Chapters Transcript Video Left Atrial Appendage Closure thank you to eric for putting this together. Um This is a huge commitment on everyone's part to be here. For example, one of my partners remain Alamar started rounding at midnight in order to get in order to get here on time. So, so this is tremendous for everybody else to be here. Uh Today I'm going to talk about left atrial appendage closure, which is one of those uh new things that we've been sort of doing at Sentara for the last three or four years. It's been studied for for for a very, very long time and we're sort of excited to have it here. Um I don't have any disclosures relevant to this talk. Um as people have talked about in the past few talks, atrial fibrillation is obviously an independent risk factor for stroke, stroke is the number one cause of adult disability worldwide. And prevention of atrial fibrillation related stroke is our primary endpoint when it comes to treating patients with atrial fibrillation. The 2014 treatment guidelines from our societies and the focused update basically state that our class one indication is to use the chat vast score in order to assess stroke risk in patients with atrial fibrillation, regardless of the type of atrial fibrillation they have. And for men who have a chad score of two or higher or women with a chat vascular of three or higher there, or anticoagulants are recommended. Again, a class one indication. So what is the left atrial appendage? The left atrial appendage is basically a structure um that derives from the primordial left atrium, it's mainly formed by the absorption of the primordial pulmonary veins and their branches. It has highly variable anatomy. And there's a suggestion amongst many studies that the more number of lobes of speculations that you see in the left atrial appendage, the higher risk of traumas formation. So this is an anatomy of the left atrial appendage. You can see these four panels. Panel A. Shows a chicken wing. Left atrial appendage, B. Is a wind sock, sees cauliflower and these cactus. So you can see a chicken wing which is basically a very severe bend in the proximal portion of the, of the left atrial appendage there. A wind sock is just one primary lobe. You can see a cauliflower sort of has a broad base there followed by several tribulations and several lobes and then a cactus which is still a primary lobe there but with several secondary lobes. And so so this is kind of what we use when we, when we evaluate what kind of device we're going to put in and what kind of implant technique we're going to use. This is an example of thrombosis in the left atrial appendage there when we see this during the case. Obviously we can't implant a left atrial appendage closure device in there. But this is very scary because most of these people essentially are on or atlantic regulation. Obviously we don't want to cardio this patient either. Uh This is an example of a left atrial appendage without clot in there compared that that up and again the during atrial fibrillation. There is stasis in the left atrial appendage as well as the left atrium and stasis related. Left atrial thrombosis is the primary predictor of T. I. A trombone embolism and ischemic stroke. And we can say that in non valvular af ipso excluding patients with moderate to severe mitral stenosis and excluding patients that have bio prosthetic prosthetic heart valves. Over 90% of stroke that caused uh that are caused by clots comes from the left atrium are essentially formed in the left atrial appendage. So the left atrial appendage, highly trauma genic and in select patients we look to close it there we go. So this is an example of flow in the left atrial appendage and sinus rhythm here on the left panel and atrial fibrillation. Uh This is a pulse, pulse wave Doppler. So we just put basically a Doppler signal here in the left atrial appendage and you can see here left atrial filling here is very robust compared to here where you see left atrial filling here is not as robust. Um um So less than 20 centimeters per second. There is considered to be uh very poor filling in the left atrial appendage and that's what causes you to have blood clots form in the in the left atrial appendage. Um So despite the fact that we have dough ax. Now You will see that about 40% of patients are still not taking Orlando coagulation therapy due to various reasons. And the increase in Orlando coagulation used increased from about 52%, only about 60% with the increase with the introduction of dough ax. And we have four days in the market right now. Yet 40% of patients are taking Orlando coagulant therapy. Um if you look at this slide here, which is which shows you uh the purple bars here, it will show you that even with max and warfarin right now about only 50% of patients on do ax had 80% endurance during a mean follow up period of 1.1 year. So we definitely need the ability to have left atrial appendage closure devices in order to treat the remaining patients. So non pharmacological options, we have three that that that are sort of commercially available right now. I want to sort of keep this talk kind of simple and not talk about the the devices that are investigational right now with the devices that were on the market and had to be pulled off the market. We're gonna talk essentially about Watchmen now because that's our mainstay Amulet just became commercially available in the last 6 to 9 months. And we haven't started doing those at at Sentara yet. And then um clip is used by our surgical colleagues in order to exclude the left atrial appendage at the time of surgery. Um The guidelines will tell you that it's a class to be indication to consider a perk you tania's left atrial appendage closure. Uh in patients who are at increased risk of stroke who have contraindications to long term anti regulation. So it's not a class one indication. But again, these this update was in 2019. We have a lot more data and I can see a more robust recommendation in the next few years to come. So how do you select patients? And this is clearly probably the next two or three slides is what I want you to go home with patient selection. They have to have non valvular atrial fibrillation. What does that mean? So people with bio prosthetic prosthetic heart valves should be excluded from receiving this device and patients with moderate to severe mitral stenosis should be excluded. They have to have an increased stroke risk. So regardless of their biological gender, they're chad's vast score has to be greater than or equal to three. That's important. They cannot be a suitable candidate for long term anti coagulation but they need to be able to tolerate short term antic regulation or at least short term dual anti platelet therapy. There's a slight discrepancy in the FDA patient selection criteria and the CMS selection criteria. But we go by the CMS because that's who pays us essentially. When I think about who to select here, I look at four or five broad categories here. So patients who've bled or who are bleeding, patients who may bleed in the future. Uh patients who are non compliant or unable to be compliant with long dramatic regulation, patients who have either occupational or lifestyle reasons why they should consider this. And then patients who have either drug interactions or drug intolerances. So when I see a patient in the office uh and I'm thinking about this, they have to fall into one of these five buckets. Usually The bleeding is the most common indication. And I just looked at my last 50 cases that I did for watchmen and bleeding was the most common indication. 70% of my patients got a left atrial appendage closure device for bleeding. Whether that's epic stasis whether that's internal hemorrhage. Gi bleeding. G you bleeding bleeding is still gonna be my most common indication, bruising or significant bruising. Is is is another good reason to do this if you want to avoid triple therapy after PC or tavern. Another good indication if patients have hemophilia or one gillibrand's disease and you're afraid to put them on an eloquence or something else. That that's a good reason to do it. If patients have ischemic stroke despite well controlled or anticoagulant therapy, that could be a reason to do it intolerances to our atlantic regulations, severe liver dysfunction if they're active. I've had a couple of people who are like mountain bikers and they're going to remote areas of Utah and stuff like that and they're very afraid of sort of taking anti coagulation because they feel like they'll bleed. Um those that's that's that's another reason to do it elderly who have falls or have cognitive impairment. And then obviously occupational reasons. I've had a couple of fishermen who go out and they fish out from the, from the, from the outer banks that I've offered this to as well. This is an example of a patient who bled on who had severe bruising on 2.5 mg of eloquence twice a day. And and she she got a watchman. So, so even though some of my colleagues laugh about this, this severe bruising that I talked about this is a good example. Um of of of somebody somebody that that that bruised when it comes to screening. We don't pre screen anymore for for left atrial appendage closure devices and for four watch mints for example. But in the past we've used both a combination of T. E. Where we take measurements at different angles in order to get an osteo measurement and a depth measurement to figure out what kind of device we need to do. We don't do that pre screen. We do that once they come in for the procedure but a perfectly acceptable way would also be to look at the ct of the left atrium look at the pulmonary veins, look at that that in relationship with the left atrial appendage and if you really are on the fence you can give this to the company the boston you can give it to boston. Scientific. They have a beautiful software called the True Plant Software which will enable you to look at the appendage in three dimensional view and will help you with with with with implant. This is an example of A. T. E. And A C. T. Here. You can see beautiful C. T. That's your left atrium there. That's the left atrial appendage there. And you can see we can take an Austrian measurement here and a depth measurement here and and make make a determination as to what device you need. This is an example of A. T. E. Again this is at the 1 35 angle here. Um This this gives you an Austrian measurement and a depth measurement. So multiple modalities, imaging modalities to help you with with determining what to do. Um This is our our mainstay of left atrial appendage closure at at Sentara. We've had this device for about two years now. It's the watchman flex device. It's got multiple different sizes so 20 in diameter uh 235 mm in diameter. So it can take appendages that have an Austrian measurement anywhere from 14 to 31 mm in diameter. Um You can see here that these times here are closed. So it's a closed structure here. The previous one would have these open barbs here. So your risk of perforation or is obviously less. And then it has active fixation anchors here. So it's got small anchors here that help attach it to the left atrial appendage tissue for stability so that you don't have any device civilizations. The implant procedure is very straightforward and most of us do it in in in under an hour now. It's under, it's done in the p lab or the Cath lab for the structural heart physicians. Um It's uh it's basically a transformer access under general anesthesia, less than a one hour procedure. We go trance septal, we get into the left atrial appendage. We implant the device. We do a couple of pools to make sure the device is in place and then we release it. And then basically what you want to do is you want to make sure that there's no leaks around the device. So there's no perry device leak. And as long as there's no perry device leak, you're good to go and you can move on to your next watchman implant for the day. So this is an example of us evaluating perry device leak on a. T. E. This is at 45 days. We can evaluate the device on C. T. As well and our colleagues at I. H. S. Have done a very very nice job of reading these cts for us and helping us determine if we have a good seal on the left atrial appendage. Why is why is a good seal important. A good seal is important for this reason. We want most of these patients who are bleeders or high risk for bleeding. We want them to come out for atlantic regulations. So having a good seal is important because less than five millimeters seal around the device helps us determine that the patients can come off for atlantic regulations at 45 days essentially. So this used to be our previous um therapy. So an implant, we would put everybody on aspirin and Plavix or aspirin and a doe ac at 45 days. We would take them off the dough ac and we would put them on aspirin plus Plavix. And then destination therapy would be lifelong. I'll tell you if you pull all the mps here that do watchmen all of us do this differently. None of us follow the guidelines that that was set by the FDA many many years ago. We have our own gestalt as to why we think one is better than the other these days. Now we have an alternative option. The most recent data that came out within the last couple of months gives you the ability to use dual anti platelet therapy for the first six months. So any dual anti platelet therapy. So aspirin plus. Anything else for the first six months followed then by destination therapy with aspirin and either 81 mg or 100 mg thereafter. Uh This is the most recent data from the L. A. Registry which was presented at C. R. T. Um in 2022 by Samir Kapadia. Uh This is our safety data and our our sort of efficacy data here it's very important. This is all watch And flex devices. This is sort of pulled out of the of the registry two year data and it's very impressive. So 16,446 watchman's implanted success rate greater than 90%. As far as implant successes is considered. And that's fantastic. When you look at the 45 day follow up you can clearly see that the the watchman flex um uh Sorry next slide. Yeah the discharge medications. When you look at when you look at it you can see that the the implant is in this trial sort of used to do attack and an aspirin 50% of the time and a doe act alone about 21% of the time. But the vibe variation in what they use over here kind of tells you what I was telling you about what we would do in a situation like this as well. When you look at your key safety endpoint here which was a combination of all cause death, ischemic stroke and events requiring intervention. It was less than half a percentage point over two years which is just unbelievable data. These kinds of safety endpoints were not seen in the earlier versions of Watchmen in the earlier trials as well. And with with the surpassed data now this is less than half a percentage point for a key safety endpoint is very impressive. Again, when you look at ischemic strokes and hemorrhagic strokes there, you can see about a quarter percent ischemic strokes, 0.1% hemorrhagic strokes. And your risk of major bleeding is less than 4%. So all excellent numbers. Pericardial effusions there a discharge and at 45 days your risk of pericardial effusion is less than half a percentage those pericardial effusions that required open cardiac surgery was about 0.03% at 45 days. Again, showing you that this device, this new generation device has truly helped us make this a very, very safe procedure. Our experience at Sentara has been tremendous. We have seven in planters now too in the structural heart interventional cardiology space, five VPs. Now that implant this, our procedure, success rate. Looking at both the initial generation watchmen and the watchman flexes. About 95% are major intra op or post procedural complications is very low at 2% Stroker systemic embolism was 0% prior to discharge it was 1% at one year and then 1% at two years and a pericardial effusion or tamponade rates was about 1.5% those that required open cardiac surgery was less than .5%. We've done a little over 1000 commercial cases right now. And that puts us at about the top 15 centers in the United States right now, there's about greater than 750 centers that are doing this. So our experience has been tremendous. I'm really proud of both our structural heart and our ep teams and our ep and planters and our surgical colleagues for sort of helping us do such a great job with, with left atrial appendage closure here at Sentara. So what does the future hold for us? The future holds for us. A couple of very, very interesting questions. So the Champion af trial I think is still enrolling right now, but it's an evaluation of watchman flex versus a doe act as a first line option to prevent stroke. So right now we're we're thinking that it is your first line option to prevent stroke. But this is a comparison of the two to see if watchman flex can be used as a first line option to prevent stroke. And then the option trial, which is we take all af ablation patients and and in half of them we were they were putting in the watchman flex. The other half are getting Orlando coagulation. And so we're trying to evaluate the feasibility of doing an af ablation and a watchman at the same time and looking at looking at sort of safety and efficacy endpoints in follow up and that trial has already finished enrolling in the United States and hopefully we'll have some some interim results soon. The last thing is, is Amulet the Amplats. Our amulet, which is a new device, which is boston Abbott's uh left atrial appendage closure device sort of received commercial uh see uh in uh In uh in about in about the middle of last this year, we're gonna start doing that first quarter of 2023. There's several of us that are sort of uh um gonna get trained in the next few months or so. So, so you'll see that as well. In summary non pharmacologic approaches to Orlando coagulant therapy, we need to consider those in patients who are sort of deemed ineligible for long term organic regulation. The best long term data is with watchmen flex right now, but longer term data will be available for other platforms as well. So we'll have many choices in the future. There's still a lingering question regarding dap versus Orlando coagulation post implant and I think that will be answered in future trials as well. Thank you so much. Published Created by Related Presenters Venkat Iyer, M.D., FACC Cardiology View Profile