Dr Natalie is an electrophysiologist and Executive Medical Director at the Texas Cardiac Arrhythmia Center in Austin Texas. He will be speaking on left atrial appendage closure versus anticoagulation. He will specifically be discussing survival benefits, stroke severity, and cognitive function with LAAC vs. anticoagulation.
All right. All right, good morning, everybody. Welcome to cardiology grand rounds. We give everyone another minute or two to log in. In the meantime, the CME code today is 89781. We'll make sure it's in the chat and Doctor Natalia is gonna show a slide here in just a moment as well. What, what do you mean? All right. Well, good morning, everybody. Once again. Welcome to cardiology. Grand rounds. Today. It is my pleasure to introduce our speaker. Doctor Andrea Natale. Doctor Natale, obtained his medical degree from the University of Florence in Italy and did it. His then did his cardiology training in Rome Italy. He came to the US where he did his cardiology ep training at the University of Wisconsin. And over the years I spent time at Duke Cleveland Clinic and now is the executive medical director at the Texas Cardiac Arrhythmia Center in Austin, Texas. Andrea is the editor in chief of the journal of A FB and DUP and serves on several national committees for the AC Cah A and the Heart Rhythm Society. Clinically. He's been very involved with the advancement of A FB ablations and left atrial appendage occlusion. And I'm very excited to hear him speak to us today about left atrial appendage closure versus anticoagulation um as is standard with our grand rounds format. Um I'll let doctor Natale present his talk and then we'll leave the last 10 minutes or so. For questions and answers. Please feel free to leave any comments or questions in the chat or Q and A tabs at the bottom. Once again, the CME code today is 89781. And with that, uh Andrea, I'll turn it over to you. Thank you for joining us. Thank you very much. It's a real pleasure uh to be invited to uh the pen around. So as you are, I'm Italian. So I apologize in advance for my uh accent. Uh There are two problems with Italian. They tend to speak fast and they use their hands, you're not gonna see my hands on video. So that's good. And I'm gonna try to speak as slowly as I can so that you can all understand. So this is the uh the code for uh uh the CME credit. Uh You see the number 89781 and uh the barcode. So let's start the uh obviously, the reason why in patient withal fibrillation stroke uh is a relevant issue is uh because of what you see here, patient a with atrial fibrillation, develop a clot in the left energy which is an important structure um in uh uh the risk of a bolic event um uh as it is recognized as a major source of 95% of the time of cardiac emboli in patients with nonviable atrial fibrillation, atrial fibrillation increased the risk of stroke by five times. Uh The uh uh stroke prevention strategy have evolved from uh what for many e was the only anti anti coagulant which is warfarin to now a series of uh uh F 10 and thrombin uh inhibitor that you see listed the year, the change um dramatically, the easy of patient with an coagulants in term of uh eliminating the need for a regular check. Uh YNR. Um and uh uh lowering the risk of uh a bleen complication. Despite that, I think we need to realize that uh in real life uh uh the vast majority of patients that need anti progress are not uh given these drugs for several reason. Uh the perception that they have a high risk of bleeding at risk of fall their age. Um So, and also the compliance over time or anti operation uh even with the new medication is uh uh not the great you see that even with the uh no a uh at 12 months, uh uh a significant number of patients uh uh uh stopped taking them or don't take them regularly. So clearly, the, the, the relevance of an alternative strategy um has become very important. Obviously, there are people that uh do not uh Latina because of the uh bleeding uh uh complication. Uh In 2015, the FDA approved the Watchman as an alternative option to long-term eu therapy. This was based on uh uh this uh p study randomized against uh uh warfarin. Uh The approval process was uh sort of delayed by uh the perception that this procedure at Iris. And we will go over this uh in the presentation. But clearly the study that this under my studies show that the Watchman implant is in a good alternative to at that time. Um uh The only at which is Warfarin. Um Now we have initial data uh on uh no a this is the uh product 17 study. It's not a huge study as um uh for other patients. But even in a small number of patients randomized to either Watchman or Amulet, um which was recently approved in the US has been approved in Europe for a long time to dogs and 95 95% of the time, this was a peak seven impatient with the um obviously um atrial fibrillation uh And uh uh Chavas of three and has bled more or equal to two to either blood in or to um closure device. And as you see here, uh even uh when uh uh knocks were used, um there was a uh equivalent risk of stroke and ti a in both group, the group with the closure device in the group with the um uh a deva operation at the long term follow up. Actually, there was a significant reduction um in non procedural uh relevant bleeding in the group uh uh receiving the closure device as compared to uh the um uh nos. So this is the conclusion of this uh uh study. When you look at the um uh meta analysis compiling uh all these uh uh study that they are to randomizing us at the f prevail in project 17. Then um you see two important uh information, one that one of the major benefit of the C device is significantly reducing the risk of hemorrhagic strokes that as you know, are really uh uh this complication that lead to death in many of these patients uh somewhat equivalent to risk of uh abo stroke. But the long term follow up uh I issue is a reduction, a significant reduction in all cause of death and all cause of cardiovascular death. And obviously, uh really uh uh uh significant reduction in measured bleeding, no procedural, measured bleeding with the K device. Uh So the the impact on uh uh cardio vasco and of course, morta I think is a relevant benefit that we should not discard the they come from the use of this technology. And we see also some real life uh registry that uh uh sort of attested to this benefit. Uh I want to show this. Uh this is a uh um a large um registry from Europe. Uh the uh uh look at patient that have embolic event on Nova and then uh how a follow up uh they do if they continue no versus they use uh they are con versus being considered for le appendix. And you see when you look at this chemist stroke us reduction uh after the implant of uh uh appendix closure device versus those that remain on anticoagulation. Uh uh significant reduction in all cause of death and also a significant reduction in chemist stroke. The one thing I want to also do that there is a group that where the closure device was combined with anti coul population that add some additional benefit. That's something that where this field is moving that I'll mention in some of the features like um uh one of uh the data is sort of suggested about the potential benefit of closing the appendage. But at the same time, conin devolution is Laos three is a surgical study that were patients undergoing cardio surgery. They were uh randomized to appendage versus not in the. Uh And you see the big difference, the vast the vast majority of the patient post uh uh appendage, uh surgical inclusion remain on anticoagulation. And you see here the, you know the benefit of the strategy across the board um regardless of the subtype uh uh of uh patient age sex, uh uh child V score. Um and um previous history tati a stroke So clearly, this opened the door to um the possibility that the cycles in the appendix uh continue an operation might be an option to the point that uh Laos four just started. This is a, a uh last three was a surgical study. This is a study where patient with eye sharp mask has to be more or equal to four randomized watchman versus watchman plus anti regulation. And there is a large study, more than 4000 patients, more than 250 size worldwide. And uh you will see that uh enrollment time uh is the next uh uh four years. And then obviously, we need about two or three year follow up. So this is an important study that will assess the uh uh benefit of uh closure, closure, the uh appendage closure um in addition to an deregulation in a group of high risk patient, um Now, let's look at the real life registry because this is also important. So here you see listed three register that in parish recently, one from uh uh Danish uh Denmark. And uh where they, they compare the the long term outcome of no versus appendix closure. And they saw that the uh in the patient that received appendix closure, uh there was a lower risk of primary composite outcome compared to the group uh the stay antic operation. And this uh include a lower risk of scanning stroke. Uh The risk of SC was comparable between the group. But there was AAA me a risk of a reduction in measure in the risk of measure bleeding and all cause mortality. Again, uh in the group, uh they receive appendix closure. Uh The group in the middle is a, a um uh registry from insurance company. Uh Again comparing um no to appendix closure. You see the number uh 8000 patient on a uh on uh uh uh with appendix closure versus uh 550,000 on no. And again, there was no significant difference in the risk of primary composite endpoint or secondary born including stroke system, embolic intra bleeding. So comparable, but there was a lower risk of mortality again in the group uh uh receiving the appendix closure. Uh The last registry uh that probably is that one parish more recently concentrated 23 in circulation is the Medicare Claim registry. Again, comparing uh appendix closure versus NOC. And this is uh uh this showed that in Medicare beneficiary uh appendix closure compared to anti regulation was associated with the reduction in the risk of debt stroke, long term bleeding both in men and women. So, real life regency really support uh uh this as an important strategy in uh uh sort of reducing uh the risk of bleeding and affecting mortality in all three of this study. As they show you, even when you look at the long term outcome from the randomized study. So clearly, uh the benefit of a pen that goes beyond um just uh uh preventing or reducing the risk of uh embolic stroke from atrial fibrillation. Uh um Now another uh issue that we look at. Uh uh and this is the, this, this is a study that uh we just published uh um uh in uh jep, we look at the severity of stroke um uh in patient with the um appended closure versus those on anti population. So, this is the uh it's not a huge study. Uh It's out of a center um as a total of uh um 100 patient, the the stroke after panos versus a larger number on uh a de operation. And we look at the C stroke uh um by using a scoring system that I'll show you. And uh uh we saw that there was a benefit. I'm not sure this is Monday. So you see that, that we have 125 patients with appendix closure uh versus 322 with dogs, we lost some follow up. And also we did two analysis, one in the total population and one in the smaller population that was put together based on a propensity score measure. So the, so the, the character they were uh so to um more balance. Uh and you see here the full cohort and then the court after uh propensity mentioning both analysis show that the severity uh of the stroke, the patient with the closure based on uh this modified ranking score uh was um uh lower than in patient or not. So, even if you have a stroke uh after an appendix closure, the the impact on patient is diminished by the appendix closure device. Then what we see in patient on uh uh uh or anti operation. And here again, you see the full cohort versus the uh uh two group uh and I want to show. So the here you see uh the same analysis uh uh compare in full court, the um the center contributing both cord versus the one they only give patient on no versus only patient on, on uh appendix closure. Then um uh you see in the middle, excluding uh appendix closure patient, they were still receiving no by the appendix closure or low dose. And we talk about low dose and then uh excluding patient uh uh the to a non compliance. And across the board, you see a benefit, a benefit in the sever stroke in the group that uh the appendix closure. So, uh this is uh from uh uh the summary of the study. Uh So another benefit uh from appendix closure uh is uh uh the uh reduction is a very good stroke when that happened. Um uh There are two large study that I think are very important that uh uh you're gonna, we're gonna see the result in the next few years. Uh This is champion a f, um, uh, committee. This is a large randomized study comparing, uh, um, was on flex to, uh, no, a, uh, in patient with the child or, uh, equal or more than two, uh, in men equal more than three. in women. The study already completed the enrollment last year. So probably in, we're already in one year in the one year, follow up. So, two more years and then we'll, we'll find out about the results. The other uh study is uh catalyst uh that is slightly smaller instead of the Watchman Flex, use the, the amulet and also um randomize his patient to uh no ox versus the amulet. And this study is still enrolling. Um and once enrollment is finished, then there is a two x three year follow up. So those are two very important studies that can change the landscape and sort of establish this technology as a true alternative right now. Uh Although many of us uh believer are using as an alternative, uh the, the the patient are mostly selected based on those that are perceived to have a higher risk of bleeding or they are intolerant to anti oul um for a previous bleeding event. Um I mentioned uh before that safety was an issue in delaying approval of this technology. Uh safety is changed by the bit from the initial legacy Watchman that you see A R to the Watchman Flex, which is the device that we're implanting. Now that is a device that can be implanted proximately. So it doesn't require dial deployment. So clearly reduce the complication rate. And you see here uh from uh uh the um uh study that led to the approval of the Washington Flex, a very low rate of uh uh complication um and also a much lower rate of uh ischemic stroke. You see uh the uh complication semi the semi event with the Washington Flex as compared to several study with the Watch, the Legacy Watchman, including uh a couple of registry both in us and Europe and the randomized study that I mentioned before. So clearly, the technology has evolved with a safer approach and still an invasive procedure. So as any invasive procedure is some risk that is uh operative dependent. And there are some guidelines that I mentioned at the end about the scale, the minimum scale, I feel I don't need to have uh to um um uh start doing this procedure. So uh let's talk about the dark side of this. Obviously, they don't believe they talk about uh uh the issue which are real. And I think we need to recognize that the two important problem because affect uh the outcome long term after implant or a pen are per device leak in the thromboses device. So let's talk about uh um per device leaks. This is the uh sort of a review or the state of the art that uh we were part of in Jack intervention um showing both Watchmen and Amulet and how uh leaks can occur. Um And the um there are options obviously for leaks that are at least here. And actually our group, I'll show you some of our, our group has been uh sort of the ff forefront of sort of publishing. First on uh all this option, you see that there are coils um uh cat abrasion and smaller device to cause uh per device leak. And I think, and I mentioned this uh after I should say this has evolved to a sort of a combined approach because we realize that uh uh co alone, a operation alone uh and closure device, a small c device alone are not necessarily the answer in many case. So we usually based on the, now that we have enough experience based on the size and the location of the leaks that we use uh uh most of the time, a combination of this uh approach. And you see um here, you know, example, coiling uh and see some of the paper published and clearly the important things that that uh is very now is that it was not clear for a while is that uh um PD uh the presence of uh per device leak. Uh it is associated with an increased risk of a bolic event. And that's something that our group uh sort of realize probably soon and that's why we're more aggressive in closing leaks. And now, I think the community has accepted this as a potential issue. Those are the sort of not guidelines but sort of a working uh uh uh a workflow uh that was proposed in this review. Uh where certainly for leak more than three millimeter, the advice to close and to watch for uh leak less than three millimeters in our practice, any leaks. And I'll mention why any leaks. Uh We consider any leaks as a, as a problem and we close all of them. Um um This is actually one of the first study to look at the uh the imp Pao leak and um a lot of follow up, but it was different from the initial report from uh the that they have that showed that there was no difference over the long term. Um And this study actually showed that any leaks uh is associated with an increased risk of uh tr and bolic event that follow up. Uh So kind of support the more our approach uh over time. So, uh uh again, let's go over uh individually, individual approach. This is uh as I mentioned, our group has been sort of on the front. This is a study where we look at RF. So what we do uh uh uh we, we identify the aerial leak and then we use an ablation cataract to up around that tissue and that cause the swelling and inflammation that result in a closure of the device. Uh closure of the leak. As you see here, the best candidate for this approach, a patient that have small and limited leak. Uh So it's limited to a small segment. Uh If you have a larger leak uh uh over a long uh uh segment of device, this become more challenging mostly because of the visualization of the leak in the manipulation of the cat at that area. Um Another strategy is uh uh detachable coil. Again, this is the, the first paper we published uh in uh uh Jack intervention um showing here um uh this approach and uh how this was able to reduce significantly um the size of the leak and many patients that abolish the leaks. Although as I mentioned, we learned that probably this approach alone um long term um is not the best. And usually we combine this with the also smaller, smaller crus device. And, and, and you know that this is the next uh uh paper that I'm gonna show where we use devices that are used for uh either um uh a SD of a smaller one to close uh uh per device leak. Uh uh Again, and you see here example, we start using this more in postsurgical closure. Um But then we've used this recently um even uh in uh per device uh uh in the vascular per device leak. And you see an example here, this is kind of AAA more recent uh uh sort of review of this uh uh multimodality approach that you against here uh here summarized with the, the review of all the paper uh with the um uh the successful uh course, as I mentioned, uh our approach now is a sort of an IBD approach where we combine um a smaller set of occluder with either coin or RF. Now, uh something that is very important is detection and uh uh uh certainly t is more operative dependent. And the, the reason why I I mentioned before we close every leak because one of the issue with the um and a little bit, even with CT we con is the size, the sizing is dependent on the technique that is used whoever is reading this this procedure, uh this uh this test. So what we actually propose in this paper is a very simple way to uh to worry about patient posture. Uh Even if uh the, the, the operator that he tell you that there is no uh leaks. So what we have seen is that when people truly have no leaks, the device is the, the uh the, the uh the T show a white devi uh um uh shadow behind the device because there is a clot. Every time you don't see a clot behind the device, you need to worry that there is a leak. Even if the te reader tell you that there's no leak. So if there is no clot behind the device, somehow there has to be a leak that might not be identified and the leak is relevant because if the leak is really small enough, the patient will develop a clot uh uh behind the device. So every time you see a dark shadow behind the device, it means there is no clot, uh you need to worry and maybe that's a, it's a group of patients where you certainly want to consider ct with contrast to identify the present Zoli and decide the uh the next step. Now, let's move to device related thrombus. Um uh This is a a large multi center study to look at predictor uh the t the hyper hypercoagulability disorder regarded few insufficiently in plantation depth. So device that are too deep in the appendage are more likely to be associated with trombo and non Pais Maria. Uh This is something that is very important because I'll talk about the uh alternative strategy after implantation. We mentioned already keeping patient, the potential benefit of keeping patient on a regular dose of blood thinner in the group of uh non paroxysmal. And I will be there are two subset of patients that uh yeah, I think you do consider the patient with history of cancer are certainly patient where we've seen a higher rate of throbs device. And obviously the non paroxysmal effort that have smoke in the left A is a group where even in a perfect with even after a perfect closure about surgical or uh in the vascular. We have seen some risk of uh um uh embolic events that need to be addressed. Uh any year you see, um sort of uh the time post implant. So we now uh uh I learned that this can happen, not, not just a one year, but even, you know, so we check the patient up to two years uh uh to make sure they don't have, they don't have stroke. So this is a, a, an important message uh uh in clinical process, we see a lot of people that receive a watchman or an A and they uh one follow up of 45 days and then they just disappear, keep imaging this patient at one year and two years because that's is probably the longest that the uh clot has been seen because that is an important uh potential uh complication that affect the benefit of this uh uh uh procedure. And here you see again, um the risk uh uh based on this sort of uh variable that uh uh increase the likelihood that some special develop thrombus on the device. And here is an example of one of these and the impact on the outcome, obviously, the risk of uh um a body and the follow up. So let's talk about detection of uh um uh a chromosome device. As I mentioned, there are two option uh C TNT E obviously T is probably more standard city now is becoming popular also because at the same time, you can use that to uh look in a more accurate way to uh the presence of leaks uh with the CT. Uh uh the same way uh when you look at leaks, uh if you do not have a cardiology reading, uh the city, I think you need to learn yourself to look at this test. Uh um because otherwise you end up with sort of information, sometimes are not. Therefore, uh it's important, there are different type of sort of imaging that we see on CT that is important to recognize and I'll talk about this. So obviously, this is clearly a clot you have to worry about uh as this one. But if you see a, a very uh um structure cloth that the uh layering, not very thick, uh those are things where we really do not uh uh no, the meaning of it. So here you see uh uh the presence of uh uh clot uh uh divided by I grade and low grade. Clearly, the I grade is something that we need to worry about, but the low grade which are laminar and no uh uh and, and the thick is less than three millimeter. Uh Right now, we do not know the relevance of this in, in the study so far in this group with low grade uh uh path. There's no, there's not been event, obviously, we need a longer than follow up. Uh But you know, clearly uh this is an area that uh where we need to learn both in, in the interpretation uh aspect and in the meaning of the finding the long term, especially when it comes down to low grade at. So I mentioned before about uh uh anticoagulation, we talk about regular regular dose, but uh uh our group actually look at the A dose no a after implantation as compared to the standard approach. Um And we use this this strategy exclusively in two patient group patients with large atrium, especially if they have smoke, even if the appendix is probably closed, an inpatient with a history of uh cancer as I mentioned before. And what we've seen is that when you compare uh the standard approach, which is uh the therapy and then baby aspirin versus a dose or no Exelon term. Um Ado Zoox was associated with a lower risk of uh thromboses device, lower risk of thrombolic event and lower risk of measured bleeding even when compared to baby aspirin. So this is something that I think we need to learn more. This is obviously is a non randomized study. There is a randomized study that we are just starting in Europe. Uh So we'll see the light probably in the next uh maybe 23 years. Uh But this data are really uh important uh because uh uh even in a group of patients that is considered high risk because they have a large agent with more com com uh comorbidity in terms of uh predictor of uh thrombo chole device, the ADOS or NOVA and not only reduce the risk of human body, even thrombo chole device, but also was associated with less bleeding than baby aspirin. So this is very important here. You see again, the uh composite uh uh event uh altogether. Um uh why is that? Uh if you look at the uh the uh assessment of uh uh anticoagulation and pla lat after implant, you see that the pla activation doesn't show big change whereas there is a big change in uh activation of uh prom in uh uh in a coagulation. So really what you see after a endovascular implant, uh uh uh is more an activation of the coag coagulation rather than plate. So it makes sense that the low dose noa uh is more effective using the risk of those problem um uh than maybe aspirin long term. Now, this is kind of a, a slide summarizing all the studies that look at Thrombo on device. And you see that the app and both the Amulet and, and uh uh uh a watchman in the range between uh uh 6% to as low as uh uh 2%. But it's real uh the good news is that uh uh now we have a, a large generation watchman that is a code in that uh uh together with other people, we just published in PPP. This is the, the um uh bench and animal experience comparing the, the Watchman Pro that is the coating versus the regular Watchman Flex showing that uh uh as you see here, there is less inflamma inflammation with the Watchman Pro. As compared to uh the uh regular Watchman flex. There is less uh uh argument in binding to the device with the uh coded device, then with the uncoded device and uh less strombus long term and better coding uh with the pro as compared to the regular flex. So this is actually available now, it just became available at the end of the last year. So we're gonna accrue data. They are actually registered to just complete the enrollment. We see the outcome. And with this device, we're exploring uh from the implant uh uh strategy that uh uh are either single Angra agent or a do or NOAC as compared to the anti a uh agent. So we'll have this data probably in the next uh uh uh year or two. Um uh I wanna mention uh uh this consensus document uh because it talked about the indication right now. Uh as I mentioned, although the data are out there already as a uh proving the benefit as an alternative. This is a class two B indication mostly in patient, some perceived control indication to blood thinner or previous bleeding, even on a blood thinner. Um And uh um they also you uh advocating follow up imaging to detect all the issue that you mentioned um of the post plant fusion device symbolization previ leak and thrombus on the device. And here sort of a, a summary, I I'm not gonna spend too much time uh sort of the minimum amount of uh uh experience uh uh for a potential operator both in left side procedure which could be ablation, uh the required concept obviously, but also with the appendix closure. The last thing I wanna mention is the cognitive function. We know that atrial fibrillation is associated with the a um increased risk of dementia of follow up. And this is a, it can be uh uh due to a variety of reason, there could be clinical stroke, silent and micro and, and uh and macro infer in the brain uh cerebral loss and also uh micro breathed um due to the ongoing anticoagulation. So what the appendix culture does to this uh uh issue. Um There are a few study uh these two issue in terms of size uh but also they don't have a comparative group but they don't have a group uh uh with uh just uh um uh blood thinner. Uh They did show uh that appendix closure do not have an adverse effect on condition. This is is done by um repeating uh uh uh mo a score uh questionnaire which is a very sensitive questionnaire to assess uh uh dementia uh in patient uh uh follow up. So, in our uh institution, we have an ongoing uh dementia study that now is around more than 500 patients uh where people have a baseline moa uh score. And then they, they do that uh six months, uh uh one year, two years. Uh And uh recently, uh we published this series again, not randomized, but in this uh large study, we uh uh selected two population, one with the wash and, and it match population that they continue to stay on anticoagulation. And we look at the moca sclera follow up and we saw that the patient on uh no a a higher risk of decline in the moole follow up which did not change in the group of patients after appendix closure and the patient after appendix closure was a 5050 on baby aspirin and a dose versus the regular dose of nose in the people that did not have appendix closure. So a stop here send it uh overall stroke frequency in similar between appendix closure and or anti V in patient with atrial fibrillation. Uh you know, va fibrillation, stro severity is reduced by uh appendix closure as compared to no. A after successor was Watchman implementation long term after dose of NOA is it was associated with the substantial reduction risk of stroke device related thrombo measured within events as compared to standard anti therapy. Um Also there are some early data that that um a significant decline in mo a score is higher in patient receiving uh long term an operation compared to those uh receiving appendix closure and uh per device leaks are associated with increased risk of pro and bolic event and should be considered for uh uh closure uh with the available strategy that I mentioned. Uh And uh uh I am thank you for your attention and uh please uh if you have any question. Uh uh um All right. Thank you very much. OK. Uh Andrea, thank you very much for, for that talk and thank you for joining us today. You know, it's very interesting. And what you're proposing is a little bit of a shift in the paradigm of thinking of around left atrial appendage inclusion. Historically, it's really been felt for patients that can't take anticoagulation at all. And really some of the data you're presenting is, is starting to have us rethink that and there may be additional benefits beyond just the group of patients that can't tolerate anticoagulation for bleeding reasons. So, thank you for joining us. Um I'd like to start off with, what's your approach and which patients do you now discuss left atrial appendage occlusion with I? Is it still the group that has bleeding problems on anticoagulation or are you starting to push that to other patients as well? Yeah, it's probably the biggest group with the patient that if some perceive intolerance. Uh But we, we have a lot of patients that uh they really um ask uh us to consider that approach as an alternative. So it's kind of more driven by patient preference, obviously, you know, in that group, uh we select people. So we, we, the people that we uh really uh consider uh people that have higher risk uh uh or stroke uh with higher risk of, you know, higher as blood. So, but we would do, I would say we, we do a, an increasing number of patients that do not necessarily add a major bleeding event. Um Mostly because it's patient driven preference. Uh Obviously, we are waiting for the to study dimension. The champion and the cay, I think champion will be the first because it's already one year in the follow up post uh uh enrollment. Uh So I think the next two year we'll see some, some data, those study will clearly change. But we already have, you know, as they show some large registry that uh uh support uh the potential long term benefit of this approach. And also we have to figure it out what I mentioned, what is the, which are the group in operation that after closure might benefit from still still some degree of anti coalition and if that can be a dose or regular dose, so we need to figure it out two more sort of practical questions for you and then we'll go through the the chat. Um Questions here. One is, how are you approaching reimbursement for this and approval for this because my understanding is there's still the requirement that two physicians are in agreement that the patient is, you know, uh a bleeding risk or intolerant of anticoagulation before you move forward. Yet, as we, we talk about shifting that to a larger group of patients that may benefit. Uh how, how do you deal with that issue right now? That's it is very important. The practicality, the process does require a non implanting physician. So somebody that does not is, doesn't do interventional procedure to sort of approve the indication. And as I said, even in the patient that where this is driven by preference, and we still select the people that have either as bled that, that they have some sort of perceived risk here because they are older, they are false. So there is still a selection process uh uh um in uh uh driving the indication. Uh um so, but uh y you're totally right that this, uh uh the process of getting approval from the insurance does include um an order from a non implanted physician, which usually in our um uh practice is either a primary care uh physician or the patient or the regular cardiologist that uh sort of a test. And, you know, as I said, we kind of do this together, uh is a discussion, uh uh uh that, uh uh you know, take place uh uh in, in this process. My next question for you. Uh again, a practical question, what is your post implant anticoagulation protocol? Um for standard, standard implantation of a one of these device. So the, the, the standard approach um uh is uh uh 45 days of anti, then do an integrated therapy for three months and then single integrated therapy. As I mentioned, I show you our data, we have those in our practice. Um This has shifted from half dose from the day after uh the implant. And then after six months, we decide if patient uh go to baby aspirin versus stay on after dose. And the two criteria we use are large atrium, we smoke um and uh uh history of cancer. Um So it is mostly breast uh for women, breast and uterine cancer for women and prostate for men. Uh But you know, men, for example, if they have pancreatic cancer, uh cancer where clearly there is an hypercoagulability, those are people who stay on after those. Uh So this has been our approach, the most of the other practice. Now this is is moved to dual, dual anti therapy from uh uh post implant for uh uh about three months and then seeing anti therapy afterwards. Um The one thing that I want to mention in patient with leaks, we have seen that after those. Uh So in patient with leaks around now, you either close it and then consider stepping down the blood thinner this day on operation. We have seen that uh half dose is actually protecting in patient with leaks. So uh as we decide uh how to address uh per device leaks, half dose has been a good strategy also in that uh subset of patient. And it's been our approach uh uh from the uh post implant uh for, for quite a while. OK. Um Just as a reminder, the CME code is 89781. Uh Andre Le, I wanna go through a couple of the questions that have come through uh in the chat section, one has to do with surgical appendage, uh um either closure or resection. So, you know, patients that are undergoing cardiac surgery for a variety of reasons, if they have atrial fibrillation will oftentimes either have their appendage ligated tied off, resected in a variety of ways. And if they have future A FB, what's your approach on these patients? Well, I think the data are good. Uh You know, right now, if I have a patient is, is having surgery of any kind cardiac surgery and uh as a uh history of A F I ask um the surgeon to cause the appendage. Um uh and I think it's becoming more standard after the last three, it is becoming more standard. The one thing that I, I asked for the end of var device, um I, I always uh um discuss with the patient, the need for imaging uh post uh uh surgical closure um before you sort of scale down the blood thinner because there are two issues that, uh, uh, are real one. We, if the, the, the surgeon decide to close the appendages with stitches or, uh, clips, uh, we've seen that, that lead to about 40% reopening, uh, which can actually be worse than, uh, you know, a completely open appendix, the risk of stroke. So you, we need, you need to make sure that's not the case also. Uh, I think now with the clip, um uh uh it is becoming better, but we've seen plenty of clips that are improperly deployed where the missile lo uh and so you need to do at least one imaging even for so post uh uh surgical closure to um assess proper closure also with the clip uh as with the this tissue, but more with the clip, there is always a little power uh stamp uh that is there. So it's also important to assess the depth of the stamp. And, and we know that the stamp less then uh um uh a centimeter are clearly not homogenic, especially if it's just smooth tissue. But there are the, there is a need for imaging, post surgical closure that I I advocate for uh before a patient uh uh is allowed to uh sort of uh uh scale down the anti anti a regimen. And, and when do you typically do that post uh surgery te is there a time frame that you have? Usually we, we kind of, uh, uh, uh, do it around three months, post, uh, um, uh, surgery. But, you know, with the, this was true for the s for the stitches. Now, with the clip, even one month, you know, is enough as long as you do one imaging at some point, just to make sure that the appendix is properly closed, there's no missing lobe and the, the, the, the stamp is not, you know, uh, really big. Uh That's uh it's enough. The one thing that I mentioned during the presentation, we also look at smoke. So actually, our data that prompted the use of those came from a large series of post surgical clip where we saw that even when the clip was probably deployed, especially of a large region with some smoke, th those group as some uh still the risk of uh Tole event. So that I imagine beyond looking at the appendix also uh should look at the size of the left in the presence of smoke in the main chamber as a way to drive uh some uh um you know, different strategy in thematic culture. That's a group where a dose actually has worked very well. So if you have a patient with a very well close appendix, but to a large and some smoke, that's a group that we will keep on half those long term right now. Couple of questions from uh Doctor Lang, who's one of our ep doctors that uh does implant uh the watchman device. So should all patients status post? Let a trail appendix closure undergo short term oral anticoagulation and or a tee prior to cardio version of non permanent A FB in the first two years, the role for more nuanced approach. Yeah. Now this is AAA an area where there is uh um uh there is no, a lot of data, we published it together with other series where we show that uh it's safe, but some of this patient have clot and I think the people that have clot and the people that kind of fell through the crack where there was no serial imaging. Um In our practice. Uh uh I have to say that if we have done um uh already imaging without seeing any issue, we don't, we just can deliver the patient without uh but this is an area where there is no consensus. So I think, you know that if you want to be on the safe side. Uh uh um uh Right now, what people uh most people do is to, to do a te to ensure that the device is not clogged and then consider maybe a 30 days uh uh blood thinner around the cardioversion uh uh for the, you know, the effect of the statin that the cardioversion can cause. But I think this is an evolving area where I think we might change in the future. And the next question from uh Doctor Lang how do you manage a patient with a history of device related? Thrombus has no clear evidence of a significant per device leak. Yeah, where those, those are people that need to stay on a blood in a regiment. Um As I as I showed before, the after those show uh a much lower risk of device of thrombose than uh baby aspirin. So usually in those patients, we we go back on regular dose and then once the device, once the thrombo is resolved, we try to scale down to half dose and see if that is enough. But those are people that clearly need to stay on some uh anticoagulation regimen. Um long term and, and the starting point is regular dose until the, the clot is dissolved and then you can try uh half dose to see if that's enough to prevent the reoccurrence of the clot. Um you know, uh or, or keep them on regular dose. Uh If you wanna be as, as you know, not take any chance right now, I I can tell you that we have close to probably 800 patient on half dose and we have maybe a couple that develop a thrombosis device and the thrombo device that we see in half dose, it's a very layer stratified, not this big sort of uh mobile clot that we see some in patient baby aspirin. Uh but you know, still it's subject to it, but it's much less frequent than in the group with baby. A so uh if, when you, once you have a clo, you are, you're gonna take some blood thinner. I think that what you need to get to figure it out if uh half dose can be enough in some of this patient uh uh versus just going back on a regular dose, this is gonna become less of it. We hope, we hope because we need to add more data, less of an issue with the new uh Watchman Flex pro that is the coding. Um The, the, the study that I show you in uh on the bench in animal is very encouraging, but obviously, we need to have data in patient and those are ongoing study that we have data in the next year or two. So hopefully there is a light at the end of the tunnel from uh from the point of a chromosome device. Andrea the next question comes from Doctor de Souza um who's also one of our EP doctors, he's saying with the pulse field ablation commercially available. Now, do you think the EP community will move towards left atrial appendage isolation and closure at the time of their a FB ablation? Yeah, we do this all in one procedure for the patient. Yes. Uh I think they can call me that I'm becoming more uh more, more popular. There is a study option that should uh uh be presented at uh this year at the entire prote AC C that is looking at the uh um concomitant uh closure versus long term anti oul postablation. So we left some, some data but clearly this is going to become uh a more popular procedure. I think more convenient for the patient. To be honest, I think we, we're gonna have to decide how to select these people because I think we have good data that uh in many of these patients. And, you know, this is actually come uh uh from our group and be also has been uh at the paper with us many years ago and their data more recently that uh if you treat a success rate of fibrillation and you have an ongoing monitoring. And today with the wearable, it's easier and the, the treat the, the the successful treatment, a fee did not require extensive abs, I think it's OK to keep these people of anti abolition without a watchman. Uh But in those they require, you know, the was for, you know, several reasons. I think the con the procedure will become more popular for sure. Well, fantastic. Uh Andrea. Thank you once again for joining us this morning. I certainly learned a lot and again, really a shift in thinking around left atrial appendage beyond just uh closing it in patients that are intolerant data, coagulation, still a lot to learn. And uh thank you for leading this field and, and really being uh uh a leader in in how we treat, uh, this growing number of patients into the future. So thank you and uh have a great day everybody. Thank you very much. It's a real pleasure. All right. Thank you. Once again. Bye bye bye. Great. Have a great day. Bye bye.
