Chapters Transcript Video Pulsed Field Ablation for A-FIB Fir first of all, thanks to you all for still being here. It's uh later in the afternoon on a, on a, a really nice day out there. So thanks for being with us. Thanks to the conference organizers. Thanks to Doctor Hern for introducing me and I'm gonna get started again. Um I'm gonna be talking about a FB management looking at update with focus on the 2023 guidelines and our um current uh workhorse for a FB ablation, pulse field ablation. I have no financial disclosures. So I'm going to define the problem. Um Look at what we have in terms of focusing on a couple of key aspects of treatment and then look at the guidelines and, and pulse field ablation. As I mentioned, when we look at the scope of atrial fibrillation, it's quite broad. It's our most common arrhythmia. We've seen increases not only in the US but also globally. Um When we look at just the US pre prevalence of it, it's grown by five with an expectation of over 12 million people uh being um uh or having an atrial fibrillation and, and probably about 11% from what we can understand, are, are not diagnosed with it. So even a bit larger than, than what this would speak to. A FB is not benign. And I think that's a key thing to recognize beyond quality of life affects um their stroke thrombolic complications. Uh You can run into issues with Brady arrhythmias that can be concomitant. Uh and they're kind of driven by the the atrial fibrillation and the fast rates with requirements for pacing support. Uh If you can't control the atrial fibrillation, it can precipitate heart failure. It's an ideology and a recognized one now for cardiomyopathy and it does affect longevity. Uh m you know, mortality rates are higher. If you have atrial fibrillation, early rhythm control is superior. And we now recognize that this is a big trial uh looking in multiple uh coun uh countries, excuse me, in which uh if you were to target rhythm control. Within the first month, you saw benefits in, in combined end points of cardiovascular death, stroke and heart failure. Ablation is now recognized really as the the best thing for first line treatment, particularly for perks is my atrial fibrillation. This is a meta analysis in 2021 in which over 1200 patients um uh through multiple trials were, were uh evaluated and found a 30% absolute risk reduction uh benefit to ablation um compared to antiarrhythmic drugs and a 13% absolute risk reduction for hospitalizations. And also a trend favoring uh uh lower risk for ablation as compared to anti drugs and heart failure. This was the one of the big trials. Uh but there were multiple others um called the Castle A F trial. But it looked at ablation as compared to drugs for rate or rhythm control with a number needed to treat of 8.6 with a mortality benefit pretty darn low to save someone's life. Uh And that's what this showed. So, um really in someone with heart failure and atrial fibrillation as a driver ablation has really become the standard of care. That's what you need to do. If, if the patient can tolerate it, just looking at practice guidelines, uh kind of pivoting to that right now in terms of strengths of recommendations and evidence, uh when you look at the, the green to the top left, uh class one indication is, is the strongest recommendation. Uh when you look at uh you know, 2 to, to 2 B that hold two is uh you know, it's reasonable and potentially reasonable. And then class three is there might be harm to doing that. So just when we're going through it just to be aware of that, just some other um things in terms of our terminology for atrial fibrillation, just so we're kind of speaking the same language when I speak of Permal atrial fibrillation, it means someone's going in and out on their own without an intervention, persistent atrial fibrillation uh is uh a condition in which a patient has atrial fibrillation for more than a week or they require some intervention to restore normal rhythm. Long-standing, persistent means that persistently in atrial fibrillation for greater than a year permit essentially means that we've are not gonna uh have any further effort to restore sinus rhythm. We're just accepting of it. Um, chronic and loan are no longer used. We've also moved away from valvular atrial fibrillation and speak more in terms of whether someone has moderate to severe mitral stenosis or mechanical valve with separate indications for use of Coumadin or warfarin for oral and coagulation. As compared to direct oral and a coagulant, we look at comprehensive management. This is a, a sort of a paradigm shift as well and you look at different stages in terms of where someone is in development or um uh actually having atrial fibrillation. And stage one is where they have uh some risk factors. Uh and you want to address those risk factors as we do sort of for all folks. Stage two is they have some structural changes and this would be where on echo, you see someone who has a significant left atrial bi atrial enlargement. The other thing that maybe some folks don't think about when you get a halter monitor and you find that they have very frequent PAC S. So in this stage, you're gonna be uh encouraged to actively screen for atrial fibrillation, best way to do it these days we'll talk more about is with wearable monitors. They're kind of everywhere now and they do a pretty darn good job of picking up atrial fibrillation. Stage three is when they have atrial fibrillation and, and going through treatment for that. And stage four is you've done everything you can do and they have atrial fibrillation, they have permanent a fib so monitoring, use of wearable monitors is now accepted. Um a lot of uh development in this space, you know, the Apple watch kind of the biggest one in ongoing trials, looking at that a big trial in terms of use of oil and a coagulation. But now now to the right, you can see there's a ring, there's a uh a Samsung ring and some others in this space too that can allow for uh you know, monitoring of atrial fibrillation, uh perhaps with even greater coverage than what you would get with a watch. Uh And then to the left was one of the original things is the cardio system and other systems like that. The the challenge and why we don't necessarily use that as much is that it requires someone to actively, you know, put their hands on there, they have to have symptoms. So if you're looking for asymptomatic screening, something that's truly wearable is better. In terms of initial evaluation, you've made a diagnosis, you know, through the watch, they see you brought them in, you get an EKG, you confirm it. Uh You want to do our usual lab work which should include uh you know, looking at CBC, looking at their chemistries and make sure their kidney functions. OK. Uh thyroid screen and then an echocardiogram, everybody should get that. Uh You don't need to know what structurally is going on. Other testing is, can be targeted if they have, you know, annal type symptoms, you want to get a stress test and those sorts of things, lifestyle modification. Uh this is uh uh you know, increasingly a focus, you know, at all sort of all levels. It can be a tough sell to patients. You know, you tell them to lose weight, exercise, stop drinking, avoid sugar and treat your hypertension, all the good things they like to hear about. Oh, but you can't have a cup of coffee because that doesn't really matter too much. We, we sort of recognize that. So, um stroke risk determination. So the guidelines focusing on this, you need to determine the patient's stroke risk. Um And there's different ways in which to do it. Some people just based off of what they have going in with the atrial fibrillation independently have a high risk and you need to anticoagulate them. We've talked about some of those folks already. If you have rheumatic mitral stenosis, you need to be anticoagulated on Coumadin. You have a mechanical mi you know, mitral aortic valve, you need to be anticoagulated. You have LV, noncompaction, your your hypertroph, other ones that people don't think about as amyloid um or just independently have an L A myopathy based off testing that we do or others, you need to be anticoagulated. Otherwise, using some kind of clinical stroke risk scoring, most commonly uses the Chad's vast scoring system. If you have uh essentially what equates to be a two or more, you should be on um oral and a coagulation. Um And, and there's um other things on there, but that's the, the main point of it in terms of stroke reduction management, um direct oil and a coagulants of our sort of our mainstay workhorses for stroke risk reduction uh because of the uh you know, the uh consistency in dosing uh and blood blood levels in effect. Um So when you, when you've got a, you know, clinical um or, or a stroke risk of 2% annualized or greater, um as unless you're in some um recognized situations where Coumadin still remains the mainstay, it's going to be a direct oil and a coagulant. If you have low stroke risk, aspirin really is felt to be no longer of benefit. So it's, it's essentially do you warrant being on an anti coagulant or not? Um uh in terms of stroke reduction management. So, device detected, um there's more data in this area. This has often been a source of, of concern and confusion in terms of what to do. And we're collecting more data on this as well, but to try to summarize as quickly as possible if you're at higher risk and you have greater than 24 hours of, of atrial fibrillation, uh, on your device. Be it a pacemaker, I CD loop recorder, whatever it is, you ought to be on an, an, a coagulant or it should be discussed if you're uh higher risk. Um, and you have anywhere from five minutes to 24 hours. It is, it's worth it to have a discussion with the patient, but more likely than not, there's going to be benefit to being on anticoagulation if it's less than five minutes, um intervals of of atrial fibrillation, at least at this point, there's no recognized benefit to oral and a coagulation. So beyond medical therapy, um looking at left atrial appendage occlusion or left atrial appendage ligation, uh there is benefit greatest scene in folks that are um intolerant to oran of coagulation, at least thus far. Um The guideline would say that um it's reasonable to look at left aal appendage occlusion if you have a clinical stroke risk score of two or more, but just be aware of C MS requires three or more. So you might meet indication but you may not get it covered. So just to be aware of that, that's just kind of one of the things we face. Um Also, when you look at left atrial appendage ligation, this is something to be aware of as well class one indication is if you get a ligation and it's successful is to continue your oral anticoagulation because there's data for that as being sort of the best way to reduce stroke risk. Um It's unclear as to whether or not stopping your anticoagulant, even if you determine that you have a successful ligation is in and of itself. Um good enough, it's a two B indication. So just to be aware of that, uh the, the that is a little bit different than, than I think what many do, but that's just what the data is in terms of per procedural and coagulation management. No need to bridge for the majority of patients. I think many are kind of aware of that already. But you do want to bridge for those who are at high highest risk to include recent T I or stroke basically within the last three months or if they have a mechanical valve, particularly a mitral valve in terms of chronic stable coronary disease or atherosclerotic peripheral vascular disease. So if someone is, is, you know, hasn't had instant thrombosis, uh they had a stent put in, you know, 13 months ago and they're doing great without any engine and that sort of thing. And they have atrial fibrillation guidelines. Class one is just be on an oral and a coagulant. Uh They don't need to be on antiplatelet therapy if you've got peripheral vascular disease similarly to be um if you don't have any, you know, you got stable symptoms, you've been revascularized, oral anticoagulation alone is, is, um, is what's recommended in terms of rate control, the usual agents. As long as you don't have essentially heart failure and your ef is all right, you want to avoid the use of rate control and calcium channel blockers. If you have moderate severe left ventricular systolic dysfunction, ef of 40 or less, also, you can use amiodarone for rate control. If you have no other options, we see that non and commonly in intensive care unit, someone who's in septic shock, um or are cer certain situations where uh blood pressure uh prevents the use of our usual rate controlling agents in terms of A FB ablation indication. So this is something that's new in our guidelines in terms of class one, first line symptomatic peral atrial fibrillation is now a class one indication for a ablation first line. Uh that's, that's uh that's sort of recognized within the community. But now out there atrial flutter has always been class one, that's nothing new, persistent atrial fibrillation or higher risk patients with pero A fib is A two A and I think in time that's probably going to change. Now with our uh P FA uh information coming forth as our as our risks further decline in terms of heart failure, patients with atrial fibrillation early rather than control. And that means during the index hospitalization, if they're in atrial fibrillation, you wanto sinus. Be it a cardioversion with a TE or now, maybe even more. So, what we're looking at is an ablation as we get more efficient with uh doing ablations, uh stabilizing them, decongesting them as best as we can and then ablating them. And I think, you know, Doctor Patel is interested in a trial looking at that pulse field ablation, some basic concepts. Essentially it is non a non the mal form of ablation using ultra rapid pulsed electricity to destabilize the cell membrane and lead to programmed cell death much different than our other thermal ablation technologies. And this is just a schematic sort of demonstrating that where you get a growing pore that goes from a reversible to irreversible one and then you get leakage of the, the uh the cell contents that leads to cell death. Also, it's important to recognize that not all P FA is the same, every company needs to re invent the wheel if you will. So everyone has to go through this, the the process to demonstrate their safety um and efficacy. Um This is just an example with fire pulse and the different trials they had to come before they optimize their wave form to what we're using right now. This is the fair pulse P FA system. I show that because this is what we're using right now. Uh since uh you know, late April and, and kudos to those that, that uh bought off and what we we, and they were selling that we, this is a good product we've done, I think about 650 cases thus far. And we've seen what has been seen elsewhere and we'll go through some of that data, but that's a fair drive um deflect sheath that we use. And to the farthest right is the F wave catheter uh that delivers the uh uh pulse field ablation, the Advent trial, um which is um their uh pivotal trial presented in the um in uh New England Journal of medicine demonstrated similar efficacy to what was seen with conventional therapy for paroxysmal atrial fibrillation, ablation. Um uh uh cohort um or study group, I should say in a more efficient manner, uh 20 minutes, less time than what was seen with conventional treatment and no fren esophageal injury um or PV stenosis seen. We look at uh the pivotal trial sub analysis. Um We see even further um what looks to be a enhancement and um effectiveness as well. And, and this is something that we're looking at as sort of a society and group is how to best determine whether or not we've had a successful ablation. Historically, we used an arbitrary 32nd cut off for effectiveness, which really is not that clinically helpful or meaningful. Now, what we're looking at is a burden and antiarrhythmic or a atrial arrhythmia burden of less than 0.1%. And that's really where we seem to find um a greater quality of life, uh cut off as well as lower risk for redo ablation, cardioversions and hospitalizations. And when we look at that, uh P FA is, is better than what we had prior. So this is looking at safety and this is um uh a large um registry coming out of Europe. Europe been doing this for several years before we had it commercially available here. 17,000 patients with a major adverse event rate less than 1% and no esophageal fistulas, no pulmonary vein stenosis and no persistent fren nerve injury. Pretty, pretty darn significant coronary razor spasm is something we do have to uh be aware of and we are aware of uh using this technology particularly when we're by the annular planes, by the coronary arteries. We prevent development with use of IV nitroglycerin higher doses. So we just have to be ready for the hemodynamic effects of that. And and keep our anesthesiologist aware of what we're doing. Acute kidney injury from aosis is a rare potential dose dependent class effect from what we understand. Uh rare blood red blood cells, excuse me, are susceptible to pulse field ablation at higher field strength, the amount that's uh needed to, to cause this is pretty well above what we typically deliver. But it's just something that we're aware of. I'm just going to go through a case kind of quickly. Uh just to kind of give you some understanding of, of what we're doing with pulse field ablation. Um The endgame is pretty similar to what we are trying to achieve with our other technologies, but obviously with a different technology, um I show some uh other things that we use uh just to demonstrate benefit to some other technologies. Here is a car of sound map and this is um essentially auto drawn as we get slices going across. Um This is a, a pretty slick technology that enables us to come with, come up with if you look on the right of the screen that that um 3d shell without any prior imaging and that's all done. Otto, we actually just so, you know, serra helped develop this uh kind of early on with uh use of, of our intracardiac I imaging. So we participate in development of this and that's just showing real time ice imaging there. This is using intracardiac echo guidance. Uh This in particular is looking at the left superior pulmonary vein and getting guidance in there. And that's just kind of showing a, a clip of it live. We also use fluoroscopy with it. This is the one downside, at least to what we have right now as we had to fall back to using some fluoro. Um And hopefully in time, we'll get away from this, I expect that we will. Uh but these are the two with fair pulse and the F wave, the two configurations that we work with the flower and the basket is noted. Um And then this is going to the rights and getting guidance into the here, the right inferior pulmonary vein. There you go. And this is our fluorosco uh fluoroscopic imaging again, showing the basket and the flower. And essentially the, the uh for this particular system, you're going to do two and two of each to ensure coverage. And this is showing a pre and post map of uh uh pulmonary vein isolation. And then here, this is some additional substrate beyond pony veins. Uh As we do have to look at uh other uh things that we find when we get in here, if you look at the, the image um with all the multi colors, essentially, if, if everything was healthy, it would all be that sort of purple color. When you get the colors in there, it's showing that there's fibrosis uh and, and substrate that can cause uh atrial fibrillation. So we target it. Uh We also have looked at areas beyond just um uh our usual treatment for atrial fibrillation uh in particular AAA rhythm that's often coexistent is uh uh atrial flutter or what we think of as a cable truck H is miss dependent flutter and that's treated with this technology as well. Other um you know, forms if you will of pulse field ablation include the er solution that is now uh part of Metronic. And this is a solution that allows for toggling between pulse field ablation and radio frequency ablation. Uh pretty slick catheter that uh is now becoming a commercially available based off the sphere. Uh persist in a fib trial, which is a randomized controlled trial, we participate in it as well compared to standard of care at the time with uh 400 plus patients who had PV I plus similar safety um and a trend towards improvement and efficacy um at a year and, and more efficient with 25 minutes less case time. Other solutions that are out there uh include uh biosense Webster uh with the admire pivotal trial, which was just published a few weeks ago with a variable loop P FA catheter integrated with Caro uh almost 300 patients with peral atrial fibrillation. 100% acute success rate with pulmonary vein isolation and a twelvemonth arrhythmia freedom of over 75% uh similar complications in terms of no esophageal injury, fren nerve injury or pulmonary vein stenosis. One nice thing is that 25% of the folks in this trial were able to get their procedure done without any fluoroscopy. Other uh biosense Webster or Car O solutions include the smart pulse, which we're going to engage in this trial as well, which uses a smart touch catheter that can toggle between pulse field ablation and our rate of frequency energy and enrollment is ongoing. The omni pulse uh which is a pretty exciting similar technology uh to the sphere of nine with a large tip FC P FA Catheter. Um the enrollment um has completed uh outside the US and we're awaiting us trial for this as well. Abbott has a solution with the volt technology. We participate in this trial as well. This was a substudy um prior to the to the larger trial which showed good initial efficacy. So these are all solutions that were looking to, to have available and we'll see who ultimately has the best solution as we mentioned. Uh everyone has a different way of treating and, and we have to investigate all of them. Uh So to summarize things, atrial fibrillation is a major health concern. We've seen notable improvements in care, greater focus on earlier preventative interventions. We've got enhanced diagnostics, more patient centric now with wearable monitors and coagulation alone for stable disease. Um uh vascular disease that is ablation moves to the first line treatment for many. Um And I think now if P fa rapidly change the ablation landscape, I would say all that are we're really looking towards for rhythm control. Really ablation is, is gonna is the way to go at this point. Published Created by Related Presenters Philip Gentlesk, M.D., F.H.R.S., F.A.C.C. Sentara Cardiology Specialists View full profile
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