Good afternoon. My name is Joan Michaels. I work at the American College of Cardiology with Carol Crone, who is at the Society for Thoracic Surgeons at STS. Together we are the program managers for the STS ACC TBT registry. Today I will be highlighting some new features in 3.0, the next generation. And Dr. John Carroll, our steering committee chair, will also then present some of the current findings and what is on the horizon for the next generation. During this presentation, I would like to review the background and development of version 3.0 and point out some data elements and new modules and new reports that we will be showing. Professionals with very specific valve expertise worked with staff to develop the data set for each new valve module. Our IT department worked tirelessly to transform our old platform to a new platform in the hope to be more flexible and nimble with making changes as new technology advances. The importance of adding the tricuspid module was noted and added in 3.0 since we are aware that off-label cases have been being done and now we will be able to collect them. We also will collect appropriate use criteria and include public reporting in 3.0. The TAVR module has been updated, definitions have been refined, and data elements have been added along with, again, data elements to include AUC and the risk model to this module. Wherever possible, data elements also have been deleted where we have found that they are no longer necessary to report on. We will continue to collect research data in 3.0 and it's important to note that all research data collected through the registry is completely separate from the outcomes report and is not included in the outcomes report that hospitals receive. One of the most important additions to 3.0 is the TVT pathway. This is important because aside selecting a particular pathway, be it TAVR, mitral repair, mitral replacement, or the newly added tricuspid pathway, you will only then see the data elements pertinent to that pathway. If by chance you are doing a dual procedure, both data elements pertaining to either TAVR and mitral or perhaps mitral and tricuspid will also show. We've changed the way we collect condition, history, procedure information, as well as adverse events, and they will be included in one section. So we will have a condition history section, as well as a procedure section, as well as an adverse events section easily found and be able to document in each module. Data elements that are routinely not documented or not performed will be an option. These options will allow a site to still acquire green status in the data quality report if it is something that is not a practice pattern within that hospital. So you will not get stuck in yellow if you do not perform this particular data request. The TAVR, the mitral repair module has also been updated to include only the data elements that are necessary to collect under that procedure, as well as the mitral valve replacement module has been scrubbed and cleaned up and some data elements have been able to be retired. And again, as I mentioned, 3.0 will include a tricuspid module to the data set. Each module will continue to collect follow up data at both 30 day and one year interval. 3.0, the next generation will have four newly revised modules within one registry. All three valves will be collected in one registry module. 3.0, the next generation also has a brand new dashboard that will allow sites to drill down not only on patient detailed data, but also on metric detailed data that will allow you to compare like facilities and monitor trends in your facility for purposes of quality improvement. As I mentioned earlier, public reporting will be included in 3.0. Now that we have over 200,000 records in the TBT registry, we have the ability to develop a risk model, which will be used for public reporting for sites launching with 3.0. Up to this point, we have always reported the in hospital risk adjusted mortality, as well as the 30 day risk adjusted mortality and in hospital stroke data. As of January, these three models will be retired in order to make way for the composite morbidity mortality risk model, which will be seen as the gold standard to measure a quality TAVR program. The composite risk model includes approximately 50 covariance, as you can see here. I would like to emphasize two in particular, the five meter walk at baseline and the baseline KCCQ are especially important to this risk model. Just like within hospital and 30 day risk adjusted mortality, you must have 90 percent or greater completion of both the baseline five meter walk test and the baseline KCCQ for a rolling three year period in order to be included in the risk model. And the risk model is what we will be using for public reporting. So it's very important. Public reporting will include a volume of all commercial access TAVR patients. So the volume of all commercial access, regardless of access, as long as it's a commercial case, it will be included. And again, the gold standard, which is the morbidity mortality composite risk model. These two elements will be used for your public reporting report. The composite risk model is a hierarchical model which will consist of six categories based on the worst possible outcome, which would be death to the best possible outcome, which is alive and free of any complication during hospitalization and at 30 day follow up period. So you can see what we will be tracking. There is both similarity and differences between what STS uses in their public reporting. You can opt in or out of any time, and that's similar to STS, as well as we will be providing star rating similar to how they do it and also public accessibility and it will be voluntary. We will also use for hospital level reports, so each hospital will get their report. If you are part of a corporation, each hospital within the corporation will get their star rating. There are also some differences between STS and TBT public reporting. A few are STS reports twice a year. We are reporting once a year at this time. And STS does have position level reporting and the TBT registry at this time will not have position level reporting. That is something we will add later on. So the review time, we'll have a few months, you will receive your report and you will have a few months to review whether or not you want to opt in or opt out. And during that time, you can review your data, decide if you want to consent to be involved in public reporting. Let us know if you identify any issues that you'd like us to address. And again, you could opt out at any time. The public reporting timeline is on target. And as we speak, reports are being sent. The draft reports are being sent to sites to determine for them to determine whether or not they want to be included in public reporting. The full launch will be October 2021. However, the draft reports are being sent out right now. Finally, probably for some, the most important advancement into 3.0, the next generation, is that in 2021, as soon as we launch, we will be opening up the registry to vendor support, which will help with the data burden of collecting data and you will be able to use your vendors. After all of this, now is my great pleasure to introduce Dr. John Carroll, who is not only our chair of our TVT steering committee, but also the chair of our TVT stakeholder advisory group. And he would like to bring out some advances and some news about what's about to come with TVT 3.0, the next generation. Thank you, Joan. That was an excellent presentation. And I would like to thank you and everyone who's attending for all their hard work in making this registry successful. And most importantly, to allow the data to be turned into knowledge to improve patient care. So I'm going to take a step back and let you know how the data that you helped collect are used. And there are a variety of different domains that it's used. I will focus on expanding knowledge that comes in a variety of different ways. But recall in device trials, it's a narrow patient population. But in clinical practice, we see and need to make decisions on how to treat patients who fall outside these clinical trials. And the registry has filled in those gaps and will continue. Secondly, it's used for hospital QA, QI for improving. We're not here to judge. We're here to help everyone improve the quality of their care. And thirdly, and I'll touch upon this later, are the regulatory uses of the TVT registry that are really very, very unique and powerful and have had an impact in a variety of ways on patient care and what we all can offer patients. So in terms of knowledge build, we have here the announcement recently of the acceptance of an update from the TVT registry focusing on the TAVR module. So this will be a joint publication in Jack and the Annals of Thoracic Surgery. In parallel, Dr. Mack is working on a manuscript that will be the state of mitral transcatheter interventions in the U.S. and will report the data on those two modules within the TVT registry. So let's take a step back. And this registry is all about transcatheter heart valve therapy. And I think now you see it's fully manifested in TAVR, what a major change it's made in the care of these patients. And it's really due to the efforts of many, including you, because you are part of the evidence development that goes on after these procedures become approved. And the benefit to these patients is enormous. There are patients who previously would never have been treated with surgery who now have improved quality of life, functional state from these transcatheter therapies. And it's also a collaboration. And yes, every institution's a bit different on the relationship. But in general, this at the national level, there's been great collaboration between these two main groups. And personally, I'd like to thank John Rumsfeld, who's been a leader in NCDR, for getting me involved in this important effort 10 years ago. So, you know, there are many novel things in this registry and one of them in the novel patient assessment and new definitions of success. And the frailty testing you do is so important to help characterize the patients we're treating. And secondly, you gather KCCQ data. How is that important? It's from the patient's mind. What is the impact of the disease in the pre-procedure era? And what is the impact of the treatment? That's what the KCCQ allows us to look at. And recall that this is about quality of life, physical limitations, social limitations from the patient perspective. And see these scores, the very poor, poor, fair, and good. That change of greater than 10 is significant. So a table from the upcoming publication shows the total number of patients, baseline KCCQ, 30-day score, one-year score, percentage of patients with both baseline and one-year, and percentage of patients with one-year with a favorable outcome, meaning they're alive with a reasonable quality of life with no significant decline from baseline KCCQ. I also have broken it down by the different risk groups that the HEART team assesses. And you can see the high-risk patients have the lowest baseline KCCQ. But look how much it jumps up at 30 days and one year, and that almost four out of five patients at one year are both alive and feeling better. And it's even higher for the intermediate and low-risk patients. So this is a testament to your gathering this important patient-reported outcome data of how we can describe the success of these procedures. So the registry has a variety of different stakeholders. It has different transcatheter therapy modules. And as Joan mentioned, expansion tricuspid is coming. We have different work groups. We have different kinds of data reports to sites with national benchmarks, but also the coming public reporting, and also the unique aspects that I've covered with frailty and patient-reported outcomes. But there are more. We've had generally CMS data linkage that allows us to follow rehospitalization rates. And the regulatory studies, like post-approval studies, have been embedded in the TVT registry from all makers of transcatheter valve therapies in the United States. This is the major graphic from the upcoming publications showing the state of TAVR, volume, indication expansion, outcomes, number of sites performing TAVR, the variation in hospital and access site. So let's dig down and see how the data you've gathered have come out. And here's TAVR, both in native valve, but also valve and valve. And you can see in 2019, 72, almost 73,000 patients in the United States had TAVR. And look at the growth over the last 10 years. It's been really just an amazingly rapid increase in the volume of patients treated. And comparing it to surgical AVR, we see here, number one, in green, in the rapidly rising volume curve, that's TAVR. In blue are isolated surgical AVRs. And you can see in 2015, at the red arrow, the crossing of more TAVRs and isolated SAVRs. And then in 2018, another major event was more TAVRs than all forms of surgical AVR. And that's really a milestone of historic proportions, because just 10 years ago, I think it still was almost inconceivable that one could have, under conscious sedation, a new heart valve implanted. And now we see how much of a sea change that's brought. And more is coming. So I'd like to characterize the two tsunamis of TAVR. The first one is what we're dealing with now, a surge of people having transcatheter aortic valve replacement by the FDA approval of the various risk groups and also the development of valve and valve therapy. Wave two is just starting and is pushed by demographics in that we're living longer, but some of us are in the baby boomer generation. And we're entering our 70s, and that's when degenerative aortic stenosis really starts rising. And so this huge population bulge in the U.S. and other countries means there are going to be many more people entering the age of aortic stenosis, unfortunately, because there's no preventative therapy. No therapy slows its progression. And so we're going to see a further increase in TAVR volume. This graph shows how the increased volume year by year has been driven by FDA approval in different risk groups. We see in 2016 and 17 intermediate risk patients started entering. We see now in 2019, after FDA approval of low risk patients, it's just starting to rise. And we also see the extreme and high risk patients have continued to be a substantial number of people every year, 31, 32,000 patients who are classified as extreme and high risk. And these are the patients who likely would never have had surgical aortic valve replacement. And if they did, their ICU stay, their outcomes would have been very different from the relatively low risk of TAVR. Valve-in-valve is an interesting phenomenon. It's, number one, very unique that now we can have a transcatheter approach to getting a new valve despite the generation of predominantly a surgical tissue valve. Because before, it was all RE-OP, and RE-OP is inherently higher risk. So we see the rapid growth of elective or planned valve-in-valve. Now, as you know, you code some valve-in-valves that are emergency, that are during the initial TAVR, where the first valve doesn't get properly placed. It slips either distally or proximally, and they have to put a second valve in. Fortunately, the volume of that is decreasing. So most of the valve-in-valve that's increasing is for surgical valves that have degenerated. But we're going to start seeing TAVR valves that degenerate, and you probably at your site have seen one or two patients like that. And that, of course, is going to increase with a huge number of patients with TAVR valves. More sites are performing TAVR, and we see that here, over 700. and that's made the treatment more accessible, hopefully, to patients. And we see here the demographics. And I like to point out something that's been very consistent. The percentage of patients undergoing TAVR who are Black or African American has been 4%, pretty straight across. And that's half to almost a third of their general representation in the whole U.S. population. So why is that? We don't see this in the micro-modules. And so this gets into the use of the registry to understand demographic, population-based differences in disease prevalence, potential access to care issues, and the specific kinds of attention that's been given to this has been using the data you collect. There have been major studies using the TVT registry data to look at baseline differences in the outcomes related to gender, geographical access, racial disparities, and the use of TAVR in people in their 90s. You know, amazing value of the knowledge gained that can help direct health care policy and help you individually making patient decisions involving patients, of course. Dynamic factors that the TVT registry has picked up include this rapid evolution and access site. A femoral access site now occurs in over 95% of patients due to both reduced risk patients coming along, but also the manufacturers have developed delivery systems that are smaller French size, and that means we can do it trans-femorally. And the early alternative access of trans-apical rapidly has fallen off, as well as direct aortic. And in this slide, we see that in more detail. Again, all these data will be in these publications that hopefully will be out within a month or two. Here we see the shift to axillary subclavian as the major form of alternative access. A little more crowded and other, including some things like trans-caval that's used by some centers. So this gives a good overview in the last few years of alternative access. Of course, we want to get better at what we are offering these patients and this demonstration of reduced mortality rates in hospital in blue, 30-day in red, in one year in this kind of, I don't know what you would call that color, tan. Year by year, it's increasing. The number of people alive, i.e. decreasing mortality rates, such that in-hospital mortality rates of 1% is really amazing, considered where we began, where we were used to 5% to 6% of patients dying during hospitalization for the procedure. And it's important to break this down now in terms of the different kinds of patients you're treating. And you know, some of them are very high prohibitive risk, but now you're seeing the low risk and we expect to see differential outcomes. And this demonstrates the lower mortality of low risk and intermediate risk versus the high prohibitive risk. So presenting the data on all patients is starting to have less meaning when we're trying to dig down and understand are outcomes improving for high prohibitive risk or are the overall declines in mortality just related to treating lower risk patients and combining those results with the high risk. And in the manuscript, we showed that mortality has dramatically come down for the high prohibitive risk by using this approach. Stroke rates have minimally changed. I think you can see the in-hospital rates have gone down from 2.2 to 1.6. We all know these are site reported and that's very different from the rates that would be reported if you sent a stroke neurologist in and did MR scans in people that the rates are perhaps even double that. But these are obviously clinically overt strokes. We haven't seen much decline and despite more and more low risk patients being treated, that probably accounts for some of the decline, but it's not as dramatic. So as we all know, this devastating complication prompts us all to think what can we do better? And so the era of cerebral protection has come along and two years ago about FDA approved the first cerebral protection device, Sentinel. Your site may or may not be using it. It was approved not because the pivotal trial showed stroke reduction, but because the pivotal trials showed debris capture and reduced number of magnetic residence lesions in the brain. So it's a different from clinical stroke. So we added Sentinel to the data collection form, as you all know, to capture that data. And we added it along with two other major advances in techniques, one being fracture of surgical valve ring when you're doing valve and valve, because otherwise putting a valve in another valve may result in patient prosthetic mismatch, a high gradient. Secondly, sometimes, fortunately not commonly, when you push open the aortic valve leaflets, you may occlude a coronary artery. Very bad, clinically disastrous complication. So lacerating that leaflet before you do the TAVR and a procedure called basilica was to prevent coronary obstruction immediately post TAVR. So these have been added. You can see the total number of patients treated year by year in this cerebral protection, fracture and laceration of the leaflets. And so there'll be subsequent publications coming along that will help us understand in real world settings, do these things make a difference? What are the benefits and what are the potential risks? And the data you collect answer those questions. There's no manufacturer doing a clinical trial on fracture of surgical valves. There's no manufacturer doing a trial on basilica. We are it. This is it. This is the way we learn. And it's the only way we can learn about these techniques going beyond single center studies, which are very limited. So in terms of cerebral protection, in two weeks, approximately at the virtual TCT meeting, we'll see the presentation of the data from the registry on the impact of using cerebral embolic protection on stroke rates, clinical stroke rates, comparing those who receive the Sentinel device during the procedure to those who do not. Does it work? Does it reduce clinical strokes? Should we continue to use it if you're already using it? Should you start using it if you don't? These are very practical issues that we hope to be part of the evidence development, not the only evidence, but part of that evidence development so we can make informed decisions for our patients. The other issue I want to highlight that I think there's been less improvement is pacemaker rates. In fact, we saw that increase that occurred early on with pacemaker rates as more patients were being treated where the self-expanding valve was now being used and slowly pacemaker rates have come down. Is it due to treating lower risk patients who have fewer right bundles, etc? These are the types of things that need to be answered. This manuscript in Jack and the Annals of Thoracic Surgery is to outline the big issues, the big data findings, and then what happens is that investigators, through the RNP process, submit the protocols, dig deep and say, why is this? What can we do? We see also here the in-hospital of 30-day pacemaker rate, there's a delta there. This is clinically concerning. I had one patient who went home doing fine and had sudden cardiac death probably from late onset heart block. We're sending many of our patients home on monitors who already have a pacemaker. These things prompt us to take action to gain knowledge and hopefully improve outcomes. I'd like to conclude in that TAVR continues to evolve. The publication coming up soon with Dr. Mack and many of us will talk about the mitral results from the registry. Yes, we've answered many, many major questions, but there are more. As you know, long-term durability, reducing some complications like stroke even further, the issue of valve leaflet thickening, and what anti-coagulation conundrum is going to be addressed potentially with a study embedded in the TVT registry? Do we need new tissue valve preparation to make it more durable? When is SAVR preferable? These are all questions that the registry will play a key role. As we're entering into our 10th year of existence, you working with us will be able to answer many of these questions. Sometimes it's hypothesis generating, sometimes it's definitive answers, but only by all of us working together can we make an impact. The fundamental impact on the regulatory system is shown by we've expanded indications using TVT registry. We've embedded post-approval studies. It's really had a major impact on bringing new therapies to patients earlier in the U.S. and monitoring them more carefully. I'll end there, and we'll have hopefully a couple minutes for questions. Thank you so much, Dr. Carroll. On behalf of all of Caber Nation, TVT Nation, I'd like to thank you for all your support over the years. I'm very happy to answer all our questions that come in. For those of you listening or watching this presentation, you need to know when a question comes in that I'm not able to answer and that we need to escalate. Dr. Carroll is our escalator, and he's always willing to answer questions and help us with advice. I'd like to start out by asking a question. I know TAVR was unique in starting out with the concept of a heart team. Some hospitals may have adopted that concept a little bit more easily than others, depending on what type of culture and setting you have. My question is, as we go down the road with TAVR and mitral and now with tricuspid, do you see the heart team concept continuing, and has that added to your decision making, and has it made your general practice more of a collaborative one, knowing that for purposes of TAVR, we ask that a heart team approach is taken? Interested in your thoughts. Thank you, Joan. We have a very strong collaborative culture here, and I think we learn a lot from our surgeons. They learn from us, and it's a shared environment. I think there are two aspects to the heart team. One is the intra-procedure, and while major complications during TAVR requiring conversion to open-heart surgery are relatively rare, they still occur, and sometimes you can identify high-risk patients who may need to go on ECMO and need surgical support. The mitral modules, especially mitral clip, that kind of complication is really rare, so that's not where heart team plays out in procedure performance. I think the major advantage is pre-procedure for patients to sit down with a multidisciplinary group, hopefully simultaneously seeing them during the same visit, getting potentially two perspectives, having questions asked and answered, and there are many patients who are going to be having choices to make and to do shared decision-making and choosing between, say, SAVR and TAVR. If you're a 55-year-old low-risk patient, I think you really do need that kind of collaborative approach, and so I expect the heart team concept to continue on in a variety of ways, but as you point out, there are major variations between settings depending on the culture, the way a hospital system is organized, and that will continue to play a role, but the heart team concept is is here to stay. Good to hear, good to hear. Crystal ball, how low is low? When we start talking about low risk and then durability of the valve, do you have any sense of is 60 as low as we'll go with TAVR? And that would be the question asked was specific to TAVR. When we talk about low risk, I know it's not just an age thing, but what do you see over the landscape of maybe the next five to ten years in terms of knowing the median age right now still hovers between 80 and 81. It's going down a little bit. Where do you think TAVR will stop and plateau at in terms of an age group, if you have a thought? Number one, it's a superb question, and I think it's increasingly on everyone's mind, and we have really limited data to make that decision, but there are some aspects that go into it. Number one, we know tissue valves, whether they're SAVR or whether they're TAVR, are going to have a limited durability, and from the low risk trials where there's long-term follow-up of patients who are likely to be alive in 10-15 years, that's going to be our first look at whether there are any substantial differences in durability, whether the differences in halt early on play out to different durability issues is an unknown. So durability will be one of the issues we're all looking for data. The second is, okay, so when the valve degenerates, we have a lot of data on TAVR and SAVR. We have very little data on TAVR and TAVR, and whether the technical challenges, the outcomes are different with what valves, we have a lot to learn, and I think that's going to say something about whether that 55-year-old starts with a SAVR, knowing that when that SAVR wears off, valve-in-valve is very feasible. TAVR and TAVR, we'll wait and see, and there'll be different subgroups, like people who come initially, they're low risk, and they have a small annulus. Maybe they need SAVR with a root enlargement and a largest tissue valve possible to make room for a second TAVR and SAVR down the road. So these are some of the issues that will drive this in low-risk patients, where it's just isolated aortic valve replacement that's needed. So five years from now, we'll have some answers, 10, hopefully many more. So one more question. When you're going in to talk with a family member as well as the patient, are you seeing one question sort of bubbling up to the top of their concern or worry point? Would it be more focused on, will I be, you know, will my loved one getting a pacemaker as a result of the TAVR or the precautions or risk of stroke? And we always hear the patient might say, I would rather die than have a stroke and be a burden to my family, but we're making advancements certainly with watching the stroke rate and the pacemaker rate, but what would you say is the most, the top question family members maybe ask or patients ask or that you discuss with your colleagues in terms of how do we limit those two from happening? Yeah. Well, it's a great question. And I say, unlike early TAVR, where it was all about survival and stroke from the procedure itself, stroke still comes up. I think the data on stroke have shown the slow but significant decline in stroke rates. And it's certainly lower in low risk and intermediate risk than high-risk patients. And we hope cerebral protection is further lowering that. And we also have a head-on-head comparison of surgical versus transcatheter aortic valve replacement in low-risk patients. One of the trials showed a lower risk of stroke in TAVR. So it's still there and still needs to be addressed and it's front and center for some patients. Pacemakers is sort of more nebulous. What are the long-term downsides of it? Does it keep you in the hospital a bit longer? Sometimes yes, sometimes no. And so I think it is, what I say is the most frequent complication of TAVR on average one out of 10 patients. And we'd love to see that lower, but I'm not sure how we're going to get there, whether it's a new design of TAVR, whether some of those patients only transiently need pacemakers, not permanently is another issue. So we're able to respond to that question, I think, with some data, but not with clarity of whether that will become an issue long-term for them. So I also see a lot of patients now coming who just say, well, I just want TAVR because I can be in and out of the hospital. I can be back to work. I can be back skiing, et cetera, in a week. And that's not entirely reasonable in terms of the rapidity of the recovery from TAVR. And that's front and center in so many people's minds of how I can get through this terrible disease and quickly and safely. These longer term issues are starting to come up. So when you're talking about a 60-year-old who's low risk, they have an average life expectancy of 20 to 30 years. So that's where people are starting to ask, well, what if this valve degenerates when I'm only 70, et cetera? So I think the nature of the conversations with patients is evolving as the field evolves. And I continue to think that's going to be the case. And we need to prepare. We need to have the data from the TVT registry to answer questions. Thank you. Data, data, data. Thank you so much. It's been a pleasure spending this time with you, Dr. Carroll. Thank you so much for the presentation. Thank you for joining us. Thank you, Joan, for everything you do.

advancements

registry

tricuspid module

TAVR module

data elements

patient care

knowledge generation

TVT pathway