AtriCure, Inc. (ATRC) Earnings Call Transcript & Summary

[Audio Gap] Of Certain remarks that may include forward-looking statements, as we've noted in the accompanying slide. In AtriCure's first investor education webcast, we are really excited to have 2 key opinion leaders for the Convergent Hybrid AF therapy with us today to share their experience with program development and expansion. As many of you know, this therapy was launched last year following the PMA approval of the EPi-Sense system for treatment of patients with long-standing persistent Afib. This approval resulted from the groundbreaking CONVERGE trial which demonstrated the superiority of Hybrid AF therapy using the EPi-Sense device to endocardio catheter ablation alone. The accompanying slide illustrates some of the key takeaways from the CONVERGE trial and notably, the durability and [indiscernible] efficacy of the procedure while also providing significant burden reduction for long-standing persistent patients, and time savings for EPs with these difficult and complex cases. We believe these results are incredibly important in the treatment of Afib as patients with long-standing persistent Afib. The most advanced and difficult-to-treat form of the disease represent nearly half of the projected 37 million patients affected by Afib worldwide and approximately 3.5 million of the projected 8 million Afib patients in the United States. We expect the journey to establish our Convergent Hybrid AF therapy as the standard of care for millions of patients will provide an expansive growth opportunity for AtriCure over the coming decade. Now on to the main program featuring a panel discussion led by Mike Carrel, President and CEO of AtriCure, along with 2 key opinion leaders. Joining us for the webcast today, Dr. Eric Buch from UCLA and Dr. Zayd Eldadah from MedStar. We have quite good credentials here so I will run through resumes, Dr. Buch's Clinical Professor of Medicine, Director Specialized Program for Atrial Fibrillation, Director of Cardiac Electrophysiology Laboratories and Associate Fellowship Program Director, clinical cardiac electrophysiology with the UCLA Cardiac Arrhythmia Center at School of Medicine of Los Angeles, California. Dr. Buch received his medical degree from the University of California, San Diego School of Medicine and completed his residency of internal medicine at Washington University, Barnes-Jewish Hospital in St. Louis, Missouri. He went on to complete his fellowship in both cardiovascular disease and clinical cardiac electrophysiology at UCLA. Dr. Buch also holds a BA in Economics and an MA and international policy studies, both from Stanford University. Dr. Buch specializes in cardiac electrophysiology. He performs both invasive and noninvasive procedures with an emphasis on treatment of atrial fibrillation, especially catheter ablation and left atrial appendage exclusion. His key research interest is optimizing tools and techniques for the treatment of cardiac arrhythmia. Now turning to Dr. Eldadah who is the Director of Cardiac Electrophysiology at MedStar Health, the largest integrated health system in the Greater Washington and Baltimore metropolitan regions. Dr. Eldadah completed a medical degree, PhD in human genetics and residency in internal medicine at the Johns Hopkins University School of Medicine. He then stayed at John Hopkins to complete fellowships in general cardiology in cardiac electrophysiology before joining the faculty at MedStar Washington Hospital Center and MedStar Georgetown University Hospital in 2004. Dr. Eldadah's clinical interests include all aspects of heart rhythm care with a special focus on atrial fibrillation and the use of medical devices to improve quality of life. His research interests include improving existing technology and developing newer, more novel ways of understanding and correcting heart rhythm problems. He holds faculty appointments at the Georgetown University and John Hopkins University School of Medicine. Now I'd like to remind listeners that we will reserve any Hybrid AF therapy adoption metrics and comments on our recent performance for the third quarter earnings call. We know that we have an eager audience and we'll share more quantitative updates in the future. With that, I will turn the call over to Mike Carrel to lead the panel discussion.

Great. Angie, thank you so much for giving us that background on, obviously, 2 incredibly well accomplished electrophysiologists from 2 different coasts and 2 really well-respected programs across the company -- or across the country, I should say. Before I kind of dive into it real quickly, just a reminder of what Angie just said, the CONVERGE trial data results were incredibly compelling to show differentiation in this long-standing difficult-to-treat patient population. You saw the durability at 18 months, you saw an over 100% improvement with Convergent, which is EPi-Sense plus catheter versus catheter all by itself and a significant burden reduction as well. So it's a compelling treatment. We're getting great feedback from customers across the country, and we thought we'd introduce you to how did 2 of the best kind of begin to implement this, and they've got different journeys. So today is really a little bit about that. So welcome both Dr. Eldadah and Dr. Buch, to the call today. We really thank you for joining us as well. So Dr. Eldadah, I'm going to start with you first because you were really an early adopter of the program. And as you and I have spoken before, we were kind of one of the reasons we went out and bought this company in contact that was really in the early stages of just starting to enroll in the trial. But after meeting with you, you convinced me that I should be basically looking at this. And you didn't say, go buy this company. You were just tell me about this great new therapy that was coming to market that you had just started. So maybe if you could begin with an overview of kind of how you started your Hybrid Afib program and then why you started to think about how Epi and Endo could work together and then what's changed in your program over time. So give us that context, it would be great.

Great. Thanks, Mike. Thanks for having us spoke here. It's a pleasure to have an opportunity to talk and maybe help some of the folks that keep the program going and growing, informed and up-to-date on what our thinking has been and the evolution along the way of this journey. Atrial fibrillation we've recognized is such a, as you can imagine, a key component of actually human aging. We tend not to even refer to it as a disease anymore because it's so tied to the human aging process the number of human beings who have it is so great that just calling it a temporary disease like an infection or a tumor is probably not accurate. It's such a biologic process. And our journey was one in which we recognized that this is a serious part of medicine, serious part of cardiology at the cornerstone of cardiac electrophysiology or heart rhythm management, and we've kind of equipped that all of us have de facto will become not just cardiologists or electrophysiologists but really [ atrial fibrillologists ] because it's the leading diagnosis that we see in our specialty. Back in the early 2000s, we were faced with the dilemma because people who had atrial fibrillation, particularly those in whom symptoms were progressing and resistant to medications were being put through the typical catheter ablation process, which in those years, were in the early -- the early iterations of catheter ablation effectiveness. Yet they weren't getting better. They needed something more. We recognized that what we were doing with the catheter from the inside of the heart was probably not enough. And it so happened that those were the days when in-contact had developed the EPi-Sense, the 400 or the modern EPi-Sense catheter to allow for an epicardial approach to the problem of atrial fibrillation, which specifically is just electrically de connecting the areas of the heart muscle that sustain the atrial fibrillation from that territory of the outside of the heart that actually is the inciting source probably of most atrial fibrillation cases. So just a simple electrical disconnection on the outside of the heart as being a more effective add-on adjunctive tool to the traditional endocardial or inside the heart disconnection process. And so we basically were using the epicardial endocardial Convergent approach in the early days of Convergent, long before the Convergent trial to treat those difficult patients. So our first Convergent Afib ablation case was actually done in December of 2011. And it so happened that this was a refractory patient or index patient 0, if you roll a patient number one, who did very, very well from an Afib management standpoint after years of suffering with Afib. He lived for many, many more years after it essentially Afib III ultimately, unfortunately, succumb to liver disease because he had a problem with Vodka was unrelated to the Afib we believer but it was a very telling case for us that this was something real. We were on to something. And so our early use of converging Afib ablation was that circumstance. The patients who are very difficult to treat had a difficult time and refractory to multiple catheter ablations at least 1 or 2 and then ultimately, the field progressed with the release of the CONVERGE data and our novel labeled indication of primarily being able to use this as a first-line therapy for long-standing persistent. But I know that was a long-winded answer to your question, but that was a quick -- a quick summary of our basically 11-year history of Convergent Afib ablation.

And maybe I'll build on that a little before we get to Dr. Buch, but maybe you can talk a little bit about how -- I know you started off with same day and have moved to stage and you've also added the clip to the program as well. Maybe give some context and perspective about how that's evolved over time for you as well.

Yes. So our learning process has been progressive and hopefully never ending, but our Convergent history started for years with a same-day procedure. We would coordinate with a cardiac surgeon. And that's a particularly rewarding element of this entire operation, if you will, literally and figuratively because the convergence to specialties, both in the room, a cardiac surgeon and a cardiac electrophysiologist on the same patient, the convergence of two service lines has been a way for us to draw together our teams combined with collective expertise really for the benefit of the patients. And that was one big source of learning and advancement for us. The staged procedure evolution started as a same-day procedure where everybody was in the same room, surgeon first, followed by the electrophysiologist. We found that, that was technically a little bit cumbersome because of the scheduling needs, the different personnel, picking a place to do it itself, which was in the early days, the electrophysiology lab and specially designed hybrid lab, what we converted to is a staged approach in which the surgical part of the procedure, the epicardial outside the heart procedure is done first under the surgeons control in the surgeon's home turf territory of the operating room. With the surgical management post procedure done by the surgical team, with the electrophysiology team consulting rounding on the patient, checking to make sure everything was okay. Patient gets discharged 2 days later, roughly or so, then comes back 4 to 6 weeks later after healing and maturation of the outside of the heart lesion sets. And then the electrophysiology procedure is done as a relatively easy outpatient, in-and-out couple hour procedure 4 hour or so recovery period and then same-day discharge with subsequent outpatient follow-up. So that's how we evolved and then in the later years, meaning in the past 4 or 5 years, our surgical partner at our institution started essentially almost 100% utilization of the AtriClip, the left atrial appendage clip adding on an additional roughly 15, 20 minutes or so of procedure time, but really achieving a very big therapeutic advance, which is eliminating the geographic substrate, the harbor, the reservoir for blood clots that cause stroke and the vast majority of atrial fibrillation related strokes. And also probably electrically disconnecting that area of the hard-left atrial appendage which we're recognizing may be a significant contributor to sustaining and perpetuating atrial fibrillation and promoting its progression from paroxysmal to persistent to longstanding persistence.

That's great. Well I appreciate that. I think everybody appreciates kind of hearing how that evolved. And I know over the course of those years, you've gone from doing, call it, a small number of cases to this year, you'll be doing well over 50 or so cases and it's continued to progress and you've opened it up and actually advance it to a new hospital. So it's just -- it's fun to watch it from the side kind of as you're kind of building out the program and having more and more referrals. Dr. Buch maybe on to you next, a little bit about the PMA approval, you really kind of got involved really after that, and you kind of came to a physician training. In fact, we went to our first hybrid physician training together back out in San Diego. Maybe you could kind of give your thought about what that training process entailed and then kind of how that led you to getting much more involved with a conversion program or establishing one at UCLA.

Sure. I can tell you the motivation was very similar to what Zayd described with this subset of patients that are very difficult to treat. And the outcomes of what we were doing before were less than spectacular. So we've done a very good job. And even since I finished training and an improved job of taking care of patients with paroxysmal AF, and to some extent, persistent but not long-standing persistent. We really didn't have a whole lot of effective treatments to offer them. So that's what interested me in this option from the beginning. And we did have an established program of open Maze procedures done concomitantly and do stand-alone as well, but it was a very invasive approach, even though the outcomes were good. Most patients and referring doctors were not interested in an open surgery, especially one on pump. So this seems to be a perfect kind of in between the ineffective endocardial ablation that we could provide and the very invasive open surgery that the surgeons could provide and a team approach as well. So that's what got me interested. And I had the benefit when I went to San Diego of learning from people like Zayd who've been doing this for years already and has gone through multiple iterations of these procedures and figured out the way that works best in their institutions. So we kind of stepped in after he tried out different ways of doing it and adopted pretty much what he's doing now from the start in our institution. So we've always done it as a staged procedure. We've always included the left atrial appendage to clip with our procedure. And we've been really impressed by how well it's worked for our patients. So that first program that I went to before we've really started doing the Convergent Hybrid procedure. It was very good to hear from people who are experienced in using it and also to hear the back and forth on the panel about how they came to the decision they came to and how they do it now versus how when they first started. Then I also visited a program where they had an established hybrid operation, and we've got to see them in action both the surgeon and the electrophysiologist which showed me hands-on practically how this procedure can be done efficiently and well. And so then we started doing our first procedures here early last year. So it's been about coming up on 2 years since we started doing the Convergent procedure in UCLA. And our volumes have increased pretty dramatically. It was one every month or 2, and then it was one more recently, about 4 a month. And I look to an increase in that volume next year as we identify more patients who might benefit.

Right. And obviously, one of the critical pieces that both of you touched on was the importance of the relationship with the cardiac surgeon that it is incredibly collaborative and important for that collaboration. Maybe you could tell us both about kind of what's worked well and how you found that surgeon, but then also maybe some of the trials and tribulations you've also gone through with that, if there are any.

I can talk about my experience. I worked with a surgeon already doing other hybrid procedures like lead extraction, epicardial BT ablation or rarely surgical support for endocardial ablation and so the surgeon that I had the most experience working with already was the one that I went to first to see if he might be interested. Not only was he interested, but he's also very curious about adopting new ideas and new techniques. And he also is a kind of natural team player. We've worked with them on research in the past and education of fellows. So he didn't have a hard time accepting that we're going to be doing this together as a team instead of the surgeon doing everything alone or the EP doing everything alone. It used to come to a branch point where the patients would go to one specialist or the other to get the entire procedure done by that person. And this is a new way of operating, and it's been very productive. I called him yesterday, you saw a patient where I had a question about the surgery that was planned. Not even his patient, but I knew I could get a hold of him and give me a quick answer. We work together all the time now and other things besides the Convergent Hybrid. So I did not have any trials and tribulations because the first person that went to ended up being a great partner who still are the only operator currently. I think there might come a time when we need another operator, and I'll work with him to identify that person.

That's awesome. Dr. Eldadah. I know Dr. Shults is someone that we know very well. He's been a trainer for us for many years. Maybe give us a little bit of history or background on kind of that relationship and how important that's been as well. I think you might be on mute, Dr. Eldadah.

My apologies.

We've all done it before.

You know how to do this after all these years of doing it, so my apologies. Similar to what Eric was describing, our history from the first time we did the procedure back in 2011 was concentrated on a single surgeon. We thought that would be a better approach, have one single surgeon because the absolute number of cases were relatively few. So to concentrate that experience and expertise into a single set of hands will probably be a better approach than distributing it among a number of surgeons. So he essentially launched our program, built it over a few years, ultimately retired from the practice of cardiac surgery and handed over the reins to Dr. Christian Shults, who took it over, I would say, about 8 years ago or so. And Dr. Shults came to the institution with a history of particular expertise and interest in borescopic surgery, minimally invasive surgery. So it was a natural fit. Also a younger surgeon at the time, very interested as Eric was mentioning in his experience in trying new things, being innovative at the forefront. And he was coming into a hospital, so MedStar Washington Hospital Center really was put on the map by its cardiac surgery program by giants like George Garcia and others in the 1980s and '90s. And so he came into a legacy program of excellence in cardiac surgery and helped take it up a notch with his particular skill set and expertise. So now he's become, as you know, a national expert, a thought leader, a trainer in Hybrid therapy on the epicardial side. So it's been a very nice relationship at that level. And really, again, as mentioned before, to converge two different service lines, two different teams, really makes for better health care. Sometimes there's a tendency modern medicine, particularly as it gets technically advanced and bureaucratically more challenging to be more insular and isolated than silo. The EP does what EP does, the interventionalist does what the interventionalist does and so forth. So any time we have an opportunity to collaborate really in real time, actively, same admission, same patient and not just at the time of the procedure, but longitudinally makes for better care. So for all those reasons, picking the right surgeon building a nice collaborative link is a win-win for everybody involved. And I think this is the reason that this can be such an attractive program for hospitals, hospital administrators like to see more procedures done in their institutions like to see collaboration. Of course, that's natural. It's not natural to be siloed and to be pulled apart and it's good for all when we work together.

And I think that leads into the next question I've got, which is you both have really successful programs and develop them obviously over different times over the past several years. Maybe you could tell us kind of what has been really crucial to you building that program? And then maybe also touch upon what were some of the logistical challenges if you had any at first. Dr. Buch, do you want to go first?

Sure. I would say that logistically, it isn't that much more difficult than the standard ablation that we were doing already. There are 2 additional steps. One is the patient needs to meet the surgeon and the second is the epicardial part of the procedure. From that point on, everything that we do in the Convergent procedure is similar to everything that we do for endocardial-only ablation including a TEE, including mapping and ablation and follow-up afterwards. We see patients at the same time points. We do the same sort of monitoring afterwards for rhythm outcomes. And so it wasn't a huge logistical challenge to set this up. And I think probably because we knew and staged, it made it easier. We didn't have to coordinate 2 different operating rooms or 2 different operators' time. So that has been not that difficult to ramp up. It turns out that for various reasons, we have quite a wait list here for endocardial ablation. Lab space limits how many we could do. And so there's a pretty good maybe 2- to 3-month waiting period for a patient that I see today that wants to be scheduled for endocardial AF ablation. If the patient instead opts for the hybrid approach, they will generally get that part of the procedure, the epicardial part earlier than I would be able to do it, and we can still slide them in 2 to 3 months when I would have done the ablation anyway. So at the end of the same period of time, they've had a more thorough ablation, including both the outside and the inside of the heart. The appendage has been closed and checked to make sure it's chronically closed. And the rhythm outcomes are better. So logistically, I think, although it is extra visits, it's not very much extra work to perform this procedure than the prior approach. One other thing I'd mention is that the surgeon besides being open to this, is also very excited to find out how patients do later. It doesn't always happen in surgical practice that they have follow-up on the patients because we're in such close communication now. I send them a map from every patient. I send them the monitors for the patients we do together, he gets a lot of feedback from me about how well the patients that we operate on together are doing. And so that provides a lot of job satisfaction for both of us. It's actually a lot more rewarding for me to take care of these patients that used to be such a challenge when I do it as part of the team.

That's great. It's interesting. I hear that feedback from a lot of surgeons. They love that interaction that they get with another physician to get that feedback and quite frankly, learn from what they did. Your math looked really good or next time maybe try to make some moves here one way or the other. Doctor Eldadah, any thoughts on yours about building a successful program in logistics.

It's very similar. The logistical difficulties, I think we overcame, like Eric was describing, when we converted to a stage procedure, the original days of trying to cram everything into a single day. You can imagine created some challenges that aren't there anymore. And so our workflow is very straightforward. It doesn't deviate too much with the addition of the hybrid component, the surgical component because it's an add-on for the patient but the workflow just includes when the decision is made generally in the electrophysiology outpatient setting, the face-to-face conversation to go with Convergent. It typically starts as I would like you to meet our surgeon to discuss this option to get an understanding of it, there's no commitment. There's no guarantee of doing it. It's just talk -- talking to the surgeon, getting to know the surgeon, feeling comfortable and being aware of the option because as you know, the nice thing, one of the things that is drawn, I think practitioners like Eric and myself and others to the field of electrophysiology is that it's not just a single fire and forget point of therapy procedure specialty. It's the procedure, the intervention and the ability to actually to do something for patients coupled with longitudinal relationship building in long term therapy and interactions and engagements with patients and their families, which is basically what atrial fibrillation is. It's not just a single point of care. It's a longitudinal process because it's a chronic biological, progressive challenge the patients have. So in that, as you were both mentioning comes the reward of good outcomes, seeing how patients do over time, being able to communicate that to the surgeon, being able, for instance, like yesterday, when I had to do 2 endocardial components of 2 prior epicardial hybrids, tell the surgeon in one, you left me virtually nothing to do. Thanks so much. It was a quick case and the other one showing the search on the exact map of the areas that were unique to that anatomy that needed extra work on the inside and brainstorming on ways of the surgical approach may be being modified to access those areas, et cetera. So a very collaborative, engaging conversation that's rewarding academically and personally and professionally as we see patients do better over the course of time. So very positive experiences across the board in building a program and it's had spillover effect. Our ability to bring together the surgical team, the cardiac electrophysiology team to converge them on convergent patients has also built better links to us as we deal with other problems such as lead extraction together, BT ablation, consulting on surgical patients, working better as a team and spillover effects even beyond that. Our ability to collaborate together on market development for our health system and for our unique specialties outside the confines of our immediate geographies as a twofold team, cardiac surgery and electrophysiology has been enhanced by our relationships built through the Convergent process. So not to overstate it, but it's been very good for our program and most of all, for our patients.

So kind of building off that a little bit as a tenure program and thinking about that collaboration, how are you thinking now about expanding the patient reach and the referral base into the broader cardiology community. I mean what do you -- I know you're already starting to make some moves in that area. Maybe you could kind of help everybody understand kind of what you guys are thinking about.

Yes. So as a referral-based specialty subspecialty, whether it's electrophysiology or even cardiac surgery, our patients, as you know, have to come to us from other practitioners. And so it's that human relationship among practitioners that's the glue and also the pipeline that keeps the work flowing, that keeps the patients coming to where they need to go to get their care. And so to build that network, that pipeline network, if you will, requires painstaking, one patient at a time, good service, one referring physician at a time, good communication and that relationship building that doesn't happen overnight, but comes over the course of time with good work and keeping your heart in the right place and making sure that the patient's best interest remain on combined North Star to guide us. And so the Convergent story was one that we've tried to promote in our community over the past 11 years since we've been using this. And the message has been simple. This is an option available to patients with your permission, with your approval and the patient's approval that we can offer them this technology to help them get better in unique circumstances. And that message gets across by direct communication by exchanging information, text messages, phone calls, dinners with patients. Programs that AtriCure has sponsored that have been very helpful in our region to be education events from our local practitioners and our own hospital public relations department has taken on the Convergent Afib ablation message on their own to promote the hospital services to the community, both referring physicians and direct to consumers in our region. And I think you all know the data, they've been very, very favorable for what that particular campaign done over the past 12 months has enabled us to achieve on the patient care side, reaching more patients and more geographies. So Convergent Afib ablation actually has been an engine has been a driver of volume of good public relations, a good relationship building for our program. And I think that's why we look upon it so favorably as we have over the past number of years, and we look forward to using it as a vehicle to do even better work and grow more in the future because the upside, as you all know, is -- it's quite significant. Atrial fibrillation is only becoming more widespread as the population ages and more and more people are living longer and longer. You wouldn't be able to market a Convergent Afib approach 100 years ago because not many people had Afib back then. Now atrial fibrillation is becoming so prevalent and all the more so. So it's literally a limitless possibility when we have an option to treat patients that not otherwise have access to these to such an advanced therapy in the numbers of patients are staggering if we think about them.

Dr. Buch, how about from your perspective, as a newer program, as you guys are getting up and running, expanding it maybe to other electrophysiologists with the new program and then out to the broader community. How big do you think you can be. You talked about doing kind of 4 cases a month, up from 1 case a month just 1.5 years ago or so and seeing that progress. What are your thoughts about kind of where you are and kind of where -- what it looks for in the future.

Yes, even though we haven't been doing it for very long, there has been a significant evolution of our program. And I think it started off with me as the 1 interested practitioner who had a fair number of patients that we weren't able to help with the endocardial ablation, at least not at a high enough success rate to be worth doing. So I first identified the patients that really we didn't have anything else to offer and kind of the very large left atrial. A very long-standing AF, cases that had a very low chance of success with any other approach, whether it's medication cardioversion or endocardial ablation. But when I saw how well it worked even for those patients, I started expanding the pool of patients that I considered to discuss this with -- offer this procedure to because I see that it works just as well for patients who are a persistent AF, not long-standing persistent and a better than current approaches. And offers for the right patient, a chance to do the most effective procedure first instead of trying other things that don't work and coming to it late, the first time ablation that's most likely to work and encompasses as well left atrial appendage management is very attractive for certain patients with persistent AF. So even within my own set of patients, I went from a very narrow set of patients to a wider set. And then the word got out among my partners. Now 4 of my partners have sent patients for the Convergent procedure. Initially, I did the endocardial Afib with them, but it's actually, as I said before, not very different from what they were doing already. And so they haven't needed me to be any more with their procedures, maybe 1 or 2. So the other EPs in our group are now interested in referring to the procedure. And then the referring doctors, the cardiologists that send us patients is in the first place. Initially, when I called them and said, I've got this idea, we should do an endocardial epicardial hybrid procedure. They said, well, what's that? That sounds like the surgery. It sounds like a MAZE procedure. It's a lot for my patient. And now they view it as a 2-part ablation procedure, different from open heart surgery, a lot less invasive with similarly good outcomes. And I actually yesterday called a referring doctor to tell him my plan and he said he thought about this hybrid approach. So he asked me about it. It turned out that patient wasn't appropriate for hybrid, but I was impressed that he brought it up. And so -- and then the last phase of our growth, which I think is still yet to be seen is other hospital systems in the area. And I've had a couple of outside EPs said this patient is not one that I can really treat well at my hospital. I'd like this patient to come to you, get the Hybrid procedure and then come back to my care afterwards. And the more we can get the word out to people like this referring doctor and cardiologists as well in the community. I think that as Zayd said before, it's almost a limitless pool of patients that might benefit.

Well, it's impressive to see how quickly your program has kind of been developed. Maybe both of you, you touched upon kind of patient outcomes. I know you measure this very closely. Maybe you can give your perspective. I talked about kind of the overall Converge trial, but maybe you could give your perspective on within your institutions, maybe a little more granular. How has this worked for your patients and how are your patients doing that are going through it. Obviously, well enough that you continue, but maybe a little bit more detail than that. Dr. Eldadah, do you want to go first?

Sure. Thanks, Mike. So I think I want to take just one step back. When we talk with patients about atrial fibrillation therapy we are very upfront with them about what we're dealing with. We try to make sure patients understand that this is a problem that's not so cleanly managed as, for instance, appendicitis and inflamed dying appendix can be cut out by a surgeon thrown into a trash can, sown up and the patient told about the surgeon you're cured, I guarantee with 0% likelihood, therefore, 100% success, you'll never have appendicitis again. We've got to get patients out of the mindset that therapies for atrial fibrillation or anything like that because if we're not clear, then anything short of complete elimination of atrial fibrillation forever more can be perceived and termed as a failure of the therapy. So it's important to note that we're not dealing with a discrete disease that has a single therapy that's either successful are not successful. So I think the upfront frank conversation that atrial fibrillation is an aging and developmental related progressive process and atrial fibrillation therapies with Convergent probably being the best available compromise between invasiveness and effectiveness. Convergent therapy is one very important step to pushback on this developmental progressive process to keep patients living longer and better without the problem and burden of atrial fibrillation that it used to be. So it's a different -- it's almost a nuanced conversation, but it's important to set up those expectations upfront because, frankly, no disrespect to Convergent atrial fibrillation, there doesn't exist to 100% cure with no exceptions to atrial fibrillation. Probably atrial cure that we'll develop. That we hope, but not at this moment. This is just one big step.

You've got some pretty smart engineer.

Ultimately, exactly, that's what you all are here to do. Right now, this is what it is. It's a compromise between invasiveness and effectiveness. And so our results, and we do track them have been more favorable than what was originally published in the CONVERGE trial, probably because in part because of patient selection because of the way the procedure is done because of the experience gained over time and our follow-up strategies. It's not a -- again a 100% confirmation that every single Convergent patient emerges without a single 1-minute period of atrial fibrillation or more ever again. The outcome of success that we set our patients up to understand is Mr. Smith, Mrs. Jones whatever, we are doing this procedure because we believe it's the most appropriate therapy for your particular circumstance and the best opportunity for us to so reduce the likelihood of future episodes of atrial fibrillation that your heart structurally will improve, but the downstream consequences of atrial fibrillation that can be a problem like heart chamber enlargement, heart failure, worsening exercise tolerance, shortness of breath and other symptoms that all of those negative effects of atrial fibrillation will become much less likely or pushed further out into the future. And then ultimately, your quality of life will be better and probably your quantity of life will be greater as well, and there's good evidence for that. So it's kind of a more general conversation basically to tell patients that we have come to the conclusion that in the best -- in your best interest would be served by this. If we had a better alternative, we would of course recommend that this is the best that we think that you would -- this is the best experience for you, the best therapy for you. That's kind of how we set it up. And if you want to talk numbers and if they press you on numbers, we can say that we believe that in patients with long-standing persistent atrial fibrillation and our experience, somewhere around 3/4 of them would -- will experience such a dramatic reduction in the burden of atrial fibrillation. That all those endpoints are much better quality of life, better exercise tolerance, reduce downstream consequences of atrial fibrillation. We try not to get into more granular endpoints than that, like monitoring data showing no electrical evidence in atrial fibrillation ever again or anything like that. Because if you get too specific about your endpoints, you set yourself up for more difficulty in achieving those end points and furthermore, it's not as meaningful. Correcting the electrical defect in atrial fibrillation takes a backseat to correct the clinical problem of atrial fibrillation. And that's what Convergent is there to do first and foremost.

Dr. Buch.

So I would push yes. The end point of note 32nd episode of AF on any monitor for the rest of your life is not really a clinically relevant one, even though that's what many studies use and that Converge used, which is it's a very strict endpoint. It really shows no detectable AF, which is interesting to know how many patients achieved that, and it was quite a few as 2 out of 3. But on the other hand, it's also important how many patients benefit, how many patients felt better, had a reduce burden of reduced structural remodeling as a result of AF, and that number is certainly higher, significantly higher. And I'd say 3/4 is probably a conservative estimate in our experience. So it's only been a couple of years we've been doing this, but the outcomes are at least that good, if not better. And so -- and we do track very carefully. We do rhythm monitors at least for a week, 3 times in the first year and then annually thereafter, just because we want to know exactly how much AF is occurring. And even by that strict criteria, it's quite effective and a very marked departure from what we were achieving before with endocardio ablation and amiodarone.

That's great. So another observation we saw in the trial was that for these difficult-to-treat population that we saw a significant reduction in the EP lab time. How does that -- I mean, have you seen that? And does that benefit you kind of in the current world in the current environment? Dr. Buch, maybe you want to go first this time?

Sure. I'll tell you, I'm one of the few people that does cryoablation as the endocardial portion of my AF ablation for Convergent. I think most people use RF. With the cryoballoon, it's already a pretty fast procedure to isolate the pulmonary veins, puncture [indiscernible] not always so fast, but the pulmonary veins are isolated even de novo. But the difference is after they've had an -- sorry, epicardial ablation procedure, the lesions that we make with the cryoballoon are much larger. They encompass most of the posterior wall even without the effort of doing so. And so that makes the procedure -- the additional ablation I have to do to fully isolate the posterior wall is minimal. And that part of the procedure is certainly faster. I haven't timed it to know if it's 40 minutes faster or some other number, but it's certainly faster. But I think another benefit, which is hard to quantify is that the ablation done after an epicardial hybrid procedure is a lot less stressful than the most difficult part of the posterior wall to ablate is the lower posterior wall, which is near the esophagus. And whether you're using cryoballoon or using RF it's difficult to safely do that without affecting the esophagus. We monitor the temperature in the esophagus and any change in the temperature is something that really causes stress for the operator and a complication that could be fatal as a Vistula between the esophagus and the atrium. So that part of the ablation is already done when the patient comes into the room for my procedure which makes everything I do less stressful and difficult and a little faster as well.

Dr. Eldadah.

Yes, I would really echo that. The majority of my personal cases for the endocardial side are still done with radio frequency energy just because we find that the work that remains for us because we have such a seasoned and talented surgeon who is able to accomplish so much in his amount of epicardial time it's generally very little. So actually, we look forward to these endocardial procedures because they tend to be relatively straightforward. The areas left we joke -- we were joking yesterday, you've turned us into Alexander The Great who [ left ] after he had no more worlds to conquer because you leave us very little to do after you do your work, Dr. Shults. A little bit in the roof, a little bit maybe on one of the anterior surfaces, et cetera, the pulmonary veins. So it tends to be a very quick and easy, relatively speaking, case. So it's rare that the endocardial portion of a Convergent ablation takes more than an hour to do. So it's a straightforward predictable procedure because it's not a de novo one for us. The work has largely been done and yes, so the simple answer is yes, it's generally a short procedure time, a simple case, less anesthesia for the patients and most importantly, a same-day discharge in and out for the endocardial portion.

So the next question that I've gotten kind of the final one we open it up to analysts to ask you some questions, we're getting all the time now, which is and we all love the fact that there are new technologies and new ways to kind of try to treat things and PFA has become kind of a word dejour with all the trials and the exciting innovations that are happening within this space. I think it'd be great for our investors to hear from you about your perspectives on pulsed field ablation and kind of it's being studied in the paroxysmal population, primarily and just give you a perspective on it, kind of where do you see it fitting in both, right now in the near future and then maybe even in the long term as well. Dr. Eldadah, do you want to go first on this one?

Sure, happy to. Thanks, Mike. So that's great. So we participated so far in the first two pulsed field ablation trial, the one run by Medtronic and the second one run by FARAPULSE, now Boston Scientific. And our take on pulsed field is probably the following, and I think I can speak for my colleagues who also participated by saying that it is a next iteration way of performing endocardial ablation well and rapidly, better than cryoballoon, which is what it's been compared to now, the jury is still out because the data aren't still in. My personal take is, it might be a little bit better, possibly a little bit safer. But I don't believe that it's going to be the holy grail for endocardial ablation, meaning complete through and through electrical disconnection forever more of the pulmonary veins from the rest of the left atrial muscle tissue and that's felt to be the mainstay critical therapeutic endpoint for dealing with paroxysmal atrial fibrillation, the episodic atrial fibrillation have to get forever electrical disconnection of those 2 anatomic territories to largely prevent subsequent paroxysmal Afib, you may not do that. And probably the reason for that is that achieving through and through electrical disconnection of tissue in the heart it's probably not possible with even pulsed field technology from the inside of the heart only. One of the things that we've learned in our Convergent Afib ablation journey is that the inside of the heart and the outside of the heart, though separated maybe by just a few millimeters are actually worlds apart. They're 2 different solar systems. There are 2 different ecosystems with fat intertwined beneath them in, [indiscernible] between them that may prevent the transmission of energy of any kind whether pulsed field-related energy, heat energy or freezing, energy from the inside to the outside, et cetera. So there's work that needs to be done on the outside, in addition to the inside, if you want to achieve an effective electrical disconnection of this area of electrically active tissue, that's a cardinal truth that we have come to understand in the course of the Convergent Afib therapy. So until we find a way to really truly get access to the full outside ecosystem geography, solar system, whatever you want to call it, universe of the heart from the inside, that's not going to be possible. I don't think pulsed field is going to do it. So there's going to be a role in our opinion, for an epicardial approach to this electrical disconnection challenge for the foreseeable future.

And I'll say in addition who has some interest in pulsed-field ablation and I've seen a lot of presentations on it. I've not done it myself. But I would say that the way I see that fitting into my practice is for paroxysmal patients. I think it is another tool that is perhaps slightly faster, safer than the balloon that I currently use to isolate pulmonary veins. The clinical data still remains to be fleshed out. I don't see it really replacing what we're doing now for Persistent AF, which requires a much broader, more thorough, hopefully, both epicardial and endocardial silence of the posterior wall in the pulmonary veins. I don't think there's any evidence right now that pulsed-field ablation is going to offer that. And so I guess the 2 patient populations I expect to maybe be using this and would be a first-time paroxysmal patient who needs just the pulmonary veins isolated. And possibly, although we'll have to see how it works, but possibly the endocardial portion of the Hybrid procedure. If we need to finish up the pulmonary veins and spots in the posterior wall that are not yet addressed epicardially, this could offer a way of doing that quickly, safely, effectively instead of the cryoballoon that are currently using.

That's great. Well, you've had enough questions from me. I know analysts are eager to probably ask you a couple of questions. So we are going to turn it over, and we'd like to thank you both for kind of sharing your experiences but turnover for the analyst Q&A now.

[Operator Instructions] Our first question comes from the line of Robbie Marcus with JPMorgan.

Great. First off, thanks for putting this together. I think it's been really helpful for analysts to get a better sense. Maybe a first question from me for both of the doctors. I think a lot of investors look at this and look at the clinical data and see the clear benefit. And you touched on this a little bit, but really, the past year plus, since it's been approved, adoption has taken a very slow upward curve. So I'd love to get your thoughts on what your view maybe as the field approaches this new procedure, what's taken so long for it to gain traction in the market. And going forward, how do you for your practices, but also for the larger U.S. physician population, how do you anticipate adoption moving forward from here on out?

Let me answer that. Thanks for the question. So I do think that there is quite a lag time between becoming interested in possibly doing this procedure and having a throughput of patients that are getting it done. And that comes from a number of factors that take some time to get going. First is the education and building a team, getting a surgeon an electrophysiologist or multiple electrophysiologists to work together on this, getting the training that's needed and then finding the patients for the procedure. But the other thing is the referral base. The doctors in our practice are just now becoming familiar after almost 2 years of doing this procedure that this is a standard first-line therapy to treat persistent or long-standing persistent AF. This is not some very niche procedure for only a very few patients. And so that took some time to let everyone know that this is available and that it's not the same as the surgery that they're may be used to in the past. I can imagine that it would be the same process in other places that are not currently doing this, that there will be some months of lead time before they start sending patients through the Hybrid procedure.

Yes, maybe I'll chime in. I totally agree, obviously, with Eric. A couple of comments I'd make, though, are the following that if you look at the history of innovations and medicine, I'll just use one simple example in our field, the defibrillator. Today, we recognize that defibrillators are life-saving people who need them have to get them as standard of care. But the transition between technology development, the first defibrillator was actually put in -- was developed in 1980 and put in a human. And today, where we're still not able to get penetration fully is telling, I think, because it's a well-known therapy. Years and years and years of clinical trials, extraordinary data demonstrating the effectiveness at saving life, not just improving life, yet there's not full adoption to the extent that we'd like it to be. In fact, just a little quick quip in the early days of defibrillator therapy. The original indication to get a light wood now we recognize as a life-saving therapy was to experience sudden cardiac death. Die basically, get resuscitated, go on living, experience sudden cardiac that again die, get resuscitated being so lucky. And then at that point, you get a defibrillator and then the field evolved from there. So I used that example not because it's exactly related, but it may be partially so. This is a therapy that is technology-based but a lot of work went into engineering, et cetera, that does require specialized expertise, a cardiac surgeons to do one part, a cardiac electrophysiologist to do the other part. So it's not as simple as issuing a pill, giving an aspirin, giving a simple therapy. It actually is an involved procedure that requires a specialized hospital with the right people on board. So there are a number of steps that have to happen. There needs to be awareness in the community there needs to be access to the physicians and practitioners and teams who do this therapy. There needs to be a good follow-up and a sustainable model. Some of the elements are in place, the patient population. definitely in place -- that will be in place forever, all the more so. We're just scratching the surface of the upside is enormous. The rest of the challenges are there, new technology adoption, particularly among referring physicians -- in the case of defibrillators, interestingly, what's been seen is that the biggest impediment to defibrillator referral, getting the patients who need the defibrillator into the hands of cardiac electrophysiologists who could actually do it was the referring cardiologist they were sitting on those patients not maliciously so, but maybe because of lack of awareness, the lack of having the therapy front of mind, et cetera. So there are a lot of challenges that stand in our way, but they're relatively surmountable challenges. They just need an effective strategy, and that's why electrophysiologists working with surgeons, working with their hospitals, PR departments working with AtriCure's marketing departments, doing technology education, therapy awareness sessions in our areas we have a terrific therapy awareness director who is going around and doing the [ few ] soft sell, educating local busy referring cardial. So referring cardiologists who are seeing 40 patients a day with all sorts of cardiac conditions may not have the bandwidth to devote their time to reading the CONVERGE trial, appreciating how effective this therapy is. So the strategy is to overcome that little impediment. If we think the bottleneck in the hands and the offices of these busy cardiologists, how to overcome that bottleneck? So that may be the area that gives us most bang for our buck to decompress and get the flow coming. And AtriCure is certainly already doing that, and I imagine they'll do more and more of that. And last thing I would say is maybe different strokes for different folks, different approaches in different environments, different circumstances, et cetera. And we have to tailor our strategy for improving that pipeline in the unique context of the geography, the health systems, the parts of the country, et cetera. So definitely, the work is cut out for us, but it's enjoyable work because at the end of the day, all the efforts converge on doing the right thing, which is making people better. So I think there's a lot of alignment in that and whether the uptick is immediate, rapid moderately. So we know it's going to be positive. And working on figuring out these little challenges will be a way to make that adoption even steeper.

Great. And maybe one more from me. You mentioned this just briefly in your results, but I'd love to hear from both of you is on patient hesitancy. It's not -- it's not a highly invasive procedure, but it's also not a totally noninvasive procedure. So how receptive are patients to doing the CONVERGE procedure? How much is push versus pull? And is that a factor in volumes going forward?

Maybe I'll try to answer that one just because it's a topic that's very near and dear to me personally. Because we deal in an interventional specialty, you're right, we don't practice just pill-based medicine or psychotherapy with our patients where it's just talk from a socially distant position. We actually touch, we invade we put patients at risk. There are complications that can happen. We have to do so very respectfully and very carefully. And the way that we have found works best is when deciding on the Convergent therapy, using this as an example or any invasive therapy for that matter. Let's just talk about Convergent therapy. The conversation has to be very respectful and very straightforward. And it goes something along the lines of this. We have -- we believe that it is in the best interest of you and your condition to consider this therapy, this is what it involves. These are the pros, these are the cons. Our ability to treat atrial fibrillation is far better now than it was 20 years ago, and that's why thankfully we can offer this. And hopefully, 20 years from now, we'll look back on this and say what we have in the future is far better than what we have today. But we can tell you in good conscience that this is what I personally would want for myself or my own family member in the same condition. I'd like you to consider it but to learn more, I'd like you to read this patient's information that we have available to you. And we have pamphlets for instance, and other online resources. And I'd also like you to meet our cardiac surgeon to talk with him, discuss pros and cons, risks and benefits that surgeons experience and develop our comfort and then we'll answer any of your questions. Thankfully, this is not an emergency procedure that has to be done right away. We have the time to think and mull it over. And ultimately, the decision is yours. We are here to make recommendations, but you as the patient have to make the decision. So if you go through a respectful conversation like that, what we found is that it's not really pushing or pulling the patient, it's trying to educate the patient, really demonstrating sincerity and we are trying to figure this out together. And the vast majority of those patients always undergo the procedure and then generally have. And hopefully, no complications happen and it's straightforward. They do have to deal with the postoperative care. It is, as you mentioned, not a walk in the park, but as one of my patients noted, which I remember, he's this big man and you would look at them and say, he's invincible. He said that Convergent ablation, that surgical part really knocked me out for a few days, and it was a little bit rough, but it was the best decision I ever made. That's what he told me. And that resonates in my mind. Yes, it's not a walk in the park, but it's, again, the best compromise between invasiveness and effectiveness for this unique category of patients in our opinion.

And I'd agree with everything that Zayd said. We almost never at an initial consultation come up with a clear plan that this is definitely going to be a Hybrid ablation. What we do is we talk about a range of options that go from rate control to [indiscernible] trial Hybrid procedure. And many patients after caring about all these, they want the procedure that's most effective, and that is the Hybrid procedure.

Our next question comes from the line of Matthew O'Brien with Piper Sandler.

I'm sorry, that cut out a little bit with Matthew from Piper.

Yes, Matthew.

Okay. And the clinicians for taking the time today out of your practices, really appreciate it. Just to put a finer point on PFA. And I appreciate the feedback. To be clear, you can't treat the back of the wall with PFA. Is that fair? And then also, have you heard -- I know you guys don't believe in it for treating this patient population. But have you heard any of your colleagues talking about waiting to see what PFA does as far as the efficacy before maybe trying the Hybrid approach?

Maybe I'll just jump in because we've done PFA. You actually can treat the back wall of the heart with PFA and there is -- we're starting a clinical trial of different parts of the country on using PFA for posterior wall ablation. So again, like Eric was mentioning before, PFA for pulmonary vein isolation, isolating the pulmonary veins is the mainstay of therapy for paroxysmal or episodic Afib ablation of both the pulmonary veins plus the posterior wall is the mainstay therapy for ablation or therapy for persistent atrial fibrillation. And you can use PFA really anywhere. You can use it isolate the veins. You can use it for the back wall of the heart. We're looking at that right now. So the ability to treat the back wall of the heart will be achieved by PFA. Maybe if I can modify what I think you were trying to say is that PFA cannot be used to directly target the outside of the heart because it doesn't attack the outside of the heart attacks, the inside of the heart and we hope that it can generate a full thickness lesion. The problem is that the tissue between the inside and the outside of the heart is not necessarily in complete contact and homogeneous that may be spacing between it, there may be fat, insulating fat layers in between. So you were still leaving behind electrically active tissue on the outside of the heart that is just unreachable by any modality currently available, whether RF or cryo or potentially even PFA, we just don't know fully because all the data aren't in yet. So the answer to your second question is, which is, are we asking our patients to wait and see whether PFA will become commercially available and widespread use before deciding on Hybrid therapy, in our practice, the answer to that is no. Because today, we actually have an FDA-acceptable indication for Convergent Afib therapy today for long-standing persistent Afib. I don't believe we're going to achieve that indication with PFA for years to come because we don't even have an FDA-approved indication of PFA for paroxysmal Afib, let alone persistent, let alone long-standing persistent. So they're kind of apples and oranges. They are different patient categories. We'll be doing Convergent, I think, for a long time before any major changes will happen because of PFA.

I would agree with that, that we can already isolate the posterior wall with current tools even before PFA is available. So that won't be a difference from what we're currently offering with cryo and RF. The difference between Hybrid and any of those approaches, all 3 of those approaches is that the other side of the atrium is treated as well. And I think that's why the outcomes are different. So I don't really expect that even if you can do posterior wall isolation endocardially with PFA that you'll be approaching the same success rate as you would from an epicardial endocardial ablation, although time will tell, and we'll see what those results show. I also wouldn't wait to refer somebody AF is a progressive remodeling of the atrium that's ongoing and waiting 2 or 3 or 5 years for another therapy that may or may not prove to be effective, I think it's not in the patient's best interest.

Got it. And that's super helpful. As a follow-up -- just to follow-up on Robbie's question a little bit about adoption. As I look at your practices, probably 4% of all cases that are done in the U.S. every year. And sorry, this is going to be a long question, but that penetration rate of just catheter-only, long-standing persistent patients is still like 10%. So you guys have come on board. Has it been staffing or coordination during the pandemic that's been challenging for a lot of hospitals and centers to get this up and running. And then is this something where next year, things should get a lot easier as far as a lot of these headwinds go, and we should start to see more of an inflection in conversion? Or is it going to be a multiyear process?

So I see it as a slow ramp up, and it takes a while to set up the system for doing this procedure. And once that system is in place, we're finding -- we're finding more and more patients that would benefit. So I feel like there's a long runway and then there's a pretty quick takeoff once everything is in place. I don't expect pandemic and COVID to have much impact from now on in how patients are treated there's less hesitancy about patients to come in from a procedure staffing shortages have been alleviated. So I think that's pretty much behind us. But I can't really speak to the ramp-up at other centers besides my own. I will say that the AtriCure staff was very helpful when we were setting up our program last year at getting both our lab staff, our nurses and our referring doctors educated about the procedure. So they were a great help, and I think there would be help with other programs as well that are launching.

Little to add to Eric's comment. I agree fully that slow and steady progression. It's going to continue to grow. And I think you'll see in different parts of the country, different rates of adoption different growth in little pockets based on all the factors that we talked about, staffing, marketing, comfort, referring physician awareness, et cetera. The effectiveness of the local therapy awareness teams and the effectiveness of local physicians and their the electrophysiologists and surgeons and their ability to engage their local referring communities. But we feel favorable. We look upon this as having a bright future, certainly in our rapidly expanding territory. We think that's going to be replicated all over the country as other centers adopt the therapy.

Our next question comes from the line of Rick Wise with Stifel.

And I'll add my thanks to both doctors and AtriCure for setting this up. Maybe just to start off with a slightly different but related direction. Talking about AtriClip usage, maybe share some of your high-level thoughts about the benefits of using the clip with CONVERGE. And when you think about it, do you think that concomitant AtriClip usage will be standard of care for all Convergent procedure providers?

So I have not in my practice, use the Convergent epicardial ablation without the AtriClip. So I don't have that perspective that Zayd might but in my mind, if you're going for an epicardial procedure, you should try to accomplish as much as you can during that procedure. And the additional few minutes and port access on the left chest to accomplish a really important goal of removing the most common source of blood clots that cause stroke, I think, is well worth it. And for that patient who has an epicardial procedure with an AtriClip, they will forever have a lower risk of stroke. And that's true even if they fail to stay in sinus rhythm. In years later, they have recurrent AF, they'll still be protected against stroke. And that will be true even if they can't take anti-coagulation in the future because of a bleeding problem. So it's almost a guaranteed benefit of this Hybrid ablation approach that is not offered with an endocardial-only approach, and I feel much better for having my patients achieve that benefit no matter the outcome of the procedure. And the last thing to say is that the Maze trial did not show a reduction in arrhythmia endpoints, but there are certainly patients who have AF, either triggered or maintained from the atrial appendage and removing that source of electrical triggering for AF as well as in our center working on the ligament of [indiscernible], I think, does improve rhythm outcomes as well as stroke outcomes.

And I'll chime in that I agree fully, completely in many respects, that extra 15 minutes now that we do it is probably the most effective 15 minutes of therapy the patients with AF will ever experience, better than anything else. So whenever our surgeon is able to do it because sometimes there are actual anatomic obstacles to getting a good AtriClip in the right place. But whenever available, it's done. It's just an extra few minutes to the procedure, wisely spent for all the reasons that Eric articulated.

Got you. And just as a follow-up for me. Congratulations to you both on your successful programs. But as Mike knows dealing with annoying analysts, we always want to quantify everything. And I was hoping just as concretely as you could help us and I'm just going to ask one way to say it, respond as you will. How many Afib cases are you doing your center, again, however you want to respond, are you doing on average a month? And what percentage of those cases now are CONVERGE. And if we're lucky enough to talk to you a year from now, let's say, what percentage of those cases would be a Convergent approach? Is it great to have to hear your thoughts about the direction.

Well, I think I would make the point that it's not only Convergent that's increasing. It's all aspects of AF treatment. More patients are being recognized, more therapies that are being provided and so our endocardial catheter ablation program has expanded rapidly in conjunction with the Hybrid program. And I think that will continue. I don't think this procedure comes at the expense of anything else that we're doing for our patients. They're just more patients that need to be treated. But to go -- I guess you wanted some numbers, as I said, we started this last year, and we were doing about 1 procedure per month. The beginning of this year was about twice that, about 2 procedures per month. I believe the second half of this year will be double that again and I see that kind of growth continuing at least for the next year or 2. There may come a point where we've kind of identified all the patients that might benefit from this. And will probably level out at some point, but not yet. So far, it's just growing. It's still a small percentage of the patients I see and even of the patients that I offer ablation to, because many patients are paroxysmal and my partners yet haven't fully adopted this approach, this option to treat their persistent, long-standing persistent patients. So I think there's still a long way for us to go within our center and that's even before we've started getting patients sent in very much from outside centers. So I foresee at least a 4x increase in our volume in the next 2 years.

On our side, it's also a similar story. Just if we take our flagship hospital, MedStar Washington Hospital in the nation's capital, we're right now doing about 1,000 days Afib ablation a year. So it's about 20 a week, and the Convergent numbers are a small proportion of that are Convergent Afib ablations are on the order of 1 to 2 a week. So we think the upside is dramatic. Our practice model is using Convergent fibrillation for the current labeled indication, long-standing persistent Afib, either with or without a prior ablation. But we are also offering Convergent Afib ablation in the unlabeled way that we were originally which is for just difficult to treat even paroxysmal and persistent Afib. So there is another category that we have to be very clear and explicit is not technically included in the FDA label, but has been acceptable and done in the past. But we expect the long-standing persistent labeled indication to continue to grow over time. And our challenges are similar to what Eric just mentioned, it's education, it's adoption, some of our practitioners that might be more faster more comfortable because of experience. We'll have a much easier time referring patients than those who may be less familiar. One of the biggest impediments to a physician adopting new technology is the hump of familiarity and comfort and ease of referrals. So if we just overcome those challenges, even among electrophysiologists, then will be limited just by our structural limitations of space and time and staffing. And that's a subject to have itself. But that first impediment is really what we're working to overcome and it's getting better.

Our next question comes from the line of Marie Thibault with BTIG.

Appreciate that you're hosting this event and taking part, we're learning a lot. I'll ask just a quick 2 questions here all at once. Would love to hear, what you think in terms of competition in your region? Are there other centers performing Convergent? Do you foresee that happening anytime and would it change the dynamic of collaboration in the region? And then secondly, what are some reasons that a surgeon wouldn't want to take part in this? It does sound like you've had great relationships with Star surgeons, but would love to hear why a surgeon might not be game for this.

I can speak to both of those. So I would say, as far as competition goes, in our area in Los Angeles, there are other centers that are nearby, I don't think within our city but close to our city that have Hybrid procedure offered and there are enough patients to go around. We're not really concerned about the fact that we might lose some patients to competing programs. I'd like to actually work more closely with some of the referring electrophysiologists in the area. I'd be happy if they send their patients for the epicardial part of the procedure, which we have developed expertise in offering and have the patients return to them for the endocardial portion of the procedure. And that those patients will be well served by getting half their procedure done in our hospital and half their procedure done at their local hospital. I think that would still be a very good outcome. And as we said before, it's not very different in actually easier to do the endocardial ablation after the epicardial has been done. As far as why wouldn't the surgeon want to do this, I will tell you that when I first brought up the idea, the surgeon that I work with told you he's motivated. He's young. He's interested in new ideas, but he was skeptical. He didn't think that the ablation done as part of the Convergent was enough ablation to be effective in these patients that are so difficult to treat. He almost thought the procedure was a little bit too easy or not invasive enough comparing his own experience with concomitant MAZE or even with totally thoracoscopic MAZE, which he was doing as well. And the surprising thing I think to him has been how good the outcomes have been with this fairly straightforward, much less invasive surgical approach, the outcomes have been great. And so he went from being a skeptic, I think, that how well can this really work. And I can offer something better is what he said at first. I can clamp the veins. I can do the posterior wall, and I can click the appendage but with a much more invasive procedure. So that's what he wanted to do it first. Now seeing is believing, and our patients are doing so well that he really enjoys doing this procedure even in preference to the more complete open procedure he was doing before.

I'll just chime in very briefly. On the competition front, the Afib population pull is basically limitless. We'll never be able to keep up even if all the hospitals in our area did Convergent Afib ablation, it wouldn't be enough. So that's really not a great concern. It's not like a small, limited number of patients that we're all fighting over, which might be the case in other clinical conditions. And we're trying to adopt a similar approach to I think what you've just heard from Eric, is that we want to offer the surgical expertise in a center that does more cardiac surgery than any other hospital in the region as being yet another offering to help local electrophysiologists enhance their practice. We're not interested in gobbling up their EP procedures. We're interested in helping their patients have access to the best care regardless who actually does the procedures. So I think the market along those lines, it would be successful and a win-win for everyone involved. And on the surgeon not being interested piece, what I have heard some surgeons say or comment is that it's just to paraphrase, the Convergent part for me that's our long experience isn't sexy enough. It's not like an open much, a big-time procedure for laying open to patients and also amazing things. So and it takes a special breed of surgeon to focus, in some cases, on thoracoscopic procedures. And so a little bit of that maybe mindset, perhaps, maybe an impediment to some surgeons wanting to adopt it. But that's okay because you want the surgeon who does this to love doing it, we want to do it and not everybody likes to do everything. Not everybody wants to be an electrophysiologist, I don't understand why, but that's another story so that's okay too. As long as you can partner as an EP with a good cardiac surgeon, who's happy doing what he's doing. And I think Eric and I are very fortunate and blessed that we have good electrophysiologists partners, a good surgical partners and that -- there are a lot of great surgeons out there, I think, when they get the opportunity to learn and do this. I foresee them also wanting to do it.

Our next question comes from the line of Bill Plovanic with Canaccord.

It's John on for Bill. I just first want to touch on, given these patients have failed numerous other procedures and therapies do you find it's difficult to find these patients even in the system today and you get some big clinic to have the conversation about the Convergent procedure.

As I was saying earlier, I think this procedure is best suited to the difficult patients that have a very strong indication for ribbon control, but as the first procedure. We have done it after failed ablation. But I think picking the patients who failed multiple prior ablations who have very extensive of left atrial fibrosis and scarring both endogenous and as a result of all the ablation that's been done before is probably not the most effective use of the technology. So those aren't the patients that we're trying to identify as the ones that have basically failed everything. And but it would be an option for those patients. I just don't think that's going to drive the growth. I think it's these patients that are currently untreated, at least in a rhythm control perspective with persistent longstanding persistent AF. Those are the ones we can help the most with this procedure. And those are the ones we're looking for. We knew that as by letting the referring doctors now, we're seeing most of these patients that there is an option. You don't have to live with AF. There are other ways of treating it now available. And when they see the outcomes, they send more patients to us to consider this procedure.

I agree. I'd also add that in our case, we try not to cherry pick our patients, of course, if we could handpick the patients for any procedure to make sure that -- to stack the odds in the favor of the greatest outcome -- the best outcome we could achieve better looking outcomes. But what we find important is to be able to have open conversations with patients to say, this is Convergent, these are its benefits. These are its risks how it's done, this is how we're using it. This is the labeled indication that the FDA has put forward based on this clinical trial. This is our experience, which is a broader patient set, and help the patient make that decision. So if we take that approach, the numbers of patients are actually fairly large. We're not afraid to use Convergent in patients because -- and the patients in whom we've selected it, we've done so because they don't have a better option. They're still struggling with atrial fibrillation despite prior ablation or medical therapy or advanced progression of their disease and we have chosen to do an interventional strategy that is Convergent ablation rather than a more dangerous strategy such as more open procedures, which we wouldn't recommend for a number of reasons. Nor the less invasive, more conservative strategies, which is just [indiscernible], let's do our best with medical therapy or even taking an approach such as ablation of the AV node, purposeful destruction of the hearts conduction system and permanent pacing therapy. We want to try to restore sinus with them. If we have a good chance of doing it what this procedure will offer it. By the same token, we don't want to just willy nilly, offer it to everybody in a nonethical way, of course, not. But we do want to take an aggressive stance that this is a good technology. It's the best in town. We hope that one day we'll look back and make and have version 3.0 of this far better than version 1.0 over 2.0. But today, this best showing town for a select group of patients. It's actually a large group. That's kind of the approach that we're taking.

And I do find that it's more common now for cardiologists to send all of their patients or most of their patients with AF, at least once to see an electrophysiologist to explore what options are available. I think in the past, in the era of the AFFIRM trial, in anticoagulate rate control being just as good as anything else. A lot of referred cardiologists don't really need the help of an EP doctor to prescribe metoprolol and anticoagulant but now with WATCHMAN, Hybrid ablation, so many options for our patients. I think it's become more commonplace to at least get electrophysiologists involved to talk about what the treatments are available and that's when the Hybrid procedure will come up.

Basically, to refer the patient to the atrial [ fibrillologists ], I think is what Eric is trying to say.

Got it. And I'd be really interested in hearing today what your mix shift is in patients undergoing Convergent who have failed previous catheter ablations versus this is a de novo ablation. And where do you see is mix shift going over time?

So I might have a different number than Zayd. But for us, it's the minority of patients that have already failed ablation. It's about 1 out of 3 is my best estimate. And I think that number will become even fewer in the future as we bring this up as at the initial consultation for the appropriate patient as a treatment option instead of trying less effective and less definitive procedures first, we might try this one, which is the most likely to be effective as the first procedure instead of the second or third.

Obviously, because of the history of our program, 11 years of doing this, the vast majority of our patients have already had a prior invasive therapy, namely catheter ablation. So but the numbers are shifting. So right now, it's for new referrals for Convergent ablation for us, it's about roughly 50-50, half have had previous therapy half for de novo. That may be the way it is for us, at least I think in our practice, which is a large and diverse one, so not all our practitioners have similar experiences, but I'll speak just most closely for my personal practice. That will be 50-50 for the foreseeable future, I think.

Our next question comes from the line of Mike Matson with Needham & Company.

It's been really helpful. I want to ask one about just the overall kind of capacity out there among the EP community to treat these now long-standing persistent patients in addition to all the other paroxysmal and persistent patients. I mean I seem to remember hearing some concern that just given the size of the market and the growth of the -- these procedures that there potentially could be some kind of bottleneck there. And now we're adding a whole another group of these patients that may need to get ablation. So any thoughts there?

I'll just -- maybe I'll take a stab at that first. So just again, with the bias of our health system, informing my answer, Convergent Afib ablation in general, is a very attractive procedure for hospital systems to bring to their centers. So there's administrative support for this therapy arm and because it supports 2 service lines, particularly in a staged approach, which can provide significant revenue to hospital systems. So it's favorable from an economic standpoint, there is significant margin on the procedure, both as a cardiac surgical procedure and has a cardiac electrophysiology procedure. In addition to all the other marketing advantages, market differentiation pieces that the hospital systems can use. So it's definitely a revenue driver and a program developer. In our particular experience our bottleneck of insufficient capacity, I'll just use our flagship hospital, Washington Hospital Center as an example. We've worked with 5 electrophysiology laboratories full-time all day doing Afib ablation, et cetera, et cetera, including the Hybrid Convergent part, the endocardial part. Our capacity started to be stretched. So we launched a construction program to build a new EP lab. We're about to finish it in February despite COVID, despite everything else, but administration said despite how tight money is, it's so important to develop another EP lab in part because of Convergent here have at it, go for it. So I don't know that that's going to be replicated else, but I suspect that with the right approach, EP procedures, both on the cardiac surgical and catheter-based side will be favorable ones that are easy to get the administrators to unclog bottleneck if it's a capacity issue. So that's a challenge that real because it does require space and time and effort, but it's a relatively straightforward challenge for the time being to overcome because again, how the finances work for these procedures for the system technical.

Yes, I think that's a good question because we are already in many centers running into constraints in terms of how many patients we can treat with the last base we have available. I don't think this will make that problem any worse because most of the patients that are getting hybrid would have gotten an ablation anyway, an endocardial ablation. So they still are occupying one slot in the EP lab on 1 day. They're also getting another procedure that's separate and in a different area where we're less constrained in terms of operating room space. And as Zayd pointed out, it's good for the hospital, it's something worth investing in. In the longer term, I think this will be part of the planning process for how much EP capacity we need. We don't work quite as quickly as your hospital system does in terms of establishing new facilities, but we're working on that. And I think that because -- it's an effective procedure that patients benefit from it will be provided and there will be space to perform these procedures. A lot more space what we needed for sure in the longer run. But right now, we're pretty much using the same amount of EP lab time that we would -- they weren't getting the Hybrid procedure.

Okay. That makes sense. And then just can you maybe comment on where things stand with guidelines, either I mean, I guess you're probably more familiar on the EP side. But is this in the guidelines, how long do you think it will take to get in if it's not and how important is that to adoption?

Zayd, you might want to answer that one. I'm not sure I have a good answer to that one.

If I understand it correctly, it's how use of Convergent therapy is going to be incorporated in the guidelines. So we just -- if we just take the category of longstanding persistent Afib which is one category that we've talked a lot about here, that category was the one for which the FDA provided the label for this approach. So I fully expect that FDA label to be translated into the next generation of the management guidelines. But in terms of hospital-based guidelines to the extent that there are, as you can all imagine, different hospitals have different degrees of management and clinical decision making. Some hospital systems are very granular and establish essentially micromanaged guidelines for a whole host of conditions and clinical problems. Other systems are loose and expect the practitioners to follow standards of care. There are a lot of elements of standard of care that are part of guidelines that, for instance, don't have formal FDA indications and vice versa. So I think ultimately, maybe the question, if I can rephrase it is, what -- how do you perceive widespread adoption to be whether or not they're incorporated into written codified guidelines or not, but how -- what does the time course or the trajectory look like for practitioners who actually do the procedures, are going to be able to do those procedures because they receive the referrals and get the buy-in from all of the appropriate stakeholders. And that's a work in progress, of course, in some centers that will be based on getting actual Convergent language into their guidelines like we have in our hospital. We actually have guidelines to specify how Convergent can be used, but they're not prescriptive. They're recommendations for our system. And even the different electrophysiologists in our program have different rates of adoption there's some who use it much more readily than others. And so it's truly a vast field. There's a lot of education that's necessary. But I think it boils down to that same simple hump model, which is there's some barriers to adoption, and they can be overcome by better communication, better education, better sharing of information of outcomes and more published literature as we have more experience in the field, further trials that are sponsored by AtriCure to demonstrate post-market results, et cetera, we'll be better positioned to do more and more of these cases in a more formal way.

I think we've exhausted all the questions from all the analysts, I first and foremost want to thank both Dr. Buch and Dr. Eldadah for giving real-world experiences, given your perspective, I know our investors really appreciate it, and they appreciate kind of both what's gone really well and also some of the things that we've got to overcome to all of our investors. Hopefully, you appreciated it. Thank you for staying a little bit extra time today. Hopefully, what you learn is, and I think Dr. Eldadah said it well, which is that these patients are limitless. There is a huge portion of the patient population out there that can benefit from the Convergent procedure. It takes time to get these programs established and well established. But as you can see from Dr. Buch's experience, we can begin to kind of move things forward and start to see a lot of great experience, especially not only at these wonderful institutions, but as we kind of push it out throughout the country. So we're excited about CONVERGE, we're excited about our future. And hopefully, you guys got a really good feel for why we are so. With that, I will say thank you once again to everybody involved and for staying at let your time. Have a great evening.

This concludes today's conference. Thank you for participating. You may now disconnect.