh AC T scan on the left that shows you the measurements that we make just to orient everybody. Again. That's the left atrium, left ventricle. That's the left atrial appendage. We take a measurement right at the ostium and then take a measurement to make sure that we have enough depth to place the correct device. This is an image of a tee at 100 and 35 degree angle. And again, we're taking images and measurements of the ostium and also depth measurements. So this is, this is my five year old um uh from 2021. How do you implant one of these devices? Uh She overhears a conversation that I have with one of my patients and just to orient you, she uses the word blood vessel to represent the left atrial appendage and trap to represent the watchman device. And the blood kind of comes into the blood vessel and it hurts the people. So if we put a trap and it co it stayed for a few days and we will move the trap, the blood will be all dry, you go through the blood vessel. So, so obviously she's, she's seven. Now she has a significantly more sophisticated understanding of this implant procedure. Now, um, she knows that the trap cannot be removed once the trap goes in, it's in there. Uh And if you ask her who, who should get a device, she kinda rolls her eyes as she pauses her youtube video and tells me everyone with a FB dad should get a device and then she goes back to watching Mr Beast on, on youtube. So, um Deepak, I, I'll, I'll reference I'll, I'll, I'll, I'll, I'll teach you these references later on because clearly you and I are not millennials or Gen Zers. So um but, but, but how, how I gotta go back here, how do we do this? Uh It's a one time implant. Uh So the trap cannot be removed. Uh It's performed in a cardiac cath lab or, or an EP lab. General anesthesia is very typical. It's, it's usually in under an hour to do the procedure. And uh it's a, it's a one night hospital say typically na na nationwide, but at center we send 95% of our patients home the same day unless they're part of a trial. So steps are very simple, Venus access anticoagulation, trans access delivery sheet in the left atrial appendage and geography of the left atrial appendage. So that you know what device sizing needs to be deploy, the device, test the device, vascular closure off general anesthesia and usually home within a couple of hours. This is a case that I did uh last week uh on a patient who had an amulet again just to orient you. Uh Let's play this here. That's the left atrial appendage. Uh We take measurements there. We take measurements, depth measurements here. This is the post with an amulet. You can see that it's completely sealed and color flow does not show any per device leaks. That's a very, very nice uh 3d image of the, of the amulet uh that shows uh sort of a complete seal there. And these are some angiographic pictures uh of the left atrial appendage and then the angiographic picture of the amulet after the uh um of the left atrial appendage after the amulet device has been placed, this is another uh tee and AC T image of a watchman device. Um And the watchman there is is deployed and you can clearly see there that there's no color flow along the the along the sides of the watchman, which clearly shows that you have good appendix seal there. Again, the CT kind of shows the same thing as well. So what's the future here? The future here is, is, is, is this gonna be first line therapy, are you gonna offer this to patients instead of anticoagulation? And there's several trials that are sort of be uh eval being evaluated right now, we should have some of those trials. Um Some of the trial data in 2023 and early 2024 champion A F which is evaluation of Watchman flex device versus do A as first line options to prevent stroke. Uh You have option which is uh Watchman flex versus Orland coagulation after PV I ablation. And then the one that we're gonna be involved in uh soon, which is catalyst, which is evaluation of the amulet uh left U appendage implant versus A A Doak. So really sort of pushing the envelope to sort of include this as sort of first line therapy for patients with a FB. So in summary, uh this is my uh second to last slide. In summary, I just want to say that uh this, this field has really grown in the last uh in the last 10 years. Uh We have several devices on the market right now. Um Non pharmacological approaches have to be considered in these patients who are sort of deemed eligible for long term uh or anticoagulation therapy. There's two commercial devices on the market right now, but several more in development uh post implant dap is seems to be very, very effective, but there's still some questions that that remain and there's some data pending from concomitant trials. Um We're gonna hold questions to the end but just as a general uh public service announcement uh uh to, to the audience, I wanna show a video from our favorite social media, Doctor Doctor Glacken and Doctor G about an audience at an academic meeting that was a fantastic talk. Thank you. I just have a few points about why everything you said is wrong. So we wrote a paper, I just put out a paper. We have a paper coming out next month. I just have a quick question. Do you read the New England Journal? Because we have a paper, you know, actually, well, technically, I know we're running out of time. So I'll make my comments brief. I have three points I'd like to make. So that's my second point. My third point. Well, I actually have 1/4 point, but my third point, I have a comment, but I haven't formulated my thoughts ahead of time. So just bear with me for the next few minutes. Thanks for the great talk. Let me just bring up an unrelated topic that's gonna completely derail the entire discussion. So this is my first time hearing about the thing that you're an expert in. Let me give you my thoughts about. Thank you for the talk. I have a question. So I do the same thing you do, but better. Thank you with that. Uh Thank you so much uh for, for inviting me here D PAC. And thank you so much for the opportunity to speak about left a appendage closure devices today. Published October 13, 2023 Created by Related Presenters Venkat Iyer, M.D. Sentara Cardiology Specialists View Full Profile
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