Current Trends in the Safety and Efficacy of Left Atrial Appendage Occlusion (non-ACE)-Current Trends in the Safety and Efficacy of Left Atrial Appendage Occlusion (non-ACE)

Current Trends in the Safety and Efficacy of Left Atrial Appendage Occlusion (non-ACE)
Video Transcription
So, thank you very much. On behalf of the option investigators, I'm going to present this abstract, which is Comparison  of Left Atrial Appendage Closure and Oral Anticoagulation After Catheter Ablation for Atrial Fibrillation.  This abstract is specifically about the concomitant and sequential cohorts of the option randomized trial. How do you advance this? Oh, okay. I got it. I got it. That's fine. Sorry.  Okay, these are my disclosures. So in terms of background, we know that left atrial appendage closure is an alternative  solution for stroke prevention, avoiding the need for long-term oral anticoagulation, especially in patients who are at risk for bleeding.  And the results of the option trial, the main trial, were already published in the New England  Journal of Medicine and showed that when compared to oral anticoagulation, implantation of a  watchman device in patients undergoing atrial fibrillation, that trial met the non-inferiority  efficacy standpoint, which consists of stroke, thromboembolism, and death, and more importantly,  met the superiority safety endpoint, which is a reduction in major bleeding or non-major clinically relevant bleeding.  The current presentation will focus on the outcomes in the concomitant and the sequential subgroups.  And just so that we can understand what is it that we are talking about, the option trial enrolled 1,600 patients who are going to undergo atrial fibrillation.  It was randomization was stratified by ablation time. So on one hand, we have patients who had the sequential group.  These patients had already had an ablation done three months to six months prior to randomization.  And these patients essentially were randomized to either watchman flex implantation or continuation of oral anticoagulation.  And there is the concomitant arm, which are patients who actually came in for atrial fibrillation  ablation, and these patients were randomized to either watchman flex implantation concomitantly with the afib ablation or oral anticoagulation.  So these are the groups that we are comparing. We are not comparing sequential to concomitant because the randomization was stratified by  ablation timing and the differences in baseline characteristics were different because ablation timing was not part of the randomization process.  So that you can see patients who underwent concomitant procedure, more of these patients actually were performed outside the U.S.  Patients who underwent concomitant were older, had worse renal function. More patients in the concomitant group had atrial fibrillation and also less patients  presented in normal rhythm, which is pretty much self-explanatory because those patients did not undergo ablation yet, whereas the sequential had already undergone ablation.  And the results in terms of the safety and the efficacy endpoints in the concomitant and the sequential group were in line with the original trial, mainly in the concomitant  group, the efficacy endpoint met the non-inferiority and the safety endpoint met the superiority in favor of the Watchman Flex versus the oral anticoagulation.  Similarly, in the sequential group, the primary safety endpoint also showed superiority with  the Watchman Flex compared to oral anticoagulation and the primary efficacy endpoint showed non-inferiority in terms of risk of stroke, thromboembolism, and death.  And this was presented in the AFIP Summit back in January 2025. More importantly, the addition of the left atrial appendage closure to the ablation procedure  did not result in additional safety events for the procedure itself. You can see in the concomitant, 2.1%, and the concomitant oral anticoagulation, 2.8%.  So the addition of the left atrial appendage closure did not increase the safety endpoint events. And more importantly, the addition of the left atrial appendage closure to the AFIP  ablation did not change the outcome of the ablation. Similar results, similar rates of cardioversions, as well as similar rates of repeat ablation.  When you look at the effectiveness of device closure in the concomitant procedure, so what happens in terms of device-related thrombus and peri-device leak, you can see that 97%  complete seal or small leaks, which means less than three millimeter at one year, which is aligned with the results of previous left atrial appendage closure data, and only one  patient in this had experienced a stroke, and that patient was actually in the leak which is three to five millimeter.  When you look at device-related thrombus in the concomitant procedure, you can see that it is, I'm sorry, it is 3.5% at one year, but notice that most of these thrombi were  laminar and were not pedunculated or globular, and no patient experienced adverse events related to device-related thrombus in this group.  When you look at the sequential procedure, you can see similarly that 98% complete seal or small leaks less than three millimeter at one year, and no patient with leak experienced  any stroke. When you look at the device-related thrombus in the sequential procedure, you can see that  the rate is very low, 0.7%, and in this subgroup, no patient experienced any adverse event related to the device-related thrombus. So there are limitations to this study.  Obviously, the ablation timing was not randomized, so the subgroup characteristics are not matched  and not directly comparable, so we're not essentially comparing sequential versus concomitant.  In the sequential group, the adverse events between ablation and randomizations were not collected, so if you've had an ablation before, we do not know what happened and whether you  had any kind of adverse effect before randomization in the sequential arm, and the patients had to survive the ablation in the sequential arm to be able to get enrolled, so we do  not have any kind of information on those patients, and patients who've had complications are less likely actually to be enrolled in the study, which might have included a bias.  And pulse-feed ablation was not available at the time of the study enrollment, and I don't think that this is going to change much the results of this study.  So in conclusion, primary option trial results are consistent within the concomitant and  sequential subgroups and aligned with prior LAEC study, namely the pinnacle flex and surpass.  Addition of left atrial appendage closure to ablation did not result in increased procedural safety events.  The ablation plus left atrial appendage closure versus ablation alone were similarly effective  in treating arrhythmia, similar rates of cardioversion, similar rates of reablation, and the addition  of left atrial appendage closure to the ablation did not result in increased adverse events of the procedure.  And effective left atrial appendage closure device seal sustained through one year in both concomitant and sequential subgroups, and in both groups the DRT were low-risk laminar  with no sequelae in terms of stroke. Thank you very much. That was an outstanding presentation. Any of you want to ask a question? Okay, we've got a question, please. No? Okay.  I have a question. So in the patients that were treated with anticoagulants, the DOACs, right, is there  any information on outcomes as it relates to the dosing that was used for the individual DOACs?  So the dose of the DOACs were the standard accepted dose, which means mainly it was used,  which is five milligrams twice a day, and for the Xeralto, which is a lesser proportion of patients, it was 20 milligrams, obviously adjusted for renal function as recommended.  So no. What I failed to mention, which I might mention, the DRT that happened in the device-related  thrombus, no patients, so these are DRTs that were detected by the core lab and not by the site, and therefore most of them, most of them, and therefore there hasn't been any  change in the oral anticoagulation regimen as dictated by the site. And despite that, there were no DRTs related, there were no strokes related to DRTs. Any other questions? Okay.  I have a question. You comment on thrombotic complications, presumably related to the device. How were those patients managed once the thrombi were identified?  So if the thrombus is identified by the site, then these were given anticoagulation and repeat imaging was done.  If the thrombus is detected by the core lab, they were blinded to that, and then the patient continued on whatever regimen the site was recommending.  So a follow-up to that, did they, those particular patients, I know these are difficult questions, did they have any increase in events, those with thrombi, as far as you know?  So that was, no, they did not actually have an increase in events that we know of, specifically.  But again, the numbers are very small, and we cannot make any generalized comments about it. Thank you very much. Outstanding job.  Okay, the next speaker is Dr. Matarek, also from the Cleveland Clinic, and in the interest of efficiency, could you just list your, the title of your presentation?  Now, we have to get onto your presentation.  Is it there? Yeah, press start. It should start any time. Perfect. Okay, very good. Thank you so much. Thank you. Thank you, Dr. Saliba.  Thank you, Dr. Michael, for your introduction. My name is Islam Matarek, and I'm from the Cleveland Clinic, and today I'm going to present  about long-term outcomes of left atrial epinephrine occlusion versus DOACs in a quite vulnerable  population in obese patients with a BMI above 40, largely excluded from many clinical trials  and this is the first long-term analysis and comparison between the two interventions in this group. I have no relevant disclosures on this topic. So obesity is a growing pandemic.  It has been growing quite a bit, especially in the United States, and frequently coexisting  with atrial fibrillation and anticoagulation in this group, especially DOACs, is complicated  as a virtue of drug-to-drug interaction, drug pharmacokinetics in this group, especially in obese patients with an increase of bleeding risk, and at the same time, an increase of  prothrombotic risk, and left atrial epinephrine occlusion may provide an alternative for long-term  DOAC therapy, and in this study, because comparative data between DOACs and left atrial epinephrine  occlusion is not there, we sought to close the gap, and the objective of the study is to compare left atrial epinephrine occlusion to DOACs in patients with obesity or in patients  with a BMI above 40 and have AFib using real-world data. So in this study, this is a retrospective study, and we used Trinetics, which is a federated  electronic health record network of more than 96 institutions, and we interrogated this database to check for patients who have AFib but also have a BMI of above 40, and  we chose the index event to be the left atrial epinephrine occlusion device or starting DOACs,  and we did propensity matching for many covariates for these patients, and we followed up on them for around 1,800 days or five years from the index event.  So as we see here, we started off with 104,000 patients. These patients had a BMI above 40, they had AFib, and there was around 104,000 of these  patients were either on, as we see here, who either have the DOACs or have underwent left atrial epinephrine occlusion.  So 103,000 patients were taking epixaben or rivarixaben, and around 1,500 patients had undergone the left atrial epinephrine occlusion.  So moving forward, we did propensity score matching, and this was done for a myriad of  comorbidities, demographics, age, ethnicity, and medications, including antilipimics, antihypertensives, and we followed these patients for mortality.  This was all cause due to inavailability of cardiovascular-specific deaths, stroke, major bleeding events, MI, and intracranial hemorrhage.  So as we see here, both groups had around 1,500 patients. They were very well balanced. The mean age was around 70 for both groups.  Around half of the patients were female, and the other comorbidities were well distributed across the board between the two groups.  With prior bleeding events, these were major bleeding events, a priority, were around 52%. So moving forward, this was our main outcome, which was left atrial appendage occlusion,  shown here as the green curve, and DOACs being the purple one. This is all-cause mortality. We see here an early diversion between the two curves, and the survival benefit of left  atrial appendage occlusion persisted all across over the five-year period of time over DOACs in this particular group.  Moving forward to secondary outcomes, including ischemic stroke, MI, major bleeding events, and intracranial hemorrhage did not show a significant difference between the two groups.  So it's quite surprising, knowing that, or us thinking of, if there was a mortality benefit, it would be O2, an improvement in stroke and major bleeding events.  So this is a forest plot depicting the results. As we see here, the one starting off, the all-cause mortality is the only one that's significant.  The other outcomes, the secondary outcomes, were not significant between the two groups. So integrating into that, and here I see one of my colleagues, Dr. Mudali, who actually  was looking into that as well, was trying to assess why is this the case? So Dr. Mudali actually found a recent meta-analysis around two years ago that pooled seven studies  that compared left atrial appendage occlusion to DOACs, but this is all comers, not obese patients, that show very similar findings to our study.  As we see here, the all-cause mortality was decreased, but all the other outcomes were not. So our study really expands and builds on this to show that this also is a finding in  obese patients. We have a mortality benefit in this study. Again, we're looking for potential mechanisms behind this potential mortality reduction.  One thing is avoidance of cumulative anticoagulant use in these patients, reduced drug-drug interactions. Many patients with obesity and AFib  also have a myriad of medical comorbidities, and removing one drug from their drug roster should help. Possible benefits also from closer procedural follow-up.  These patients were followed up a little bit more in this study, and potentially some confounders, such as unmeasured adverse events, anemia, frailty. If this patient had undergone  a left atrial appendage occlusion, potentially the physician has thought that this patient is good enough to get a left atrial appendage occlusion, at least in this study.  So that also can confound the picture. Again, our study, as any retrospective cohort study, has limitations, including its observational design  with residual confounding that cannot be excluded as we talked about, and we don't have any data about the left atrial appendage occlusion device type.  So this was either getting a left atrial appendage occlusion, this was all transcatheter-based versus DOACs, and we don't know which device exactly.  And outcomes were limited to coded events, subclinical events that were not coded. For example, someone is on DOACs and has a fall and dies thereafter.  This might not be coded as a major bleeding event, although a major bleeding event might have caused the mortality of these patients. Our study is rather hypothesis-generating  rather than dictating clinical decision-making, but for us, we feel that this is a space that deserves some more information down the line. In conclusion, in this particular study,  patients with AFib and obesity, left atrial appendage occlusion had significantly lower mortality, but similar and comparable stroke, MI, major bleeding events relative to DOACs.  I'm happy to answer any questions.  Thank you.  Again, that was an outstanding presentation. Any of you guys or ladies want to, yeah, question. Do you want to come to the microphone?  Thank you very much for that. Here, you can go to the microphone. How did you measure BMI, number one, and number two? The curves look like the separation  was in the first six months or nine months, and then they were parallel. Could you explain that?  Okay.  So, I'm just gonna go back to the curve so everyone in the audience can see. So, these are the two curves. So, the first question, how to account for BMI.  BMI was calculated in regards to weight estimates and heights in the EMR. So, these results were pulled from Trinetics, which has these results,  were calculated from the index event, the BMI information from there, weight and height. So, that's one. Two, you raise a good point.  So, the question was, why is there an early separation? Thereafter, there is relative, you know, parallel or relative equal distribution of mortality between the two.  I think one possible situation is our data does not account for adherence. So, potentially, we lost a few patients who were not adherent to medications.  But thereafter, the patients who stayed here were adherent. Maybe that's one potential confounder of the study. I think that might be it.  I mean, other things, you know, we cannot measure. And again, left atrial epithelial occlusion is, you do it and you forget about it.  You don't have to measure about anti-coagulation anymore. So, that's one potential rationale behind that. Thank you for an excellent question.  Okay, I'd like to ask you a question. Have you heard of the concept obesity paradox,  which was first described in patients with coronary disease and actually later in patients with atrial fibrillation?  And the question is, did you look at these outcomes  as a function of the BMI?  That's a great question. So, your question is whether the outcome of AFib was directly related to a BMI in specific?  In other words, as the BMI increased, did the events increase or decrease? That's a great question. We didn't stratify according to BMI level,  but I think that's one study we can look into and see whether patients who have a higher BMI, let's say excessive obesity, more than 50, whether these patients have a higher benefit  from left atrial epithelial occlusion versus DOAC, or if there is any pulling of the results to one side or another in these patients. Thank you. Great job, thank you.  Can you just move so we can move the slides to... Okay, the next speaker is Dr. Togeshi.  Yeah, and if you can, where are you here?  I can't see, are those slides up? Not yet.  Oh, they are. Okay, those slides are up. Now, I looked at your slides. You have a lot of slides, but only 10 minutes, okay.  Thank you, Chair. Happy to be here today to present our finding about predictors of incidence and factors associated with progression of PDR.  As we know, PACT-genius left atrial appendage closure is a prophylactic treatment for stroke in patient with non-valvular AF. Residual PDR has been reported to be associated  with adverse events, so we sought to study the occurrence and progression of PDR as well as associated risk factors.  There are several mechanisms leading to PDR. These include off-axis due to misalignment to LAA, and number two is two proximal deployments  leading to a leak around the shoulder and missed robe in the setting of a separate multiple robe.  And number four is disc distortion in dual seal. And number five is a trans-fabric leak due to incomplete endocerialization.  Incidence of any PDR has been reported  to range from 70% to 54%, and the presence of PDR were associated with stroke events.  As factors associated with PDR, non-modifiable factors were gender, aerobic cardiomyopathy, and non-paroxysmal AF, high JASBAS score, large LAA, and complex LAA.  A modifiable factor is a device undersizing single-robed LAO such as a Watchman, non-conjunctural access to the LAA.  This figure show temporal change of PDR. Larger PDR are less likely to regress to or stabilize over time. In Watchman flex and amulet, the data is less clear due to a smaller number  of report cases.  So we sought to investigate factors and predictors associated with the incidence and the progression of PDR.  We studied retrospectively from November 2070 to March 2023 with Watchman to flex and amulet.  Similarity of PDR were categorized in minor and moderate and major, and as well as change of PDR was categorized improved and changed or worsened.  The first imaging follow-up was performed at 45 or 90 days, and the second imaging follow-up was conducted between six to 12 months. TE or CT were performed as a follow-up imaging.  As a total, 1,048 patients underwent LLC. 69% were male, and mean age was 75 years, and mean CHA2DS2-VASc was four. With successful implantation achieved in 1,018 cases,  imaging was available for 970 patients at the first imaging follow-up. Among the LLC devices, there are 325 of Watchman 2, 493 of Watchman flex, and 200 of amulets.  This figure shows transition of anti-thrombotic medication from discharge after procedure to first imaging follow-up. The most common regimen was OAC plus SAPT,  followed by DAPT or SAPT. The regimen was switched to SAPT followed by DAPT  to second follow-up image.  This figure shows incidence of PDR by severity. At first, imaging follow-up range from 50.6 to 80%.  The presence of PDR was decreased to a range from 9% to 10.4% at second imaging follow-up.  And there are no significant difference in presence of PDR for each device type.  This figure shows comparison PDR versus non-PDR group. The PDR group had a higher prevalence of non-paroxysmal AF and the use of Watchman 2,  and exhibited larger maximal rounding dimension and larger ostium diameter and deeper area depth and lower compression rate.  For reference, the right figure illustrates how our measurements were defined. Area ostium diameter is from CX to the ridge site.  Maximal rounding dimension was a maximal dimension at optimal device deployment site. And area depth were a dimension from larger maximal rounding dimension to end array.  A logistic regression analysis showed maximal rounding dimension and lower compression rates were independent factor for incidence of PDR.  The next figure shows change of PDR. Overall, 47% of PDR improved and 42% remained unchanged and 11% worsened.  Among blue indicated Watchman 2 and green indicated Watchman Flex, red is amyloids.  Among non-PDR group, eight patients developed worsened PDR.  And meanwhile, at second follow-up, no major leaks were observed in amyloids group.  Maybe in dual seal mechanism tend to have a minor leak  and are likely to stabilize our regression.  This figure shows change of PDR by each device type.  Presence of PDR decreased in all device type.  The range from 6.1% to 7.7%.  Next table show comparison PDR changed. There are no significant difference PDR change in baseline characteristics or morphology  or Watchman's device type or severity at first or of bats.  Usage of immunosuppressant drug are associated with PDR worsening or unchanged group.  This is in Watchman 2 or Flex. Comparison of PDR change by mechanism.  This mechanism revealed two proximal placements were associated with a PDR worsening or unchanged group. But other mechanism such as a distal placement  or poor opposition due to the pectinate muscle or ophioxus etcheric were not significant, not associated with a worsening or unchanged.  This is a limitation. Three device were evaluated collectively with a stratified analysis. Since the evaluation was conducted using either CT or TE, depending on the device,  the assessment of PDR is prone to either underestimation.  In conclusion, the occurrence of PDR was associated with both modifiable and non-modifiable factors such as use of Watchman 2, lower compression rate, maximum running dimension  and non-paroxysmal AF. Once present, the regression of PDR was influenced by immunosuppressant usage. Thank you for listening.  Thank you.  That was an outstanding presentation. Any questions from the audience regarding this topic?  You covered a lot of territory and you gave a very, very good presentation.  Is there any particular device that you would think  is limited?  Or do you think that the ideology of these leaks are more related to the individual performing the procedure  rather than the device?  Thank you for good question. So,  showing table, so device mechanism of PDR differ from  define device type. In Amulet device type is most leak was a leak from proximal disk.  From proximal disk. So, this table show Watchman mechanism, Watchman 2. So, we should, in Watchman device, we should deploy and not provide, so avoiding to proximal displacement,  more distal placement we should try. So, like this figure, so Amulet was no major leak in second follow-up.  So, I think of Amulet device type, Amulet device C in a long tab field.  That was excellent presentation. Thank you very much. And you made it in time.  All right, good. Okay, so the next speaker,  where's the next speaker?  Yeah. The next speaker is from Kansas City and it's Dr. Kapadi. And if you could just introduce your topic yourself and we need to move these slides up.  Okay.  Okay, perfect, I think we can all see it now. So thank you for the introduction. My name is Ashish, and I'll be presenting on how the size of the left atrial appendage  residual stomp can impact trauma embolism and erythema genicidae. Okay, so I won't go too much into this because I'm sure everyone here is aware of left atrial  appendage occlusions, but I will say there are two ways to do it epicardially. Basically you can do it via a traditional epicardial method, which is either the atrioclip  or the lariat, and the atrioclip is also what we more consider a surgical approach because the surgeon has to do it, and then you also have the lariat, which is more of  a hybrid approach. And then you also have the surgical way of excluding the left atrial appendage, and typically this is achieved by the surgeon within an open heart surgery.  There are multiple ways of doing it. Either way you do it, however, you can form a stomp, unfortunately.  And so studies have already shown that leaving behind a stomp can result in traumagenicity and erythema genicidae in these patients, but expectantly you would expect the stomp  size to have some influence, but this has never been formally evaluated. So in our study we actually went ahead and evaluated whether the size of a stomp post  exclusion is associated with a risk of the thromboembolism or erythema recurrence. So we actually did a simple retrospective.  It's actually a single center study, I believe, I apologize for that typo. From June 2018 onwards, patients who underwent LA exclusion at our institute, and so this  is all patients that underwent either atrioclip, lariat, or surgical methods. We reviewed all the charts for baseline and procedural characteristics, and most importantly  the endpoints for thromboembolic events defined as any stroke, any TIA, and of course any systemic thromboembolism as well.  And then we also looked for any atrial arrhythmia recurrence defined as the traditional greater  than 30 seconds as seen typically on a loop recorder or some sort of other vocal monitoring device in the charts.  And then lastly we performed univariate and multivariate logistic regression analysis to see if any of these could be predictors.  And so we have the baseline characteristics here, and just like every other study that has been presented thus far, these patients tend to be older, I don't know if you can  see the error or whatnot, but they tend to be older. They have, of course, a mix of paroxysmal persistent, and I think in the way that it  was documented, it was documented as permanent, but it should be more of a longstanding persistent atrial fibrillation as well.  And on average these patients had atrial fibrillation for multiple years at a time, with an average chance of ASC of 3.9 and a high spread of 3.5 as well.  The majority of these patients underwent closure with an atroclip procedure, so about 80.4%, and then the next most common were a lariat procedure, which we actually perform  quite frequently at our institutes, and we continue to perform more. And then there was a very small number of patients that underwent surgical left atrial  appendage exclusion with either some sort of cutting, sewing, or stapling, or a suture exclusion.  And in all of these patients, or I apologize, not in all, but in almost all of them, about three-fourths of them, there was intraoperative TE performed.  Of course, the ones that undergo surgical exclusion may not require that, or do not require that, because there's direct visualization.  After the procedure, there was an average central leak size of 3.2, but this only occurred in, I believe, three or four patients.  And then we had a significant number of patients that ended up requiring a stump or a leak closure. We ended up looking at actually 500 patients in total, so on the next slide.  So in here, we can actually show that we did basically categorize the stump sizes from less than 10, 10 to 20, and above 20 millimeters.  And so when we had less than 10, we did have an increasing number of, I apologize, when we had, when we look at it in comparison to the stump sizes going from less than 10 to  greater than 20, we have an increasing number of stroke, we have an increasing number of TAA, and we have an increasing number of systemic femoral embolism.  And then at the same time, when we look at the recurrent arrhythmia, we also see that there's more focal arrhythmia, there's a reentrant, and then there's a more active appendage.  But the active appendage is noted in people that are typically 10 to 20 millimeters. And it's important to kind of contextualize this and note that typically when we look  at these patients, stumps greater than 10 millimeters are what we're clinically worried about, at least that's my understanding.  And so the less than 10 millimeters, we may not have necessarily done anything about it. But the greater than 10, we may have gone back in and reclosed it or something like  that if the thrombolytic event is high enough. So basically, the central leak was noted in 2% of the cohort.  And then as I was mentioning before, there was a leak or a stump closure in about 10%. And this is typically done with a recurrent left atrial appendage endocardial device.  When we did multivariate regression analysis, the only intraoperative TEE was predictive. I apologize, I don't have the odds ratio on here, but it was about a 4.0 with a statistical  significance without the odds ratio crossing the 1 and a p-value less than 0.01. Of course, these results have to be taken in context of its limitations.  This was a single center retrospective design. So of course, there's going to be some selection bias in some of the patients to begin with.  There's going to be other confounding effects as well. Additionally, while we measure some of the time to event, we did not perform any Kaplan-Meier  or regression analysis to determine the actual time to event and whether that was influenced by these stump sites.  And so with this, I will say that the results that we found were consistent with what has been found in the literature previously.  So patients with a residual stump continue to be at increased risk for thromboembolic events and recurrent arrhythmias.  But then we also show that increasing stump size, which we expected to have some impact, it does also increase the risk of these thromboembolic events and the arrhythmogenic events.  But using intraoperative TEE in these patients would be integral for reducing it, as it was  the only thing that, on univariate and multivariate analysis, was statistically significant. With that, I will open it up to any questions. Again, that was really outstanding.  Any questions from anybody in the audience? That gentleman over there is moving a little bit. Do you have a question? No. Okay. So I have a question.  You mentioned that there was an increase in arrhythmias in patients with stumps. Can you define what type of arrhythmia was it? Was it atrial fibrillation or what was it? Yeah.  So that's actually a good question. And as I was looking at my slides, I was like, I should have probably defined that at some point as well.  So what we were looking at was specifically any form of atrial fibrillation, whether paroxysmal  or paroxysmal, whatever, that we also included atrial flutters and atrial tachycardias in that definition of arrhythmia recurrence. Very good. All right. Very good.  That's excellent. Thank you very much. All right. Now we have the last speaker. Can you just ... Yeah, I'd just like to introduce him. It's Dr. Uri. Okay. And you're from New York?  Yes. Langone? Yeah. Okay. Very good. And if you could just introduce yourself with the topic. Sure. Yeah. So, yeah, thank you very much to the organizers.  So this is a study that we did on the refractory left atrial appendage thrombi. And so we did a combined mechanical vacuum aspiration and the left atrial appendage closure.  And it's a great honor to present this on behalf of all of the co-authors. And Dr. Salim was supposed to be the presenting author, but unfortunately she couldn't make it.  So I'm here. So yeah, so it's important to mention that this is ... So the subset of this patients  has been presented in the recent manuscript, which was published in JAMA Cardiology. And this situation, which I think in EP all of us encounter every now and then when there's  a small subset of patients with high-risk atrial fibrillation and then persistent left atrial appendage thrombus, despite optimal oral anticoagulation.  And it's always a challenge to see what to do with them, especially in patients who either  have more risk of bleeding, which kind of precludes the enhanced doses of oral anticoagulation, or they have embolism, even though they are taking the oral anticoagulation.  And these patients have limited non-surgical options. So the objective of this study was to introduce and to evaluate a novel management strategy  combining the percutaneous mechanical left atrial appendage thrombectomy with a handheld device with a cerebral protection device, followed by left atrial appendage closure  in patients with a refractory left atrial appendage thrombus. So yeah, so essentially the procedure included this ... So it was a cerebral protection percutaneous  mechanical thrombectomy and left atrial appendage closure. So a total of 28 patients underwent left atrial mechanical vacuum aspiration from August 2023 to November 2024.  This prospective study included 11 patients with a resistant left atrial appendage thrombus. And it's also just important to note that all of these cases were done not in NYU, but  in Mount Sinai Hospital. So yeah, so the cerebral protective device was deployed if feasible. Then the balloon atrial septostomy was performed as needed for the transeptal axis.  Aspiration thrombectomy with a 24-inch mechanical aspiration device was performed. And then this followed by the left atrial appendage closure.  And this is the kind of thrombus that we were able to aspirate in some patients. So as I mentioned before, so there were 11 patients with the mean age of 77, the majority  of them were male with the high CHAT-VASC score of five. So they had left atrial appendage thrombus. They have contraindications to heightened oral anticoagulation.  And they underwent thrombectomy plus left atrial appendage occlusion. So nine out of 11 patients, so they received the cerebral protective device.  One patient had, just because of the anatomy, the device couldn't be deployed. And one patient had very calcified radial artery, so also the device couldn't be deployed.  Ten patients out of 11 underwent the HL, so balloon HL septostomy to aid in intranseptal axis.  And only one patient had small residual thrombus in the left HL appendage, which was compressed by the left HL appendage occlusion device.  So in 10 out of 11 patients, so complete thrombus removal was achieved. And successful left HL appendage closure device was placed.  One patient had a possible small thrombus fragment, which was recovered from the cerebral protective device, but pathology was negative.  One patient did experience distal left brachial artery thromboembolism, which required a thrombosis and a suction thrombectomy.  But complete revascularization was achieved without any kind of deficits. And in the follow-up, four to 15 months follow-up, there were no adverse events during this period.  So in conclusion, the percutaneous vacuum aspiration followed by left HL appendage closure represents a promising strategy for patients with refractory left HL appendage thrombus,  especially if there's a contraindication to enhanced oral anticoagulation therapy.  Thank you. That was absolutely outstanding. Any questions from the audience? Okay, so I have a question here.  In patients that have these thrombotic complications, were they evaluated for a hypercoagulable  state, and did they have any history of pathologic thrombi occurring in other locations, such as deep vein thrombosis?  So yeah, it's not presented here, but there were no other pathological locations of thrombosis.  And again, we didn't look specifically for the hypercoagulable workup, but some of these patients were evaluated. Any comments on any of the other lectures or this one?  Okay, well, this is a first for me to participate in a program like this, using the headphones and the technology and so forth.  It's actually very, very interesting, because I think all the presentations were absolutely terrific and to a point, and were very, very good.  So I thank you all for attending, and I congratulate the speakers on doing an outstanding job by any standards. Thank you very much. Thank you.