Dr. Divyang Patel at Sentara Heart's Electrophysiology Services describes pulsed field ablation (PFA) for atrial fibrillation (AFib) treatment and his experience with this catheter based treatment. Instead of using heat or cold energy as in traditional ablation, the PFA catheter therapy uses short bursts of high energy to affect heart tissue that causes AFib. PFA therapy at Sentara has been successfully delivering this service offering patients quicker recovery times and fewer side effects than traditional ablation. Pulsed field ablation has allowed increased safety, efficacy, and possibly new environments of practice for electrophysiologists for treatment of atrial fibrillation.
Thank you guys for joining us. Uh, February is Heart Month. And I thought it'd be a good idea to talk about pulse field ablation as we've evolved in our ablation technology from radio frequency or cryoballoon, which is heat or cold energy to isolate the pulmonary veins into selective tissue specific safer, more effective therapy called pulse field ablation. Um, so the title of my talk is Pulse Field Ablation. It should be first line treatment for atrial fibrillation. It beats drugs every day. Um, we shouldn't be using radio frequency or cryo balloon. It's precise, it's safe, and it's very innovative. Um, and so thank you everyone for joining online in person. And you can see on top um is how we used to do ablation, which is point by point um sort of playing video games, heating up each part of the heart. Uh, the problem with this is there's other structures that lie right against the heart. The esophagus is one. This can narrow pulmonary veins, um, it can cause other issues with phrenic nerve and stuff like that, so. Into a more precise, um, easier, faster procedure called pulse field ablation. So just to give you an outline, usually we end the presentation with thanks, but I think the efforts of pulse field ablation deserve thanks up front from everyone, including leadership to the lab staff and stuff like that. So we'll talk about that. I'll discuss the patient case which I think is important to go over because these types of patients were not being offered ablation. Um, they were thought to be too sick, too old, too frail, and so I think with pulse field ablation, I think we've really evolved the technology to offer ablation to anyone. Um, I'll talk about the burden of atrial fibrillation. I'll talk about treatment options. We'll go over some trial data. I'll show our data, um, from Centera, um, that Boston Scientific was kind enough to provide and we'll talk about future directions where I see the field evolving. So first off, uh, first off, I want to say thanks to the cardiovascular service line, um, supply chain and hospital leadership. This was a more expensive technology. Um, there were some issues, but they got through it and they provided this, and we were 2nd in the state of Virginia and one of the first in the country to get multiple systems for pulse field ablation. I want to thank our referring physicians and surgeons who entrust us in using this technology to help their patients with atrial fibrillation. Anesthesia is a crucial team. The last staff, many of whom are here in person and listening online, is crucial, along with the clinic nurses, the physician assistants who help with scheduling and see patients in the office and see patients in recovery. The pre-op and post op holding areas or schedulers or supply ordering staff, um, the companies for developing better tools and putting in the hands of capable physicians and most of all our patients for trusting us with any time we use new technology. The picture on the right shows what I think of as a diverse village and truly it takes a diverse team members to make this possible for it to be a success, which it has been. So these are some of the lab staff on the left. You have the Carelex team on the bottom, you have the heart hospitals team and on the right top, you have the Virginia Beach team. So many thanks, but there are many more players behind this making pulse field ablation successful. So this is a patient I saw in my clinic, and I would argue before pulse field ablation, many people would not offer this type of patient an ablation. So she was a 91 year old female. She had a history of hypertension, sick sinus syndrome. She got a pacemaker in 2018. She presents with atrial fibrillation to my clinic and atypical flutter. Her ejection fraction has decreased from what I thought was normal, but she never had an echo for five years. It's now 33%. Her lay is 48%. She failed TE cardioversion times 2, and second time she was already on amiodarone, and she's still in atypical flutter heart rates in 110. She comes to my clinic to discuss options and. Besides that, she says, you know, I walked 9 holes with my husband when he plays golf, and this flutter and fibrillation, I can't even walk a hole, so I need options. And so I told her these are the three options we think about with atrial fibrillation. One is ablate the node and upgrade your device, given her rejection fraction is now 33% to a CRT or conduction system pacing. The problem with that approach is you lose AV synchrony and so even though you may achieve rate control, you may not get the full shortness of breath benefit that sinus rhythm holds. You could do rate control, so rates 110, but she's been adequately on metoprolol and diltiazem and digoxin, I would argue, are harmful medications. And the last is an atrial fibrillation ablation though I told her your risk is high, you're 91, your ejection fraction is low, anything could go wrong and you could either die or have a prolonged hospitalization with this. And she said, you know what, quality of life is important to me. I realize I'm 91. I want to proceed with ablation. And so I said this is a reasonable approach, and in the era of pulse field ablation, I think everyone should be an ablation candidate. So I did a PFA ablation using ferro pulse. Um, I did a PVI and posterior wall. She had scarring and I induced perimitral flutter, so I did a mitralannular line. I did a CTI flutter ablation. At the end of the ablation, I could not induce any more arrhythmias, and I said, this is an adequate endpoint. I've done as much as I can do. Total procedure time. Now, to give you an example, doing it. A 91 year old with a scarred atrium back in the day with radio frequency. This would have taken 6 hours, a lot of ablation, maybe we didn't isolate the veins. It took me 2 hours and 5 minutes from skin access to ending the case and catheters out from intubation to exhibition. This whole case, a 91 year old, and this is multiple lines. So it's isolating the veins, doing a roof line, a floor line, a perimitral CTI. And trying to induce a full EP study, this would take forever back in the day with radio frequency. And she's 91. She, I did a same day discharge on her. She felt fine in recovery. She had no fluid in radio frequency, we used to give 2 to 3 L of fluid for an ablation like this. I, I discharged her same day from Carelex Hospital. She lived in Williamsburg. She drove up to Williamsburg, and this is Suzanne. This is the epic note. Suzanne's one of our amazing nurses. Um, you can see from the epic note she comes in for a nurse visit at EKG stats post afib ablation. And I save that top part to show proof that she is 91. She's doing well, feels much better since the ablation. Breathing is better. She's sleeping well, denies any episodes of Afib. Her groin incisions have healed. Her blood pressure is a little high because she got lost coming into the office. Uh, but we're gonna stop her amnio in a month, um, and patients gonna contact our office for any changes. So with pulse field ablation, we were able to do what I thought was an untreatable patient discharge her same day from an ablation, get her home and get her in sinus rhythm walking again on the golf course. So to put into perspective now that you've seen that patient, let's talk about the global epidemic of atrial fibrillation, and you can see by here the projected number of patients will increase by 2050. We're just scratching the surface of. Recognizing afib, and that number will increase as baby boomers get older, as more and more patients get older. We are better recognizing Afib because people are wearing Apple watches, Cardimos out, people are recognizing symptoms of Afib, and so asymptomatic Afib is also being picked up and so you'll see that increase over time, and you can see from multiple projections that that'll double by 2050 from what we're seeing in 2020. And so it's really gonna be important to treat it early in the disease process and treat it with effective tools. It is dangerous. So when we think about afib, atrial fibrillation increases the risk of stroke. It leads to decreased quality of life. It leads to multiple heart failure hospital admissions and ER visits. Any of our hospitals, you could see at least 1 to 2 patients, at least on the cardiology service and the EP service every day coming in with atrial fibrillation with RBR, and I would argue the first episode is when we should intervene. And not wait until the 2nd, 3rd, 4th, or 5th episode to say, hey, you need an ablation now. It leads to pacemaker implantations for slow rhythms, right? And so a lot of times people with atrial fibrillation will have conversion pauses where they come out of afib, or the medications we use suppress the AV node and that causes worsening issues, and then we put in pacemakers which get infected over time, which lead to lead failures over time. The complications with pacemakers over time are about 1 to 2% per year. And so if you're thinking that Afib will lead to pacemakers, instead of treating the Afib, you should just treat the Afib instead of putting in pacemakers. And we know that data suggests that atrial fibrillation increases mortality. Here's the economic burden of afib. So you can see these bar graphs on the left and the right. The majority of costs associated with afib atrial fibrillation are not ablation. It's not cardioversions. The majority of costs are what you see in the red and the green. It's hospitalizations. So inpatient care is about 70 to 80% of costs, and you can see on the right the hospitalizations is where all of the costs for Afib are going. So you really have to stop the disease process first and then um you'll prevent hospitalizations, you'll prevent ER visits, you'll prevent heart failure exacerbations. And the reason for this is a firm set the field backwards. So back in 2002, this was the major study that came out suggesting they studied rate versus rhythm control, and they looked at two different strategies. Should we put people in sinus rhythm or should we focus on rate control with a bunch of meds, metoprolol, digoxin, diltiazem? They randomized 4000 patients. There's no difference in mortality. But there's a lot of flaws with the study, including anticoagulation was stopped if maintaining sinus rhythm, which we know is a flawed thinking because some patients can have some Afib even if they're in sinus for short periods of time. They didn't enroll younger patients or patients with severe symptoms. So if a patient came to me and I said, I'm really feeling my Afib, they didn't enroll them in that trial. They didn't enroll younger patients, 30 year olds, 40-year-olds, 50 year olds who we might no benefit from being in sinus and they, they feel their Afib. And early stages of ablation in 2002 we didn't have the right tools. Contact force was not out. We were having difficulty isolating pulmonary veins, um, and you needed to fail two antiarrhythmic drugs to get an ablation, which our thinking is evolved as ablation has gotten safer. We've moved from failing any drugs to just let's just ablate atrial fibrillation. And so this study set the field backwards because people thought you didn't need to treat afib aggressively, uh, but then we did future studies which I'll show which showed that treating aggressively works better. So this is the East AF net, and the nice part of EP is we do a lot of randomized trials, and we do these trials and they end up in New England Journal because they're practice changing trials. So this is the East AFET trial which shows that early rhythm control is the answer in atrial fibrillation. They randomized 2700 patients in 11 countries, and if you're early in your disease process in the 1st 36 days to 2 months rate versus rhythm control, the patients who got rhythm control, meaning they were cardioverted, Um, they were placed on antiarrhythmic therapy or they got ablated, did better for primary and combined end point of cardiovascular death, stroke, heart failure, or ACS. And so I think if you're looking for some kind of benefit, I think the majority of patients you see in the hospital, you should strive to get sinus rhythm, um, with the resources you have available. So this is where the field changed, and this is a nice way of thinking about it. The old way on the left is pills. You must take pills. You must take your metoprolol, you must take your diltiazem. You must fail fleconide, propafenone, dronearone, amiodarone, all these sotalol, teosin. Uh, the new way of thinking is let's just ablate your afib. If 91 year olds are getting home the same day, while T is in 3 days in the hospital, you may have cardiac arrest, you may have long term, uh, harm, you may say that, hey, why not just ablate your atrial fibrillation. And so our, our field has evolved from failed drug first to let's ablate first and if you fail ablation, maybe think about antiarrhythmic or a second ablation. If we look at antiarrhythmic drugs and patients ask me this in the clinic, do they work? And so there's two studies that came out at the same time. One was the stop AF trial and the other one was the early AF trial. So this is comparing cryo balloon against anti-arrhythmic drugs, and I tell people every study when you compare ablation first line against drugs, ablation is always more effective. So in this cryobaloon study, um, published in 2020, you can see drugs, and this is what I quote patients, drugs work about 45% of the time. So if you have paroxysmol Afib and someone puts you on flaconide sotalol, uh, propafenone, drenetaneurone, whatever they want, it's gonna work about 40% of the time. And so if you give me that odds, I would say that's that's not great odds. I want better odds. And if you could see from the top, ablation works about 70-80% of the time at preventing a fib. And so ablation always beats drug therapy. And if we look, uh, some people say they must work. Let's do another study. Drugs have to work. It has to be better than ablation. If you look here in the other study, the early AF study, they put in loop recorders on everyone patients who got ablated, patients who got antiarrhythmic drugs, antiarrhythmic drugs, freedom from Afib is about 30% of the time. It sucks. Um, ablation is about 60-70%, so there is no cure for Afib, but ablation is the most effective tool we have against afib. And they're not benign, right? So every couple of months I get a call from one of my cardiology partners, hey, look at this chest CT or look at this X-ray, and someone has started amiodarone on a patient, and yes, it can be oral, it can be IV and you see lung toxicity. And so I would argue amiodarone only should be done in the sickest patient that's in the hospital that has a low EF but you see things like this all the time. And if you look at meta-analysis of drugs, not all the drugs lead to mortality, but if you look at Sotool, you can see the odds ratio doesn't cross one. And so the randomized trials with Sotool, I would argue that there is some harm with Sotool against placebo and every year we see uh fleconide toxicity. We see teosin with torso on the floor, we see a pharmacist or patient not paying attention with their teosin with um with the other drugs they're taking like azith azithromycin and things like that. So antiarrhythmic drugs are not benign. And so I tell patients, do you want an upfront risk of an ablation procedure which we'll go over some of the risks and we'll talk about those, or would you want a lifetime risk of drug therapy? It's like paying a mortgage, right? One, you. If you have money you pay up front, and that's the upfront risk of the procedure. The other one is more of a lifetime risk and as our ablation gets safer and more effective, I would argue that the upfront risk is worth is better than the lifetime risk of drugs. We know ablation improves quality of life. So in this Cabana study they looked at randomizing patients to ablation 1100 against drugs, and they found that ablation led to significant improvement in quality of life. People don't like drugs. Flacoide causes a lower resting heart rate. Sodol causes lower resting heart rate. Ablation. Improves your exercise capacity, improves your quality of life index way more significant than drug therapy. Some people are still not believers of ablation. They say, hey, this thing you guys do in EP it's like playing video games. I'm not sure it does anything, you know, it's not like saving a patient from this or that. So this was an innovative study. People said, let's do a sham study. I would argue that a sham study should not be done because we have multiple data points. But anyway, a group in Europe did a sham PBI study. They randomized 10 250 patients or yeah, 120 patients, 62 got ablation. They got pulmonary vein isolation with cryoablation. 61 got sham procedure. They went to sleep with anesthesia. They got cardioverted out of the afib, and they put a groin axis and paced the frene. They woke up, they didn't tell either group, OK, did you get an ablation or did you not? And you could see the burden of Afib decreased at 60% compared to 35%, and there's a significant quality of life benefit, um, with the ablation arm compared to the sham procedure. So this isn't just a sham procedure, we're just not doing something to do something. It truly improves quality of life, it decreases burden of afib and improves downstream cost. And ablation reduces healthcare costs. So this is from the circa dose study which looked at quality of life and healthcare utilization. So looking at patients who got randomized either to ablation or drug therapy and you could see in the year before. Ablation, the cardioversions, they were receiving half the patients at least got cardioverted once that went down to 10%. 68% had an ER visit that went down to 25%, and the hospitalizations went down as well. So ablation from the year before ablation to the year after, 75% decrease in cardioversion, 62% decrease in ER visits, 43% decrease in hospitalization. An 86% decrease in antiarrhythmic use and this is important because Afib represents 2% of healthcare costs across the healthcare industry. So if you're looking at cancer treatment, kidney treatment, diabetes treatment, 2% of all costs go into AIB. And so if we can decrease costs with ablation, uh, we're moving the field forward. And then there is a mortality benefit in heart failure. So we looked at catheter ablation and Doctor Gentis was one of the first to look at retrospective data, and then they published prospective data. Um, this is from Nasir Marrouch published in 2018, in patients who we think have tachy induced cardiomyopathy, ablation beats medical therapy, including antiarrhythmic drugs, and saves lives. So, as much as beta blockers and ACE inhibitors help, ablation also saves lives. It's a safe treatment, but complications still occur, right? So if we look at this paper published on 90, about 90 randomized control trials published between 2013 and 2022, this is 15,000 patients undergoing first catheter-based ablation for atrial fibrillation. We could see procedure related complications. So you can see here the complication rate overall was about 5.5%. In the contemporary era that went down to about 4%. Still, I would argue high, uh, but it has come down. So overall, the highest number of complications you'll see are vascular complications, and that has gone down with the use of ultrasound. But tamponade was a concern, strokes were concerned. Um, some people had pulmonary vein stenosis. We used to worry about effusions, atrial esophageal fistulas, phrenic nerve palsy. So even though the complication rate has gone down, I would argue that 4% total complication rate is high and 2% serious complication rate was still high, that some of the referring physicians did not trust ablation as a safe therapy. And so that's where the field and companies needed to evolve and said we need to develop safer technology. We need to make it safer, more effective, um, and, and these two things will make the field move forward and help a lot of patients. So this is where pulse field energy arrives, right? So now we know ablation is more effective than drugs, but we need to make it more safer and more effective. So on the left is us doing ablation the old way, radio frequency, and you could see all it does is heats up the tissues, and it can damage the phrenic nerve up here, it can damage the esophagus because these structures sit right next to it. And every. You hear about phrenic nerve damage outside the right superior pulmonary vein. You hear about esophageal fistulas, which is potentially life threatening and patients can die. Uh, because it heats up surrounding structures. Same thing with the cryob balloon. They invented cryobaloon thinking it would be more effective, um, and while the pulmonary vein stenosis was less, it still damaged phrenic nerves, uh, because, uh. And it damaged the esophagus because of close proximity. You're just freezing tissue, but now with pulse field ablation where that has arrived, all it does is electroporates the cardiomyocytes without damaging adjacent structures. So you get a normal phrenic nerve, normal esophagus, you don't stenose the pulmonary veins, and it seems to be a more effective therapy, but also more it's a safer technology. So this is how it works. It basically you apply electrical current, it attacks the cyto cytoskeleton membrane, and then the electricity seeps into the cells and causes the cells to electroporate or destroy itself. And so it causes lysis and death of the cardiomyocyte and its programmed the pulse field is programmed just to be selective for the cardiac cell and not the surrounding structures, and that's over time with the development of the pulse field energy and different programming and the companies each have their own programming whether they do bipolar, monopolar and how much they use, uh, but this is how they developed in the last 5 to 10 years. This is the tool we currently have um at our disposal called the Fer pulse generator made by Boston Scientific. It includes a pulse field ablation generator, a steerable sheath, and the pulse field ablation catheter. So when we look at the Advent trial, which is paroxysmal atrial fibrillation, head to head against RF ablation, um, patients had to fail an antiarrhythmic drug before this, uh, before they were randomized to either group. You could see treatment success was similar between pulse field ablation and thermal ablation, and device related serious events were similar 2.1 against 1.5. Uh, the trial was non-inferiority trial, meaning they didn't enroll thousands of patients to show that Pulse field is better than RF or RF is better than Pulse field. They're just trying to get this device out into the field and into the hands of operators. Um, who, who have been used to it, so it had similar efficacy 20 minutes faster, and the two complications we were most worried about with the phrenic nerve, esophageal injury, and pulmonary vein stenosis, they saw 0 cases of it in the trial. So it's very tissue specific and worked just as well. And then we look at the 17,000 plus manifest patients who were treated in their multi-center registry, and it's important with FerriPulse now over 300,000 patients have been treated worldwide with PFA technology. And so this Boston Scientific uh required in the European study and they're doing the one similar in America postmarketing study. They used 106 centers with 413 different electrophysiologists with 17,000 patients. Their major adverse events were low, less than 1%. No cases of esophageal fistula, no cases of pulmonary vein stenosis or persistent phrenic nerve injury. There can be partial phrenic nerve transient that improves over time. Uh, we've seen one case of that, um, but again, if you could see from the left in the total study, the stroke risks are very low, 0.12. Pericardial effusion rates are 0.36, um, and still minor vascular complications probably in Europe. The ultrasound rates are low, uh, but so these, this technology has evolved into a very safe less than 1% risk type of procedure which know. With no life threatening issues with fistulas, um, or phrenic nerve injury. But we did see some new complications from pulse field ablation, right? So one of the things they saw is acute kidney injury, and they think that may be related to hemolysis of blood cells. So instead of electro porating tissue, if you're not in contact with tissue and it's in the blood pool, it can hemolyze the red blood cells and that can affect your kidneys. Um, it usually occurred in less than 1 in 1000 patients, and it's related to the number of doses given, and they saw an inflection at over 100s or 100 lesions given. And so if you get more than 100 lesions, the companies all recommend giving IV fluids to flush the kidneys so the hemolysis doesn't cause acute kidney injury. There were cases of coronary vasospasm, so this is a case where someone's trying to do a flutter ablation, and you could see when they apply energy, you could see this PDA or RCA coming off here. You could see this becomes stenosis. They give some nitro and that improves significantly. So if we're doing a flutter line, a lot of us will uptreat treat before doing the flutter line with nitroglycerin to prevent that. Here's some intraprocedural images of what ferro pulse looks like, um, so here's the cerebral sheath, here's the CS catheter, here's the device in the flower form. Here's an ice image looking at the left superior pulmonary vein, and these two basket and flower is how we get wide anral circumferential ablation around the pulmonary veins. And so we use these two modalities, um, because this is what has been studied in the trials in their post-registry approval for a safer, more effective therapy. Mapping does help. So if we look at the image on the left, mapping does two things for us. It reduces radiation, which is important for our staff who are in the lab every day, making sure we're not on the fluoro pedal, because if you don't use mapping, you don't know where you are. You can really reduce your milligrade to, I would argue, less than 10 mg if you use mapping. And sometimes every now and again if our ice images are poor and fluoros poor, we'll have some areas that we didn't know recovered and we'll go back in and map and say, hey, I didn't get this area as well as I thought. And so there could be normal voltage that if we have mapping we could go back in and say, OK, this area I need to touch up. You can see here this is what the flower looks like in different forms as you're doing in PVI. This on the left is a pre-map of a PVI and posterior wall isolation, and this is after ferro pulse. This took about 35 minutes to do, probably. If we look at the advent data when they characterized Afib burden as less than 0.1%, because a lot of the Afib recurrences weren't real recurrences, it was a few seconds of Afib. PFA was seen to be more effective than thermal energy. So if you look at these bar graphs, when you characterize, OK, how free of Afib are you, PFA is more effective than thermal if it's less than 0.1%. And so from this original data, it's showing out to be that pulse field ablation is not only safer from an esophageal fistula standpoint, from a pulmonary vein stenosis phrenic nerve injury standpoint, but it seems to be more effective. Than radio frequency. So, this is Dr. Kiel's. Uh, picture because I'll talk about the Ferra which we're getting soon at Norfolk in the next month, um, this is a new technology which looks at dual toggle pulse field and radio frequency, um, and this was published in Nature Medicine and Centera Heart Hospital was lucky enough to be in the trial headed by one of my partners, Doctor Keel. And you can see here they're basically using pulse field on the posterior wall, but you could toggle the radio frequency the old way where you're not worried about adjacent structures. This takes a little longer of a procedure to do compared to Ferro pulse, but it does durably isolate the pulmonary veins. They compared this against radio frequency ablation. And you can see here there's a trend, 0.06, so not really meeting statistical significance, but there's a trend towards less recurrence of afib in the investigational of Ferra arm compared to the old way of doing it radio frequency. Um, in a difficult patient population, so these are patients with persistent atrial fibrillation where their Afib is difficult to get into sinus rhythm. And so these patients we struggle with, and so if we have newer technologies that seem to be more effective than the old way, it'll reduce hospitalizations, reduce ER visits, and reduce heart failure exacerbations. So this is our data, um, and I'd like to again thank the Heart Hospital of Virginia Beach General and Carelex um for allowing pulse field ablation and really pioneering it and doing some of the most cases in the country. So we've done about 1200 total cases of pulse field ablation. We do about 30 to 40 cases per week and so it's become the workhorse. Um, it's allowed our skin to skin time to decrease. So an usual PVI back in the day used to take 2 to 3, sometimes 4 hours. Um, Jeff remembers the first time we started a fellowship in 2018 when it used to be a 6 to 8 hour endeavor. Now our skin to skin times for PVI are about 60 minutes among the nine of us partners. Um, and then PVI and let's say you needed to do other lines, posterior wall and stuff, our, our skin to skin baseline times are about 65, maybe 66 minutes, and you can see over time from when we started in May of 24 to now our times have decreased, we've gotten faster. I would argue that the field is moving. Towards maybe a PCI type of field where it's gonna take an hour to do the procedure skin to skin is gonna be an hour. It's gonna be more how long does it take to intubate, extubate, um, what are your closure devices, how do you have two labs running, things like that. So an hour for a procedure that used to take 8 hours. Is very effective for patients with low EFs or patients who can't be under anesthesia for that long or patients who are too sick with an EF of 5% who are on multiple pressors you want to get them in, do the ablation and get them out and so this is proven to be a very much of a big success, but then we we also should track our complications, right? So out of the 1200 people always ask in my clinic, what have you seen in complications? We've seen one patient with a pericardial effusion requiring a pericardial window. Um, that patient was done at a non-heart hospital non CT surgical site and still got the effective treatment they needed for further care. We've seen one patient with acute kidney injury requiring temporary dialysis, which improved in kidney function. About a couple weeks later we've seen one transient frantic nerve paralysis that improved in post-op recovery. We've seen one case of hemoptysis probably due to the wire that the flower catheter goes over one case of vascular injury requiring thrombin injection. So I would argue vascular cases and phrenic nerve transient hemoptysis or we shouldn't worry about, but I would think the major complication rate of 0.17%. With zero strokes, 0% stroke, and 0% mortality on 1200 patients, and we've pushed the field. We've said let's do pulse field on sicker patients and sicker and sicker and older and and so this data is really good and it's reassuring because 0.17%, I would argue that drugs cause way more harm than 0.17%. And this is a patient anecdote. I, I put this slide in there because there was a patient and this is sometimes patients have trouble getting into clinic or something. I knew this patient from somewhere he got my name because he found out he was in a fib. He texted me he's ready for an ablation, and this is some of the stuff our our lab staff don't see. We don't see patients do well, and I always tell him if you see my patients in clinic, you should come to clinic because it puts a face to all the work you guys put in. And so this is one of my patients. I'm ready to get an ablation. I bladed him and I'm like, OK, I ablated him at the heart hospital, but this is true at Carelax or Virginia Beach. We see patients all the time recovering and they all feel great. Um, you fixed me, I'm feeling better than I have in a long time. And so these are some of the great benefits we're seeing with this technology. We're getting patients in faster, we're getting more of them, we're getting safer, more effective treatments. Here's some of the future directions with pulse field ablation. So on the left is papillary muscle. We struggle sometimes with PVCs in papillary muscles, uh, because the tissue is much thicker, it's harder to get a deeper, more transmeral lesion. With pulse field ablation, you can see the lesion is much deeper and wider compared to radio frequency energy. And so other areas, the LV summit, um, epicardium, and you could see it provides a much deeper lesion. So I think in the future we'll be using pulse field ablation also in the ventricle, um, significant portions of time. I think once you have better technology, it's how do you get these patients and so I would argue that the next step is getting these patients in the hands of ablationists who can ablate them faster and so you can see on the left there's a mortality benefit um to early catheter ablation compared to other therapies. So I think the next roadway is ER to EP pathways. Um, so people don't have to see gen cards for someone to rubber stamp and say, OK, you should see EP for your Afib. They should just go directly from the ER to see an EP to get ablated. And so I think APC led Afib clinics, um, to get them into ablation because faster ablation will reduce hospitalization, will reduce healthcare costs, will reduce all of the downstream things we see with worsening Afib. And then I would argue that non-surgical site ablation, the future is already here. Uh, we have similar safety and efficacy at our sites without CT surgery, which is CarePlex Hospital or Beach. That 91 year old patient with a low EF I did at CarePlex Hospital because they didn't want to drive across the bridge and tunnel. We're doing the same patients we do there for a fib that we would do at the heart hospitals. Um, this is a letter from our society HRS that CMS has denied ASC coverage for ablations, but I think as the field gets safer, if you have a complication rate of 0.17% and even the complication of fusion can get to the heart hospital in time. For patients who don't want to pay for parking, they don't want a large parking lot. They don't want 400 people. They don't want to see sick people in the hospital gown. For younger patients or outpatients, they just want to get in and out, in their procedure. I think they're looking for ambulatory surge centers to get their procedures done. It's easier. It's faster, it's. And it's just as safe and you can see on the right, uh Roderick Tung is one of pioneers and EP is setting up the first university-based cardiovascular ambulatory Sur center, and I think the field will evolve where our patients will demand it. um, and electrophysiologist will want to for afib ablation leave the hospital for a more intimate. Um, and more cost-effective setting called an ambulatory Sur center. Uh, but I think in the next 2 to 3 years, you'll see CMS approve it. So here are the conclusions. Afib is increasingly common, will represent 2% of all healthcare costs in the future. Sinus rhythm is important to improve mortality, quality of life, prevent re-hospitalization. Ablation is more effective than antiarrhythmic drugs. Pulse field ablation has allowed increased safety, efficacy, and new environments of practice for electrophysiologists, um, and I wanted to thank, um, everyone from hospitals Leadership Service line. Uh, partners, lab members, referring physicians for trust in moving the field forward to pulse field ablation.
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