All right, hello everybody, my name is Devin Shrivastava and today I'm joined with my presenter here beside me, Cameron Shrivastava, and we have some data that we'd like to present to you about access to transcatheter aortic valve replacement procedure. So we conducted this study in a town in South Carolina, Spartanburg, South Carolina. It has a population of about 35,000 and we characterized access to this procedure in the primary hospital in the area, Spartanburg Medical Center. So we are excited to present the data and look forward to the conversations that it generates. So first we'll take a look at the problem scope. As we all know, of course, aortic stenosis has large impact on our population and it's primarily a disease of aging, and of course our population is aging in this country as it is in many places around the world as well, so of course it follows that aortic stenosis is also increasing. And as you can see here on the bottom of the slide, this is just a representation of the prevalence of the disease as you get older. So decade by decade, of course, you start to really see an increase, especially as you get into this population range of around 80 to 89 years old. So this slide depicts the natural history of aortic stenosis. So you can see that there's typically a long latent period of disease onset, but as soon as the symptoms onset, you can see that we have two diverging paths here on this graph. The bottom half actually is prior, when we weren't treating the aortic stenosis via valve replacement, and so you can see that the mortality is very sharp after the onset of symptoms. You get, you know, shortness of breath or swelling in the legs, obviously heart failure, or you can pass out with syncope or even chest pain with with angina as symptoms, and your mortality is very strong after the onset of those symptoms. However, once we've developed procedures to actually replace the aortic valve, you can see that the survival actually continues on the same trajectory as before, so we have very good outcomes with aortic valve replacement. So this slide also depicts the lethality of this disease. So you can see this is a survival curve, and you can see within five years of developing aortic stenosis, the outcome is quite dismal for patients who have just been medically managed. So if we just treat the symptoms that accompany aortic stenosis, high blood pressure, shortness of breath, passing out, chest pain, then within five years, you can see from the survival curve, 80% of patients will die. And so another thing that I should point out actually is that both the curve on this slide and the one in the previous slide actually came from large-scale studies, most very well known in the field, most prominently the one from the Mayo Clinic study of the natural history of onset of aortic stenosis, which was a study back in the 1960s. They ran the study for about 30 years. This was before we had methods of replacing the aortic valve, and they studied sort of just what happens to these patients. So you can see that this is a very severe disease for a severe aortic stenosis. So now we'll take a little closer look here at sort of the profile of your prognosis if you're experiencing symptoms for severe aortic stenosis. So if you have an onset of these symptoms, we can take a look at what your life expectancy actually is without treatment. So if you have angina, you have a life expectancy of around five years. If you're having syncope, of course, two to three years. And of course, the most severe one, as shown on the slide, is if you have congestive heart failure, your life expectancy, if you're showing that symptom, is down to just one to two years. And if you notice, actually, on the bottom of the slide as well, you can see that the event rate in asymptomatic severe aortic stenosis, so say you have severe aortic stenosis, but you're not showing symptoms, you do still see mortality in about 1% of patients per year. So this, of course, has led to significant research and development advancement in this area so that we can treat this disease, which is so prevalent in the population. And the therapy that's come is to be able to not just treat the disease medically, but actually to treat it as a therapy and replace the entire aortic valve for severe aortic stenotic patients. And you can see it's the operative mortality in elderly, so elderly being patients of around 70 years or older, is around 4%. So not terrible risk for these procedures. And with morbidity, so risk of infection, hospitalizations, post procedure around three to 10%. So a relatively safe procedure for a very deadly disease. All right, and so this is just another representation of the dramatic improvement that we see from this aortic valve replacement. And this is surgically. So I don't think you have to be a scientist to appreciate the divergence in these two curves. But you can see from the probabilities in the bottom, right, that these are very statistically significantly different. So if you treat aortic stenosis medically, you know that very dramatic drop off within the first year or two, where your survival immediately gets to around 20%. Whereas if you if you do replace the aortic valve, you have this sustained benefit over time of survival. So patients seem to do very well with this aortic valve replacement as a treatment option. And yeah, so we'll move to the next slide. So obviously, as as we've seen, aortic valve replacement is a very beneficial procedure. And it's something that for patients who are experiencing severe aortic stenosis, we want to get we want to them to be able to have these aortic valves replaced. So now, one of the biggest problems, however, with driving that uptake actually is that, as you saw earlier, the mortality or the onset of the this aortic stenosis comes in the aging population. And of course, as you get older, you also become a little bit more fragile, and it becomes more difficult for you to actually undergo open heart surgery to have your chest cracked open and have that traditional open heart surgery. So to be able to actually introduce aortic valve replacement in this very elderly population, there was a lot of sort of energy trying to come up with a new procedure. And that what they've come up with is transcatheter, aortic valve replacement. So instead of having to open the heart up, you can actually go just through the wrist and replace the aortic valve. And so interestingly, this is actually the 20th anniversary of TAVR, transcatheter, aortic valve replacement being introduced. This was first done by a French doctor, Dr. Cribillet, 20 years ago to this year. And so you can see on this slide here, if you look on the left side, the rates of TAVR usage have just been exploding. You can see they're up about 680% in terms of their volume from 2012 to 2019. And you can see over time that there's also an increase in terms of the overall aortic valve replacements that are happening. So perhaps we actually are even extending an aortic valve replacement option to a new patient population that didn't previously have access to this prior because they weren't able to undergo the intense aortic valve replacement through open, traditional open heart surgery. Of course, with any introduction of a new procedure, we have to validate that it's equally as beneficial. And you can see here over on the right that TAVR has very similar rates to SAVR, surgical aortic valve replacement, in terms of readmission rates, in terms of mortality within one year. So overall, this has been a very big benefit, revolutionary procedure for a large, significant patient population that undergoes a very lethal disease. And I'll describe it a little bit more in the next slide as well. So let's take a little bit closer of a look of comparing TAVR versus SAVR. So one of the primary benefits of it is that it's been shown to have lower complication risks and shorter recovery times. So if you look on the on the left side of the screen, you can see that TAVR, as compared to standard therapy, has a lower cause of death from any cause. And it also has a significantly lower rate of death as from a cardiovascular cause. And this is over a two year period. And so very sort of striking data, as you can see the TAVR curves in the red versus SAVR in the blue. Now, if you look over to the right side of the slide, this is where we're sort of taking a look at the impact of the therapeutic regimen on the patient's life. And so you can see TAVR is in the solid black line versus SAVR in the dotted black line. You can see that the average length of stay in days for TAVR is significantly less. This is over the period of one year than with SAVR. So both in terms of the recovery time and in terms of the impact in terms of death, as compared to SAVR, TAVR actually appears to be performing better. So now, of course, as TAVR has been gradually introduced across the country, in the past 20 years or so, we really want to take a long and hard look to see what the uptake of this procedure is. Now, we know that it has very beneficial outcomes for patients in terms of the improvement of their aortic stenosis, as well as reduced complication risk, shorter recovery times, and perhaps is able to give access to an aortic valve replacement to a population that didn't have access to it prior due to the difficulty in undergoing open heart surgery. So this is data, as you can see at the bottom of the screen, this is data from the TVT registry, the Transcatheter Valve Therapy Registry. It's a national database of the uptake of this procedure. And you can see that there is a disparity along racial lines with Black people actually constituting a significantly lower proportion of TAVR patients than their population representation. And so this was characterized over a period of two years from 2012 to 2014 is the data that we're showing currently on the slide, but actually has continued over the past eight years as well. Now, what has not been characterized is that a cause for this disparity. And of course, this is a national study. So these are just numbers, there could be many potential reasons for us to see this disparity. And this is broad data, but it does illustrate a national trend that's occurring. And so that, of course, leads us to question, you know, what is the reason for this disparity? And is there a way that we should be working to address this? So this leads us to the purpose of our study, which was to be able to characterize the TAVR uptake at a more granular level. So really look getting into that community level, and looking at the sort of uptake of this procedure in a patient population, and really characterizing that, so that we can sort of get an idea of, you know, does this disparity exist, First of all, on a community level, and is it also, you know, what are the reasons for this as well? This, of course, studying, taking their benefits to both large and small studies. When you look at a smaller population, you can get a little bit more detailed information. And so these studies actually, this sort of study has not been done before. And so we're very excited to present to you the data that we have collected. So this is just a little bit of the background and methodology of our study. So of course, we're looking at the TAVR patient population in a small Southern town. So I mentioned at the start of this presentation, we characterize the TAVR patient population in Spartanburg, South Carolina, which has very high rate of cardiovascular disease in the region of our country where there's high levels of heart disease. And it also has a significant black population allowing us to be able to fully characterize this disease as best as we can in the town. So as I mentioned earlier, the goal of the study was to understand the observed nationwide phenomena at a more localized level using these clinical demographic and social studies. So we actually were looking at TAVR uptake in the Spartanburg Regional Healthcare System, which is one of the few centers in the state of South Carolina, actually, which offers TAVR as a treatment option. And it was introduced there in 2017. And so the de-identified patient data was collected and analyzed from the 321 patients that had received TAVR as of January 8th, 2022. And also a healthcare accessibility survey was distributed to 200 community members over the age of 35. So in the candidate range for having aortic stenosis and garnering a response rate of around 50%. So now I'd like to turn the presentation over to my co-presenter, Cameron Srivastava, who will take you through the data and results. Hello, everyone. My name is Cameron, and I'd like to thank Devin for going over the background information for our research. And now I'm excited to present the data that we actually collected. And so the first thing I'd like to talk to you about is to actually analyze demographics of both the data from the TAVR patients who were treated at Spartanburg Medical Center, as well as the demographics of the survey respondents from the survey that was distributed. And so, as Devin mentioned, age is obviously very much associated with risk of aortic stenosis. Significant risk increases after the age of 35. And as illustrated here, in both of our populations, the age range is over the age of 35, which allows us to have a comparison of risk of aortic stenosis. And as we know, gender is also associated with the risk of both aortic stenosis and TAVR. Males typically have higher incidences of aortic stenosis, but with our survey respondent population, we were only predominantly able to collect data from females. So this was one of the limitations of our results. And it could also be, you know, a lack of the ability to engage males in community healthcare initiatives. So here we can actually take a closer look at and characterize the racial demographics of the TAVR patient population that we studied, who had received, the patients who had received TAVR at Spartanburg Medical Center. And so from that population of 321 patients, around 7.4% of them were black, and 91.9% are white. And now this actually illustrates the disparity that Devin was actually talking about earlier on a national level, because the demographics of Spartanburg are much higher in black population representation, closer to 20 to 30%. Whereas in treatment with TAVR here, we're seeing that blacks only constituted about 7.4% of that initial TAVR cohort. And then after we had kind of analyzed this TAVR patient population at Spartanburg Medical Center, we conducted our own healthcare accessibility survey, and we predominantly gave this survey out to black members of our community to really take a look at what could be causing some of these disparities. So we had around 94% of respondents to that survey were black. And in the next few slides, we're gonna take a look at some of the results that we gathered from that survey. So here we're taking a look at the insurance status of the patients who received TAVR. And as you can see, virtually every patient who got TAVR had insurance. And TAVR being a costly procedure, having insurance is pretty much a requirement in order to get that procedure. Now on the right, with the healthcare accessibility survey that we gave out, you can see that the profile of individuals who have insurance in this population is slightly different. There are a fair number of individuals in this population, the survey respondents that actually did not have insurance. So now let's take a look at the primary care physician status of both populations. Primary care physician status, obviously being important because having a primary care physician is vital. Annual checkups are important because if you are having some symptoms of aortic stenosis, often the primary care physician is the first line of defense in that they will refer you to a specialist such as a cardiologist. And so now let's observe these differences here between the TAVR patient population and the survey respondents. And what we see is that above 95% of the TAVR patients had that primary care physician. Whereas with the survey respondents, we can see that it's a lot more split towards 50-50 with around 70% having the primary care physician, but a large proportion not having primary care physician. Another factor that could contribute towards receiving a TAVR procedure is prior healthcare exposure. And we examined this by looking at whether the patient had gone into the hospital and received a surgery or an echocardiogram prior to them actually receiving the TAVR procedure. And as you can see on the left, virtually all of the TAVR patients had had various healthcare exposures prior to them receiving a TAVR procedure. Whereas the survey respondents were less likely to have had healthcare exposure to the healthcare system. And so what we can kind of take away from this is that perhaps having healthcare exposure could be a factor that's contributing towards patient's amenability to undergoing a TAVR procedure. And so what we also see is from the survey respondents, perhaps our population is not having as much of that exposure to the healthcare system, which could be a factor in causing this overall disparity. So another well-characterized factor towards healthcare disparity is socioeconomic status. And we examined this in our study by using household valuation of our TAVR patients and our survey respondents as a marker of wealth. And what we've seen in our data is that the TAVR patients were on average more wealthy and having a higher average income than our survey respondents. And this could indicate that income is playing some role in access to the TAVR procedure. But what we concluded is that income is not the sole factor that contributes to this disparity. The need for aortic stenosis is correlated heavily with having a risk factor for the disease. And so we examined for the TAVR patient population, the amount of patients that had at least one risk factor and the vast majority of these patients did have at least one risk factor. And from the survey respondents, we also observed that a vast majority of the survey respondents had at least one risk factor for aortic stenosis as well. And so in combination from these results, we can see that there is a vast need for aortic stenotic intervention in this community. Great, thanks Cameron. Okay, so now we're taking just a look at the overall comparison between the two patient populations that we analyze. You can see that the TAVR patient population had higher rates of insurance, higher affiliation with a primary care physician, more prior healthcare exposures and higher approximated income levels demonstrating the characteristics of TAVR patients as compared to the general population, which was modeled by this Healthcare Accessibility Survey. However, one common key factor was that the survey respondents did indicate a similar aortic stenosis risk factor stratification. So we're able to see some of the contributing factors to this TAVR patient population as compared to the survey respondents. However, these actually do not fully constitute the difference that is seen in terms of the TAVR uptake among different races as we'll look at in the next slide. So as mentioned prior, there are contributing factors that could be responsible for this healthcare disparity seen in this community. However, we do see that there is an impact along the lines of race, particularly highlighted by the social studies that we conducted. You can see on this slide at the bottom, some of the example reasons for unfair treatment. And so, I mean, this is greatly exhibited in terms of the overall lack of trust in the healthcare system, seen by the Healthcare Accessibility Survey respondents. And you can see that there is skepticism towards the healthcare system along racial lines in some cases as well. So there is a need to address this disparity in the community. So I'll just pause for a second so you can read some of the quotes on the bottom of the slide. So with that, we'll just take a quick stab at some next steps. So we can see that there are racial disparities in TAVR at a local level, which is also seen in other diseases, particularly highlighted by COVID-19 in the past three years. So local education campaigns at the local level, at the national level, and also financial support for change in infrastructure really are very important to kind of set the tone for ultimately delivering these new life-changing treatments equitably to all races. And we also do think that particularly in the South Carolina, Spartanburg, South Carolina community that clinician referral programs could make strong impact, increasing clinician referral through primary care physicians who are the sort of first line of analysis of some of the symptoms that patients present with is very important in delivering TAVR in particular. So we'd just like to thank all our partners in helping us conduct this research, Spartanburg Regional Health Care System in particular, and the community organizations who we engage with in Spartanburg, South Carolina, including the Believers Fellowship Assembly, Barry's Barbershop, New Faith International Church, Messiah Missionary Baptist Church. And additionally, we'd like to thank all the survey respondents. With that, thank you for listening, and we look forward to engaging with you further online.

transcatheter aortic valve replacement

TAVR procedures

racial disparities

aortic stenosis

access to TAVR

survival rates