Chapters Transcript Video Percutaneous Left Atrial Appendage Closure I'm just gonna talk about left atrial appendage occlusion. One of the most boring topics in ep uh but one that affects our patients every day. So it's good to be boring. It is and it's why the structural guys do it as well. So the first part of uh left atrial appendage occlusion, uh Doctor gentler touched about is stroke reduction consideration. So by the guidelines, people should be on anticoagulation if you use a clinical risk score and their Chad's va score is high enough. Um It's a class one indication and you should look at the risk factors. So you should notice whether they have hypertension female. Um and all of the other things that he touched upon, but then gets into left atrial appendage occlusion. And the newest part in the 2023 guidelines, it's a two way indication. Now. So if you think patients are at ac va score of greater than two, and have a contraindication, long term, oral anticoagulation, whether it's bleeding or other causes, left atrial appendage occlusion is reasonable. Um And then the other part of cardiac surgery is if they have atrial fibrillation and cardiac s and they're undergoing mitral valve surgery, uh cabbage or any other part, they should undergo atrop or any other thing to excise their left atrial appendage to lower their stroke risk. So, where does strokes occur in atrial fibrillation? If you look back in the nineties where they did transesophageal echocardiogram on everyone, over 91% of strokes or clots in atrial fibrillation are in the appendage. So if you look at the red bars, that's all appendages, the blue is left atrium. So very few strokes happen and clots form in the left atrium. The patients who they may form on our patients with mitral stenosis, females, people with mechanical valves, you may see um clots in the left atrium, but majority of them are in that stupid unnecessary structure called the appendage. And you can see right, the transesophageal echo shows a nice ball in that um appendage. Um And so this is why we start people on oral anticoagulation and why we look for ways to reduce that risk. So, anticoagulation isn't always the answer. You know, every hospital including us participate in the N CD R because the C MS wants a registry of what's happening with patients and their outcomes. And this study published in 2016 shows that majority of patients don't actually take their oral anticoagulation. So you could see the wide spectrum from Chad's vast score of 0 to 9. It should be 100% in that blue or gray bar. But over 50% are not taking their oral anticoagulation. Some are just on aspirin, some are on aspirin and A PPY 212, some are taking nothing. And so this is one of the challenges and why we have to come up with solutions. So these are some of the reasons people tell me in the office, why they don't want to take their blood thinners. Some people say, you know, remembering the Eliquis twice a day, you know, I can't remember it at night. I keep forgetting it. I don't wanna take it. Another is false. A lot of the patients we see are frail elderly, they're falling, they're worried about hitting their head on anticoagulation. A third is fears of bleeding. They get bruised on their arms. They're fearful because they've had epistaxis or other previous bleeds. This one's becoming more important cost. Um as inflation has affected the economy. Eliquis, all of our novel anti oral anticoagulants are not cheap. Um They're not generic. Um And the government is working on pricing but the cost has not come down significantly. A lot of patients will complain about that. Complicating surgical timing. So if you need a hip surgery, you may need to stop your blood thinner and then restart it. And so patients don't really wanna, if they get back injections every couple of months, they don't wanna worry about coming off or coming back on. Um And then the last one is need for nsaids for arthritis. So there's a gamut of reasons why people don't wanna take blood thinners. And if it was me, I'd take a 30 minute procedure to get, get it dealt with forever anyway. So here are the bleeding risks. We don't really think about this. But when you look at even the best medications we have to prevent stroke, the bleeding risks are anywhere from 2 to 4% per year. So you may say, you know, a watchman or an amulet has a 1% risk of complication. But even all of these other things have bleeding risk. And if you look at Warfarin, it's in the 3 to 3.5% grade. But a lot of patients are discontinued on Warfarin because of bleeding or they can't maintain a therapeutic inr. Here's the types of left atrial appendage occlusion. We have the Atro clip is the one used by cardiac surgeons. It's been the mainstay before back in the day, they used to suture and we really as electrophysiologist didn't like sutures because sometimes they would be incomplete sutures with the attra clip. You get a nice seal and I haven't seen many leaks um around the device and it pretty much excludes the appendage. There's a Tiger Paw system, Lariat, um which a couple of my colleagues have done, which was cumbersome, but you have to get epicardial access outside of the heart and then put a lasso based around the appendage. There's the watchman which is the main workhorse we've done over 1200 Centa with exceedingly low complication rates and Platzer and then the Amulet, which is the Saint Jude one, which we've done some of those as well. So here's the randomized trial data and people always say the problem with Watchman, you know, I don't want to refer patients for Watchmen or left atrial appendage occlusion because it's always compared against Warfarin. This is where the data comes from. So the protect A F data showed that Warfarin head to head against Watchmen. Watchmen had lower primary events. Um and it had superiority uh because those patients did not bleed. Um And you could see from the right, the problem with this trial was it was the original Watchman 2.5 device and the government and C MS did not like that 5% pericardial effusion rate. So even though the device was safe, people's bleeding stopped everything that the government thought that 5% was a high pericardial effusion rate. And so they mandated a second trial. And so that is where the prevail trial comes. Um the second trial and you could see that pericardial effusion rate went down. Um And you could see head to head control versus the device in the Prevailed Registry. Um It did better um than conventional Warfarin therapy. However, what about do a so we know that Watchman is better than Warfarin. But what about head to head against? Do a and So prog 17 randomized clinical trial was for about 400 high vers patients who were randomized. Their mean Chad Vask was 4.7. Um And you could see head to head, it was non inferior compared to do a. Um So this is the original watchman um 2.5 and so head to head against Doak, there was no significant difference. But now I would say that in the future, we'll see more and more left atrial appendage devices because the technology will only get better. The first device was first generation, the second device gets better. We don't have the Watchman Flex Pro, but we're hoping to get it soon. But you can see on the right, the company listened to feedback and made a better device. So the first one, you could only use it once the second one, you could do a full recapture, you have better anchors, you don't have anchors that can stick out and cause the appendage to rip open. The first generation on the left was much sharper. You could see that flexible on the right, which looks like the P fa catheters. It's very soft. You could navigate around the left atrium and appendage with ease. And so that has really improved the safety of the device um and ease of implanting the device over time. So this is the pinnacle Flex trial, which was based on the Watchman Flex device. You can see on the left, the complication rates were 0.5%. So we talk about 1% risk with our patients. The trial data really shows that in the real world um in and pinnacle flanks, it's less than 1% less than half a percent. Um And so these devices are just getting safer and safer and the Surpass registry. So Surpass was 100,000 patients with watchmen. So over 100 and I wanna say 70,000 Watchmen have been implanted to date. Uh At Cento we've done over 1300 making us one of the top eight centers in the country and implanting these. Um the key safety end point are the complication rate. This is real world. So you would expect it to be higher than trials because these companies pick trial operators that are experienced. But even in the real world, the safety endpoint was 0.45%. So matched the pinnacle flex study. Um 83% of patients had no leaks. Um The ischemic stroke risk was 1.2% and 6.4% major bleeding risk. And so even I tell patients, even if you take Coumadin, even if you take an direct oral anticoagulant, you may have a stroke. Um And so I think the ischemic stroke rates is similar to being on anticoagulation and you could see on the right the leaks. Um and you could see that the leaks are very low. So if you look at leaks greater than five millimeters, which is where the data shows harm in more strokes. It's less than 0.03%. So less pericardial effusions, less complications, less leaks is where the field is evolving. And these are lessons from surgery. And I bring this up because cardiac surgeons um in patients with atrial fibrillation did this nice study where they randomized patients to no occlusion versus occlusion. And it was over, I think 5000 patients and patients who got left atrial appendage occlusion, which means they used a clip or whatever, had a lower ischemic stroke risk. And so I think the future is when doctor Talreja or Doctor Summers do a mi clip, they're gonna put a watchman in. When we do an ablation, we're gonna put a watchman in, right? And so I think we're, we're learning from surgery as the devices get better. Hey, leaving a device and you don't have to take a blood thinner afterward is gonna be great if we're in the left atrium anyway, doing other interventions, we're gonna close off and do your appendage. And so these are all of the trials that are coming out and you'll see it and where all of the data comes from. So the option trial, uh which is the one we're excited about as electrophysiologist, enrolled 1600 patients and they randomized them to both an ablation and left atrial appendage occlusion together or an ablation and no A um because C MS just to prove that you could do both together, we're gonna have data at A H A in about a month. And I think the data is gonna be favorable that there's no difference. And so as electrophysiologist, we're gonna be inclined to offer patients who may meet an indication for needing left atrial appendage occlusion to do both at the same time. And I would imagine in the mitral space, they'll also have that. But another trial is champion A F. So champion A F is nice because it's gonna be, let's say it's a person like me. If I have a chance of a score of two or higher, I just want a appendage occlusion. I've never bled, I've never bruised. I don't fall. I don't wanna go to a non implanting cardiologist. Can I just get a watchman? And that trial will show whether head to head against a direct oral anticoagulant, whether watchman can beat it. And so I think we're learning more and more and I applaud industry actually for doing randomized trials because that's how we get better data. Here are some of the challenges and why we're not where the surgeons are, right? We should be where the surgeons are, but we're not right because of the type of devices we have. So one of the challenges we have is D RT. So what do I mean by that you can see on, on the left there. Uh There's a watchman but there's a clot that has developed on top of the device and some of the risk factors for clots developing on top of the device are the age of the patient. Older patients seem to be more at risk of developing these permanent atrial fibrillation. A higher chance vas coagulopathy and renal disease. And so even though the D RT rates are low, they're not zero compared to surgical patients. So what do we do about D RT S? Um people have done vacuum suction of clots. People have sent them to surgery. Some people have usually we would start them on a blood thinner back again to resolve the D RT and reimage. But because it's a foreign body clots can form on top of the device. So even though the D RT rates are less than 0.5% it's still not zero. And I hope companies will have better products that over time and I think they will, that will reduce that risk. The other risk we see and this is not that much of a challenge, is perry device leak. So you could see from the top why leaks develop. You may not cover a lobe completely. Um The, the watchman may be tilted in different orientations and we know that leaks greater than five millimeters are at increased risk of causing strokes on the right. You see leaks greater than five millimeters. If we have leaks, we send them to our structural colleagues. Sometimes they can put plugs in them. Um And we have different workarounds on leaks, but these are the two challenges remaining on better device um creation. I'll just briefly talk about the Amulet device. So this is one made by Abbott where they randomize patients to both Watchmen and Amulet. So the novel function of this device is it's a hat with a cap on top. So you get a better seal because I unlike uh just a Watchman device, you get a cap on top to really suction in that appendage. Um and head to head no difference in outcomes except lower risk of leaks. But at the trade off of a higher pericardial effusion rate. So if you look on the right, the pericardial fusion rate was almost double Watchman. Uh but the leak rate was less and that's just because of how the devices, uh how the device is, but even Amulet is making a safer device. And so we'll have trial date on both of these. We're excited about ice guided left atrial appendage occlusion. You might have been at one of the booths um be and we've learned a lot about where imaging can help and certainly 40 ice. Um and we're thankful for the service line and other people on allowing us to use this because it reduces the need for general anesthesia, reduces the risk um need uh for tee and we can put a left, we can put an ice catheter through the fossa ovalis and in 3d, we can image um as our watchman goes in. And so I think this as this gets cheaper, we'll use more of this. Uh because it's the main workhorse for atrial fibrillation ablations. Here's some cool future devices. Every company wants to make a device because no one wants to take meds. Uh And so there these are all of these things that are coming out. The Laminar is cool because it's like tying off a bread basket. It basically or a bag of bread. It basically cinches off the appendage and just cinches the appendage completely. But we're gonna participate, we have done the conformal trial. We're participating, Laminar, we're doing the next generation amulet. We're hopeful to get Watchman Flex Pro which has a nice coating on the device um that pre events D RT s. And so the conclusions are left atrial appendage occlusion is growing in volume and will grow even more given issues surrounding do ax and warfarin trials are ongoing to improve indications for left atrial appendage occlusion. We're excited about trial which comes out at A H A allowing us to do concomitant ablation and watchmen in the same procedure. Newer designs from companies are trying to make the procedure safer, remove leaks and device related thrombus and they'll become faster and will rely on better technology including CT scan and 40 I to improve safety and efficiency of procedures. Published November 14, 2024 Created by Related Presenters Divyang Patel, M.D. Sentara Cardiology Specialists View Full Profile
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