Chapters Transcript Video Atrial Fibrillation in 2023: Ablation for All? Dr. Erick Kiehl discusses treatment options for atrial fibrillation in 2023 and the newest technology choices for patients to consider. All right. So the title of my talk is Atrial Fibrillation in 2023 Ablation For All. And, and it's kind of a controversial title on purpose because first of all, it's Saturday morning and if you're not going to be a little controversial on Saturday morning, then I'm not sure when to be. Um I joined the division here about uh about four years ago and, and to Phil's point, there's been a lot of change even in just the four years I've been here. Um And so I'm not sure whether the right answer is ablation for all, but I'm gonna pose the question and go through the data that we have and, and how it supports um those indications. So, let's see next. OK. So these are my disclosures. Um I have a lot of them and I don't think that's necessarily a bad thing. It means that we're working with our partners and industry. Um I am directly compensated from an ablation space by Biosense Webster. I'm on their advisory board and you will see some biosense Webster specific slides. Um But I do a lot of research with other companies as well uh in the ablation space uh affair or Medtronic, which is doing some pulse fi technology, what we get into and then, and then biosense as well as well as Abbot. So some outlines and goals. The first thing we want to describe is why is a FB bad. So why do we even care about it? I want to demystify what an ablation procedure is for all of you a little bit. Um and then review some landmark clinical trial data and, and kind of look over time how things have changed in, in different patient populations, how things are different, then contextualize that clinical trial data by reviewing some real world outcomes. And those are actually my own and then discuss what the future looks like and then highlight basically how we can get from point A to point B. And so how important integrated care pathways are to make a FB management timely and effective for patients. So I'm gonna do a couple more poll questions and this is like my first foray into this QR Code stuff, but I've seen other people do it and it looked cool. So these two we've already done. So I don't know if we can go live on these ones. It should be the same QR Code and I don't want to spend a ton of time because we've got a lot of slides and there's a busy, busy um uh uh busy agenda. But first question is a rate control strategy using a V nodal blockers is now and should remain the mainstay or preferred approach for patients with rate controlled atrial fibrillation. Just give it like 30 seconds. And I just want to get a sense of what people think and I'll, I'll tell you all four of the next questions. There is not a right answer. They're designed to be thought provoking and get a sense of the audience. All right. So it looks like about two thirds think that that's not true. And a third think that that is true and that's OK. All right. Let's go to the next question if we can. All right. So what is the success rate of a fibrillation in 2023? 90%? 80%? 60% 50% or none of the above? And I'll tell you with this question, I pulled some of my eps and got five different answers. So, all right. So most people think somewhere between 60 80% some people think 90%. OK. Let's go to the next question. Uh So I was a little bit wordy. There's neither clinical trial data nor consensus guideline recommendation to support the use of a first line ablation strategy for recently diagnosed A FB. Basically, this is asking, is there any indication where we abate somebody the first time they're diagnosed? And Phil may have alluded to some changes here. So 80 20 people think that there is indication to a blade right away we go to the next line. All right. Uh I think this is the last one. So there exists a distinct patient population. So that includes people with really low ef severe left atrial dilation or long-standing persistent A FB or attempts at rhythm control via ablation or antiarrhythmic drugs are highly likely to be futile and of little clinical benefit. This is basically a wordy way of saying there are certain people who should not abate and not surprisingly, the overwhelming uh audience thinks the answer to this question is true. All right. So let's go to the meat of the slides if it's OK, then. All right. So why do we care about a FB? I said that's the first thing we were going to talk about. So I'm an unabashed Michigan fan. So if anyone's an Ohio State fan, I'm sorry, but it's Saturday. Um And so, you know, we care about atrial fibrillation for three reasons and this is the first anyone who's done clinic with me knows that this is like my rote speech that I give to every patient. So we treat a FB for three reasons to prevent stroke, to prevent heart failure. And and I would expand that to say adverse remodeling. So, you know, dilation of the left atrium uh interval, pulmonary hypertension, micro regurgitation, tricuspid regurgitation. So, but basically heart failure in the general sense of things and then symptoms. So when you talk about that, really, what you're saying is OK. There's this, there's this misconception that ablation means you can come off your blood thinner. That's not really the case, the stroke risk persists. And I think VCA will probably talk a little bit about that uh in, in one of the later talks here uh shortly. Um So basically, that's blood thinner, left atrial appendage occlusion. So really the two reasons we treat people are to either reverse some processes going on in the heart, treat their heart failure symptoms or just treat their symptoms. And and as we all know, those symptoms can be anything from the range of just fatigue, not feeling yourself, indigestion, palpitations. And so every patient is a little bit different, but the rest of the slides just think about that in that concept. So this is an ablation procedure that I did in 2021 and I just wanted to go through a couple of slides and um not trying to be like a public service announcement, but this is actually available on my ctera provider uh uh resources website. This came about as a um request actually of one of my patients in Williamsburg who said, you know, I'd really love to see what an in information looks like before I do the procedure. And I said, well, would you let me videotape it and he was kind enough to let me do it. And there's some things in this video that are now outdated, but it's allowed patients to see what the procedure looks like beforehand. And so if you have patients that you're referring or have a question, regardless of who you are, um we can make this available for them to watch. So first things, first, we use ultrasound guided access for everything we do uh procedures on uninterrupted oral anticoagulation. So that's just me basically tempting the uh right femoral vein and then, and then getting access. And so that's made our procedures safer from a bleeding perspective. We use a lot of intracardiac ultrasound. So this is actually a technology called Cardo Sand where we're using the ultrasound to draw direct contours of the uh that's the left inferior pulmonary vein. You'll see the left superior pulmonary vein here. And then um one of the outdated things I think you'll see in a second is I think we draw the esophagus here. And what you'll see is there's an esophageal temperature probe down here. Um As a proof that ablation has changed a lot in the last couple of years. Now, we've moved to esophageal cooling devices as opposed to uh temperature devices to reduce a rare complication called ATRIO esophageal fistula. And so I don't even take contrast of the esophagus anymore. That's the right, inferior and right superior pulmonary vein. So this allows us to use a little bit less fluoroscopy. Um Different providers use different degrees of, of fluoroscopy during their procedures. Phil, for instance, is pretty much completely fluoro free So it saves the patients himself and the, and the lab staff uh both fluoro exposure, you know, in terms of cancer risk, but also, you know, it saves their backs, which is really important. So then we go trans seal. So, you know, a FB is usually a left atrial arrhythmia. So we go from the right atrium to the left atrium and, and this is a video basically showing um a sheath. And again, this is also a little outdated. It's using a needle. Uh Now we use most of us use this wire called the versa cross, which is an electrified wire. And basically what we're using uh is ultrasound and X ray to get from the left to the right atrium. And then we'll do most of our work uh in, in, in, in the left atrium. So, um this is pre abla ablation mapping. Um I'm using something called the pray catheter. So in this uh purple is healthy, red is electrically silent. And what you can see in the bottom right is that the X ray panel is off. So, uh we've all dropped our lead and we're going flo flo free at this point. Um And, and the catheter is going out and creating a a geometric matrix to see what, you know, kind of pre-existing scar is there. So, in this particular patient, very normal healthy voltage. Um And so this should be a good candidate for just pulmonary vein isolation. So, um another big advancement and we'll go through this over time. But um we're zeroing our ablation catheter here. So ablation catheter has a contact for a sensor that allows us to see how much force we're touching. Um And make sure that then when we're actually ablating, we can, we can be confident that we're, we're providing um you know, uh an indexed ablation uh value that's been shown histologically to have uh good outcomes and it's a safety issue as well. So this is that index I was talking about. So this is there's different algorithms for different companies, but this happens to be a biosense Webster ablation. And so it's probably hard to see from back there. But those little red dots that are showing up on the screen are ablation lesions that we're delivering. And uh when we come on, it shows you the power, which in this case is 40 watts. Most of us use. Well, I use 50 watts. Now the blue is the contact for us and the aqua at the bottom is this index. And what we know is there are there are certain targets we can hit. That's basically a composite, those uh time uh power and contact for us that allows us to determine when we can move to the next spot. So it's not just I'll a blade until the signal is gone or um I feel like I've been there long enough, it allows us to be more efficient and objective, not subjective on how we do our cases. So after we've done the procedure, what you can see is we kind of encircle both the pulmonary veins. Uh You can see my catheter out in the vein and you might see these little kind of blue signals randomly firing through. And then when I move outside of where I've ablated now, the blue and the yellow all light up. So that's right because we didn't ablate there and then we'll take the catheter and put it back into the pulmonary vein here in a second. Just wait for it. I think I did a little bit. Yeah. So right there, you see the blue signals go away and then right there you'll see a fire, you'll see another fire in a second. That's actually conceptually how a FB uh works is that the pulmonary veins in most patients will fire off and, and degenerate the heart into atrial fibrillation. So, the concept of ablation is if you isolate the pulmonary veins or another area in, in a different patient where a FB comes from, uh you can, you can modulate the arrhythmia initiation uh and uh and maintenance. So this is what it kind of looks like before and after and then uh that's not enough. So we want to make sure that there aren't cousin rhythms of atrial fibrillation. So most of us will use a drug called isoproterenol and we'll paste the heart of like 300 beats a minute in the top chamber. And what you can see in this strip is us basically inducing a rhythm called atrial flutter. And this wasn't preplanned, it just happened. And so it allowed us to get a nice pretty map. So this is by atrial. Well, it is a ac of tricuspid flutter, but it's a uh or what we refer to as typical flutter with saw tooth waves. And the color scheme here is actually the activation of the um of the arrhythmia. So what you can see is everything spinning around the tricuspid valve on the right and passively breaking out to the left atrium. And so what this tells us is we need to ablate the CT I line. So on the top, right, you can see us uh getting ready to um cauterize um that line basically right in if you can see, but this line right here is the cava Trick epi and this, this is the cava Trick epi theism in a different view. So um this is us actually cauterizing. You can see that line getting a little bit bright and white, that's edema that's locally uh forming as we're blading. And then this is as we're blading, you'll see actually in the bottom left, the yellow signals go away right there and that's termination of the arrhythmia to sinus rhythm. And this is us then doing kind of the same activation mapping and you'll see across our ablation line when they tilt the screen up on the left that the, the arrows are now colliding at the line. So it can't get, it can't get through anymore. Therefore, you, you can't have atrial flutter anymore. So then at the end of the procedure, um, we don't use sandbags or four hours of, of pressure anymore. A lot of us use these things called Vass. Um, there's different other types of Venus closures. You can use. This is an unnecessarily long video to be perfectly honest. But um basically, it's, it's, it's showing us put the, put the um uh the closure device in will then take the uh take the IV out and at the end of the video, which I'm not gonna have you sit and watch for a minute, there's just this little teeny pinhole. Uh And so this is a procedure done really without scalpels at this point. So I wanna then pivot and say, OK, well, what about ablation today because of compared to ablation in the past? And I'm a big back to the future fan. So um you're gonna see a couple back to the future slides in here. So this is not a history lesson, but um ablation was first developed in 1981 and it was kind of um barbaric, barbaric, I would say, I mean, it was, it was basically shocking the A V node. Uh So it wasn't what we think of as ablation now. And in the 19 nineties. Um There were pioneers kind of in atrial fibrillation, including uh Sonny Jackman, uh Mark Josephson and Bill Stevenson that really um began to evolve ablation into radio frequency technology as we think of it today, radio frequency is burning or cauterizing. Um but it was primarily for SVT things like wolf Parkinson white and ventricular tachycardia. So A FB really wasn't a thing until the late nineties and this is the concept I was just talking about about the pulmonary veins firing. This is a nice case I had of a, of a patient who had a, a pulmonary vein atrial tachycardia. And you can see in the, in the right, basically the um the red and all the arrows emanating from the right superior pulmonary vein. And what uh hasse showed in bordeaux France was that basically, um they could map out pulmonary vein triggers for atrial fibrillation. They would actually go into the pulmonary vein and a blade deep in the pulmonary vein. And acutely, they had good success at, at, at uh freedom from a FB. But um what they found is there was high rates of pulmonary veins, noses, patients would have a FB come back and long term, this wasn't really a great procedure, just a blading far out in the pulmonary veins. And that's probably because all the pulmonary veins were, were rhythmatic and they were just a bla in one spot and they weren't getting in a complete line of block. So then around 2001 things evolved to uh wide an circumferential ablation, which is basically encircling the pulmonary veins, which is still the standard of care today in the left uh screen, you can see this little lasso catheter, which is what we use. We basically put it around and we had a blade around the lasso and actually, I did my fellowship from 2014 to 2019 and we were still using the lasso. Um I don't think I can't remember the last time we've used the lasso um since I've been here. So this is a picture of John brush. And I remember uh when I was deciding whether I wanted to come here or not, I, I I'm very interested in research. I, I talked to John a little bit and one of the things he, he brought up to me was um you know, how successful is a fibrillation. Um And, and um he, he, he told me last night when we were talking actually that he, he was kind of a skeptic and he's changed his opinion for a variety of reasons. But um there, there are, there are, there's a big problem in the way we've defined success with a FB ablation. So for SVT ablation, you know, if you have Wolf Parkinson's white, you get it or you don't, right? So you need a cure for a FB ablation. It's a FB is a very complicated disease process, the pulmonary veins are the triggers in a lot of patients. But the posterior wall, there's other areas that are triggers in other patients. And so it, it, it's a chronic disease just like hypertension or diabetes that needs to be managed as such. So for us to expect that we're gonna ablate and you're never gonna have a FB again, that actually does happen for a lot of patients, but that's not really the expectation. Um Clinical trials look at cure. So less than 30 seconds of a FB at one year, follow up and mortality. But in the real world, we look at burden reduction, quality of life and reverse remodeling on echo. What do I mean by burden reduction? So if you're in a FB all the time, let's say you've been in a FB for three years, you have long standing persistent A FB. And then after we do an ablation at one year, you've had 31 seconds of a FB versus 29 seconds of a FB, you're not going to care the difference, right? But in a clinical trial, it would be a failure. And in uh in real life, it would be a success. So we look at debulking increasingly now, but I think our guidelines are a little bit behind. And so when we talk about success, I put up that slide early. What's the success rate? 90 80 60 50 none of the above. My answer is none of the above because it depends what you define success as it depends what the patient is. If you look at the clinical trial, cure number over time, when ablation first started, those numbers were more like 50 to 60 more modern trials depending on how often you look are showing things between 70 90. So anyone who answered that question got it right. So we'll go through uh some of the clinical trials that I think are pivotal. Um Hopefully not in too much detail because I don't want this to be a clinical trial show. But I think it's important to understand where our data comes from. So Cabana was probably the biggest ablation trial ever run. It was run from 2009 through 2017 in terms of patient enrollment. And it was basically a randomized trial of anti arrhythmic drugs uh versus ablation. Um It's true that about 12% of the patients in the um drug arm got just avino blockers, but in general, it was a um antm drugs versus ablation. Uh Most patients were symptomatic. There was a mix of paroxysmal persistent, long-standing, persistent patients. And about a third of patients had uh heart failure, symptoms of which 5% had uh reduced efs of which there was a subsequent um uh postdoc analysis and the outcomes uh were the primary outcome is a composite mortality, stroke, serious bleeding and cardiac arrest and the secondary outcomes were a FB recurrence quality of life, hospitalizations, costs and left atrial size and function before I go to the actual results. There's some big problems with this trial first took eight years to enroll. So ablation changed a ton over eight years. I've been here four years and we're not even doing the same thing we were doing. So you're kind of comparing apples to oranges through the trial? Second, they, they modified their outcomes in the middle of the trial. Um for a variety of reasons that the people who ran this trial are excellent, excellent tps. Um But any trial that takes eight years to run, uh there are some issues with it. And so if you look at the primary outcomes, primary outcome of mortality, stroke, cardiac arrest and serious bleeding. When I went through that slide of what are the reasons we treat a FB for? Not a lot of them are around there, right? Strokes on there. But, but that's what blood thinners are for. So, um a lot of the things that are important actually in this trial are the secondary outcomes. So, and I mentioned this. So over time from 2009 to 2017, a lot of stuff changed. So in 2009, we didn't have cryo uh PV I which a lot of us use, we didn't have irrigated RF catheters. So when we were ablating, if a clot formed on our catheter, we weren't really delivering good energy. We, we didn't have contact force catheters so we could have been floating in the middle of the atrium and thinking we were ablating tissue and we weren't, we didn't have high density mapping systems to be able to see where we had gaps in our lesions. All of those changes in red span, the time of the Cabana trial since then, things have changed even more. We have the index ablation, the SharePoint thing I showed you earlier uh pulse field trials, which we'll get to in a little while started in 2022. Um Starting here in a week or two, we're going to start using this device called Q dot which is a low irrigation, high power, short duration RF um uh uh modality uh that in theory should make this procedure safer and quicker and more efficient, particularly for heart failure patients. And then starting next year, I think we'll see commercially available pulse field ablation, which will be a paradigm shift. So with that context, um the big I think, take home message and this is a new England Jam Up paper. You know, I I think you have to say what the intention to treat outcomes showed. So the primary outcome which remember was mortality, stroke, uh bleeding uh and cardiac arrest did not show a sta statistically a significant difference between ablation and uh an rhythmic drugs. So the tag, the tagline on CNN was like ablation is not as good as we think it is. So, but here's a secondary outcome. So, ablation versus drug therapy, um a significant difference at one year um in terms of recurrent a FB and uh mortality or cardiovascular hospitalization with ablation as compared to anti drugs. And again, getting back to that number, remember, this is trials from 2009 to 2017 at one year catheter ablation was about 60% effective at cure. As I'm going to use the term I never use that term with patients though. Um Another big problem is uh you know, the kryptonite for randomized control trials is crossover. So 10% of the ab patients randomized to ablation never got it. And 30% of the patients assigned to Anth drugs got it. And so when you analyze the intention to treat analysis, um there's a, you're analyzing a lot of people in the arm, they didn't actually get what they got if you look at uh the per protocol or as treated analysis, actually for the primary outcome, which I wouldn't have thought would have seen a difference. There was a market improvement with catheter ablation. So um that's for all comers remember that was a heterogeneous cohort. So what about for patients who are just diagnosed with a FB? So these are two trials that came out. Um These are their enrollment times, not when it was published, the trials were published in the same uh New England journal article uh or edition in 2021 1 was run out of Cleveland Clinic by my former um uh section had Samawa and then the other one was run out of uh Canada by Jason Andrade. And basically, they, they did very similar things. They were cryoablation versus anti rhythmic drug in the stop A F first, you had to have recurrent symptomatic A FB. So you had to have two episodes, you couldn't have been on an anti rhythmic drug and you had to have a not dilated left atrium in the early af trial. The first episode, you could ablate again. No anti drugs and the outcomes were slightly different and how they monitored was slightly different. But they looked at uh in the stop a first trial, uh less than 30 greater than equal to 30 seconds of AFI but one year that's the same thing you're going to hear again and again, they looked at cardioversion, second ablation and need for a new anti drug. Basically saying clinically it didn't work. And then in the early A F trial, they put loop records in everyone. And that's an important distinction because the more you look, the more you're going to find and so that's number, but it may not be clinically meaningful. And they also looked at symptomatic A FB afi burden quality of life and adverse events. And these are the trials, the trial results. So very similar reductions of about 30% at one year in terms of uh recurrent A FB. And what you'll see is in the Stop A F first trial is 75% freedom from A FB. And in the early A F it was 60% freedom from a FB. And that is probably just how you detect. So the early A F people all have loop recorders. So we caught everything. Patients in the stop A F first had EKG S and serial holders. So you're more likely to miss things every now and again. But importantly, in the early F trial, they had that secondary outcome of symptomatic A FB. So, OK, the loop record catches a FB 40% of the time but only 10% of the time. Do the patients have any knowledge that it was going on? And if ablation is used and A FB is treatment is, is targeted, oftentimes for symptoms, then this is a really important stat. So again, it comes to that 90% thing I had on there. So in this trial, I'd say the answer could be 90%. So what about in heart failure? So, um there are two, there's a ton of trials on a FB and heart failure. But the, these are two of my favorites, the camera camera MRI study which is 2017 and the Castle A F study which is 2018. And what you can see in these, in these trials is basically patients that were pretty sick. Their efs were 35% and the camera MRI L A diameter was five which is, which is pretty significantly dilated. This one was uh pulmonary vein plus postural isolation versus Gold Directed medical therapy. What you can see in the bar graph is market improvement in in ejection fraction with ablation versus medical rate control in the Castle A A trial which is run by Meroe and uh was published in the New England Journal. Uh Most of these patients were persistent, all of them had defibrillators. Um I think they were all Biron C RT DS. It's kind of a weird trial design but um and it was basically uh a fri plus whatever lesions you want uh versus goal directed medical therapy. And they showed a 12% absolute reduction in mortality and a 15% reduction in heart failure hospitalization. I just want to be clear about this. This isn't 15% compared to one, it's 15% total. So the number needed to treat there to save one life in this in these patients is is about eight. If you compare that to other things we do in cardiovascular medicine, this is this is a class one indication or should be, we'll get to what it actually is in a second. And in this case, even in sick patients further on, we saw a 63% cure rate of a FB. So what do the guidelines say, so the guidelines basically say this. So there's a two way indication to ablate anyone with symptomatic. Uh A FB, it's not a class one indication that may change in time because these guidelines are only from 2017. And you may say, well, it's 2023. Why don't you guys have an updated guideline? Um I just actually served on the uh conduction system basing guideline that was released by AC C Hr S and having done that, I can appreciate why it takes a long time. Uh It's, it's a very long, laborious but extremely intellectually stimulating process for, for heart failure where we see a 12% absolute reduction. It's only a two B indication. I mean, that's, that will not be the case when it comes out again. So there are some caveats and this was my last question, the people who shouldn't ablate. Um Is there an age cut off for ablation? The short answer is no, there's not a lot of data for patients in clinical trials over the age of 80 to 85. Our, our new pulse field trials that cut off was 80 years old. Um And age isn't the only thing there's I had a 92 year old that I did an a fibrillation on because her, her symptom was that she couldn't push mow her one acre law. So she's probably healthier than I am and she's been doing great. But then there are some 50 year olds who are wheelchair bound on dialysis. Um they shouldn't be considered candidates. Frailty is really important. We know a lot about this in the structural space. So frailty is probably more important than age. If you actually look at the data, uh Pascual and Tang who was at Penn at the time now was at Cleveland Clinic showed it it has a really nice paper from a while back. So I'm sure this is even better now that with better technology show that really results were sim pretty similar in terms of complications and success with patients uh in their eighties, can a patient be too obese? Um The short answer is yes, we know that lifestyle modification still matters. I cut some slides out just for time, but you know, weight loss still matters. Um uh uh sleep apnea treatment probably still matters. Alcohol cessation still matters. So it's not just ablation and drugs, but um in this trial, which was run by one of my former co fellows. Um Owen Donelly who's in the picture and it's just just, oh sorry, I want to go back um just for kind of levity. This, there's a sign at Cleveland Clinic where I did fellowship at the surgical or as it says through these portals past the world's greatest cardiothoracic and vascular surgical teams. And it's like somebody printed out and held attica and put it on the wall. So we all took pictures next to it. But in any event, um, so, uh, the short answer is you can be too obese to have a good outcome. But actually bariatric surgery, if you look at patients who got bariatric surgery plus ablation, they did just as well as patients who, um, we're not obese and with all these weight loss drugs that are coming out and there's a recent, uh, publication, I'm blanking on the name of the drug in heart failure, patients doing great weight loss. I it'll be interesting to see what this does for a FB management. Um Well, what about persistent AFI B? I've shown you some heterogeneous trials that basically show, you know, similar outcomes with uh A FB and per is one persistent. But we've always said, OK, we don't really understand how to ablate persistent A FB, the veins aren't all that matters. I love this trials and it's called the Era A F trials published in the New England Journal in 2022. And it basically showed that if you find areas that have low voltage beforehand and you ablate them um that patients can have almost a 70% of freedom from airfare about one year. And the interesting thing is these are patients that had scar, you ablated the scar, they did just as well as patients who adjusted the veins and they had no scar. So it shows that even though we'd like to see these patients earlier, um you can still get good outcomes. This trial just came out. So I'm gonna do three slidess on this because I think it's really important for everyone to see these slides. This is called the Castle HTX trial. It was a single center German study. It came out like two weeks ago and it's been blowing up. Ep Twitter or X or whatever Twitter is now. Um But basically this is, this is a trial um that in Germany and I've talked to John, hurry about this and, and so these patients are probably not as sick as our patients that are referred for transplant. If you look at the characteristics uh on the right. But basically, these were patients that were referred for heart transplant or LVAD and had a FB and they were randomized to goal directed medical therapy and advanced therapy work up versus ablation. Plus that and these patients were sick, 70% had class 3 to 4 heart failure symptoms. Uh The mean duration patients had been in a FB was 3 to 4 years. So this was long standing persistent A FB and all the uh atria were dilated. The mean ef I think was in the twenties. These are the C AM curves. There are other ones that are equally impressive, but basically, the trial was stopped at 18 months because of efficacy because there was a 22% absolute risk reduction in in death transplant and LVAD. So this isn't, this is not some, you know, symptomatic quality of life score. This is death, heart transplant and LVD. So what it shows is probably we should be ablating people that we weren't before. And in the last question I asked you that 90% of people said that or maybe it was 85% of people said that there probably are people we shouldn't have blade. I agree. There are, but we probably should be thinking a little bit more about who we shouldn't, shouldn't ablate because of this. If you look at this number, what these tables are probably a little hard to see. The thing that's really important here is a lot of these patients still had a FB after you a bla them. But, uh, in the right table, what you'll see is we basically turned a lot of people from persistent to paroxysmal, meaning they still had a FB, the mean burden of a FB in the left table is still 20%. Um And so it means that you don't have to get rid of a FB altogether but persistent. A FB probably is, is detrimental in these patients. So let's go back in time. So the affirm trial in 20 22,002 is probably still the most quoted trial. I think when I'm like walking around and I see an internal medicine, you know, around that, you know, rate was the same as rhythm control, but just know that a FB didn't a FB ablation didn't even exist when this trial came out. Um 25% of the patients in the trial had clinical heart failure, ef reduction, which we know has a benefit now and there were no secondary end points. Again, we didn't look at quality of life a FB recurrence. So my question is, does asymptomatic a FB even exist? I think the answer is probably there are, but I have a nice case here. It's kind of hard to publish. But I have five people in Williamsburg who all are uh cyclists, some of them are tandem cyclists and they all were convinced they had, they had no symptoms and we did a cardio version, all five of them and they all wore vo two max uh monitors for me and they all did better and the one who did his tandem bike, his wife could tell the difference the next day. So I think whether you have to say that you have to do something about them because it depends what the symptom benefit is. I think it's debatable, but I don't really know that we really have good data. That asymptomatic AFI B is a thing. So I, I wouldn't quote this trial. I think it's irrelevant now. So does this, how does this compare to the real world? So these are my own data from the last four years. So I've done this was I pulled this in June for another grand rounds. I was doing so it's not updated. The numbers are bigger now, but 350 patients, what you can see in my patient population is unfortunately, a lot of the patients are persistent and long-standing, persistent. That's partially, I think because my clinics in Hampton and there's an underserved population there, but 50% have already been on anti rhythmic drugs and most of them are first time. Uh uh A FB ablations about uh 20% of my patients had severed left atrial dilation and 15% had reduced efs. So if you look at the clinical trial outcomes, which is the 30 seconds freedom from a FB. Um I'm very fastidious about how I do this. I don't put lup quarters in everyone, but I have a lot of people get Apple watches and cardio tracings and I do a lot of monitors. So I think these numbers, if everyone had a loop record would be lower. But in general, the numbers you see here are 70 to 90% even the sick patients. So our outcomes are very good these days, the complication rates are low and you can see what they are there. I've also gone through further and said, ok, well, if I'm gonna, patients want to say, ok, well, how am I gonna do afterwards? So, I've gone and looked through, ok, if, if I can induce another arrhythmia, what's the likelihood that you're gonna do poorly or? Well? And it turns out it depends on what I induce and I don't think any of the other eps would be surprised by this typical flutter patients do fine perimiter flutter. A little worse, weird atrial flutter, atrial tachycardia is a little worse. If there's an arrhythmia, I can't terminate in general. I'm looking at ANTM drugs in those patients and what really matters. Not just the freedom from ab uh, this is the trial is similar to the early A F trials and and the stop A F first trial. So about 13% of patients have over prolonged follow up. That's about four years have needed an enteric drug cardioversion or redo A fri only seven per 8% of patients have needed a redo A FBL. But most patients have changed from persistent to paroxysmal and for patients who have devices, you can see their median and mean, I got to get back to back up. We don't have enough road to get up to eight. We don't need no, this is a slide. This is a slide for pulse field ablation because there's new technology coming next year. And I think that's, that's what all of us were, were excited about, about pulse field. I think the shine might be off a little bit but this is where the future is going. So, non-surgical site ablation. So um uh care Lex Hospital for those of you from, from the peninsula, we opened up uh an ablation uh program there in 2019. There is not surgical back up there. And there's a good paper from John Puccini who I'll, I'll just plug is giving grand rounds on Tuesday. So everyone go to grand rounds um that showed safety at, at non surgical site uh centers. And what you can see there is that the blue is 2021 the orange is 2022 and the gray through March was 2023. So we're doing a lot of off-site surgical ablation. I think the next frontier here will be ambulatory surgical centers probably in the next couple of years. This is what's coming out um In a couple of weeks. This is Q dot Which is uh a Biosense Webster uh technology that basically allows us to ablate for 90 watts in four seconds. And there's a nice trial by uh Jose Osorio who's kind of like a AFB efficiency guru. Um And some of our team here, we actually went down to his lab in Alabama before he moved to, to, to look at ways we can improve our workflow and she had very good outcomes. And so we'll, we'll see, I think there's a lot of hope that this will be a nice, a nice uh approach for patients who we really want to minimize the amount of fluid you give during an ablation. So pulse field. So what are the general concepts people have heard this term? So right now we use thermal ablation. So radio frequency or uh cryo. So heating or cooling, I have non thermal with an asterisk because it's non thermal. But there's some data showing that there probably is some thermal injury from from pulse field. Um But it's a lot more minimal, it's ultra rapid pulse electricity that destabilizes cell membrane pores leading to cell death. So you may have heard the term electroporation. This is what this is and, and the advantage of it is there is different tissue selectivity. So you can ablate the atrial myocyte and not get the nearby esophagus or the front nerve. So what do we know about pulse field ablation? So there's really, there's multiple pulse fields. But uh the first big trial we had came out, came out not that long ago, um run by Reddy. Uh And it was the, the advent trials. It was a really well done trial. Actually, it was radio frequency versus cry versus pulse field. Uh In Parex is a FB and, and what it showed essentially was that I think a lot of us hoped it would be better. It wasn't better. It was as good in this trial again as we get further on through time, success is better, 70% success rate, but it was faster by 20 minutes, which is important when we have long wait lists. And um and didn't really show any, any, any complications. This is a trial that'll be coming out soon. Um uh Phil and I actually did the first pulse field ablation case in the state of Virginia for persistent A FB. This is, this is the map from that um using a Fara, which is now bought out by Medtronic. Um This trial ended last year uh was extremely well done, I thought um And uh I'm fortunate enough to actually be cori the manuscript. Um So I can't talk more about it, but um we'll have data for you soon. So, what are our barriers to optimizing a afi care going forward? Well, so I've basically shown you evidence that I think should have, should have impressed upon you that there is increasing indications to ablate a lot of different people, our populations, as everyone knows, it's also more comorbid. So it's gonna be an increased demand for a FB ablation. If you look at it, arrhythmia care represents the largest recent increase in C MS expenditures of the last couple of years. So this, this isn't just hypo hypothetical. This is real. There's fewer cardiac electrophysiologist per capita than any other medical specialist. Good news is that is not the case here. But um despite that, we're not filling fellowship spots. So it's going to be less and less of us and more and more patients to ablate. We're getting patients already that are referred to late. You know, 60% of my patients are persistent and if we can get to them earlier, we can reverse remodeling before it happens. If we do. What we're doing now, this is the problem. So this is John Puccini's data, data from Duke. The average patient from the time they get diagnosed at the time they get ablated is 4 to 8 years in the US. That's problematic in Ontario Canada. Um And because it's a Canadian health care system, they have some pretty good data. The meantime to referral was 218 days just for reference in our group, we are a little bit better than that, but sometimes our referral patterns can be six months too. Um And over that time period, if you look at it, basically 20% of patients while they waited, had death, heart failure, hospitalizations or had to go to the er, so we're using health care resources because we can't get people ablated. And if you look at the Intermountain data from Jared Bunch, what you'll see is that there's a mortality increase every time you wait and this is even in patients with normal efs. So back to the Michigan thing, you can't do things without a team. You know, there's the, the, the whole speech of the team, the team, the team. Uh if we think of that way, take into consideration what effect does it have on the team? You'll be more successful. So how can we fix this? We're working on direct er to ep pathways PC P to EP pathways and this isn't a knock on general cardiologist. It's just if we're going to be the ones to make the decision to ablate. The sooner they get to us, the better we'll do. We're looking at a FB access clinics that are ABC led to triage patients and try and get them on with us by wait time. We need administrative support um for the most efficient technology and we need investment in our lab personnel so that we can run our labs and then we need prioritization of early rhythm controls, particularly in heart failure patients. And this is proof not concept. So uh the top slide is uh DJ lock already. Uh basically showing that if you have an er dep pathway, you can see patients within patients get a bladed within 50 days versus 100 and 80 days in the bottom is a recent trial. It came out in Jack Ep that showed if you have blade heart failure patients within 90 days versus uh usual standard of care, there's a quick splitting of the C AM curves for mortality. And then this is uh Dip Patel, one of our newer EPS who presented a a HR S shark tank and that was a picture that they made him take. So I put it on there and then you can see uh basically after the Castle HTX trial came up, this, this big uh this big uh Twitter explosion. And so people have been talking about GDMT plus ablation as the new tagline. So this is a take home message ablation is efficacious and safe for an expanding population of a FB patients. The days of rate control are largely over. Just let us decide who to ab blade and not. We're not going to say yes to everyone. But if we can't see them, we won't ever ablate them. This is our team. Uh Phil Gentles, Tanya Hernia. Uh John Gramas, Jeff Hadley Van A Ier myself div Patel Shigo, Asas and Ian WTZ. We have nine eps um and we were spread all throughout the uh throughout the region and uh I actually finished on time. Deepak. Published October 13, 2023 Created by Related Presenters Erich Kiehl, M.D. Sentara Cardiology Specialists View Full Profile
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