Is a Left Atrial Appendage Closure a Good Option to Prevent Stroke for People With Atrial Fibrillation?

Podcast Transcript

Announcer:

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Walid Saliba, MD:

Hello and welcome to another episode of Love Your Heart. I'm Dr. Walid Saliba. I'm the director of the Atrial Fibrillation Center at the Cleveland Clinic. And with me is Dr. Oussama Wazni. He is the section head of Cardiac Electrophysiology at the Cleveland Clinic. Today we'll be talking about the result of a new study, the results of which is actually going to change the way we practice treatment of atrial fibrillation. So, Dr. Wazni, can you tell us, first of all, what is atrial fibrillation?

Oussama Wazni, MD, MBA:

So atrial fibrillation is the most common, persistent arrhythmia that patients can have. So it's when the atrium, the upper chamber of the heart, fibrillates or quivers, instead of beating regularly. It's really just quivering, going very, very fast. It's going about 400 to 600 beats per minute. That is not what a patient would feel, because the heart itself, the main chamber, the ventricle cannot beat at 400 to 600 beats per minute. There's something called an AV node that blocks most of these. But then the patient, if they felt their pulse, they'd feel that it's racing. They'd have palpitations, and they'd feel that their rhythm is actually very irregular.

AFib patients will come to us most of the time, they will complain that they have palpitations. Palpitations means that they can feel their heartbeat racing, is irregular. They can also feel that they're short of breath. They may feel that they have less endurance. For example, they could do a chore easily, but now they're huffing and puffing at the end of the chore. So that's most of the time why they would seek our help. Some other times they'll be referred. Sometimes AFib is silent. A patient will not know that they have atrial fibrillation, but they'll be going in for a procedure or to their doctor for a routine appointment, and the doctor listens to them and says, "Okay, the rate is fast. The rhythm is irregular. You may have AFib," and they make a diagnosis. And that's actually a more dangerous aspect of atrial fibrillation, and so we'll talk about this in a little bit.

Walid Saliba, MD:

How do you diagnose atrial fibrillation?

Oussama Wazni, MD, MBA:

That's very important. Again, like I said, the patient may come to us because of symptoms, but these symptoms may come and go. They say, "Oh, Doc, I feel great most of the time, but sometimes I have these symptoms." Or sometimes they have the symptoms all the time. Or if it's silent AFib, they don't know that they have it, but it was diagnosed incidentally. If they're having the symptoms right now, we can do an EKG, and we can see it on an EKG, which is a tracing of their electrical heart activity, or heart electrical activity. Or we can give them a monitor if it's coming and going, because they may be a normal rhythm right now when we're seeing them, but they may be having it episodically, and that's where we call it paroxysmal atrial fibrillation. So we give them a monitor, and based on that, we make a diagnosis.

Walid Saliba, MD:

So we definitely need to capture it on an EKG, on a monitor to document the presence of atrial fibrillation. So now I have atrial fibrillation. How do you treat it?

Oussama Wazni, MD, MBA:

That's a very, very important question. The patients come to us thinking, especially the ones who have symptoms, that we're going to quickly hone in on getting rid of the symptoms. Actually, the most important aspect of managing atrial fibrillation is prevention of stroke, because that is the thing that can cause death or handicap a patient. So that's the most important aspect of managing AFib. And to prevent a stroke in those patients who have a higher risk of stroke, and we have a score that we work with to identify or to quantify the risk of stroke. It's called the CHA2DS2-VASc score, which is congestive heart failure, hypertension, age, diabetes, gender, vascular disease, or a previous history of stroke. So we take all of these risk factors into consideration and decide whether a patient should be on a blood thinner to prevent stroke.

Why a blood thinner? Because, like I said, when the atrium is not pumping, it’s just quivering, there is a pocket in the left atrium called appendage, or one of my patients called it the stroke sac. In that appendage you can have a pooling of blood, and then the pooled blood can cause a clot, and that clot can travel to the brain and cause a stroke. So that's why it's very important to reduce the risk of stroke by giving the patient blood thinners. That's how we do it now.

The second aspect of managing AFib is to make sure they don't have heart failure, because sometimes when they're in atrial fibrillation, the rate is very fast. If it's too fast for too long, the patient can develop heart failure. So we give them another medication called a beta blocker to slow down the heart rate.

And finally, actually it's the symptoms, and we try to alleviate those symptoms by getting rid of the AFib, because when they have AFib, they are very symptomatic. The usual way of getting rid of AFib used to be antiarrhythmic drugs, but because of a study that we did here at the Cleveland Clinic and published in big journals, we've shown that it's actually better to proceed with an ablation as first-line therapy. So we go into the atrium, we ablate those areas where AFib comes from, and hopefully we can, depending on the type of atrial fibrillation and the patient's condition, be successful anywhere from 60 to 85% of the time.

Walid Saliba, MD:

So you mentioned that treatment of the rhythm, atrial fibrillation as a rhythm, can be done with antiarrhythmic medication and better off with ablation.

Oussama Wazni, MD, MBA:

Yes.

Walid Saliba, MD:

And also you mentioned that the most important part of the treatment is stroke prevention in patients who are at a high risk of stroke, and you said that we give them anticoagulation. Are there any other ways that we can reduce the risk of stroke in patients who are at a high risk with atrial fibrillation?

Oussama Wazni, MD, MBA:

So now we have a patient who we introduced or we started on anticoagulation to decrease the risk of stroke. But these blood thinners are just that, blood thinners, and a big side effect or the side effect from blood thinners is bleeding. So we start a blood thinner. Some patients will not be able to take the blood thinner, because they will have a bleeding episode, or they have a bleeding tendency. Another reason patients don't like blood thinners is they have to remember to take it, so there's an issue of compliance, and taking the medication every day, either twice a day or once a day, can be an issue. Actually, about a quarter of patients after a few years will stop taking the medicine, even though they need to continue taking the medicine.

So right now there is an alternative to oral anticoagulants, to blood thinners, and that is something called left atrial appendage closure device. That, today, is indicated for patients who have bleeding problems. So a patient who cannot take a blood thinner for whatever reason, we have an alternative to it by closing the left atrial appendage with this device. It's been shown to decrease the risk of stroke to almost the same extent as warfarin, which is the one that it was compared to. It was never compared to the new oral anticoagulants, but in our experience it's been almost the same or comparable to it. The reason this is important is because I think it decreases the risk of stroke, but then the patient doesn't have to take a blood thinner that's causing them to have bleeding issues.

Walid Saliba, MD:

So this is very interesting. If you have atrial fibrillation, you can have an ablation. If you're at risk of stroke, you can take oral anticoagulation. But if you cannot take oral anticoagulation, we can close the left atrial appendage with those devices such as the Watchman device. How about in patients who do not or can take oral anticoagulation? Is there a possibility for them to offer the luxury of having a Watchman FLX even though they can take blood thinners? Is this better? Is this worse? Is this the same?

Oussama Wazni, MD, MBA:

Currently the left atrial appendage closure devices are not indicated for a patient who can take a blood thinner. But a lot of our patients actually come to us also thinking that once we do an ablation, they can stop the blood thinner.

Walid Saliba, MD:

Which is a mistake.

Oussama Wazni, MD, MBA:

That's a big mistake. Actually, it's a very big mistake because... For many reasons. One is because, from a patient standpoint, if they think they don't have AFib, when in fact they can have AFib. Now, the patient will ask me, "Well, how? I felt it before, and I know, doctor, I know that I'm not having AFib." The problem is that there is something called silent atrial fibrillation that can happen after ablation. Up to 50% of recurrences of atrial fibrillation after ablation are silent. So when we do monitoring afterwards, the patient will say, "I feel good," but the monitor shows that they can be still in AFib.

Walid Saliba, MD:

Does this mean they're still at risk of stroke?

Oussama Wazni, MD, MBA:

So this means that they are still at risk of stroke. If they stop the blood thinner, then they can get a stroke. Now, on the other hand, from the doctor's point of view, we can have a patient who we did an ablation, and we think that they're successful, but the guidelines tell us that we should continue blood thinners depending on the risk of stroke and not on whether the ablation was successful. From that point of view, and actually from the patient, a patient who had an ablation but truly had a successful one, why should we continue a blood thinner in somebody who doesn't have AFib anymore?

Walid Saliba, MD:

What is the problem with that?

Oussama Wazni, MD, MBA:

Because now we're exposing them to a blood thinner that can cause bleeding, either major or even not major but clinically relevant, meaning they have to go to the ER for it or they have to go to the doctor for it. So it's a Catch 22 kind of problem. In the patient who has silent AFib and the patient doesn't know that they have it is, "Why should I be on a blood thinner?" We have to tell them, "No, you have to be on it, because you can have a stroke." On the other side, you have a patient who really doesn't have AFib, and they tell you, "Well, why am I on the blood thinner?" You say, "Well, because the guidelines say you have to, and what if you get silent AFib before?" So that's why actually we came up with the study that we're going to talk about, the OPTION study.

Walid Saliba, MD:

It is very logical that if we can have a procedure, a device or a means to reduce the risk of stroke without necessarily increasing the risk of bleeding, that would be a very welcome strategy. This is what the OPTION trial is about that we're going to hear from Dr. Wazni, who was the principal investigator of the study. So can you guide us, Dr. Wazni, through the design of the trial and what were the primary and secondary endpoints that you looked at?

Oussama Wazni, MD, MBA:

So because of this conflict that we have in managing patients, we decided to design the study called the OPTION trial and see, in patients who have an ablation but are also at risk for stroke, what if we just close their appendage and not have to worry about blood thinners? Because then if we close the appendage with the device, hopefully we can reduce the risk of stroke. But because also we close the appendage, they don't have to take a blood thinner. We would also reduce the risk of bleeding. Or if we reduce the risk of stroke at least to same extent as a blood thinner and also reduce the risk of bleeding. So we designed it in patients who are coming for an ablation and have a higher risk of stroke. We took them and randomized them, meaning equally, one to one. In one group, we closed the appendage. In another group, we continued blood thinners. And we followed them for three years. And then we got the results just recently.

Walid Saliba, MD:

So these are patients who are coming for an ablation for atrial fibrillation, and you randomize them. Half will get the anticoagulation as per guidelines, and the other half, what we think is the logical solution, but needs to be proven, put a left atrial appendage closure device. What did you find?

Oussama Wazni, MD, MBA:

So we found that the device decreased the risk of stroke to the same extent as the blood thinner. So the risk of stroke was low in both, but they were similarly low. So 1.2% in the device group versus 1.3% in the anticoagulation group. So it actually performed very well and as well as a blood thinner. But the good news is, without the risk of bleeding, because the risk of bleeding was much higher in the blood thinner group versus the device group, 18.1% versus 8.5%.

Walid Saliba, MD:

And obviously the reduction in the risk of bleeding is because they're not taking oral anticoagulation.

Oussama Wazni, MD, MBA:

Exactly.

Walid Saliba, MD:

And it's impressive that just closing the left atrial appendage with the device gave us the same risk reduction of stroke as being on oral anticoagulation.

Oussama Wazni, MD, MBA:

Yep. And the important thing also is that these oral anticoagulants are all the new anticoagulants. So we're not talking about warfarin. 95% of the patients in the study were on the newer anticoagulants, not on warfarin.

Walid Saliba, MD:

So I understand that when you do an ablation, you go under anesthesia, you go through the groin, and you have access to the left atrium. But I also understand that for left atrial appendage closure, these are the same steps that you go through. Can't we do those procedures both at the same time, since you're there?

Oussama Wazni, MD, MBA:

Yeah. In fact, in the study, in OPTION, 40% of the patients got it combined with the ablation.

Walid Saliba, MD:

As one procedure.

Oussama Wazni, MD, MBA:

As one procedure. And even more, at the Clinic, we've already been doing this since 2017, combining the ablation plus closure of the appendage, but only in those patients who, because of the indications, need an ablation because of symptoms and also who need closure of the appendage because they're having bleeding problems. I think with OPTION, this is going to expand indication to any patient who's getting an ablation but has a moderate to high risk of stroke.

Walid Saliba, MD:

So this is very important, because now, as a patient, I will have a choice when I come for an ablation. And if I have a high risk of stroke by the CHA2DS2–VASc score that you mentioned, I might have a choice to have a left atrial appendage closure, so as to have the same reduction of stroke without the ongoing risk of bleeding by being on oral anticoagulation. And it's definitely going to change the way we practice to a certain extent.

Oussama Wazni, MD, MBA:

I think it will. I think it will change the way we practice. I think patients will have more choices. I don't want to use the word option, because that's the study, but they will have more choices. They will have more options. And the physicians will have more choices and more options to manage this problem. So it will be very nice that the patient will get an ablation to reduce their symptoms, improve their symptoms, reduce the risk of heart failure, and at the same time reduce the risk of stroke and reduce the risk of bleeding, because they'll be protected without the complications of taking a blood thinner.

Walid Saliba, MD:

All in potentially one procedure. I think this is very interesting, and it's going to be a very much welcome way of treating atrial fibrillation by patients and physicians alike. So if you have atrial fibrillation, and if you're considering having an ablation, this is something actually to discuss with your physician, as to whether you are a candidate to have a combined procedure or left atrial appendage closure device. You do not necessarily need to have contraindication to oral anticoagulation to maybe consider a left atrial appendage closure device.

Oussama Wazni, MD, MBA:

So this will be in the future. But in the meantime, again, we have the largest experience in the country of combined AFib ablation plus left atrial appendage closure in a patient who's indicated to have both. So again, we've been doing this since 2017 or even earlier. We've done more than 500 patients with very good outcomes, whether with respect to reduction of stroke and also prevention of bleeding. The procedure itself is very safe and with very low likelihood of having a complication. Because of our work, there have been new developments. We have the most experience in combining these two procedures together.

Walid Saliba, MD:

So thank you very much for joining us for another episode of Love Your Heart. And until then, we wish you the best of health.

Oussama Wazni, MD, MBA:

Thank you.

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