Western AF Symposium 2024: Session 18 Roundtable

Managing the Risk of Bleeding in My Atrial Fibrillation Patient 

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Featured is the Session 18 Roundtable entitled "Managing the Risk of Bleeding in My Atrial Fibrillation Patient" from WAFib 2024. 

Discussants: Mohamed Elshazly, MD; Bassam Wanna, MD; Jill Schaeffer, CRNP; Monique Young, APRN; William Cho, PA-C

Moderator: Brent Wilson, MD; Christopher McGann, MD

Christopher McGann, MD: Thanks everyone for hanging in there—these are the last 2 sessions. Brent will introduce himself in a second as well. My name is Chris McGann, cardiologist, and I was part of CARMA for years. I've been coming to this conference since it was founded. We are both imagers, but we will not be speaking so much about anticoagulation, but all these guests here will. So, we'll be posing questions to them and anybody from the audience can raise issues about anticoagulation that you have for the panel.

Brent Wilson, MD: Thank you, Chris. I'm Brent Wilson, and as Nassir would say, a son of CARMA. I have been part of the CARMA group for a long time. As Nassir says, CARMA forever. It is a privilege for us to be here with the panel members today. I currently work at Intermountain Healthcare here in Murray. We have a robust EP program and are just starting to get into atrial fibrosis imaging. We thought we'd start today by having the panelists each introduce themselves and go through not only who they are and where they're coming from, but what type of practice they're in, if it's mostly hospital-based or clinic-based, and what kind of patients they are treating on a routine basis. Let’s start down on this side with Mohamed. 

Mohamed Elshazly, MD: I'm Mohamed Elshazly. I'm a cardiac electrophysiologist at Orlando Health. I did some work with digital health and remote monitoring, so that's a huge interest of mine coupled with some artificial intelligence (AI) and all that. So, happy to be here. 

Bassam Wanna, MD: I'm Bassam Wanna. I trained with Nassir at the University of Utah and then joined Tulane University in 2019 at the same time as Nassir. I'm the program director for electrophysiology (EP) now, and mainly, I see clinical patients and do a lot of lead extractions.

Jill Schaeffer, CRNP: I'm Jill Schaeffer. I'm a nurse practitioner (NP) at Penn Medicine - Lancaster General Health. It is on the East Coast, about an hour outside of Philadelphia, and an area known for its Amish population. I'm the manager of our NPs and my clinical work is EP. We have 29 NPs. We're both hospital- and clinic-based. We built a program 25 years ago, so it's a pretty mature, team-based NP and physician-led practice, so I'm looking forward to the discussion today. Thank you, Nassir, for asking us to come. 

Monique Young, APRN: I'm Monique Young. I work for Tulane School of Medicine. Nassir is my boss. I run the NP program and MRI programs, and I have 6 attendings. We have a hospital/clinic base, and the MRI programs are a big part of our practice. I’m glad to be here.

William Cho, PA-C: Good afternoon, everyone. My name is William Cho. I'm a physician assistant at the University of Utah. I currently help manage the cardiology NP/PA group. My clinical practice is in EP. I've been in EP for 10 to 15 years now.

Christopher McGann, MD: So, Brent and I are imagers but obviously have had a lot of interaction with electrophysiologists throughout our careers. I currently work at Swedish Heart and Vascular in Seattle, and we just started a clinic a year ago, a foundation-funded clinic called SCAN clinic, which is an atrial fibrillation (AF) clinic. It stands for Swedish Comprehensive AF Clinic. We did that because we felt like AF was not necessarily managed well in the community. There was a lot of AF out there that landed in emergency rooms or in primary care offices that wasn't necessarily being treated as aggressively as we wanted it to be addressed, and anticoagulation was a big part of that. It was all staffed by all non-invasive doctors, by the way, so the electrophysiologists don't staff the clinic. That was by design. So, even though we're imagers, we have a very strong interest in AF and the treatments for it. I'll start off with asking the panel what I think is probably the most difficult question, because there is probably the practice variation with this, and that is, how you're managing anticoagulation after successful ablation and what is considered successful ablation. I think we’ll probably get a lot of different answers, but we'll start with that one as it is probably one of the bigger question.

Mohamed Elshazly, MD: I can start. So, as you said, there's a lot of practice variations. I actually like to think of anticoagulation after ablation more of an art, rather than a science. The reason is I don't think there's been very strong data supporting continuing anticoagulation forever, especially after achieving sinus rhythm, although the guideline recommends it. But we haven't really done the good clinical trials long term to look at that. So, I think there's a lot here, and also, I think it really depends on the physician. Some physicians are more tech savvy or tech friendly, they're happy using monitors against smartwatches, portable ECGs, etc, and others are more friendly with using loop monitors. So, you'll see a lot of practice variation. I personally like to think of AF in 2 categories, symptomatic and asymptomatic. So, the ones who don't really feel their AF symptoms. These are the ones that, after ablation, I feel like I really need to monitor them, especially if their CHA₂DS₂-VASc score is high. When I have a discussion with them, I say I'm going to do the ablation, but when you go in and out of AF, I cannot tell you that, because you can never really tell when you're in and out of it. This is versus the other ones who can immediately tell you they go in and out of AF and they feel the symptoms; these are the ones I am more comfortable monitoring by symptoms. I feel like most of my patients want to get off anticoagulation or at least that's a question that comes up. So again, very high CHA₂DS₂-VASc, I'd say probably 5, 6 and above. I tell them that I'd probably prefer to maintain anticoagulation, and the reason is there's some data from high CHA₂DS₂-VASc scores, even in patients without AF showing some stroke risk. So, I'll have a discussion with them, but again, I think it comes down to their preference. If they really want to come off it, direct oral anticoagulants are expensive, then I'll push for more of a monitoring strategy. So yes, so when I have discussions with asymptomatic patients, I’ll ask about implanting a loop, because then if they want to come off anticoagulation, I can take them off anticoagulation in 1 month or 3 months, depending on their CHA₂DS₂-VASc score. I also tell them I can figure out when AF will recur a year or 2 years from now. I'm really heavy on monitoring. For the symptomatic ones, I'm more comfortable with relying on their symptoms. There are the ones in the middle who have the watches who are very reliable at using them, and for these people, I will even teach them and we'll go through how to use it, make sure they're recording them on their app, how to download the PDFs, and how to send them. I'll use all this data. Again, I feel like it's more of an art than a science. 

Brent Wilson, MD: What percentage of your patients do you think is 6 months or off? 

Mohamed Elshazly, MD: I'd say right now probably 30%-40%, because I feel that the rest are kind of higher CHA₂DS₂-VASc score, maybe continue on. Again, paroxysmal versus persistent also kind of makes a difference. 

Brent Wilson, MD: That 60 to 70 plan is for long-term anticoagulation? 

Mohamed Elshazly, MD: Again, it's either long term or their preference. I give them the option. But if they want to come off anticoagulation, I prefer monitoring with some continuous monitoring either with a smartwatch or a loop, so I offer them that. 

Brent Wilson, MD: Excellent. Bassam?

Bassam Wanna, MD: So, I tend to be more on the conservative side as far as post ablation. I go by the risk factor of the CHA₂DS₂-VASc score, so I tend to keep them on anticoagulation regardless, even if it's considered successful or they have some recurrences. 

Brent Wilson, MD: Bassam, you're saying CHA₂DS₂-VASc 2 and above? 

Bassam Wanna, MD: Two or 3 and above. For intermediate risk patients, I tend to keep them on oral anticoagulation.

Brent Wilson, MD: What about maintenance of sinus rhythm, at 6 months with no symptomatic episodes? 

Bassam Wanna, MD: There are some studies that haven't shown the relationship between time of stroke and AF episodes, for example. I'm always worried that their risk is higher than the normal population, so I tend to keep them on oral anticoagulation. 

Mohamed Elshazly, MD: Quick question to follow up on that. If they tell you they have a smartwatch or a loop, do you tell them okay, we'll just watch it? 

Bassam Wanna, MD: Sometimes. If their burden is very low, like less than 1% on the loop monitor, which I tend to trust a bit more, I would maybe agree to stopping oral anticoagulation after 6 months. 

Brent Wilson, MD: Jill, what have you seen at Penn? 

Jill Schaeffer, CRNP: I think it's an important question. As our group, we agree with you. We tell people as they're going into the PVI, don't do this because you want to come off anticoagulation because your risk is high. We've certainly all had our anecdotes of the person who was very symptomatic with their AF, but then after PVI, all of a sudden we did monitoring, they still had some AF here and there, but they didn't feel it. But keep in mind that it's just recently that we're jumping to PVI so quickly now. Before, these folks were failing drugs and then they were offered, and we only did it on symptomatic people. All of that's changing. So, I think our thoughts on this because of hopefully doing this earlier before there's as much scar, may change that whole conversation. A lot of the trials that are looking at the watch, incidence of AF, pill-in-the-pocket anticoagulation, I think are really important to know. 

Brent Wilson, MD: So, do you guys use pill-in-the-pocket anticoagulation? 

Jill Schaeffer, CRNP: We talk about it. Again, we have a lot of elderly folks, so it's not very common, but all of these things come down to a lot of discussions with the patients. That's our care practice that we keep this on, that you're going to have people who might have bleeding or bruising, and in our AF clinics, when you get that relationship with a patient, it's amazing to me what people confess to you once they have the relationship. I think it's fair to say that no matter what we say, there are people that stop their drugs, or don't take them, or have them and hold them if they have a bruise on their arm. So, I think it's important that we know if our patients aren't really taking them all the time the way we think they are. Knowing and having patients document via a watch, or like what do we do with the patient who has a pacemaker, where we know for sure there's no AF. If they have concerns, we are much more likely to say that we can stop the AF but we have your alerts on. Come to us if your AF is more than half an hour, and we'll have another discussion. That's a common scenario of a discussion with a patient, where we're very confident of what the AF burden is, and we'll have that conversation. 

Brent Wilson, MD: So, if 6 months post successful ablation, continued sinus rhythm, no symptomatic episodes, what percentage of your patients are off anticoagulation? 

Jill Schaeffer, CRNP: I think that percentage is really, at this time, quite low, less than 20%. 

Brent Wilson, MD: Thank you. Monique, tell us what you guys do at Tulane.

Monique Young, APRN: I definitely incorporate a lot of fibrosis maps, because you can have a CV score of 1 and have a UTAH scar of 4 or 3. So, I definitely use that. I agree with Bassam with the CV scores. You have to look at it. I agree with Jill in that you have to personalize care. It is not cookie-cutter medicine. It's not because you have this score that you have to do this. I definitely utilize monitoring. I have an email still since the first time I presented at Western AF that I still have patients that send me ECGs. So, I do think at the 6-month mark, we do look at it, we look at the burden, we look at what they're doing, lifestyles, and using our device clinic. You have to have a good team relationship and know that they're going to tell you if this person is not being monitored or being monitored, or if the patient has an episode. And they do. So, I think it's a team approach. I think it's about the patient relationship and trust. As Jill said, how many patients come into our clinics and miss a dose? Or miss 2 weeks of doses and we don't even know it? So, that's pretty much what we do as well. 

Brent Wilson, MD: Thank you. And last but not least, Professor Cho. 

William Cho, PA-C: Thank you. So, in Utah, there's a little bit of variation in practice, but in general, after an AF ablation, we mail our patients an ambulatory monitor, and during the blanking period, a large majority of our patients are on antiarrhythmic drug therapies. So, if a 3-month post-ablation monitor doesn't show any AF or flutter, the patient hasn't had any symptomatic awareness of recurrent arrhythmias, we'll go ahead and stop the antiarrhythmic drug at that 3-month visit. We'll subsequently order another monitor at the 6-month post-ablation mark, so 3 months after discontinuation of the medicine, and if that 6-month monitor does not show any recurrent atrial arrhythmias, we tend to discontinue anticoagulation at that point with exception to a high CHA₂DS₂-VASc score, prior history of TIA/stroke, valvular heart disease, or other pro-thrombotic states. Now, in patients with AF that is asymptomatic, we'll have a shared decision-making conversation with the patient where we'll present their stroke risk and have a discussion with them. Most of those patients do end up wanting to take a blood thinner, but there are some that would rather walk the line, and thus far, I don't think we've had a large rate of stroke in these patients, so it seems to have worked out for us. 

Christopher McGann, MD: Will, so 6 months after successful maintenance of sinus rhythm after AF ablation, what percentage of your patients do you think are off anticoagulation? 

William Cho, PA-C: If I were to guess, I’d probably say somewhere in the range of 40% to 50%.

Christopher McGann, MD: So, you can see how much variation there is. That's why I really wanted to bring this one up first, because I think it's one of the most difficult ones. I can tell you that in the SCAN clinic that I'm part of in Seattle, we approach it similar to what Will described. If there is a guideline for this, the guidelines in EP seem to say that if you have a successful ablation, that you should anticoagulate 3 months afterwards and if there's no recurrences, then it's sort of a decision about the stroke risk. You're a low CHA₂DS₂-VASc score (1), people are more confident in stopping anticoagulation in our clinic. If it's a higher CHA₂DS₂-VASc (3 or above), certainly it's really continued indefinitely. A CHA₂DS₂-VASc score of 2 has a lot of variation there. But there's not a lot of guides on this one out there, so it's not surprising that we're hearing so many different ways of managing it. Before we leave it, one of the things I wanted to mention is that one of our electrophysiologists raised to me that there's a study named the OCEAN trial that's in the middle of enrolling. Maybe you all want to speak to that. Do you think it's going to shed any light in this space that you think it's going to be important?

Mohamed Elshazly, MD: Yes, I'm not personally well versed with the details of the trial, but I know it should be out within 2 or 3 years and it's looking to answer this specific question. I'm not sure if any of the folks here, maybe Dr. Marrouche, or anyone knows more details about the trial. 

Christopher McGann, MD: In short, the trial is designed as rivaroxaban (Xarelto) versus aspirin post ablation, and is there reduction in stroke risk and successful ablations post ablation? I'm not sure how they're managing the CHA₂DS₂-VASc in that, but I guess it will at least get to part of the question on the newer anticoagulation agents. 

Nassir Marrouche, MD: Rod is doing a lot of work on that question of stopping anticoagulation, but I think that's an open question that we're waiting on. A couple of trials, actually, not only OPTION, but the OCEAN trial—both of them are ongoing. One is closure devices and one is a Canadian trial that Atul Verma is doing, stopping blood thinners or aspirin versus discontinuation of treatment. I think these trials, hopefully this year, they will be presented, one of them will be presented in November, I think, at the AHA. 

Mohamed Elshazly, MD: I think the OPTION trial is at AHA, yes. 

Nassir Marrouche, MD: The OCEAN trial, I think, there will be some follow-up to answer that question about stopping blood thinners after ablation. Aspirin versus continuation, we'll get an answer for that. But I think what Rod is working on is very important, and that's what I want to hear from everybody. As you heard from Monique and Will, there's no yes or no answer. You see the patient and we do an image, although other people do something else. If it's a CHA₂DS₂-VASc 3 or 4, it's easy. It's like, you feel relief and give them blood thinners. But others don't want to have blood thinners and they talk to you about it. That is why I would like to hear other people’s approaches about the ablation. There's always another part that I would like to hear from the panel as well. In general, when you anticoagulate your patients, at what point in today's era with the closure devices and so on, do you decide to implant a closure device, ablate them as well, or do you just continue blood thinners or change the dose? I mean, dosing is an issue, right? High-dose, low-dose rivaroxaban, apixaban (Eliquis), do you change the dose first? Do you do closure devices first? I would like to hear from you. This is an important topic for bleeding and the dilemma we deal with. At what stage you decide to lower your blood thinners if you have a patient who has a GI bleed and on, for example, 20 milligrams of apixaban, do you cut it by half and continue or do you just send them for a closure device? The same thing with apixaban? I think I would like Rod to comment on his trial as well. 

Rod Passman, MD: First, thank you for the free advertising, Nassir. I really appreciate it. So, the trial that we're doing is called REACT-AF. Basically, it's what you're talking about. I mean, this is not a one-size-fits-all problem. It doesn't make sense that we treat patients with a CHA₂DS₂-VASc of 8 or 9 in chronic AF with the same doses of the same anticogulants for the same period of time as you do someone with a CHA₂DS₂-VASc of 3 who had an ablation for persistent AF and now doesn't have AF anymore. So, what we're trying to say is maybe this isn't a forever decision. Maybe you don't need to say we're going to stop it for good or we're going to continue it for good. What we've done is we have a customized algorithm on a smartwatch that will alert you in real time if you're having a prolonged episode and you could restart your previously prescribed DOAC for 30 days. So, if you have one episode a year, you'll be on your DOAC for a month. If you have 1 episode every 30 days, you're never going to get off your DOAC. So, I think that hopefully we can sort of maximize the benefit and reduce the risk and really personalize the treatment. But I think, all of what you described is sort of a manifestation of how confused we are and how we believe it doesn't make sense. It doesn't make sense that the patient we see in front of us who we have ablated and every monitor that you do on them and every cardiotracing they do shows sinus rhythm and you tell that 65-year-old with hypertension, they need to be on anticoagulation for the rest of their lives, it just doesn't make sense. So, I think that these clinical questions that you all are expressing is something that we all see, but these fundamental questions need to be answered, and unfortunately, I think the technology has sort of outpaced our ability to deal with it, and now we must ask some really, very basic questions. So, I guess I'm intrigued, because you sort of said the guidelines are kind of murky on what you do, but actually, the guidelines say to continue anticoagulation. And we're not just talking about ablation. I mean, I know this is a room full of ablationists, but what about that patient that you cardioverted a year ago and is still in sinus rhythm? Well that patient was on an antiarrhythmic drug and doing very well. This isn't just an ablation strategy. This is really for everyone. And let's face it, the majority of patients in the world, and it's a worldwide problem, aren't going to be treated by the people in this room with ablation. So, we need to find solutions that are applicable to the tens of millions of people who have this disease worldwide. So, it is intriguing to me that the guidelines say it will continue and if you stop, by the way, you’d better monitor them intensively. What does that mean that you have to monitor someone intensively? I bet you might ask that question when you stop anticoagulation. I'll ask the panel, how aggressively do you monitor? These smartwatches are not designed to pick up obviously an hour of AF in the middle of the night. You're going to miss those individuals. So I would say when you make that decision, and let me, if you don't mind me going from right to left, ask when you make that decision to stop, what kind of safety net do we have in place? Especially when we know we convert a lot of symptomatic AF into asymptomatic AF, we put patients on drugs, or do an ablation. So, is it smartwatches, loop recorders, or intermittent external monitors? Could I just get a sort of sampling from the group? 

Mohamed Elshazly, MD: Yes, I know that these are all important points, and again, just reflecting some of the points that all of us have gotten the referrals for left appendage occlusion on patients where you look and you're like, but they haven't had AF for 5 years, why are they still on anticoagulation? So, this is a very important point. Now, again, I always start to go back and kind of imagine an ideal world where everyone is being continuously monitored their whole life with an ECG. Imagine this ideal world exists. What would each of us do? That's how I like to think about it. In thinking about it, the REACT-AF trial is the perfect trial to kind of answer this intermittent anticoagulation question. So, now I'm going to try and mimic that ideal world with the tools that I have. Again, smartwatches for people who own them and know how to use them; always ask them if they use them most of the time, because as you said, some people take them off when they go to sleep. So, you have to be able to be okay with that risk of not wearing the watch for 4 or 5 hours. Then, there are others where, again, they don't wear the smartwatch or they don't have one or they're not interested in getting one. Those are the ones I might talk to about the loop. But I'm very heavy on the monitoring part, because that's how I think, again, of an ideal world where everyone can be monitored. And then one question for you, Dr. Passman: is ablation an exclusion criteria for REACT-AF or not? 

Rod Passman, MD: No, no, not at all. It has to be at least 2 months post ablation, but already about 60% of our patients are ablated.

Mohamed Elshazly, MD: Perfect. 

Rod Passman, MD: So, for those of you using loop recorders, how is that scalable? You must have really great device people who check a lot. But what if an event happens on Friday morning, and you don't know about it until Monday at best? I mean, there's some inherent risk. So, as you go through, is that a concern about using these devices? I mean, maybe one day we will have real-time notification of a device inside your body to your smartphone saying you're having AF now. That would be great. But like those who use implantable monitors, does insurance pay for that routinely? And are you concerned about sort of the scalability and the cost and the inherent delays in response times as we go down? 

Bassam Wanna, MD: So basically, I tend to trust the loop recorders and patients with devices more, as far as decisions to stop anticoagulation, if they've not had AF for a long time. As far as, let's say, back to your question, whether they had the AF episode on Friday morning and you don't know about it until Monday, so, over the past few days, I guess the overall picture of things, the risk of stroke is very low. So, they would be very unfortunate and unlucky if they had it and they didn't know about it, but I guess medically/legally, you were still probably liable. So, that brings up the issue of if you need to continue monitoring throughout the weekend and who's going to notify you about all these episodes, you need to have the infrastructure, which thankfully at Tulane, we have that infrastructure right now. 

Audience question: There's no really good time correlation between the timing of AF and the risk of stroke. We know that. There's days delay, right? 

Rod Passman, MD: I would actually disagree with you. There are 2 papers out now, sort of case control studies — we have a study of 900 stroke patients with clinical devices showing that the risk of stroke in 30 days of a prolonged AF episode goes up about 5-fold and goes back down. The studies you're referring to, like TRENDS and ASSERT, where they have devices in people and the AF happened in December, but the stroke happened in May. First, very few of those strokes would thought to be cardiometabolic in nature. These patients had multiple risk factors for stroke. Therefore, why are we surprised when a diabetic who has hypertension and heart failure has a stroke that's unrelated to their AF, but we don't even know whether this was a cardiometabolic event? So, I think that that's a fundamental question here. And I think that the studies that went on earlier, and I'll share with you a comment, whether it's the myopathy, and if that's true, and if we believe that it's myopathy that causes the stroke, then none of us should ever be stopping at anticoagulation once the AF occurs. 

Nassir Marrouche, MD: I have a question for you. [INAUDIBLE] 

Rod Passman, MD: Yes, I totally agree, and when we wrote this, you needed to fail multiple drugs before getting an ablation. Now that that is changing before our eyes, maybe that's going to be reflective of this country's view of it, but I would love to be 50/50 and if anyone wants to be a site who has a big general cardiology program and uses a lot of drugs, that would be great, but I do want this to be generalizable. As far as inclusion criteria, basically CHA₂DS₂-VASc 1 to 4, no prior stroke or TIA, and no indication or the presence of another device, so we wouldn't take someone with a loop recorder. Why? Because you're going to use that loop recorder to make decisions even if you're in the control arm. So, we're taking patients already on anticoagulation and we're giving them a 50/50 chance of either continuing it or being given a new Apple watch with a special algorithm in it that will alert them in real time. So, we also want to make sure these patients have low burdens of AF. So, we need some sort of monitor on them for about a week showing they don't have a lot of AF. And pretty much that's it. I mean, obviously a lot of other things. You cannot have a tattoo on your wrist, for example. That's not a good thing for the Apple watch. But for the most part, we want to make this pretty generalizable, and I think that we see these patients in our clinic all the time. This is the most common discussion that we have, I think, about anticoagulation. So again, we hope that this will enroll quickly and be applicable, even though the landscape of AF treatment is changing quickly before our eyes, so we'll see. I would make one comment about OCEAN. I think one unique part about OCEAN is the trial was stopped early and we don't know why. But they used loop recorders, so basically, if you had no AF for 2 years on a loop recorder post ablation, then you got randomized to either continue anticoagulation or go on antiplatelet therapy. So, I think that there's a lot to be learned, but I do think that we're going to be able to personalize care in a lot better way than the sort half-handed approach that we have today. 

Bassam Wanna, MD: So, to take this discussion one step further and to answer Nassir's question about using left atrial appendage closure devices, so right now what we're facing is if we take a patient for an AF ablation and do a concurrent Watchman (Boston Scientific) or Amplatzer Amulet (Abbott) occlusion device, we're getting pushback from the hospitals because CMS is not covering both procedures during the same day. So, we're having to bring them back separately. I think as a society we can work on getting that approved through Medicare and CMS, possibly for having both procedures during the same day. I don't know what the other members of the panel think. 

Jill Schaeffer, CRNP: I think for us, if I have someone who I talk to, and you have this shared medical decision-making about the risk for stroke. We know they're at risk for bleeding, but like we've talked about at this meeting, most people fear stroke a lot more than bleeding. We tell them if you have bleeding, give us a call. So, it's not uncommon, or not an everyday thing, but it's certainly a conversation that if you start someone on rivaroxaban, and if they call back and say, "I have rectal bleeding," and they never did before, you stop the drug. But I think it's really important. Yes, we'll talk about Watchman, but a lot of times you're uncovering an undetected cancer that bled because you challenged them with anticoagulation. So, it's really important that those folks get screened and get seen by GI. Sometimes we will try a different anticoagulant to see if that's different, it's important to know if it is hemorrhoidal bleeding. So, there's all kinds of contexts of bleeding. We talked about the AF guidelines today. Many of my patients have varying renal function, and they live at that 1.4 and they're 82. So, what is the dose of the apixaban when their creatinine is 1.4 and then they're put on an increased dose of diuretic, and now it flirts with 1.6? So, keeping a really close eye on those folks is important so that we can correctly manage their risk of bleeding, and then, if that doesn't work, and people have persistent bleeding, then we talk about a left atrial appendage closure device and do that. But the other conversation to that is, especially for our frail and elderly people, there are vascular complications, what if we get a device-related thrombi? Those are conversations that you have trading one thing for another thing. Thankfully, those things are rare, but when it happens to the one person, they're upset with you if you didn't talk about it. So those are the kinds of conversations that are every day in the clinic about what's best for you and what you want to challenge. 

Sana Al-Khatib, MD, MHS: Great discussion. I have 2 questions, one for you and one for Rod Passman. I’ll start with the question for you, Rod. If I heard you correctly, you said that patients cannot have a device to be enrolled in REACT-AF. What if they end up needing a device during the course of the trial? How are you handling those patients? My question to the panel is, as we all know, you must have shared decision-making before you can proceed with left appendage occlusion device insertion. Can you tell us about how that is set up in your practice? Because the operators and their team cannot actually have that shared decision-making discussion with the patient. It should be the general cardiologist, which definitely creates some challenges.

Rod Passman, MD: Great question. There are 2 reasons. I mentioned one if you get a device. The other problem is if you V-pace during your AF, the watch will see that as sinus rhythm. It'll be very regular. So, you wouldn't be a good candidate. So, if you got a device, you would have to cross over to the chronic anticoagulation because the watch would no longer be reliable. 

Monique Young, APRN: For your question on shared decision-making, I think it's a relationship you have with your general cardiologist. For most of the time, especially, it's more of your private insurers than Medicare. You need the form. So, it's the APPs who generally are the ones that navigate us to avoid delays in getting the patients to the procedures and to educate and have this good relationship. I have not ran into too many delays in getting that form. The other thing that I've done most recently is in Epic, that shared decision-making is on our side, but also, I've kind of implemented to the other groups that we need this in there, because if not, they're not going to get approved, they're not going to go through. To go back to what Jill said, it's to have this conversation. We have many patients who come up and get referred, they need a Watchman. They sit on that cusp of do they really need a Watchman or do they need an ablation. First, reduce their numbers, and then you reduce their stroke risk. I call it show and tell, like, this is what it is. So, show the patients and say, you may not need this or you may. Or you have patients that come in for the ablation and not for the Watchman, and you're thinking this person really needs a Watchman. So, then you implement a plan, and again, there is shared decision-making, education, and if the patient knows this may not work or that this may happen, and they know the forefront of what their plan is, then they feel a part of it. 

Jill Schaeffer, CRNP: They often come in because they saw it on TV. The direct-to-consumer marketing is strong and they say this is what we want so they can come off that dreaded anticoagulation, and it's a great conversation. A lot of times when you talk about what it involves and draw pictures and do show and tell, patients then get to decide what it is or whether it is really truly for them, because the commercial doesn't go through all of that. So, that's really important. 

Monique Young, APRN: Yes, and you do, you just have to have a conversation.

Jill Schaeffer, CRNP: We also use our general cardiologist for that. 

Christopher McGann, MD: Will, you've been pretty quiet down there. When do you reach for a Watchman? When do you put a Watchman device in? 

William Cho, PA-C: In our EP practice, we currently don't have any Watchman implanters that are with our interventional service, but in general, we tend to be pretty conservative with Watchman implants. We still feel like there is a lot of data to see and learn from. Alternatively, in some instances we do reduced-dose anticoagulation. I think there are a few studies out there that that compare standard dose versus reduced-dose anticoagulation in the high CHA₂DS₂-VASc population. These are usually older patients and more frail patients, but there are a few studies that have shown no significant increase in stroke risk between the 2 groups. 

Jill Schaeffer, CRNP: In the Watchman population in our group, we do have variation among our physicians. Some keep the anticoagulation strategy immediately post Watchman as it was in the trial with full-dose anticoagulation plus the antiplatelet. But there's others that have switched to a different strategy of reduced-dose anticoagulation. So, you go from apixaban 5 down to 2.5 for 6 months and then just stop it then and start on aspirin. I wonder what others do, because personally, I haven't seen any difference in complications, strokes, etc. 

Mohamed Elshazly, MD: I think the FDA had approved the strategy of clopidogrel (Plavix) and aspirin. I don't think they approved the strategy of half-dose apixaban. But they already have the new generation of devices that are coming up. I think eventually it's going to be just single antiplatelet because of the coating that's on the device. I think that's what we're kind of moving towards. 

Brent Wilson, MD: Mohammed, what about what about your practice in terms of implanting a Watchman? 

Mohamed Elshazly, MD: Yes, so I'll get the referrals most of the time. Again, people who, for different reasons, are bleeding, I put them in one category and then it's reversible or irreversible. So, I want to make sure that the bleeding has been worked up, looked at, that kind of thing. Let's say if it's irreversible bleeding, that's a clear-cut kind of indication for me of people who are candidates for long-term anticogulation. That's the wording that I use, and for me I think it makes so much sense. The reversible ones, again, if we find out what it is, it's a one-time event, fine, but if it's a recurrent event like those with multiple polyps or these kinds of things, then I'm more flexible towards placing a Watchman. Now, the other category that we see a lot of are the falls, and I remember initially when we were talking about Watchman and some people were like, yes with multiple falls, to think about Watchman. Then, I got this patient one time who had one fall a year ago. An older guy, he was here because he wanted to discuss Watchman. His son had brought him in to discuss Watchman. I don't know how they figured it out—maybe direct to consumer or what not. I asked him if he had fallen once and he said yes, a year ago. I asked if there had been falls then, and he said, no, I use a walker and I'm fine. So, I talked to him about Watchman, and he said, I'll take the walker. So, patient preferences can vary, but I think it's important to have that conversation with them.

Brent Wilson, MD: We have a couple of questions in the audience. 

Audience question: I have 2 questions. The first is, I know this meeting is all about AF, but I just want to ask a question in terms of anticoagulation for people who only have clinical typical atrial flutter and you ablate them. They're considered clinically cured from typical AF flutter. Since medical training, I've been told all the time that in terms of anticoagulation to treat typical flutter the same way as AF, that's by the risk assessment, but nowadays obviously, we're talking about all the new technologies, digital health and then smartwatches and all kinds of monitoring. So, I'm interested in knowing how the experts feel in terms of how you would assess your patient's risk for anticoagulation to prevent stroke in people who only have typical flutter. Does it rely on the CHA₂DS₂-VASc score or other clinical risk score, or put them on a smartwatch or loop recorder for long-term monitoring, or a combination of both? The second question is in terms of a left atrial appendage occluder device versus anticoagulation. I don't know if you all have similar experience because of the DOAC cost; especially even with Medicare, it’s actually still forbidden for a lot of patients and then they're also probably the same ones who are challenged in situations either socially or geographically where they couldn't do coumadin. So, in that case, would you consider them for a Watchman device instead? 

Brent Wilson, MD: Bassam, do you want to take that one? 

Bassam Wanna, MD: Sure, so basically, that's one of the criteria on the left atrial appendage closure worksheet was difficulty being compliant with your oral anticoagulation. So, you would consider them for Watchman or Amulet closure. As far as the flutter, so I think that there was a dichotomy maybe in the past where atrial flutter was treated as its own separate entity and you would maybe anticoagulate for a few weeks and then stop. I think if you dig deeper, most of these patients are going to show up with AF somehow, somewhere. So possibly, I don't know if a loop recorder is necessary just for flutter, but maybe repeated the 30-day monitors in the long run would be reasonable.

Audience question: I literally had more than one patient show up in the clinic after flutter ablation. They tell me they have a smartwatch and never had any AF. Their CHA₂DS₂-VASc score is like 2, with age or hypertension, and they say, "I don't want to take blood thinners unless it's absolutely necessary." Is that something you can consider maybe if they have like a reliable monitor system, to consider taking them off?

Bassam Wanna, MD: I mean, that's the decision you would make with your patient, definitely it's reasonable to monitor them in the long term, I would say. 

Mohamed Elshazly, MD: Yes, I'd say if they have a monitor and they don't have symptoms and they're wearing the watch, I don't see a reason to continue. Again, Bassam made an important point that they can coexist almost 30%, 20% to 30% of flutters will have coexistent AF. So just knowing that over time, you're aware of that kind of thing. 

Edward J. Schloss, MD: So, this is an interesting talk. We're talking about the patient perspectives on what they would want. As I have kind of “grown up” in EP, I have noted how antiplatelets have pretty much gotten a pass, and I don't think anybody says “I don't want a PCI because I'm going to have to go on dual antiplatelet therapy.” But antithrombotics have had a bad name forever, and I think that was largely earned, rightfully so, because of the inconvenience and the disasters that sometimes occurred with warfarin. So, imagine a world where warfarin never existed, DOACs were the same price as aspirin, and here we are today. Would Watchman have a market right now and would patients ask for it? Because I see so much misconception in my office, I see everybody showing their arms, and in my experience, much of that is from antiplatelets that they're already going to be on anyway. I tell them, your arms are still going to look like that, that's not going to change. Aside from a couple of recent trials, the safety of antiplatelets and DOACs is fairly similar. 

Mohamed Elshazly, MD: It's something that we think about all the time. Again, a lot of the studies have shown that the safety profile of apixaban or any DOAC in general is very similar to antiplatelets. So, that's a very reasonable question. My only concern is compliance. Again, patients who are diagnosed with AF in their 60s and they've got to be on a BID drug for like 30, 40 years. Are they really going to be taking it every day? So, I think that's where it comes in. Then also, the idea of taking a medication is also sometimes an issue. So, I think that's a question that always comes to my mind, is assuming CHAMPION shows non-inferiority and should be published next year. CHAMPION is a study looking at left atrial occlusion, Watchman specifically, in people with the lowest CHA₂DS₂-VASC score or a moderate CHA₂DS₂-VASC score. If this shows non-inferiority, I always ask the question, is anyone going to want to be on anticoagulation? I don't know what the answer is going to be. Again, part of this is the bad reputation, but every single patient that I see is not happy with being on an anticoagulant. That's the problem.

Jill Schaeffer, CRNP: There was a question on the iPad that someone asked because we were talking about AF alerts on devices and what we set them for. The question was, how long do you program them? If we are planning a device in someone who has never had AF, we set the AF alerts for 30 minutes. If it becomes known that they have AF and we're treating for that, then we can deactivate the AF alert, but we keep the ventricular high-rate alert on so that we can adjust from there. So, the question was, do we turn off alerts once we know about AF to avoid data deluge? Yes, we learned early on that we needed to do that, because keep in mind it's not just the technicians and the nurses who have to deal with it, but that your inbox will have to deal with that. So, it takes that away. They're anticoagulated. We know they have AF. They feel okay. They're monitored carefully through appointments, but we do want to know about ventricular high rates. 

Brent Wilson, MD: Excellent. Thank you. We did have about another dozen or so questions, but I think we're getting the signal that it's time to wrap up. We would like to thank our outstanding panelists today and the audience participation for a wonderful discussion about anticoagulation, and we look forward to wrapping up Western AF this year with the last session.

The transcripts have been edited for clarity and length.