Combining Procedures to Reduce Stroke Risk in AFib

Podcast Transcript

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Dr. Oussama Wazni, MD, MBA:

Good morning, everybody, and welcome once more to another podcast from the EP (electrophysiology) section at Cleveland Clinic. I am Oussama Wazni. I'm the section head of electrophysiology here at the clinic. With me today is Dr. Mohamed Kanj, and he's the director of the AFib program and also co-director of the EP labs here at Cleveland Clinic. Good morning and welcome, Dr. Kanj.

Dr. Mohamed Kanj, MD:

Thank you. Thank you, Oussama. Thank you very much for having me.

Dr. Oussama Wazni, MD, MBA:

So, a new development today that we're going to talk about is the combined atrial fibrillation ablation and also left atrial appendage closure, which can be achieved with a device called the WATCHMAN device, or also more recently the new Amulet device. Our experience here has been mostly with one of the two devices.

We're going to start off by just giving you a summary on AFib ablation and where we are right now, and then also left atrial appendage closure separately. Then, we will try to combine both of them in our discussion. Dr. Kanj, when do you think a patient should be concerned about atrial fibrillation? What are some of the indications that a patient may have atrial fibrillation?

Dr. Mohamed Kanj, MD:

So, a lot of times, patients come to us when they have atrial fibrillation, and they can have a variety of symptoms. A lot of the patients come to us with palpitations, and that bothers them. Their heart is irregular, their heart is fast. But what's more important to us is that when patients go into atrial fibrillation, they're more tired, they're more fatigued. They have lack of energy. All of these are actually signs that they may have atrial fibrillation. A lot of the times, when they have these symptoms, they go to see their family physicians or general cardiologist and get an EKG, a Holter monitor or, even these days, these home EKG monitors record an irregular rhythm, an atrial fibrillation, and then they come to us with a diagnosis of atrial fibrillation.

I think over the past 20 years, we have enough data to suggest that atrial fibrillation is not a nuisance disease. It actually could be a malignant disease that we need to address as soon as possible. Thanks to the work that you have done over the past 20 years to pioneer and push us forward, we can treat every patient with atrial fibrillation.

Dr. Oussama Wazni, MD, MBA:

So, there has been an evolution of the way we look at the treatment of atrial fibrillation. In the past we used to try medications first, but because of the work we have done here at Cleveland Clinic and the work that has been done elsewhere, right now we have moved towards first-line ablation instead of trying a medication first. Can you just elaborate a little bit on that concept?

Dr. Mohamed Kanj, MD:

The medication route is not a bad route. It's a good route, but the problem with it is that the success rate is limited, and patients actually have to take these medications for the rest of their lives. What we've seen is that the efficacy of this strategy declines with time. Also, what we've seen is that the risks of these medications accumulate with time. These medications, they're not the safest medications. As we wait longer and longer, we see common patients coming back to us with side effects from these medications, whether it's symptoms, whether it’s bradycardia causing the need for a pacemaker, or passing out. They're not the safest strategy for patients with atrial ablation in the long term.

Over the past 20 years, as you mentioned, a lot of work that was done here at Cleveland Clinic plus someplace else, we challenged that concept and moved towards early ablation. The study that you published five, six years ago and the recent study that you published recently have demonstrated that early atrial fibrillation ablation for both paroxysmal as well as persistent atrial fibrillation is a superior strategy compared to anti-arrhythmic medications.

Dr. Oussama Wazni, MD, MBA:

In your first answer, you alluded to the fact that in the past, we thought that AFib was just a nuisance disease and were treating it only to manage symptoms. But could you tell us about more recent data to suggest otherwise?

Dr. Mohamed Kanj, MD:

Yes, earlier trials thought that if we treat atrial fibrillation, we're only treating symptoms. However, what we've seen over the past five to six years from randomized clinical trials is that AFib is not a nuisance disease. AFib is associated with stroke, AFib is associated with heart failure, AFib is associated with mortality, AFib is associated with decreased mental capacity and delirium, atrial fibrillation is associated with worsening kidney function. Recent clinical trials have shown that if you manage atrial fibrillation and you're able to address atrial fibrillation, you can see all these benefits over time.

Dr. Oussama Wazni, MD, MBA:

So, maintenance of normal rhythm is very important to reduce the risk of stroke, heart failure, hospitalization, mental decline and also kidney function. It's very important for us to get rid of the AFib, restore some normal rhythm, and then maintain normal rhythm. What the studies have shown is that the best way to maintain a normal rhythm is actually to do an ablation. Also, the recent studies have shown that if you can effectively maintain normal rhythm, you reduce the other healthcare conditions that we were talking about, namely stroke, heart failure, hospitalization and the rest.

So, that's good. Now we're setting the stage that we should really ablate sooner rather than later. We've already shown it in paroxysmal patients, so that's when AFib comes and goes within a period of seven days, and also in persistent patients, in those patients where the atrial fibrillation lasts more than seven days, and you need a cardioversion to get them back into normal rhythm.

Now, the most important aspect, though, of management of atrial fibrillation is stroke prevention. What can we do to reduce, other than ablating the AFib? What else should we do? What is the foundation of managing AFib in terms of the prevention of stroke?

Dr. Mohamed Kanj, MD:

Over the past 70 years, we've seen this association between atrial fibrillation and stroke. What it looks like is that there's a small pouch inside the heart called the left atrial appendage, which is found in the left atrium. Usually, this is the area where it harbors most of the strokes. We've seen that from surgical data from this institution, from echo data from this institution. This is usually the culprit for most strokes in patients with atrial fibrillation. Our strategy to address that was to give people anticoagulation, and now we have data suggesting that if you fix the AFib, you could lower the risk of stroke. But over the past 20 years or so, we've looked at surgical as well as percutaneous strategies to address the left atrial appendage. We have now multiple devices, as you mentioned, WATCHMAN, Amulet, as well as other devices that looked at this strategy to decrease the risk of stroke by addressing or plugging the left atrial appendage.

Dr. Oussama Wazni, MD, MBA:

Most patients, we really have to assess their risk, stratify them, meaning assess the risk of stroke in AFib. If they reach a certain threshold, they should be on a blood thinner. Now, these other procedures we're talking about are recommended right now in patients who are not able to tolerate blood thinners in the long term. That's when we would try to decrease the risk of stroke by mechanically closing the left atrial appendage, whether it's surgically or with a device that we place percutaneously. Now, who is the patient who would benefit from a combined procedure, meaning doing the ablation plus closing the left atrial appendage at the same time?

Dr. Mohamed Kanj, MD:

Okay. This is a strategy that we've been thinking about for the past more than 10 years. We've pioneered this at Cleveland Clinic since 2015, and we were trying to push that envelope because what we've seen is that of patients who have atrial fibrillation, they need their stroke addressed. A lot of patients who come into the labs for atrial fibrillation ablation also have an increased risk of stroke, and they have an increased risk of bleeding. Patients who have atrial fibrillation and have an increased risk of bleeding to where we’re going to put in a WATCHMAN, they also need their atrial fibrillation addressed.

A lot of our patients actually fit in that category. Right now, the indication for closing their left atrial appendage is patients who had prior bleeding, patients that are increased risk of bleeding, patients at increased risk of stroke despite oral anticoagulation, all of these has been an indication for a stroke, indication for a WATCHMAN or closure of the left atrial appendage. But what we've seen is that this group of patients who need an ablation and the patients who need closure, there's a lot of overlap, Oussama, between these two groups. If you look closely, you'll find out that this group constitutes a good percentage of patients with atrial fibrillation.

Dr. Oussama Wazni, MD, MBA:

So, just to quickly summarize things. You have a patient who is symptomatic with atrial fibrillation, but also needs stroke prevention. On the other hand, that person, that patient may not be able to take long-term anticoagulants because of either previous major bleeding or risk of ongoing bleeding. Therefore, the best approach for these patients is to do an ablation plus left atrial appendage closure at the same time. Could you tell us, what are the benefits of doing them together? Because, of course, we pioneered it in 2015, but even when we did it, there were a lot of people who were questioning that strategy. First of all, let's discuss why they would question the strategy and then why we thought that this would be beneficial for our patients.

Dr. Mohamed Kanj, MD:

Okay. I think it's a fair concern that a lot of people raised because there are a lot of variables. One of the things that you want to make sure of is the safety of the procedure. You want to make sure that when you combine both procedures, are you subjecting patients to an increased risk?

The second thing is the efficacy of the procedure. Does doing the procedure, for example, an ablation, affect the outcome of a closure device, or does doing a closure device affect the outcome of an ablation?

These are valid questions, but what we have seen from our data here at Cleveland Clinic is that actually there was no increased risk of complications from doing both procedures at the same time. In fact, we've seen a better safety strategy because you don't have to bring patients for another procedure and that will decrease the risk of complications of the procedure.

And at the same time, the efficacy, we did not see that doing an ablation will decrease the efficacy of a closure device or doing a closure device will decrease the efficacy of doing an ablation. However, there are patients that, when we were doing the procedure, we elected not to perform both procedures if we see certain changes with the echocardiogram or the ultrasound that we put inside the heart, for example, swelling. If we've seen changes, then we elected not to perform both procedures. But the vast majority, we were able to do both procedures at the same time.

Dr. Oussama Wazni, MD, MBA:

The swelling that Dr. Kanj is mentioning is what we call the landing zone of where the device would sit. Sometimes, because the ablation encroaches on that area, there could be swelling, and then at that time we may elect not to implant the device, but those are the minority of patients.

Now we've set the stage. A patient who needs an ablation and also needs left atrial appendage closure, I think the best strategy is to combine them together. Frankly, we've shown that it does decrease the risk. We should not have to expose the patient to two procedures. We have to get access in the groin, put them under general anesthesia twice, do a transseptal puncture, get into the left atrium twice. Instead of doing all of these steps two times in two separate procedures, we can combine them all into one procedure. Over the years, we've developed the skill to decrease the risk of the ablation and left atrial appendage closure. That's why we thought doing it together is the right answer.

Now, there was a recent study that we led here from Cleveland Clinic called OPTION, and this was just published in the last two years. That's when, nationally, the combined strategy took off. Up until then, from 2015 until about two, three years ago, we were probably the only institution in the country that was doing this on a regular basis. But once the OPTION study was published, this took off, and now the biggest growth in procedures for left atrial appendage closure is in patients who get the combined procedure. Can you tell us just quickly about the OPTION trial and what it showed?

Dr. Mohamed Kanj, MD:

So again, Oussama, you led this OPTION trial, so you're best person to talk about it, but I'm going to summarize. With the OPTION trial, we looked at patients who have atrial fibrillation, came into the lab for atrial fibrillation ablation. Half of these individuals, we elected to do an ablation and continue on oral anticoagulation. Then the other half we elected to do the AFib ablation and put a WATCHMAN at the same time or shortly after the atrial fibrillation ablation. We monitored these patients for around three years. What we've noticed is that, after monitoring three years, the risk of stroke was the same in the two groups. The success rate of atrial fibrillation ablation was the same in the two groups. This is similar to what we've seen at Cleveland Clinic. What we've seen is that the risk of major bleeding and complications was lowered by, I think, 55 to 60% in the group that got the WATCHMAN compared to the ones who stayed on oral anticoagulation.

Dr. Oussama Wazni, MD, MBA:

The bleeding, just to clarify, medically, it was not major bleeding. It was what we call clinically relevant non-major bleeding, which was still important bleeding and significant bleeding, it just didn't hit the criteria of major bleeding based on medical literature. But still a lot of bleeding, meaning they could have a GI bleed that did not need transfusion, they could have nose bleeds that take them to the hospital. It's any bleeding that needed medical attention but did not hit the criteria of major bleeding.

But importantly, in the OPTION trial, like Dr. Kanj just mentioned, the combined procedure did not decrease the efficacy of the device in terms of reducing the risk of stroke and it did not decrease the efficacy of ablation. The safety during the procedure was actually very, very high. We did not even have one single tamponade or perforation of the heart during the combined procedure.

So, that was using radiofrequency and cryoablation, freezing or heating the tissue. Now we're beyond that. Now there's something called pulsed field ablation. It's a legitimate question saying, "Okay, you did OPTION, but it was a strategy of thermal energy ablation and left atrial appendage closure." Does your use of pulsed field ablation change that in any way or is it the same? Has pulsed field ablation maybe increased the concept or encouraged more people to do the combined procedure?

Dr. Mohamed Kanj, MD:

I think we also have data to suggest that pulsed field should encourage people to do a combined procedure. The reason for this is that, doing an ablation with pulsed field ablation, the procedure is shorter. You don't require a lot of fluids compared to the radiofrequency ablation. There are less changes in the shape of the left atrial appendage. Some data suggests there's less swelling inside the heart. We have recent data from Cleveland Clinic here that was recently published looking at the safety and the efficacy of the combined procedure with WATCHMAN as well as pulsed field ablation. We saw the same thing. We’ve seen encouraging data that this strategy is safe, as well as effective.

I think with the efficiency and the efficacy of doing pulsed field ablation, it made this procedure, Oussama, relatively short, and short is not a bad thing. It's really good for our patients because these patients are sicker, they are older. If you can get them through this procedure in around an hour and a half, where you can do a combined procedure, that's very good for our patients. This is safe and effective for our patients. That's why I think a lot of our patients who need AFib ablation may require left atrial appendage closure at the same time. But more importantly, the patients who need a left atrial appendage occlusion, I think these patients, really we should address their atrial fibrillation at the same time.

Dr. Oussama Wazni, MD, MBA:

So, this is a very important point that Dr. Kanj mentioned right now. We've been talking about patients who come in needing an ablation, and then we add left atrial appendage closure, because that's how we do it in the procedure. We do the ablation, then do left atrial appendage closure in the same procedure. But because pulsed field ablation is faster, safer and basically patients can go home the same day, now we're seeing patients who are referred to us for left atrial appendage closure, and then we discuss with them an ablation.

Let's talk about those briefly because we have to move on to what do we do after. Who is the patient who is referred to you for left atrial appendage closure, but then you would say, "Maybe I also should consider an ablation in this patient."

Dr. Mohamed Kanj, MD:

A lot of patients, if they have, for example, again, symptoms, if they have structural heart disease, getting them back in sinus rhythm is very important. For example, if they have symptoms, I think you have to try to get them back in sinus rhythm. If they have heart failure, meaning a weaker heart, you have to try to get them back in sinus rhythm. If you see this individual has valvular regurgitation, their valves are leaking. A lot of these patients, if you fix their atrial fibrillation, you see improvement in their valves. If their left atrium is not too big, these get an advantage. Or if patients, they haven't been in atrial fibrillation for decades. I mean, I think every patient needs an attempt to try to get them back in sinus rhythm if you think that they're going to get benefit from that.

Dr. Oussama Wazni, MD, MBA:

That's an important point. What happens usually is that the patient and their medical team could have already discounted AFib because they've had it for a few years. They haven't made much success in treating it. The patient maybe got used to it, and now what they're faced with is the issue with bleeding from an anticoagulant.

So, then the problem that's now facing them acutely is, how do I manage their anticoagulation since they're bleeding? So, they refer them to us for left atrial appendage closure, but then when we look at the patient in totality, because of what we mentioned earlier in the podcast. It's not just about symptoms, it's about heart failure, it's about stroke prevention in addition to ablation itself, maintaining normal rhythm. That's why now, even when the patient comes to us just for a left atrial appendage closure because of bleeding, we are not just blindsided by that fact. We're managing the patient in totality. That's why I think it's a very important thing to keep in mind. Yes, a lot of patients who are referred for left atrial appendage closure because they're faced now with acute problem of bleeding will benefit also from an ablation.

Now, during the procedure, we still do it the same way, meaning we ablate and then we close the appendage. But this time we added the ablation to the original plan of what they came in for.

Just briefly, can you describe the procedure itself, and then what does the patient expect after the procedure?

Dr. Mohamed Kanj, MD:

All these procedures are done under general anesthesia. Patients come to the operating room, they'll be under general anesthesia, we prep them and drape them. We put intravenous access in the right and left groin, and then we take catheters from the leg all the way up to the heart. We find the areas that most of the time cause atrial ablation around the pulmonary veins and the posterior wall. We cauterize them by pulsed field ablation, and then at the end, we place a left atrial appendage closure device, which is WATCHMAN or one of these devices.

We have two ways of doing the guidance to place the WATCHMAN. The guidance is like using a camera, we call it ultrasound. We can do this procedure using transesophageal echo, where the patients, while they're asleep, will have a probe inserted from the mouth down to the swallowing tube and that gives us an idea about the shape of the left atrial appendage and guide us through the procedure. Or we can do what we call intracardiac echo where we put an ultrasound probe in from the left leg or from the right leg, and that will guide the imaging procedure so we can successfully put the left atrial appendage closure device.

A lot of times, patients can spend the night or go home the same day. What to expect? We've been closing the leg puncture site by an inside stitch or a plug. Patients will be ambulated within two to three hours. We tell them to take it easy for a few days. They usually go back to their normal lifestyle between five to seven days.

Dr. Oussama Wazni, MD, MBA:

So, it's a relatively quick procedure. Most patients are discharged the same day, and they're back to their activities within five to seven days. Now, when can they expect to stop the anticoagulation?

Dr. Mohamed Kanj, MD:

So that's a very good question, an excellent question. We want to make sure that the left atrial appendage closure device is well seated, there's no significant leak, there's no blood clot. We do that screening between two to three months. Most of the time we do it at three months. If that time we find out that it is well seated, there's no significant leak, there's no clot in the device – and we see that in around 98% of patients, 97, 98% – this is when we transition anticoagulation to aspirin or a single antiplatelet therapy.

However, sometimes we may extend this duration if, for example, we still need to work on the AFib. For example, patients who require another AFib ablation or something like that, we may need to extend that duration until we know that we've addressed the atrial fibrillation at the same time.

Dr. Oussama Wazni, MD, MBA:

We touched on it, but we didn't talk about it specifically. Are there instances when you go in with the plan to ablate and also close the appendage, but then decide not to close the appendage?

Dr. Mohamed Kanj, MD:

Yes. If the anatomy is not fit for a closure device. For example, if the anatomy is too big or too small, then it cannot fit a closure device. If we see, for example, significant swelling, as you mentioned, at the area where we're going to put the left atrial appendage closure device, we back off. We bring the patient back another time because again, our standard is very high here at Cleveland Clinic, so we want to make sure. We only have one shot to put that left atrial appendage in. We really want to make sure that, if we put it in, it's the best way to put it in and the best chance is that this device is going to stay in the right place.

Dr. Oussama Wazni, MD, MBA:

This is a very important point. Once that left atrial appendage closure device is in, it's in. It's very hard to take it out. It can be taken out. If there are leaks, it's very hard to close the leaks. That's why, at Cleveland Clinic here, we really are very particular on the placement of that left atrial appendage closure device to make sure it fits well, that it's not going to move, there's not going to be any leak and it's going to be the most perfect result. If we can't achieve that, we will not put one in. Then, we would consider other ways of closing the appendage, whether it's by clipping the appendage surgically or getting a device later in time.

In general, most patients do very, very well. We are able to close the appendage in more than 98% of the patients while we're doing the combined procedure at the same time. Patients end up stopping their anticoagulation within two to three months. Most patients, depending on the stage of their atrial fibrillation, do very well from the ablation standpoint. The success rate is around 70% for everybody. Now some will be lower, some will be higher, depending again on how progressed the atrial fibrillation is. Any final take-home message from you, Dr. Kanj? Then, I'll wrap up.

Dr. Mohamed Kanj, MD:

I think we're very grateful that our patients trust us. I think it's very important to seek a center where they're experienced in doing excellent AFib ablation, excellent left atrial appendage closure device and excellent combined procedure. I think you want to make sure of that, because these two procedures are two different procedures, the operator has to be excellent in doing both and excellent in doing both together.

Dr. Oussama Wazni, MD, MBA:

Very well said. Another aspect of this that we didn't touch upon too much is that we're in the heart and we're doing two procedures and complications can happen. They're very rare, but they can happen. Patients should go to a center where complications can be handled effectively and efficiently. Here at Cleveland Clinic, we are blessed that we are very good at handling the complications, but also, if needed, we have a whole surgical team that is available onsite in case there is a bad complication. Thankfully, we've been able to handle all major complications with no long-term effects for the patients. That's why it's very important to be careful in selecting where a patient is going to have their procedure.

I think this is something that's very promising. At Cleveland Clinic, now almost 50% of our procedures for left atrial appendage closure are a combined procedure, where the patients get ablation plus left atrial appendage closure. Our success rates have been very high. Our complication rates have been very, very low. It's been a long, long time since we needed surgical intervention to help a patient who has had a complication.

In the future, there are actually a few more developments that are coming. Right now, as we discussed, we will do an ablation when it's indicated to treat symptoms to prevent stroke, to prevent heart failure. We would close the appendage in patients who are having difficulty taking oral anticoagulation. But in the future, it is conceivable that the left atrial appendage closure device may replace anticoagulation even in those patients who can take anticoagulation. Now, you may ask, "Why would we want to do that?" There are many reasons why. The most important one is compliance, so that the patients don't have to take a medication every day, and we replace it with a device that can help them with that. Any final thoughts, Dr. Kanj?

Dr. Mohamed Kanj, MD:

No, I think you summarized it very well. Thank you for having me.

Dr. Oussama Wazni, MD, MBA:

Thank you. Thank you everybody for attending this podcast. Until next time. In the meantime, if you have any questions, please feel free to reach out to us. We'll be happy to answer them.

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