All right, everybody, thanks for your patience. Appreciate it. It's great to see so many people in person and online, too. It's an exciting day for Edwards. I'm Mark Wilterding, Head of Investor Relations. I'm joined by Sidney and Linda, and like I said, we really appreciate your time here. We've got about 45 minutes for the session today. It'll be a combination of some prepared remarks from the panel you see in front of you, as well as some time for Q&A. Before we get into it, I'll just call your attention to the forward-looking statement here. Please just take a second to familiarize yourself with it. It's also available on our website. And so with that, let me turn it over to our CEO, Bernard Zovighian.
Thank you, Mark. Everyone, you know, welcome, good afternoon. You know, as you know, TCT is always an important, you know, meeting, you know, for us. It is a meeting where we can show our commitment to science and evidence. And indeed, you know, today was a big day. It was a big day for patients. It was a big day for the clinical community, and it was a big day for the company. Allow me to stepping back, you know, twenty years ago. You know, we had a vision to change, you know, the practice of medicine for aortic stenosis patients. And after years of research and development, in 2007, we launched our first, you know, SAPIEN platform. At the time, I'm sure you all remember, surgery was the standard of care.
2010 was also a big day for patients. It was probably, you know, the first big day for patients. You remember the PARTNER 1B, where TAVR proved to be a viable option for inoperable AS patients. Since then, so in the last 14 years, I want to highlight three things. First, we brought extensive research, clinical research, evidence, science, comparing TAVR to SAVR. Eight New England Journal of Medicine publication, so best in class. Two, we had an amazing innovation journey. SAPIEN XT, the second platform, SAPIEN 3, Ultra, Ultra RESILIA, which is today, the preferred TAVR option globally by physician to treat, you know, all of their patients. And three, we learned a lot about the disease.
The number of patients that we all thought at the time is way bigger today because of this fourteen years of research, fourteen years of innovation, fourteen years of partnership with the clinical community. Today, you know, we see EARLY TAVR as one of the most critical data set since, you know, PARTNER-1B. This is truly about, you know, the strategy for disease management, the first study like that for AS patients. It is a big day for patients and physicians, so physicians will be able to better take care of their patients. It is also a big day for the company. Starting today, we know that the AS opportunity in front of us is way bigger than what we thought also yesterday. So it is a very exciting day. You know, the entire Edwards team is, you know, super excited about the data.
You know, I know that, you know, we are going to have many plans, you know, to make sure we educate, train, and make sure that your patients are well taken care of. So I am joined today with Larry Wood, our Global Leader of TAVR, and Dr. Philippe Genereux, very distinguished interventional cardiologist and Co-director of the Structural Heart Program at the Morristown Medical Center in New Jersey. He's, you know, the PI of the EARLY TAVR, so no one can better speak about the trial design, trial outcome, and what that means, you know, to patients. With that, Philippe, please. Thank you so much.
Okay, let's look at this. All right, guys, thanks for having me and, very, very exciting day today for Edwards, but more importantly for us and the patients. I'm going to walk through the study briefly, and then we can ask questions, so EARLY TAVR was a prospective, very large, the largest actually, prospective, multicenter randomized controlled trial, evaluating a patient with severe AS and no symptoms, among patients aged 65 and above, STS score 10 or less, which means that there are patients low risk, intermediate risk, high risk. All risks were included in this and normal ejection fraction, meaning the heart was normal. Patient-- important point is the asymptomatic status of the patient were confirmed with negative stress test, negative treadmill stress test.
All patients had to pass a treadmill and to be labeled as asymptomatic, which is no trial ever done that. Patients were randomized one for one to either transcatheter TAVR with S3 or S3 Ultra to clinical surveillance. The primary endpoint was the primary endpoint of a composite of all-cause death, stroke, or unplanned cardiovascular hospitalization at a minimum of two years. That's the primary endpoint you all saw today. The composite of death, stroke, unplanned cardiovascular hospitalization was 51.2% in the clinical surveillance and 35.1% in the EARLY TAVR group, which was associated with a 50% decrease of the primary endpoint, with the number needed to treat. Six patients needed to treat to save one event at two years, which is excellent in medicine. The mean follow-up of the trial was almost four years.
Very important, the granularity, our patients convert to symptom. The patients that were in the clinical surveillance were followed thoroughly, and the conversion to symptom and AVR happened at a median time of 11 months. It's very important to see that at six months, already, 26% of the patients need AVR, need a TAVR. 47% at one year and more than 70% at 24 months. To put it in perspective, the guidelines tell us to follow the patient every six to 12 months, and already at 12 months, there's 50% of the patients that already need an AVR. We characterize the way the patient in a clinical surveillance convert to symptom, to AVR. Did they convert with no symptom? Did they receive an AVR with no symptom?
Did they receive an AVR because there was a little bit of shortness of breath or fatigue? Or did they have advanced signs or severe signs of heart failure with acute decompensation? And we talk about severe heart failure at three or four, which means you cannot breathe at rest. Syncope, passing out, ventricular arrhythmia, fluid on the lungs, pulmonary edema. Those are dramatic ways to have the first symptoms. And what we show, which actually those are extremely important for medicine in general, is the signs and symptoms at conversion to AVR in a clinical surveillance group were about 40% of the time severe, advanced. In spite of being normal ejection fraction, baseline, negative stress test literally six months ago.
Progressive signs and symptoms in 60% and only 2% converted to AVR when they are having no symptoms, but all of them actually had other reasons to be converted. We can go on. This slide is also very important because the proportion of patients presenting with advanced signs and symptoms was consistent through time, including the early converters. The patients at 0-6 months that convert to symptoms, which convert to AVR, also present dramatically 40% of the time in a type of crash and burn scenario. And that was constant through time, showing that the disease progression is very unpredictable, and when the disease hit, a lot of time it hit hard.
So I think the main conclusion that makes no doubt to everyone is that in patients with asymptomatic severe AS, a strategy of EARLY TAVR compared to clinical surveillance resulted in a significant reduction in the primary endpoint of death, stroke, unplanned cardiovascular hospitalization. We assessed this endpoint with multiple variations. We took death, stroke, and heart failure only. We took death, stroke, and conversion with advanced signs and symptoms, and all the different permutations of this endpoint lead to the same conclusion, a reduction of 50% actually of the primary endpoint. Important is like when we did this EARLY TAVR procedure, it was not associated with an excess mortality or stroke.
This is important, and as a matter of fact, we had a numerically lower stroke with early strategy compared to waiting for symptoms, which is very interesting, and we can debate that after. We prevent a clinically meaningful decline in quality of life in clinical surveillance patients, we subsequently convert to AVR, and we improve some measures of LV, left ventricle, and LA, left atrium function. We prevent a decline in quality of life, and we prevent cardiac damage to accumulate, which are all important potentially for long-term mortality. The clinical indication for the cardiologist in me and for the community is giving the benefit observed and the lack of harm. EARLY TAVR may be preferred to clinically, to clinical surveillance in patients with asymptomatic severe AS, especially when combined with the challenges of timely symptom recognition and prompt treatment in a real-world setting.
I think I'm going to stop there.
Thank you, Philippe.
Thanks, everybody for coming today. As Bernard and Philippe have alluded to, this is a huge day in terms of advancing the science and evidence around the treatment of aortic stenosis. A couple of things that I think are really important nuances of the trial that people, I don't know that they've put enough time and attention into. The first thing is the quality of the patients who went in this. If you look at these patients, they all underwent a stress test, or 90% of them, over 90% of them underwent a stress test. So these patients are confirmed to be truly asymptomatic because they were able to pass a stress test. Every one of them, 100% of the patients, were in NYHA Class one.
Their KCCQ scores were 93, and their ejection fractions are 67. So if there was ever a group of patients that should be able to tolerate symptoms or to delay the onset of symptoms, it would be this group. They feel perfect. They're all in NYHA Class one, and they all have healthy ventricles. So when we designed this trial, one of the big things. We only—there's only a couple of things we didn't know. We didn't know how many patients could pass a stress test, and we had no idea the rate of progression to symptoms. Other than that, we knew everything. So we put a two-year endpoint on this trial because we believed in this population, it was going to take a long period of time for people to develop symptoms, and so we expected that we'd maybe see some adverse events that happened.
But in this population, it was remarkable to see how quickly and how unpredictably bad things happened. So this was a slide that wasn't in the main podium just for sake of time, but I think it's incredibly illustrative. If you look at the different curves, these are the reduction in quality of life scores for these patients. So even in patients that crossed over the red line, zero to three months, they had a 15-plus point drop in their KCCQ. Now think about that in the context of device development that we do today. If you make a device and it has a 15% improvement in quality of life, we see that it's a major thing. Joanne said from the podium today that anything greater than 10 points is very significant. So these people are having the inverse of that happening.
They're having this rapid decline, and I think that that's really critical, that this watchful waiting period is not benign, and I will say that, you know, Philippe did a good job of explaining this, but I think the thing that is critically important is this clinical surveillance slide looks terrible. 40% of the people have something very bad happen to them. Now, I know there's going to be naysayers and say, "Yeah, but they eventually got their TAVR, so it was okay and they didn't die," but you have to put this in human context. How many of you get a call in the middle of the night from a sibling that said, "Mom woke up, she couldn't breathe, and we just took her to the ER?" That is a day that you're not going to forget, and that's what's happening to these patients.
So this is not a benign thing. You have patients in this group, in the red group, they're going in NYHA Class three and four. They're having their ejection fraction decline less than 50. They're having very bad things happen to them. It's happening to them very quickly, and it's happening to them very unpredictably. And this is incredibly meaningful as we think about doing these patients. But this is the best clinical surveillance has to offer, and I'll tell you why. The patients to enter into this trial meant they had to have a discussion with a cardiologist and a surgeon. They had to be educated on the aortic stenosis disease. They had to be told that their treatment course would be TAVR, and they went and had a CT so that we knew that they were anatomically suitable for TAVR.
Basically, all of the pre-screening work had been done. So in this trial, when a patient showed up with symptoms or a hospitalization, they were crossed over in an average of 32 days. In the real world, it takes between 150 and 180 days for a patient to go through the entire screening process for TAVR. So you can imagine what would happen if these patients were waiting another five or six months for treatment in this clinical surveillance arm. That's the struggle that we have with trials. These patients are closely monitored, they're well educated, they've already agreed to have the procedure because they had to agree to that for randomization. So they were able to move very, very quickly to care, and we knew they were anatomically suitable. That can never happen in the real world.
And that's one of the things that I think is most powerful about interpreting this data and making sure that we understand how this is going to apply to guideline changes and how it's going to apply to transforming patient care. But this primary endpoint is very powerful. I know people are going to fixate, and they're going to say that, "Well, but you don't show a mortality benefit." And that's because in this trial, patients weren't allowed to progress. They were crossed over within thirty days of them presenting with symptoms. And so it wasn't that bad things happened, but we caught them before they died. I do. I believe, and I can't prove it because the trial wouldn't allow for it because it would have been unethical to do.
If we'd have left those patients for another six months, more bad things would have happened to them. There's no way that that would have just stayed benign. So I think these are just really important things to consider. And the other thing is that the stroke rate, we would have never anticipated the stroke rate would be lower in the treatment arm versus the clinical surveillance arm. What most clinicians say with making the case for watchful waiting is there's two primary things they say. The first thing is there's always a risk of doing an intervention, and so a patient is going to pay a penalty for that intervention. And the second thing is, I'm starting the clock on valve durability, so I don't, you know, I want to wait so I can make that tissue valve last as long as possible. But this just completely destroys that.
It completely destroys it because you have 26% of the patients crossing over at six months, and you have half of them crossing at a year. So this valve durability case doesn't really make any sense, and we show that it's actually more dangerous from a stroke perspective to wait than it is to have your early intervention. So there's absolutely no penalty for having the early intervention, and there's tremendous benefit for having the early intervention, and that's why I think this data set is so powerful. So with that, I think we'll take Q&A.
Perfect. Thanks, everyone. We've got about a half hour, so if you have a question, just raise your hand. We'll make sure to get a mic to you, and if you could just limit it to one question so we can get to as many as possible. Peter, first question?
Hey, thanks, and, congrats on the trial. That was just extraordinary. It's always great to watch, doctors just stand up and cheer. I mean, so, I mean, stepping back, I mean, you know, just looking at sort of the patient pools and both the, you know, the patients that are with the cardiologists doing watch and waiting, also the patients actually with the, you know, the interventionists, cardiologists, kind of, you know, within your pools, kind of size of market kind of does this expand? I mean, that's sort of...
I know it's impossible to sort of to model that, but I mean, you know, as we think about sort of how much this expands sort of, you know, these patient pools, how do you guys think about within your practice, within the doctors you talk to on both those two buckets in terms of the referrals and also kind of within your own patients that are watch and waiting? Kind of how do we see that expand?
Philippe, you want to, to talk about, you know, how you see that in your practice? But I can make some comment about, you know, what we learned in the past, you know, years.
Absolutely, so I think there's three buckets of patients that will come Monday morning to me. The first one is a trial patient, the one with a severe AS, no symptoms, normal EF. Read this in New England and say, "Hey, that's me." I can give a number if you want. Larry will criticize me. Maybe it's not enough, it's too much. I don't know. But let's pretend it's between 20% to 40% growth for those number, okay? The real patient that fit the trial. Okay. Why? Because they live with their referring doctor, and the referring doctor owes to them, and they say, "Oh, you're fine. You don't have symptoms." And he's gonna see the New England like, "Okay, I'm gonna refer now.
I almost have no choice." The second bucket of patients are the ones that have severe AS and have mild symptoms. They are like fatigue, but they say, "You know, it's fatigue. It's like, it's okay, it's age, and blah, blah, blah." This bucket is, it's very hard to put a number on because this, they are probably the ones that are undertreated. You know, they, they make, they are part of the 40%, 50% undertreated patients, because when you query databases, like EGNITE, CardioCare or whatever, they, they're there, and they have class one indication, they are not treated. Why? Because their symptoms are not severe enough. So those Braunwald curves are so important because they're in the yellow zone and they're not treated yet. So this bucket can really explode the volume in your TAVR program.
The third bucket is the patient where AS is hard to diagnose by echo, okay? Echo done in other hospital, 10, 15 minutes is screening. "Oh, it's moderate to severe. Okay, I see you in one year, two years." And then when they come to see me, we take an hour and a half, and we find severe, right? So this trial will show, okay, maybe I don't want to miss severe now. So you're gonna have moderate to severe or moderate that's gonna refer to us to be better stratified. So those three buckets for me will probably flood actually the office in different proportion that we're gonna learn. And I would say the characteristic of EARLY TAVR is it's not only one risk strata. You know, P3, great, but it's only low risk. It's 30% market, whatever the number is.
P2A, intermediate risk only. P1, high risk, extreme risk. This is all risks. This is everyone. This is 65 and above. So I, I think this, this has the potential to, I don't say double, triple, whatever, because I'm not an analyst and I'm not Larry neither, but I would say clinically, I will see an influx of patients, because from database that we query in echo, there's a lot of patients there, and there's a halo effect where we're gonna start to see that's gonna legitimize all the other patients that were not referred, that were not patients typical of the trial. They were like, already having symptoms, fatigue, blah, blah, blah. So the, the growth will be there for sure. And if I have to put a number, I said, that's gonna be minimum, minimum 20-30% at minimum.
That's me trying to be an analyst here, but yeah.
Thank you. Thank you, Philippe. So let me add a couple of things and see if Larry wants to add a couple of things, too. You know, when we look at our learning in the space, what we have seen is, you know, the more we learn, the more the TAVR adoption increased, the more innovation we brought, you know, to the space, the more evidence we brought. We have seen that, you know, the opportunity was getting larger and larger in the last, you know, ten years. There is, you know, in my mind, you know, few things here for sure. Right now with this data, the opportunity is bigger, larger. It is going to take some time.
We are going to see, you know, early adopters, and then, you know, we will have to see the guideline changes, NCD, all these kind of things, you know, takes time. The good thing about taking time is we are going to see, you know, a multitude of opportunities ahead of us, like we had in the last 10 years, and we are projecting over the next, you know, in our future here. So it is a great thing, you know, for patients, it is a great thing for the field, it is a great thing for us as a company. Larry, you want to add anything?
Yeah, just a couple of things. One, one of the things that the trial showed is that one in five patients can't pass a stress test. So one in five patients that is told they're asymptomatic truly are not asymptomatic. And so that, I think, shines a light on this. I think the other thing is the guidelines, as most people interpret them, say annual follow-up is adequate. Well, this, this data completely destroys the idea that you could follow these people annually and adequately make sure that you were, you were finding their symptoms or finding any of those things. And so I think it, it absolutely destroys that. And I think those are gonna be powerful things as we start taking on guidelines and as we start taking on, some of the other challenges in education ahead of us.
Nobody can argue with the slide that shows the red, yellow, breakdown of these patients and the rapid progression to symptoms and bad things happening to these patients. And I think those things are gonna be transformative. I was speaking to physicians today, and they were already saying: This is gonna change the conversation I have with a patient. I can't just send them out of my office and tell them, "I'll see you in a year and you'll be fine.
Thank you, Mark. David Roman from Goldman Sachs. You talked a lot about in the presentation today about the impact of this being a randomized controlled study, so each cohort being very well managed. But maybe you could take us into kind of the real-world setting and help us think about how this impacts workflow in the general cardiologist who spends, what, eight minutes per patient, maybe, as they're going through a visit. So help us think through the patient visit into the general cardiologist to when they show up at a center like yours, for example.
You're right. So the EARLY TAVR was a state of hypervigilance. It was not even clean surveillance, it was hypervigilance. You have the trial every year, follow-up, you have six to 12 months, but the cardiologist, you have a research nurse. They were like watched like hawk, and you know, they're little and puffing, boom, they have the TAVR. So is it reproducible in reality? No, that means the patient will do worse than that. So that this is where the benefit and mortality will show. Typically in practice, so what happened is you see a patient with severe AS, no symptom, and the patient, "Oh, you know, mild AS, no symptoms. See you in one year." There is no stress test. People don't do that, okay? It's like this is 15% penetration in the US.
Second, they don't do a CAT scan to see if TAVR is doable or not, okay? They just say, "We're gonna cross that bridge when we arrive there, when you have symptoms." So then, you lose a lot of patient like that, because within a year, there's people that died. There are people that, like, come to the ER 40% of the time, and then you want to do a CAT scan. You need to do contrast. The kidney are damaged. You can't. They spend longer time in the hospital for the pre-screening. They need teeth removed. They need everything. They need to be ready. Then they get the TAVR, and they stay longer. So the cost-effectiveness of a wait, watchful waiting is terrible for the health system.
So we, of course, we're going to run this analysis, but the strategy of, "Hey, put your ducks in a row. You have moderate AS." Because the game is going to moderate AS, by the way. It's severe AS, it's over. So moderate AS, you need, you need to send a patient. First of all, confirm it's not severe, because half of them are severe, by the way. And then when you confirm it's severe, CAT scan, are you TAVR candidate or no? And okay, now you want to go on a cruise for two weeks, fine, but when you come back, we're going to do this. So we're going to plan with the patient. You are going to have an elective surgery. Your hip need to be changed, elective. You're not going to wait for the fracture.
You're not going to wait for the fall, which is dramatic, which the length of stay is double, triple. So that's what we're going to come to light. So in the real world, this is what we see. The watchful waiting strategy is associated with longer length of stay, dramatic in the hospital. I need to squeeze the patient in. I do ten TAVR on Monday, and now I need to add an eleven one. People are not happy. I'm going to do on Tuesday, and the length of stay is long, and this is why we have more stroke, why we have more infections during the hospitalization. So it's more complex on the healthcare system to wait for symptom. It's better to be reactive. So right now, we're very, very. It's very better to be proactive. Right now, we're very reactive.
It's fine. We're going to cross that bridge when happen, and bad thing happen. The wait is not an option anymore. It's going to be, why you want to wait? The guideline, when you look at this, and we spoke with them a little bit, what is the list of pro for intervention? What is the list of pro for waiting? No one is able to find me one argument, and that's what going to happen. We're going to wait for what? Because I'm scared, but that's fine. But so I think that there's not a lot of pro other than the durability argument, which is completely destroyed by the data, the natural history, that at one year, you have 50% accord, at two years, 70%.
So if you're sixty-five years old, two years is nothing in thirty, over thirty years life expectancy. So I would say that right now it's chaos. The way we do medicine is chaos. You wait for the crash and burn scenario. It's better to land the plane when there's still fuel in the gas tank, and not crash and burn.
Yeah, I'd say just to add to that, the other compelling thing that this demands is a discussion about prioritization of your AS patients. As centers struggle with workflow, and they're like: You know, I have all these different therapies coming in, and I'm trying to figure out who I have to treat first. This is a very compelling story for why you need to treat your AS patients first, why they need to be prioritized, because they don't wait well.
Chris?
Thanks. Chris Pasquale, Nephron. Larry, just to pick up on that point, we've talked a lot about capacity constraints over the last few months. Now we're talking about the TAM potentially expanding. So how do we think about the ability of centers to handle an influx of patients if that materializes?
Yeah. I think it's a great question, and it's one that we're going to be working through, obviously, more in the coming months. I think one of the things that hospitals wonder about when they think about investing or they think about adding capacity is: Am I seeing a bolus of patients, or am I going to see a long-term shift in the number of patients that are coming in for a particular therapy? If I think it's just a bolus, then I might wait before investing or hiring staff or doing those sorts of things. If I know definitively that this is the new normal and this is what's coming ahead of me, I think hospitals are much more likely to invest, and they're much more likely to address that.
But maybe, Philippe, you can talk about how you guys see this at Morristown.
Yes. So when I joined Morristown seven years ago, we were doing one hundred and fifty TAVR. Now we do eight hundred. Okay, we adapted. Now we're probably going to be twelve hundred next year. Why? Well, I called philanthropy in my hospital. I say, "I need two new cath lab." "We're going to do it. We're going to roll our sleeves and work." It's not a matter of can we do it? It's a matter of patients need it. And when the philanthropy of the hospital or the administration understand that, they're happy. They're going to make money. I mean, they're going to have twelve hundred patients that are going to need a CAT scan, and they need echo, they need follow-up, that's going to need...
So for me, it's not even a question: are we capable to absorb the volume? It's going to be. We need to plan now, so I think the year ahead of us will give us okay. Everyone on Monday will have a little talk with the administration, like I did a couple of months ago, so guys, by twenty thirty-five, we're going to have, like, three times the volume. It's time. I don't want to be caught off guard with not enough nurse, not enough cath lab, so we're going to see a transformation of this, and this is why we're going to start to do. Right now in Morristown, for example, we do 800 TAVR. We do probably eight TAVR for two days and 15 days. Well, now we're going to do eight a day. It's a great thing. I'm going to hire a new colleague.
That's fine. And we're going to adapt. So we're not. We're going to roll up our sleeve and work more, which we like to. So I think it's going to be fine. And the growth of TAVR. It's not like we are unaware that TAVR will grow. We quadruple the volume almost in 7 years, or even more. Yeah, we can adapt. But yeah, we're going to have to build cath lab, we're going to have to build staff, we're going to have to do things differently, maybe more efficiently. The good thing is the device, the case now are taking, you know, 20, 30 minutes, go on the next day. So we're gonna, but we're going to adapt. Yeah.
I think, you know, this is a good example about, you know, the Morristown. Morristown example is a good example about what's happening across the nation. You know, all of the TAVR centers have proven to us they can scale. In the last five years, you know, everybody scaled, everybody grew. You know, they were able to diagnose more patients, screen more patients, treat more patients. The workflow we talk about, you know, this year, we are part of a problem. We came in with a new disease for them to treat, tricuspid, a new technology to be trained on, and we provide, you know, extensive training, and we are not the only one. You know, there are more technology out there.
And so all of these centers, you know, they are. What they have to do is they have to grow TAVR, they have to grow mitral, they have to learn tricuspid and create new processes, you know, for tricuspid. And then, you know, grow Watchman and grow, you know, everything else. But there is one thing for sure, like, you know, like Philippe said, they are committed, they are dedicated, they did it. All of these procedures are important. There is a large unmet patient need, and they are profitable, which is important, you know, for the healthcare system. So it is why, you know, we said, you know, it is a transition. It is going not. It is not going to last, you know, a few days, a few weeks. It's not going to last, you know, a few years.
It's a matter of quarters. Thank you.
Thanks, Robbie Marcus, JP Morgan. After such compelling data, how do you think about the speed of adoption? Do you think you'll need a guideline change? Do you think of this as in a couple of months for everybody to get the message, or do you think this will be more of a practice change that takes a longer, multiple years?
I think the beauty of doing high-quality science, like, Edwards do all the time, is, it's in New England. Okay? It's not in JACC, it's not in JAMA, it's in New England, which doctors, general practitioners see and do, and the title is TAVR for Severe Aortic Valve Stenosis Patient. They're going to see that, okay, and then the conclusion, it's superior. Okay? EARLY TAVR is superior to waiting. So first look, abstract conclusion. Okay, I send my patient. So you're going to have people that are going to send right away when they read the journal. Does everyone read the journal? No, but, you know, we can educate them. So I think that the fact that it's in New England helps a lot because it's like a seal of approval. If the New England say it, this is medicine. New England change medicine.
They publish papers that change medicine. They don't publish, you know, rubbish. So this is a good study. So that's what has its effect. After that, you know, it's going to be hard to hold on this patient because patient will read this and they say, well, I'm fatigued. And so I think the adoption will be before the guideline, before CMS. Why? Because they refer to us, I'm going to do an echo, I'm going to do biomarkers. So the data I'm going to treat, you know, when people... And then you're going to plan and, you know, sometimes if you question the patient, are you sure you don't have, you're not fatigue? Oh, yeah, yeah, I slowed down lately. Okay, symptoms. So I think the concept of symptoms all of a sudden would be very flexible in light of those data.
So it's going to be the opposite, you know? It's like, yeah, you can treat. We have no symptoms. So, oh, yeah, I'm fatigued. And so I think you're going to see an adoption before all those great things. And the reality, documentation of symptom is very hard. It's subjective. It's not like it's an objective metric that you can do with a blood test. It's a very subjective patient-doctor relationship, and now you ask the question. So I think the adoption might be, you know, big boulders and also a drip through time also. So, yeah.
I think part of our job is to amplify and educate. That's just going to be part of our job to make sure that the data gets disseminated. We'll work with the societies closely and, you know, try to accelerate that process as much as possible.
Let me add, you know, something. It is always, you know, difficult to predict, you know, what, what's going to happen despite, you know, the meaningful, science, out there. But, you know, if you look at, you know, low risk, you know, what happens at low risk? We have seen, like, you know, leaders, early adopter, the physician, you know, making a early decision. And then, so we have seen, you know, some kind of pick up, you know, right, you know, after, you know, the presentation and publication. And then when we got, you know, the indication, an inflection point. So is it going to be a good leading indicator or what is going to happen here or not? We don't know, but this is what happened in the past. Physician can make, you know, this kind of decision.
Matt?
Matt Miksic, Barclays. So, congrats on the results and the study and all the hard work that went into it. Couple questions. Obviously, it's a big deal for market expansion and for patients, but thinking about maybe the way in which TAVR and SAVR surgical valves have been kind of contemplated by the centers, by patients, by doctors, you know, conversations with patients, and also thinking about the competitive landscape. If you could maybe describe how perhaps having conversations before a patient is on label for a surgical valve might change utilization, adoption, penetration, and how this kind of, you know, will cross over, impact, benefit or not, Medtronic and Evolut. Thanks.
I mean, I'll maybe start. I think Philippe can weigh in, but convincing a patient to have a TAVR when their KCCQ score is 93 and they feel fine, you know, we were able to do it, but it was a slow enrolling trial, and it wasn't super easy to do. I think convincing that same patient to have surgery is gonna be monumentally more difficult. And as it relates to the competitive side of it, the curves on you know the yellow and red curve, that is the disease progression of aortic stenosis. That's not a class effect, it's not device-specific. It's just this is the disease, and this is how quickly it manifests itself in patients. The primary endpoint, that is device-specific.
We know SAPIEN 3, and you saw it in all the trials that you saw today. It delivered incredibly low rates of complications, incredibly low rates of stroke, incredibly low rates of pacemakers and all those other sorts of things. If you were going to use a device that didn't deliver on all those outcomes that our platform does, then you wouldn't necessarily see the same results. So you can't just apply the primary endpoint analysis to every other competitive device because, you know, we're the only platform that's demonstrated 99% of our patients are alive and well at a year in PARTNER 3, and, you know, that 90% of our patients were alive at a year with the outcomes that we have. So I think, you know, the disease is what it is, but, you know, the device matters.
Travis Steed, Bank of America. Curious if timing on when you submitted to the FDA, when you expect the label indication, CMS, NCD, assuming you don't DRG with that, and I didn't know if you had any thoughts on the TAVR UNLOAD data for moderate that came out, even though this was supposed to be an EARLY TAVR event.
Do you want to take this, Larry?
Sure. So as it relates to, you know, we've already had preliminary discussions with FDA. FDA is aware of the data, so we'll be working through the label expansion process. I don't have any timing to provide on that. I think we'll provide an update on that at the investor conference, and we can be a lot more specific then. You know, it's... You got to remember, the data was just presented a matter of hours ago, so, you know, and we haven't been able to share this data broadly with anyone because it was embargoed through the New England Journal process. So we'll get started on that.
In terms of the National Coverage Determination, I think this is a moment in time to look at that and to start thinking about how we update that. But you know, it's important to remember, like, as we get the label indication, and we do all of that work, you know, right now, surgery doesn't have a National Coverage Determination. Everything's covered under local coverage, and that's how it gets paid for. And I think, you know, it'd be hard to argue that this procedure isn't medically necessary. Now, the advantage of having an NCD is it just standardizes it for the whole country and ensures everybody gets equal access, and it's not subject to local contractor discretion.
But we think there's a compelling case for why this therapy is important for patients.
Maybe last question from Larry Biegelsen.
Thanks a lot. Thanks for fitting me in, and congrats on the data. You know, Robbie asked about kind of the pace of adoption. I want to try to push you a little bit more on maybe quantification. How much? You know, we can look at 2019, you know, when you came out with low risk. The, you can see from the stock reaction today, the market's a little skeptical. You know, how... If you think about where is the low risk analog, you know, how stimulative do you think this will be? What, you know, how much of an acceleration, and how do you address some of the pushback, like, one you alluded to, it's an asymptomatic patient, hard to convince that patient to have a procedure. And second, the pull forward, you know, that, you know, you're just pulling patients forward.
So I know you're not going to give us numbers, but-
Yeah.
Directionally, how stimulative do you think this could be to the TAVR market? Thanks.
Yeah, I mean, there's, there's differences between the low risk and, and this from the perspective that a lot of those patients that immediately got treated were patients that were being screened for surgery and then got flipped to TAVR. So it wasn't, you know. So it does, it is going to take time for patients to work their way through the system. I think the, the patient conversation is totally different in light of this data. I mean, if you sit with a patient and they say they feel fine, I mean, a lot of patients with, with 90% blockage in their coronary feel fine, but nobody sits there and lets them go home with a 90% blockage in their coronary because they tell them they have a ticking time bomb and bad things are going to happen to them.
I think in light of the EARLY TAVR data, we now have the ability to sit here and say, "You know, you may not die tomorrow, but, you know, you could be rehospitalized. You could have this deterioration in your quality of life, and those things can happen rapidly and unpredictably. And you can have episodes of syncope. You can have episodes where you're hospitalized or even sudden arrest." All of those things are things that can happen. The problem with the Braunwald curve is it said there is no penalty in waiting. It's a benign disease until you have onset of symptoms, and this just completely destroys 60 years of dogma. I think that's just going to change every conversation that physicians have once they're educated and once they're up to speed on the data. Some of that stuff's going to take some time, for sure.
I mean, you know, it does take time to change guidelines, but I don't think anybody can argue with the power of the data set that that's been produced.
So yeah, one thing I will add to this, the more I think about the question about the daily clinic. Practicality will win, so it's like a device, ease of use always wins, okay? You never use a complex device, you use the easiest one to use. This strategy is practical. It's easy to use. You have severe AS, you refer. If you're a busy clinician, you want to see 40, 50 patients a day, and you have severe AS coming with no symptoms, that's going to take three minutes. I'm going to refer you to an expert. I'm not going to dance around the stress tests, explain pros and cons. You can refer. So that, I think that's what's going to happen in the mind, like, severe AS, refer.
Instead of dancing around, it's going to be practical, and then we can go to moderate. But that's the practicality of just get the CAT scan, get referred, and treated.
We believe, you know, this one will have a big impact on the opportunity. What we are going to give you in a few weeks from now in New York at the investor conference, a deep dive about, you know, how do we think about that, you know. Again, you know, today was, you know, the first day about us, you know, releasing the data. All of this data were embargoed, so even our team, we didn't have access, you know, many other people didn't have access to this data. So between now and investor conference, we are going to work on that, and you will see, you know, our take on, you know, this market. But again, remember, you know, what we are going to tell you is what we think.
And again, you know, we are going to learn a lot in the next, you know, few years about, you know, patients with no symptoms. And I bet, you know, the opportunity that, you know, we are going to tell you in December is going to be bigger next year and bigger in the year after. So again, you know, let's be ready for that. So let me, you know, close, you know, this meeting. You know, as I said in my opening, you know, I believe it is a big day, a big day for patients, big day for physicians and the clinical community. You know, big day, big day for the company. You know, TAVR is a very important, you know, franchise, you know, for Edwards. And today, you know, what we brought here is a different way of thinking.
We brought, you know, evidence to think about, you know, disease management. It is truly a data, you know, to further unlock, you know, this potential ahead of us. You know, this kind of excellent, you know, high-quality clinical research cannot happen, you know, without, you know, the partnership with a physician, with the clinical community, and with leaders like Dr. Philippe Genereux. Philippe, you know, thank you so much for being with us. Thank you so much for having led us, you know, through this amazing trial, and I know you have much more to come. Thank you so much. Thank you, everyone.