Blood Thinners or Watchman Device Navigating AFIB Stroke Prevention

Most patients diagnosed with atrial fibrillation (AFIB) are handed a prescription for blood thinners often without ever learning about another potentially life-changing option. In this episode of Cardiovascular Therapeutics Unplugged, Dr. Aditya Mehra deep dives into the two main tools for stroke prevention in AFIB: traditional anticoagulants and the innovative Watchman device. He breaks down how blood clots form in the heart, why stroke prevention must be one of the very first conversations in AFIB care, and what patients need to know to make the right decisions for themselves. Whether you’re newly diagnosed, struggling with the side effects of blood thinners, or simply curious about new advances in heart treatment, this episode arms you with the questions and answers that could shape your journey.

00:00 Discussing atrial fibrillation tools

06:44 Understanding Atrial Fibrillation Basics

10:08 Left atrial appendage and heart function

13:33 Assessing bleeding risk with HAS-BLED score

17:08 Addressing anticoagulation gaps

18:22 Stroke risk in elderly patients

23:17 Watchman device heart procedure

26:55 Comparing Watchman device to warfarin

31:36 Patient awareness of new tech

33:02 Discussing patient education on AFib

36:19 Discussion on AFIB stroke prevention

Transcript

SPEAKER_00 0:00

Atrial fibrillation is driving the train of a stroke. There are 30 to 40% of eligible atrial fibrillation patients who are either not anticoagulated or are on subtherapeutic regimens of anticoagulants. Watchman device, it's indicated for these non-valvular atrial fibrillation patients who are at increased risk of stroke, and they're not in general candidates for these blood thinners. Sometimes nothing happens, but when a stroke happens, it changes your life completely. It changes the life of people around you completely if you're in a wheelchair and you can't walk or you can't take care of daily activities. And for the right patient, it changes the complete risk calculus of their life.

SPEAKER_01 1:09

What many of them are never told is that for some patients, there is actually another option entirely. Welcome back to Cardiovascular Therapeutics Unplugged, real conversations about heart treatments that change lives. Today, Dr. Mara is breaking down the two main tools for preventing stroke and AFib, blood thinners and the watchman device, and what every patient really needs to know to make the right decision for themselves. So hi Dr. Mara, it's great to see you as always. Hi, Layla. This is a really good, important conversation. So it's great to see you as always and hop into this. I know we talked a little bit about this on the last show. So this will be more of a deep dive.

SPEAKER_00 1:44

Yeah, it's great to be back and speaking about atrial fibrillation. I know we started out, we talked at length about atrial fibrillation in in a past episode, but here in this episode, we're kind of just talking more about anticoagulants and more specifically the left atrial appendage occluder device. And I'm gonna be calling it Watchmen for ease. There are a couple of them on the market, but uh this is the one that we're just gonna kind of it's it's the more common one that we use locally here. So I'm gonna be referring to the device as Watchmen for a majority of the this podcast. So we have to understand that I'll start by what I see on a daily basis. When I walk through a a stroke unit on a Monday morning at the hospital and we've been consulted as cardiologists to see a patient who's had a devastating stroke, one of the things that becomes apparent is that a substantial fraction of those patients have what's called an embolic stroke, meaning that it originated likely from the heart and embolized to the brain, leading to a devastating stroke. And when you dig into those stories, you end up finding one of three things that they had known atrial fibrillation and they were possibly inadequately anticoagulated, or they had atrial fibrillation that was just discovered when they have their index episode of stroke, or they had what's called a cryptogenic stroke. And on monitoring, we find this peroxysmal atrial fibrillation. So this is the subset of patients that we wanted to talk about today who uh unfortunately have these cardioembolic events and are at risk of recurrent cardioembolic events and strokes. So that's where anticoagulants and watchman devices and left atrial appendage occluder devices come in.

SPEAKER_01 3:37

So AFib is often framed as something that you manage and live with. But when the conversation turns to stroke risk, the stakes shift dramatically, right? But before we get into the treatment options, can you give listeners a real sense of how significant that risk is and why preventing stroke has to be the first conversation really any cardiologist has with an aphib patient?

SPEAKER_00 4:00

Yeah. So when I'm speaking to a patient with a stroke or atrial fibrillation, one of the things I say is atrial fibrillation is driving the train of a stroke. It's the strokes engine. And, you know, just to go back to the epidemiology that we talked about in a previous podcast, six million Americans are affected by atrial fibrillation. 30 to 40 million people globally are affected by atrial fibrillation. And by 2050, this number of Americans is supposed to grow to about 15 million. It is quite prevalent. It is one of the most sustained cardiac arrhythmias, and it's responsible for 15 to 20 percent of ischemic strokes, which rises to 30% in patients over 80. So the older you get, the risk of having a stroke with atrial fibrillation goes up. The risk of developing AFib is one in four for adults over 40, and that's something that is a real risk. And it climbs steeply with age, as I said, in octogenarians, the risk can be about 15%. So when people are having what's called paroxysmal atrial fibrillation, the concern for an embolic stroke goes up, and that is what we have to address on a regular basis.

SPEAKER_01 5:20

That's a pretty significant statistic. I didn't realize it was actually that that common. And I think something that also is common, people talk about blood clot or hear blood clot frequently and kind of assume that it could form anywhere, or maybe not even really know how it's formed. But with AFib, there's a really specific location in the heart where the overwhelming majority of dangerous clots originate, so which is something that I learned. I did not know that up until now. So can you walk us through the anatomy and why the left atrial appendage is so central to this risk and why understanding that anatomy is actually the key to understanding both treatment options?

SPEAKER_00 5:58

Atrial fibrillation comes from the two words that are in its name, atrium and fibrillation, it comes from the left atrium most commonly, where it is fibrillating, meaning that it's not pumping uniformly and regularly. It's fibrillating. So anytime, as we talked about in our P episode, anytime blood doesn't move in the body, there's stasis of blood, there's an increased tendency to for the blood to clot. And when the left atrium is fibrillating, there's stasis of blood and slow flow of blood that happens over there. That increases the risk of forming a clot in the heart. And the left atrial appendage is a vestigial structure, a conical vestigial structure that is, that is, comes off the left atrium, that is more prone to forming the clot because it's a small opening coming off the left atrium. And when a clot forms there, it can embolize from there to the brain most commonly. So the left atrial appendage, even though it's not doing much otherwise, but becomes very, very important and plays a significant role in the setting of atrial fibrillation and risk of stroke. Speaking of the left atrial appendage, it's like I said, it's an embryological remnant of the original primitive left atrium. And it's a finger-like conical structure. It's got little trabeculations, which are variable morphology. Some people describe it as a cauliflower-like structure, a windsock. It sits in the pericardial space between the left upper pulmonary vein and the left ventricular free wall, which is relevant that because that makes it more accessible to treating with a watchman device instead of entering the pericardial space, which is the sac that surrounds the heart. So you can go transeptally from the right atrium to the left atrium. This is a little more technical, but you don't have to puncture the sac that surrounds the heart to place this left atrial appendage device in there. So in normal rhythm, sinus rhythm, the left atrial appendage actually contracts normally and the velocities of blood in there are very normal. They're usually around 40 to 60 centimeters per second when we check them on the echoes or ultrasounds of the heart. And when the contractile function is lost, the velocity velocities drop to less than 20 centimeters per second, and that increases the risk of stasis and leads to that Birchild's triad that we talked about in our DVD pulmonary embolism podcast. And that leads to increased risk of clot formation and embolization and going into the cerebral circulation of the brain. So that's where the left atrial appendage really becomes an important structure.

SPEAKER_01 8:48

And anticoagulants are the standard of care for most aphib patients with meaningful stroke risk, but for good reason, right? So they're also one of the most anxiety-producing prescriptions a patient can receive. So can you kind of walk us through how these medications really work and shift to newer NOACs has changed in practice and the fears that patients bring to you when, you know, they deserve to be taken seriously versus the ones that may just be kind of overblown?

SPEAKER_00 9:17

Yeah. So let's talk about again the risk of stroke. And one of the how we risk stratify patients who have atrial fibrillation, one of the most common scores that are used is called the CHADS 2 VAS score, which is takes into account the patients, if the patient has had a history of congestive heart failure, hypertension, their age, if they have diabetes, if they've had a prior stroke, if they've got vascular disease, if they're female, those things pretend based the higher the ChadS2 BAS score is, the higher the risk of basically having a risk of stroke with AFEB. So if somebody's, for example, if their age is greater than 75, they'll get a risk, a score of two. If they've got diabetes, they get a score of one. If they've had a prior stroke, they get a score of two. And once you start getting above six your total score, your risk of stroke goes to about 10% per year. So that is a very high risk. And so that patient will need to be anticoagulated. If somebody's got a very, very low risk, that person, you know, might just need aspirin for anticoagulation and not one of the novel oral anticoagulants that you were talking about. This score is, again, placing somebody on these strong blood thinners is weighed against their risk of bleeding, because we have to balance that out, the risk of a stroke versus the risk of falls, prior history of bleeding. And the most common score we use to assess their bleeding risk is called the has bled score. And that's the other side of the coin. It helps us quantify their bleeding risk. It doesn't mean that if somebody has a high has blood score, that we should withhold anticoagulation. It does, you know, help us modify the bleeding risk if they're on other blood thinners, if they have antiplatelet agents on board, if they have a history of alcohol use. We try to modify that so that we can still treat their risk of a stroke and decrease their risk of stroke in the future with the blood thinners. So a high-haz blood score, just to make a point, is not an absolute contraindication to putting somebody on blood thinners. Now, the most common blood thinners have been warfarin, which is a vitamin K antagonist, a historic one. You have to check your blood work on it, what's called the INR. But the other ones that have come out over the years have been Dabigatrin, riveroxaban, epixaban, and also another one called adoxaban. They went through their rigorous clinical trials. For example, the most common one these days used epixaban and riveroxaban. They had a rocket AF trial was for riveroxaban, which showed benefit and was non-inferior to warfarin. And then the Aristotle trial for epixaban showed, again, reduced bleeding and reduced strokes compared to warfarin. It was actually superior to warfarin in that trial. So those are the two landmark kind of critical trials that brought these drugs to the market and have completely transformed the way we anticoagulate these patients instead of checking blood work regularly with warfarin. Warfarin still has a very, very important role. It's right for some patients who were not candidates for these novel anticoagulants, but these drugs have kind of transformed the landscape of anticoagulation. A few principles, specifically getting into, you know, how do you choose from the four different novel oral anticoagulants? Apixaban has the most favorable gastrointestinal bleeding profile, for example. It's preferred for elderly patients. The debigatron has more reversibility that's available on the market, but again requires some dose adjustment for kidney patients, kidney failure patients, and has a slightly higher GI bleeding risk. And then riveroxaban has a very appealing once-a-day dosing regimen. But dose adjustments are made based on age and kidney function in most of these novel oral anticoagulants.

SPEAKER_01 13:17

And so for most AFib patients, anticoagulants are well tolerated and the conversation kind of ends there. But there's a real population for whom long-term blood thinners carry serious risks of their own. So, with that being said, who do you think those patients are and what makes their calculus genuinely different?

SPEAKER_00 13:38

When we start thinking about these, first of all, there's a real world gap. One thing I wanted to talk about. Even though clear guideline recommendations are there for anticoagulation, there are 30 to 40% of eligible atrial fibrillation patients who are either not anticoagulated or are on subtherapeutic regimens of anticoagulants. And these patients, you know, who have a higher risk of bleeding, the rate of non-anticoagulation is even higher. So this represents a massive population of high-risk individuals which are not getting the right and effective stroke prevention regimen. So that becomes critical in understanding when you start thinking about the left atrial appendage occluder devices. That's one scenario. The other scenario in the real world is when something goes wrong, meaning that a patient has had a major bleed, most commonly a GI bleed or an intracranial bleed on these novel oral anticoagulant drugs. So it becomes important to consider other alternatives. Another scenario is as these patients, their stroke risk is going up when they get into their 80s, but also their fall risk goes up. And if they have either they're falling a lot, or also if they've got dementia and they're not really compliant with their drugs, they don't remember to take their oral anticoagulants morning and evening. They don't have anybody to help them out. So we start thinking about stroke risk mitigation with these newer um clutter devices. So that's that scenario is the one that you know we consider these things.

SPEAKER_01 15:18

And then the watchman device you've mentioned in this episode, but also briefly in other episodes as well. But that's a this is why the Watchman device has been available for more than a decade, I believe. So being that it's been around for so long, it still for some reason remains one of the most underutilized and least understood options in AFib care. So most patients have never even heard of it at diagnosis. So can you explain what it is and what happens during the procedure and also what that recovery looks like?

SPEAKER_00 15:47

Yeah. So the Watchman device is indicated for these patients. We specifically, again, let's talk about who it's indicated for. Yeah. It's indicated for these non-valvular atrial fibrillation patients who are at increased risk of stroke or they've had prior strokes, and they're not in general candidates for these blood thinners. Their doctors might have recommended anticoagulation therapy, but they might not be doing well on these blood thinners now. The formal indication is that it is a broad indication. First, when we see these patients in our office, we try to classify them into their contraindications, true contraindications to blood thinners. So it goes along with, first of all, missing the diagnosis of atrial fibrillation. And then just like some people are not adequately anticoagulated, some people are not offered this therapy adequately by their physicians. This is a conversation that is important to have, and the patient should be given the option in the right setting by their cardiologist. It's an invasive procedure, no doubt about it. It's done by an electrophysiologist or an interventional cardiologist in some cases. It's usually a same day or an overnight stay procedure. It's done through the groin. Most of the time, you go into the femoral vein. The operator will put in catheters and sheets into the right femoral vein, take up these devices all the way up the inferior vena cava into the right side of the heart, and then they do what's called a transeptal puncture to get into the left atrium and then the left atrial appendage, and then place this structure called the watchman device or the left atrial appendage occluder device in that left atrial appendage. It is, that's exactly as the name suggests, it occludes blood flow to that area so that over time that area shuts down and doesn't form a plot and decreases the risk of stroke. You still have to take blood thinners for some time so that this foreign object that is placed in the left atrial appendage has a chance to endothelialize, meaning become a part of the left atrial appendage. And it's usually an overnight stay. It is done percutaneously. It's not an open procedure. You're not cutting the chest open. It is done through the femoral vein, and everything comes out at the end, the sheath and the groin from the and the vein is closed either with manual pressure or it is closed with a closure device, a vascular closure device. A patient might go home the same day if they've been observed adequately for the day, or they might stay overnight, depending on the institution's general procedure policies. After a device is placed, there's still a need for blood thinners for some time. But as you know, we're doing this for patients who we're trying to take off blood thinners. So for some time, for 45 days or so, those patients will continue on blood thinners. For about 45 days, you continue their novel oral anticoagulants or their warfarin along with aspirin. And after that, you repeat, you do what's called a transesophageal echocardiogram, and you see, make sure that there's a complete seal in that left atrial appendage, and you stop the blood thinner and continue aspirin and platics. More or more trials are coming out comparing whether you need this dual antiplatelet therapy with aspirin and platics, or you just need one, but that's where we are. And then six months later, we repeat another ultrasound to see if you know the seal is complete. Is there any periodice leakage happening? And we continue just the aspirin. So that's essentially the procedure in a nutshell and the follow-up after that.

SPEAKER_01 19:37

Wow, that that's pretty complex. It's it's more complex than I had realized, honestly. And the watchman has FDA approval and clinical trial data behind it, but patients will still ask the direct question to you is this actually as good as staying on blood thinner? So, how do you feel about that? And how would you answer that honestly to a patient? And beyond that, also, what do you think listeners should really understand about how the evidence should be and should not be interpreted?

SPEAKER_00 20:04

Yeah, so there are multiple trials now that have happened that have compared the Watchman device to either warfarin or now the novel oral anticoagulants. The landmark study that happened was the Protect AF study, PRO Protect AF study that compared warfarin to Watchmen. And there was a large study with over 700 patients, and it was a randomized clinical trial. And basically what that showed was non-inferiority of the Watchman device compared to warfarin for the composite endpoint of a stroke and cardiovascular death. So it was non-inferior warfarin. And procedural complications were a little higher, so that led to a slightly increased adverse events. But as the operator experience was taken into account, that procedural complication went down. Long-term mortality showed that Watchmen was superior after five years. So that's I mean, long-term follow-up showed that a watchman was superior as far as the primary endpoint was concerned. So a very uh clinically important trial that brought this uh device onto the market. There were other trials like the Prevail trial and the new certain trials that are studying the new generation of Watchmen devices called the Watchman Flex, such as the Champion AF trial, shown benefit of the Watchman device. So we're looking forward to the Champion AF results, which are expected you know soon in 2026-2027, which is comparing Watchman Flex to no the DOAC therapy in AFib patients.

SPEAKER_01 21:44

And then for a patient sitting across from you who has AFib and a meaningful stroke rest, can you walk us through what the decision-making process actually entails and what it looks like? Or what tips the scale toward blood thinners and what moves towards recommending Watchmen? So, how are those things really? Decided.

SPEAKER_00 22:00

Yeah. So again, like we talked about it, you know, once you risk stratify them that they're at high risk of a stroke, you have to explain to them that this is not a benign condition. This is something that is carries with it possibly a 10% risk of stroke per year, which is huge. So then you weigh a blood thinner. The first line is always a blood thinner, unless they have, like I said, an absolute contraindication. If somebody's not able to tolerate it, then you offer them watchmen. But still, the first line is a blood thinner. Now, the Champion AF trial might change that as more and more data comes out. And if there's superiority of a Val Watchmen flex device compared to the DOAX, then that might change the guidelines. But right now we offer the blood thinners because they do bring down the risk to less than 1% in most patients per year. So that's that's a huge benefit. If somebody's having GI bleeds or falls and this and that, obviously if they're not a candidate just at the initial stages, then we offer this right then and there, considering taking the procedural complications which are low in the hands of a good operator into account. And then anatomically, you know, they have CAT scans done preoperatively to assess the adequacy of and the anatomy of the left atrial appendage, whether it's going to be suitable in the eyes of the operator, electrophysiologist, or intermedicinal cardiologist doing the procedure. Is it going to be a good left atrial appendage anatomically for complete occlusion and seal with a watchman device? Those things are taken into account.

SPEAKER_01 23:35

And it's interesting because there's a lot of patients, AFIP patients, that actually go through their entire treatment journey and don't even really know that the watchman exists. Is that pretty common?

SPEAKER_00 23:45

It's becoming less and less common. I would say that like any other technology, first it's, you know, a small niche of people at academic centers who are aware of things, and then it gets out into the community. And now it's been around for a while, and I think most people hear about it. There's a large amount of direct-to-consumer marketing that happens also on television. So it's difficult for patients to, I mean, we have a lot of patients that ask about it before we mention it. So it's good. I guess overall it's good that the patient and the consumer is aware of what's out there. But it is really uh it really the onus is on the physician or cardiologist to kind of talk about it, make sure that you've got an informed patient about the latest tech that's out there to treat any condition.

SPEAKER_01 24:31

With that being said, since some patients don't know it exists, but and then they find out maybe later on, or they never really have that real conversation about whether their blood thinner is the right long-term plan for them specifically, or the watchman might be better. But what questions do you wish that more patients would bring into the room and what should they expect from a cardiologist who is taking this seriously?

SPEAKER_00 24:53

The patients first need to understand what they have. I always try to make sure that they understand what atrial fibrillation is. And then we get to the management part of things. It's like any other disease process that, you know, I want the patient who have complete knowledge and get complete transparency from me to understand and get educated about what they're dealing with. And then we talk about what's out there. And the questions they need to ask again is what is my risk of stroke? What is the risk of bleeding on these blood thinners? What is the risk of not taking the blood thinners? These are the questions that they want to ask. Where do you fall on the spectrum of a young patient who is athletic, who doesn't have cong any other of the Chad's too vascular risk criteria? Is a low risk patient, somebody who's got diabetes, congestive heart failure, prior stroke is a high-risk patient. So they can ask those questions. Where do I fall on the spectrum of risk? Where do I, and if they're talking about the device, what is, you know, and just like the questions that you asked, how long do they stay? What are the complications? What does the procedure entail? Do I have to be on blood thinners after the procedure? What is the duration? And really, really informed patients will ask me about the clinical data behind things. So yeah, just having frank conversations about the disease process and its management options is generally what I expect from patients. Yeah.

SPEAKER_01 26:13

And for someone listening right now who has AFib, whether they're on blood thinners or they have been told they should be, or quietly stop taking one because of the fear of the side effects that we talked about, or just became too much. What is the single most important thing you really want them to walk away from this episode knowing?

SPEAKER_00 26:30

The single most important thing I want people to understand is that AFib can have devastating consequences. Don't take it lightly. It is a very common arrhythmia. Sometimes people put their guard down. Sometimes nothing happens. But when a stroke happens, it changes your life completely. It changes the life of people around you completely if you're in a wheelchair and you can't walk or you can't take care of daily activities. That is one thing that you want to take away. The second thing you want to take away is that we have management options that are available that can really mitigate the risk of stroke in AFib. And having frank conversations with your physician, having frank conversations about the risks and benefits of the various therapies is one of the takeaway messages. I think you should have that with your physician in any condition.

SPEAKER_01 27:13

Absolutely. And stroke prevention in AFib is one of the most important decisions a patient will face. And too often it's treated as though it's not a decision at all. So knowing your options and understanding the evidence and really walking into the appointment prepared to ask the right questions, that is what really changes the outcome. So this is such a helpful conversation for patients that will be having this conversation with their providers. So, Dr. Mara, thank you so much for making sure that every listener really leaves with exactly that, with that knowledge and the right questions to ask. And before we wrap up this great episode, are there any other thoughts or anything you wanted to add in or anything you think is important for listeners to know?

SPEAKER_00 27:52

You know, in closing, if you can project the trajectory of risk for a patient and you can anticipate what is coming down the pike, you know, have the conversation about the oral anticoagulants, have the conversation proactively about left atrial appendage occluder devices, the conversion from oral anticoagulants to left atrial appendage occluder devices if necessary. Have that conversation proactively. The procedure is safer than ever. The procedure is more durable than ever. And for the right patient, it changes the complete risk calculus of their life for the rest of their life. So essentially, in closing, you know, that's what I want to say.

SPEAKER_01 28:32

Absolutely. Thank you so much for all this information. And this was another great episode. This was Cardiovascular Therapeutics Unplugged. Real conversations about heart treatments that change lives. Make sure that you follow and share and subscribe to the show and share it with someone who can benefit from it. And I can't wait to talk to you soon. We have another great episode coming up. And I'll talk to you soon.

SPEAKER_00 28:52

Thanks, guys, for listening. Appreciate it. Thank you.