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Investor Day 2018 Part 1

Dec 5, 2018

Speaker 1

Hi, everybody. Thanks for being here. Sorry about

Speaker 2

the glitch here. We have a little video show. We could show it later. But first of all, we're really appreciative to have you all here. We thought we'd share something that we a journey that we've been on.

Typically at Ruth Life Sciences, we get very focused on those patients who are treating the critically ill or those people going through a big procedure. We try and be expert to make sure that these patients have a wonderful experience during that hour or 2 where we're really involved. Over time, we've gotten quite an education. We've always learned in the past from the physicians and their impression is that all the patients that need the procedures show up at their office door and that they get treated. And more time has gone on, we've come to understand that many of these patients indeed never come to the office store of the treater.

And we've been on a journey to learn more about that. And we're going to invest a little bit of time with you to share part of our journey. And so we've asked Don Bobo to assemble a team of some experts and share our journey with you. Don, welcome to the stage. Thanks.

Speaker 1

Thanks, Mike. So welcome, everybody. And let me go ahead and start by asking Doctor. Matt Brennan and Matti Petrescu to come join me on stage. And I'll take a few minutes and try to frame the journey we've been on the past year, understanding what patients really experience and encounter as they're on a journey to being diagnosed with aortic stenosis.

And I'll try to keep mine moving and then Doctor. Brennan will talk about a number of the learnings that we had from this work. And then Doctor. Petrescu, who is the Head of the ECHO Lab at Swedish in Seattle, will actually talk about one of our initiatives to try to improve the quality and close treatment gaps around ECHO. So, with that, let's go ahead and see if the slides work.

Yes. So this is an oversimplified attempt to express the process that patients go through when they get diagnosed with severe aortic stenosis. There is typically an echo exam that's done where they have to measure parameters. You see behind me 3 columns that get filled out. And depending on how severe the jet velocity is or the gradient determines whether the physician goes to the next step and that is attempts to evaluate symptoms.

And it's the combination of signs and symptoms that actually drive the diagnosis of aortic stenosis. So we actually had a chance in the last year to get a very large cohort of data. This is a group of 80,000,000 patients that have been collected and the data curated over the last 10 years. And from this, we said, look, what if we could take the EHR data, which is comprehensive, physician notes, tests, ECHO results, and the claims data and actually create a cohort of patients where we have all of the information on their journey over 3 years through a diagnosis of aortic stenosis. Wonder what we could learn, wonder how that understanding would change our view of this disease.

So, we ended up with a longitudinal time series march of these patients across time and we were able to understand insights by provider, by system, by who connected the signs and symptoms and what ultimately happened to these patients. And so, let me spend a brief moment taking you on this journey. So, at the very beginning, this is a group of patients 2 years before the cohort that were treated were treated. And you had some of these that had information in the health record that said they were moderate AS. You had some where there was information saying that they were severe AS and you had some that were undiagnosed.

There was no particular mention of ECHO findings or symptoms. So, this is the starting point on this journey for these patients. And as we go through this, this is going to reflect largely a group of patients that get diagnosed. So, as we're able to play through this 3 year tape, at some point, you reach a stage where there are signs and symptoms that align up with the guideline classification for severe aortic stenosis. And at this particular point in time, a majority are being seen by a general cardiologist, a minority are being seen by a PCP.

Now, it's important to understand that we were able to connect signs and symptoms. It doesn't mean that the physician actually caught this guideline diagnosis. At some point, a significant minority got sent to a treater and you can see the PCP actually picked up some of these patients and sent them into a general cardiologist. And the red group went to a treater, the gray group un referred. The next step in the March is a group of these were treated.

And in this particular illustration, you see for the first time the emergence of mortality as these patients were or weren't sent through the PCP or general cardiologist to a treater. And if you look at this group a year after the cohort that were treated, you had about a third that were treated, you had about a third that died and you had the rest that were left untreated. They are in the system. There are clear signs and symptoms. So this understanding really drove a couple of learnings for us.

First of all, if I were to take it back in other conferences where we talked and when Larry talks about his business, we used to say half these patients are asymptomatic. In this particular data set, they're almost all symptomatic. Physicians may not catch that, but there are clear signs and symptoms that say this is guideline disease, it's not about symptoms. The other thing we realized is as we looked across the stakeholders, patients, physicians or systems, there are barriers to diagnosis and referrals across every stakeholder. Patients often don't understand the symptoms.

They don't appreciate the burden of the disease. They don't understand the mortality risk that they face. Physicians oftentimes can't connect signs and symptoms over time. They're busy. Oftentimes these symptoms get conflated with old age.

And then systems where we do echos and there are referrals, a lot of learnings around what goes on when a patient encounters a system. So, we are tonight, we will have the opportunity to have Doctor. Brennan bring to life some of the learnings around physicians and patients and then Doctor. Petreski will talk specifically about an initiative we have. The other learning we experienced is if I take you back over a couple of 3 years, we would look at the 1,200,000 aortic stenosis patients and say probably 18% to 20% are being treated.

This is a prevalence. As we take our self read this data set, it's probably 1 in 10. So, the magnitude of under treatment ended up being bigger than we thought. And while highly effective treatments are essential, we say there's probably more we should be doing. So there is a systematic approach that we're looking at to actually increase disease and therapy awareness to try to get at some of these treatment gaps and barriers.

One of the initiatives that some of you may have had a chance to see back around the corner is a service partnership with centers to actually get into the Echolab and significantly improve the way echos are collected and the feedback the echo labs are able to respond to in referral. And Doctor. Petrowski will take you through that, but here is a little bit of a teaser. On my left, there is a chart that think of every column as 100 patients and where there is gray, the 3 important echo variables were measured. Where it's white, patients went for an echo and those parameters were never measured.

So, when Echolabs respond to this or saying, look, at least if a patient goes for an echo, we should measure it. Systems that have implemented CardioCare have seen this kind of improvement in the quality of the echo that's being collected. So, while this journey and these learnings, there's no one silver bullet, we really look at this and say a broad effort going at disease awareness with patients and providers, therapy awareness with physicians and some targeted program like CardioCare are going to be an important part of the growth of this particular therapy segment. So with that as a setup, let me go ahead and invite Doctor. Matt Brennan.

He is a physician at Duke. He has been partnering with us on this work over the last year or 2 to come and bring to life some of the additional learnings we had as we did this work. Matt?

Speaker 2

Thanks, Don. Appreciate it. So Don and his team have asked me to share with you a little bit about the journey of an AS patient, so that you can understand from our perspective what we see as clinicians. I'm an interventional cardiologist. I work at Duke.

I've been on faculty for the past, I guess, 8 years now in my training at Duke as well. And we're on a clinic that's basically valvular and coronary heart disease. So this is what I deal with all day long. And so I'm going to try and help you to understand the journey of the patient. And hopefully, if I do my job at the end of this talk, you're going to be able to look and understand what are those deficiencies in our care and where is it that we're losing patients.

And you'll understand the scope of the problems, but you can reflect back to the numbers that Don has given you and try and understand why this drives us to do better and where the areas for improvement lie. So I'm going to start with a very deeply personal story. I'm going to call this patient Mr. G. He was a patient of mine for a couple of years and became a good friend.

He and his wife came to every appointment together, a terrific, terrific guy. 52 years old when I met him, he was a debilitated carpenter. He had had a fall at work and had fractured his back and had significant leg weakness and pain, which he dealt with absolute grace. He also happened to have a bicuspid aortic valve. And when I met him, his aortic valve gradient was over 60, which Don just told you, over 40 is severe.

So, over 60 is quite severe. But despite that, his ejection fraction was normal. He was completely asymptomatic, although arguably he couldn't get out and run a marathon. So, could you really assess that? So, we engaged on a program of checking his, what's called the ProBNP, it's a marker of cardiac strain every 6 months to evaluate whether or not his ventricle was feeling the effects.

And we were going to use that in his symptoms in addition to kind of check his symptoms to tell when he needed to go for a valve. But something came up. Don's leg weakness or excuse me, Mr. G's leg weakness progressed and the pain progressed and he came in the clinic and he needed a back surgery. His back surgeon was pretty insistent on it.

He was pretty insistent that he couldn't go on. And more we talked about the possibilities. Mr. G could have gone for a surgery first at the time. TAVR was not an option for him.

He was 2. He was not high enough risk by the standards at the time. And so we talked it through and reluctantly I gave him clearance for a surgery after talking to him about the devastating hemodynamic collapse that he could experience with his induction to the surgery, etcetera. Remarkably, he went through his back surgery, had no problems. He flew through it, was observed overnight, In the morning, it was looking terrific.

He and his wife went home. He collapsed and died that afternoon. His wife called me to tell me, thanks for the care that I had provided. She said her husband would have wanted her to do that and wanted me to know how much they appreciated the opportunity to get through the surgery, so on and so forth. And I don't tell you about his case, because I enjoy sharing the ghosts.

We all have ghosts that come with us in our care as clinicians, but it's not because I want to burden you with that, but more because I want you to understand that this is a very fickle disease. It's a disease that can turn on a coin and we have to be prepared to meet that challenge. These can be some of the most difficult patients in our practice as cardiologists. They tend to be older patients. They tend to be more comorbid.

I'll give you another example. This is a common scenario, but this gentleman I met, we'll call him Mr. W, met in the ICU, the intensive care unit. I was a consultant. He was in cardiogenic shock.

He was, by all means, on death's door bed. He was still conversant, late 60s, early 70s. And the team the ICU team called me in to see was there anything else that we could offer and why in the world was his ventricle so sick, His heart, why was it not squeezing the way that it was supposed to? And so I went back and looked at the echo and in fact it had been interpreted incorrectly. He appeared to have what's called low flow, low gradient aortic valve stenosis.

I suggested that he needed an aortic valve replacement. I found a surgeon, a younger surgeon who was willing to take on his care. The surgery was rocky, but he got through it and his ventricle flew. When you relieve this obstruction, people love it. He now comes in annually.

I see him, his ventricles back to completely normal, having a great life, sees his grandkids, a much more uplifting story. On a different day, with a different consultant, with a different surgeon, this patient may get a different treatment. This is one of many stories that all of us carry around and hopefully it helps you to understand why this disease process in our country is so undertreated. Although we've been improving over time, if you look in the right set of figures here, pre TAV or early TAV or contemporary practice, our treatment rates and now these are for diagnosed patients, so objectively diagnosed patients. Our treatment rates are increasing, but we still need 65% of patients by the OPTIM data set and I think this is probably true based on practice untreated.

And that's a problem. It's part of partly built because of historic paradigms. We've come up, all of us, and the systems were built in an era where many of our patients couldn't be treated because surgery, open surgery was the only possibility. And so outdated systems, outdated ways of thinking have led to this place where a lot of patients are no longer being treated, but this can be fixed. This is a problem that can be fixed and it needs to be fixed for our patients' good.

We know that when patients with severe symptomatic aorticulphinosis are treated, their survival improves, their quality of life improves and it really doesn't matter who they are. African American, women, older patients, doesn't matter who they are. Their symptoms will improve, again, data from the Optum dataset, but it's been replicated before. So we know that we've got a treatment that works. We know that we have a problem.

Why not just fix the system, right? So to understand this problem, why are patients being undertreated, you really have to understand the road that they these patients follow, the appropriate road to get to treatment because this is not a disease process where you want to take the road less traveled. That's not here, right? So I'm going to ask you for a second, imagine a patient, this patient has calcific degenerative aortic valve disease and that'll take you back in time. And this patient's 40s, 50s, no signs of any problems.

They've gotten normal physical exams all the way along and suddenly their valve starts to harden. Ideally, the primary care physician puts a stethoscope on the patient's chest and says appropriately, look, you've hardening of your valve, I'm going to send you for an echocardiogram. That patient goes for an echocardiogram. They get their diagnosis. They're referred to a cardiologist.

The cardiologist then follows them as that disease progresses and eventually they become symptomatic. The patient's immediately referred for treatment and within a span of a couple of weeks, the patient gets treated. They go on with the rest of their life. No problems. The problem is this road has hazards, the murmur is missed, the echo is misinterpreted, the symptoms are misappropriated to COPD or the symptoms are misappropriated to COPD or something else, the referral is delayed, the patient is misinformed about what's going on, ultimately the treatment is delayed and lives are lost.

Clearing these hazards out of the way though will save lives and that's what we're about here. That's what we're trying to do with these initiatives. So although 80% of the U. S. Population has annual contact with the medical system, if you look in the right hand panel, very few of our providers are actually equipped with the skills that it takes to diagnose aortic thalastenosis.

If you look the second line over a set of bars over, you'll see aortic thalastenosis, diagnostic accuracy of a graduating medical resident less than 10%. This was a study that was done in 1997 published in JAMA. This has been reproduced on multiple fronts. Those of us who practice probably a little bit better than this, but I think this gives you a sense of the scope. 80% of patients will see their doc within a year every year.

But just because you see a doc doesn't mean that that doc knows what they're listening for when they pull out that stethoscope. And this shows you the problem here. Patients missing their visits, they have an opportunity, the doc puts the stethoscope on, but under treated patients, you need to understand that we were all raised in a system that said that aortic valve stenosis was an indolent disease. So, like prostate cancer, for example, you have aortic sclerosis or you have mild aortic valve disease, sir or ma'am, you will probably never have to deal with this in your life. That's what we were all taught.

So that's far from the truth. The truth is that 7 years from an aortic sclerosis diagnosis, most patients will develop severe aortic stenosis. 4 years from a mild to moderate diagnosis, they'll have severe aortic valve stenosis. That brings up a problem when you have people who are used to sitting back and saying, hey, this is not a problem. And I would say that it's actually a bigger deal in my mind that patients bigger than that patients are not getting echoes is that patients are getting those echoes.

The provider is getting a note back says, hey, you've got mild, your patient has mild disease. Now that patient and the provider sit back and they say, oh, this is no big deal, I don't have to think about it again until a patient shows up like that Mr. W who is in the intensive care unit on desk bed, that's his initial incident heart failure episode. And we're just looking back to his chart and 5 years earlier, he got a diagnosis of mild aortic thalastinosis. That's a major problem, but it's one, again, that's correctable.

So, let's say that your doc does the right thing, that you're diagnosed appropriately, that you get referred on to a cardiologist. These again are data from the Optum dataset that hopefully show you that it depends your likelihood of actually getting treatment. You go to a cardiologist, right, you're going to get standard care across the board, right? That's what we offer. Except not really.

So it depends on which cardiologist you go see as to whether or not you actually get treated. There's an over 200% chance of a different treatment. You'll get valve replacement or not, depending on which cardiologist you go to in the United States. Right? Randomly, somebody picks up the phone, picks up a consultation, 200% difference between whether or not you're treated, and that makes the difference.

The bottom third of referring providers will have a 23% increase in the risk of death for their patients. It makes a huge difference. This is a problem that can be fixed. And unfortunately, in our society, this does not impact everyone the same, right? So, the first sign of this, you look at the U.

S. Census, minority patients minorities, individuals are over 20% of people in this country, right? But they're 5% to 10% of the treated people, patients in this country. So 20% of the population, 5% to 10% of those treated. We looked in the ASM database to see was this did we see the same problem there?

And the answer is yes. African Americans, grossly undertreated in this country, women, grossly undertreated in this country and the elderly. This is a problem that affects a large group of patients. And thinking of it as opportunities, this is an opportunity for us to reach out to a population and really make a difference. This is something that lives that can be saved by just correcting a few of our biases, intrinsic biases.

So, let's say that this patient then the right thing happens, this patient gets referred on for treatment, is that patient going to get treated? Well, the first thing to know is that delays are inevitable, right? In our system, these are data from Northwestern, prominent medical system, right? Data that Chris Malaesry presented in 2014, 1 in 4 patients waited 5 weeks from their referral to treatment until they actually got the treatment, 5 weeks, 1 in 4. That 5 week wait corresponds with an 8% increased mortality rate for those patients.

It matters when you get treated as well. And finally, 17% of patients who get referred for treatment, 17% who get referred, they show up at the office to get their treatment, don't get treated. And why? 1 in 3 of those patients who don't get treated will elect not to be treated themselves. Why in the world would you elect for that?

It's essentially a day procedure now. It's a couple of day procedure. You're out of the hospital with the TAVR procedure within a couple of days. Why in the world would you take on that risk of mortality, the quality of life hit? The same one in 3 say that they're uncertain about the choice that they've made.

Well, why? If you look at the other characteristics, if you really dig into these patients, what they tell you is that they weren't adequately prepared for the decision. They just weren't educated. This is education. Education is easy.

We can do this. We can do that. That's easy. So, can we move the needle? The answer is yes.

We're already moving the needle. So the question is, do any of you think that 30% treatment rates are adequate movement of that needle? I think I would certainly, as a doc, say the answer is no. We're leaving 65% of people with a deadly disease untreated. We can move this needle way farther along and we have to for our patient's good.

It's with the advent of TAVR, the bottom lines, if you look here, so you've got 2 sets of lines. You have pre TAVR and post TAVR. With the advent of TAVR, what you see is that in the elderly, we've made great strides. We've made great strides. Those are the bottom lines here.

We moved from a place where the patients over 80 were grossly untreated to a place where they're just kind of untreated. They're still quite untreated though. We still have room to go in women. We still have room to go in racial minorities as well. This is an area where we can make strides and it's an area where we need to.

Education is key for our providers. Education is key for our patients and this community of patients. But it's also key that we put in place systems that keep up with the technology and systems that will recognize patients, diagnose them appropriately and refer them quickly to therapy. Doctor. Petrescu is going to tell you a little bit about one of those systems, CardioCare and the implementation at her facility and help you to understand one of the attempts and the success model that it brings of trying to get these patients treated.

But hopefully, I've left you with an understanding of what the problem is here, right? We have patients who are being under diagnosed. We have patients who are being undertreated. These are not high hurdles. We're at 35% treatment rates and these are the folks who are diagnosed.

About all the people who the PCP that wasn't one of those 9%, 10% and knew what they were listening for, they missed it or the echo was missed or the symptoms were chalked up to smoking. There's a huge group of patients here who are untreated. And our goal over the next several years, part of my career is going to be dedicated to trying to reach those patients and get them in so that we can get them treated, we can save their lives. Thank you for your time.

Speaker 3

Okay. So that was really great. It was really great to see your presentations. And it's really an honor for me to be here with all of you guys and to share with you guys my story of a cardiologist and to take you on a journey into the heart of what happens in the Ecolab and what happens when we take care of our patients And how does all that relate to all the data that you've seen tonight, to the population health data, to patient outcomes, to quality standards and things like that? So a little bit about me.

So I've been a cardiologist at Swedish Medical Center in Seattle for more than 10 years. Swedish is one of the large it's part of the Providence system that includes about 50 hospitals. It's a center of excellence, it's a coronary center. We it's a really great place to work at lots of great state of the art programs and it's a very collaborative environment. I personally wear a lot of hats that I do, but amongst my roles, the one that I am most meaningful to me is my role as the Director of the Ecolab.

And this is something I'm very passionate about. And I'm happy to say that at this point in time, we have a state of the art Echolab. And we have a great team, a phenomenal team, and that we really are aligned in our values of excellence and quality. And we're always trying to raise the bar on quality because we know that quality, best quality translates to best patient outcomes. And we're going to talk about that.

But I want to take you on a journey a little bit first on what is that Echolab experience like. And when the patient is coming in, as you saw, and have patient experience and a patient journey, what does it look like? And give you a little bit of insight. So when the patient is coming in and getting evaluated, getting diagnosed and then getting to the proper therapy, there's a process and the very first thing that happens to these patients, they have to get an echo, right? The echo is the very first thing that needs to happen.

So echo is done. And from the echo, there's all this information that is being used to diagnose to make a diagnosis of what is the pathology, structural pathology for that patient and what is the severity. And to be honest, as a cardiologist and as a part of the Echolab, I have to say that echo is a lot of times taken for granted. Oh, it's an echo. Everybody focuses on the procedures and things like that.

But really, the ECHO is a cornerstone of what's going to happen to these patients because the information, the data that we use from the ECHO is going to determine is this patient going to have a surgery or not? Is this patient going to receive a transcatheter procedure or not? Or the disease is the disease advanced that it needs therapy or not? So we're making critical patient life decisions based on the echo, right? So it only makes sense that we expect that the information from this ECHO, we expect that it should be of the highest possible quality and accuracy, consistent, reliable, because we're dealing with patient life.

So we're making decisions based on this ECHO data, right? And in the ideal world, we would like to believe that, yes, all ECHOs are going to have this high quality and accuracy. But in the real world, unfortunately, that's not always the case. In the real world, there are actually a variation of quality that can exist at multiple levels in the process that can actually significantly impact the accuracy of the echo and hence potentially impact misdiagnosis or under diagnosis. And you already saw what happens when we under diagnose.

We could be missing patients, basically dying as a result of that. So let me take you on a journey of how that would actually happen for a patient, right? So when the patient comes in to get evaluated and they get an echo, there's a stenographer that comes in to perform the echo. So the stenographer comes in and gets a series of images and performs measurements, which are then used to come up with a diagnosis. Well, each stenographer is supposed to follow a specific echo protocol, right?

So the echo protocol basically has all the requirements of what they have to measure. So the echo protocol is the first variant that determines the quality of that echo, because not all echo protocols are created equal. Some echo protocols are going to be very thorough and complete and standardized, whereas other echo protocols are going to be more minimal, basic and even lacking. So it's going to vary from one institution to the other. They're not all created equal.

The ones that are comprehensive are going to be better in diagnosis. The ones that are lacking could potentially miss things. So that's the first variant. 2nd variant is at the level of the stenographer. So, stenographers are not all going to be the same.

There are some stenographers that are going to put a lot of effort and really do a great job on the imaging, making sure that they're getting accurate measurements, making sure that they're always following the protocol as they're required to do. And then there are some ethnographers that may not always be following compliance to the protocol. They may not always be trying as hard and so forth. That's the second variation that can impact the quality and hence the accuracy of that echo. And the third is at the level of the interpreting cardiologist.

So once the sonographer has done their share, then it goes to the cardiologist. So like Matt and I, and then we get the echo and then it is the cardiologist's responsibility to review all the data, to settle any discrepancies in the data and then to come up with a final diagnosis, right? But there's a variation to the cardiologist. There's some there's a variation to the experience, the expertise, some are board certified in echo and others aren't. So that can also impact this.

So these are some of the things that are going on that a lot of times there's not as much awareness. And I can share with you a story that really drives home this important point of quality of the echos and how that can impact patient lives. So we had a we were talking about this not too long ago in our conference, 40 year old male, no prior medical history, developed sudden onset of dyspnea and presents to an outside institution, not Swedish. When he arrives there, he's found to be in congestive heart failure, so he gets an echo. The echo that is done at that institution reports mild mitral regurgitation and normal ejection fracture.

So nothing really in the way of the heart. In the meantime, the patient continues to develop progressive heart failure now within cardiogenic shock on multiple pressers. So within 2 days of that presentation, the sensor is Swedish to us to see if we can help the patient out. Upon arrival to the ICU, there is an echo that we get right away, which discovers the presence of a flail mitral leaflet related to a portal rupture with torrential wide open MR, but it was an eccentric jet. So sometimes you have these irregular mitral regurgitation jets and it was clearly there and it was severe and that was a cause for the patient's presentation.

So the patient goes on to get surgery while in cardiogenic shock. And we know whether when patients have cardiogenic shock, that's going to impact the outcome. It's not going to be as favorable, right? So the patient thankfully made it, but barely made it. So we said, okay, let's take both of these echo side by side in our meeting.

So we took a look at the echo side by side, the one at Swedish and the one 2 days at the outside facility. And sure enough, it was there, the pathology, but it was missed. It was completely missed. And why is that? Well, we figured out that number 1, the protocol at their facility was quite, let's just say, limited.

So it was not as comprehensive. That was the first thing. Second thing, the sonographer performance also was a bit suboptimal. Sonographers have a responsibility to really chase the jets when they're eccentric. And well, the quality of that was not as good.

And also the interpreting cardiologist missed the diagnosis that was there. So the problem is that all three quality checks were missed, right? So this really shows you, really illustrates how clearly patients' lives are dependent upon the quality standards of these ECCO studies. And so it's stories like these that motivates our team at Swedish to really, really always raise the bar on quality, not settle for anything lower than that, because we're talking about patients' lives here linked to quality. This is a big deal we're talking about.

And so that's where we're at. And I can share with you that although we have a state of the art ECHO program now, it always wasn't always the case. When I arrived many years back, it was actually kind of a ghost town. There was not much in the way of leadership there. There was not the protocols were quite minimal.

There was not much quantitative assessment. And it took days or even weeks to get an Echolad, believe it or not. And there was only one person who was Echol board certified and that was myself. And that's how the status was. And by the way, that is quite typical of many other institutions across the country.

So when I got there and when I saw that, I was like, oh my goodness, we have lots to do here. And so I really was motivated to get the quality standards and to get everything working. But I have to say, it was not easy. I met a lot of resistance. I was not popular because I was trying to get people to do more and work more, the sonographers and the cardiologists.

And nobody likes to work more. I mean, get out of the comfort zone. So anyway, the bottom line is over the years, I realized that what worked, what got us there was I had to get a good team. I couldn't do it alone. So I got a good team of myself and the we had a great team leader for the non invasive lab and we also got role models.

So we got lead sonographers to serve as role models. So that was really important, getting to the team. The second thing was that it was hard to get people to just do things, because people human nature, why would you want to do more? So it was really we realized more about inspiring and motivating them so that they want to do more by helping them to realize that what they are doing, they're not doing it for me, but they're doing it to actually because they're part of a team and they're impacting patients' lives. So that's kind of how we got there.

And you can see why quality is so important to us. So when we heard about CardioCare, we saw the opportunity because we saw that it allowed us to have visibility of our equity data and how this transparency would be very, very important in uncovering what it is that we need to work on. And so this is something that we were very excited about and a lot of but some people were a little objecting to that, like, well, why do you need to do anything because your lab is doing so great. And the answer to that is, well, how do you know how what you how do you know what you don't know until you know? I mean, how do you know until you actually look and have this visibility?

Because when we talk about quality, quality is not something that we have achieved at the ceiling and then we're done and we can all go home. Quality is something that we can always, always improve upon. It's a dynamic and evolving process that we can always work and improve upon. So I'm going to show you guys some of the data that we've got with partnering with CardioCare and when we sat down and we uncovered some really incredible insights by looking at our data. So the first insight would be, we realized how important it is to standardize sonographer performance.

And you've seen the heat map. So we're looking here at Ecolab protocol compliance, which means how good were the sonographers at being compliant to the protocol, which requires that all three of these measurements are made. As you can see at the top, I don't know if there's a very no. Okay. Well, there are specific measurements that you see at the top, velocity, mean pressure gradient and ABA that are required to be assessed in each and every single echo.

And if you are getting those measurements and you're compliant and if you're not, if there's any white spaces anywhere, that means there's not their compliance is not there. So you can see we're 91% compliant. And remember the heat discussed, but to clarify each column is 100 patients and then each bar over there represents 1 echo, 1 patient. And if you have a white space, it means that the measurement wasn't done. If it's gray, it means that it's no it's a normal or mild.

Orange means moderate severity and red means severe, okay? So we looked at our data, we said, wow, we're 91. So first thing we said is, hey, we're pretty good because if you look at other places around the country, that number is like in the 40. So we said, okay, relatively speaking, we're doing pretty good. But then we said, wow, there's like a lot of spaces, what space is there?

So our eyes were drawn to the white spaces because those white spaces what it represents is that those patients did not have the opportunity to have a comprehensive echo. And that means they were denied the opportunity to have the highest level of accuracy and hence potentially be at risk for under diagnosis or misdiagnosis. And so you might say, well, it's only 9%, but if you look at population data, we're talking like 20,000 patients that represents about 1800 patients. So what we did is we said, okay, let's take a look at the compliance linking it to the synovial for level. Now we know exactly who's doing what.

We can quantify that. And we know who needs to do the work. So we were able to do that, provided that as feedback. And then we repeated the evaluation and you can see now the compliance improved to 93%. First of all, we already started out with the 91%, so it's already pretty high.

So if you have other places where they start lower like in the 40s, that interval net positive will be much greater. But even for us, 91% to 93%, I know it may seem like it's only 2%, but 2% for, again, 20,000 large population health data, that represents 400 patient lives. And to be honest, one patient to be honest is enough to matter. I mean that one white space could represent the patient I talked about in the cardiogenic shock that was missed because it wasn't they didn't have a comprehensive echo. So that was the first insight.

The next insight that we uncovered was that we identified significant variability across locations. So you can see here the Site A and Site B looking at the compliance. They're both Swedish, but there are different campuses. Site A represents our the main campus and then site B is about 30 minutes away. But you can see that there's quite a significant difference and variation there in the same Swedish name, but different campuses.

And this is really, it was a jaw dropper for us when we saw this because we had no Type C had some issues, but we didn't realize it was this bad, all these white spaces could be patients again being denied opportunity to have a proper diagnosis and then hence be at risk for being undertreated as a result of under diagnosis. And so imagine if geographically the patient goes to site A, they have the better opportunity, whereas if they go to site B because of geographic reasons, well, that basically denied the opportunity to a proper comprehensive evaluation. This is big deal. So this is and for patients, they don't know. From a patient perspective, they're trusting the name Swedish.

So they're not realizing there's a discrepancy. So it's not really fair to the patient. So anyway, we looked at this and we said, wow, this is really important. And we realized how critical it is that we want to make sure that quality standards are really consistent across all campuses under the one name Swedish, under the same system Swedish. And so this is really critical data that will really motivated us to start talking with leadership at the higher ups to really start the conversations of getting the 5B up to speed.

And without this kind of data, those conversations could have been quite uncomfortable. But now with this fact based data, we were able to really start those conversations and really get things going. And the last thing, it was the insight with the importance of care pathways. And we heard all about the under diagnosis, right? We heard about this and how patient mortality.

I mean, there's this incredible data. So how can we do better? How can we actually make a difference in patients' lives and save patients' lives and get those the diagnosis and the treatment up? So these are care pathways that you see here the first red bar 100 percent represents patients that met 1 or more of the parameters and met severe criteria. Out of them, 64% met severe were diagnosed with severe AF, 25% was moderate.

You can see how many went on to get referred and how many went on to get therapy completed. But when you look at this data, we realize how critical because this is the data that's so important for us as cardiologists because we're actually using the data for the sake, for the survival of our patients. So we can consider how important it is to develop care pathways for the severe and the moderate patients, so that for the severe patients, we would have care pathways in place that would ensure that once somebody is diagnosed with severe ASH, there is proper recognition, communication and then referral to the cardiology team to make sure these patients are getting timely treatment. And the same thing for the moderates. For the moderates, there should be care pathways in place to make sure that these patients with moderates that they're getting yearly echo evaluation, so that once they hit severe, they are promptly recognized so they can be treated.

And a clinical story I can share with you guys, we were just discussing this not too long ago in our TAVR conference. We sit around the table, specialists, surgeons, cardiologists, imaging and we don't discuss patients because they're very complex. You need a team to make a decision. So we had a patient that presented, 90 year old patient with multiple comorbidities presented with shock state, an echo that shows severe aortic stenosis and injection fraction of 15% to 20%. Patient is in heart failure, also has pneumonia, has a whole bunch of stuff.

So now we're trying to figure out what do we do with this patient? And so we said, well, let's take a look when was this patient's last echo. And when we looked, we thought that the last echo the patient had was 4 years ago when the patient is diagnosed with moderate aortic stenosis. So from 4 years until 4 years within this 4 year period of time, there was no other echo done. Had there been in place a care pathway that ensured that there were yearly evaluation with ECHO, that once this patient would have hit the severe, then this patient could have been recognized and treated before the low ES, before the heart failure, before the cardiogenic shock.

And perhaps this patient's life could have been saved, but unfortunately this patient did not make it because he was just too sick. So you wait, stories like these that really show us how these care pathways really serve as opportunities to save patients' lives. And the next slide that you can see when we this is just recent, we just got a hold of this like days ago, that you can see when we take a look at what therapy is being implemented on our patients, more than 50% is medical management. I mean, there's no medical management of aortic stenosis, medical management equals no management. This is a big deal.

And then we said, well, who's really taking care of these patients? And you can see here in the bar that 2 thirds of these patients that are being referred, the care stops for the general cardiologist. They don't get referred further, unfortunately. So this is new data that we are moving now having lots of opportunities that we can work upon. So I will end by saying that as a cardiologist, one of the most frustrating things, I'm sure Matt will agree, is that one of the most frustrating things for us is when we get to patients and it's too late or when things got missed, like the cases I showed, because the quality of that standard.

This is really heartbreaking for us because then we can't really help anyone. And so the way that we see Cardiacare is by partnering up with institutions across the country that this can really serve as a platform over which we could really powerfully transform the way we take care of patients by shifting to population health care, which allows us to have the visibility of data, this transparency, which allows us then to identify these opportunities as you saw, which can be used then to bridge the diagnostic and the therapeutic gaps and hopefully save patients' lives because all patients really deserve the highest possible quality. Thank you so much for your attention.

Speaker 1

So, we got about 10 or 15 minutes to do some Q and A. There are microphones that will be around. Go ahead and raise your hand and we'll give you a microphone.

Speaker 4

Hi, thanks. Isaac Ro from Goldman. Doctor, I really enjoyed the first part of your presentation. And I thought you made an interesting comment around access to the technology. And it's something that's come up, I think, a little bit in the recent nightcap conversations as it relates to giving equal and fair access to the marketplace for TAVR.

But there's a little debate about whether or not that should happen. I'd just like you to weigh in on

Speaker 1

how you think that's going

Speaker 4

to play out, just speaking from your own reach and then maybe both of you could comment on how you think that's going to play out. It seems like a big part of tapping into the market is just giving the technology broader access.

Speaker 1

Can I

Speaker 2

act as though he was directing that at you?

Speaker 1

I think

Speaker 2

he was He's a doctor. I mean, I can give you my perspective. There are clearly two sides to every argument. My perspective is that increased access leads to better outcomes. That's my perspective for patients.

I think that that's played out previously with other technologies. It's played out with PCI, for example, in the United States. So, Seaport, which is a trial, big trial to look at, should we be able to have STEMI care and PCI, well, this was PCI care in smaller hospitals. The answer was yes. Patients do better, do just as well as those institutions.

I think the technology for TAVR has gotten to the same place. The closer you keep a treatment to a patient's care, I think the more likely you are that patients are going to say yes to that treatment and get the care that they need. So from my perspective, I think being closer to the patients is the right thing, which means dispersion of technology. You have to do it responsibly. So proctoring is important, education is important, quality checks are absolutely important.

For TAVR and for SAVR, both, there are registries. For a time, I ran both of those analytic groups at Duke. They are solid registries that track outcomes. My opinion is that the right way to judge programs is not based on their volume, but rather on their outcomes. If you have a small volume center that's doing excellent outcomes, why would you shut that center down?

If you have a high volume center that's doing poorly, you can do as many towers as you want. If you're killing people, you ought to be reeducated. So I think we ought to be using prior experience to dictate who stays open. But to answer your specific question about the MedCAC, I watched it on video. I didn't go.

I was on call that day. But I definitely I weighed in with public comments. I know the CMS folks who are trying to wrestle with grapple with this issue very well. I've had multiple conversations with them. And I've been very clear about my opinion, which is that we need open dispersion of the technology.

And for my money, I think that they've done it. So far, industry has done the right thing with making sure that that's a responsible rollout. I don't see any reason to believe that it's going to be any different moving forward. So thank you for the question.

Speaker 1

Matt, do you have a different view?

Speaker 3

I think you answered it perfectly. I very much agree with everything you said.

Speaker 1

Perfect. Yes.

Speaker 2

Hi, Glenn Navarro with RBC. This is more for you, Don. In Doctor. Brendan's presentation, 65% of patients that are coming through the system are still not getting treatment. So what is Edwards doing to get that number higher and to educate the cardiologists in the system?

Thanks.

Speaker 1

Thanks for the question. And some of this Larry tomorrow, his talk he'll get after, but I had one slide that kind of illustrate a little bit of our own journey. As we've looked at this, we think there's real opportunities for education to patients. And so that's a theme. I think there's a lot of education interaction with physicians and general cardiologists that don't always or can't always put signs and symptoms together in a way that would motivate the kind of action that Matt and Matti talked about.

So we've increased our investment in those areas where we can't do it on our own. So partnerships with physicians and groups to try to get that out, we think is going to be key. And I would expect we're going to continue to learn what works and what's effective to get the hazards, I guess, as Matt called them, off the road. But simply, it's incremental investment that we're making.

Speaker 5

Thanks. A question for Doctor. Brennan. I was just wondering, curious, did the slide that you put up that 10% of generalists are able to diagnose these arystinosis through auscultation was shocking. If you could just let us in on like what percentage of patients do you think you examine with severe aortic stenosis you could diagnose just by hospitalization?

And should we be assuming that generalists are not even laying the stethoscope on the patient's chest? And then lastly, we some of us with background with the ECO technology. Is there any drive that elderly patients or every patient should have a non physician kind of automated technology to update your own AO physical? Thanks a lot.

Speaker 2

I'd say yes. Absolutely to your last question, that's the first time that I've seen that technology that's exciting to me. And I think it's exciting beyond rolling it out to primary care docs. I think it potentially has impact if you roll it out to a CVS clinic that has a blood pressure cuff. I mean, yes, it should be.

That's a fun a cardiograph. We used to do those back in the day. I would say we really got away from them absolutely that would help with diagnosis. Personally, I would say that I'm reasonably accurate at diagnosing severe AS. I'm occasionally tripped up by a bicuspid, seem to have this S2 that we listen for and sometimes I get tripped up by those.

I would say the way that you teach yourself is you listen to the chest, you go back and look at the ECHO report. But remember, I did an additional 5 years of training beyond my internal medicine residency, right, to become an an interventional cardiologist. So and paid a special interest and a special attention to diagnosis of bowel disease through physical exam. So, I would say that I'm pretty good, but nowhere close to perfect. And so we hear something.

Ideally, I think, if a primary care doc could just or the device the Ecos device could simply say there's a murmur, give the patient an alert that says you've got a murmur, get an echo. If we could take it back far, we would expand tremendously these numbers. The difference between the 30% treatment rates that I showed and the 10% that Don showed is the difference between diagnosed and undiagnosed, right? I think we can make a huge difference in our treatment rates if we were to do that. So yes, I see a role for that device, an exciting role for that device.

It takes time and it takes when I came out of medicine residency, no, I couldn't do this. I couldn't do this.

Speaker 1

Let's go to this side.

Speaker 5

Thank you very much. Jason Mills, Canaccord Genuity. For both doctors, what do

Speaker 1

you think the single most impactful

Speaker 5

thing that can be done to, let's say, double the number of TAVRs that go into patients in any given year by any constituency, whether it be manufacturers improving the devices, imaging technologies, improving the care pathways. I know I'm putting you

Speaker 2

on the spot and there

Speaker 5

are probably many things that could be done collectively and maybe a couple of things together. But if you

Speaker 1

had to pick the single most impactful thing that

Speaker 5

you think would that would impact the number of patients that get these life saving devices, what would it be?

Speaker 1

Maddy, you want

Speaker 3

to go first? I'm going to say because actually we were looking at this data and we have our structural team when we got together and this is exactly what we were looking at. And if I were to choose a top thing, because we noticed and you saw the data that it really depends who you refer to, right? It really depends on that, because if you refer to valve specialists, then you can the chances are you're going to probably get a much better therapy. You're going to because valve specialists are really trained into teasing these things out.

Are you symptomatic? Well, if you're not having symptoms, what are you like really getting to the bottom of? Are you truly symptomatic or not? There's all these tests that can be done like stress test really uncovered. There's also indications for surgery even though you're asymptomatic.

So there's a lot more awareness with dial specialists. Whereas in general, when we looked at our data, the cardiologists that were not like in the structural arena, they were not referring because they were calling the patients asymptomatic. And when we looked at our doctors, well, they were asymptomatic, but the Vmax was like in the critical, which means, yes, that does meet criteria or they were asymptomatic, but they were not really asking the question. They were not really, can that patient do a stress test? They were not following the patients properly.

So it really doesn't matter who you refer to. So I think there's a lot of room for education. What we did in our facility when we saw the data that we can see that medical management is higher in the general cardiologist versus eval, we actually then started educating the cardiologist, just educating and educating, showing data, showing why you've got to do more. But ultimately, my personal feeling is that patients would be better served if they go to the valve specialist, the valve team, because they have the higher level of knowledge and updated information and the guidelines and really take that the expertise in this area.

Speaker 1

Matt?

Speaker 2

I think that would absolutely move the bar. I think so from there's a lot of low hanging fruit here, a lot and it's because we designed the system and with old technology in mind, there's a lot of low hanging fruit. But if it were if I had the dollars to invest, I'd invest them in direct to patient communication personally. And that would be the importance of your physical exam if you have been told that you have a murmur, the importance of an echo and critically don't leave it at a one time echo, because what I see more than any other issue is that the patient had a mild aortic stenosis diagnosis. They were told that they were fine.

5 years later, they're in the ICU. So don't leave it at that one time that goes. So it would be a direct to patient education campaign if I had to put there's so much to look and improve here, but that's if I had to put 1.

Speaker 1

Yes. So one final question, Bruce.

Speaker 6

60% of the suspected patients did in fact have severe stenosis, right, so it was confirmed. And 20% were ultimately treated, but 24% were medically managed. Why were those 24% medically managed? So, that seems like the high yield thing where you don't have to change anything because they're already in the bucket.

Speaker 3

So that's exactly kind of when we looked at this data and we looked and we saw these patients weren't actually getting referred to the cardiologists, but the cardiologists that were having to make decisions, do these patients need to get treatment or not. And the problem is that they were the general practitioner, general cardiologist for making the call on that. And I think the problem with that is that they don't number 1, they're not asking the right questions about the patients. Number 2, they don't have the expertise and the knowledge basis that, for instance, there is many there are criteria that even they're asymptomatic, you actually can still have surgery. Or how do you mean you're truly asymptomatic?

There's tests that can be done. So I think the problem with our data is without what we found when we actually looked, we really looked into great detail is that cardiologists are just kind of not as expertise and really teasing out the symptoms and as aware of the guidelines. So this is kind of what's going on in the country. Patients are being under managed.

Speaker 1

So those 24%, to be clear, the next

Speaker 3

Those patients were met they were severe aortic stenosis. Whether or not they met guidelines depends on you have to go back to each patient to find out were they symptomatic, what are the specific cutoffs. So that we would have to we don't have the information if they met their guidelines, but it's severe aortic stenosis.

Speaker 2

So what we found from the Optum data is that 60% or 67% of patients who need those guideline definitions severe and symptomatic aren't being treated. The 7% of patients who meet those guideline definitions severe and symptomatic aren't being treated. So it's a large group of patients. We I just finished up this past year a big grant with PCORI, which is the Patient Centered Outcome Research Institute, to create a shared decision making tool online for patients to help patients and families understand the disease better. I agree that educating our docs, cardiologists tend not to be stupid people.

They tend to be some of the higher achievers in medicine residencies to get selected for that field. They can be taught. I think for a general cardiologist, I do think that we need to we absolutely need to direct, again, education at those general cardiologists. But also, again, back to the patients themselves, I think if patients are calling for treatment or they're asking the right questions, they're ultimately going to get treated.

Speaker 1

Okay. I think what we're going to

Speaker 2

do is to end the formal program at this point. Thanks very much, Doctor. Brennan, Doctor. Pitezcu, Don for your informative

Speaker 1

session. They're going to hang around for a

Speaker 2

while and you are also welcome to do that. There's some coffee and dessert and we're happy to mingle with you for a little while longer. Take care.

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