Melanie Cole, MS (Host): Welcome to UAB Med Cast. I'm Melanie Cole and joining me today is Dr. Tom McElderry. He's an Assistant Professor and Section Chief in Electrophysiology and the Co-Director of the Heart and Vascular Center at UAB Medicine. He's here to update us on the Watchman device and procedure.

Dr. McElderry, it's a pleasure to have you join us. We did a previous podcast on this topic. I'd like you to start by updating us, what's different now. It's a pretty exciting time in your field. Tell us a little bit about AFib and what you've been seeing in the trends.

Tom McElderry, MD: Yes, Melanie. Thank you. A lot's changed, particularly in the area of left atrial appendage occlusion. I think we probably, called this procedure a Watchman, every time we mentioned it in our last podcast, but now there's another device on the market that we have to use in patients with the appropriate anatomy.

It's called the Amulet device. The Watchman device itself has changed and the design is much safer. It's more efficient to implant. It's easier for the doctor and the patient. In fact, almost all of our left atrial appendage occlusion patients, come in and have the procedure done and are able to leave the hospital the same day.

So it's, really been an exciting time in this field and we're looking forward to even further advancements as we continue to study and refine this technology.

Host: Wow. You know, technology's moving so fast. So Doctor, in what ways, specifically are devices such as Watchman and Amulet, evolving that treatment of left atrial appendage closures?

Tom McElderry, MD: I, think there's several ways that they're evolving the treatment. Perhaps the first is, looking at different options for blood thinners after implant. The entire point of the left atrial appendage occlusion procedure is to try to get people off of as many blood thinners as possible. Since we last talked, an alternative regimen to continuing warfarin are direct oral anticoagulants like Eliquis and Xarelto has been approved. It's a regimen similar to what people get after a coronary stent. It's using a medicine called Plavix plus aspirin for 90 days, and then people can get to just a baby aspirin a day after that. With some new coatings that, the manufacturers are using for the devices that allow tissue overgrowth in a more controlled fashion, I think we're gonna be able to modify these regimens and get people down to baby aspirin or maybe no, anticoagulant therapy whatsoever, in a faster, more efficient fashion.

Host: Has anything changed as far as patient selection? Has it expanded so that now it includes many more patients?

Tom McElderry, MD: I think so. I think initially we reserved the Watchman device for patients who had very substantial bleeding, GI bleeds, nose bleeds, falls where they bump their heads and have subdural hematomas. One of the reasons for that was at the time the Watchman implant was more challenging to accomplish.

And quite honestly, there were some sharp edges on that device that could, for lack of a more elegant way to describe it, could poke a hole in the heart, which of course is a very big deal. With the newer devices and the procedure complication rates down to well under 1%, we feel like we can expand that population a bit.

 I'll tell you, one of the patient populations that we see that can benefit from this device now is, is people with arthritis who need to take medicines like Motrin or Mobic, ibuprofen that we know, in combination with blood thinners can really increase the risk of bleeding complications. So being able to do the Watchman device or Amulet device for them and get them down to just a baby aspirin a day to allow them to take the medicine that they need for their arthritis can really be a big deal from a lifestyle standpoint, for these people. So that's, uh, really the population we're seeing the most growth in.

Host: And what do you feel are some factors that play the biggest role in impacting outcome for these patients? Tell us a little bit about what you've seen as far as Watchman and Amulet and the after effects.

Tom McElderry, MD: Well, the patients love it. The ability to get off of these blood thinners and be on fewer medicines is fantastic. I think that the advances in the procedure and the procedural safety, the elimination of the need for transesophageal echo during the procedure has been a real advance for us. I think that as we move from

2D Intracardiac echo to 3D intracardiac echo is gonna make the procedure even better for the patients and, and quite honestly for the physicians as well, because it's gonna allow us to place that device in a better

fashion so that we can eliminate any potential leaks around the device. By doing that and being able to do it as a same day discharge procedure, it's really been great for the patients, it's actually, pretty easy for them to recover from as well.

Host: With the advent of intraoperative imaging that you were just discussing, can you tell us a little bit about the learning curve now? Because when this first came out and you and I did a podcast about it, it was pretty new to many physicians. Tell us a little bit about what you're seeing now.

Tom McElderry, MD: There's definitely still a learning curve. I think with all of our procedures, there's a learning curve, but, as the imaging improves, particularly with the three dimensional intracardiac echo, it allows the operator to get many different looks at the device and exactly how it sits within the appendage, so that we can ensure that there aren't any leaks and there aren't any other issues with the device.

And so I guess with that aspect, it does make it easier to implant and might make the learning curve a little less. The other thing too, is that with some of the advances in the device, you're able to deploy it, look at it, and if you're not thrilled with the device placement; you can recapture and reposition and deploy and look again, and that ability was limited with the first generation devices.

Host: That is exciting. That's pretty cool actually. Now, has UAB Medicine been involved in any clinical trials related to Watchman and Amulet?

Tom McElderry, MD: Absolutely. With respect to one of your earlier questions about patient population, we would love to offer this to more patients and we would love to show that this is equivalent or maybe even better than oral anticoagulant therapy. And so, UAB has been involved in two clinical trials, one with an Amulet device called the Catalyst Study and one with the Watchman device called Champion AF. And both of those studies have looked at the left atrial appendage occlusion device as a true alternative to oral anticoagulant therapy, so patients agreed to enroll in the study. There was a randomization, so a coin flip, if you will, whether they stay on their medicine like Eliquis or Xarelto or whether they get a Watchman device.

And so we're gonna follow those patients for about four or five years and look and see how they do. And there are a few things that are important to me in this study. Of course, the first is stroke, but we also know that people who take oral anticoagulants, have a lower risk of neurocognitive decline and dementia. Probably from teeny little imperceptible strokes that accumulate over time and create damage to the brain. If we can show that the left atrial appendage occlusion devices not only protect people from stroke, but also from neurocognitive decline and dementia; I think, this is gonna be a terrific alternative to blood thinners to anyone who has atrial fibrillation and is at risk for stroke based on their CHADS VASC risk score.

Host: Dr. McElderry, is there any difference in which device you use? Do you have a preference?

Tom McElderry, MD: Well, I think every patient's anatomy is different and I think the ability to have multiple tools to address a problem is important. And so we look at anatomy and try to make a decision on a patient by patient basis, which device is best for that patient. Now that being said, presently the Watchman Flex device is a little bit more mature technology.

It was the first to market and then was the first to have an iterative development. So I think you'll see that we do more Watchman devices than Amulet devices, but competition in this marketplace is fantastic because as each manufacturer's device gets better and new devices become available, then the patients and the doctors are gonna win.

Host: 100%. As we wrap up, what are the conditions under which you believe patients would benefit most, from your experience, this procedure, and the experts at UAB Medicine? I'd like you to summarize for other providers and referring physicians what you would like them to know about the work that you're doing as it relates to left atrial appendage closure devices.

Tom McElderry, MD: Definitely. I'd like folks to know that this isn't the left atrial appendage occlusion procedure from six or seven years ago where there was a one to 2% risk of cardiac tamponade. I'd like people to know that in our large NCDR database, when we look at the surpass data, that the procedural complication rate is less than one half percent. We're able to do these procedures now very safely. We're able to do them efficiently without the need for transesophageal echo.

We're able to do them as same day admission and discharge so that the burden on the patients and their families is substantially reduced. And that the anticoagulant regimen after procedural implant for most patients is only about 90 days with aspirin and Plavix, and then to a baby aspirin alone afterwards.

So we've come a long way since you and I talked last, and, we're excited about some of the things in the future with the new coatings on the device, and, some of these new studies that may one day make left atrial appendage occlusion a true alternative to oral anticoagulant therapy as first line treatment.

Host: Beautifully said and such an exciting time. Dr. McElderry, thank you so much for joining us and giving us an update on all those exciting things that you're doing at UAB Medicine. And for more information, please visit our website at uabmedicine.org/physician. That concludes this episode of UAB Med Cast. I'm Melanie Cole.

Thanks so much for joining us today.