Watchman Device and Procedure

Additional Info

• Audio File:uab/ua145.mp3
• Doctors:McElderry, Tom
• Featured Speaker:Tom McElderry, MD
• CME Series:Medical Innovations
• Post Test URL:https://cmecourses.som.uab.edu/mod/quiz/view.php?id=4159
• Guest Bio:Tom McElderry, MD is the Section Chief, Electrophysiology , Co-Director, Heart & Vascular Center. 
  
  Learn more about Tom McElderry, MD 
  
  
  
  Release Date: August 31, 2020
  Expiration Date: August 31, 2023
  
  Disclosure Information:
  
  Planners:
  Ronan O’Beirne, EdD, MBA
  Director, UAB Continuing Medical Education
  
  Katelyn Hiden
  Physician Marketing Manager, UAB Health System
  
  The planners have no commercial affiliations to disclose.
  
  Presenters:
  Tom McElderry, MD
  Assistant Professor, Section Chief, Electrophysiology; Co-Director, Heart & Vascular Center
  
  The speaker has no financial relationships related to the content of this activity to disclose.
  
  There is no commercial support for this activity.
• Transcription:Melanie Cole: UAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of 0.25 AMA PRA category one credit. To collect credit, please visit UABmedicine.org/medcast and complete the episodes post-test.
  
  Introduction: Welcome to UAB Med Cast, a continuing education podcast from medical professionals bringing knowledge to your world. Here's Melanie Cole.
  
  Host: Welcome to UAB Med Cast. I'm Melanie Cole and today we're discussing the Watchman procedure. Joining me is Dr. Tom McElderry. He's an Assistant Professor and the Section Chief in Electrophysiology and the Co-Director of the Heart and Vascular Center at UAB Medicine. Dr. McElderry, I'm so glad to have you join us today. Tell us a little bit about what you're seeing in the trends for a AFIB as of now.
  
  Dr. McElderry: Oh yes. Great to have this conversation with you. Thank you for the opportunity. We have seen over the past 10 years or so. More and more patients come to the diagnosis of atrial fibrillation. I believe that access to medical care and in particular access to personal devices that will actually diagnose your atrial fibrillation has increased the number of patients that we have the opportunity to see nowadays and I think it's fantastic that people are taking such an investment in their own healthcare. And monitoring a number of different parameters including heart rhythm on their own.
  
  Host: Well, that's certainly is true. So tell us a little bit about the American College of Cardiology and the American Heart Association focused update of their 2014 AFib treatment guidelines. What's changed?
  
  Dr. McElderry: I guess a number of things have changed. Probably the most important is how we protect people from the risk of stroke and mini stroke and even memory problems and cognitive decline that can be associated with folks who have atrial fibrillation and aren't adequately managed. With the most recent update, they basically engineered aspirin as a treatment option out of the equation. There are two reasons for this. I think number one is aspirin really was not an effective therapy to help protect people from the risk of atrial fibrillation. And number two is that we have other blood thinner medicines that have exactly the same risk of bleeding but doing much better job of protecting people from the risk of stroke and systemic embolism. And like I mentioned, probably even memory problems and dementia as well. In addition to the blood thinner medications people can take there is another option that's particularly great for folks who have trouble taking blood thinners and that's left atrial appendage occlusion. And the one device that's on the market now is called the Watchman device.
  
  Host: So as you've said, there are many oral anticoagulants and they're an important therapy, but they do come with risk factors and limitations and many patients don't even want to continue to take them so they need an alternative. You mentioned the Watchman. Tell us a little bit about this procedure, Doctor, and when you're, when you're really choosing it for your patients.
  
  Dr. McElderry: I think initially we were very deliberate with the rollout of left atrial appendage occlusion. We wanted to see how the device handled in our own hands and make sure that the safety that we saw in clinical studies was the same safety that was out in clinical practice. And in fact, if you look at some of the registry data, it seems that complications continued to decline even past what we saw in the clinical studies. I think the Watchman is a great device for patients who either can't take blood thinners because they've had bleeding risk. Typically that's the GI bleeding. Also patients for it increased risk of a falls or other serious complications of oral anticoagulant therapy. And even in a number of patients, that cost becomes such an issue for these novel agents that they're just not going to take them. And we need to find another alternative to manage their risk of stroke.
  
  Host: So then let's talk about patient selection and tell us who is an ideal candidate and who might not be a candidate for this procedure?
  
  Dr. McElderry: Great. So I think almost anyone who has atrial fibrillation could be a candidate for this therapy. We initially focused on patients who had a contraindication or relative contraindication to oral anticoagulant therapy. But I think it's moving more into the realm of patient preference. So I think for the most part, anybody who's on oral anticoagulant therapy for an indication of Afib could be considered for this procedure. Now, patients who are on anticoagulant therapy for reasons other than atrial fibrillation or in addition to atrial fibrillation would not be good candidates for this procedure. Patients who are not able to take any anticoagulant therapy for any period of time also would not be good candidates for this procedure. Presently unlabeled, patients would be on warfarin for about six weeks and then be on dual antiplatelet therapy with aspirin and Plavix out in the six months.
  
  And then aspirin alone. Clinical practice has really changed over the last several years where most of our patients are not on Warfarin at all if they are on one of the novel agents. We only keep that for six weeks and then transition to the Plavix and aspirin therapy. But many are, they're saying most of our patients only take dual antiplatelet therapy in conjunction with having the Watchman procedure. And we're typically stopping that in the four to six month range and transitioning to aspirin alone after that. So for folks who just couldn't take dual antiplatelet therapy, there would be a risk of device related thrombus and I don't think the Watchman would be a good procedure for those guys.
  
  Host: Well, thank you for that answers. So as you're telling us why it's a good choice to reduce the risk of stroke as well as blood thinners, what's the procedure like? How does it work and do you have any technical considerations you'd like other providers to know?
  
  Dr. McElderry: So the procedure is really pretty straightforward. Currently what we do is patients come to the heart and vascular center in the morning, we take them to the procedure room. We do a transesophageal echo at the time of the procedure. Initially we had been doing screening echoes, but we found that the rate at which people screened out for their procedure was so low that it just didn't seem necessary. So we actually do the screening, echo and the procedure at the same time. As long as the appendage is large enough for the device but not too large. Then we proceed with the procedure which is a femoral venous access followed by a transseptal puncture, and then entry into the left atrium, left atrial appendage. We place a pigtail catheter in the left atrial appendage and then advance a delivery sheath over that. And then we position the Watchman device in the appendage and retract the sheath, which unsheathes the device, which then expands in the appendage and we use the transesophageal echo to make measurements to show that the device is well approximated appropriately compressed and has no leaks around it. We've also started using some intercardiac echo to compliment that and it may be in the future that we eliminate transesophogeal echo altogether and do the procedure with intracardiac echo alone.
  
  Host: How have been your outcomes Doctor?
  
  Dr. McElderry: Oh, I think our patients have done really well. They've been very appreciative of the therapy and the lifestyle changes that it affords them by not having to take blood thinners. For the most part, patients are able to come in, have the procedure done and go home the next day. And so we've been very pleased with this device and look forward to some of the other devices that will come be coming out in the future.
  
  Host: And talk about the post-implant drug regimen. You mentioned it a little bit before. Do your patients still have to be on their meds after this procedure?
  
  Dr. McElderry: They do. I mentioned that on label therapy would have people on warfarin or maybe a novel agent for about six weeks. They would then have a transesophageal echo to confirm that the device was well approximated without significant lakes or device related thrombus. And then transition over to Plavix and aspirin, you know, dual antiplatelet therapy for about six months and then would decrease the aspirin therapy alone. For the most part though, we've really transitioned away from that and patients are on dual antiplatelet therapy for the first four to six months. They get a transesophogeal echo to confirm no device related thrombus and good approximation without leak. And then their transition to aspirin therapy for another six months. And then if all looks good at that point, they be on no oral anticoagulant therapy at that time.
  
  Host: So as we wrap up, what does the future hold for stroke reduction in AFib patients? Do you have any interesting studies or research you'd like other providers to know, wrap it up for us?
  
  Dr. McElderry: Oh, absolutely. I think this is an exciting space for us to begin. I think that the FDA and then us say you may be locally, we're, we're deliberate with this technology to ensure that it maintains the safety and efficacy of other comparable therapies. As I look to the future we're going to be involved in a study that looks at, in a randomized fashion and patients taking no act versus a left atrial appendage occlusion. I see that the Watchman flex device will probably be out in the next six months, which should make the implant procedure both easier and safer. And then we're also currently enrolling in a clinical study of the Watchman device versus the Wavecrest device, which is a left atrial appendage occluded with a little bit different design that we're excited about that technology as well. So I think this is something that we're going to be able to offer to more and more patients and I think the future is bright for left atrial appendage occlusion.
  
  Host: Thank you so much Dr. McElderry for coming on with us today and sharing your expertise and telling us about the really fascinating Watchman procedure. Thank you again, a community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That concludes this episode of UAB Med Cast. For more information on resources available at UAB Medicine, please visit our website at UABmedicine.org/physician. Please also remember to subscribe, rate, and review this podcast and all the other UAB podcasts. I'm Melanie Cole.
• Hosts:Melanie Cole, MS