Regarding 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 two 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 endocardial catheter ablation alone. The accompanying slide illustrates some of the key takeaways from the CONVERGE trial, notably the durability and long-lasting 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. 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, onto the main program, featuring a panel discussion led by Michael Carrel, President and CEO of AtriCure, along with two key opinion leaders. Joining us for the webcast today, Dr. Eric Buch from UCLA and Dr. Zayd Eldadah from MedStar. They have quite the credentials here, so I'll run through resumes. Dr.
Buch is Clinical Professor of Medicine, Director of Specialized Program for Atrial Fibrillation, Director of Cardiac Electrophysiology Laboratories, and Associate Fellowship Program Director, Clinical Cardiac Electrophysiology with UCLA Cardiac Arrhythmia Center at School of Medicine in 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 in international policy studies, both from Stanford University. Dr. Buch specializes in cardiac electrophysiology. He performs both invasive and non-invasive 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 arrhythmias. 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 Johns Hopkins to complete fellowships in general cardiology and 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 Johns Hopkins University Schools 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 two incredibly well-accomplished electrophysiologists from two different coasts and two really well-respected programs across the company or across the country, I should say. Before I kinda 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 conversion, which is EPi-Sense plus catheter versus catheter all by itself, and a significant burden reduction, as well. 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 two of the best kind of begin to implement this, and they've got different journeys.
Today is really a little bit about that. Welcome both Dr. Eldadah and Dr. Buch to the call today. We really thank you for joining us, as well. Dr. Eldadah, I'm gonna start with you first, because you were really an early adopter of the program. As you and I have spoken before, you were kind of one of the reasons we went out and bought this company nContact that was really in the early stages of just starting to enroll in the trial. After meeting with you convinced me that I should be basically looking at this. You didn't say, "Go buy this company." You were just telling me about this great new therapy that was coming to market that you had just started.
Maybe if you could begin with an overview of kind of how you started your hybrid AFib program and then, you know, why you started to think about how Epi and Endo could work together, and then what's changed in your program over time. Give us that context. It'd be great.
No, great. Thanks, Mike. Thanks for having us both 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.
Our journey was one in which we've 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 quit, that all of us have de facto 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 a 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 iterations of catheter ablation effectiveness. Yet they weren't getting better. They needed something more.
We recognized that what we were doing with a catheter from the inside of the heart was probably not enough, and it so happened that those were the days when nContact had developed the EPi-Sense, the forerunner to the modern EPi-Sense catheter, to allow for an epicardial approach to the problem of atrial fibrillation. Which specifically is just electrically deconnecting 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. 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. We basically were using the epicardial, endocardial Convergent approach in the early days of Convergent, long before the CONVERGE trial, to treat those difficult patients.
Our first Convergent AFib ablation case was actually done in December 2011, and it so happened that this was a refractory patient, our index patient zero, if you will, or 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 afterward, essentially AFib free. Ultimately, unfortunately succumbed to liver disease because he had a problem with vodka that was unrelated to the AFib, we believe. It was a very telling case for us that this was something real, we were onto something, and so our early use of Convergent AFib ablation was that circumstance. The patients who were very difficult to treat, had a difficult time and refractory to multiple catheter ablations, at least one or two.
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. I know that was a long-winded answer to your question. That was a quick summary of our basically 11-year history of Convergent AFib ablation.
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 staged, 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.
Yeah. Our learning process has been progressive and hopefully never ending. Our Convergent history started four years with a same-day procedure. We would coordinate with a cardiac surgeon. That's a particularly rewarding element of this entire operation, if you will, literally and figuratively, because the convergence of two 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 team's combined collective expertise really for the benefit of the patients. 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 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 was a staged approach in which the surgical part of the procedure, the epicardial outside the heart procedure, is done first under the surgeon's 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 4-6 weeks later after healing and maturation of the outside of the heart lesion sets.
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. That's how we evolved. In the later years, meaning in the past four or five years, our surgical partner at our institution started essentially almost 100% utilization of the AtriClip, the left atrial appendage clip, adding on an additional, apparently, roughly 15, 20 minutes or so of procedure time.
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 heart, the 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 long-standing persistent.
That's great. Well, I appreciate that. I think everybody appreciates kinda hearing how that evolved. I know over the course of those years, you've gone from doing, call it, you know, a small number of cases to this year you'll be doing, you know, well over 50 or so cases, and it's continued to progress, and you've opened it up and actually advanced it to a new hospital. It's just 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 kinda came to a physician training. In fact, we went to our first hybrid physician training together back out in San Diego.
You know, maybe you could kind of give your thought about what that training process entailed and then kinda how that led you to getting much more involved with a Convergent 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. We've done a very good job, and even since I finished training, 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. That's what interested me in this option from the beginning. We did have an established program of open maze procedures done concomitantly and done standalone 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.
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. That's what got me interested. I had the benefit when I went to San Diego of learning from people like Zayd, who'd been doing this for years already and had gone through multiple iterations of these procedures and figured out the way that works best in their institution. 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 at our institution. We've always done it as a staged procedure. We've always included the left atrial appendage clip with our procedure.
We've been really impressed by how well it's worked for our patients. That first program that I went to before we even 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. I also visited a program where they had an established hybrid operation and 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. We started doing our first procedures here early last year.
It's been about coming up on 2 years since we started doing the Convergent procedure at UCLA. Our volumes have increased pretty dramatically. It was 1 every month or two, and then it was 1 more recently, about 4 a month. I look to an increase in that volume next year as we identify more patients who might benefit.
All right. 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, you know, 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 VT ablation, or rarely surgical support for endocardial ablation. 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. He also is a kinda natural team player. We've worked with him on research in the past and education of fellows. He didn't have a hard time accepting that we're gonna 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 and get the entire procedure done by that person.
Mm-hmm.
This is a new way of operating, and it's been very productive. I called him yesterday to see a patient where I had a question about the surgery that was planned, not even his patient, but I knew I could get ahold of him. He'd give me a quick answer. We work together all the time now on other things besides the Convergent hybrid. I did not have any trials and tribulations because the first person I went to ended up being a great partner who is still.
Mm-hmm.
Our 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. Zayd Eldadah, I know, Dr. Christian Schultz 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. Zayd Eldadah.
My apologies. These Zoom video conferences.
We've all done that before.
You'd think I'd know how to do this after all these years of doing them. 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. To concentrate that experience and expertise into a single set of hands would probably be better, a better approach than distributing it among a number of surgeons. 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 Schultz, who took it over, I would say about eight years ago or so. Dr.
Schultz came to the institution with a history of particular expertise and interest in thoracoscopic surgery, minimally invasive surgery. It was a natural fit. He was also a younger surgeon at the time, very interested, as Eric Buch was mentioning, in his experience in trying new things, being innovative at the forefront. He was coming into a hospital. 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 1990s. 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. Now he's become, as you know, a national expert, a thought leader, a trainer in hybrid therapy on the epicardial side.
It's been a very nice relationship at that level. Really, again, as mentioned before, to converge two different service lines, two different teams, really makes for better healthcare. Sometimes there's a tendency in modern medicine, particularly as it gets technically advanced and bureaucratically more challenging to be more insular and isolated and siloed. The EP does what the EP does, the interventionalist does what the interventionalist does, and so forth. Anytime 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. For all those reasons, picking the right surgeon, building a nice collaborative link is a win-win for everybody involved. 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. It's good for all when we work together.
I think that leads into the next question I've got, which is you both have really successful programs, and developed 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 two 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. It wasn't a huge logistical challenge to set this up. I think probably because we do it staged, it made it easier. We didn't have to coordinate two different operating rooms or two different operators' time.
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 can do. There is a pretty good maybe 2-3 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 first part of the procedure, the epicardial part, earlier than I would be able to do it. We can still slot them in at 2-3 months when I would have done the ablation anyway. 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. 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 him a map from every patient. I send him 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. 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 a 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 do. Oh, your map looked really good or what, you know, next time maybe try to make some moves here, one way or the other. Dr. Zayd Eldadah, any thoughts on yours about building a successful program and the logistics?
It's very similar. You know, the logistical difficulties I think we overcame, like Eric was describing when we converted to a staged procedure. The original days of trying to cram everything into a single day, you can imagine, created some challenges that aren't there anymore. Our workflow is very straightforward. It doesn't deviate too much with the addition of the hybrid component or the surgical component 'cause it's an add-on for the patient. 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 has drawn, I think, the 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, the ability to actually do something for patients, coupled with longitudinal relationship building and 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 that patients have.
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 two endocardial components of two 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 surgeon the exact map of the areas that were unique to that anatomy that needed extra work on the inside and brainstorming on ways that the surgical approach may be being modified to access those areas, et cetera. A very collaborative, engaging conversation that's rewarding academically and personally and professionally as we see patients do better over the course of time.
Very positive experiences across the board in building a program, and it has spillover effects. 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, VT 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. Not to overstate it, but it's been very good for our program and most of all for our patients.
Kind of building off that a little bit as a tenured 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, I know you're already starting to make some moves in that area. Maybe you could kinda help everybody understand kinda what you guys are thinking about.
Yeah. As a referral-based specialty, a subspecialty, whether it's electrophysiology or even cardiac surgery, our patients, as you know, have to come to us from other practitioners. 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. 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 our combined North Star to guide us.
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. 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 for our local practitioners. 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, on both referring physicians and direct to consumers in our region. 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 in more geographies. Convergent AFib ablation actually has been an engine, has been a driver of volume, of good public relations, of good relationship building for our program. I think that's why we look upon it so favorably, as we have over the past number of years. 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 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. It's literally a limitless possibility when we have an option to treat patients that might not otherwise have access to these, to such an advanced therapy. 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 within your program and then out to the broader community, how big do you think it can be? You talked about doing kind of four cases a month up from one case a month just a year and a half ago or so and seeing that progress. What are your thoughts about kinda where you are and kinda where what it looks like for in the future?
Yeah. Even though we haven't been doing it for very long, there has been a significant evolution of our program. I think it started off with me as the one 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. I first identified the patients that really we didn't have anything else to offer, and kind of the very large left atria, 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.
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 at persistent AF, not long-standing persistent, in fact, 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. 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, four of my partners have sent patients for the Convergent procedure. Initially, I did the endocardial mapping 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 at any more of their procedures, maybe one or two. The other EPs in our group are now interested in referring for the procedure. Then the referring doctors, the cardiologists that send us patients 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 a surgery. It sounds like a maze procedure. It's a lot for my patient." Now they view it as a two-part ablation procedure, different from a open heart surgery.
A lot less invasive with similarly good outcomes. I actually yesterday called a referring doctor to tell him my plan, and he said, "Have you thought about this hybrid approach?" He asked me about it. It turned out that patient wasn't appropriate for hybrid, but I was impressed that he brought it up. The last phase of our growth, which I think is still yet to be seen, is other hospital systems in the area. I've had a couple of outside EPs say, "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." 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's kind of been developed. Maybe both of you touched upon kinda patient outcomes. I know you measure this very closely. Maybe you could 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 wanna go first?
Sure. Thanks, Mike. I think 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. An inflamed, dying appendix can be cut out by a surgeon, thrown into a trash can, sewn up, and the patient told by the surgeon, "You're cured, I guarantee you, with 0% likelihood, therefore 100% success, you'll never have appendicitis again." We've gotta get patients out of the mindset that therapy is for atrial fibrillation or anything like that. Because if we're not clear, then anything short of complete elimination of atrial fibrillation forevermore can be perceived and termed as a failure of the therapy.
It's important to note that we're not dealing with a discrete disease that has a single therapy that's either successful or not successful. 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 push back, push back 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. It's a different. It's almost a nuanced conversation, but it's important to set up those expectations up front. Because frankly, no disrespect to Convergent atrial fibrillation, there doesn't exist a 100% cure with no exceptions to atrial fibrillation. Probably each cure will develop it, we hope, but not at this moment.
This is just one big step along the way.
We've got some pretty smart engineers here.
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. 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, again, a 100% confirmation that every single Convergent patient emerges without a single, one-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 reduce the likelihood of future episodes of atrial fibrillation, that your heart structurally will improve, that 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. That 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. It's kind of a more general conversation, basically to tell patients that we have come to the conclusion that your best interest would be served by this.
If we had a better alternative, we would of course recommend it. This is the best that we think that you would, that this is the best experience for you, the best therapy for you. That's kind of how we set it up. If you wanna talk numbers, and if they press you on numbers, we can say that we believe that in patients with long-standing persistent atrial fibrillation, in our experience, somewhere around three-quarters of them would go--will experience such a dramatic reduction in the burden of atrial fibrillation that all those endpoints are met. Better quality of life, better exercise tolerance, reduced downstream consequences of atrial fibrillation. We try not to get into more granular endpoints than that, like monitoring data showing no electrical evidence of 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 endpoints. Furthermore, it's not as meaningful. Correcting the electrical defect in atrial fibrillation takes a backseat to correcting the clinical problem of atrial fibrillation, and that's what Convergent is there to do first and foremost.
I would agree with that.
Dr. Buch?
Yeah. The endpoint of no 30-second 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's what 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. It was two out of three. But on the other hand, it's also important how many patients benefited. How many patients felt better, had a reduced burden of AF, reduced structural remodeling as a result of AF. That number is certainly higher, significantly higher. I'd say three-fourths is probably a conservative estimate in our experience.
Now, it's only been a couple of years that we've been doing this, but the outcomes are at least that good, if not better. We do track very carefully. We do rhythm monitors at least for a week, three times in the first year, and then annually thereafter, just because we wanna know exactly how much AF is occurring. Even by that strict criterion, it's quite effective. In a very marked departure from what we were achieving before with endocardial ablation and amiodarone.
That's great. Another observation we saw in the trial was that for this difficult to treat population, that we saw a significant reduction in the EP lab time. How does that, I mean, have you seen that? Does that benefit you kind of in the current world, in the current environment? Dr. Buch, maybe you wanna go first this time.
Sure. I'll tell you, I'm one of the few people that does cryoballoon ablation 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. Well, not always so fast, but the pulmonary veins are quickly isolated, even de novo. The difference is, after they've had an 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. 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. I think another benefit, which is hard to quantify, is that the ablation done after an epicardial hybrid procedure is a lot less stressful. The most difficult part of the posterior wall to ablate is the lower posterior wall, which is near the esophagus. Whether you're using cryo balloon 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. A complication that could be fatal is a fistula between the esophagus and the atrium.
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?
Yeah. I'd really echo that. The majority of my personal cases for the endocardial side are still done with radiofrequency energy just because we find that the work that remains for us, because we have such a seasoned and talented surgeon who's 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, you know, we joke, like we were joking yesterday, you've turned us into Alexander the Great, who wept after he had no more worlds to conquer because you leave us very little to do after you do your work, Dr. Schultz. A little bit in the roof, a little bit maybe on one of the anterior surfaces, et cetera, the pulmonary veins.
It tends to be a very quick and easy, relatively speaking, case. It's rare that the endocardial portion of a convergent ablation takes more than an hour to do. It's a straightforward, predictable procedure because it's not a de novo one for us. The work has largely been done. The simple answer is, yes, it's generally a short procedure time, a simple case, less anesthesia for the patient, and most importantly, a same-day discharge, in and out for the endocardial portion.
The next question that I've gotten, kind of the final one before we open it up to analysts to ask you some questions, is one 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 du jour, 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. Just give your perspective on it, kind of where do you see it fitting in both, you know, right now, in the near future, and then maybe even in the long term as well. Dr.
Eldadah, do you wanna go first on this one?
Sure. Happy to. Thanks, Mike. Yeah, that's great. We participated so far in the first two pulsed field ablation trials, the one run by Medtronic and the second one run by Farapulse, now Boston Scientific. 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 being compared to now. The jury is still out because the data aren't in yet.
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 forevermore of the pulmonary veins from the rest of the left atrial muscle tissue. That's felt to be the mainstay critical therapeutic endpoint for dealing with paroxysmal atrial fibrillation, the episodic atrial fibrillation.
You have to get forever electrical disconnection of those two anatomic territories to largely prevent subsequent paroxysmal AFib. It may not do that. Probably the reason for that is that achieving through and through electrical disconnection of tissue in the heart is probably not possible with even pulse 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 two different solar systems. They're two different ecosystems with fat intertwined beneath them, interlaced 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. 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.
Until we find a way to really, truly get access to the full outside ecosystem, geography, solar system, whatever you wanna call it, universe of the heart from the inside, that's not gonna be possible. I don't think pulsed field is gonna do it. There's going to be a role, in our opinion, for an epicardial approach to this electrical disconnection challenge for the foreseeable future.
Dr. Buch, any additional comments?
Also as someone who has some interest in pulsed field ablation, and I've seen a lot of presentations on it, I've not done it myself. 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 the 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 and the pulmonary veins. I don't think there's any evidence right now that pulsed field ablation is going to offer that.
I guess the two patient populations I expect to maybe be using this in would be a first-time paroxysmal patient who needs just the pulmonary veins isolated. 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 on 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 I'm currently using.
That's great. Well, you know, you've had enough questions from me. I know our analysts are eager to probably ask you a couple questions. We are gonna turn it over, and we'd like to thank you both for kind of sharing your experiences, but turn it over for the analyst Q&A now.
Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. We ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robbie Marcus with J.P. Morgan. Your line is now open.
Great. First off, thanks for putting this together. I think it's been really helpful for analysts to get a better sense. Thanks. Maybe first question from me for both of the doctors. You know, I think a lot of investors look at this and look at the clinical data and see the clear benefit. You touched on this a little bit, but you know, really the past year plus since it's been approved, you know, adoption has taken a very slow upward curve. I'd love to get your thoughts on what your view maybe as the field approaches this new procedure. You know, what's taken so long for it to gain traction in the market?
Going forward, how do you know, for your practices, but also for the larger US physician population, how do you anticipate adoption moving forward from here on out?
Let me answer that. Thanks for the question. 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. That comes from a number of factors that take some time to get going. First is the education and building the 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.
The other thing is the referral base. The doctors in our practice are just now becoming familiar after almost two years of doing this procedure, that this is a standard first line therapy to treat persistent long-standing persistent AF. This is not some very niche procedure for only a very few patients.
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 maybe 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 would be some months of lead time before they start sending patients through the hybrid procedure.
Yeah. Maybe I'll chime in. I totally agree, obviously, with Eric. The couple of comments I'd make, though, are the following, that if you look at the history of innovations in 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. It's standard of care.
The transition between technology development, the first defibrillator was actually developed in 1980 and put in a human. 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 LifeVest what now we recognize as a life-saving therapy was to experience sudden cardiac death, die basically, get resuscitated, go on living, experience sudden cardiac death again, die, get resuscitated, being so lucky. Then at that point, you'd get a defibrillator, and then the field evolved from there. I use that example not because it's exactly related, but it may be partially so.
This is a therapy that is technology-based, that a lot of work went into engineering, et cetera, that does require specialized expertise. A cardiac surgeon to do one part, a cardiac electrophysiologist to do the other part. 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. 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 good follow-up and a sustainable model. Some of the elements are in place. The patient population, definitely in place. That'll be in place forever, all the more so. We're just scratching the surface, so 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 a defibrillator into the hands of a cardiac electrophysiologist 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, lack of having the therapy front of mind, et cetera. There are a lot of challenges that stand in our way, but they're relatively surmountable challenges. They just need an effective strategy. That's why electrophysiologists working with surgeons, working with our hospital's PR departments, working with AtriCure's marketing departments, doing technology education, therapy awareness sessions. You know, in our area, we have a terrific therapy awareness director who's going around and doing the, if you will, soft sell, educating local busy referring cardiologists.
Referring cardiologists who's 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. Strategies to overcome that little impediment. If we think the bottleneck is in the hands of, in the offices of these busy cardiologists, how to overcome that bottleneck. That may be the area that gives us most bang for our buck to decompress and get the flow coming. AtriCure is certainly already doing that, and I imagine they'll do more and more of that. Last thing I would say is maybe different strokes for different folks, different approaches in different environments, different circumstances, et cetera.
We have to tailor our strategy for improving that pipeline to the unique context of the geography, the health systems, parts of the country, et cetera. 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. I think there's a lot of alignment in that. Whether the uptick is immediate or rapid, moderately so, we know it's going to be positive. Working, figuring out these little challenges will be a way to make that adoption even steeper.
Great. Maybe one more from me. You mentioned this just briefly in your result, but I'd love to hear from both of you on patient hesitancy. You know, it's not a highly invasive procedure, but it's also not a totally non-invasive 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? Thanks.
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 physician. 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. The way that we have found works best is when deciding on the Convergent therapy, we're using this as an example, or any invasive therapy for that matter, but 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 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. 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. 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. To learn more, I'd like you to read this patient information that we have available to you, and we have pamphlets, for instance, and other online resources.
I'd also like you to meet our cardiac surgeon to talk with him, discuss pros and cons, risks and benefits, that surgeon's experience, and develop a comfort. 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's yours.
We are here to make recommendations, but you, as the patient, have to make the decision. 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. We are trying to figure this out together. The vast majority of those patients always undergo the procedure and they're generally happy, 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. As one of my patients noted, which I remember, he's this big man, and you would look at him 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. Yeah, 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.
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 antiarrhythmic drug, do a hybrid procedure. Many patients, after hearing about all these, they want the procedure that's most effective, and that is the hybrid procedure.
Great. Thanks a lot.
Thank you. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is now open.
Hey, I'm sorry that cut out a little bit. Was it Matt O'Brien from Piper?
Yes, Matthew.
Yes, sir.
Okay, thanks for taking the questions 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, but to be clear, you can't treat the back of the wall with PFA. Is that fair? 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 we're starting a clinical trial in different parts of the country on using PFA for posterior wall ablation. Again, like Eric was mentioning before, PFA for pulmonary vein isolation, isolating the four 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. You can use PFA really anywhere. You can use it to isolate the veins. You can use it for the back wall of the heart. We're looking at that right now. 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. It attacks the inside of the heart, and you 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. There may be spacing between it. There may be fat, insulating fat layers in between, so you are 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 'cause all the data aren't in yet.
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 gonna 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. They're kind of apples and oranges. They're 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 we can already isolate the posterior wall with current tools even before PFA is available. 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 three 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. 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 is not in the patient's best interest.
Got it. And that's super helpful. As a follow-up, you know, just to follow up on Robbie's question a little bit about adoption. As I look at your practices, you're probably 4% of all cases that are done in the U.S. every year. Sorry, this is gonna be a long question, but that penetration rate of just catheter-only long-standing persistent patients is still, like, 10%. You guys have come on board. Has it been staffing or, you know, coordination during the pandemic that's been challenging for a lot of hospitals and centers to get this up and running?
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 Convergent, or is it gonna be a multi-year process? Thank you.
I see it as a slow ramp-up, and it takes a while to set up the system for doing this procedure. Once that system is in place, we're finding more and more patients that would benefit. I feel like there's a long runway, and then there's a pretty quick take-off once everything's in place. I don't expect the pandemic and COVID to have much impact from now on in how patients are treated. There's less hesitancy about patients to come in for a procedure. The staffing shortages have been alleviated. I think that's pretty much behind us. 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. They were a great help, and I think they would be helpful to 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 growths 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 the electrophysiologists and surgeons and their ability to engage their local referring communities. We feel favorable. We, you know, we look upon this as having a bright future, certainly in our rapidly expanding territory. We think that's gonna be replicated all over the country as other centers adopt the therapy.
Thank you. Our next question comes from the line of Rick Wise with Stifel. Your line is now open.
Thank you very much. I'll add my thanks to both doctors and to AtriCure for setting this up. Maybe just to start off in 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 Convergent. When you think about it, do you think that concomitant AtriClip usage will be standard of care for all Convergent procedure providers?
I have not, in my practice, used the Convergent epicardial ablation without the AtriClip, so I don't have that perspective that Zayd might. In my mind, if you're going for an epicardial procedure, you should try to accomplish as much as you can during that procedure. 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. For that patient who has an epicardial procedure with an AtriClip, they will forever have a lower risk of stroke. That's true even if they fail to stay in sinus rhythm. If years later they have recurrent AF, they'll still be protected against stroke.
That'll be true even if they can't take anticoagulation in the future because of a bleeding problem. 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. The last thing to say is that the AMATROL did not show a reduction in arrhythmia endpoints, but there are certainly patients who have AF either triggered or maintained from the atrial appendage. Removing that source of electrical triggering for AF, as well as in our center working on the ligament of Marshall, I think does improve rhythm outcomes as well as stroke outcomes.
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. Whenever our surgeon is able to do it, 'cause 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.
Gotcha. Congratulations to you both on your successful programs. As Mike knows, dealing with annoying analysts, we always wanna quantify everything. I was hoping as concretely as you could help us, and I'm just gonna ask it one way, say it, respond as you will. How many AFib cases are you doing at your center? Again, however you wanna respond. Are you doing on average a month? What percentage of those cases now are Convergent? 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? You know, it's just great to hear your thoughts about the direction. Thank you so much.
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 are being provided. Our endocardial catheter ablation program has expanded rapidly in conjunction with the hybrid program, and I think that'll 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. To go, I guess, you wanted some numbers. As I said, we started this last year, and we were doing about one procedure per month. The beginning of this year was about twice that, about two 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 two. There may come a point where we've kind of identified all the patients that might benefit from this, and we'll 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. 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.
I foresee at least a 4 times increase in our volume in the next 2 years.
Yeah, on our side, it's also a similar story. Just if you take our flagship hospital, MedStar Washington Hospital Center in the nation's capital, we're right now doing about 1,000 AFib ablations a year, so it's about 20 a week. The Convergent numbers are a small proportion of that. Our Convergent AFib ablations are on the order of 1-2 a week. We think the upside is dramatic. Our practice model is using Convergent AFib ablation for the current labeled indication, long-standing persistent AFib, either with or without a prior ablation. 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.
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. We expect the long-standing persistent labeled indication to continue to grow over time. Our challenges are similar to what Eric just mentioned. It's education, it's adoption. Some of our practitioners that might be more facile and more comfortable because of experience will 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 referral. If we just overcome those challenges, even among electrophysiologists, then we'll be limited just by our structural limitations of space and time and staffing. That's a subject in and of itself.
That first impediment is really what we're working to overcome, and it's getting better.
Thank you so much, you both.
Thank you. Our next question comes from the line of Marie Thibault with BTIG. Your line is now active.
Hi. Thank you so much for taking the questions. I appreciate that you're hosting this event and taking part. We're learning a lot. I'll ask just a quick two 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 soon? Would it change the dynamic of collaboration in the region? Then secondly, what are some reasons that a surgeon wouldn't wanna take part in this? It does sound like you've had great relationships with star surgeons, but would love to hear, you know, why a surgeon might not be game for this. Thanks so much.
I can speak to both of those. 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 a hybrid procedure offered. 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 sent 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.
that those patients 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. as we said before, it's not very different and actually easier to do the endocardial ablation after the epicardial has been done. as far as why wouldn't a surgeon want to do this, I will tell you that when I first brought up the idea. The surgeon that I work with, I 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. 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. 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 clip the appendage, but with a much more invasive procedure. That's what he wanted to do at 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 pool 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. 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. 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 of who actually does the procedures. I think if we market along those lines, it will be successful and a win-win for everyone involved. On the surgeon not being interested piece, what I have heard some surgeons say or comment is that, just to paraphrase, the Convergent part for me, this hour-long experience isn't sexy enough. It's not like an open macho big time procedure, filleting open a patient, doing all sorts of amazing things. It takes a special breed of surgeon to focus in some cases on thoracoscopic procedures. A little bit of that maybe mindset, perhaps may be an impediment to some surgeons wanting to adopt it.
That's okay because you want the surgeon who does this to love doing it and wanna do this. Not everybody likes to do everything. Not everybody wants to be an electrophysiologist. I don't understand why, but that's another story. 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. I think Eric and I are very fortunate and blessed that we have good electrophysiologist partner, a good surgical partners. 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.
Thank you so much.
Thank you. Our next question comes from the line of William Plovanic with Canaccord Genuity. Your line is now open.
Hi, it's John on for Bill. Thanks for taking our questions and hosting this webcast. I just first wanna touch on, given these patients have failed numerous other procedures and therapies, do you find it difficult to find these patients even in the system today and to get them to the 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 rhythm control, but as the first procedure. We have done it after failed ablation. I think picking the patients who've failed multiple prior ablations, who have very extensive 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. Those aren't the patients that we're trying to identify as the ones that have basically failed everything. You know, it would be an option for those patients. I just don't think that's gonna drive the growth.
I think it's these patients that are currently untreated, at least in a rhythm control perspective, with persistent, long-standing persistent AF, that those are the ones we can help the most with this procedure, and those are the ones we're looking for. We do that by letting the referring doctors know, 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. When they see the outcomes, they send more patients to us, to consider this procedure.
I agree. I'd also add that, you know, 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 it's to stack the odds in the favor of the greatest outcome, the best outcome, we could achieve better-looking outcomes. But what's important is to be able to have open conversations with patients to say, "This is Convergent. These are its benefits. These are its risks. This is 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. If we take that approach, the numbers of patients are actually fairly large.
We're not afraid to use convergence in patients because in the patients in whom we've selected it, we've done so because they don't have the better option. They're still struggling with atrial fibrillation despite prior ablation or medical therapy or advanced progression of their disease. 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 live with your AFib, let's do our best with medical therapy or even taking an approach such as ablation of the AV node, purposeful destruction of the heart's conduction system and permanent pacing therapy. We want to try to restore sinus rhythm. If we have a good chance of doing it with this procedure, we'll offer it.
By the same token, we don't wanna just willy-nilly offer it to everybody in a non-ethical way. Of course not. We do wanna 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 have version 3.0 of this far better than version 1.0 or 2.0. Today, this is the best show in town for a select group of patients. It's actually a large group. That's kind of the approach that we're taking.
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, and anticoagulant rate control being just as good as anything else, a lot of referring cardiologists thought, "I don't really need the help of an EP doctor to prescribe metoprolol and an anticoagulant." Now with WATCHMAN hybrid ablation, so many options for our patients, I think it's become more commonplace to at least get electrophysiologist 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 fibrillologist, I think is what Eric's trying to say.
Yeah.
Got it. Thank you. 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. Where do you see this mix shift going over time?
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 one out of three is my best estimate. I think that number will become even fewer in the future as we bring this up at the initial consultation or 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.
Yeah. 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. The numbers are shifting. Right now, it's, you know, for new referrals for Convergent ablation, for us, it's about roughly 50/50. Half have had previous therapy, half are 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. I'll speak just most closely from my personal practice. It'll be 50/50 for the foreseeable future, I think.
Great. Thank you.
Thank you. Our next question comes from the line of Mike Matson with Needham & Company. Your line is now open.
Yeah. Thanks for taking my questions, and thanks for hosting this event. It's been really helpful. You know, I wanna ask one about just the overall kind of capacity out there among the EP community to, you know, 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, you know, given the size of the market and the growth of these procedures, that there potentially could be some kind of, you know, bottleneck there. You know, now we're adding a whole nother group of these patients that may need to get ablation. Any thoughts there?
Maybe I'll take a stab at that first. 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. There's administrative support for this therapy arm. Because it supports two service lines, particularly in a staged approach, which can provide significant revenue to hospital systems. It's favorable from an economic standpoint. There's significant margin on the procedure, both as a cardiac surgical procedure and as a cardiac electrophysiology procedure. In addition to all the other marketing advantages, market differentiation pieces that the hospital systems can use. 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 five 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, 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." I don't know that that's gonna be replicated elsewhere, 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 the bottleneck if it's a capacity issue. That's a challenge that is 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, technically feasible.
Yeah. 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 lab space 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. They still are occupying one slot in the EP lab on one 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. 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. I think that because it's a effective procedure that patients benefit from, it will be provided, and there will be space to perform these procedures. A lot more space will be 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 if they weren't getting the hybrid procedure.
Okay, thanks. That makes sense. 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 you know, is this in the guidelines? You know, how long do you think it'll take to get in if it's not? How important is that to adoption?
Zayd, you might wanna answer that one. I'm not sure I have a good answer to that one.
Yeah, if I understand it correctly, it's how use of Convergent therapy is gonna be incorporated in the guidelines. If we just take the category of long-standing 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. I fully expect that FDA label to be translated into the next iteration of the AFib management guidelines. In terms of hospital-based guidelines to the extent that there are, as you can all imagine, different hospitals have different degrees of management of clinical decision-making. Some hospital systems are very granular and establish essentially micro-managed guidelines for a whole host of conditions and clinical problems. Other systems are loose and expect the practitioners to follow standards of care.
You know, 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. I think ultimately the, maybe the question, if I can rephrase it, is how do you foresee widespread adoption to be whether or not they're incorporated into written codified guidelines or not. What does the time course or the trajectory look like for practitioners who actually do the procedures are gonna be able to do those procedures 'cause they receive the referrals and get the buy-in from all the appropriate stakeholders. That's a work in progress, of course. In some centers, that'll 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.
They're not prescriptive, they're recommendations for our system. Even the different electrophysiologists in our program have different rates of adoption, interestingly. There's some who use it much more readily than others. It's truly a vast field. There's a lot of education that's necessary. I think it boils down to that same old, that same simple hump model, which is there's some barriers to adoption, and they can be overcome by better communication, better education, a better sharing of information about 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.
Well, great.
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, giving your perspective. I know our investors really appreciate it, and they appreciate kinda 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 learned 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 kinda move things forward and start to see a lot of great experiences, especially not only at these wonderful institutions, but as we kinda push it out throughout the country. 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 a little extra time. Have a great evening.
Thank you.
Thanks.
This concludes today's conference. Thank you for participating. You may now disconnect.