Good morning. We're going to go ahead and get started. So this is the LAO session, Antithermodic Therapy After LAO Changes in Care. And I'm honored to introduce our speaker this morning. He is Associate Professor of Medicine with the University of Texas in Houston. He's also the Director of Structural Heart Intervention Program at UTHealth and he's also part of our LAO Steering Committee. So we're happy to have Dr. Abhijit Doble present today. One reminder, and I think you probably already all know this, if you want to ask questions just go to the app at the bottom of the app as the Q&A, just click on that and type in your questions. And at the end we'll go through as many as we can. Thank you. Welcome. »» Thank you, Julie. All right. Good morning everyone. I hope you can listen to me fine. So I'm one of the members on the Steering Committee for the LAO Registry and I'll try to kind of impart some nuances about antithrombotic therapy after left atrial appendage occlusion. And the changes that are occurring right now, the changes that happened in the last couple of years, which will be instrumental in the registry moving forward. So these are my disclosures. The objective for today's talk is to recognize at least one change in antithrombotic medications, dosing and duration of LAO patient. We will also try to identify strategies for prescription writing, patient communication, their follow-up monitoring and communication with the providers. And we'll also try to recognize the potential for bleeding events with antithrombotic therapy changes that happens in these patients with atrial fibrillation. So before we dive into the regimen or antithrombotic antiplatelet therapy after LAO, it's very important to recognize the evolution of the devices that happen in this field. So as you can recall, the first device that was FDA approved was in 2015, and it used to call it a Watchman 2.5 or just plain Watchman device. And with that device, the field changed. Now we call it mechanical prophylaxis for stroke prevention in patients with AFib. Then almost five years later, an iteration of Watchman device called Watchman Flex, that came, and that was in 2020. And immediately followed by a few months after that, Abbott also introduced their device in the market called Implancer Amulet device. So there are small differences amongst each of these devices, which is beyond the scope of this talk, but in terms of antithrombotic antiplatelet regimen, I'll kind of try to highlight them briefly here. And then just a few weeks ago, Watchman Flex got upgraded to call Watchman Flex Pro device. So this device, this first device that was basically came with some kind of coating outside to repel clots. So it comes with the hemocon layering on this device. And this device was just introduced, I believe, a few weeks ago. The first one in the country was done literally not more than two or three weeks ago. So this is a relatively new device. First five years in the LAO field, the standard was 45 days of aspirin and warfarin, followed by dual antiplatelet therapy for another four and a half months, followed by 325 milligrams of aspirin for the rest of the life for the patients. So this was our standard until 2020. And this is what the registry is based on. This is what the CMS criteria are based on. And all the research that was done prior to 2020 was based on that. After the introduction of Amulet device in 2021, that came up with the labeling of only requiring dual antiplatelet therapy immediately post implant. So no anticoagulation, just the DAPT. And shortly after that, Watchman Flex also came up with the new labeling, which only mandates DAPT now and not the oral anticoagulation therapy. There are two things that are very important to know. Even though the labeling says that you can use DAPT for both, Watchman or the Boston Scientific Company that makes Watchman still strongly recommends oral anticoagulation therapy and aspirin therapy for the first 45 days. Patients who cannot tolerate that can have DAPT, but they're still sticking to their old recommendation that they use for the older Watchman device. However, for the Amulet, you can use oral anticoagulation, but it's strongly discouraged to use oral anticoagulation immediately post transplant, and that is because of the slightly higher risk of pericardial effusion after the implantation of this device. So for Watchman, still recommended to go with 45 days of oral anticoagulation plus aspirin. For Amulet, just the DAPT, and oral anticoagulation only in special circumstances that we'll come and talk about. So we can safely say now that we live in the DAPT post implant era for the LAAO. Even though those are company recommendations, majority of the patients now end up going home on DAPT after either of the devices. And there are also clinical studies that are going to start with just a single antiplatelet therapy after the Watchman Flex Pro device, and those studies are being kind of designed and getting conducted as we speak right now. We don't use this device anymore. That's the Watchman 2.5 or the older Watchman. And my prediction is once after a complete rollout of the Watchman Flex Pro device, which is the newest iteration of Watchman, we will not see the Watchman Pro also. So the two devices moving forward in the next two years or so will be Amulet and Watchman Flex Pro. Why is this important for us to go in such detail about antithrombotic and antiplatelet regimen for these devices? There are two reasons. So there are short-term implications of these therapies, and there are long-terms. And when we talk about long-terms, there are two very well-recognized entities that can happen after the Watchman or Amulet device implantation. Number one is called peridevice leak, meaning there's a leak around the device that can subsequently predispose these patients for more thromboembolic events. And the second entity is called device-related thrombus. The device-related thrombus, we think it's less with the newer devices, especially with the coating that it comes with. That coating is antithrombotic and helps to repel anything that can stick to these devices. However, this is still an issue. So we know that from prior studies of the Watchman that you can see in the first Kaplan-Meier curve, which is A, that the peridevice leak was strongly associated with future stroke or systemic embolism in the Watchman pivotal trials. And as you can see in the graph B, which is the real-life registry, which is our own NCDR registry, they have shown that the peridevice leak was strongly associated with stroke TIA or systemic embolism. So it defeats the very purpose of implanting this device if you leave these leaks behind and do not act on it. So this is just going a little bit into the technical details, but the reasons for leakage could be the incomplete closure of the left atrial appendage. That can happen due to non-coaxial device implantation. So as you can see in A. In B, the diagram B, you can see that there is a second lobe next to the major lobe, which can have the leakage coming around it. And the third one is the side lobe. So all these are very valid and difficult and challenging anatomies, and operators usually spend a fair amount of time to make that the appendage is completely closed. But sometimes you can leave the leak behind. This device leak, as we know, that there are more events associated with it. In the future, hopefully the newer devices will minimize this. Using interprocedural imaging judiciously, preplanning these procedures with pre-procedure imaging studies will definitely improve this complication in the future. The second complication that can happen after either of the device implantation is called the device-related thrombus, or DRT. So we have very limited clinical data on that, but there are real-life registries that have shown that the device-related thrombus still happens in about 3% of the patients, if you look more carefully, which is also associated with higher risk of stroke and systemic embolism. So there are some risk factors for that, which always should be kept in mind. One is the older the patient, the higher incidence of device-related thrombus. Higher stroke, any coagulation disorder, permanent atrial fibrillation, low ejection fraction or kidney disease. There are also some procedural factors. And also, patients who only went home on dual antiplatelet therapy had higher risk for device-related thrombus. And that's why WatchmanFlex device in Boston is still sticking with their first 45 days of oral anticoagulation therapy as standard of care. So that's all the clinical trials and randomized trials and the company-related data. But when we looked into the NCDR-LAO registry, post-Watchman implant in over 30,000 patients, so this is what we found. Only about 37% of the patients, they go home on the recommended regimen. And another 21% goes home on DOAC, which is also the direct oral anticoagulation plus aspirin. Other patients, more than 45%, they only went home on either Warfarin or DOAC alone or DAPT alone or other, meaning maybe single antiplatelet therapy. So this is an interesting observation. What they found was that Warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse event. So you have guidelines telling us one thing and we have the real registry data that's telling us something else, meaning that the lower anticoagulation post-procedure is actually better to lower the risk of adverse outcome. So where do you draw a line? So this is where the combination of registry data and the clinical trial comes in play. And the current recommendation for antithrombotic antiplatelet therapy post-procedure for amyloid is very clear. So you use dual antiplatelet therapy for six months and then single platelet therapy with low-dose aspirin. We call it destination therapy. So they will take it for the rest of their lives. For WATCH-1, we have two options. The option number one is you do oral anticoagulation therapy and low-dose aspirin for 45 days followed by another four and a half months of dual antiplatelet therapy alone. However, if you or if the operator or the imager, they see a leak which is more than five millimeter, then oral anticoagulation therapy plus aspirin should be continued in either of the devices. And they will stay on this regimen until there is a documented seal of that leak, meaning the leak is less than five millimeter, is acceptable, is associated with lesser number of strokes and systemic thromboembolism. And this is the option number two. So again, for amyloid, it's the same. DAP for six months followed by aspirin for the rest of their life. For WATCH-1, the option number two is DAP or dual antiplatelet therapy for six months followed by aspirin, low-dose aspirin as a destination therapy for the rest of their lives. Again, same caveat. If there is a leak more than five millimeter, they stay on oral anticoagulation until the leak is sealed. And this is where the role of imaging comes in. How do you know there is a leak? How do you know there is a thrombus? Because most of the procedures intra-procedurally, when they come out of the cath lab or the OR, the procedure went fine, everything was okay, and then they go home. But most of these complications are detected later on. And that's why it's really important to have your first imaging study between day 45 and three months. That's not only CMS requirement and recommendation, but also the companies also recommend the same thing. And this is in the IFU for both devices. So we can go with either TEE or NAL with the newer generation protocols for the CT. The CT is also acceptable. There are also some incidents of late device-related thrombus. And hence, the second imaging study, again, endorsed by CMS, the manufacturing companies, and the guidelines, is to have a second imaging study between month six and 12. I know a lot of centers, after they're done with the first study, do not focus on that second part. But that second part is also very important. And I think it's our duty, delegation, to make sure that these patients either come back at our centers to get these studies done, or they get done in different hospitals or with the different providers, but we actually look at the images and get the reports for these procedures. Because you have to submit this information in the registry as well. So a few key points, post-implant. Everyone gets lifelong single antiplatelet therapy. Everybody. Oral anticoagulation therapy and aspirin for 45 days is still preferred after Watchman. Dual antiplatelet therapy is still preferred after Amulet for 45 days, and they prefer it over oral anticoagulation therapy. 45 days to six months DAP for both the devices. And beyond six months, single antiplatelet therapy as a destination therapy. However, if there is a device-related thrombus, then oral anticoagulation therapy should be continued until there is a documented resolution of the thrombus on the device. And if there is a device, peri-device leak of more than five millimeter, then oral anticoagulation therapy should be continued until the seal is documented. And seal, documented seal closure doesn't necessarily equate to the complete closure of the seal. It just means that the seal, you need to document that the seal is less than five millimeter, which is acceptable. So slightly changing the gear and going into the oral anticoagulants that we have right now. There are five FDA-approved oral anticoagulation therapy that we have available. The first one is warfarin, it's called vitamin K antagonist. It's been around for more than 25, 30, maybe close to 50 years. One caveat with that is that we have to monitor the INR, which may be difficult for a lot of our elderly patients who receive LAAO. The other four, they're called DOAC, or direct oral anticoagulants. They're dabigatran, rivaroxaban, apixaban, and edoxaban. And the major bleeding associated with each of them is shown there. As you can see, the lowest bleeding profile is with apixaban, or Eloquiz. So remember that old caveat with the older Watchman device where everybody needs to go home on warfarin and aspirin? Actually that has changed. So now patients can go home, if the oral anticoagulation therapy is recommended, they can go home on DOAC, which is actually preferred over warfarin for two reasons. One is it's related to lower bleeding risk, and number two, we don't have to monitor it. So it's less cumbersome for patients to take a DOAC over warfarin. We already talked about that the lowest bleeding profile is apixaban, so that's kind of preferred in patients who are at higher bleeding risk. There are two most studied oral anticoagulation after LAO, or I should say two most studied DOACs. Apixaban, the dosing for that is 5mg twice a day, and the other one is rivaroxaban. Rivaroxaban should always be given with the meal for better absorption, and it's once-a-day medication, the dose is 20mg. However, the lower doses of apixaban are also approved, and rivaroxaban are also approved. So 2.5mg twice a day for apixaban, and 15mg once a day for rivaroxaban. And when would you do that? For apixaban, if somebody is older than 80, less than 60 kilos of weight, and reacting with more than 1.5. So if they have two of any three, they receive the lower dose of apixaban. Whereas for rivaroxaban, there is only one criteria. If there is creatinine clearance, or GFR is less than 50, then they go on the lower dose of rivaroxaban, which is 15mg. And I on purpose tried not to talk about dabigatran and edoxaban, because those therapies are still used, but less frequently. So just to kind of keep things simple, at our center, we send patients home on either of these two medications. And it's also very important to know these nuances, because now, you know, our practice is dependent on what insurance covers and approves these things. And a lot of insurance companies, such as Blue Cross Blue Shield, or Cigna, they have contracted with one or the other drugs. So for example, if Blue Cross Blue Shield will only approve apixaban, they will not approve rivaroxaban unless there is a documented allergy to that medication. So we need to find out about those things through different channels. And those are very useful, so that patients ultimately do not suffer. Because you send a prescription in, and patients don't get it, and they show up for their visit whenever two or three weeks later, and they haven't received any oral anticoagulation. And now they may have a clot on the device. So all these things, it's better to sort them out beforehand, rather than finding out later. Choice of antiplatelet agent. For single antiplatelet therapy, low-dose aspirin is still preferred. So there are other medications, but aspirin is the drug of choice for that. For second agent, typically clopidogrel or Plavix is used. However, if somebody had a prior procedure, such as coronary intervention, peripheral vascular strain, carotid intervention, and they're already taking either Ticagrelor or Prasugrel, we can even continue that as a second antiplatelet therapy. So once the procedure is done, patient goes home, you've documented that they have no thrombus relief, and you send them home on appropriate either antiplatelet or anti-thrombotic regimen. It's very important to follow up on this patient. So periodic checks on the patients. You need to keep the referring provider, because they are key in maintaining and keep your programs afloat. You have to keep them informed about what you did and what kind of antiplatelet or anti-thrombotic regimen that we send patients home on. Formulating anti-coagulation therapy short-term and long-term at the time of discharge is also very important, kind of set some expectations with the patients and the referring providers and the team within. And then as we spoke, follow-up imaging is also instrumental and important and recommended. So let's touch upon all these four points, right? So I'll tell you, at our center, we typically see these patients back in two weeks. We don't leave it up to the referring provider, we just bring them back, and one of our advanced practice providers or the physicians will see these patients. And this is for two things. Number one, you do a groin check, make sure their groins are fine, because there are groin complications associated with these procedures. Number two, you inquire about the medication compliance, if they're taking it properly. And number three, you also ask them about any kind of new event, any problems that happen with the medication refill and things like that. So it's some kind of reassurance policy for the patient that we're not leaving them up to 45 days on their own. We're going to see them back in two weeks, they feel confident, our team feel confident, and it kind of makes the entire process really efficient. And we also talked about referring provider. You have to keep them in the loop. We at our center, we send them a letter immediately after, outlining their antithrombotic, antiplatelet regimen afterwards, and also the appropriate follow-ups and expectations. Oral anticoagulation management starts in the hospital before the patient goes home. So the planning for oral anticoagulation, dual antiplatelet therapy or single antiplatelet therapy plan, now at 45 days and six months, should be formulated at the time of discharge. And the follow-up imaging, especially the first one, should also be set up before the patient goes home from the hospital. So whether it be 45 days, whether it be three months, it's important to kind of schedule that right up front and give patients the information about it. I would also say that with the newer devices and the CT protocols becoming more and more efficient and more accurate, actually, I would say, than TE, a lot of centers are moving away from TE and going for the CTs, post-implant and even pre-implant. So that's something to keep in mind to work with your local radiology team. Because the protocol for this one is very different. It's a venous-phase CT that we have to get. And the protocol needs to be set up, validated internally in the hospital, and also overlap some of the patients with both TE and CT to make sure that the protocol is working, the things are going smooth. So at our centers, this is how we rolled it out. For about six months or so, we did both TE and CT on this patient, made sure that the things are okay and they're matching with each other. And then we kind of now moved away from TEs in over 50% of the patients. So they just get CT afterwards. There are certain strategies that you can implement to improve the adherence of the patients to the medications. And this is a nice little diagram from European Heart Rhythm Association practice guidelines. So as you can see, it's not just the patient who is going to make sure that they're going to stick to their medication regimen. So we have to involve the patient and family, educate them. Then there are certain pharmacy databases that you can access locally. You can do that, too, just to see if the medications were refilled by the patient. Involvement of the family member, pre-specified follow-up, we already talked about that. So everything needs to be set up right before the patient goes home from the hospital after LAAO. Some patients use pill organizer and medication boxes, and those are great if the patient uses them. Sometimes they just put pills in there and the box stays on the cabinet, they never touch it. So it's important that somebody follows up on that. You know, we have new technology ads. Even through some of the electronic health records, you can now see and do the remote monitoring for these patients. And again, once a day versus twice a day. This is very important. Patients in the geriatric populations, the studies have shown, the simplest of the regimens are easier to adhere to. So some patients who are non-compliant, not on purpose, but just because they forget, it's better to simplify the regimen for them and move away from twice a day to once a day regimen. So now let's spend a few minutes on understanding the left atrial appendage occlusion registry for the medications. And again, CMS and NCDR LAO registry requirements are the following. So there are six entries, or six follow-up visits that you need to enter. They start at 45 days, six months, one year, two years, three years, and four years. However, hospitals are only responsible for the data submission for up to two years. All right? I'm sorry. Third and fourth year of data is the responsibility of CMS and the registry, and they will gather that through the Medicare claim. Again, to what extent it happens, I'm not sure, but that's not our responsibility. That's not the responsibility of the program. But it is the responsibility of the program to submit these first four data points. Forty-five days, which almost everybody does, but we have seen that the six months, one year, and two years, it fades away slowly, the data points. But if you're going to study these devices, if you're going to implement some quality metrics, if you're going to say what the new guidelines should be, the data drives it. So it's very, very important to submit this data. And a lot of programs have dedicated people. They have LAO coordinators, they have structural coordinators. So whatever the local mechanism is, it's very important to set the reminders and the timers and fill it up. So these four visits, especially related to the medication changes, antithrombotic, antiplatelet, you submit the medication changes during those visits, document any bleeding events during that time frame. This is just an example from the older version, as Julie pointed out. It's version number 1.3, we are on version 1.4 now. But roughly, you can see, you know, it's very straightforward. So it asks you for the antiplatelet agent, whether they're on it, and whether it was stopped and what was the reason. And if you drop down, there are very specific reasons that you can fill out. And this is the follow-up medication, antiplatelet regimen, again, very simple, whether the patient is on this medication or if it was stopped, what was the day it was stopped. So again, this is from the older version. There are newer, there's a newer version, version 1.4 that's available, that we've been using it since, I believe, October 2022, October last year. All right, so in conclusion, post-implant, DAP for six months, followed by lifelong single antiplatelet therapy. So that should be the goal. Now, if we need to use oral anticoagulation therapy, we're shying away from warfarin now and moving more towards the DOAC. This is preferred over warfarin if oral anticoagulation is needed. Post-implant imaging is necessary and recommended to evaluate for device-related thrombus and peri-device leak. And if we find either, then the oral anticoagulation therapy is mandatory in either case after talking to the patient and the referring provider. So with that, I will stop here, and I think we can take any questions that came through. »» Thank you. Can you hear me okay? Can you hear me? Let me just move it closer. How's that? There we go. Now I can hear me. There are a couple of questions, so I'll go through as many as I can. So lots of questions about imaging post, what about TE or CTE at four months versus 45 days, or three months versus 45 days? You know, we require the 45-day follow-up. Providers are waiting three months to get CTE, and it tends to fall out of the window. So they just want to know your thoughts and what your practice is. So right now it's 45 days, from the recommendation standpoint, from registry standpoint. However, I can tell you that some of the centers, including ours, depending on the patient, depending on how the procedure went, we would opt in at three months, which is really not optimal. I think it's based on the patient preference. Sometimes they just don't want to come that soon after, especially if it's a TE. They'll come back for CTE, but for TE, they'll try to push back as much as they can. So 45 days is what is recommended by the CMS guidelines and the companies. So I think that's what the driving message should be. And if you do it at three months, I believe it falls, right after 89 days, it falls outside of the registry. So they allow you to go up to 45 days on either side. But if you go like 91 days, then it falls off. Then it will be counted towards your second imaging study, if it makes any sense. So meaning, let's say if you do a TE at day 95 post-implant, and nothing between the implant and the day 95, your first window or first period will be empty, meaning you're non-compliant with the submission of data. However, the second imaging study will be counted towards your second imaging study for which the window starts at that point. »» Is there a DOAC dosage recommendation, full dose versus half dose with single anticoagulant? »» Single anticoagulant? »» Yes, thank you. »» Yeah. »» Thank you, madam. »» Let me go back to this. So this is the typical recommendation with normal renal function. So let me simplify this. Everybody with severe liver dysfunction, we try to avoid DOAC, because these are direct oral anticoagulants, they act on factor Xa, which is produced in the liver. So if your liver is damaged, you try not to use this. In that case, we will use warfarin. But more often than liver dysfunction is the kidney dysfunction, because most of these patients will have some degree of renal failure. And if they have renal failure, this is the low dose that is recommended. For apixaban it's 2.5 mg twice a day, for rivaroxaban it's 15 mg once a day. And when do you do that? For rivaroxaban, if the creatinine clearance is less than 50, then you would go for low dose. For apixaban, any of the two criterias out of three. So if they're above the age of 80, if their weight is less than 60 kilos, or if their creatinine is more than 1.5, if they have any two of these three criterias, then we'll go to the lower dose. And the single antiplatelet with this is typically aspirin. But if the patient had some complicated history, received a coronary stain, then it's Pandora's Box. So they can go home on Plavix plus one of these medications. They can go home on warfarin plus ticagrelor, for example. So it's a really complicated thing. But for simple patients who do not have any other indication for dual antiplatelet therapy, simplest regimen is to give DOAC plus aspirin. And I think you said they must be two of the variables to use the lower dose of Pixaban? Yes. Yeah. Okay. Two of the three things. Two of the three. Okay. And is DRT risk comparable between Watchman and Amulet in the role ADAPT versus anticoagulant regimen in DRT? So you can't comment on that because there is no head-to-head comparison between the two devices. There was a Swiss Aparo trial that was done in Europe, very less number of patients using older generation of Watchman device. The peri-device leak, however, on the other side is slightly higher in the Watchman. And that's because if you can see the design of the Amulet versus the Watchman, there is a disc on the Amulet that kind of gives you dual seal mechanism. So if your first lobe cannot seal it, the second disc will cover it. So peri-device leak is slightly less with the Amulet versus Watchman. But the device-related numbers, I don't think we're in a position to say that there is any difference between two devices based on the current data that we have. And again, we don't have any registry, and again, correct me if I'm wrong, I don't think we have any registry data that came out after the Amulet started, Amulet implantation started from the registry itself. I don't think there was any published data for that. And then once we get more and more, we'll probably know more about that. What data justified DAPT for six months post LAI instead of 45 days? So for WatchmanFlex, there was a registry of patients that they did that they sent home on DAPT versus a Warfarin and did not see any differences in the major adverse cardiovascular events. So their DAPT indication came from that small registry. It wasn't a randomized thing. There was some also pinnacle FLX study that was the original study that came from Watchman. It also had some patients that went home on DAPT only. So I think it was a combination of those patients and the other registry data. For Amulet, this data came directly from the Amulet IDE study, based on which the Amulet was approved by the FDA. And in that, their preferred regimen was DAPT and not oral anticoagulation. So that indication came directly from that original study. And when the Amulet was approved, actually it was approved for DAPT, not the oral anticoagulation, as a preferred therapy post-implant. Is there a recommended antithermotic therapy post-leak closure? No. I mean, really, you can go with either vitamin K antagonist, i.e., Warfarin, or the DOAC. You know, with the current indication, typically the Watchman is implanted if they're at higher risk. And the patients who are at higher risk for bleeding, the one way to minimize their risk is to use DOAC, not the Warfarin, as you can see from this small study that was published a long time ago. Actually, the apixaban was associated with the lowest risk for bleeding. So typically, if the patient is already taking Warfarin, I would send them home on Warfarin and baby aspirin. If they're not taking anything, if they're naïve to any kind of anticoagulation, I would prefer DOAC, specifically apixaban. So at our center, if we see any device-related traumas or leak, we try to simplify and change the regimen if it falls in accordance with the patient to apixaban and aspirin. So really, in real life, we're moving away from Warfarin. And many other indications, too. We're moving away from Warfarin. Even for AFib, without getting LAO, DOAC is preferred treatment. So we're moving away from Warfarin and going to the DOAC. »» Any advice on how to get more physician engagement with all the follow-ups after the initial? »» I thought that would be a good one to ask. »» So the physicians, there are two parts to the physician. One is the implanting physician and one is the referring physician. And with LAO, there are a lot of gray zones. Unlike, you know, I don't know how many of you also handle the structural, such as TAVR and MitraClip. For them, it's very standard. Expectation is already set at the beginning. For LAO, it's not. So for the implanting physician, it's very easy to get them on board. I don't think they're going to say no for this imaging follow-ups because, you know, they want to know. And if they don't, I think it's the job of the coordinators and the hospital quality control to make sure that they're on board with this appropriate follow-up protocols. When it comes down to the referring physicians, it's really challenging. Because sometimes they would want to keep hold on to these imaging studies. They would like to perform the TEEs post-implant by themselves, which sometimes is adequate. Sometimes they're not. Because really the centers who are doing LAO are more apt to recognizing the small nuances, such as peritoneal vise leak and thrombus. In our centers, all these TEEs are done by designated structural imagers. So sometimes it's easier and probably appropriate to talk to the referring providers, not immediately after the procedure, but on a sideline when you go and approach them for different reasons. That this is how the protocol has been set up at the institution for LAO. And that we will be making sure that they get these post-imaging studies done. One-year and two-year follow-up, we don't need imaging for that. And again, those follow-up information can be obtained from their office by their clinic notes. So you don't necessarily have to see them in the clinic. However, that's preferred. But for any reason, if that's not possible, you can get those information from the referring providers. For post-imaging, I would say I think it's probably better if they're done at the center where the LAO was done. And preferably by the same imager who was involved in the LAO implantation. »» Guidance on protocol, the time frame for holding oral anti-coagulant slash DAPT for procedures? »» Okay. So it's a very good question. And that question comes up for the other structural procedures as well. If they're not taking anti-coagulation and if they're only taking either single anti-platelet or dual anti-platelet therapy, we do not hold that for the procedure. So even if they're on Ticagrelor or Prasug with the strong anti-platelet agents, we don't hold it. They continue it through and through, even post-implantation. If they're taking one of these newer DOACs, dabigatran, rivaroxaban, apixaban, or edoxaban, then the recommendation is to stop it at least 48 hours before the procedure. Preferably 72 hours. For warfarin, if they have therapeutic INR, should be stopped at least five days before. And an INR should be checked on the morning of the procedure to make sure that it's subtherapeutic close to 1 or less than 1.5. If it is not, some people are slow metabolizer and then their INR is still high on the day they show up, we typically give them vitamin K low dose in the morning. We check it in two hours. And if it's low, then we'll still proceed with the procedure. Remember, these are elective procedures. And there is no need to rush. So if their INR is 2.2 when they come in. And sometime if the operator wants to bite the bullet and do the procedure, these patients are at a higher risk for bleeding post and during the procedure. So should be avoided. Well, these are societal recommendations. I mean, this is not me talking. These are out there. I mean, how many how much of this gets followed through is debatable, but the recommendations guidelines are out there. Do you recommend doing TEE at 60 days for amulet implant patients instead of 45 days to give appendage time to seal and prevent leakage? Yeah. So that's coming from the company and the industry. You know, I would try to ignore that as much as it comes from the device reps. However, it doesn't have to be 45 days, right? I mean, there's a window for that. So you can give it a little bit more time and do it at 60 days, which will still fall within the registry parameters and the recommendations. So sometime, you know, I mean, we had these instances they say, oh, just do it six months after. No, that's not acceptable. You should do it 45 to 60 days, you know, 65, 70 days. I mean, you know, five days plus, minus, is it going to make much of a difference? Probably not. But three months, more than that, will probably do. So I would do it in that window. Because remember, there's also a second real risk of device-related traumas too. So you're giving it more time to close the leak at the expense of the patient may develop clot on these devices if there was a leak present. So there's a risk and balance involved in every decision that we make, and this is one of those things. And I can tell you, the more devices that will come in the future, this is only going to get more complicated and murky. So I would go by the IFU that comes with the device, the exact FDA recommendation that comes with the device, CMS requirement and guidelines, and the societal guidelines. Because those are peer-reviewed. The device representative's opinions are not peer-reviewed. Do you send any of your LAO patients home same day, and do you use anesthesia or moderate sedation? Okay. So that's a really good question and set up for the next talk that we have around 4 o'clock on the registry. But right now, across the nation, I mean, we don't, we keep them in house and everybody goes home on the next day, except a few rare exceptions that we've met. But across the nation, I would tell you, more than one out of four patients is going home the same day. And that number is only increasing every month. And the reason for that is better techniques for the implantation, lesser complications, better device planning, using conscious sedation versus general anesthesia for the procedure. Because a lot of centers have now adopted the intracardiac echogram, echocardiogram or ICE protocols. The procedure is done just like a simple left heart cath, takes a little bit extra time than it would take from the TE perspective, however, also minimizes the time associated with the anesthesia and the recovery. So we don't send patients home on the same day, but a lot of centers are doing it. And if you end up sending the patients home same day, I think they need to have a little bit more rigorous follow-up, probably within one to two weeks after the procedure, or at least a phone call, to make sure they're okay. »» Rivera Saban, although it is once a day, but has the highest complication, is it worth the convenient and the highest complication? »» I'm sorry, which one? Rivera Saban? »» Rivera Saban. »» It has the highest bleeding rate, yes. But again, if you look at that one study, yes, it is. Across the board, apixaban has the lowest. The more studies that came out, this is the study from 2014, so almost 10 years ago. So the more studies that came out after that, once people realized the dose adjustment for renal failure, that is still, that's not 3.6%, it's less than 2.5 at the current scenario. However, the convenience with this drug is that it's a once-a-day medication. So patient compliance with Rivera Saban is much better as compared to every other. So Rivera Saban is also once a day, but it's super expensive, a lot of insurance don't cover that. So I'm really stuck with these three options, dabigatran, Rivera Saban, and apixaban. So if the patient can take apixaban, if their insurance approves it, I would use apixaban. If not, then Rivera Saban. I think I've answered all. How does, oh well, we'll be talking about this later too. How does your practice get shared decisions with your patients? So again, I think it's the next talk, but it's a multifaceted approach. We have many players now. The LAO programs are not as simple as the valve programs. There are many players involved. Many more players want to be involved. And it's not just, you know, I mean, I think, raise your hand if your centers are allowing or having watch months or amulets done by only either EP or interventional, or both. Both, yeah? I mean, that kind of makes it a little bit more complicated, right? Because a lot of interventionalists who do these procedures, they already have a structural program inbuilt, and they kind of absorb LAO into that armamentarium. So their follow-ups are standard, versus when electrophysiology, there is a new field evolving called structural EP. With that, if they don't have an existing program, it's very challenging for that side of the curve for the LAO to have, you know, as crispy of a follow-up for this procedure as they would. So shared decision-making for electrophysiologists would be a little bit different than for the interventional cardiologists, and we'll go in more detail when we go into the next talk. But it's a really multifaceted thing. Whatever suits the patient needs. »» I think that's related to the antithrombotics. But I will make a general comment about, there were lots of questions about the follow-up and is NCDR going to be talking about all the multiple follow-ups for LAO. And that's what we, the Steering Committee, it is on the agenda when we do meet. Because the 45-day especially, you know, not because of the three months and all the changes that are happening within the last year, which is what we were talking about earlier. So just stay tuned is what I can say. Yes, we do have those discussions. We do listen to you. And it is part of what our Steering Committee does. We bring those new things to the committee. We discuss. And if we are able to make changes and updates, then we do. I'm sure if you participate in other registries, you know that there are updates, definitely. But we appreciate all your input along the way because that's what drives, you know, the data that we get. You're out there in the trenches. »» Well, thank you very much, everyone. »» Thank you.

antithrombotic therapy

left atrial appendage occlusion

Watchman

Amulet

medication regimen

post-implant imaging

oral anticoagulants

antiplatelet agents

follow-up monitoring