Good afternoon, everyone. I'm Mark Wilterding, Head of Investor Relations at Edwards. Thanks, everyone, for coming back. I know there's a lot going on today at TCT, but really excited to see you all back here in person. For those of you online, thanks for joining us as well. Big day for us here at Edwards, and we've got a great panel to talk you through the results of the TRISCEND II data that we showed earlier today. For the next 45 minutes, we'll have the panel on stage as we did on Monday, an opportunity for you guys to ask questions, and we'll go from there. So real quick, I'll just remind you that we do have some cautionary statements here, forward-looking statements. Just make sure you read through those. With that, I'll turn it over to our CEO, Bernard Zovighian.
Thank you, Mark. Thanks, everyone. It's very impressive to see a full room. I know it is Wednesday afternoon, a big week for all of you. We appreciate the interest in the company, and again, another exciting day for us, exciting TCT. It has been great for patients with this TRISCEND II study, and we are going to be focusing on TRISCEND II, but a big day for patients. These patients have a terrible quality of life, and EVOQUE is a great solution. It is also a great day for physicians and the clinical community. They now have science to make their decisions, medical decisions, and a great day for the company. We have been very successful with TAVR for 20 years, and having EVOQUE with this kind of data, with this kind of evidence, with this kind of impact to patients is super exciting.
But I want to do a little bit like I did on Monday, and I want to bring you back. Like our TMTT leadership story about eight years ago, nine years ago, we had a vision to transform care for mitral and tricuspid patients. And we knew through our 65 years of pioneering leadership that these patients were diverse and complex at the same time, so that having a comprehensive portfolio was necessary, a comprehensive portfolio with breakthrough technology, science, and partnership with physicians. You all know that we started with PASCAL. And PASCAL as a technology is differentiated. We are seeing a strong adoption. It is going very fast in the U.S. and in Europe and everywhere where we bring PASCAL to market and to patients. And we see PASCAL and the TR segment as being a big opportunity in front of us.
There is still a lot to do. There is still a lot of adoption for us to get. Second was EVOQUE, the first and only tricuspid replacement technology. There is a very high patient and physician demand, and Daveen is going to talk about it. So you are going to hear more from a physician standpoint and from Daveen's standpoint. There is more to come soon also. The SAPIEN M3 is going to be soon approved, and it is going to be again the first mitral tricuspid replacement technology available in the market in Europe first next year and thereafter in the U.S. But today, let's stay focused on EVOQUE. And we have this very exciting TRISCEND II data presented this morning. So let me introduce our very impressive panel. First, Dr. Ted Feldman is our Senior VP of Global Medical Affairs for TMTT. Everybody knows Ted.
He has been a pioneer in structural heart, highly published, and he has been instrumental in the last six years with the company, bringing the mitral and tricuspid research to the next level. Dr. Susheel Kodali, Interventional Cardiologist, Director of the Structural Heart and Valve Center at Columbia University, New York-Presbyterian Hospital, one of our global TRISCEND II PIs. Dr. Suzanne Arnold, Associate Professor of Medicine at the University of Missouri and Clinical Scholar for Saint Luke's Mid-America Heart Institute. And very important for this field, a clinical cardiologist and a widely recognized expert in quality of life research. And of course, Daveen Chopra, Global Leader of TMTT. So with that, let me turn over to Ted to start this conversation. Ted.
Great. Thanks very much, and I think I have only one slide with the trial conclusions, and I don't know who's controlling the slides. Great. Thank you. This trial is the first randomized trial in tricuspid valve replacement, and first both from the perspective of many years' history of surgical tricuspid valve therapy, absent any randomized controlled trial evaluations, and brings us the first approved tricuspid valve replacement device, also including even in the universe of surgical therapies, so the design of the trial as a randomized prospective evaluation of this therapy, you saw the results earlier this morning, was pretty key in leading us to this pathway, and I just want to emphasize a couple of points about the trial. First, that we received breakthrough designation from FDA for the EVOQUE device because it serves a truly completely unmet patient need, and that allowed us a two-part trial.
Dr. Kodali presented the initial phase of the trial one year ago, 150 patients with six-month data. And that, in fact, was the basis of FDA approval. And today, the primary outcome of the trial, which is a one-year composite, and Susheel will talk about that for a moment. So on the one hand, this is a very heavy lift and a remarkable achievement. On the other, remarkable in that from first-in-human implant to FDA approval was barely four years. And I think that's a record in terms of a completely new category of therapy receiving an approval in the U.S. Dr. Kodali.
Sure. So I think most of you have probably seen the presentation. I was fortunate to be one of the global PIs along with Rebecca Hahn and Vinod Thourani and Philipp Lurz. This was a global study. This was sort of the culmination of a lot of work. And Ted mentioned that tricuspid regurgitation is sort of an unmet need, and we've seen that. And this journey started 10 years ago. And we've started with other devices, and it's trying to understand how do we provide treatment options for this population. And this is really sort of the culmination of all of that to get to an approved device. The trial was, as Ted mentioned, do you want me to just highlight results or just sort of a couple of topics? Yeah. Okay. So it was a randomized trial, two-to-one randomization.
The technical success and ability to deliver the valve was excellent, more than 95%. The safety events were similar to what we saw before in the 150. There is some bleeding risk, which I think can be mitigated with some of our sort of clinical pathway changes in terms of how we anticoagulate and how aggressive we are. There were conduction requirements for new pacemakers, which were, again, similar to what we saw in the initial 150 and something that we continue to look at more closely. But for the primary endpoint, which is a hierarchical endpoint of safety and effectiveness, and this was a hierarchical endpoint looking at hard endpoints such as mortality, tricuspid valve intervention, but also other endpoints such as quality of life, six-minute walk, and NYHA class, comparing TTVR versus EVOQUE was highly significant, favoring TTVR.
And that was using the Finkelstein-Schoenfeld, just showing that there was a difference. But to calculate the magnitude of the effect, we used a win ratio. And win ratio basically compares the patients in the groups with each patient being compared to every other patient. And you just calculate the number of wins. And then you basically look at all-cause mortality, which patient won compared to each one, and you get all these pairs. And when there's a tie, you go to the next event. And the win ratio was 2.02, which was, again, highly significant. So clearly showing benefit. We also showed that the procedure was feasible, as I said, but also eliminated TR. And I think that's one of the differentiators from repair technologies is that replacement eliminates TR, where 99.1% had moderate or less and 95% had mild or less. So this was that the valve works.
And at one year, we saw good stability of valve results. And these patients will continue to be followed out to five years with serial echos. So continue to follow that. And I think that this is sort of the initial results. And then I'll let Dr. Arnold sort of comment on some of the quality of life results, which she presented separately in this morning's session.
Great. So I'm Suzanne Arnold, and I'm an outcomes researcher and clinical cardiologist. And the one thing I want to kind of mention before I get into the details of the results is I've presented the health status outcomes from a lot of different trials. And typically, what happens is the clinical results get presented at one meeting, and then the health status results get presented at the next meeting because it's considered secondary. It's not quite as important. And this is a really interesting trial for me because it's been one of the first ones where the clinical results and the health status results were prioritized both, and they were both presented at the same meeting. And I think this really highlights the importance that these health status results were placed because they are so important to these patients.
And so I just want to highlight that because it's really important as somebody who takes care of these patients to see this being highlighted. In terms of what we saw, we saw that the TTVR arm had a moderately large improvement in health status that was present by one month. But importantly, this continued to grow through six months and was stable through one year. And at one year, the treatment difference was 18 points. And just to put that into perspective, 5 points is considered a minimal clinically important difference on this measure, and 10 points is a moderately large improvement. So this was a really large change that was seen in the intervention arm.
Thank you. I think we are ready to take questions.
We are. Thank you very much. The first question from Anthony.
Thanks, Anthony Petrone. Congratulations on the data. I guess the first one would just be to level set symptomatic severe tricuspid regurgitation. How many of these patients are out there? And do you think that this data will drive earlier intervention versus optimal medical therapy in the near term? And then we think of quality of life versus mortality. Mortality wasn't there, but at the panel, they mentioned that the mortality rate overall of tricuspid is low. So really, the quality of life should be more heavily weighted in the decision-making process, just considering, again, that there is lower mortality versus aortic. So how does that play out? Thanks.
So maybe let me start, and I will ask Ted, or Daveen, or Susheel to further your comment. I will make two comments. The first one is it was one of the fastest enrolling randomized trials. And it is always a leading indicator that there are many patients in need and that physicians are trusting the technology and they don't have any other solutions. The second one is a little bit of a comment we made on Monday for aortic stenosis, where when it is one of the first studies in the space, we don't know well this disease. At the time, 20 years ago, we believed that aortic stenosis was not necessarily as big as it is today. And so these are two leading indicators that tell us that it's probably bigger than what we think, and we are going to learn more. I think who wants to go next? Ted or Susheel?
To address the potential population size, there's a number that is cited repeatedly in the cardiovascular literature that there are 1.6 million patients with severe or greater TR in the United States. That number is derived from old population data and is probably wrong. And if we're going to call it wrong, it's because it is based on information that's 20 years old, and the population has grown and aged. So I would have to imagine it's an underestimate if it's anything. So that's one key point. And that said, there isn't a specific measure. Nobody's ever looked really hard to try to figure out what is the universe in the U.S. of severe or greater tricuspid regurgitation. The idea that mortality is low depends on the population that's studied.
When we started working on designing these trials, we were looking at retrospective historical data that suggested one-year mortality rates between 30%-40% for severe or greater TR. We've subsequently come to appreciate that those are mixed populations, mostly with left-sided heart disease and left heart failure, who were captured in older echo databases. We've done some population exploratory studies now and published them. There's a Colin Barker paper from two or three years ago that we produced that do show that depending on how you look at the population, the annual mortality rates for isolated tricuspid regurg in an older population tend to be closer to 10% or 15% than they are to 40%. You get those higher rates only with patients who have multiple left-sided heart problems. I think those are a couple of your bigger points. Other comments?
No, I think I agree, and I think the population is a little bit uncertain. What I can say is that as our population ages, HFpEF increases, atrial fibrillation increases, these are all determinants of what cause right-sided heart disease over time. Now, we're going to get better at managing them, but right now, this is a therapy that we get a fair number of referrals for. I would say I get more referrals for tricuspid than mitral right now because there aren't good treatment options. I think that lack of treatment options and these patients are very symptomatic drive a lot of this. And we're seeing quite a bit of that, and we work with our heart failure colleagues quite closely on it. The issue of mortality is an intriguing one, and I caution us to say that there isn't mortality benefit with this therapy.
This study wasn't powered for mortality. This patient population we enrolled right now didn't show mortality benefit, but I strongly believe there are groups that are going to have a mortality benefit. Whether it's patients with more severe TR, whether it's patients with what we do know is atrial functional TR, the mortalities are low, but ventricular functional and others, it's high, and you enroll a higher population in patients that are very sick, you are going to derive benefit, and I think we just don't know the groups that are going to get the mortality benefit. There is quality of life seen throughout, but we need more data. We're going to continue it to identify those patients, but these patients are also coming and are self-referring to an extent too as we see more and more of this data.
Because when you have lack of treatment options, this is what we see. And we saw this with TAVR in the early days when patients were inoperable and didn't have options. So I think this is the beginning of data. We're going to continue to get more. But there's clear benefit in quality of life, but I do think there's mortality benefit. But I can't say where or at right now.
Thank you, Danielle.
Good afternoon. Sorry, Danielle and Tulsi with UBS. Thank you guys so much for doing this. I'm just curious about how the data that we've seen today sort of changes the conversation between intervening via TEER versus replacement and sort of how you see that evolving over time. I mean, obviously, Edwards will eventually have a TEER product as well. But just curious about how that plays out over the next few years.
I'm happy to take that.
Yeah, go ahead, Susheel. Maybe Ted's up.
Yeah. No, I think it's an important point. It's going to be a lot of discussion. What I would say is there are anatomic restrictions to both therapies, but that's not the enTEERe cohort. So I don't know what that number is, but maybe there's some bars on either side where TTVR is not an option because you're not an anticoagulation candidate or the RV function is too poor or whatever reason. And there are a lot of patients where TEER is not a candidate because of leaflet complexity, five leaflets instead of three, pacing leads, leaflet tethering. And fundamentally, I think if I'm going to choose a patient, if I don't think I can get their TR down to mild to moderate or at least moderate with TEER, then I don't think that's a therapy I'm going to pursue if TTVR is an option.
That's sort of my bias. So I look at can I anatomically and I also look at clinical factors. Someone's having hepatic congestion and ascites. I really want to eliminate TR. So in that patient, I might say I'm going to do replacement more. I think there's a lot of people where replacement is going to be an easier procedure because just being very honest, the imaging requirements for TEER are higher. The availability of good echocardiographers. I mean, interventionalists are in some ways everywhere, but a dime a dozen.
The structural imagers are much more limited, and the imaging burden for TEER is higher. That being said, whether it's TriClip or PASCAL, there's a clear role, and we're going to continue to see that. But I think both are great options for patients as long as we can reduce TR at least to moderate or less, in my opinion, or eliminate it. And so we have to be able to say we can do it, but that's how I choose. I don't know if anyone feels differently.
Yeah, I would echo your comments and say I think about it as a Venn diagram and the giant universe of severe symptomatic tricuspid disease. We think it's really large. We don't know how big. And at this stage, all we know is that we have within that very large circle a group that are treatable with TEER and part of that group that are ideal for TEER and then a zone of no overlap where EVOQUE we know can be used successfully. The overlap, I think, is where there's a lot of uncertainty. And today, within most parts of the world, only one tool on the market, people will try TEER knowing that they have a low level of confidence that they're going to get a great result. And where replacement and repair settle in that zone is going to take a long time to develop.
Yeah, and we're just going to need to collect evidence base for it too and look at it.
Thank you. Richard Newitter from Truist Securities. Congrats on the data. Two for me. The first is just on the pacer rate. And I'm curious just to hear your thoughts on that. What steps can you take to potentially kind of alleviate that aspect going forward and product iterations, etc.? And then just the second question I'm going to have is just on the crossover. Can you just talk a little bit about how you think that might impact what we'll see at two years? And how is that accounted for when you guys kind of initially put the trial together? Thanks.
Maybe let me make a quick comment, and Daveen, you can talk about what we have in mind in terms of iterations here. What you can count from us is do what we did for TAVR. Remember, we had five generations of SAPIEN platform. The first one to our Resilia today is very different. In 15 years, we had the best platform always, but we improved the platform always, and here, we have the same vision, and Daveen is leading this one.
Yeah. Well, just a couple of points. If you look at PASCAL today, a couple of years out, we're on our third generation. For EVOQUE, we've already started our second generation a couple of years back. So we are and one of the things we are trying to look for from design is how, as we understand what causes pacemaker rates, how can we potentially from a design help optimize and reduce that? So that's definitely front and center on our line and something we'll look to improve and we believe will improve with future generations. The other questions?
The second part of the question?
Oh, crossover.
Oh, the crossover.
I think about that as we approach the end.
I mean, I can make a quick comment. It's going to be an issue in terms of the two-year data. We're going to have such a small cohort at two years, and it's going to be a biased cohort of probably patients that are actually doing okay that the two-year data isn't going to answer those questions that we'd like to. Obviously, to the point of mortality benefit, I think same as before. If we follow these patients long enough, I think these curves separate. But we're not going to be able to get that in this study with the crossovers.
David.
Thank you, David Roman from Goldman Sachs. One question just on you made a reference to more patients getting referred to you for tricuspid versus mitral. I mean, one of the things that has been challenging, I think, is this technology has gone beyond TAVR is the speed at which some of these categories have developed. I think we're 13 years post-MitraClip launch or something like that, and it's just scratching $1 billion. TAVR was there in less than half the amount of time. So how should we think about the adoption rate of tricuspid valve replacement in your practice? And how do you think the data today influence that relative to what physicians might have been hoping for yesterday?
Maybe let me take the first part of the question and talk about the mitral trajectory. You're right about a long time for the mitral TEER to become a $1 billion segment and opportunity. But I think you need to remember what happened there. One technology, very little innovation, mixed clinical evidence compared to on the TAVR side, a couple of technologies, a lot of innovations, and great evidence being generated by two companies. When I look at what's happening on the mitral side, mitral TEER side since a few years, now there is a second company. Both companies now are generating clinical evidence, are innovating. And what we are seeing is the mitral TEER market is now growing double digit in the last few quarters. Daveen, you want to add anything to that?
No, I think that's perfect. We've seen that, I think, as far as you bring together more resources, more interest, more attention, more people in the field, more people talking to referrers, disease awareness grows, disease referrals grows, and ultimately, the market starts accelerating. So we believe in mitral, we're getting that now in mitral TEER, and we're probably going to see that pretty soon in mitral replacement, these opportunities for more patients to be treated and an accelerating growth.
So that's the exciting part on mitral. So the mitral opportunity now is growing. There is more patients. There is more opportunity. And mitral replacement, again, is going to be soon approved in Europe and soon after in the U.S. So this mitral dynamic is changing and will further change in the years to come. On the tricuspid side, do you want to add anything here, Susheel?
Yeah, no. And we have sort of a selected we're an academic institution and some of those things. What I will say is on the mitral side, there are other options, whether it's surgery, heart failure therapies, and things. And there's a real growth in thinking about mitral disease. And that's why the TEER volumes continue to grow.
We do need a replacement device because there's a lot of patients that are not TEER eligible, and that limits some of that growth. And I think having an option for replacement. But on the tricuspid side, the issue is the medical therapy is diuretics, which make people miserable. There aren't surgical options. And these patients are very, very symptomatic. And maybe I think Suzanne can comment. What drives referrals to send, patients to send, for what I see is like, "I'm miserable. I don't want to live this way," and maybe you can comment on why we start getting these patients that have no other options.
Yeah. So I mean, if you look at kind of baseline health status symptoms, I mean, these are highly symptomatic patients. On average, NYHA class III, which is minimal shortness of breath just with regular activities or I'm sorry, shortness of breath with minimal activities. And there is no GDMT for right-sided heart failure. There's no medical therapy other than diuretics and maybe SGLT2 inhibitors. So for most of the patients that I have had who have had symptomatic TEER, it was, "Sorry. I mean, we'll titrate your diuretics as much as possible." And so now that we have treatment options available, there's someone to refer them to. So I do think that there are a lot of patients out there. We have to get word out to obviously the referring physicians to get those patients to the right place.
If I could just have one quick follow-up here. In the study, one of the things that we've heard a lot is there's definitely a learning curve with this device. Did you look at outcomes and procedure-related complications in the first half of the patients treated versus the second half of the patients treated? Did you see any improvement in outcomes correlated with learning curve?
Ted, could you take this one?
Yeah. We showed a forest plot in the presentation today. Oh, maybe we didn't show the less than 10-case. Yeah, we didn't show that. So with tricuspid TEER, there's been evidence that sites that have a less than 10-case experience have less good outcomes than sites with a 10-case-plus experience. And we looked at that in the TRISCEND II trial and saw absolutely no difference in primary outcome, which includes safety and efficacy components based on experience. And another, I think, strong indicator about the teachability of the procedure is that the device time, which is guide catheter in to guide catheter out, has throughout the experience been around an hour with narrow confidence limits. And that's twice or half the time or two-thirds of the time of even the best tricuspid TEER experiences. And tricuspid TEER is associated with a large confidence interval. And translate that.
If you're a physician operator and you walk into an EVOQUE procedure, you expect it to take about an hour, and you have confidence that that'll be the case. When you walk into a TEER procedure, you expect it to take 90 minutes, and you've got your fingers crossed that it doesn't take three and a half hours, and you have that uncertainty every time you start a procedure.
Yeah. David Rescott with Baird, thanks for taking the questions and congrats on the data. Maybe one for the management team and then for the physicians as well. You've talked a lot about in the TMTT bucket how there's a toolbox approach to addressing tricuspid and mitral regurgitation. And we obviously have questions about the capacity constraints within certain centers. When you think about focusing on a tricuspid replacement, potentially a tricuspid repair at some point with PASCAL, M3 PASCAL on the repair side as well longer term, how do you focus on or balance getting all of these therapies out there as opposed to focusing individually on one of those?
And the same question would be for the physicians around if there's questions around three or four-hour procedures. There's different workups, different patient identification ways in which you're going after them. How do you balance all four of those different or five of those different therapies as opposed to, again, just focusing on one? Yeah. I'll start by answering that. I mean, obviously, for us, we believe to treat the maximum number of patients, having a repair and replace technology is huge for patients, right? Just as we've heard today already, TEER versus replacement, they both add a lot of value to a lot of patients. And so for us, it's as we bring each technology around, we're clearly kind of trying to focus deep on it, but offer the Edwards expertise to help make the procedure as efficient as possible.
As we heard today about with EVOQUE, right? A mean of an hour time. It's an efficient procedure. People are relatively easy to learn and then eliminate TEER, right? No difference in learning curve, whether you're in case one or case ten, as we just heard from Ted. So in that way, we love those kinds of procedures. And our work along the way with our high-touch model is to help support physicians so that they can continue to not only learn the therapy, but then get more efficient with the therapy and go faster with it and treat more patients.
We believe we have a hand in trying to, with our model, with our clinical specialists and the way we help screen cases, to be a part of that and find those efficiencies so that we can bring these therapies in and grow because there is so much patient and physician unmet need, and especially today with EVOQUE, so much demand for these therapies happening right now. I don't know if Susheel or Suzanne want to make some comments.
No. I mean, I think the capacity stuff that you mentioned is an interesting thing. I mean, I think it's dependent on the institution. At our place, we have, I think, six TAVR operators, and only one or two of us really do mitral tricuspid. So it's and so, yes, I probably do less TAVRs because I'm doing mitral tricuspid, but I hope that the rest of my team and physicians and our volumes are stable on TAVR because I have other people doing it. But there are institutions where there's limited structural operators and one to two, or where there's limited imagers, and/or there's limited time in the lab and limited space in the hospital. These tricuspid patients, they do stay in the hospital longer. They take beds. And so there's trade-offs, and it's going to be institution-dependent whether it constrains. It's going to be operator-dependent. So many number of hours in a day or whatever it is. And so I think it's just dependent on the location.
Hey, thank you. Mike Polark from Wolfe Research. My question is on these overlap patients, folks that might be suitable for both TEER and replacement. How do you think that conversation goes with the patient? What's presented to the patient? I'm thinking about EVOQUE showed a higher AE rate in the trial, but has done better on TEER resolution versus TEER, which showed a really low AE rate. So maybe any early anecdotes where patients would qualify for both, how it's presented, and how the conversation ends.
That's a good one for maybe two others.
Sure. Sure. Yeah. No, I mean, these conversations are not easy because I think we're still learning a lot about the data. I think there are things that we'll push, and I think they rely a lot on the physicians to say, "What's the right option for me?" And we have our preferences. For example, there's data out there that we know that the tricuspid valve is only three leaflets in half of the patients. And in a lot of patients, it's five leaflets. There's data out there, if you do edge-to-edge and with five leaflets, that the results aren't as good. And we have that bias. And I'm like, "If somebody has massive detrimental TEER and five leaflets, my confidence level is going to be that I'm not going to get a great result." And I'm going to tell the patient, I tell the patient, "There's two options.
Your anatomy, I'm not confident I'm going to get a great result with TEER, and I favor replacement." Same patient, if they've had bleeding issues and have a WATCHMAN and there's real concern that they're going to be able to tolerate anticoagulation, I will say, "You know what? This is not ideal, but I think I can reduce it with edge-to-edge." Sometimes it's unpredictable because it's the predictability, Ted's point of what is the predictability of the, not even the procedure duration, but the predictability of TEER. I sometimes struggle with. Because I've had five leaflet cases where I've gotten to mild, and I'm like, "Why did that happen in that case?" The next week, I feel confident I do another TEER, and it doesn't. I'm like, "Why?" That predictability is where it is, so it's a clinical decision. If they're bleeding risk or their RV is poor, it might lead me to TEER, even if it's not ideal. Fundamentally, we're going to balance them.
Thanks a lot. Larry Biegelsen from Wells Fargo. One for Dr. Kodali, one for Dr. Arnold. Dr. Kodali, can you put this mortality question to bed for us, please? FDA teased us in the SSED with the 18-month data, 25, 13, I think it was. Why didn't you show the data and do the crossovers? Basically, does that negate us ever seeing? Because what we did, we all looked at kind of statistics. If you ran the sample size higher, you would have eventually seen a stat sig mortality benefit. So can you put that to bed for us? And maybe I'll just ask my second question for Dr. Arnold. Can you talk about the lack of concordance in the quality of life benefit, New York Heart Association benefit, and a lack of benefit on heart failure hospitalizations? Is that something you typically see? Thanks.
Let me address the 18 months in the SSED and 12 months in the primary outcome, and that's exactly what it is. The SSED is a document that is created by FDA, and their request from us at that time point, given relatively limited data, was 18 months, even though the end of those curves have very small numbers of patients and are less meaningful, so this presentation is 12-month primary outcome data, and then the next big time point is a two-year analysis that we'll see in obviously approximately a year, and maybe Susheel, you want to address the whole crossover?
Yeah. No. And I think we will see longer-term data as we. This was sort of the presentation of the primary endpoint in the one-year data, and we'll see longer-term data as it comes out. Unfortunately, as you said, it may be a little bit limited because of crossovers. And crossovers are probably more selective in the patients that are more symptomatic. And so I don't know what we make of the data after that one-year time point, I mean, and what those curves do. It's important to keep in mind this study was not powered for mortality. I think Dr. Arnold did an analysis and looking at the likelihood of showing a mortality benefit with the numbers we enrolled, it was pretty low because it's the numbers. But it's also a very complex patient population. And Dr.
Arnold's TRI-QUAL study showed that patients that had their KCCQ score at 30 days predicted outcomes, including mortality and heart failure hospitalization, right? So there is benefit. And we've seen study from TRILUMINATE, getting two-grade, three-grade reduction correlates to greater improvements in KCCQ score. Those are also associated with hard endpoints. So yes, this study did not show mortality benefit. It doesn't mean there's not. It's not powered for it. The patient population we enrolled was heterogeneous. Atrial functional TR, there's natural history studies showing that the mortality at one year is less than 10% in atrial functional TR. And that's a good percentage of the patients we enrolled, not all. So we took this mixed bag of patients, put them in there in not a study that was powered for mortality, but we have indicators. And I think all of the data show positive effects of treatment.
The hepatic congestion with the GGT changing, the RV remodeling that we see with decreasing RV dimensions and IVC dimensions, six-minute walk, they're all sort of concordant to benefit. But the mortality question, I'll let Suzanne weigh in as well and your comment. But I do really think that that's not put to rest. I can't put it to rest, and I don't know what study is going to put it to rest right now in which population.
Yeah. So thank you for that question. I love this one because we've looked at this in a number of ways. So one is with TRI-QUAL, which was an FDA-funded study of eight single-arm and three randomized trials of different tricuspid transcatheter valve interventions. And then we've looked at this in TRILUMINATE. We looked at it in TRISCEND. And we know that patients, if you have an improvement in KCCQ acute, that is associated with a reduction in the risk of heart failure hospitalization mortality. So we don't see that translate into these mortality reductions and heart failure hospitalization reductions in these trials, but they're underpowered because the event rates in the control arm were low. But I don't think there is discordance. I think it's, I don't want to say perceived discordance between the two because the patients who improve still do have a reduction in that risk of heart failure hospitalization mortality.
Josh, can you be quick?
Really quick?
Thank you for squeezing me in. Josh Chang from TD Cowen. I wanted to just ask about the commercial launch. I know you guys are being intentionally deliberate, making sure these early cases have good outcomes. My understanding there's a big staffing requirement. You have to get a pre-procedure CT, get evaluated by Edwards, and then there's the imagers as well. So just, I mean, how do you ramp from here? And then does that kind of time between getting a patient in a queue by the cardiologist and then getting the procedure done, does that narrow over time? And I guess, when do you put the pedal to the metal in terms of this launch with EVOQUE?
No, I think overall in the commercial launch, we're very happy with how things are going. There is a huge physician demand. There's a huge patient demand for therapy to help them. And so I think for us in our model, of our high-touch model of really working closely with centers, yes, there is a pre-case screening plan. Yes, there is a procedure. We have Edwards people in the room to support the physicians to help ensure they get the best possible outcomes. That whole process I mentioned earlier, it's going to keep getting more efficient. It's going to keep growing. It's going to keep scaling. I look at some of our physician trainings. I think for the next six months, all our physician training slots are filled out or something like that because there's so much demand.
But we're going to keep scaling, keep growing, keep building, increasing capacity, and trying to support as many patients as possible. Because for me, if I maybe pull back for a second because I know it's one of the last questions, it's an exciting time for tricuspid patients here in the U.S. There's now multiple approved therapies. There is so much interest and demand from physicians and patients to get therapy. And with the data we saw today, we saw a therapy that can eliminate TEER.
That's easy to learn. That's reproducible short in time, and that really has amazing quality of life outcomes for patients. While this group of patients, as Susheel kind of said, showed a numerical improvement in heart failure hospitalizations and mortality, for me, it's exciting. And I think there's so much more to go. We will continue to improve. We'll continue to work with physicians and continue to get more efficient and keep growing and scaling and helping treat more patients.
Thank you. No, thank you, everyone. So I want to reflect on this week. I think it is an important one to do that. It has been a great week, about 20 presentations, two New England Journal of Medicine publications, many other publications across TAVR and TMTT. And so it's clearly underscoring our scientific commitment and scientific leadership in TAVR and TMTT. Another reflection is about the kind of special company we are. A few years ago, it was only about TAVR. Today, TAVR is very important, and TMTT is becoming more and more important. And now we have a new area, new therapeutic area that we are starting with AR, with implantable heart failure. And we are going to apply our playbook, best technology, best innovation, world-class evidence to be able to treat more patients, and at the end of the day, achieve sustainable growth.
So I am super confident. I'm super excited about the many years ahead of us. It's not going to be linear like it was in the last 10 years. It was not also. It will not be. But super confident about the trajectory. I want to thank our panelists, Dr. Susheel Kodali and Dr. Suzanne Arnold. Thank you so much for being great leaders in the space and great leaders in this study. Ted and Daveen, thank you very much to all of you. Thanks for having stayed so long with us. Have a great rest of your day.