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Post Procedure Anticoagulation Medication Strategi ...
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Post Procedure Anticoagulation Medication Strategies and Variations - Varosy
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Hello, everyone. Thank you for joining us today. I'd like to take a moment to introduce Dr. Paul Verossi, who will be presenting for us in the LAO Registry regarding post-procedure anticoagulation medication strategies and variations. Thank you, Dr. Verossi, for joining us today. Thank you so much, Christina, and thank you to the organizers of the ACC Quality Summit. It's an honor and a privilege to be here to talk with you all about what is a controversial and challenging topic for all of us in managing these patients undergoing left atrial appendage occlusion for reasons that will become clear over the next half hour or so. So over the next 30 minutes, roughly, I'm going to go over a handful of things, and it's important to give you some of the background, including why this is such an issue of dealing with medication regimens, including why nonvalvular fib is associated both with high risk of stroke and bleeding, the use of left atrial appendage occlusion for nonvalvular atrial fibrillation, and the drug regimens that have been approved for that, the emergence of DOAC therapy, and the timing of that, and why that's in conflict with what we're seeing, and some of the challenges around what the FDA approved drug regimen using warfarin, and then some of the emerging evidence around left atrial appendage occlusion and use of DOACs and things like that, and how the left atrial appendage occlusion registry has evolved to address some of these challenges. So why bother with left atrial appendage occlusion? Nonvalvular atrial fibrillation, as you all know, is a very common condition that's associated with increased stroke risk, and most of that, but not all, is due to formation of thrombus in the left atrial appendage. Anticoagulation with oral anticoagulants, and classically over many decades that was warfarin or aspirin, definitely reduces the risk, but it's problematic in many patients due to increased bleeding risk, unstable INRs, things like that, and occlusion of the left atrial appendage with the approved Watchman device is an alternative to oral anticoagulation. So as we said, atrial fibrillation is common and increasing in prevalence with age and comorbidity. It's associated with overall, across the population of patients with AFib, with a five-fold increased in stroke risk and two-fold increased mortality, not so much mainly due to the AFib itself, but due to the associated comorbidities and age. This famous paper from Alan Go and colleagues in JAMA almost 20 years ago predicted the increasing prevalence of atrial fibrillation with the advancing age of the population, and this is largely borne out to be true. We know in inpatients with nonvalvular AFib that the CHADS-VASc score is a strong predictor of thromboembolic stroke risk, and that really is an acronym that stands for congestive heart failure, hypertension, age, and you get either one or two points for age for age, one point between ages 65 and 74, and two points for 75 years or greater, diabetes mellitus, two points for history of stroke or TIA, history of atherosclerotic vascular disease in the form of either prior MI or known peripheral arterial disease. The single point, as I mentioned, for age is between 65 and 74 and one point for sex. Obviously, the increase in the number of points leads to an increased grading of risk, and those patients with a stroke risk of two or greater generally would recommend some form of oral anticoagulation, and those patients with three or greater who have a reason to seek an alternative are at high enough risk that the Watchman device or left atrial appendage occlusion in general may be considered. If you consider the Hasblad score, I think it's important to note that there are several things in the the bleeding risk prediction which includes things like hypertension, abnormal liver and renal function, history of stroke, history of bleed, those patients that are elderly or with labile INRs or with use of drugs and alcohol. There's a lot of overlap between the things that are associated with high risk of bleeding and those things that are associated with high risk of stroke. So there's a real dilemma here, and that dilemma is there's substantial overlap, and many of the patients who are at high risk of stroke are also at very high risk of bleeding. If we consider what those treatment options historically have been, really it was Warfarin versus aspirin versus saying the patient's too high risk for us to do anything to treat them at all for this risk and just tolerate their high risk of stroke, and that's where the Watchman device and other forms of left atrial appendage occlusion come in. Warfarin does have substantial disadvantages in many patients. It requires taking a medication that has drug-drug interactions. There are also Warfarin-specific problems including burdensome INR testing that are difficult for some patients to get to clinics or get their blood tested in some way. Achieving a stable INR between two and three is difficult and can't actually be accomplished in everybody. Some patients just can't get stable, and bleeding risk is definitely an issue. There are some patients due to fall risk, predisposing conditions, and other sorts of things definitely have potentially even life-threatening bleeds that make Warfarin not a good option. This is where the Watchman comes in as a potential alternative in those patients who may have an increased stroke risk, but a reason to seek a therapeutic alternative to oral anticoagulation. It's an endocardial implant, as you know, that's placed in the left atrial appendage like an upside down umbrella via transeptal catheterization, and once in place over time forms a seal and ultimately endothelializes over the surface, leading to elimination of the risk of thromboembolic stroke from the left atrial appendage under ideal circumstances. The evidence from this comes from two large randomized trials, the Protect-AF and Prevail trials, and on the basis of those two trial results showing reasonable efficacy in comparison with Warfarin indefinitely reduced bleeding risk, that this was a reasonable alternative, and that was approved by the FDA in March of 2015. If we go and look in a little bit more detail at the actual evidence from, say, the Protect-AF trial with a particular focus on the timelines of how this was approved, the Protect-AF trial enrolled 707 patients in a two-to-one randomization strategy with double the number toward the Watchman device versus to Warfarin, enrolling patients between 2005 and 2008, and was ultimately published in 2014. Similarly, the Prevail trial, a follow-up trial when the FDA requested additional data, enrollment was not actually described in the published manuscript in JAK, but enrolled 407 patients similarly with a two-to-one randomization strategy and then published in 2014, again leading to the approval in 2015. All this resulted in the March 2015 approval of the Watchman device from the FDA, and importantly, it's worth going through a couple of things in that FDA-labeled approval. This was approved for patients with non-valvular AFib and increased stroke risk who have an indication for anticoagulation, and importantly, that the patient's suitable for Warfarin therapy, at least for the short term, to get them through the peri-procedural period because the Protect-AF and Prevail trials were conducted with Warfarin, as in the regimen I'm about to show you, and where there's some reason in these patients, due to high bleeding risk, fall risk, or other issues, that there's a reason to seek an alternative to oral anticoagulation. Now, this is the regimen that was tested in both Protect-AF and Prevail. These patients received Warfarin with an INR goal of two to three, starting at the time of implant and going until day 45 or at such point that the LAA is sealed. They begin with aspirin between 81 and 100 milligrams at the time of implant until the left atrial appendage is sealed, and at that point, go up to full dose aspirin of 300 to 325 milligrams. Clopidogrel is started from the point that Warfarin is stopped at day 45 or when the left atrial appendage is sealed, and is continued until six months with the goal of trying to get to the point where the endothelialization process over the Watchman device can be achieved. Similarly, when the Center for Medicare and Medicaid Services came out with its coverage determination, it came out with similar sorts of things, but with a handful of important differences, including that the Watchman device would be reimbursable from their perspective for patients with non-valvular AFib and increased stroke risk, that they required a shared decision-making interaction be conducted for the consideration of the treatment options. Patients had to be suitable for short-term, but not necessarily long-term, Warfarin therapy, and with an emphasis on Warfarin. They also requested a collaborative approach involving an electrophysiologist and or interventional cardiologist or cardiothoracic surgeon who is trained in performing both the procedure and has conducted at least 25 transseptals and at least 12 of these left atrial appendage occlusion procedures in the preceding two years. Also, they mandated enrollment in a registry with follow-up meeting the CMS requirements, and the NCDR left atrial appendage occlusion registry was ultimately approved for that purpose. So some of you may be asking, well, what about direct oral anticoagulants? And this is why I mentioned the timelines and schedules of where things were coming from. Well, looking at the first of these three big trials that were published on the New England Journal of Medicine, the RELI trial, which compared davigatrin versus Warfarin, just shy of 20,000 patients and followed them over several years. Importantly, just like we looked at the Watchman trials, this trial was enrolling between 2005 and 2007 and then published ultimately in 2009, showing comparable effects on stroke risk reduction and perhaps lower bleeding risk in comparison with Warfarin. ROCCA-AF published two years later, but with a similar enrollment period between 2006 and 2009 and published in 2011, similar results with Rivaroxaban versus Warfarin. And the most promising of these was the Aristotle trial comparing Apixaban versus Warfarin, actually with an enrollment period of between 2006 and 2010, and then published in 2011, a week after the ROCCA-AF trial in September of that year. And this one, Apixaban, I think for many of us is the most promising in part because it may have the most striking benefits in relation to Warfarin in terms of stroke risk reduction, maybe superior, and may even have better bleeding risk reduction compared with Warfarin than with the other ones. So there's some significant advantages to treating these patients in general at high risk of bleeding and stroke over Warfarin. It's easier to take for most patients, a medicine that doesn't require testing, and because these medications target specific parts of the clotting factor system rather than a shotgun approach to vitamin K dependent factors in general, they're more stable in their anticoagulation effects and don't have dietary restrictions. There probably is a slightly lower bleeding risk with these medicines in part because of the less lability associated with them. And they are as effective or better than Warfarin for stroke risk reduction. In the early days, reversal in the event of a significant bleeding event was a problem before the advent of reversal agents, but now that we have Adarocizumab and Dexanet-alpha as potential reversal agents for dabigatran and for Rivaroxaban and Apixaban respectively, that issue is less severe. But what it does leave us with is a potential wild west of anticoagulation, where now we've got multiple DOACs out on the market that provide a pretty attractive alternative, and in light of the new guidelines that in fact favor the use of DOAC therapy over Warfarin, it's hard to argue that we shouldn't be using these potentially in patients. And then we've also got multiple antiplatelet agents beyond the clopidogrel that was the original P2Y12 inhibitor that was approved for the use of with the Watchman device. So at the end of the day, what we've got is patients who are at high risk of both stroke and bleeding. We've got a bunch of new drugs that might be better than some of the medicines that are on the FDA-approved regimen, and we've got one regimen that's been approved, and it kind of puts all of us taking care of these patients into a conflict that we don't really know exactly how we're supposed to navigate taking care of these patients. Well, there's actually useful information from a number of different fronts to suggest that beyond just the question of whether DOAC should be a potential alternative that we haven't really been hasn't been studied or certainly wasn't part of the FDA-approved regimen because of the timing of the fact that those studies came out at the same time essentially as the results from the Watchman trials that had been studied with Warfarin. In the Evolution Registry, looking at the use of Watchman in Europe where these devices have been used for some time with a different approach, including patients that are too high risk for oral anticoagulation at all, they looked at their outcomes and essentially found this. In contrast to the way that this was approached in the United States, almost two-thirds of the patients in the Evolution Registry in Europe were completely unsuitable for oral anticoagulation, meaning that their bleeding risk was so high that they couldn't even tolerate short-term oral anticoagulation. This is relevant because after Watchman therapy in the Evolution Registry, just over a quarter of the patients were on an oral anticoagulant such as Warfarin or DOAC, and almost 60% were on dual antiplatelet therapy with aspirin plus some P2Y12 inhibitor without an oral anticoagulant at all. Up to 7% of the patients were on a single antiplatelet agent. Strikingly, their outcomes of stroke risk were not too much different than those observed in the Watchman trials. This brings the real question to, well, can we safely manage these patients with something other than the approved FDA regimen? So what does this mean for the left atrial appendage occlusion registry? Well, we suspect that there is likely a large amount of variation in practice across the NCDR enrolling sites and throughout the country. I'll ask you to stay tuned. There will be more data coming on this with several future publications and abstracts to be presented at national meetings from ongoing NCDR research studies that are underway. I would also say that the outcomes with these off-label drug regimens are much less well-known, especially in real-world practice here in the United States. As a result of these changes, the left atrial appendage occlusion registry had to evolve with a couple of goals. We wanted to be able to capture these evolving practices, to understand the physician's rationales, and neither condone nor condemn the use of off-label practices. We made these changes in conjunction with both the FDA and the Center for Medicare and Medicaid Services, and working in collaboration with Boston Scientific, who also had a great interest in trying to understand the outcomes of the patients undergoing the Watchman device in this country. This is where the NCDR left atrial appendage occlusion registry version 1.2 update came in, a fairly robust set of changes to the registry, specifically focused around capturing some of the issues around these different regimens that are out there. These included both trying to capture in some detail medications that patients had received prior to the Watchman procedure, both in the immediate period of time and ever, including things that they've tried in the past, things that were being treated currently at the time of the implant procedure, things that they had been treated with but then held at the time of the procedure or never received. In addition, at the time of discharge and at each of the subsequent follow-up visits, a fairly robust capture of information around the kinds of treatment strategies, not just the medications that they're actually receiving at the time of discharge, but what the intended approach is, including what the overall approach to the post-procedure drug strategy and the primary rationale for why when these could be captured, including trying to identify whether this was a continuation of a pre-implant regimen, patient's preference, an approach that had become, for a number of reasons, the standard practice at that center, history of bleeding events that it might have led to, changes or any other issues that could be in there. These included several different reasons why one of these might be captured, such as that the patient had a medical reason, such as allergy, intolerance, bleeding-related problems, or patient preference to not be on that medication, or in some cases that no good reason could be identified. There are a number of unanswered questions that I think we need to address, and I think that the LAO Registry will be able to help here, including determining what the prevalence of the use of these off-label regimens is in the United States in real-world practice. I suspect, based on my clinical experience here, and also talking with colleagues around the country, that this is likely to be very, very high for all the reasons that we've talked about. We don't know what the real-world outcomes are likely to be in the lactation-appendage occlusion registry, but we'll be able to tell you that over the coming years. We also don't know what the results of upcoming and ongoing randomized trials are, including the AMULET trial, which is a randomized trial by Abbott with the use of their Amplatzer cardiac plug device specifically for that. Interestingly and importantly, that trial does not involve the use of an oral anticoagulant and only antiplatelet agents by design. I think many of us will be very interested to see the results of that. The ASAP2 trial, which is a Watchman trial involving Boston Scientific and enrolling patients in whom oral anticoagulation is contraindicated, and it's looking at two different approaches, one of no antiplatelet, that's the control group, and those patients receiving a single antiplatelet treatment. At least as far as the clinicaltrials.gov site says that this trial continues to enroll, but I do know that enrollment has been challenging. The bottom line with all of this is that we're dealing with a fair amount of uncertainty in what to do. We have, on the one hand, an FDA-approved regimen that was approved on the basis of trials that were done concurrently with trials bringing out an entirely new class of drugs that many of us believe could, in fact, be a better alternative to warfarin in the first place. So even if they can tolerate any medicine, why not consider giving them one that might have a lower risk of bleeding but we don't understand terribly well with this particular device. Second, there are data to suggest that these procedures might even be done safely without an oral anticoagulant entirely, especially based on the results from the Evolution Registry and other findings from Europe. In that context, it's important to say that just because something is off-label doesn't necessarily mean that it's right or wrong. It just means that we have a fair amount of uncertainty in the science of what we should be doing. So I think it's pretty important for us to not necessarily impugn sites that are doing things one particular way or another and underscores the need for more data. I also think that as physicians, we're having to navigate these medication options after left H-lipinage occlusion for the reasons that I just described in the absence of definitive evidence and this is a really difficult place, I think, for all of us to be. But I would say stay tuned. We have more to come from the left H-lipinage occlusion registry and we'll look forward to presenting those data as the years come. So over roughly the last 25 minutes or so, we've talked through a handful of things, including why non-valvular AFib is associated with both high stroke and bleeding risk. We talked about the emerging evidence for the use of left H-lipinage occlusion with the Watchman device for non-valvular atrial fibrillation in the context of the FDA approval, the CMS reimbursement rule, and the development of the left H-lipinage occlusion registry. We talked about the fact that DOAC therapy emerged about the same time that left H-lipinage occlusion with the Watchman device was being developed, creating this inherent conflict between the FDA approved drug regimen involving warfarin and the emerging DOAC evidence and the post-release of the Watchman device evidence showing that it might be safely performed even in the absence of an oral anticoagulant entirely, and how the left H-lipinage occlusion version 1.2 registry update has given us additional tools for capturing some of these evolving drug regimens in the face of this complexity. With that, I'll say thank you and we'll move on to take some questions. Thank you very much Dr. Barosi for that wonderful presentation, highlighting all the variations that we're seeing in anticoagulation use with the LAO registry and highlighting how all the data that we're currently collecting will help guide our future direction of understanding what's happening in the real world, and we look forward to the additional manuscripts and publications that we'll be seeing coming out of the registry to answer some of these questions that we have. So I'm just going to skip over to our questions that have come in. Our first question, we're looking at, we just had the recent approval of the Next Generation Watchman device, the Watchman FLX, and that device was approved post the Pinnacle FLX trial, and the question is, does this mean that any oral anticoagulant, either the Doax or Warfarin, can be used post-procedure and that for the registry that would be considered an FDA-labeled dosing regimen, and that's for answering sequence 8525 in your post-procedure medication strategy, that they would be able to utilize the Doax or Warfarin and that would be considered an FDA-labeled dosing regimen based on this new Watchman FLX approval in July. Now, truthfully, I am not 100% certain about whether there was a change, but I don't think so in the FDA's medication labeling. I think that with the approval, the existing FDA-labeled drug regimen that I described is still the approved one, but I could be wrong. So, yeah, so I was looking up some information specific to the Pinnacle FLX trial that was done, where it indicates that actually Noax were used as the post-implant drug regimen, and so due to those similarities in the Watchman closure device and delivery system, the Watchman FLX closure device, the results of that Pinnacle FLX study are applicable then to Watchman as well and support use of Noax with Watchman in the delivery system. So, there was some information conveyed through Pinnacle FLX where it was stated any OAC, any oral anticoagulant with aspirin prescribed with the implant of the device would be part of the approved post-medication strategy. Great news for all of us then. Thank you for educating me, Christina. Yeah, so that was some information I saw posted in the literature with the device approval, and that was, again, based on how the Pinnacle FLX trial was run. Great. Another question is asking, so I think this is in alignment with this new guidance with the release of the Watchman FLX. Can the patient remain on aspirin 81 milligrams indefinitely now and not switch to the 325 milligram at the time of 45-day or the six-month visit? Yeah. And then, so I think along with that guidance, the new guidance is stating any aspirin, not necessarily 81 or 325 dosing. So, basically, that's at the discretion of the provider, the aspirin dose. And importantly, the registry is capable of capturing whatever is actually happening. So, I think our primary focus is on identifying what's going on there rather than necessarily whether it is as labeled or not. Exactly. And I think what we've stated many times before, right, each provider is evaluating the patient based on that patient's unique needs and condition. And as you said, Dr. Varosi, we're trying to capture what is happening, not dictating what must happen, as that's, again, based on the patient needs at the provider's discretion. Okay. Another question, it's medication. What if our patient remained on aspirin and their oral anticoagulants for a full six months? Do they still need to add a P2Y12 at some point? Or if they've stayed on both aspirin and oral anticoagulant for six months, do they even need the P2Y12? Well, again, the labeled regimen includes a P2Y12 from the point of cessation of oral anticoagulant at day 45 through six months. But there are certainly patients, including one that we just referred not too long ago, who has a severe anaphylaxis aspirin allergy. There's no way that she's going to be able to tolerate aspirin at any point. So again, I would say the focus should be on trying to capture what is happening to a greater degree than whether it is concordant with the FDA labeled regimen or not, precisely because of the uncertainties that we have and what we all should be doing. And you may have specifically addressed this, but are there any current trials or studies happening where a P2Y12 medication is used immediately post-implant instead of any oral anticoagulants? Do we know? Yes, certainly. And I mentioned both the ASAP2 trial, which is looking at a Watchman device in patients who are so high-risk of bleeding that they are unsuitable for oral anticoagulant. And the option in them is single-weight antiplatelet therapy or indeed no antiplatelet at all. These are the extreme high-risk patients. So that's one. And with other devices, certainly the M trial involves the Abbott implants or cardiac plug device that involves a treatment regimen with no oral anticoagulant at all, primarily based on a P2Y12. Okay. And are there any, we spoke about published findings that will be coming from the registry. Are there any published findings that currently exist that can be shared? Sure. The two main ones that I would highlight are, in abstract form, the results of the first 1,000 patients from the registry that were the subset for Boston Scientific's nested post-approval study. Some facts about the registry is that this is one of a handful of situations where you've got a professional society-run clinical registry that is actually serving as the formal regulatory body for the registry. And so actually serving as the formal regulatory post-approval study with the FDA in conjunction with the company. And those data were presented in abstract form a couple of years ago at ACC Scientific Sessions, looking at the procedural safety of that subset. The primary findings of the study were that the patients in the NCDR, left neutral appendage occlusion registry, are substantially older and a higher CHADS-VASc score on average than the two major randomized trials, PROTECT-AF and PREVAIL, as well as the EVOLUTION registry. And despite that greater risk age and comorbidity, the periprocedural risk of adverse events was well below the safety margin that was pre-specified in the approval of the device at 1.49%, which I think is a pretty striking thing considering that the early data in that first thousand patients really represented a lot of new sites that were still relatively low volume. This is, I think, a very interesting and promising finding. Second, just in the last couple of, last few weeks, in fact, Jim Freeman from Yale and leading the Illinois Relic Centers team that has approached a lot of the work for the analysis of the registry, and also the PI of an NIH R1 study called SAFELY-AF, was the first author of the LAO registry's first published manuscript that was in JAC, looking at some of the baseline data and numbers around the registry. It wasn't so much relevant to our presentation today because that publication, because of the controversies around anticoagulation, did not really include any data on the anticoagulation strategies used in the registry, but that will be coming in future future studies. And I think we've answered this already, but with all these variations in drug regimens, does the NCDR recommend a particular drug strategy for sites to take? That's a good question, and I think it's important to say that no, we don't, that how we really want to focus on, again, I can't say this enough times, is trying to identify what is happening, not so much trying to be a traffic cop telling sites that this is what they should be doing. This is an enormously challenging, evolving, and complex space in taking care of these patients for all the reasons that we've been talking about. So no, we don't condone one particular regimen at all. Will the LAAO registry support different left atrial appendage occlusion devices and their associated post-procedure regimens as they become available? Absolutely. This has been one of the intents of the registry since its beginning to be a clinical registry for any catheter-based left atrial appendage occlusion procedure agnostic at the specific manufacturer. Currently, the registry does support collection already on the Watchman device, as well as the Lariat device for the endoepi approach. And we suspect that it would be very easy for the registry to pivot to be able to capture the newer devices that are emerging on the market as well in various stages of trials and heading toward approval. I say catheter-based because there has been some question about whether the LAAO registry can capture surgical left atrial appendage occlusion. And I think that that poses some challenges. And given the strength of the already existing Society of Thoracic Surgeons, STS, database registry program, I really believe that those approaches for things such as the Atrioclip and other kinds of surgical approaches are really better captured there than with our registry. Thank you. Are there potential challenges in capturing adverse events, including medication-related bleeding, in a registry like the LAO registry? Absolutely. And this was a topic of some discussion with both Boston Scientific and with the FDA in comparing registry-based approaches to more conventional consent-based clinical registries run by a separate program. Specifically, in a conventional post-approval study, patients sign a consent form that allows for capture of proxy interviews and gathering of outside hospital records and things like that that make it much more straightforward to capture additional information when events occur outside the hospitals, including out-of-hospital death. In a clinical registry, there isn't a formal informed consent process in the same kind of rigorous way. What that means is that the ongoing capture of the data through those approaches that can be used in clinical trials and other sorts of consent-based enrollment registry programs just can't be done. We can't conduct proxy interviews directly from the registry. All that follow-up has to be done by the site itself to bring the data back to us. This is critically important in the setting of thinking about ensuring that we're capturing adequately any adverse events that occur, that the onus really is on the sites to try to stay in contact to make sure that they have adequate follow-up with the patients clinically to be sure that we're not missing adverse events among those patients that might be otherwise considered lost to follow-up. Wherever possible, if there's something that occurs and the patient gets admitted to the hospital, try to understand exactly what happened and gathering those records at the individual site and using that as a mechanism to report back to NCDR is really important for us to ensure that we're not missing things. If, for example, we had a rate of loss to follow-up of less than 5% in the registry, we would have a pretty good sense that the likelihood that there were a huge number of events that were missing is likely to be low. But if that loss to follow-up rate approaches 30% or 40%, it's very possible that there could be patients having events that we just won't ever know about, and that would be a point of concern to us. So yes, we do want to have as much follow-up as we can, and this is where those of you who are working on the participant site end of things and collecting these data recognize how challenging it is, but this is why it's so critically important that you're doing the great work that you're doing to gather those data to support the science and our understanding of what to do about a number of things, including what these medication regimens should be over time. Exactly, yeah. I just would like to echo that and again, thank all of our sites because we know it's a large-scale effort to collect the follow-up information, but as Dr. Rossi has just explained, you can see how extremely valuable it is for the care of patients and to improve their quality and broaden indication. So it's greatly appreciated all the effort that goes into this, and we know it's a heavy lift. Okay, I think we have one more question. Does a higher CHADS-VASc risk score impact procedural outcomes, do you think? That's a good question, and will be among the questions that we're hoping to answer with the data from the long-term follow-up and outcomes. Okay, I think that's all we have. Again, I want to thank you, Dr. Rossi, for your time today. Thank you, Christina, and thank you to the organizing committee.
Video Summary
Dr. Paul Verossi presents on post-procedure anticoagulation medication strategies and variations in the LAO Registry. He discusses the background, challenges, and controversies surrounding the management of patients undergoing left atrial appendage occlusion for non-valvular atrial fibrillation. Dr. Verossi explains the use of oral anticoagulants, the emergence of direct oral anticoagulants (DOACs), and the conflicts between DOAC therapy and the FDA-approved drug regimen using warfarin. He also highlights the challenges of managing patients at high risk of both stroke and bleeding. Dr. Verossi mentions the use of the Watchman device for left atrial appendage occlusion as an alternative to oral anticoagulation and the evolving evidence around DOACs and their use in combination with left atrial appendage occlusion. He emphasizes the need for more data and the role of the NCDR left atrial appendage occlusion registry in capturing and understanding the evolving practices and outcomes in real-world practice. The video concludes with a Q&A session, addressing questions about medication regimens, the use of P2Y12 inhibitors, the role of the registry in capturing adverse events, and the impact of CHADS-VASc risk scores on procedural outcomes.
Keywords
anticoagulation medication
LAO Registry
left atrial appendage occlusion
DOAC therapy
warfarin
stroke
bleeding
Watchman device
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