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EP-EDGE brings you the latest in cardiac electrophysiology — from breakthrough research and clinical insights to future-shaping innovations. Hosted by Dr. Niraj Sharma, an electrophysiologist with over 15 years of experience, each episode delivers clear, evidence-based updates designed to inform, inspire, and elevate your practice.
Hello, everyone. Welcome to EP Edge podcast. I'm doctor Neera Sharma. We have come a long way since John Madden in 1949 performed the first left atrial appendage ligation. We now know that ninety percent of thrombi form in the left atrial appendage in patients without valvular heart disease, and even in patients with valvular heart disease in fifty seven percent.
Dr Niraj Sharma:Since the original PROTECT and PREVAIL trials and the subsequent approval of WATCHMAN, about a decade ago in 2015, we've had multiple device modifications and the arrival of another left atrial appendage occlusion device in The United States, the Ambulet. Combining atrial fibrillation ablation and concurrent implant of left atrial appendage device makes sense and was addressed in the OPTIONS trial, but the sequencing of these procedures was addressed in the combination trial. Okay, let's have a deeper dive. This is an AI narration in a conversational fashion based on my LinkedIn newsletter. As always, this has been personally vetted.
AI 1:Okay, today we're doing a deep dive into left atrial appendage occlusion, LA AO. It's this really key strategy for stroke risk in AFib patients, you know the ones who just can't do the long term blood thinners.
AI 2:Right, the oral anticoagulants or OACs. Yeah. And to really get LA AO you kind of have to understand the problem itself, the left atrial appendage.
AI 1:It's this little pouch off the atrium, but it's not so simple, is it?
AI 2:Not at all. It's actually incredibly variable. And some shapes, they actually call them things like broccoli or cauliflower shapes.
AI 1:Broccoli. Seriously.
AI 2:Seriously. And those carry a much higher risk for clots. The historical data, well, suggests something like ninety percent of thrombi in non valvular AF patients. They're found right there.
AI 1:Ninety percent. Wow. Okay. So that really frames why occlusion is even a thing.
AI 2:Exactly. It's the prime suspect.
AI 1:So today, let's unpack the latest clinical evidence. We've got trial results. We've got complication management, merging strategies. Things are moving fast here.
AI 2:They really are. Guidelines are changing as we speak.
AI 1:Let's start with a big comparison. LAAO versus just sticking with OAC. The OPTION trial looked at this, right? Specifically LA AO combined with AF ablation.
AI 2:Yes, OPPO. And the headline finding was non inferiority. So LA AO plus ablation wasn't worse than OAC alone for that composite endpoint death stroke system embolism over three years.
AI 1:Non inferior, okay. But that doesn't sound like a slam dunk on its own.
AI 2:Ah, but then you look at the safety data and that's where it gets interesting. The LAAO group had significantly lower non procedure related bleeding. We're talking eight point five percent versus eighteen point one percent.
AI 1:Wait, hang on. So basically equal on preventing the main events, but nearly half the major bleeding long term.
AI 2:Precisely. That's a huge potential benefit, suggesting you can potentially stop OAC earlier in these high risk patients having ablation if they get the LAAO.
AI 1:That is a big deal for quality of life but, it hinges on the procedure itself being safe, right? Which brings up timing.
AI 2:Exactly. Does the occlusion happen before or after the ablation? The combination trial tackled this head on. The recommendation is pretty strongly occlusion first.
AI 1:Occlusion first. Why does the order matter so much?
AI 2:Well, it turns out doing the occlusion first significantly cut down on two key long term problems. First, device related thrombus DRT. That's a clot on the device itself. It dropped from eight point two percent down to just one percent.
AI 1:Wow, from eight percent to one percent. That's significant.
AI 2:Yes. And second, chronic para device leak, PDL, you know, where blood still seeps around the edge of the device. That went from fifteen point five percent down to five point two percent.
AI 1:Okay. So occlusion first seems to lead to a cleaner, more durable result long term.
AI 2:That's the idea. Minimizing those delayed complications is critical.
AI 1:Right. And then there are the devices themselves. Swiss Apero compared the two main players, Amulet and Watchmen FLX. Any clear winner there after three years?
AI 2:Well, winner might be strong but Amulet showed a consistent trend towards fewer ischemic events and importantly significantly fewer definite or possible device related thromi again It was 3.7% for Amulet versus 11.8% for WATCHMAN FLX.
AI 1:Nearly a threefold difference in DRT risk. That's definitely something to consider in device choice.
AI 2:Absolutely. The device platform seems to matter for that specific complication.
AI 1:Okay. So the evidence for LAO seems pretty solid, especially with the right timing and maybe device choice. But there's always a but, isn't there? Let's talk complications. The really scary one seems to be these, silent cerebral embolisms.
AI 2:Ah, yes. S C E. This is probably the most critical procedural complication we need to be vigilant about. The Nanjing study really brought this into focus.
AI 1:What did they find? How common is this?
AI 2:It was frankly startling. They found new MRI detected brain lesions during the LA AO procedure in thirty eight point seven percent of patients. Almost four out of ten.
AI 1:Nearly forty percent. That doesn't sound very silent. Are these just little blips on an MRI or do they actually matter?
AI 2:That's the crucial question and the answer is unfortunately they matter. These are not benign findings. Patients who had these SCEs showed significant cognitive decline.
AI 1:Decline how? Like noticeable?
AI 2:Yes. Measured by standard tests like the MMSE and MoCA scores, we're talking a drop of nearly five points on the MMSE for instance. And the really concerning part, that cognitive decline didn't recover at one year follow-up.
AI 1:So the brain injury, even if clinically silent initially, had lasting consequences on thinking and memory. Wow.
AI 2:Exactly. It really underscores the need to protect the brain during the procedure. Things like, you know, meticulous technique, maybe higher anticoagulation targets during the implant. It becomes paramount.
AI 1:Okay, so LA AO is established. It's got a Class II recommendation now in The US, slightly lower at II in Europe, but we absolutely have to keep hammering on procedural safety, minimizing SCE, DRT, PDL.
AI 2:Vigilance is key, Absolutely.
AI 1:So looking ahead then, what's on the horizon? What could change the game for LAO?
AI 2:Doctor: Well, are two really big external forces I think. First, there's the idea of prophylactic LAO. The LA APS trial is looking at this.
AI 1:Prophylactic, you mean including the appendage before someone even develops AFib?
AI 2:Exactly. In patients who are still in normal sinus rhythm but may be at high risk, could we prevent strokes before the AF even starts? LE APS is investigating that though results are a ways off, maybe 2,032.
AI 1:Fascinating. Preemptive stripe on the LIA and the second force?
AI 2:Pharmaceuticals. Specifically, the new factor AKA inhibitors that are in development.
AI 1:Ah, the ones that promise anticoagulation without the bleeding risk. The sort of holy grail.
AI 2:That's the hope. Reduce stroke risk effectively like current OACs, but without significantly increasing major bleeding. If they truly deliver on that promise.
AI 1:Then it really challenges the main rationale for LAA, which is avoiding OAC bleeding, right?
AI 2:It does. It poses a really interesting question for the future. If factor AKA inhibitors essentially eliminate the leading penalty of anticoagulation, LAAO become a niche therapy reserved only for patients who fail even these new drugs?
AI 1:Or does LAPS prove that getting rid of the LEA before AFib is the ultimate prevention, regardless of drug options?
AI 2:That's the tension right there. Will the future be pharmacological, mechanical, or perhaps a combination? That's really the big question defining the next decade in stroke prevention for AFib.
AI 1:A fascinating dilemma. Pharmacology versus preemptive mechanics. We'll definitely be watching how that plays out.
Dr Niraj Sharma:Left atrial appendage occlusion is no longer an alternative. It's reshaping how we think about anticoagulation in patients with atrial fibrillation. These are patients at high risk for bleeding or those who have already bled. However, we need to be cognizant and watch out for device related thrombi, peri device leaks, and now the increasing body of evidence showing the high risk of silent cerebral lesions. Thank you again for joining me on this episode of EP Edge.
Dr Niraj Sharma:If you need data sources and infographics, this can be found in my LinkedIn newsletter. I love to hear from you. You can email me at ephcastgmail dot com or via LinkedIn. This is Doctor. Neeraj Sharma.
Dr Niraj Sharma:Bye for now.