Could a Left Atrial Appendage Closure (LAA) be Helpful for You? Part 1

Podcast Transcript

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Oussama Wazni, MD, MBA:

Hello everybody, and welcome once more to a podcast from Cleveland Clinic Electrophysiology. I am Oussama Wazni, the Section Head of EP here at the Cleveland Clinic, and today I'm joined with Dr. Walid Saliba, who is the Director of the EP Lab and Director of Atrial Fibrillation Center, Dr. Mohamed Kanj, who is the Co-Director of the EP Lab, and Dr. Tyler Taigen, who is the Director of the Outpatient Department and also Director of our Quality Outcomes Program here at the Cleveland Clinic.

Oussama Wazni, MD, MBA:

Thank you very much for joining us. We will be talking today about left atrial appendage closure in a setting of atrial fibrillation and patients who cannot tolerate anticoagulation. Walid, could you tell us just briefly, what are the current indications for left atrial appendage closure?

Walid Saliba, MD:

Sure. So left atrial appendage closure is a procedure that has specific indications currently in the U.S. It is indicated for patients who have what we call nonvalvular atrial fibrillation, meaning atrial fibrillation that is not due to mitral valve stenosis and these patients do not have mechanical mitral valve. So in patients with nonvalvular atrial fibrillation who are indicated for anticoagulation, this means that they have a risk of stroke based on a certain risk factor scale that we have that we call the CHADSVASC score. If the risk of stroke is significant, that warrants anticoagulation, they need to be on oral anticoagulation, but for some reason, which is usually bleeding or risk of bleeding, they cannot be on longterm oral anticoagulation. So those patients are at risk of having a stroke. They need to be on anticoagulation, but cannot take it. Therefore, closing the left atrial appendage in those patients will reduce the risk of stroke without the need to be on longterm oral anticoagulation.

Oussama Wazni, MD, MBA:

So basically it's an alternative for oral anticoagulation in patients who have risk of bleeding or already had a major bleed. Could you just please expand for us on what the CHADSVASC score is because I'm sure a lot of our patients and even some physicians are asking. This CHADSVASC score is something of a black box. Could you expand on that please for us?

Walid Saliba, MD:

Sure. So the CHADSVASC score is a clinical scale that evaluates the risk of stroke that patients with nonvalvular atrial fibrillation have, and it's a mnemonic, so CHADSVASC, the C, the H, and what have you, each one is for a certain disease or clinical entity. Most importantly is age. Usually more than 65 gives you a point of one, more than 75, two points. Gender, female get a point of one, they are at high risk. The presence of heart failure, the presence of vascular disease, a prior history of stroke, a history of hypertension, as well as history of diabetes mellitus.

Walid Saliba, MD:

So these are risk factors. You get points for each one of these risk factors, and then based on the total score, we evaluate what is your yearly risk of stroke. Are these the only things? No, there are some other risk factors that we look at as clinicians, but this is what is readily available in the Clinic as far as we are concerned.

Oussama Wazni, MD, MBA:

So to simplify, just for those of you with a good memory, C is for congestive heart failure, H is for hypertension, A is for age, D is for diabetes, S is for stroke, and VASC is for vascular disease, and S also is for sex, usually female gender. So there you go, you have the CHADSVASC score. Based on that, if you have a score of two or more, you're supposed to be on a blood thinner or an anticoagulant in the presence of atrial fibrillation to prevent stroke. If it is one, you can do nothing, take aspirin or oral anticoagulation. I frankly prefer an oral anticoagulant. If the CHADVASC score is zero, then usually the answer is nothing, not to take anything. So basically now then, we've established that somebody whose CHADVASC score is two or higher, and they should be on a blood thinner but cannot because of bleeding problems, then they're indicated for left atrial appendage closure.

Oussama Wazni, MD, MBA:

All right, so now the patients come to you, Dr. Saliba, and say, "I want this Watchman. I can't take a blood thinner, or a left atrial appendage closure, and I can't take a blood thinner." Are you able, or are we able now, to provide this therapy with no anticoagulation at all, no background anticoagulation at all? Or do they need to be on a blood thinner for a certain period of time?

Walid Saliba, MD:

So that is a good question because traditionally with the first device that we had on the market, which is the Watchman device, the recommendation was that the patient needs to be on oral anticoagulant for a short period of time, usually it's for 45 days after the implant, following which we do an imaging procedure to make sure that the device is well in place and well-sealed, and if that is the case, then we would stop the oral anticoagulant.

Walid Saliba, MD:

So for the Watchman device, current indications and recommendation is that you need to be able to take oral anticoagulant for a short period of time, that 45 days, and in our experience, even though patients have had contraindications or relative contraindications to being on longterm oral anticoagulation, giving them short term oral anticoagulation is feasible and not necessarily risky. This has been based on our experience.

Walid Saliba, MD:

With the new Amulet device that is on the market, with that device, you do not need to be on oral anticoagulants following the procedure, but yet still you need to be on what we call dual antiplatelet therapy, which is Plavix and aspirin. That is not to say that the risk of bleeding is significantly less compared to oral anticoagulants. There is still an ongoing risk of bleeding that usually for a short period of time is acceptable for those procedures.

Oussama Wazni, MD, MBA:

Very good. So the main reason to stay on an oral anticoagulant for these six weeks after implantation is so that there is something called endothelialization where the patient's own tissue grows over the device. This is important because of an issue with the clots forming on the device, otherwise called DRT or Device-Related Thrombus, and that's a problem because then we have to extend the period of giving anticoagulation so that that can resolve. Now, are there any new developments, Dr. Saliba, that maybe will help us avoid oral anticoagulation altogether after we implant a device?

Walid Saliba, MD:

So as Dr. Wazni said, this is really the Achilles heel, if you want, of those devices. Every time you put foreign material or metal in the vascular space, there is a certain risk of forming a clot, and this is why we have to give that either anticoagulant or antiplatelet therapy to try to mitigate as much as possible formation of clots on those devices.

Walid Saliba, MD:

Now, there is also certain research that we are involved with trying to, I would say, coat the device or the fabric that is on the device to reduce as much as possible the risk of this clotting from forming. We are currently conducting some research, it's still in the animal stage, looking at what is it that increases the risk of clot formation and, with these new coatings or these new devices, are we essentially reducing the risk of clot formation? The results so far are very encouraging, hopefully to be able to put those devices in the future without the need of blood thinning medication thereafter.

Oussama Wazni, MD, MBA:

So it looks like it's conceivable we will reach a stage where we'll have a device where we do not need to use anticoagulants in these patients, and that's very important because some of our patients have significant bleeding issues. All right, now Dr. Kanj, who is our Co-Director of the EP Lab, could you tell us if we are able to do a left atrial appendage closure at the time of atrial fibrillation ablation, and who is the ideal patient for this procedure?

Mohamed Kanj, MD:

This is an excellent question. I mean, it's not uncommon that we have patients who may need atrial fibrillation ablation, but at the same time, they have some concerns about taking oral anticoagulation or vice versa, especially that we know that procedure where we close the left atrial appendage technically shares a lot of the steps with an ablation procedure.

Mohamed Kanj, MD:

So here at the Cleveland Clinic, we've had good experience so far with doing concomitant procedures. We've been doing that for the past almost six years, and we've had great track records with excellent safety and efficacy of both of these procedures being done at the same time. I think we are probably one of the few centers, if not the biggest center in the U.S., who perform both of the procedures at the same time.

Mohamed Kanj, MD:

The advantage is patients could have both things done in one visit, the ablation at the same time as closing the left atrial appendage. In this way, we hope that for patients taking care of the atrial fibrillation, but at the same time being able to come off oral anticoagulation two to three months after doing the concomitant procedure.

Oussama Wazni, MD, MBA:

So could you tell us about how many we've done so far?

Mohamed Kanj, MD:

So we have done around 300-plus patients, and so far some of these patients, 150 of them, we've had more than a year of excellent follow up with a very, very low complication rate. We did not see that doing both procedures would increase the complication rate significantly, but we're getting, in fact, good results, excellent results.

Oussama Wazni, MD, MBA:

I think this is the highest single center experience in the world. I mean, there's some pool data from other places, but I don't think that a single center has been able to achieve this number, so that's a great testament to the teamwork that we do here at the Clinic because this also involves a clinical cardiologist, an imaging cardiologist, the own patient's physician, and our team here at the Cleveland Clinic.

Oussama Wazni, MD, MBA:

We look forward to seeing you in the next podcast from Cleveland Clinic Electrophysiology. Thank you.

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