In this webinar, expert Electrophysiologists from Penn Medicine discuss Atrial fibrillation outcomes, ablation versus medical management, new management strategies, future technologies to be used for best patient outcomes, and clinical trials happening at Penn Presbyterian Hospital at Penn Medicine.Â
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all right. Good morning, everybody. Welcome to the new academic year for grand round and just upcoming year is gonna have some significant changes because of the co bid situation. But hopefully there are some good changes that have come out of this. And one of that is Grand Rounds will now be on a virtual platform, hopefully for more folks to enjoy. So today's our first session for the new academic year, and I'm excited to announce our two speakers for today and the topic being an update on management of atrial fib relation. The first speaker today will be John Belinda. He's the director of electrophysiology at Penn Presbyterian Medical Center, and our second speaker will be Bend Sousa, also an electro physiologist. There have been a lot of interesting studies and data that have come out about atrial fibrillation in the last year. For a lot of folks have heard of the cabana trial, and as we move into more and more technology for stroke reduction, Andre atrial fibrillation ablation. We thought it was a good time to let John and Ben give us an update on atrial fibrillation management as well as's the Future Research Studies that are ongoing that will help answer, hopefully, fill in some of the gaps that we have right now for atrial fib relation. This is a CMI event, and for those folks that are comfortable with our CMI uh, credit codes, uh, it's 66416 which you can text to the number on the screen for those that are new. You do have to register one time and after that, conclude the credit by entering the code, either online or through the text feature. Again, the code is 66416 I'll put that in the chat box. Um, in that way, folks can access it if they need to. John will start things off, and then we'll move on to bend at the end. We're gonna try to keep about 10 minutes for questions and answers. If you guys have any questions or comments, please feel free to use the Q and A tab or the the chat Cabot the bottom. I will be monitoring those, and we'll keep track of those again. We'll try to get to the questions at the end of the session, and we should have about 10 minutes for that. So with that introduction, I'm gonna turn things over to John, who will get us started. All right, John, Do you wanna actually? All right. Good morning, everyone s Oh, this will be our update in atrial fib relation. And let me just get to control the screen. So no relevant disclosures for this talk for either. Better myself. Eso We're gonna go through some case examples. We're gonna look at some outcomes of a F ablation versus medical management. We'll talk a little bit about our relation strategies, technology developments over the past few years, future technologies and some clinical trials that are going on at Penn Presbyterian. I wanted to start with a current case example and s. So this is a case. Uh, that's just in the last couple of weeks. The 74 year old woman, no coronary artery disease, history of tachycardia cardiomyopathy a few years ago, treated with D. C. Cardioversion in an iota run and had recovered her ventricular function as of last year, and it had been maintaining Sinus rhythm. Covad, 19, occurred, and she's been followed remotely on her pacemaker and also has had telemedicine visits and characterizes having asymptomatic a fib prior to her next clinic visit, we had to come in for getting an echocardiogram. And at that time, her only complaint was a little shortness of breath, which she thought was from wearing her mask. Um, if you look at her 1/5 burden, it really sort of picked up starting January and has become persistent since May. Her heart rates seem like they're adequately controlled. So with that, you wouldn't think much would happen to we're overall heart function since it was normal last year. And if we look at our ejection fraction now, it's been read as being an ejection fraction of 20%. So this is, uh, you know, something terrible that happens with cove it that we're not monitoring people or not able to see them. Or, uh, it's just things get a little bit misplaced now, with lenient versus strict rate control. This isn't supposed to happen. This is New England Journal paper from about 10 years ago. If you just target heart rate less than 110 beats per minute, people should be okay, and she was certainly less than 100 10 ft per minute on average. But if you look at more recent data, and this is actually a heart failure group with preserved ejection fraction where you stratify by the overall heart rates. First of all, in a fit people don't survive as well as if, as they are if they're in Sinus rhythm but also in a fib. If you look at just greater than 90 beats per minute, there's a pretty quick drop off rate where people do worse and there's a worst survival. And she may be sort of in that kind of a group where she quickly had worsening of our heart function. So I want to talk a little bit about, and I often say this to patients that I think that life is better in Sinus rhythm. So we just said that you know the presence of a worsens mortality. But let's look at some potential benefits of maintaining science rhythm with a fib ablation the improvements and cognitive outcome. Lower mortality and heart failure patients potentially lower mortality. Overall in a fit patients lower stroke rates, more hospitalization rates for heart failure. Let's look at cognitive outcomes. So this is a study. You know, the idea here is in a fib you may have some cerebral, hyper purplish fusion may have had more inflammation. Hyper credibility Lead to some clinical strokes or silent in FARC's. You have brain changes and ultimately leading to some cognitive impairment and dementia. So the hypothesis is that if you can maintain science rhythm with doing in a fib ablation to reduce the burden of a fib, you may have a better cognitive outcome. So looking at 308 ablation, patient's following up at three months at one year. And using this, it's called the Montreal Cognitive Assessment Score. Looking at that versus control patients and medically treated group, according to guidelines, very matched controls. Ablation Patient's did better over time, and in particular, people that had some baseline cognitive impairment had improvements compared to baseline. Sure, now Cabana is a big topic, and so let's spend a little bit of time talking about Cabana. So this is a randomized control trial of anti arrhythmic drugs versus ablation and to trying to look at hard endpoints for the primary endpoint intention to treat on mortality, disabling stroke or serious bleeding. Doug Packer of ran this trial, and he had the right idea at the right time, but I will say execution was difficult. He was asked for years at conferences House Cabana going and he would look a little bit pain when he'd be answering and trying to say, We're going to be coming to an end point sometime soon. In the end, it was a moderate sized study. About 2000 patients mean age of 68. Of all of the patients assigned to ablation, 90% received ablation their international problems with basically patients being assigned to the ablation arm but then not having insurance coverage and a variety of reasons not actually receiving the desire therapy. And even worse, 28% of patients assigned to drug ended up having an ablation. And this is sort of AH problem when you can't effectively execute a randomized trial. Because both the investigators and the patients felt that a F ablation was more effective and wanted the therapy. And actually investigators have a duty to inform patients off developments during the trial, and that led to a lot of crossovers and so on attention to treat basis. There really was no significant outcome if you actually look at therapy delivered there was a significant outcome in terms of reduced mortality. Let's look at some more trials in some more recent data. Okay, an important trial is Castle A F, not the largest trialing, but yet it's a heart failure trial where people had class 23 or four, heart failure had an ejection fraction less than 35% and had a defibrillator. There were 179 patients in the catheter ablation arm and 184 patients in the eighth in the control arm. After 30 eight months, there were significantly fewer deaths in the ablation group, with a hazard ratio of 0.53 which was highly significant. And that really changed a bit of how we approached heart failure patients in a fib. So that's a relatively small trial. But how Generalize Herbal is this. If you look at a database of 130 million patients and try and find the patients that are similar to Castle A EV, so in this ablation group, what they're able to find is patients with a fib and heart failure. They had 7000 ablation patient's. This is 40 times the size of Castle a f now, uh, and the outcome. If you match a propensity score of 90 different characteristics, try and really match these patients up. Well, the mortality hazard ratio was 0.67 So not quite as much as Castle A F, but highly significant. So this occurred if you take all heart failure patients and a similar hazard ratio, this is for death or hospitalization. If you take all patients or the ones that are strictly enrolled would match up with Castle A up. So they had a defibrillator. Ejection fraction was low enough. So is there more data to say that this a fib ablation impacts mortality? Well, uh, this is a California study of F ablation, uh, enrollment from 2005 to 2013. So I actually probably contributed a number of years ago to these patients. So there's 4000 patients, So this is about four times the size of cabana heterogeneous population from California. And there was a lower mortality in patients that received ablation with a hazard ratio of point 59 There are also fewer strokes and fewer hemorrhagic strokes. Now, let's look at another meta analysis of ablation, So this is 27,000 ablation patient's versus compared to 213,000 medical groups. Um, and they did match controls again. So this is about 27 times the size of cabana, and there's a hazard ratio for mortality off 0.62 again, highly significant. Looking at huge databases. There's also fewer strokes. The hazard ratio of 0.63 and there were fewer hospitalizations for heart failure with a has a ratio of 0.64 So to me, this suggests that now there's more life if you're in Sinus rhythm. So the benefits of maintaining Sinus rhythm appeared to be an improved cognitive outcome. Lower mortality and heart failure patients lower mortality overall in patients with a fib and also fewer strokes and hospitalizations for heart failure. There's all sorts of other data out there also in terms of improved quality of life on and certainly improved times in Sinus rhythm. Now moving on a little bit, we'll talk a little bit about ablation of a fib, and I'll say there's a lot of different strategies and a fair amount of confusion about you know, what's the right strategy to use? Um, if you look at more single center type studies. I'm you will see benefit of linear ablation. If you look at, uh, single center studies, you can see the, uh, ablation of complex fraction Electra Grams helps out. But how? Generalize a ble is this into large trials in clinical practice. And what has happened is this is a little bit older data. So this is 2015. This is before Contact Force, um, newer technologies to try and really standardized things. We couldn't see too much of a difference between ablation strategies. But this is probably also a problem off the therapy being able to adequately be delivered. And so we want to move from 2015 to 2020. And we want to move from, uh, the higher efficacy toe, higher safety. And so how are we going to do that? And what has happened in the last few years? Well, we've gotten better at understanding how to deliver lesions and be effective with those lesions were delivering. And so if we're trying to get pulmonary vein isolation, we could get more durable pulmonary vein isolation. If we're trying to get linear ablation or a blade, other areas we can get more effective lesions today, so it's a little bit complex. But so to try and predict lesion size Uh, try and go through this quickly. You don't need to learn this, but so lesion size is a function of resistant and conductive heating with short legion duration. It's mostly a function of resistive heating, which is a function of current tissue, uh, current being delivered into the tissue tissue against and time and making a number of assumptions of normal tissue cooling. The electro tip uniforms, uh, contact force being delivered. What you end up with is an equation using, uh, multiple linear regression versus bench. Top data of what's in ablation index is a function of contact force power in time. And really, what that allows us to do is to have a mortar predictable lesion. And that is actually a significant advancement in the past few years having this incorporated into the mapping systems and being able to be a bit more controlled in our relations. So if you use this data, let's look at some data over time in terms of being able toe, achieve durable pulmonary vein isolation. If you look at what we're doing in 2015. Before we had Contact force. It's really just we're moving our catheter around and we think that we have to sort of the art of ablation able to achieve durable pulmonary vein isolation about 62% of the time if you add contact force. So we know that we actually are in good contact with the tissue are more likely to deliver a lesion, get durable isolation 74% of the time you start. This is called the first time index. If you work at trying to get some measure of actually achieving a lesion, you get a higher rate of durable pulmonary vein isolation. And with now using even better measures of predicting lesion formation, you get up Teoh a success rate of 93% for durable pulmonary vein isolation. And as you actually achieve the a desired ablation lesion set, you actually have an improvement and atrial fibrillation outcomes. If you look at this is a relatively small study. But it's kind of an ideal group for pulmonary vein isolation. Using these tools, you have a mean age of 62 not too many risk factors. A relatively normal left atrial size. Join, uh, pulmonary vein isolation. With modern tools, you can achieve a success rate that's relatively high. A 12 months, 83% success rate. But the way we look at success may actually be a little bit wrong, and we should probably use some additional tools for assessing success. So among that 83% that had no a fib detected on implantable loop recorders you go from time and a fib of 3% 20% an 83% of the group. But among the failures that spent before the ablation 5% of the time in a fib they're resulting burden of a fib is point 27 And so although they've had recurrent a fib documented on their loop recorder, they may have actually also have had a clinical success. And so we should also be thinking about time spent in a fib, and not just whether or not you've had a single recurrence, which would be defined as a quote failure of ablation. Now, just to talk a little bit about strategies, Um, it does seem that as you get toe or dilated atrium and more advanced disease that you do have to doom or in order to achieve successful rhythm control. Uh, this is just an example. There's numerous studies out there, but if you just do pulmonary vein isolation and you have, uh, left atrial disease and you have persisted a fib, uh, the outcome opponent in isolation is only about 50% in terms of maintaining Sinus rhythm. And if you add pushed to your wall, which many of my colleagues do and I do myself, you do have a higher success rate about 70% after many months. Also, Michael Isthmus Block if it's a chief, uh, in ablation, can improve survival. This has been known way back to 2000 and three. I remember when this paper came out, um, improve success rates for at one year in 100 patients from 69 to 87. My Christmas has always been a difficult target to achieve if you try and target my Christmas and don't achieve block. And there's a high rate of recurrence of atrial tachycardia is in particular mitral isthmus flutter. But when you do achieve mitral isthmus block, it actually predicts a very high success rate for ablation of a fib So let's just do a quick example of doing ablation using current technologies. Uh, so the 72 year old man with persistent a fib for about six months mildly symptomatic, and he was compliant with my advice in terms of risk factor reduction. He stopped drinking alcohol, which he had been kind of heavy drinker beforehand. You lost £25. You started to use CPAC for treating sleep happy. Um, And so now we're gonna take him to do an ablation with our current technologies. Uh, I had started out his case with doing a mitral isthmus situation. This is that ablation index we're talking about. You can measure ongoing as I'm doing the oblation the distance between my last lesion and how much, Uh, energy is being delivered into the tissue at that time. Um, in order to achieve complete mitral isthmus block. This is about where the living with Marshall travels had toe Blake relatively deep and ultimately was able to achieve my troll isthmus block, then went across the left atrial roof and pacing from the left atrial appendage with lasso Catherine looking posterior. I could tell that I had achieved roof line. Block continued around the right pulmonary veins, and now I had to approach the posterior wall. I put contrast in the in the esophagus so I can see where it is. And you can see this lasso is kind of covering the esophagus and the corresponding three dimensional map, alas, of Katherine all across the posterior wall. And so, rather than try and draw a line toe, either cut into the pulmonary vein. What I did is I just isolated the pulmonary veins along with the post to your wall at the same time with doing a single, inferior line. And I had also completed the line to isolate off the left pulmonary veins. Now this was this, Legion said, would be difficult to do with our older technologies. But now that we could predict lesions a lot better, it's much easier to draw a line with ablation that will actually be blocked. Um, and this is just kind of fun to show that I tested for induction of a fib afterwards, with burst atrial pacing immediately going back to Sinus rhythm. This would put 90% of the audience into a fib. Try again, can't get him in tow. 1/5 try again. Get one A PC at the end of this, and this is after six months of persistent 1/5. So over time we think that lesion prediction has improved outcomes, and that's where we are today. And we're looking forward to what new technologies will actually help us out in the near future. And the most exciting technology out there are upcoming technology at this time is electric operation or post electric fields, and the idea here is to deliver high voltage with the catheter in a short poles that causes electric operation are basically the tissue. It's little holes in it, and that kills the cells. However, just by the nature of things, it turns out that there is tissue selectivity and mild cardio is much more sensitive to electro operation than nerves, coronaries and also the esophagus. And having this tissue selectivity may actually improve the safety profile of this. But also, um, it may be a relatively rapid way of being able to do an ablation, and this is an example looking at what happens with Electra operation versus radio frequency ablation the esophagus with electro operation completely preserved. And if you do ablation over the esophagus. You can have transmitter on the, uh, necrosis of the esophageal wall. So this actually is potentially a huge safety improvement. And, uh, this has been done actually, in patients at this point, Uh, there's some tool sets out there for delivering, actually, both Electra operation or our energy. Depending on location in the atrium, you could do pulmonary vein isolation, or you could do successful linear ablation with Elektra Parisian. So, um, at this time, uh, in terms of conclusions. So I do think that rhythm control of a fib eyes important and improves outcomes. Important outcomes. Cognitive functions improve mortality in patients with heart failure is improved. And if you look at huge data sets, mortality and a thimble, patients in general has improved. I do think that the past few years that technologies that are now available that weren't even available just a few years ago have allowed us to do safer and more effective ablation. As we can predict, the lesion sets and customized unleashing sets even more, and in the near future, there will probably be electric oration be available. And with that, we may even improve safety further. So I'm gonna give better question. He's gonna be ableto talk about this in the next part. So 60 year old man with persistent ate the noun Sinus rhythm after a five ablation. It's tolerating eloquence. Chad's vascular three. What's gonna be the long term approach? That's gonna be ideal for him? This is sort of a t up for one of the trials. You do a lot of different things, but, um, I do think that a clinical trial looking at Hey, if we put in a watchman and you don't have to worry about anti coagulation compliance, G I Bleeding falls, rhythm, intracranial hemorrhage at this taxes, other accidents. This guy's 60 years old, hopefully is gonna live to the age of 90. And if you could do a one time therapy potentially and not need 30 years of anti coagulation, that may actually be a huge benefit. So, Ben, let's switch over to you. All right? Great, John, thank you very much. And, you know, I think it was a great job of giving us no review. And where things stand with atrial fibrillation. I know they're gonna be a bunch of questions on who the ideal patient is for ablation How do we monitor for recurrence of atrial fib relation? And what do we do with anti coagulation afterwards? So kind of the before and the after the procedure. And we could maybe discussed that a little bit more at the end here. So next up, we have been to Sousa, who, through several ongoing and upcoming trials, will hopefully be able to answer and fill in some of the gaps that we have right now. So, Ben, I'm gonna turn it over to you. And if you want to go ahead and do the screen share, we'll get you going. Ben, I don't think we can hear you. Alright, How about now? Can you hear me now, Samir? Yep. Now we got you alright. My airpods were not working. I apologize if there's some background noise. I'm over in Cherry Hill planning for a nice, busy day clinic. So, um, let's make sure. Can you see my slides now? Yep. We got your slides and I can hear you nice and clear. Uh, that was a great summary, John of everything that we're looking at in a fib. And it's an exciting time in our field because the technology continues to improve, and there's lots of clinical trials that we're gonna be doing it at Presby that really will help to answer some of those questions. So in answer to your question, we don't know S So what are we supposed to do in patients after in a fib ablation in terms of anti coagulation? Currently, the guidelines state that you should be on a not coagulation like you should prior to an ablation based on your chad score. But if you think about it, why should you be on anti coagulation if you remove the reason that you need to be on anti coagulation? And so there's a trial currently ongoing in Canada, looking at implantable loop monitors and patients that air you're out from a fib ablation and seeing if it's safe to stop there. Any calculation and then a trial that we're gonna be talking about involving the watchman device and left a trope ended closure is potentially an option for patients to come off their anti coagulation as well, which we'll talk about a little bit more detail. I'll make sure I get through all of this so that we can have time for questions and also go back toe doing some work. And so a Zai had mentioned earlier. Technology's improved drastically. I think one of the main issues with a fib ablation in general for are referring and for all of us is that it's sort of a black box. Nobody knows what the heck were doing. And certainly if someone wanders into my lab while I'm doing a fibrillation, it looks like I'm playing a video game. It's kind of like it, but it's really a big unknown in terms of what we do. And our job is to explain why we do the things we do, how we do them and why they're important for our patients. In which is an epidemic of growing a fib. Ablation patients numbers continue to grow. There's millions of Americans, whether most common abnormal heart rhythm in America and across the world. And so because John had mentioned, we use mapping systems that honestly have improved drastically over the course of the last 10, 15, 20 years on, you can see here sort of the timeline of that. Now what we currently use for the most part at Penn Presbyterian and at all of the University of Pennsylvania, for the most part is radio frequency ablation. So this is where we take a catheter and cauterize or burn away the abnormal tissue for whatever abnormal heart rhythm of patient has. There is another technology, which is cryo ablation, which is essentially a balloon that goes into the office of the pulmonary veins and freezes all of the tissue just different ways to kill abnormal tissue on one of the benefits and risks of both. Now again, as I mentioned, we generally use radio frequency ablation the benefit of that. It's a catheter that we can move to wherever we wanted to in the heart, meaning that we can avoid certain structures that we don't want to damage, in particular the frantic nerves. So there's about a 3 to 4% risk of frantic nerve paralysis, especially with right veins, because that's where the frantic nerve runs right on top of which is devastating because you can lose half of your vital capacity from a lung standpoint, if that nervous damage, and so that's the main benefit of using radio frequency ablation. The drawback is that the heating that can cause on the back of the wall meeting. The poster wall is where the esophagus is, and that's if damage to that meeting the most life threatening thing being in 80 fistula a tree esophageal fistula is life threatening, with mortality greater than 90% even if its picked up early eso. How do we do this? Safer and better, just as John had mentioned on DWI. Continue tohave benefits toe show that our outcomes are improved, but we have to prove it. And so one of the things that were involved in a pen is a registry that I enroll with a couple of other sites across the country and what we're doing is gathering data on bits registry data. It's retrospective, but this is amongst high volume operators that do a lot of procedures. They used minimal fluoroscope e on to achieve sort of an overall goal. We're collecting hopefully up to 4000 patients to start to answer some of those questions that we had talked about because most of the data that we looked at is using older technology. So the difficulty in doing any research, study or clinical trials that every year it changes. So I got a new Cather every year we get a new toy, something that we can use that hopefully will help with outcomes. But then the data that was collected is obsolete in some circumstances. So that's why it's always been difficult to do clinical trials, especially in our field. And as John had mentioned, it's hard to get any peace to agree on exactly the strategy to go about treating a fib in the lab. So another clinical trial that we're gonna be involved in a pen on din fact where the universal Pennsylvania is the national, um P for this international study and pass quality, Santana and myself are involved on its first line radio frequency ablation versus anti arrhythmic drugs for persistent a fib or the raft trial. Eso. Here's some data from previous trials, and essentially, what we're looking at is the recurrence of atrial fibrillation and now persistent atrial fibrillation. And John had mentioned earlier. Our success rates are not as good as we would like them to be with persistent atrial fib relation. But we all wholeheartedly believe in the world, a VP that ablation is superior to medications for persistent offenders. You know that the guidelines air one a and vacation for paroxysmal atrial fibrillation that has failed drugs. But to a indication for persistent on DSO, we want to improve that. We want to do better with these patients, and unfortunately, we tend to see more and more persistent atrial fib. Relation. Um, just in terms of timing, off referrals and patients getting tow us much later than we would like them to, um, this is the A fib free survival in previous randomized control trials. As we have mentioned, the sort of cumulative average is about 80 to 90% success rate of a fib. Free survival, which is what I quote my patients. Um, but this is for paroxysmal. You can see for drugs, that number is about 50 to 60% which is again, um, pretty much what is born out in all the data that unfortunately, we don't have better medications to treat this, and they come with side effects. Certainly, for all of us who have seen ammo toxicity, whether along liver or thyroid could be quite devastating in are certainly young and healthy patients otherwise who have a fit. And so this study is essentially random izing patients who are first time persistent atrial fib relation as first line therapy, as opposed to waiting to see if they have a complication related to a medication or failure of that medication. With the hypothesis, being ablation is better than anti arrhythmic drugs on DSO. This has not been actually shown yet, and so it's a very interesting clinical trial. And essentially, what we're looking for is patients who are new persistent atrial fib relation. Sometime within the previous nine months, they have to have document of persistent aphids, which is more than seven days, or requiring a cardioversion. So I would ask if you have a patient that is in the hospital, or that you were planning to do a cardioversion on that has not been on a drug, get rather than put them on amiodarone or put them on another anti really medication. They would be a candidate for this trial, and this trial could hopefully prove the superiority of atrial fibrillation ablation to medications. And again, what we're looking for is recurrent. And so after a blanking period, which is normally what we call sort of a healing phase while your heart is healing from all the fun that we did do it in the lab after that time period, we're looking for recurrence, and, um, we'll see. And so again, we're collecting a lot of data related to this. We've already enrolled some patients at Penn and participating in this multi center international trial. And so this is again just showing, um, eligibility. If you're not sure, just reach out to us or our research team. Katie, Elizabeth and, uh, you know, we'd be happy to screen the patient to see if they're eligible. So John had mentioned pulse field ablation or electro operation. So this is a really fascinating technology that a lot of the world are really excited about. And the reason is, I had mentioned Regardless, have how we currently oblate tissue, either with a cry a balloon or with the radio frequency ablation catheter. We're causing collateral damage, damage to the esophagus or damage to the frantic nerve. If we conduce do ablation without causing any of those long term complications, which can be devastating, you know we'll push the field forward in terms of what we can offer for our patients. And so again, as we have mentioned, the damage that can occur from these procedures is rare. Onda again that the risk of an esophageal injury causing official is quite low 0.5% or less. And I mentioned the 2 to 4% risk of cry balloon, causing frantic nerve palsy. But there is no risk of either of these with pulse field ablation. At least that's what we believe. So at at Presby we will be involved in a nice idea investigational trial involving this technology. So this is sort of what it looks like. It's a basket type catheter, and it basically delivers that, um, non thermal energy so delivers or destroys necrosis tissue without actually delivering heat or cold on DSO. This is already a technology that's used in oncology for solid tumors that are close to blood vessels or other things that you don't want to damage that can't be respected. And a Z John. It also mentioned cardiac Mile sites tend to be very sensitive to this, so it actually works out very well that you can kill the tissue you want thio without hurting the esophagus or hurting any other part of the body on DSO. We're gonna be involved in this trial that's going to be coming up over the course of the next year, and I'll certainly keep you posted. And in that regard so another trial that we're going to be involved in and sort of shifting gears from ablation to talk about left atrial appendage closure on DSO, as you guys know left atrial appendage closure is an indication for patients who can't tolerate long term anti coagulation, whether it be toe generally bleeding issues or falls or non adherents. But the most common question that I get in patients who come to me who are going to have any fib ablation is they say, Doc, I don't really wanna be on anti coagulation for the rest of my life. If I get this ablation, that means I don't have to be on anti coagulation, right? And the answer is, as we had had alluded to earlier, based on the guidelines, no. And while some of us in the field do believe that with an appropriation of ablation and screening with either implantable loop monitor or a combination of global telemetry in an apple watch or cardiac, um, can we safely stop anti coagulation? We hope so, and we think so, but we don't know. So because we've never proven it in the data. And so what this is looking at is, can we close off the left atrial appendage, where 90 to 95% of class form in non valvular a fib to get patients off their anti coagulation who are not at a bleeding risk, meaning that they're not having those bleeding issues or the reasons to get a watchman that are currently in the FDA guidelines? So essentially, this is a trial in which we're using, actually the new integration of the watchman device called the Watchman Flex Device. And so essentially, it's looking for non inferiority inferiority to know act including, um, Coumadin or no acts. The main criticism of previous watchman studies is that they randomized trials were to come in in, which is obviously not in general, what we're using for most of our patients for stroke prevention, who have atrial fibrillation. And so we're looking at safety and points in terms of bleeding is sort of the major one that we're looking at in these patients on DSO. This is a huge trial 230 sites globally and were involved in it at Presbyterian. Um, John and I are the primary investigators for this and essentially what? We're looking at his randomize in these patients. We've already started the process. Unfortunately, when Kobe hit, a lot of our clinical trials had to be suspended. But now we're sort of back and running again. And so this is going to be looking at this is the anti coagulation profile in these patients post, um, to see if we can safely stop anti coagulation and patients who receive a watchman device post a fib ablation. So patients had in a fib ablation already and basically three months to six months after we would discuss with them the possibility of placing a watchman device versus staying on anti coagulation on dfars, lowing them for I believe it's three years to see outcomes. So unfortunately, because of logistical reasons and financial reasons, we cannot do the watchman device at the time of Catholic ablation. Though it is involved in the trial, we essentially won't get paid for watchman device if we do that. And so, unfortunately, this has to be done in a stepwise approach as opposed to doing it concomitantly or at the same time, the goal overall is after after we get out of this data that we can petition insurance companies and Medicare and say, Listen, this is the best thing for your patient Were already in the left atrium. We're already doing ablation. Why can't we deploy watching devices Well, to get the patients off anti coagulation, get them into Sinus rhythm and make them feel better with all the data that John had presented earlier in terms of outcomes of a fib ablation. But we're working on it. It's a work in progress. Um, it's a really fascinating trial again, the Watchman flex devices and improved version of the previous watchman device that allows us to accommodate different size appendages that we weren't able to before. Generally, 95% of patients are a candidate for a watchman based on left atrial size and anatomy. Andi. This will further improve our chances to be able thio use watchman and all of our patients. Uh, it also is an easier device deploy, and it's safer based on some changes that they made. So the risk of perforation has decreased in the Newark iteration of watchman, which is one of the nice things about us getting to use this device and were the first ones to use it. Um, in Philadelphia, I believe. And in the University of Pennsylvania system, certainly. Um and so the future and a clinical trial we will also be involved in over the course of the next year or so is going to be called the Champion Trial. And this is a randomized trial of the new watchman device watchman flex to anti coagulation in all patients with non value 1/5 not having a fib ablation, symptomatic or asymptomatic from a native ablation. A Febreze standpoint, I should say. Not a bleeding risk, meaning not patients who are already having bleeding or falling or have some reason toe come off of anti coagulation just based on personal preference. So if you have a patient that says, you know, I don't wanna be on anti coagulation and again they're not a candidate for a native ablation, for whatever reason, um, this will be a trial for them, and it's fascinating that we're gonna be able to look at this in patients just across the board. It's gonna be a huge clinical trial, will be involved in a pen. Onda Presbyterian, and I'm really excited about the future with this device and with being able to offer patients to not be on that anti coagulation toe, offer them safer, a fib ablation options with better efficacy. To be able to treat as we have mentioned is sort of a growing problem of millions of Americans who have they found? Um, and so I'll leave it there so that we have enough time for questions for John, myself or anyone else. Onda looking forward, Thio participating all these clinical trials. And if there's anything that you guys have questions on, please ask um, myself. I want to give a big shout out to Katie and Elizabeth, who do a wonderful job with all the research that we dio A to Presby, and I would not be able to do anything. Its president Thank you everybody, and we'll open it up from there. Great, thank you very much. Ben Jonah's well remind folks that feel free to use the chat or the Q and A tabs at the bottom of the screen if you want to enter any questions in the meantime, John and Ben, I'll get things started off here is there an ideal patient for ablation? And are there certain patients that are not good candidates for ablation, either come or abilities left ventricular ejection Fraction left atrial size. Are there certain things that you guys look for and either the ideal or the not ideal candidate John, You want to take that one first? All right, well, there's sort of Ah, I think that in a lot of cases we can customize what we do in the lab to what the patient needs, and I and we'll start out with sort of the on the simple side. People that are paroxysmal, um, have a relatively normal left atrial size. Uh, they really should be pretty successful with control of their A fib with just doing pulmonary vein isolation. And I think the data with current technology is sort of bears that that actually is a pretty successful strategy in these patients. On the opposite side, you know, people have explored people that you generally say are kind of not that great of a candidate, so they've got the bad ejection fraction. They have a defibrillator, that clinical heart failure, let's say, class three heart failure. But in some ways They also have the most to potentially benefit from restoration of Sinus rhythm. And although it may be an intimidating ablation toe have to dio, it also is probably the most benefit the number needed to treat toe actually have. Amortality improvement is relatively low in that group. That's the Castle HF group, and so I think that we should be aggressive about doing the A five abrasions and even patients. They're relatively difficult, difficult at baseline. You have to be a little bit more careful, you know, watch their fluid balance is trying to optimize them before coming in for an ablation. But that said, if you could get them to maintain Sinus rhythm and there's lots of strategies that we have to sort of doing a more extensive ablation to try and get them under control, they actually have the most to benefit from maintaining Sinus rhythm. Your comments Ben Yeah, I agree, John. I think that so what we've seen in the data is that less than 10% who are patients who are eligible for native ablation across the board are referred for it. So the penetration of patients who need it based on the guidelines are not sent to us. And the main issue is that, um, the timing of a referral Thio an electro physiologist. Foreign ablation is generally too late, and so the longer that you wait, just as you had mentioned from your left, atrial size is sort of a marker of damage that occurs to the heart for lack of better term. So when you see the severely dilated left atrium, if a patient has been persistent, a fib symptomatic for a year well, the horse is out of the barn. For the most part, we can still help them, but you've now decrease your success rates. Now we're working on things to be able to help with that. But don't let your patient get that far ahead if they continue tohave symptoms. I look at the correlation with chest pain. We would never leave a patient having continued episodes of chest pain without doing something from an ischemia evaluation. But for a fit, well, let him go for a lot longer and say You can live with it. Here's a beta blocker in your any calculation, Andi. I think that's wrong. And unfortunately, that sort of is the general contestants with a fib ablation. So Theano, sir, is yes. There are certain markers that patients are higher, lower success rate and potentially higher risk. But our technology improves significantly. The amount of flu that we used to give off with catheters has decreased significantly, so we're not volume overloading them like the way that we had previously used. We are imaging modalities, including into cardiac echo, an electron atomic mapping where we electrically reconstruct the heart. Without fluoroscope. E has taken procedural times from 68 hours, found less than two hours um, floro times from 60 to 100 minutes, toe less than two minutes or zero minutes of flora and some operators hands. And so the efficacy and safety has improved significantly. Unfortunately, I think there's still a stigma associated with a population that people still think of the way we did things 10, 15 years ago, which we don't anymore, and it continues to improve. And I think that's sort of the take home point from my standpoint. All right, great John and Ben, keeping with this idea of patient selection, a question came in from Dr Boris, which has to do with in patients that have had episodes of atrial fib. Let's say, for example, post op in the setting of pneumonia and setting of sepsis. Um, you The feeling is that most likely, these patients will have Maura Fib in the future. Onda. What's the right timing for somebody that may have had a provoked episode of their, you know, provoked first episode of atrial fib and tagging on to Dr Borders? This question. Are there predictors that you guys use either on the E k G or or other markers that may help predict who's at greatest risk of future atrial fib after they've had one episode? John, you want to start? Well, so one of the predictors is just left a drill size. So rather than the E k g, it's looking at the echocardiogram and the structure of the heart and theme or dilated the left atrium is the higher the risk of future it. Vivien's Nothing is a perfect predictor, but that's certainly one of the sort of structural elements they look at. And then you look at the constellation of other risk factors that you could just drive from the chads massacre and the higher the chance. Vascular also predicts higher risk of future a fib and higher need for anti coagulation. And so, you know, all of these are gonna be, uh, you know, patient specific decisions, and there isn't a great, uh, generalized answer. But I would look at the structure of the heart Chad's Bhaskar, and talk to the patient in terms of how to manage that anti coagulation over time. Yeah, I agree. And John had mentioned, you know, you have the patient who is will be sleep apnea, diabetes or pre diabetes. Hypertension, who has an episode of pneumonia and gets a fib. They're probably gonna have more a fib in the future. It may not be in a year or two or five, but it will be there in the future. And so sort of going back to my point from before. Not waiting too long and meaning not wait until the patients become persistent in atrial fibrillation is the right way to do it, and there's no harm in having them seeing electro physiologist earlier rather than later. There is harm and having it seeing electro physiologist later in terms of success on DSO screening patients with EKGs to look for left atrial debilitation. Doing echoes on patients and following them clinically certainly can help now that you know the technology's improved in terms of monitoring of patients. Whether you know the Apple Watch is a big one that you know, we're discovering more and more patients early on that air having paroxysmal atrial fibrillation, which is a whole separate, different conversation. But that is the way of the future. And that's technology. And patients are monitoring their own heart rates and their heart rhythms a lot more than they used Thio. And so we're discovering a lot more stuff than we used to, which I think is a good thing. But it does come with Mawr. Um, you know, difficulty in terms of managing those patients, but it allows us to know earlier on that they are having a certainly symptomatic atrial arrhythmia. I do wanna put a plug in to these early patients also for risk factor modification. Um, it is important for progression of the disease. Um, I do talk to all of my patients about risk factor modification, and some of them actually listen. And so some people drastically cut back on their alcohol. Some people do actually lose weight when they're counseled repeatedly by a number of different positions that it's important to lose weight. It actually predicts whether or not you're gonna have future a fib. It's important to Dio, and some people listen and it is helpful in the big picture. I agree. Yeah, there's good data on showing that anti, you know, changing risk factor stratification. Just as John mentioned losing weight diet, exercise, um, treatment of sleep apnea is the most under recognized one that has actually shown even host a fib ablation to increase success rates. And so those are all super important. You know, we would love to develop a sort of holistic approach to treating this, um, you know, moving forward. Meaning not just seeing electro physiologist talk about ablation, but talk about a fib as a disease process that you know that we can work on with everyone you know, together. Dietitian, weight loss, sleep medicine. Um, toe be able to help. And there's been we kicked around the idea, certainly a pen, and we're hoping that we're going to continue to build that for our patients in the future so that we can continue to be what we want which is the center of excellence for treatment of atrial fibrillation. You guys mentioned that the over the last 20 years, the success of the of the atrial fib ablation has gone up with newer technology. Newer techniques for ablation. What percent of patient need a second procedure now that, I think largely depends on what their their substrate is to start out with. And so if you have the ideal patient that you know, not that much left atrial ability, ation, and, um, not a whole lot of other risk factors. The frequency of needing a second inflation is much less and particularly with having better a lesion prediction, Um, with the current technologies s. So I think that you have both of safer and more predictable outcome, and I don't have a percentage answer. But in people that have persistent a fib and you have to do a more extensive ablation, um, they certainly are at a higher risk of needing a second procedure. And if some of this I will say when you do a second procedure, if you've done a fair amount of work in the first procedure, and often what happens is we see they've they've healed over. Some of the initial lesion says it's a lot easier to do the second procedure and be successful because you've already done most of the ground work the first time. Um, and it's so let's say, worst case scenario. Let's say we're talking about a heart failure. Patient low ejection fraction violated left atrium. Maybe the likelihood of meeting a second procedure could be as high as 50%. But if you do a second procedure now, they're maintaining Sinus rhythm. That actually has a big impact on survival. Agreed yet so that, you know the data is we showed earlier. And this is national data, though it's probably better than this is for P. A F Approximate defibrillation success rate on bats generally looked at at least a year out with not having any clinical recurrence of a fib is 85 to 90%. So the chance that you're gonna have a recurrence is 10 to 15%. Um, but for persistence, it's lower. And just as John mentioned, everybody is different. We actually learn a lot at the time of the procedure. When we do that detailed electrical map of the heart we see how large the heart is with inter cardiac echo. We see how much scarring has occurred due to the persistent atrial fibrillation, and I'll tell patients, they said. Listen, that was I had to do a lot of work to be able to keep you out of a fib. You may need to be on a drug in addition to having an ablation to keep you in Sinus rhythm. But as long as we can do that, doesn't matter. Will pay one that's safe for you, whether it be Flag and I open on the Fed, Allied or Soda law and try to avoid amiodarone at all costs and the majority of our patients, Um and so that's a conversation that we have with the patients when we first meet with them, and it's all related to how far along in the disease process they've already progressed before. We get to see them in the first place. So guys, next question, um, whatever. We offer a patient, a 30 day event monitor, and especially if they have to wear it a few times. There's always this kind of look of Do I really have to do that? Especially if they have to do it before their ablation and potentially monitoring for after the ablation. Every time we talk about implantable loop recorders, patient love, the you know, they love the idea of having a continuous monitor for for upto, you know, three years at a time. Are you guys looking at placing those at the time of ablation? Is that something that could be done? Eyes that covered by insurance? Or does this require yet another visit back to the hospital on? But some point will this be done in the office? Um, kind of Where do things go with implantable loop recorders? Yeah, all good questions. Um, smear. So I'll start. So, Thea answer is can we put an implantable Luke monitoring at the time of ablation? Yes, we can. Will we get paid for it now? And so, meaning the hospital will not get paid for it. So, um, in the subset of patients, generally, I bring up the discussion of implanting a loop monitor when we're talking about potentially stopping anti coagulation or beyond the healing phase of their ablation meeting at that three month or generally I'll talk to them at a close to a one year post ablation timeframe because it's a nice clinical marker that we said you went in here and you didn't have any symptoms at all. Unfortunately, and we think partly when we're a bleeding, this electrically abnormal tissue were also changing the nerve input into the heart. So the majority of patients who have a fib after an ablation Ah, large majority of them don't feel it. They're asymptomatic. And so that ends up being clinically important in terms of the decision of stopping anti coagulation. If you are going to go down that route in a patient that you feel is appropriate and safe to do so. And so, um, the answer is, generally we don't implant them at the time of the A fib ablation just related toe insurance and cost unfortunately, um, but And can we implant these in the office is the second question on the answer is yes, The reimbursement from a hospital standpoint, this somewhat decreased, as opposed to implanting him in the office. And so we've kicked this around and weighed the benefits, you know? So I'm in Cherry Hill today, five patient that once an implantable Luke monitor. I said, Okay, I have to get you scheduled to come up to Philadelphia to have it done. And that may be a nonstarter for some of our patients. They may say, No, I don't want to drive across the bridge and deal with, you know, a pandemic. Right now I want toe I'm not going to get. And so these are things that we have continued to look at, Andre. We could certainly implant them in the office or in a surgical type center like we have here in Cherry Hill. Um, in the future, and we've looked at it. But right now, we're currently still in planting them in a hospital setting, which requires two minutes of lidocaine, an injection of a device, and then you're out the door. No, I ve no sedation, anything like that. They could drive home after that kind of thing. So, um, it is, uh, certainly an option. And it's something we're going to continue to evaluate. Moving forward. The battery longevity of the newest Medtronic devices that are going to come out this year are 4.5 years, so you can monitor a patient for years and years and years if you want Thio with the newest generation of their implantable Umar, so that technology continues to get better, too. And as I mentioned earlier, a lot of folks have an apple watch, um, and are getting those type of E k G type monitor watches. And the most recent data shows that they're They're quite sensitive in terms of ruling out atrial fibrillation, meaning they're good at finding normal. They're just not very specific, so you'll get false positives. You'll get PCs or you'll get artifact and you'll get noise. The patient will get an alert that says, possibly fib, and they'll freak out and they'll, you know, email your my pen medicine Yoon. So, um, you have to keep that in mind. But it is a growing technology and an interesting one, um, to talk about patients in terms of monitoring post ablation or just in general, look what just one more thing to this. So at a health system level, there have been some discussion about putting in Luke monitors trying to do it. Uh, you know, like a month or so before in ablation. So you have some quantification before and after. That would really be the most precise way of quantifying the response to an ablation that would be ideal. Um, but it has not been adopted. And generally I'm following along with what? What been suggested is when you start to make clinical decisions down the road. If you seem like you've been successful a ways out and a patient wants to get off of antique regulation, you could potentially have that kind of a discussion if we monitor you continuously and your your risk seems to be low enough, um, using a loop monitor to help direct antique regulation therapy down the road. All right, I think there two more questions and hopefully we can answer these in the next two minutes. Andi, obviously still a lot toe to discuss them to learn about atrial fib relation. Dr. RLX question is, do we have local data on frequency of complications such as frantic nerve injury esophageal injury here at Penn? So I Yeah, most of this is sort of by personal experience. I don't think that I have transparency toe throughout the whole health system. I can say that I have had softened deal injury in the past, and when I had adopted using, uh uh putting contrast in the esophagus and strict an atomic avoidance really haven't seen anything since then, and I've been doing it that way for the past eight years. Andan. Fortunately, there were some events before that and, you know, as a practitioner trying to help people, you know, it's it's devastating to have that happen. Um, and I do think that an atomic avoidance, uh, works pretty well, and I haven't had anything happened in a number of years now. Frantic nerve injury hasn't happened very often with us. We don't really use the cry a balloon, which, um, seems to have the highest risk of frantic nerve injury. We could pace to look for the frantic nerve. Um, I've encountered frantic nerve injury with ablation in the right side of the septum, which is sort of a more extensive ablation approach and have been doing less of that. Haven't seen a frantic nerve injury in a number of years, but, uh can occur. Ben. Yeah, agreed. We're we are collecting our own data from a you know, a few I standpoint at Penn Presby, and as I mentioned registry data, we will be participating in one of multiple national registries the hard part about studying these type of, in particular soft tissue injuries. They're very blow, meaning the chance of it happening is so low that how do you tease out which subset of patients we did something to that would potentially increase that risk. And as I mentioned, the catheters continue to change every year so that our delivery of energy continues to change. Ultimately, if it ends up being the way that we deliver, energy doesn't cause any damage to the to the frantic or soft Jill Nerve with something like Elect operation Wonderful. Then we basically remove those from the table. But we just need to make sure that we're not trading one thing for another that we just don't know about which we'll find out. That's why we do clinical trials, and that's why we investigate thes types of advances in therapy. And so, um, you know my personal experience We did. I did have one patient that had a menace. Official official and thank goodness, um, Karin Lukas or nurse practitioner picked it up immediately. And that's kind of the key is that, um if a patient you know, a couple of weeks out from ablation is complaining about significant reflux type symptoms were complaining about symptoms. We have to take it very seriously. And so we rushed her and got a CAT scan identified it. She had surgery, it was fixed and she lived. Thank God, but it was a devastating complication because she was healthy. Otherwise, except for her a film. And so, um, you know, just as John mentioned the data, is that it happens very, very infrequently. But if it's not picked up quickly and even sometimes if it is picked up quickly, it z lethal. And so, you know, we really, um, want to continue to do better at finding these patients. But there's so many variables, everything from size of the patient, where the esophagus lives, you know, compared to John had mentioned imaging of the esophagus to try to figure out where it is. There's techniques that people are doing where they deviate the esophagus, they put something in and they pull it away from the pericardium, which comes with risks, obviously too. And so there's a There's a lot of people looking at how we can do this better, and we have improved with our technology to decrease and mitigate that risk. But it's still there, and it's still a risk that you have to quote to patients when we talk to them about a fib ablation. So we only do it for people who need it, obviously, and the benefits certainly outweigh the risk. And while the risks are low there there and we have toe, take that very seriously. All right, last question. We'll try to answer this and maybe just a minute or two here and then wrap things up. We may at some point need a whole talk on wearable devices, actually, as technology advances, how comfortable are you guys after an ablation and using either the Apple Watch one of the other kind of E k G based watches or the cardia device, as you're kind of way of monitoring for recurrent a fib after ablation and potentially stopping anti coagulation Johnny one. Yeah, I've gone back and forth on how comfortable I am with this, and I would say that over time I've become, you know, a little bit less comfortable there, sort of. You know, patients have to keep doing it and they have to participate, and, um, you know I'm most comfortable with, like an apple watch where they're wearing it continuously. And they have, like, a lot of time that they're monitoring themselves. Um, and I get uncomfortable. I try and use the cardio, but I also, you know, try and get people thio use it on a regular basis. The tricky thing is, is that when people feel well and they haven't had anything happened for, let's say, 300 days in a row, it's kind of easy for them to sort of put it to the side and not do it on the 301st day and thereafter. Then it becomes sort of, um, something in the past. Um and so you know the implantable loop recorders? Uh, you know, it is a little bit of procedure. There's some cost involved with it, but it certainly gives you the most extensive and direct information. Um, it really comes down to compliance issue and you have tow talk to patients carefully and whether or not they're gonna be compliant with being able to use these devices. Yeah, I agree. And so it's John had mentioned on implantable loop monitor gets the data, regardless of whether the patient wants the Senate or not, it will automatically transmit through Bluetooth. And so that's the best option. Because you know cardi on one end of the spectrum, you have to use it and it's not continuous. It's it's basically you. Put your fingers on it when you have symptoms. I'd mentioned there's a large percentage patients of asymptomatic, if it not ideal. If you're stopping in that population and the apple watch, you know patients are not always wearing a 24 7 on def. They need to charge the battery on it, or if they choose not to wear when they're exercising or or doing whatever it's not. It's very patient dependent. The implantable monitors air independent of what the patient is doing, and so I think those are the best options. Still, um, technology continues to improve those, so I think it is in an option. And the other thing that John had mentioned, every patient's different. The patient has the highest Chad's vast score who had a symbolic stroke before. I'm really I'm not thrilled about stopping that patients anti coagulation again, the watchman device in those patients. It's a really interesting subset, and we're gonna answer that question over the course of the next year, so on. That's really, I think, where the future is. It would be perfect if, in the future I could do a watchman device and in a fib ablation to treat symptomatic and stopping a regulation and not have to worry about them. Having either the two issues related Thio. I'll see the primary reason that I'm interested in the watch the Watchman trial. The option trial is because I do think it is the future. And if you can, really cut down on the risk of stroke and not have to do it a lot of this monitoring and have to keep taking anti coagulation. You have to have this sort of chronic worry after doing in a fib ablation. I think that's just the ideal approach, right. Well, then, John, thank you very much for speaking today and sharing all of your knowledge on atrial fib. Relation. Linda, as always, thank you very much for organizing this and getting everyone together on DFO. All the technical help appreciate everyone that logged in and hopefully this formats working for folks. We'll see everybody in August. We've got to talks in August for grand rounds. One is on cardiac amyloid and one is on cardio oncology, so invites to follow again. The code for today's talk is, um uh 66416 It's in the chat Q and A tabs. Otherwise, everyone have a great day and we will see you in August. Thanks, everybody. Be safe. Take care now. Thanks much.
