Western AF Symposium 2024: Session 2 Roundtable

Every AF Patient Deserves At Least a PVI

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Featured is the Session 2 Roundtable entitled "Every AF Patient Deserves At Least a PVI" from WAFib 2023. 

Moderator: Johannes Brachmann, MD, PhD

Moderator: Hugh Calkins, MD

Discussant: John Mandrola, MD

Discussant: Christian Mahnkopf, MD, PhD

Discussant: Jeanne Poole, MD

Discussant: Walid Saliba, MD

Discussant: Usman Siddiqui, MD

Calkins: The next session is a roundtable discussion and the topic we've been given is every atrial fibrillation (AF) patient deserves at least a pulmonary vein isolation (PVI). So, this is a session where there won't be slides or talks, but we have a number of experts here and we're going to their perspective, and then we'll have lots of opportunities for questions. I'm Hugh Calkins from Johns Hopkins in Baltimore. Johannes Brachmann is the cochair of this session. Nassir, we're very grateful to you for inviting us. I'm going to start by having each of the panel members introduce themselves and tell us a little about their practice and their setting

Saliba: I’m Walid Saliba, I’m sitting in for Dr. Wazni from the Cleveland Clinic. I’m looking forward to the discussion.

Calkins: Tell us about your RF practice. Are you an RF guy, cryo guy, or PFA guy? Share any comments on how much time you spend in the lab these days taking care of AF.

Saliba: In terms of background, we've been doing this for the past 25 years. I'm mostly an RF guy, probably less than 5% cryo at this point. We do spend a good 3 days a week in the lab performing AF ablation procedures. Obviously, with the advent of PFA, we're starting to see a switch from RF to PFA in our procedures.

Calkins: Tell us a few comments on how many EP labs, how many EP electrophysiologists on your team.

Saliba: The last time I checked, we're up to 28 electrophysiologists on our team and we have 9 EP labs, so like the San Francisco bridge, there's always a lab in reconstruction and revamping all the time. This is how they paint the San Francisco bridge—it's always starting somewhere. We're obviously a very busy practice. It's maybe not as efficient as people in private practice in terms of turnover and number of procedures in the lab per day per person, but we do adhere to a strict regimen and we are very proud of it.

Calkins: Jeanne, do you want to introduce yourself? Tell us a little about where you're from and how you interact with AF.

Poole: How I interact with AF?

Calkins: How you deal with AF and what part of your practice does AF represent?

Poole: Jeannie Poole from the University of Washington. AF is a huge part I think of everybody's practice. We see so many patients in the clinical arena. I don't do AF ablation, but I see tons of patients. I refer them to my colleagues for AF ablation. I talk about risk factor modification every day in the clinic.

Mahnkopf: Good morning. I'm Christian Mahnkopf. I'm not an EP guy. I started my EP training in 2009, but then I went over to imaging and I'm mostly involved in cardiac MRI, but nevertheless, as chief of cardiology, I see these AF patients every day. We run 2 labs in our department dedicated for EP procedures. We have at least 2 to 3 PVI ablations every day and we just started with PFA, so I'm really excited to hear this discussion.

Mandrola: I'm John Mandrola, I am in my 20th year. This is 20 years of PVI for me. I started in 2004, I had a 2-year foray with cryo, but now I do RF. I'm in private practice with one other partner in the same hospital that I started in in 1996.

Siddiqui: Usman Siddiqui, I'm director of the electrophysiology program for AdventHealth System in Orlando. We are very heavy in AF ablation. We do about 4 to 5 AF per single operator a day. I think for us, the transition over the last several years has been understanding what happens at the tissue level. One of the best things I did was to put my lead down several years ago. Since then, I have tried to focus a little more on what the catheter actually is doing at the tissue level. So, we use a lot of intracardiac echo. We try to monitor temperature with different tools, and we follow our data very closely. Thank you so much for the invite, and we'll be happy to share it.

Calkins: So, we have a wonderful group here, and the challenge is we're going to address the topic of every AF patient deserves at least a PVI. We'll start with Jeanne Poole. What do you make of this? Actually, Johannes will make a few comments and introduce himself.

Brachmann: I think it's a great session, and I really appreciate that Nassir gave us the opportunity. I think as we have seen already, this is a very diverse group of people at the table, and I think it's a great opportunity to talk about this. Just to give a very brief introductory remark, I just Googled it. When you put in the Internet “every patient deserves a PVI,” they still have plenty of comments saying, “PVI is the last resort after many drugs have failed.” It's still something that we need to address, and I'm glad that we have John here to give feedback on media and the public views. The other aspect that I would like to address today is also are we talking about the developed north or are we talking about minorities? Are we talking about the developing south or the people that have needs? Can we really offer this to how many people? So, I'm delighted that we can open this discussion and I turn it again to you, but I think this is going to be a really interesting discussion.

Calkins: So, we'll start with Jeanne sharing her comments on does every patient need AF ablation, or what do you see its role now and where are we going with this field?

Poole: I guess the key word there is deserve. I think we have to sort of pick apart what that really means. It implies that to not provide or recommend AF ablation to a patient is that you're doing something really wrong. But we know that that's not true. We know that there is a lot of data from AFNET-4 that for early AF patients, 80% of those patients were treated with an antiarrhythmic drug, that those patients did really well. So, I think just out of the box here, you could say that for patients with their first diagnosis of AF, what they deserve is a full conversation about what the options are for treating AF. They deserve a hard look at their risk factor modification, such as if they're hypertension is out of control. All the stuff that Christine was talking about is really critical. You need to first provide them with a trip down to your friendly weight management group. I think that that's really, for me when I was thinking about this title, what was underpinning that is that we know that PVI is the base for all the major randomized clinical trials. You all talk about that PVI versus doing other sets of lesions, but I think from a clinical perspective, it completely depends upon where in the course of that patient's illness are you now touching that patient? Are you now seeing that patient early? Late? Is it in women who now have HFpEF that we don't really know what to do about, so that's why we're going to do CABANA heart failure? Where are they in the spectrum of the disease? We know that the earlier we treat patients in their disease history, the better off they are. That's true in ICD therapy. It's true in CRT therapy. We need to think about women, which I'll talk about a little later, but part of the problem there is they're simply not recognized and not diagnosed until they're far down the road. So, I would say that no, not every single patient needs to have PVI up front. I think every single patient should have a conversation about that and have that be offered to them, but with a more comprehensive perspective about where you can modify their trajectory of AF.

Calkins: Walid, I'd be interested to know what you're doing now in your practice in terms of at what point do you, with one episode of AF, 10 episodes of AF, 3% AF burden, what's your threshold for encouraging or suggesting AF ablation? Then, if you think about where we're going in 5 years, will it be you have one episode of AF and you're heading to the EP lab? What's happening now at the Cleveland Clinic and what's going to be happening in 5 years if you had a magical prediction ball?

Saliba: I hate to think of ourselves as trigger happy, but looking at a title like this, the thing that catches my eye is “every.” That is the term that I'm going have an issue with. The fact that I always have problems, and as we all know, putting AF patients all in one bag and that's the diversity of AF is so vast that I don't think that every AF patient deserves at least a PVI. I would take the question differently. I would say, who does not deserve a PVI? Who are the patients that I see in my clinic that I’d say forget it, let's not take you to the lab. But everybody else will at least have a discussion about taking them to the lab. So, who are the patients I will not take to the lab? These are the traditional patients that we know. You know, the elderly patients who have an intrinsically controlled ventricular rate and are fairly asymptomatic. They're satisfied with the way they are. I would not push to do a PVI on patients like this. Obviously, patients who have AF from secondary causes, etiology that are reversible, also I would not necessarily take those to the lab. The question becomes a little more problematic when you see in the Midwest, patients who are very obese and have AF. Do you take those to the lab or do you tell them that they have to lose some weight before you address their AF from the interventional standpoint? But other than that, I think all the other patients who are referred to us at the clinic, because we are a referral place for ablation, come with the intention to have an AF ablation. These are the patients that we offer them the PVI. So, the majority of patients deserve at least a PVI.

Calkins: Do you have a BMI cutoff? Is it 45, 50, 60?

Saliba: It's a BMI cutoff plus eyeball test. You have to look at the patient and see if I'm standing at the fluoro table and I’m trying to do an ablation, how comfortable am I with what's going on and what kind of problems am I going to run into? Because it's monkey work to do a PVI. What's more important is that if you have a problem with a patient on the table, is somebody going to be able to help you out to put that patient off in view of their BMI status? That's what I think of mostly. It's safety, not the efficacy of what I do.

Calkins: Do you have any thoughts about, you talked about the elderly, but the one group that I'm increasingly aware of is patients who are frail, the 90-pound or 80-pound, 75-year-old lady. Do you have a little bit of caution or reserve when you take a patient like that into the EP lab, or are you doing them all the time?

Saliba: I mean, obviously, if somebody is frail, then you have to think twice, and it's a spectrum in terms of what is your threshold to take somebody to the lab or not. As was said, it comes down to a discussion with the patient that what are the expectations, what are we trying to achieve, and what is the likelihood of achieving that? If the likelihood of achieving a good outcome is there, my threshold to take them to the lab is definitely much lower. So, there are a lot of parameters that are involved in this decision-making, and I tell the patients that they have to play a central role in making that decision, and it's not just us.

Calkins: So, now we're going to move to the left side of our panel.

Mahnkopf: When I prepared myself for this discussion, I tried to think back to my med school time and when you've got a multiple-choice question. I tried to prepare but when you read the title “Every patient deserves at least a PVI,” you think back to multiple choice questions. You always know when you have “every”, “always”, and “never”, in the answer, it's always wrong, right? I think it's the same in here, so it makes it quite easy. But nevertheless, I think the patients that deserve PVI, at least a PVI, grow every day. Why is that? Because we close our gap of knowledge every day with every trial, with every publication. Looking back 5 to 10 years before CASTLE-AF, you would never ablate a patient with severe heart failure. You would never touch them. Now we got CASTLE-HTx from Christian Sohns and Philipp Sommer. You have never touched a patient waiting for heart transplantation before. We're now talking about frail patients. What does that mean? If you have an elderly patient, and in my opinion, age is not a diagnosis. If you have elderly patients with angina, you bring them to the cath lab, right? If you have an elderly patient with symptomatic AF, why not bring them to the EP theater? Because we have new technologies. PFA takes about an hour or so to cure these patients, to bring symptoms down, to bring the burden down, to raise quality of life. Even these patients deserve it. I think we will close our gap of knowledge in all these small groups of patients where we have no idea if it works or not. Let's talk about asymptomatic patients, right? So, 10 years ago, never touched them. I think you had this great publication in the European Heart Journal where you discuss these asymptomatic patients. But are asymptomatic patients really asymptomatic? Ask them, do you have dyspnea when you exercise? They say no. Then you ask, are you exercising? And they say no due to AF. So, they're not asymptomatic. I'm completely with Jeanne, who says nearly every AF patient deserves at least a PVI. But you need to communicate with your patients. I think you need to have a specific goal for every patient to individualize methods and talk about precision medicine in every patient. You have to make your decision together with a patient.

Calkins: Thank you for those comments. In the asymptomatic AF ablation in 2017, we included that in the consensus document, and that was a bold move. There's a lot of strong debate, but ultimately it passed. There was a 2b indication. But Prash [Sanders] and Mina [Chung] in the new AF guidelines, I was very pleased to see that ablation of asymptomatic AF got a thumbs-up, 2b, even from the ACC and AHA. So, I think your point is, one, are they really symptomatic or not? But even if they are asymptomatic, it's still something you can consider. It's not a class I, but I was struck by that. One of the many things in that 500-page document.

Mandrola: When I started learning about AF ablation 20 years ago, I set up a Google alert. The Google alert’s purpose was to teach me different things and tricks about AF ablation. But this morning, I got one with 5 notifications about how big the AF ablation market is going to be. So, I think we would measure our success as a field is if we were decreasing the number of PVIs that we were doing, not increasing, because if we're decreasing the number of PVIs, that means that we're educating our patients better. That means that we're getting them to lose weight, drink less wine, unless they're Italian. If they're Italian, Luigi [Di Biase] tells me it's okay. But the point is that I'm torn because, of course PVI has a role. I've seen it. It transforms some people. But I think we're running amuck as a field by this crazy increase in the number of PVIs. So, I concur with everything that's been said about having a conversation with patients. Being part of the conversation is being part a psychologist and part a primary care physician, and I just think we should be very conservative about where we're going in this field.

Calkins: I think one of the reasons the number of AF ablations is skyrocketing is all the data basically suggesting treating it earlier seems to be more effective, the first-line studies that were done, the 3 randomized trials of flecainide… I'm giving you the ammunition. Tell us. I mean, that's how I interpret the increase and that the increase is appropriate. Yes, people should lose weight and whatever. We should work on that. But I think it's that people are now aware that it really works and it changes outcomes.

Mandrola: Nassir, thank you for not having a debate and making me use slides. But look, I don't think we should make patients with AF suffer. I tell patients all the time, you don't have to wait 5 years. You don't have to suffer with this. But we don't have to do it after their first or second episode. We can be doctors to these patients and we can work with them to learn about their condition and treat other risk factors. I've actually moved to use a lot less antiarrhythmics and move towards AF ablation before antiarrhythmics. But this movement to early AF ablation, these trials have a lot of limitations and I don't want to go through all of them now, but the evidentiary base has not convinced me to move to earlier AF ablation. I think there are other causal factors in the increase in PVIs, not just the evidence.

Siddiqui: I'm going to stick my neck out over here, and I think I may flunk this question because I may say yes to this because these patients were referred to us after seeing primary care cardiologists, maybe even an electrophysiologist like John, and then come to us and are miserable. So, I think the attitude that you want to have before you go see that patient is does this patient deserve at least a PVI? That's a question you want to ask yourself, right? Everybody needs to look into their techniques that if you are offering a PVI, are you able to provide them a durable PVI? Whether you do reduce, like everybody does reduce, the area that you isolated was actually isolated when you went back, or if not, that's something that needs to be worked on. These trials that we're seeing recently is something we've been practicing for years, right? I'm so happy that these things are finally coming out in multicenter randomized trials like STOP AF and we’re treating these patients early. The biggest question is CIRCA-DOSE, where we're seeing some retardation or progression of disease. So, all those questions are there. I'm guilty of offering these ablations to patients who are miserable with symptoms, but are obese. I mean, their BMI may be in the range of 45 to 48, but they're just big guys and they feel AF, and the AF is still not persistent, it's still paroxysmal. I have treated several of those in my practice, where actually they haven't had any weight loss, but they have no recurrence of AF on loop recorders, so there is anecdotal data of that. I had a 90-year-old patient who came in, and this is anecdotal and just my personal experience, who we offered AF because he was so symptomatic, and he came to my office and did pushups because he felt so good. In Florida, we run into many octogenarians. There's one patient who feels AF when she's hunting at 88 years of age, sitting in a tree, shooting deer, and she says, "My heart goes crazy." When we put a monitor on her it shows she has AF and she cannot tolerate antiarrhythmic drugs. So, we have this wide variety of patients. So, before walking into that room, I think questioning yourself, can you offer this patient a durable PVI? That's the question. The second question is symptomatic. Symptoms play a big role. When the patient is completely asymptomatic, you need to ask yourself, should we wait? Then, the burden comes into it all and maybe long-term monitoring. I can talk forever about this if you want me to stop. So, what do we do for durable PVI? I've used single shots and I've used RF, but looking at that lesion formation, looking at where you're doing the lesion, tailoring your approach of how the substrate looks even in paroxysmal AF makes a difference and understanding where this is. Then after a PVI, maybe waiting a little, let's not rush things that much. We do quite a few cases in a day, but wait a little. Make sure those veins don't reconnect. A lot of people go ahead and do empiric CTI. Andrea [Natale] has been a big believer in that, that most of these typical flutter lines if you wish, spending time on that, might as well wait and spend a little more time on that PVI to make sure that PVI is durable. I believe that if you can get that percentage higher to 90%-95%, and I see patients all the time who come to us after had 2, 3, 4 ablations, despite contact force, despite all the new technology, and the veins are still connected. That's something where I think the field has to change. I think with pulsed field, the concept of stability of a lesion goes away a little. I think you need to touch it, you can deliver the energy very quickly so you may be able to see a much better result long-term down the road because the concept of stability is not there. Here you have to hold the catheter against a moving heart, and a lot of times the reconnections happen, and that may be the reason you may be seeing failure. The other thing I want to talk about is actually the safety. Look as a field at what we have done. The safety percentage is less than 1% of any adverse events. All the recent data IDE trials, and if you look at STOP AF, if you look at ADVENT, which was just published, it's less than 1%. So, you can do these procedures with less than 1% complication rate. So why not offer it to our patients?

Calkins: Johannes is going to emcee the next phase of our discussion.

Brachmann: I would also like to start with PV. We have appropriate access for all the patients. That is, we're talking about the educated patient that sees the cardiologist. They can express their needs, their symptoms, they get this attention. But I have some sort of impression that we have groups of the population that are not easily accessible, that may need special attention. I mean, you have been focusing on women patients. This is something that we also need to put into action. If you really want to have more patients, maybe not every patient, but I'd like the idea to increase that as a point to access these groups as well. What do you think?

Poole: I agree. I would say, however, that even in the patients that are accessible, there's a wide variety of the phenotype of those patients when they get to those electrophysiologists, and it goes back to my original comments. The majority of patients that we see have been stuck in primary care physicians' offices, getting just rate control. This isn't a problem of health care access for those, or a problem of not having diagnosed those patients. It's a problem of inappropriate therapy and lack of education, so there's that group. In those patients, they're going to go for an ablation and I think we would all recommend them. Then there's the group of the people who are either early diagnosed, and that's where I made the point that I think you need to have full conversations with them. There's this other group of people who don't have good access to health care or have it, but their symptoms simply are dismissed. The real tragedy about those patients is they may lose their opportunity to deserve at least a PVI, because you may now be seeing those people late at the time where they have multiple comorbidities and their chance of success with PVI is going to start decreasing. Globally, I think that we have huge problems.

Calkins: One of the problems we have is there's only so many electrophysiologists and EP labs in the country. I suspect most people in this room that perform these procedures have fairly long waiting lists. I think they're just going to continue to get longer and longer because the number of the new electrophysiologists we're training is relatively slow. There is a slow rate of training and also opening new EP labs takes a long time. Does anyone want to comment on this shortage? What's your perspective? Anyone who wants to comment on the number of electrophysiologists versus the need, and what are we going to do so we can offer everyone a PVI?

Saliba: I think we are in an era of shifting procedures in terms of how long the procedure is going to take, and I think that even though most electrophysiologists have a long waiting time, the fact that you're going to be able to put more patients through the labs and the fact that we are seeing more and more labs that do not require sophisticated equipment like fluoroscopy and what have you, that might actually take a big chunk of decreasing the number of patients who are being referred for PVI. The problem is going to be the redo PVIs and these are the patients that take a lot of time if they have flutters and you have to go and map. This is where the problem I think is going to happen if indeed the new technology is going to lead to more flutters then what we have seen with RF. So, I don't know the answer.

Calkins: Does anyone from Europe want to comment on PFA in these iatrogenic flutters? Are you seeing this or not seeing this? Does anyone want to comment?

Mahnkopf: Maybe not on PFA, of course, since we just started with the first 5 to 10 cases. But I think the question that is just discussed is very important. So, I have this on my notes. Even if we say, yes, every patient deserves at least a PVI, we have to ask ourselves, do we have the chance to offer a PVI to every patient? Because we are running short of resources, especially in Europe, we have big problems in the health care system. When you look at the current guidelines from the ESC, it says ablation should be performed by a well-trained cardiologist, so we are running out of doctors, nurses, we have had a lot of beds close, cath labs will be closed down, hospitals will be closed down, and we see more and more AF patients every year. So, I'm just wondering if you have the resources. From right now, I would say no, we do not have the chance to offer a PVI to every patient. We will see what happens within the next 5 years.

Brachmann: John, we've briefly touched on the question also of how many patients we need to deal with. If you look at the absolute numbers of how many AF patients we have in North America, in Europe, or worldwide, is it even reasonable to assume that we can in the foreseeable future of the next 10 years that we can offer this therapy to all the patients?

Mandrola: We have a lot of problems in US health care, and we have a lot of inequities and disparities, and of all the things that I could think of to improve it, having more electrophysiologists would be about 100 on that list. I really don't think there's a huge problem in providing appropriate AF care in most places. I work in a city of about a million people in the middle of America. I work at a 500-bed hospital. My partner and I have about a month waiting list and if somebody really needs to be done, we can do it a little earlier. I do a little work with a partner of mine in a clinic downtown where there's poor people, and when I go down there, I feel inept because the last thing that these patients that clinic need is an electrophysiologist. They need someone to help them get their food and basic medicines, so again, I reiterate I don't think doing more AF ablation is the answer to a lot of major health care problems, but I will admit that there is disparity. In rural Kentucky, I don't doubt that there are patients with symptomatic AF that cannot get care, just like probably in rural areas of Europe, but again, I think our role in fixing health disparities is pretty small.

Siddiqui: Yes, I think the same. I think the focus really should be on quality measures. Like whenever an AF program gets introduced to any new hospital, it should come with specific quality measures of what kind of ablation is getting done and what kind of results. The promise that we're delivering to our patients needs to be fulfilled. So, rather than bringing in more electrophysiologists, I think focus should be getting better quality.

Brachmann: I would also maybe comment on do we need to also focus more on prevention? Is this something that, of course, it's not immediately what we're talking about today because obviously when we say every patient deserves at least a PVI, but if we can make the number of AF patients smaller, then maybe for those that are remaining, can we then offer them better access to the system? Want to comment?

Saliba: If we take some of the most offending risk factors like obesity, and we know the Australian group is here and they've talked about weight loss and the impact that it has on outcome of AF ablation. I think that with this new era of medications to reduce weight and the impact that's going to have on the prevalence of AF after that is something that's going to be very exciting. I think that we're going to see less AF with the use of these medications.

Calkins: There was a wonderful talk that Steve Nissen gave at Hopkins, and his talk basically discussed about how important obesity is and basically said telling patients to lose weight just doesn't work. They either have to do bariatric surgery or these new medications.

Saliba: This is why there are clinical trials about bariatric surgery. We have one going at the clinic, and also about these new medications, Ozempic et al, to see if that can actually result in change in behavior of AF thereafter and maybe those patients will do better without having an ablation. All of us in our clinic have seen patients who have AF who were scheduled to have an ablation and for some reason lost weight voluntarily, and their AF burden went so far down that they said "I do not want to have an ablation now" and we held off.

Audience question: This room is full of a lot of people who are very involved in medical care of our patients and doing a good job. We have another big problem that's happening in our profession in the United States, and that's retention of electrophysiologists. I am currently not board certified in electrophysiology or cardiology, and only a grandfather in general medicine because of all the changes in regulatory issues that we have. I work in an academic center, and right now, I cannot bill for insurance payments. I cannot practice medicine in my institution and have privileges at my hospital because the American Board of Internal Medicine has revoked all my credentials. I have been working the last 11 years trying to fix this problem and there are huge conflicts of interest with the ACGME. Regulators are a huge reason why patients aren’t going to get good care because we will not stay in our profession. So, I really think we need to rethink that. I’ll leave it at that.

Audience question: So, just picking up a view from Europe in respect to Hugh’s and John Mandrola’s point, the target has to be to reduce the number of AF ablations. And if you were to arrive at a conclusion about the discussion in the last few minutes, you would say that weight loss is the key. It’s not easy. It is difficult. And it feels bad to patients to be told to lose weight. Patients don’t do what they’re told, they do what feels good. And we have to find a way of making it feel good. For me, the great white hope in these new drugs is it will kickstart something that will allow patients to feel good by losing weight and that that will be a perpetuating cycle. Now, there is some evidence that that is the case. Smoking is a public health intervention. The public health doctors pat themselves on the back for having reduced smoking. Actually, the inflection point only came when it became socially unacceptable to smoke. So, that was the point that it began to feel bad and individuals felt good by stopping smoking. That is the sort of thing we need to do. These drugs can result in weight loss that is quick enough to create that feel good. Interestingly, in terms of Europe, we have such long waiting times for AF ablation now that we are now mandated to put patients over a BMI of 27 or 30, depending on which way you look at it, on to a weight loss program while they are on a waiting list. It’s a pragmatic way of using the wait time fruitfully. But these drugs have the possibility of resulting in such rapid weight loss that we could make doing good feel good.

Mandrola: I just love that comment, because I think that if we put as much energy in our field, Heart Rhythm Society, ACC, into changing views about cardiometabolic risk factors as we do PFA or any other new technology, we would impact health dramatically. I understand we love procedures and it's so wonderful to see the PVs go away and it's great. But again, PVI is not the answer. The answer is things like that. I'm positive on these new drugs, but I also think it's more north of that in changing societal norms. We, as a professional society, and leaders of health could change that if we changed our conversation.

Brachmann: Of course, it's not only the risk of AF, it's also the risk of diabetes, of many other diseases. I was wondering, Jeanne, do we have on the opposite side also a trend to say with obesity that it is more acceptable today? As you said, in society we talk about body shaming and that people who are obese are acceptable. Is this something that we need to change or how can we approach this? What do you think?

Poole: Yes, this is a problem now. It was a bad problem when people were made to feel bad about themselves and now it's a bad problem when they don't recognize any longer that being overweight is still a problem to their health. So, that's all going to involve a lot of education. But as the person sitting there in front of your patient who has AF who's obese, I think you should spend time trying to explain to them how they could feel better, how they may have less AF, they may avoid a procedure given all the other aspects that you're considering for that patient. So, it's really critical. We also have to have this get funded well. Prevention in the US is not funded well. It's very hard to be able to set up any kind of collaborative agreement with other clinics that works really smoothly. The ideal is you have a multidisciplinary team of people that deal with weight loss and sleep apnea, but it's really hard. For me, when I refer a patient to the weight loss clinic, it is 4 to 6 months before they will be seen. I get these absurd questions back, saying, has your patient had binge eating lately? I don't know how to answer them, because every time I answer them, I get another email back telling me that they don't qualify for the weight loss clinic. So, this is a huge issue that is a medical societal issue. It is a public issue for campaigns. It is really a huge issue that is going to require people beyond the Heart Rhythm Society to engage in.

Sana Al-Khatib, MD, MHS: Thank you very much for a great discussion and a great topic. I do want to go back to the point that was raised about the less than 1% risk of complications and remind us all that that was actually obtained in randomized clinical trials where the operators were the best operators and the patients were relatively healthy, but when you look actually at the majority of patients undergoing this procedure in clinical practice, these things may not apply. So, I think we as clinicians should definitely keep in mind that when you're looking at the patient, and something Walid said that's really resonated with me, where he said I look at the patient and I know if they run into trouble, I want to know that I'm going to be able to help them and I'm going to be able to save them. I think this is really incumbent on us to think that it's not less than 1% for all patients. There are patients who will have a higher risk of complications. That brings me to my question of going back to the older people who are frail, because those people are more likely to have complications from our procedures. In fact, if you think of symptomatic AF in a very old frail person, yes, they're going to have symptoms, they're not going to be very active, but is it the AF? Or is it the multiple other things that these people usually suffer from? I think we need to think of that. So, I'd love to get more thoughts about what is your approach to that older frail patient in trying to discern whether their symptoms are indeed due to the AF or not, and what discussion do you have with the patient regarding the benefit versus risk profile for the procedure?

Mandrola: The complications comments are as good as what we're talking about. So, this is a great forum. But the idea on complications, thank you for that comment, because it's not about the percent. One percent is fine. One percent is low. But it's the asymmetry of complications from PVI. Every time I burn on a posterior wall of a 35- or 40-year-old, I'm worried that one month later I'm going to get a call that that patient has a problem. So, it's not the 1%. That's a low rate, and we've done better. But every time we do that procedure, especially with this posterior wall isolation business, we're putting our patients at risk for a catastrophic complication, and we all know about them. So, I think that's the way I think about complications. That's the way I think about reducing the number of PVIs that I do, not increasing it.

Siddiqui: I don't disagree to this. I think the key word you use here is frail. Really, if you cannot impact the quality of life of that octogenarian older patient, there's no advantage of offering them PVI. But not everybody should be put in the same shoe size, right? There are octogenarian patients, especially where they're active, they're outside, they're driving, like I gave you the example, and their quality of life gets impacted with AF, and there's really nothing else wrong with them except AF. So, putting everybody in the same box is not right, that's a clinical judgment, that's the question you want to answer when you go inside the room, so I think there's nothing wrong with that. Going back to your question about complication rate, we need to escalate our level skill to that point where we can get the complication rate down, because if you look at all these registries, that's where a lot of these things come out, so if you look at the REAL AF registry which is going to be discussed a little bit later, or even if you look at the MANIFEST registry for PFA, these are several operators, several thousand patients, several sites. So, I think the phenomena of low complication rate is going global. It's really up to what your comfort level is.

Mahnkopf: Yes, so we focus a little on these patients because in the part of Germany where I live, and like everywhere in the world, I think it's our job to focus on these patients that benefit most from PVI and not focus on patients that do not deserve the PVI from this point of view. On the other hand, I think there's so many elderly patients, 75 and order, treated by family doctors or internal medicine, who are not even shown to the EP guys. They are told, you suffer from AF, you're doing okay now, but you're 75 years old, so you do not deserve a PVI. I think this is a major problem, because then you see them 5 years later when it's not paroxysmal, when it's longstanding persistent, and then you need to talk to the patient. I think this is very important, but focus on the patients that really have a benefit. For me, it's an improvement in quality of life and symptoms. I don't look at the age as the only factor for this.

Thomas Deering, MD: The guidelines have been very helpful and they've allowed us to open up a box to treat people appropriately. But if you go back to the Indo-European origin of that word guideline, I mean it's to know, to learn everything we can, to see, separate the forest from the trees, and then to lead appropriately. Shared decision-making is important. Many patients, though, I think in that process, turn to the doctor and say, "Dr. Calkins, what would you recommend if I was your mother?" So many times we try to share our ideas, but we've actually got to put ourselves in their shoes. So, I would like to ask you a question, and John, I like what you've been saying. I think we're doing too many AF ablations, although I do think there are some people who have limited knowledge health care resources who we should be attacking. But are there groups of people, because it says every patient a PVI, like you said Christian, “every” is never right, even though that's using never, which is also something you should answer in the exams, and I don't think every patient does. But I think the answer to this question is clearly no. So maybe you could tell us some of the folks that you wouldn't want to do. What about an individual of any age who has a small amount of AF noted on an implantable device who has normal LV function, normal left atrial size, and is asymptomatic? We talked about lifestyle; should they be asked to take medications and lose weight, refrain from alcohol, especially if they have limited resources? John, you've got a waiting list of a month, maybe you could put someone in who is actually more active. What about the frail, like Sana asked about elderly patients? What about the older patient who is symptomatic? I see too many times people come in, they're elderly, they're symptomatic, they have AF, and they were referred for an ablation. I don't know about you guys, but I will frequently want to do a cardioversion with or without meds to see if it makes a difference. Because if it doesn't, and they're 84 years of age, and I'm not impacting on the quality or the duration of their life, why should I do it? So, when would you stand back and say maybe we need to refrain, maybe we need to be a little more cautious? I'd like to know what the panel thinks.

Saliba: Thanks for the comment. I would say every patient deserves a cardioversion, definitely. Because that gives you a lot. It gives you any change in clinical status or symptom improvement, and it gives you an idea about the pattern and the recurrence rate of their AF. That will factor into your decision as to what you want to do as far as ablation is concerned. I want to say 2 things. I tell patients that AF ablation is an investment, and it depends how much one invests in, and what is your expected return on your investment. It is the frustration with the AF, physical, psychological, or whatever, that drives the aggressiveness of the therapy from doing nothing to medications to ablation. But also, I want to say that the reason why we can sit down today and talk about who gets ablation and who doesn't get ablation is because over the past 10-15 years, we have stepped out of our boundaries to do AF ablation on patients who we are not totally comfortable with and this is how we actually develop and advance the field slowly beyond, and this is how guidelines are made in retrospect, is because we tend to get a little outside our comfort zones and outside what we are used to do, and we shouldn't actually shoot this down completely. I think that we have to continue doing that, and this is how we advance within the safety constraints.

Brachmann: The next question I would like to ask is there also a minimum requirement? We talk about the frail, the very elderly patients that have no symptoms or may not improve from ablation, but do we also need to ask for a minimum? How early should we do it? If you say every patient deserves a PVI, could it be a patient with a single episode of 40 seconds? What is your opinion as a practice but also overall?

Poole: I think that covers a wide variety of different types of patients, and again, this is where the shared decision-making comes in. So, it depends, I mean if you're talking about a patient that has a little AF on their pacemaker and they have a low CHA2DS2-VASc score, no, obviously I don't think any of us would do that. But there's a whole range of interesting patients that get referred in. So, I do a second clinic during my week at a hospital that treats an underserved patient population, so that's where I end up seeing a lot of patients coming in who had their first AF episode and got sent to that emergency room, for instance. So, what I do with each and every one of those is take a look at all of their risk factors. If they show up in the ED, they are by definition symptomatic patients, and so that's a patient that is going to deserve something. Oftentimes, that is a patient I'll refer to my colleagues for PVI, but not until before I look at everything, which in that patient population includes a lot of things like do they have a stable home situation and do they show up to their appointments? Because PVI catheter ablation is a commitment. Doing anything else with these patients is a commitment. So, I think that it's easier to identify that ceiling of the frail, the elderly, maybe the older women. But I think it's less easy to define that on baseline, because it's just such a variety. You have to really make sure you're not dealing with something that is a reversible cause and you would hate to commit them to an antiarrhythmic drug or anything if that were the case. So, I think it's a wide variety of patients.

Audience question: Thank you for this. This has been a very interesting discussion. I was reminded last year in our HRS discussions with CMS, one of the comments that really caught my attention was somebody saying, in reference to CMS, they need to understand that 1 out of 6 Americans are going to end up on our table. I was shocked by that statement in part because of the tip of the iceberg concept of the idea of the symptomatic troubled people are the ones who are coming to our attention, and by definition, we're the fixers and they're the problem, so as a result, we feel like we need to fix the problem on a population basis. But I do genuinely think that the bottom of the iceberg are patients with a combination of things which is much less symptoms, many more comorbidities, so this is one of their problems but not their problem. I would like to sort of appeal the point of the 1% comment, because when you talk about shared decision-making and complication management and so on, it's actually not 1%. What do you tell them with redos? Don't you tell them 1 out of 5 patients needs to redo? They think that's a complication. When you say, "No, you'll have to stay on the blood thinner," they'll often say to me no, because they think they're doing it to reduce their stroke risk and we have compelling evidence that proves they'll never have a stroke. So, I think not if you go to the people who are troubled, those are the people who will accept those things because those are acceptable costs of getting to cure. But I think the general population, this is the next point, has much more reservation if it's balanced shared decision-making around the risk-benefit ratio because of either their comorbidities or their burden.

Poole: Can I just comment on that? I think you said something really important, which is we're busily quoting to patients it's less than 1% this and less than 1% that. I've always said to patients this is true in the ICD and CRT stuff that I was more involved in. But it's less than 1%. But if that one 1% happens to you, you are the person that actually had that complication, and you need to think about that. So, we've spent a lot of time describing that overall risk. What's the risk if you don't have a catheter ablation? Maybe we do an antiarrhythmic drug. Are you a female? You're more at risk for long QT. So, it's what that individual patient might experience if they're the one because it's easy to just have this conversation about consenting the patients for any procedure and ramble through all the whole list of things, but then say it's less than 1%. It's not likely to happen.

Brachmann: Of course, we're dealing with the problem that patients perceive any procedure as more dangerous than drugs, and we know that all the drugs also have serious side effects, but unfortunately we are now moving to the end of the session. We have to be on time. Thank you for allowing us to have this session and to all the speakers.

The transcripts have been edited for clarity and length.