Dr. Matthew Summers, Program Director of Structural Heart and Co-Director of the Sentara Heart Valve Center at Sentara, discusses the need for pre-procedural planning using computational modeling to guide treatment options for cardiac patient undergoing valve procedures at Sentara.Â
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Not just our most uh high risk and complex uh uh procedures and surgeries and to guide our therapies like decisions with uh between Saver and Taver uh but also uh the routine ones to try to head off complications that are becoming increasingly rare but in the context of increasing volumes increasingly difficult to find that quote unquote needle in the haystack where uh. You know we're trying to find the one annual rupture every year that that happens you know on a on a random Wednesday on a patient that we didn't predict and a lot of that is predicated on on how we use historical modeling and planning for these procedures um and how that's morphed over time. So the title of this talk is Computational modeling and Advanced Pre-procedural simulations to guide uh structural heart interventions. And so for just a brief outline, I'll, I'll go through, uh, this is mostly case based. I've highlighted 5 cases where we found incredible value with with this 3D modeling and and pre-procedural simulations, um, but I'll, I'll walk through a little bit of the history of how we plan the structural heart procedures, uh, and then how we're currently using them, uh, from the in the context of making decisions about, uh, SAR versus Tavern which valve platform we use, uh, how we're preserving options for patients in the future, what's called lifetime management. Um, interp procedural risk mitigation, so particularly coronary occlusion, um, and annular rupture risks, and then, uh, we're even getting ways to predict post procedural outcomes like hemodynamics, uh, bio prosthetic valve degeneration, and I'll give some examples on how that's morphing into mitral valve therapy simulations as well. And so if you look at the history of Taver really this, this kind of started in 2010, and this is a good case example for how we modeled things historically and how we model things now and so in 2010 we were guiding all of our procedures by TEE for for TaR and even until about 2014, 2015 in intermediate risk, uh, Taver populations if you're a woman, you got a 23 SapiXT if you're a man, you got a 26. So if you think about all the variation that exists at the annulus in our Ecotech see this every single day, every valve is different and so the fact that two sizes fit fit all is is ridiculous. The fact that we can take the resolution of a TEE um and expect, you know, it's great for live imaging, but expect it to model what's gonna happen in a procedure in the setting of that anatomical complexity. Um, is rudimentary as well. And then when you look at 2015 or so, the last 10 years, we've been using CT scans to make very precise measurements and at submillimeter resolutions we can measure things and try to predict the risks of things like coronary oclusion or model redo tavers. People have made their whole careers off of 3D printing people's CT scans and then doing the procedures inside of those and then that certainly was an interest of ours as we were tackling more complex cases but ultimately what you're doing there is you're taking plastic or TPU and you're in, you know, you know, implanting a valve into that and it's a static non-tissue sort of characteristic model and so it's really looking at uh anatomic relations between different cardiac structures more than it is anything else. And then we, we morphed into from doing this at uh some of these cases at ODU into what's called virtual 3D prints which are still static images, um, but they use your CT scan to embed virtual 3D geometry inside of patients. This is the Valve and Mac case that we did and had materialized, uh, which is a company that that uh takes your CT scans and does 3D modeling. Uh, model that valve and Mac and you can see the calcium is actually protruding into the stent frame so you're still taking a 3D print and you're putting a virtual, uh, geometry inside of it it doesn't show you what tissues do in response to that stent therapy. So what we've, we've started modeling and what we started using the last two years is computational dynamic 3D modeling which basically takes patients. The models were built by taking pre-AR CT scans and 30 dayAR CT scans and looking what that stent does in relation to individual anatomy, and they can predict with enough data points within 10% uh what that stent, what that taver is gonna look like at 30 days. And if you can do that, the vast majority of complications in Taver are related to that stent deforming native anatomy you're pushing native anatomy out of the way. And so we now have the ability, and we've been using this company for the past 2 years, uh, to individualize treatments, implant valves in a variety of different anatomical, uh, variations, see what that tissue does in response to the stent. And with enough data points you can use that to guide your valve therapy decisions. You can use that to uh head off complications and now we're getting to the point where we can predict post procedural outcomes in response to this dynamic modeling, but this is an app that they've developed that we'll be using at the beginning of next year where we can quite literally embed our first valve different heights. It'll show you where the risk of annular rupture is where coronary oclusion risk happens. And it'll even show you what valve you can use uh in 10 to 15 years for the redota. So we're now getting to the point where it's, it's a given that we're gonna get through the index procedure. We're talking about what the next valve would be and and dictating our implantation depth and some of our valve selections based on. The patient's individual unique anatomy so that we preserve options in the future and so we've morphed from TEE just 15 years ago to size all of these things, having two valve sized now being in the 4th generation of taver valves with three very good options and still very, very good surgical therapies, uh, and we're trying to determine really which valve works best for each individual patient and which risks each patient has individually for those specific valves and so um I'll use uh. This is a jumping off point for for how we're approaching things nowadays, so most people know this, um, we are a large volume taver center. Our, our teams, you guys, our cardiologists take care of more than 1000, uh, aortic valve patients per year that are sent our way, and we do between 500 and 550 tavers a year. And so that volume comes with a couple different things. It comes with a large volume of increasingly lower risk patients. Uh, where we're trying to take already low risk events like annular rupture and coronary inclusion and we're trying to make them even lower, and we're trying to find those one or two patients every single year they're gonna have that event again with rudimentary prep procedural planning and modeling, um, and we're also getting an increasing bolus of redo tavers and valve and valve tavers and tavers that are at risk for annular rupture and a variety of different complexities that make, uh, a different subset of patients also more and more difficult to to manage. And so if you look at Tavern and break it down into two eras, I, I came out of training right here in between the two eras of 2019, um, initially Taver was being used to to treat people that didn't have any other options, so most of you have practiced either through through echo or cath lab or through cardiology during those initial years when we didn't have options for patients we're sending. 80 and 90 year olds with severe AS to hospice uh when they had symptoms, um, so the 1st 10 years of travel is really trying to get people without options of treatment and then trying to get them through it unscathed 24 French sheets, bad peripheral arterial disease, um. A high annular rupture risk, very, very, uh, uh, rudimentary, uh, type valves, uh, again two valves for, for all sizes, uh, makes the procedure much more complex to to fit a square peg in a round hole, so to speak, and patients really, uh, had when we talked to those when I talked to those folks in, in, uh, in fellowship, they were trying to make sure that they had an option. Are they gonna be OK? Are they gonna get through the procedure and that dictated all the conversations. But in the last five years things have morphed. It's now that we have low risk indications and we had in 2019 we had two low risk trials that came out that showed that folks over the age of 65, they have a tricuspid valve. TR was not inferior to surgery. Now we have 10 year data through the notion trial it shows that TR actually has superior rates of, uh, SVD and valve degeneration than Taver and superior rates of hemodynamics because of valve design. And so we've morphed into now uh patients are expecting to get through the procedure unphased expecting to get through the procedure without complications, and they're asking, well, what do I do next? Can I go home the same day? How many days in the hospital can I, do I have to stay, um, when I, when can I get back to exercising? So just in the past 5 years, the nature of these conversations have changed pretty dramatically. And so as a large program like we have, um, really the two goals are how do we continue to lower those already low in procedural risks and improve outcomes but still preserve the option for patients uh when they're older and aren't great surgical candidates or maybe have a higher surgical risk. How are we timing uh the fact that patients sometimes need 3 valves nowadays. And when are they gonna get their strenotomy? How feasible is it to do a third taver? Is it more difficult to explant their taver and do or then do a redo taver? And so there's a variety of factors that are that are, are, are, um, blossoming in in our field as far as how we take care of those patients and the index valve selection really is is key there. And then how do we prepare uh for the simultaneously increasing volumes um of both lower risk what we call common taver and complex tavern. Just to give you a lay of the land, we have 3 commercially available taver platforms. There's a balloon expandable valve platform, Sapien that you hear about, and there's two self-expanding val valve platforms we use uh a majority of our cases, the Medtronic Evolute FX plus we are using quite a bit of Navitor, which is another self-expanding valve. This is intra-annular. This is intra-annular. This is super annular, and both of these are self-expanding valves. The benefits to this is basically 70% of the market share right now, but it's a set it and it's where you deploy it is where it ends up so you shoot for a 90/10 implant or an 80/20 implant, you know, if you're worried about the annuals, you subtract out a CC of volume from the balloon or if you're, you know, trying to size it very specifically for a patient's anatomy sometimes you add a CC of fill volume or two CCs of fill volume. It's relatively imprecise and what we've noticed over time with head to head trials is the hemodynamics of these valves differ pretty significantly from the self-expanding valves. The self-expanding valves in particular superannular valves basically take your annulus and all the variations that occur at it, and it puts a larger valve up in the sinuses where you can have symmetric expansion of a prosthetic valve. It's almost a built-in root enlargement. Uh, by, by doing that, it comes at the expense historically with higher pacemaker rates, but we now have 10 year data, the earliest platform of core valve, uh, that shows again lower SVD rates than surgery. The newest one is, is Abbott and Avatar, which has a lot of ease of use, uh, uh, uh, features. It's got bigger cells, taxes coronaries. Both of these valves have the capabilities to do what's called commission alignment. So we can bracket these big cells right in front of the left main and make sure that we do feasibility is preserved, uh, but they also have some issues with pacemaker rates and we don't have long term data yet this two year trial data for high risk patients and it's only indicated right now for high risk patients. So we have 33 players, we have 3 different features and we have a lot of different clinical factors and anatomic factors that help guide us in these decisions. Uh, if you take one thing away from this, this talk, I, I hope you take away how, uh, much we perseverate about these decisions, not just between Saver and Taver but how much we perseverate about these decisions of which valve platform is gonna work for best for each individual patient. And when I put pen to paper and and try to figure out all the different factors that that uh prompt us to use a certain valve in a certain patient, there's 20 different uh factors here. When I came out of training in 2019 again during the transition from these two periods or eras of Taver I, I had done 92% sapiens, so I was relatively unfamiliar with uh evolutes with self-expanding valves. Um, we, we certainly knew that self-expanding valves had better hemodynamics and there was this uh this concept of patient prosthesis mismatch that was uh bearing itself out and and follow ups and higher gradients afterwards. We didn't like taking balloon expandable valves and forcing them into complex calcified anatomy because the risk of annular rupture, so we're subtracting out volume valve and valves like small annulus, like small patients, we didn't like packing another valve inside of the prosthetic valve and causing hemodynamic issues. Um, but this by and large favored mostly balloon expandable valves, better sheaths, lower pacemaker rates. The difference was 5% versus 20% pacemaker rate with the self-expanding valves. Patients had to stay longer watching conduction abnormalities. We didn't have commissional alignment and so we were really worried about coronary access. Um, our partners would say, you know, if I stepped on fluoro during the stemmi and saw a core valve, I would, I would grimace because I know it would be difficult to get into the coronaries. A lot of the features of Tavern, a lot of the data that's come out in the 5 years since have have really addressed all those issues. The biggest takeaway that we've had in the data for the past few years is that hemodynamics are are very, very significant factors in the durability of the valve and the performance of the valve long term. And so the hemodynamically performing valves, uh, evolutes and navis very likely are going to have that sustained performance for a longer period of time. And poor hemodynamics really begat the hard clinical end points in the 5 to 10 year time frame where we have reinventions where we have explants and surgery and we have all the risks that are associated with them and so hemodynamics have really uh driven a lot of our transition towards now where 85% self-expanding valves instead of in spite of a slightly higher pacemaker risk, a technique called cusp overlap. Which we were one of the highest enrollers and then in a trial called Optimize, uh, allowed us to implant higher and reduced our pacemaker rates from 15 to 20% with self-expanding valves to 5 to 7%, and they hover between 7 and 10% depending on uh what patient population we have. We have 55% of our patients have uh baseline bundle branch plaques and so they come into the procedure with higher. Uh, risk of pacemaker, but you can see over time this is more for a variety of reasons we built in commercial alignment. Our surgeons have gotten, uh, more local experience with explants and feel that using a nightinol valve and being able to put that in cold saline and have the valve contract leads to less root, uh, replacements and repairs. Um, that's our local experience and then cusp overlap, uh, techniques have allowed us. Um, to get lower single digit pacemaker rates that have really equaled the playing field here. We have all of this milieu of decisions, uh, with one head to head trial and that head to head trial was Evolute versus Sapien and patients with small annuli so patients with the cross sectional area of less than 430, that's basically intentionally designed. To look at hemodynamics in the patients where it's likely to shine best, which is in the 20 and 23 S3, so 70+% women, they're small valves. You're either putting something in the annual subloon expandable valve and not getting great hemodynamics, or you're putting that valve up a bigger valve up in the sinuses and getting better hemodynamics, and does that matter? And so what you see and what the the naysayers will say is, well, there's no difference in hard end points through two years stroke, MI, uh, re-hospitalization. But what we see is that we have significant bioprosthetic bowel dysfunction at 2 years. If I take anyone with an annulus of less than 430, which is about half of our patients, and I put a sapien in them, a balloon expandable valve, I cause BVD at 2 years every time I do that, make that decision 3 times. And so sapiens are an independent predictor of uh bioprosthetic bowel dysfunction at 2 years. It hasn't led to outcomes, hard outcomes, but what we see is we see patients back at 1 month in 1 year. What we see is that 1 month. gradients are 18. We took them to taver, you know, for paradoxic low flow, low gradient. The gradient was 38. Now all of a sudden their gradients are 18 at one month. Patients get their echo read and it says moderate aortic stenosis before you even get a chance to see them in post op at that one month visit. And you're scheduling repeat echoes at 6 months or 3 months you're starting emeric antic coagulation at 9 months because you see those gradients rise. We're not seeing valve reinventions here. We're not seeing redo tavers here. We're not seeing explants here. We're seeing emeric antic coagulation, repeat CT scans, TEEs, all of these things that, uh, are, are premonitory for, um, what will lead to the uh harder outcomes. And it's important to know that 4:30, this annular area of 20 and 23s, you didn't get that absolute risk reduction stopping at that measure. We don't know what happens above. Does PPM? Does BVD happen at the 26 and 29 sapients, and we think it does. We think hemodynamics is a consistent message that, that, uh, that is an outcome measure for post have or that we need to be, um. Focusing on some sort of measure of completion and in coronaries we have IVIS measurements to say that we did a good good job or IFR measurements that we can say we we had ischemia before and we fixed it and now we have a measure of normalization afterwards with TR it was again in the first era, let's subtract a CC of volume because the annuals looks kind of nasty. um, we'll try to shoot for a gradient less than 10 and then. You know, the valve is in they're out of the room. Now it's how do we get them the best performing valve? We've got 3 different platforms. There's a lot of different factors that go into those decisions and how are we gonna make all those decisions for each individual patient. And as I mentioned, we have good data now. I can tell patients when I started, I, I, I said, you know, they would ask how long it lasted. I say, well, it's based on surgical literature where the average is 13 years, but the median time to valve and valve to average is 8 years, um, but it's a scatter plot if you look at the surgical, uh, durability. And uh reinterventions over the age of 75 re due to uh surgeries were very, very rare and so people did not meet that end point of reintervention just because they weren't offered surgery. So the data is really, really muddy for surgical longevity, have longevity. It's becoming clear that Taver is uh non-inferior through 7 years now with Sapien, 5 years with uh evolute, but through 10 years we can assess durability in the in the very first iterations of our valve platforms with self-expanding valves, and we know that it's at least as durable as surgery through 10 years. And so how are we approaching these decisions? And so this is this is designed, uh, this was designed when we revamped our, our valve uh clinic and our multidisciplinary valve conference every single one of our patients that comes through. That you refer to structural heart or the Valve Center for considerations of what not just TaR versus SAR but which Taver platform they have concomitant coronary disease, how are we gonna manage that is all those 20 decision points are distilled down to one slide and that's important so we can review 25 to 30 of these every Monday morning. That's an open conference at 7 a.m. every Monday, uh, here, uh, med students come to. It's on teams. Anyone is welcome if you want to see sort of. How the the sausage is made um as far as how we make all these decisions, it's quite complex and I think in good faith we're doing everything in our power and using all the tools to make really individual choices, not just on which valve is gonna perform best for the patient but which one is going to be. Uh, the lowest risk for each of those individual patients and you can see we've used clinical factors we've used, uh, you know, ileofemorals. There's annular anatomy where we're making these measurements again, CT is still fairly rudimentary. A lot of these VTC and BTSTJ measurements that dictate whether we use leaflet modification are are relatively imprecise and they're based on normalizing a measure to a wide variation in annular anatomy. And so it's not good enough, but this is good enough, I think, and it's only gonna build and get better. This is how we're making decisions now. So this is a 72 year old bicuspid and instead of, uh, just subtracting a CC of volume because we see calcium on a cross sectional axial image of a CT scan and making decisions, you know, that I like sapien and I train on sapien, so I'm gonna use sapien or, you know, evolutes have a high pacemaker rate, uh, even though I've got a, you know, a bunch of EPs that do physiologic pacing and, and, and left bundle pacing. And the patients come out of their tavern or after the tavern mission with a narrow QRS than they had. This allows us to to try to pick the valve based on each individual patient's anatomy and then also this modeling has allowed us to develop certain risk calculations that are much, much more precise that are three dimensionally uh uh constructed and then validated through machine learning. So AI inputs and finds variables like this coronary inclusion measure DLC over D. Which is a three dimensional uh stenosis and flow into the sinus and that is uh much, much, much more uh precise of a test than anything we've ever used. And so again this is what's coming um is that we're gonna very quickly be able to model each of the valve platforms in each patient's anatomy this is a web app that they've developed we can change our implant depth we can look at what the native anatomy does and what the coronary flows. Uh, maybe we can look at the importance of commissional alignment. We can target our first implant depth, maybe a little bit lower in relation to a mous septum that portends a lower pacemaker rate so that we can implant a sapien in 15 years a little bit higher. And so we're going into procedures much, much, much more precise. And so to highlight this, the complexity of these cases of these, these decisions, I wanted to highlight two cases first for valve therapy disposition and procedural guidance and how we're, we're going into these procedures now. For the past 3 weeks we've hosted, uh, sessions with this company Medtronic who's partnered with them, and we've done basically 4 or 5 live cases all guided by this, uh, modeling, um, to, to demonstrate the complexity and how we're going into these cases. This first one is a radiation heart disease uh patient that had been followed for several years, was very, very active and the decision came up um. About First Tower versus Saver and the goals really were to try to minimize risk achieve durability in the context of being very, very functional, and then preserve redo options. So this is the echocardiogram. You can see a pretty significant aortic stenosis, some degree of aortic insufficiency of peak velocity of 4.7. But really what you see here is a a really hostile type of annular anatomy, something that's very concerning this calcium pattern, this nodular calcium, um, you can see that extending down into the LVL flow track. The coronary heights traditionally we use a number of 10. If it's under 10, we get a little bit concerned. If it's over 10, we don't get concerned, but 25% of coronary conclusions happen with a height of over 10. So that's the level of precision we were doing things just a few years ago. We look at sinus symmetry, we look at horizontal aorta, and ultimately when all things are created equal, um, we have the decision between two very good performing valves that are predicting hemodynamics that are very good for both platforms. So I would have said 5 years ago we would have either sent a radiation heart disease patient to to surgery and and dealt with all the issues after that or we would have probably taken a sapine and subtracted volume because of the risk of pacemaker with the right bundle branch block and now we go into this with this kind of data so I know that this patient has is between sizes for Sapien 26 and 29 and evolute 29 and 34. And so really this demonstrates the complexity of the things that we're balancing. I can choose between balloon expandable or self expanding, and I have tweener sizes. There's no real risk of coronary inclusion. This number is 0.7, anything less than that is significant. Stent opposition shows exactly what that stent at 30 days is going to do in relation to the native anatomy, so it predicts PVL. It'll actually tell you where the ear val the leak is going to occur, and you can plan for it. We know that actually with the balloon expandable valves we don't get a whole lot of PVL. It's up to 0.7. If we undersized an evolute, we would get several areas of PVL. But if we slightly oversized 15% is really within the IFU, we would not get any PVL. But here's what's really important is that the stretch analysis if we just put a sapien in, the risk of annular rupture would be significant. So we go into this and we have two different sizes as I mentioned. This is actually showing the sapien expanding and you can see that calcium getting pushed into the annus. This is how annular ruptures occur and so we would have had a significant issue with annular rupture. You can see the calcium patterns not just in cross section where there's a spicul of calcium and you say ah it looks kind of bad. You can see exactly where every calcium spiculle is and what happens in response to the stents. If we undersize the stents, so even if we go down to a 26, which is 3.4% undersized, we still have that concern for the calcium protruding into the annulus. So annular rupture, this shows you this is called aerial stretch so it basically takes the point of maximum calcium exertion from the native anatomy in response to the uh stent. So anything over 1.5 is 100% sensitive for annular rupture. So your red spots are where annual rupture would occur, and you can see with 29 significant areas in that that calcification. And 26 it's still 1.6%. That's 100% sensitive, only 57% specific this, this, uh, aerial stretch, but in in a low frequency event that has high consequences, you want something that's 100% sensitive, um, and then you focus on specificity afterwards. So when we look at the self expanding valves, this is again a 34. You can see that the tissue doesn't get pushed into the sinuses nearly uh uh much at all, and that's because the design of this valve, it's night and all valve itself expands it doesn't force itself with the balloon into the native anatomy it conforms to the anatomy. It doesn't exert as much uh uh movement on the leaflets into the sinuses, but you get a very good valve performance higher up in the sinuses unencumbered from all the, uh, annular eccentricity and variations that occur. If we downsize to a 29, it still looks good we're 5% undersized doing that so there's really no, uh, you know, benefit to downsizing and evolute. And then if we look at coronary occlusion, I can now see exactly why coronary occlude and there's no risk of coronary occlusion with either of the 2 S3 sizes. I can see 3 dimensional into each of the coronary osteum and it's when these coronaries are low, again less than 10, or the sinuses are narrow and you get sequestration by the native leaflets. That's why coronary inclusion happens. When I go to the evolut, which historically would have said, well, a young guy that's very functional has some coronary disease, we wanna make sure that we can reacts the coronaries. We wanna make sure that um. You know, we're we're not causing a sinus sequestration with a superannular valve. We can now see that there's unencumbered flow with both valve platforms into the left main and the right qua of your artery, and you can see the importance of commiral alignment. These are the commiss evolutes the only valve that you can actually bracket your left maine with the commissures to make sure you're equidistant between them and preserve coronary access. And then looking at stent acquisition, so PBL, there's no gaps we upsize to a 29, but again that's coming at the, the risk of, uh, annular rupture if we downsize, we're still getting some gaps that are developing and then from a 29 there's multiple areas of stent under expansion and risk for PBL with the 34 there's not. And then we can go even further and say what are we gonna do uh when this gentleman is in his 80s and what are the valvey interventions gonna look like and we can actually show what a sapien had node 5 implant in this 34 would look like and what it would do to the calcium. We can plan our implant depth of the first procedure based on the risk of that second procedure with needing a balloon expandable valve or self expanding valve. So instead of going into this procedure saying we're gonna subtract some CCs off of a of a uh sapien, we go into this procedure saying we're between two sizes we like the hemodynamic performance of an evolute. The pacemaker risk is not trivial, got an incomplete right bundle branch block. Uh, and the membrane is septum is short, uh, but you know what the penalty for a pacemaker in this scenario is not, not all that bad. We can do we can do a physiologic pacer and get through without any issue and preserve your ability to get an S3 in the future with a smaller valve inside the frame of the the evolute. So this is the procedure you can see it's a very high implant trying to avoid that pacemaker. These dots are at 3 millimeters. If we can get 3 millimeters in this cusp overlap at the non cornering cusp, we can get uh single digit pacemaker rates, but again. The conduction anatomy is variable in each patient as well and so some people have a membranous septum that's 1 millimeter and they're gonna get a pacemaker no matter which valve you put in. Some people have a right bundle on a membranous septum at 10. And so no matter where you put the valve you if you put it into the ventricle, they're not going to get a pacemaker and so all of this is variable and the old adages of, you know, self expanding valves we avoid them because the pacemakers and blueon expandable valves we use them because the pacemakers are low, it's not good enough for individual patients and so this was one deployment ended up with a peak to peak of 4, ended up getting uh a left bundle branch pacer and was doing great. The second case is is another use that that we've seen. This is uh one of Doctor Per's patients, um. That we saw he's 76 so typically would be a taver candidate someone that we would do everything we could to exhaust taver um but what we see in historical measures is we see, you know, some pretty nasty, not at the annuals necessarily, but some pretty nasty calcium lower and up into the leaflets. And so this is something that we would have taken on in the past, but we're a little bit concerned about the LVOT calcium. So thinking about the 1 in 500, the 0.4% chance of annual rupture every year. This is the the patient we're in historical, uh, planning, we may have missed. We may have, you know, been falsely reassured that the annuals looks OK and we would have maybe subtracted some volume out of out of a uh a sapien and gotten away with it in some scenarios and not gotten away with it in other scenarios. But when you look at this comparing the sapien and the evolute, you can see we got we have significant risk of annual rupture with a stretch of 1.9, no coronary risks necessarily, but a lot of gaps between the stent and the native anatomy. So even if we downsize the valve, we're creating, we're trading annular rupture risk for PBL and when you look at where this annual rupture is gonna occur. It makes sense to you that if you're just looking at the cross section at the annulus and making your decisions about BEV versus SEV you're missing all this calcium that the setting of a shallow or narrow sinus can still protrude through and cause issues and so. When we we try to navigate that with either self expanding valve or we try to navigate that by subtracting volume from a a balloon expandable valve, we're just trading that for severe PVL and so we're trading one problem for another. And it's not benign even though we, we fixed them on, you know, not uncommonly my first case today is a PVL closure, uh, post taver. um, we go into those PVLs now knowing with this imaging exactly where it's gonna occur, knowing what views we're going to, uh, engage the PVL and and what size it's gonna be and which plugs we're gonna go into. So instead of these being 4 hour PVL procedures, um, they're they're now 30 minute to 1 hour procedures. So we sent this patient to surgery and this is Doctor Kemp's quote, um, and you can see the correlation between the anatomy and what he saw intraoperatively and so this patient, even though they were 76, I would argue, uh, we gave them the safer therapy by sending them to surgery and so we're making decisions in real time, not just on Saber versus Taver uh but with which valve platforms uh we use with much more sophistication than we were even two years ago. So the other thing is risk mitigation and coronary occlusion risk is, is probably the most validated of all the measures that have come out of this, but coronary inclusion happens in taver for one of three reasons. So first, you can get distal embolization that can happen at any point in time just from thrombus on the leaflets, but the two mechanisms generally are the native leaflets or bioprosthetic leaflets get pinned up and basically occlude the coronary osteum, or you get sequestration of tube graft in the sinuses such that you don't get any sinus flow. The rates are relatively low and so in natives, uh, anatomy it's 0.4 to 0.7%. It's sixfold higher in Valve and Valrido tavers, but that's still less than 5% total risk. And every time you see us write basilica or cleave or Unicorn or all these ridiculous acronyms, uh, that people come up with, what we're talking about is these between 0.4% and 3.5% of patients that are at high risk for this. And the gatekeeper for the decisions and when we're taking electrified wires and lacerating leaflets is often very imprecise CT data and not this kind of modeling and so we're overusing those high risk procedures in a relatively low frequency event that arguably has very, very high complication rates and that's why we do it. If you have coronary occlusion, with the, the old adage is you don't have a coronary occlusion problem, you have a lack of ECMO problem because people decompensate so quickly. If you can get a stent and they still have a 22% mortality, if you convince the surgeon to open them up and bypass, they have a 50% mortality, but if you can't do either of those things, every single patient dies. And so in the setting of a low frequency event with high consequence, using imprecise upfront data to guide those adjunctive procedures isn't good enough. This is what we have. I mean this is so complex. This is, this is a ridiculous paper. It's trying to define this called the vivid criteria. Um, it's trying to define, uh, sinus dimensions and coronary heights and giving you risks, uh, base of coronary oclusion based on these anatomic variations, but what it leads to is that you can't validate it. Anyone that was high risk in this complex classification scheme, um, didn't have a coronary occlusion event again because it's a low frequency event, so we're kind of flying blind. This is not flying blind anymore. This is the variable that AI came up with that basically looks at a three dimensional DLC over D flow into the sinuses and validate against BTC, which is we use 4 millimeters for all patients if they're under 4 millimeters, that's your virtual valve to the coronary on a CT scan. You can measure that 10 times and get 10 different answers and we're making decisions about basilica based on that. If you validate that this new measure against that, it's uh got ROC curves that are 2.5 times better. It's 100% sensitive and 95.7% specific. So we have much better measures and predictors of these low frequency but high consequence events in Taver and that's how we make already low complication rates even lower. A case that highlights this. This is a 70 year old female with bioprosthetic AS. She had a Magna E 3300 in 2013 with concomitant repair, severe COPD, and she came in with bioprosthetic aortic stenosis. By traditional measures, you can see we have coronary heights of 6 and 5. They're under 10, so we're already concerned. We have VTCs of 4.2. We measure it 5 times and we get 3 on one side of 4 and 2 on one side on the other side of 4. We have VTCs on the left that are maybe a little bit more favorable BTSTJs that look OK. So would we, would we do a basilica in this case? Would we do both leaflets? The coronaries are low. The question is, um, is this what we're gonna base this on? Is this imprecise information? And no, we can use this exact modeling to to be more precise and when we do that we can see even if you dispel a lot of the, the, the AI machine learning sort of biomarkers and these risk factors that have been developed just from a three dimensional understanding of what that patient's native anatomy is gonna do in response to the stent. And seeing the flow into the coronaries, what you can see is that with a uh with a balloon expandable 23, it's actually the sapien valve pushes the native leaflets up into the right coronary much more and you you actually can't see the right coronary here above the right coronary leaflet. You've got very limited flow into the sinuses so that flagged us uh to coronary occlusion but isolated on the right. Now we would fracture this valve and so even though we're gonna use a self expanding valve we would be post dilating with a 24 true and so we'd be replicating what would happen with the 23 sapien if not a little bit more. When we do that with a uh self expanding valve you can see we don't have problems with flow into the sinuses but again this patient had a component of patient prosthesis mismatch so we want to take this old surgical valve and we put a Kevlar balloon in and we fracture the old valve to make the new stent expand more. So if we're gonna do that, uh, we are actually increasing the risk like a balloon expandable valve. So now instead of going to this procedure and saying OK yeah let's just do basilica on both and exposing that patient to really high risk um we can model the actual basilica this is what a basilica is you see the laceration of the leaflets right here and right. It's actually here and on the left side. So that linear laceration is what a basilica is. And we made a decision to just do the right, and we did something called cleave and so this is a uh multi-purpose guide you can see how low the corner is. This is the back end of a J wire that's electrified with a 40 charger inside of it. It's all guided by 3D multiplanner reconstruction. We create a little pinhole in the the native right leaflet. We dilate that balloon in exchange for a uh LV wire safari wire. We dilate that with the 12 balloons. So again we're in a keyhole in the leaflet here with the balloon that's inflated, and we're doing that to obliterate the leaflet so that it doesn't swing up and block the coronary and we actually deploy the valve in that keyhole and it's working perfectly even though we're not in the central orifice of the valve, we're in an intentional leaflet perforation. And then we expand that valve with a post dilation and then you'll see the fracture of the old surgical ring as well. So there's where it fractured right there. The patient had no PVL. Um, they had a mean grading of 4 and a peak to peak of 4, so did extraordinarily well. Likewise, it's allowed us to use dedicated purpose built tools uh to navigate more complex leaflet, uh, uh, modification, uh, requirements. This is a patient that had a 23 S3 in 2018 and again came in with, uh, bio prosthetic aortic stenosis. This is very complex. This is a redo tavern. If you look back at her, uh, imaging from 2018, she had low coronary heights, relatively low corner heights, and narrow sinuses. So when we see red here on our old uh modeling this means that we were a little bit concerned about hemodynamics with putting in a sapien. The EOAs were predicted to to to have a little bit of PPM, but we made that decision because we were worried about the coronaries. Now that Valve came back and you know even two years afterwards she's starting to get mean gradients in the 20s since 2020, she's on empiric anticoagulation. So back to the smart trial, this is what manifests at year seven is that those gradients that were 20 and 25, 2 years out from her valve are now, you know, 40 and she's symptomatic. We've got to retreat. By traditional measures, again, the stent frame actually comes the sapping came up above the leaflets. We have low corner heights, uh, shallow, or narrow VTCs, less than 4, and very shallow VTSDJs, so the risk of coronary inclusion is, is tremendous both by sinus sequestration and by the, uh, tavern leaflets propping up and causing coronary occlusion. So this would get swing swung up and basically block flow into the coronary. Now we can model this and we can say, Look, if we do a uh evolute and deploy a little bit lower, we're gonna mitigate the risk of sinus sequestration. Uh, is the sinus sequestration gonna be all we need to do? Do we, do we still need to lacerate the leaflets? The frame is still above the left main and, and the calcium tip, and are these models valid in in such a unique scenario, someone that has a generated S3 that we're putting an evolute in. But ultimately we used this purpose built tool so instead of doing 30 of these a year we do 5 to 7 a year and we can use dedicated tools like this device called the shortcut uh that's purpose built and allows us to safely lacerate these leaflets, sometimes lacerate both of them. In under 20 minutes instead of doing electrified wires, snaring wires, putting a V and a kink in the wire, and then electrifying them and and lacerating the leaflet, which is what a basilica is, or instead of perforating through the base of a leaflet and deploying a valve in that perforation. We have a device now that that does all this is purpose built and has been demonstrated to be safe. What it does is come down on top of the leaflet. There's a cutting element And what's nice about this is you cross the valve, you have an LV wire it goes through your taver sheath and so you can lacerate through over the wire that you're gonna deliver the taver through you can lacerate you can come up and you can turn it and lacerate the other side. So we've done 8 of these cases thus far. But more importantly, before we started using modeling for 500 tavers with about 10% being our redo or valve and valve, the highest risk patients, we were doing almost 30 basilica cases a year and so almost half, a little over half of our of our patients were getting. Uh, extra procedures that are higher risk and we were doing that because of the fear of the high consequence event of coronary inclusion. Well, now with more precise imaging and modeling we can focus on the patients that absolutely need that the most and use arguably a more expensive device but use it in the patients that actually need it and now we're doing like I said, uh, between 7 and 10 a year instead of 30 a year. This is that case. This is us lacerating the left. You can see it's just a gentle push on the wire. The cutting element has already perforated the base of the leaflet. And the leaflet is lacerated. This is all guided by 3D MPR by Doctor Cohen so he can actually show me if I'm equidistant between the commissures and if I'm cutting through the the largest portion of the leaflet. And then we just spin it over and do the right. And this took 17 minutes to do a double basilica with a dedicated device whereas before it would have taken us 2.5 hours so we can also do more cases, uh, and patients wait less. This is the valve we intentionally deployed a little bit low based on some of that planning and so again we went in with more precision you can see the coronary filling. And then the final coronary inclusion case is one where we we used uh the shortcut again but it highlights really if if you didn't understand basilica and why it's necessary, this case highlights that you can see the bioprosthetic leaflet all but completely occluding flow into the sinuses and so the DLC over Ds were 0.1 and 0.3 in this, and you can see exactly why you have coronary occlusion. You cannot see into the coronaries on the left or the right. And more importantly it shows you what a leaflet modification looks like this is what the basilica does. You can see it splays by creating that linear laceration. This is without and the left and the right, this is with and the left and the right. And we chose an intra-annular valve here which is technically off label because they're they're a newer valve but because we would have still had sinus sequestration. You can see that laceration beautifully on on TEE. And then we lacerated the right in the same fashion. And then we fractured the valve. And had good coronary filling with a peak to peak of 6 and no PVL. So this patient had no symptoms at 30 days. This was just, uh, 2 months ago and so we, we, we've, uh, we're presenting this and we're publishing on this is that, uh, our pre-modeling versus post-modeling has dramatically reduced our necessity for the higher risk leaflet modification cases in spite of having a new tool that makes it easier to do those cases, so arguably changing that treatment threshold to lower to reaching for a shortcut any time we have concerns, we've still reduced our total rate of necessary leaflet modifications. and helped in that fashion. So what's coming next, so these models are based on. You know, data sets that are getting broader and broader and more robust and so also becoming more and more predictive. We can now predict halt by using index echo and looking at flow on the CT scans. Again, you can take pre-CTs is all you need, and you can look at your virtual valve deployments and with machine learning and statistical analysis you can get predictors of uh bioprosthetic valve dysfunction at least by halt, and we can predict hemodynamics. So before we go into a case, we can now say this patient with an evolute is gonna have this gradient through 3 months or Sapien is gonna have this gradient through 3 months. And so we're now getting the ability to when we're making the decisions about which valve platform surgery versus tava we're now getting the ability and we'll very quickly get more and more uh precision with the ability to see what the result is going to be not just immediately during the procedure but at 3 years, 5 years, 10 years as more data is input into these models. And then finally we're also using this to guide mitral procedures. These are just a few examples. It's a little bit grainy here, but um we've done several open atrial valve and macs so you can see how dense this calcification is that would take even in the best surgical hands like Doctor Scortino would take hours to debulk in a in a very you know high risk 82 year old patient and instead we can deploy intraoperatively, uh, in patients that have high risk of outflow tract obstruction. We can deploy intraoperatively a sapien. This is an Arctic procedure where patients had a prior clip we can deploy a valve on the other side of that clip. This is transeptal valve and Max. We can make sure that there's enough calcification when you see us talking about lampoons just like basilica and leaflet modification. We're worried about that native leaflet or the bioprosthetic leaflet swinging forward and causing neo LV outflow tract obstruction. And this is an example of of one of those cases. So this is an 81 year old, uh, that we did a valve and Mac TMVR on and had high risk of, uh, this native leaflet swinging in and causing outflow track obstruction. We can now see the LV outflow track in three dimensions instead of just taking a static two dimensional image, and we modeled a 29S3 at a 9010 deployment with three extra CCs of volume filled in. And with that complex Mac we could also predict where the PBL is going to occur. This is 3D MPR that procedure. This is us doing a septostomy, so this is the benefit of cardiac imaging and Doctor Cohen and our our advanced imagers have really. Taking it to where we can we can model all of this stuff, but if we can't do it, it's just pretty pictures. If you can model and you can have interp procedural guidance now you can do those cases and so they've increased our capacity to take on these cases where patients previously and that lots of other centers are just sent to hospice like we used to do for Tavern. So this is septostomy. This is just deploying. You can see how difficult these can be. That's the Mac that we're deploying and that's a sapien we're coming transeptal through that septostomy. And if you're just, you know, a millimeter or 2 more ventricular, it embolizes into the valve and into the ventricle in a patient that doesn't have a surgical backup. So some of the, the, the highest risk cases we do, but we're going into them, at least in my perspective with lower heart rates than we were historically, uh, because we have very, very robust planning and modeling data on the front end. This case was also done with significant risk for uh uh alpha tract obstruction because of septal hypertrophy and and Div Patel did a procedure called a scorpion where he did uh uh bipolar ablation of the septum to thin the septum because we couldn't do an alcohol septal ablation. So our main trans mitral gradient was 3, our peak to peak LVOT was only 4, and we did an ASD closure again, even routine things like ASD closures are better with advanced images. And so in conclusion, um, pre-procedural planning for structural heart is definitely involved. Taver's only about 15 years mature. We went from TE sizing and planning on every single patient just a little over 10 years ago and making uh valve decisions about whether you're a man or a female getting a 23 or 26 or what we had some rudimentary measures on echoed guiding some of those decisions on valve size to then having CTA multiplanar reconstruction and making two dimensional measurements. To taking patients CT scans and printing them physically printing them to creating virtual 3D prints to now having dynamic computational modeling to guide these, and this allows us to pick the best therapy, not just TaR versus Sab but also which one of the three valves is gonna work uniquely for that patient's unique anatomy, not just with respect to uh durability and um. Other measures of outcomes but in risk uh modulation and risk mitigation for that patient's individual risk based on their anatomy as patient volumes increase, what we're trying to do is find that 0.4% annual rupture risk in the 1 in 500 tavers every year that's gonna occur randomly on a on a Friday or a Monday is the third case and someone we didn't predict because we had rudimentary ways of predicting and now we have with using this kind of technology. Much, much more precision to finding that quote unquote needle in the haystack and at the simultaneous point of having to take on more and more complex tavers and reinterventions, uh, we can now plan with so much more precision even in the most complex mitral procedures, um, with these dedicated tools and we can use purpose built devices like Shortcut and the patients 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Matt Summers, uh, the program director of Structural Heart. I know most of the people in the, in the audience here are our ego teams and our cath lab teams, um, but I wanted to, to give a talk today highlighting what we've been doing instructural Hart as far as how we're planning some of these both routine, what we call common and complex procedures, and so, um, we've been using, uh, quite a bit of computational modeling and pre-procedural simulations to help guide.","start_time":"0.0","end_time":"24.26","items":[0,1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98]},{"id":1,"transcript":"Not just our most uh high risk and complex uh uh procedures and surgeries and to guide our therapies like decisions with uh between Saver and Taver uh but also uh the routine ones to try to head off complications that are becoming increasingly rare but in the context of increasing volumes increasingly difficult to find that quote unquote needle in the haystack where uh.","start_time":"24.479","end_time":"49.11","items":[99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164]},{"id":2,"transcript":"You know we're trying to find the one annual rupture every year that that happens you know on a on a random Wednesday on a patient that we didn't predict and a lot of that is predicated on on how we use historical modeling and planning for these procedures um and how that's morphed over time. So the title of this talk is Computational modeling and Advanced Pre-procedural simulations to guide uh structural heart interventions.","start_time":"49.479","end_time":"70.389","items":[165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241]},{"id":3,"transcript":"And so for just a brief outline, I'll, I'll go through, uh, this is mostly case based. I've highlighted 5 cases where we found incredible value with with this 3D modeling and and pre-procedural simulations, um, but I'll, I'll walk through a little bit of the history of how we plan the structural heart procedures, uh, and then how we're currently using them, uh, from the in the context of making decisions about, uh, SAR versus Tavern which valve platform we use, uh, how we're preserving options for patients in the future, what's called lifetime management.","start_time":"71.559","end_time":"101.26","items":[242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355]},{"id":4,"transcript":"Um, interp procedural risk mitigation, so particularly coronary occlusion, um, and annular rupture risks, and then, uh, we're even getting ways to predict post procedural outcomes like hemodynamics, uh, bio prosthetic valve degeneration, and I'll give some examples on how that's morphing into mitral valve therapy simulations as well.","start_time":"101.669","end_time":"122.19","items":[356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415]},{"id":5,"transcript":"And so if you look at the history of Taver really this, this kind of started in 2010, and this is a good case example for how we modeled things historically and how we model things now and so in 2010 we were guiding all of our procedures by TEE for for TaR and even until about 2014, 2015 in intermediate risk, uh, Taver populations if you're a woman, you got a 23 SapiXT if you're a man, you got a 26.","start_time":"123.989","end_time":"148.19","items":[416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505]},{"id":6,"transcript":"So if you think about all the variation that exists at the annulus in our Ecotech see this every single day, every valve is different and so the fact that two sizes fit fit all is is ridiculous. The fact that we can take the resolution of a TEE um and expect, you know, it's great for live imaging, but expect it to model what's gonna happen in a procedure in the setting of that anatomical complexity.","start_time":"148.49","end_time":"172.179","items":[506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588]},{"id":7,"transcript":"Um, is rudimentary as well. And then when you look at 2015 or so, the last 10 years, we've been using CT scans to make very precise measurements and at submillimeter resolutions we can measure things and try to predict the risks of things like coronary oclusion or model redo tavers.","start_time":"172.35","end_time":"190.33","items":[589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644]},{"id":8,"transcript":"People have made their whole careers off of 3D printing people's CT scans and then doing the procedures inside of those and then that certainly was an interest of ours as we were tackling more complex cases but ultimately what you're doing there is you're taking plastic or TPU and you're in, you know, you know, implanting a valve into that and it's a static non-tissue sort of characteristic model and so it's really looking at uh anatomic relations between different cardiac structures more than it is anything else.","start_time":"190.63","end_time":"218.619","items":[645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,724,725,726,727,728,729,730,731,732,733,734,735,736,737]},{"id":9,"transcript":"And then we, we morphed into from doing this at uh some of these cases at ODU into what's called virtual 3D prints which are still static images, um, but they use your CT scan to embed virtual 3D geometry inside of patients. This is the Valve and Mac case that we did and had materialized, uh, which is a company that that uh takes your CT scans and does 3D modeling.","start_time":"218.91","end_time":"241.96","items":[738,739,740,741,742,743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,760,761,762,763,764,765,766,767,768,769,770,771,772,773,774,775,776,777,778,779,780,781,782,783,784,785,786,787,788,789,790,791,792,793,794,795,796,797,798,799,800,801,802,803,804,805,806,807,808,809,810,811,812,813,814,815,816]},{"id":10,"transcript":"Uh, model that valve and Mac and you can see the calcium is actually protruding into the stent frame so you're still taking a 3D print and you're putting a virtual, uh, geometry inside of it it doesn't show you what tissues do in response to that stent therapy.","start_time":"242.25","end_time":"256.67","items":[817,818,819,820,821,822,823,824,825,826,827,828,829,830,831,832,833,834,835,836,837,838,839,840,841,842,843,844,845,846,847,848,849,850,851,852,853,854,855,856,857,858,859,860,861,862,863,864,865,866,867,868,869]},{"id":11,"transcript":"So what we've, we've started modeling and what we started using the last two years is computational dynamic 3D modeling which basically takes patients. The models were built by taking pre-AR CT scans and 30 dayAR CT scans and looking what that stent does in relation to individual anatomy, and they can predict with enough data points within 10% uh what that stent, what that taver is gonna look like at 30 days.","start_time":"257.01","end_time":"282.47","items":[870,871,872,873,874,875,876,877,878,879,880,881,882,883,884,885,886,887,888,889,890,891,892,893,894,895,896,897,898,899,900,901,902,903,904,905,906,907,908,909,910,911,912,913,914,915,916,917,918,919,920,921,922,923,924,925,926,927,928,929,930,931,932,933,934,935,936,937,938,939,940,941,942,943,944,945,946,947]},{"id":12,"transcript":"And if you can do that, the vast majority of complications in Taver are related to that stent deforming native anatomy you're pushing native anatomy out of the way. And so we now have the ability, and we've been using this company for the past 2 years, uh, to individualize treatments, implant valves in a variety of different anatomical, uh, variations, see what that tissue does in response to the stent.","start_time":"282.709","end_time":"306.25","items":[948,949,950,951,952,953,954,955,956,957,958,959,960,961,962,963,964,965,966,967,968,969,970,971,972,973,974,975,976,977,978,979,980,981,982,983,984,985,986,987,988,989,990,991,992,993,994,995,996,997,998,999,1000,1001,1002,1003,1004,1005,1006,1007,1008,1009,1010,1011,1012,1013,1014,1015,1016,1017,1018,1019,1020,1021,1022,1023,1024,1025,1026,1027,1028]},{"id":13,"transcript":"And with enough data points you can use that to guide your valve therapy decisions. You can use that to uh head off complications and now we're getting to the point where we can predict post procedural outcomes in response to this dynamic modeling, but this is an app that they've developed that we'll be using at the beginning of next year where we can quite literally embed our first valve different heights. It'll show you where the risk of annular rupture is where coronary oclusion risk happens.","start_time":"306.45","end_time":"332.29","items":[1029,1030,1031,1032,1033,1034,1035,1036,1037,1038,1039,1040,1041,1042,1043,1044,1045,1046,1047,1048,1049,1050,1051,1052,1053,1054,1055,1056,1057,1058,1059,1060,1061,1062,1063,1064,1065,1066,1067,1068,1069,1070,1071,1072,1073,1074,1075,1076,1077,1078,1079,1080,1081,1082,1083,1084,1085,1086,1087,1088,1089,1090,1091,1092,1093,1094,1095,1096,1097,1098,1099,1100,1101,1102,1103,1104,1105,1106,1107,1108,1109,1110,1111,1112,1113,1114,1115,1116,1117,1118,1119,1120]},{"id":14,"transcript":"And it'll even show you what valve you can use uh in 10 to 15 years for the redota. So we're now getting to the point where it's, it's a given that we're gonna get through the index procedure. We're talking about what the next valve would be and and dictating our implantation depth and some of our valve selections based on.","start_time":"332.54","end_time":"349.049","items":[1121,1122,1123,1124,1125,1126,1127,1128,1129,1130,1131,1132,1133,1134,1135,1136,1137,1138,1139,1140,1141,1142,1143,1144,1145,1146,1147,1148,1149,1150,1151,1152,1153,1154,1155,1156,1157,1158,1159,1160,1161,1162,1163,1164,1165,1166,1167,1168,1169,1170,1171,1172,1173,1174,1175,1176,1177,1178,1179,1180,1181,1182,1183,1184,1185,1186]},{"id":15,"transcript":"The patient's individual unique anatomy so that we preserve options in the future and so we've morphed from TEE just 15 years ago to size all of these things, having two valve sized now being in the 4th generation of taver valves with three very good options and still very, very good surgical therapies, uh, and we're trying to determine really which valve works best for each individual patient and which risks each patient has individually for those specific valves and so um I'll use uh.","start_time":"349.059","end_time":"378.39","items":[1187,1188,1189,1190,1191,1192,1193,1194,1195,1196,1197,1198,1199,1200,1201,1202,1203,1204,1205,1206,1207,1208,1209,1210,1211,1212,1213,1214,1215,1216,1217,1218,1219,1220,1221,1222,1223,1224,1225,1226,1227,1228,1229,1230,1231,1232,1233,1234,1235,1236,1237,1238,1239,1240,1241,1242,1243,1244,1245,1246,1247,1248,1249,1250,1251,1252,1253,1254,1255,1256,1257,1258,1259,1260,1261,1262,1263,1264,1265,1266,1267,1268,1269,1270,1271,1272,1273,1274,1275,1276,1277]},{"id":16,"transcript":"This is a jumping off point for for how we're approaching things nowadays, so most people know this, um, we are a large volume taver center. Our, our teams, you guys, our cardiologists take care of more than 1000, uh, aortic valve patients per year that are sent our way, and we do between 500 and 550 tavers a year. And so that volume comes with a couple different things. It comes with a large volume of increasingly lower risk patients.","start_time":"378.549","end_time":"404.079","items":[1278,1279,1280,1281,1282,1283,1284,1285,1286,1287,1288,1289,1290,1291,1292,1293,1294,1295,1296,1297,1298,1299,1300,1301,1302,1303,1304,1305,1306,1307,1308,1309,1310,1311,1312,1313,1314,1315,1316,1317,1318,1319,1320,1321,1322,1323,1324,1325,1326,1327,1328,1329,1330,1331,1332,1333,1334,1335,1336,1337,1338,1339,1340,1341,1342,1343,1344,1345,1346,1347,1348,1349,1350,1351,1352,1353,1354,1355,1356,1357,1358,1359,1360,1361,1362,1363,1364,1365,1366,1367,1368,1369,1370,1371]},{"id":17,"transcript":"Uh, where we're trying to take already low risk events like annular rupture and coronary inclusion and we're trying to make them even lower, and we're trying to find those one or two patients every single year they're gonna have that event again with rudimentary prep procedural planning and modeling, um, and we're also getting an increasing bolus of redo tavers and valve and valve tavers and tavers that are at risk for annular rupture and a variety of different complexities that make, uh, a different subset of patients also more and more difficult to to manage.","start_time":"404.32","end_time":"432.67","items":[1372,1373,1374,1375,1376,1377,1378,1379,1380,1381,1382,1383,1384,1385,1386,1387,1388,1389,1390,1391,1392,1393,1394,1395,1396,1397,1398,1399,1400,1401,1402,1403,1404,1405,1406,1407,1408,1409,1410,1411,1412,1413,1414,1415,1416,1417,1418,1419,1420,1421,1422,1423,1424,1425,1426,1427,1428,1429,1430,1431,1432,1433,1434,1435,1436,1437,1438,1439,1440,1441,1442,1443,1444,1445,1446,1447,1448,1449,1450,1451,1452,1453,1454,1455,1456,1457,1458,1459,1460,1461,1462,1463,1464,1465,1466,1467,1468,1469,1470,1471,1472,1473,1474,1475]},{"id":18,"transcript":"And so if you look at Tavern and break it down into two eras, I, I came out of training right here in between the two eras of 2019, um, initially Taver was being used to to treat people that didn't have any other options, so most of you have practiced either through through echo or cath lab or through cardiology during those initial years when we didn't have options for patients we're sending.","start_time":"432.97","end_time":"455.399","items":[1476,1477,1478,1479,1480,1481,1482,1483,1484,1485,1486,1487,1488,1489,1490,1491,1492,1493,1494,1495,1496,1497,1498,1499,1500,1501,1502,1503,1504,1505,1506,1507,1508,1509,1510,1511,1512,1513,1514,1515,1516,1517,1518,1519,1520,1521,1522,1523,1524,1525,1526,1527,1528,1529,1530,1531,1532,1533,1534,1535,1536,1537,1538,1539,1540,1541,1542,1543,1544,1545,1546,1547,1548,1549,1550,1551,1552,1553,1554,1555]},{"id":19,"transcript":"80 and 90 year olds with severe AS to hospice uh when they had symptoms, um, so the 1st 10 years of travel is really trying to get people without options of treatment and then trying to get them through it unscathed 24 French sheets, bad peripheral arterial disease, um.","start_time":"455.57","end_time":"471.64","items":[1556,1557,1558,1559,1560,1561,1562,1563,1564,1565,1566,1567,1568,1569,1570,1571,1572,1573,1574,1575,1576,1577,1578,1579,1580,1581,1582,1583,1584,1585,1586,1587,1588,1589,1590,1591,1592,1593,1594,1595,1596,1597,1598,1599,1600,1601,1602,1603,1604,1605,1606,1607,1608,1609,1610]},{"id":20,"transcript":"A high annular rupture risk, very, very, uh, uh, rudimentary, uh, type valves, uh, again two valves for, for all sizes, uh, makes the procedure much more complex to to fit a square peg in a round hole, so to speak, and patients really, uh, had when we talked to those when I talked to those folks in, in, uh, in fellowship, they were trying to make sure that they had an option. Are they gonna be OK? Are they gonna get through the procedure and that dictated all the conversations.","start_time":"472.049","end_time":"498.309","items":[1611,1612,1613,1614,1615,1616,1617,1618,1619,1620,1621,1622,1623,1624,1625,1626,1627,1628,1629,1630,1631,1632,1633,1634,1635,1636,1637,1638,1639,1640,1641,1642,1643,1644,1645,1646,1647,1648,1649,1650,1651,1652,1653,1654,1655,1656,1657,1658,1659,1660,1661,1662,1663,1664,1665,1666,1667,1668,1669,1670,1671,1672,1673,1674,1675,1676,1677,1678,1679,1680,1681,1682,1683,1684,1685,1686,1687,1688,1689,1690,1691,1692,1693,1694,1695,1696,1697,1698,1699,1700,1701,1702,1703,1704,1705,1706,1707,1708,1709,1710,1711,1712,1713,1714,1715,1716,1717,1718,1719,1720,1721,1722,1723,1724]},{"id":21,"transcript":"But in the last five years things have morphed. It's now that we have low risk indications and we had in 2019 we had two low risk trials that came out that showed that folks over the age of 65, they have a tricuspid valve. TR was not inferior to surgery. Now we have 10 year data through the notion trial it shows that TR actually has superior rates of, uh, SVD and valve degeneration than Taver and superior rates of hemodynamics because of valve design.","start_time":"498.45","end_time":"526.07","items":[1725,1726,1727,1728,1729,1730,1731,1732,1733,1734,1735,1736,1737,1738,1739,1740,1741,1742,1743,1744,1745,1746,1747,1748,1749,1750,1751,1752,1753,1754,1755,1756,1757,1758,1759,1760,1761,1762,1763,1764,1765,1766,1767,1768,1769,1770,1771,1772,1773,1774,1775,1776,1777,1778,1779,1780,1781,1782,1783,1784,1785,1786,1787,1788,1789,1790,1791,1792,1793,1794,1795,1796,1797,1798,1799,1800,1801,1802,1803,1804,1805,1806,1807,1808,1809,1810,1811,1812,1813,1814,1815,1816,1817]},{"id":22,"transcript":"And so we've morphed into now uh patients are expecting to get through the procedure unphased expecting to get through the procedure without complications, and they're asking, well, what do I do next? Can I go home the same day? How many days in the hospital can I, do I have to stay, um, when I, when can I get back to exercising? So just in the past 5 years, the nature of these conversations have changed pretty dramatically.","start_time":"526.349","end_time":"548.429","items":[1818,1819,1820,1821,1822,1823,1824,1825,1826,1827,1828,1829,1830,1831,1832,1833,1834,1835,1836,1837,1838,1839,1840,1841,1842,1843,1844,1845,1846,1847,1848,1849,1850,1851,1852,1853,1854,1855,1856,1857,1858,1859,1860,1861,1862,1863,1864,1865,1866,1867,1868,1869,1870,1871,1872,1873,1874,1875,1876,1877,1878,1879,1880,1881,1882,1883,1884,1885,1886,1887,1888,1889,1890,1891,1892,1893,1894,1895,1896,1897,1898,1899,1900,1901,1902,1903,1904,1905,1906,1907,1908]},{"id":23,"transcript":"And so as a large program like we have, um, really the two goals are how do we continue to lower those already low in procedural risks and improve outcomes but still preserve the option for patients uh when they're older and aren't great surgical candidates or maybe have a higher surgical risk. How are we timing uh the fact that patients sometimes need 3 valves nowadays.","start_time":"548.7","end_time":"570.65","items":[1909,1910,1911,1912,1913,1914,1915,1916,1917,1918,1919,1920,1921,1922,1923,1924,1925,1926,1927,1928,1929,1930,1931,1932,1933,1934,1935,1936,1937,1938,1939,1940,1941,1942,1943,1944,1945,1946,1947,1948,1949,1950,1951,1952,1953,1954,1955,1956,1957,1958,1959,1960,1961,1962,1963,1964,1965,1966,1967,1968,1969,1970,1971,1972,1973,1974,1975,1976,1977,1978,1979]},{"id":24,"transcript":"And when are they gonna get their strenotomy? How feasible is it to do a third taver? Is it more difficult to explant their taver and do or then do a redo taver? And so there's a variety of factors that are that are, are, are, um, blossoming in in our field as far as how we take care of those patients and the index valve selection really is is key there.","start_time":"570.799","end_time":"590.929","items":[1980,1981,1982,1983,1984,1985,1986,1987,1988,1989,1990,1991,1992,1993,1994,1995,1996,1997,1998,1999,2000,2001,2002,2003,2004,2005,2006,2007,2008,2009,2010,2011,2012,2013,2014,2015,2016,2017,2018,2019,2020,2021,2022,2023,2024,2025,2026,2027,2028,2029,2030,2031,2032,2033,2034,2035,2036,2037,2038,2039,2040,2041,2042,2043,2044,2045,2046,2047,2048,2049,2050,2051,2052,2053,2054,2055,2056,2057,2058,2059]},{"id":25,"transcript":"And then how do we prepare uh for the simultaneously increasing volumes um of both lower risk what we call common taver and complex tavern.","start_time":"591.15","end_time":"601.01","items":[2060,2061,2062,2063,2064,2065,2066,2067,2068,2069,2070,2071,2072,2073,2074,2075,2076,2077,2078,2079,2080,2081,2082,2083,2084,2085]},{"id":26,"transcript":"Just to give you a lay of the land, we have 3 commercially available taver platforms. There's a balloon expandable valve platform, Sapien that you hear about, and there's two self-expanding val valve platforms we use uh a majority of our cases, the Medtronic Evolute FX plus we are using quite a bit of Navitor, which is another self-expanding valve. This is intra-annular. This is intra-annular. This is super annular, and both of these are self-expanding valves.","start_time":"602.049","end_time":"629.599","items":[2086,2087,2088,2089,2090,2091,2092,2093,2094,2095,2096,2097,2098,2099,2100,2101,2102,2103,2104,2105,2106,2107,2108,2109,2110,2111,2112,2113,2114,2115,2116,2117,2118,2119,2120,2121,2122,2123,2124,2125,2126,2127,2128,2129,2130,2131,2132,2133,2134,2135,2136,2137,2138,2139,2140,2141,2142,2143,2144,2145,2146,2147,2148,2149,2150,2151,2152,2153,2154,2155,2156,2157,2158,2159,2160,2161,2162,2163,2164,2165,2166,2167,2168,2169,2170,2171,2172,2173]},{"id":27,"transcript":"The benefits to this is basically 70% of the market share right now, but it's a set it and it's where you deploy it is where it ends up so you shoot for a 90/10 implant or an 80/20 implant, you know, if you're worried about the annuals, you subtract out a CC of volume from the balloon or if you're, you know, trying to size it very specifically for a patient's anatomy sometimes you add a CC of fill volume or two CCs of fill volume.","start_time":"629.75","end_time":"653.46","items":[2174,2175,2176,2177,2178,2179,2180,2181,2182,2183,2184,2185,2186,2187,2188,2189,2190,2191,2192,2193,2194,2195,2196,2197,2198,2199,2200,2201,2202,2203,2204,2205,2206,2207,2208,2209,2210,2211,2212,2213,2214,2215,2216,2217,2218,2219,2220,2221,2222,2223,2224,2225,2226,2227,2228,2229,2230,2231,2232,2233,2234,2235,2236,2237,2238,2239,2240,2241,2242,2243,2244,2245,2246,2247,2248,2249,2250,2251,2252,2253,2254,2255,2256,2257,2258,2259,2260,2261,2262,2263,2264,2265,2266,2267]},{"id":28,"transcript":"It's relatively imprecise and what we've noticed over time with head to head trials is the hemodynamics of these valves differ pretty significantly from the self-expanding valves. The self-expanding valves in particular superannular valves basically take your annulus and all the variations that occur at it, and it puts a larger valve up in the sinuses where you can have symmetric expansion of a prosthetic valve. It's almost a built-in root enlargement.","start_time":"653.69","end_time":"677.039","items":[2268,2269,2270,2271,2272,2273,2274,2275,2276,2277,2278,2279,2280,2281,2282,2283,2284,2285,2286,2287,2288,2289,2290,2291,2292,2293,2294,2295,2296,2297,2298,2299,2300,2301,2302,2303,2304,2305,2306,2307,2308,2309,2310,2311,2312,2313,2314,2315,2316,2317,2318,2319,2320,2321,2322,2323,2324,2325,2326,2327,2328,2329,2330,2331,2332,2333,2334,2335,2336,2337,2338,2339,2340,2341,2342,2343]},{"id":29,"transcript":"Uh, by, by doing that, it comes at the expense historically with higher pacemaker rates, but we now have 10 year data, the earliest platform of core valve, uh, that shows again lower SVD rates than surgery. The newest one is, is Abbott and Avatar, which has a lot of ease of use, uh, uh, uh, features. It's got bigger cells, taxes coronaries. Both of these valves have the capabilities to do what's called commission alignment.","start_time":"677.309","end_time":"700.469","items":[2344,2345,2346,2347,2348,2349,2350,2351,2352,2353,2354,2355,2356,2357,2358,2359,2360,2361,2362,2363,2364,2365,2366,2367,2368,2369,2370,2371,2372,2373,2374,2375,2376,2377,2378,2379,2380,2381,2382,2383,2384,2385,2386,2387,2388,2389,2390,2391,2392,2393,2394,2395,2396,2397,2398,2399,2400,2401,2402,2403,2404,2405,2406,2407,2408,2409,2410,2411,2412,2413,2414,2415,2416,2417,2418,2419,2420,2421,2422,2423,2424,2425,2426,2427,2428,2429,2430,2431,2432,2433,2434,2435,2436,2437]},{"id":30,"transcript":"So we can bracket these big cells right in front of the left main and make sure that we do feasibility is preserved, uh, but they also have some issues with pacemaker rates and we don't have long term data yet this two year trial data for high risk patients and it's only indicated right now for high risk patients.","start_time":"700.64","end_time":"716.549","items":[2438,2439,2440,2441,2442,2443,2444,2445,2446,2447,2448,2449,2450,2451,2452,2453,2454,2455,2456,2457,2458,2459,2460,2461,2462,2463,2464,2465,2466,2467,2468,2469,2470,2471,2472,2473,2474,2475,2476,2477,2478,2479,2480,2481,2482,2483,2484,2485,2486,2487,2488,2489,2490,2491,2492,2493,2494,2495,2496,2497,2498,2499,2500]},{"id":31,"transcript":"So we have 33 players, we have 3 different features and we have a lot of different clinical factors and anatomic factors that help guide us in these decisions.","start_time":"717.88","end_time":"727.239","items":[2501,2502,2503,2504,2505,2506,2507,2508,2509,2510,2511,2512,2513,2514,2515,2516,2517,2518,2519,2520,2521,2522,2523,2524,2525,2526,2527,2528,2529,2530,2531]},{"id":32,"transcript":"Uh, if you take one thing away from this, this talk, I, I hope you take away how, uh, much we perseverate about these decisions, not just between Saver and Taver but how much we perseverate about these decisions of which valve platform is gonna work for best for each individual patient. And when I put pen to paper and and try to figure out all the different factors that that uh prompt us to use a certain valve in a certain patient, there's 20 different uh factors here.","start_time":"727.869","end_time":"753.01","items":[2532,2533,2534,2535,2536,2537,2538,2539,2540,2541,2542,2543,2544,2545,2546,2547,2548,2549,2550,2551,2552,2553,2554,2555,2556,2557,2558,2559,2560,2561,2562,2563,2564,2565,2566,2567,2568,2569,2570,2571,2572,2573,2574,2575,2576,2577,2578,2579,2580,2581,2582,2583,2584,2585,2586,2587,2588,2589,2590,2591,2592,2593,2594,2595,2596,2597,2598,2599,2600,2601,2602,2603,2604,2605,2606,2607,2608,2609,2610,2611,2612,2613,2614,2615,2616,2617,2618,2619,2620,2621,2622,2623,2624,2625,2626,2627,2628,2629,2630]},{"id":33,"transcript":"When I came out of training in 2019 again during the transition from these two periods or eras of Taver I, I had done 92% sapiens, so I was relatively unfamiliar with uh evolutes with self-expanding valves. Um, we, we certainly knew that self-expanding valves had better hemodynamics and there was this uh this concept of patient prosthesis mismatch that was uh bearing itself out and and follow ups and higher gradients afterwards.","start_time":"753.15","end_time":"779.08","items":[2631,2632,2633,2634,2635,2636,2637,2638,2639,2640,2641,2642,2643,2644,2645,2646,2647,2648,2649,2650,2651,2652,2653,2654,2655,2656,2657,2658,2659,2660,2661,2662,2663,2664,2665,2666,2667,2668,2669,2670,2671,2672,2673,2674,2675,2676,2677,2678,2679,2680,2681,2682,2683,2684,2685,2686,2687,2688,2689,2690,2691,2692,2693,2694,2695,2696,2697,2698,2699,2700,2701,2702,2703,2704,2705,2706,2707,2708,2709]},{"id":34,"transcript":"We didn't like taking balloon expandable valves and forcing them into complex calcified anatomy because the risk of annular rupture, so we're subtracting out volume valve and valves like small annulus, like small patients, we didn't like packing another valve inside of the prosthetic valve and causing hemodynamic issues.","start_time":"779.349","end_time":"798.15","items":[2710,2711,2712,2713,2714,2715,2716,2717,2718,2719,2720,2721,2722,2723,2724,2725,2726,2727,2728,2729,2730,2731,2732,2733,2734,2735,2736,2737,2738,2739,2740,2741,2742,2743,2744,2745,2746,2747,2748,2749,2750,2751,2752,2753,2754,2755,2756,2757,2758,2759,2760,2761,2762]},{"id":35,"transcript":"Um, but this by and large favored mostly balloon expandable valves, better sheaths, lower pacemaker rates. The difference was 5% versus 20% pacemaker rate with the self-expanding valves. Patients had to stay longer watching conduction abnormalities. We didn't have commissional alignment and so we were really worried about coronary access. Um, our partners would say, you know, if I stepped on fluoro during the stemmi and saw a core valve, I would, I would grimace because I know it would be difficult to get into the coronaries.","start_time":"798.349","end_time":"826.299","items":[2763,2764,2765,2766,2767,2768,2769,2770,2771,2772,2773,2774,2775,2776,2777,2778,2779,2780,2781,2782,2783,2784,2785,2786,2787,2788,2789,2790,2791,2792,2793,2794,2795,2796,2797,2798,2799,2800,2801,2802,2803,2804,2805,2806,2807,2808,2809,2810,2811,2812,2813,2814,2815,2816,2817,2818,2819,2820,2821,2822,2823,2824,2825,2826,2827,2828,2829,2830,2831,2832,2833,2834,2835,2836,2837,2838,2839,2840,2841,2842,2843,2844,2845,2846,2847,2848,2849,2850,2851,2852,2853,2854,2855,2856,2857,2858,2859,2860,2861,2862]},{"id":36,"transcript":"A lot of the features of Tavern, a lot of the data that's come out in the 5 years since have have really addressed all those issues. The biggest takeaway that we've had in the data for the past few years is that hemodynamics are are very, very significant factors in the durability of the valve and the performance of the valve long term. And so the hemodynamically performing valves, uh, evolutes and navis very likely are going to have that sustained performance for a longer period of time.","start_time":"826.479","end_time":"855.65","items":[2863,2864,2865,2866,2867,2868,2869,2870,2871,2872,2873,2874,2875,2876,2877,2878,2879,2880,2881,2882,2883,2884,2885,2886,2887,2888,2889,2890,2891,2892,2893,2894,2895,2896,2897,2898,2899,2900,2901,2902,2903,2904,2905,2906,2907,2908,2909,2910,2911,2912,2913,2914,2915,2916,2917,2918,2919,2920,2921,2922,2923,2924,2925,2926,2927,2928,2929,2930,2931,2932,2933,2934,2935,2936,2937,2938,2939,2940,2941,2942,2943,2944,2945,2946,2947,2948,2949,2950,2951,2952,2953,2954,2955,2956,2957,2958]},{"id":37,"transcript":"And poor hemodynamics really begat the hard clinical end points in the 5 to 10 year time frame where we have reinventions where we have explants and surgery and we have all the risks that are associated with them and so hemodynamics have really uh driven a lot of our transition towards now where 85% self-expanding valves instead of in spite of a slightly higher pacemaker risk, a technique called cusp overlap.","start_time":"855.95","end_time":"879.549","items":[2959,2960,2961,2962,2963,2964,2965,2966,2967,2968,2969,2970,2971,2972,2973,2974,2975,2976,2977,2978,2979,2980,2981,2982,2983,2984,2985,2986,2987,2988,2989,2990,2991,2992,2993,2994,2995,2996,2997,2998,2999,3000,3001,3002,3003,3004,3005,3006,3007,3008,3009,3010,3011,3012,3013,3014,3015,3016,3017,3018,3019,3020,3021,3022,3023,3024,3025,3026,3027,3028,3029,3030,3031,3032]},{"id":38,"transcript":"Which we were one of the highest enrollers and then in a trial called Optimize, uh, allowed us to implant higher and reduced our pacemaker rates from 15 to 20% with self-expanding valves to 5 to 7%, and they hover between 7 and 10% depending on uh what patient population we have. We have 55% of our patients have uh baseline bundle branch plaques and so they come into the procedure with higher.","start_time":"880.119","end_time":"904.719","items":[3033,3034,3035,3036,3037,3038,3039,3040,3041,3042,3043,3044,3045,3046,3047,3048,3049,3050,3051,3052,3053,3054,3055,3056,3057,3058,3059,3060,3061,3062,3063,3064,3065,3066,3067,3068,3069,3070,3071,3072,3073,3074,3075,3076,3077,3078,3079,3080,3081,3082,3083,3084,3085,3086,3087,3088,3089,3090,3091,3092,3093,3094,3095,3096,3097,3098,3099,3100,3101,3102,3103,3104,3105,3106,3107,3108,3109,3110]},{"id":39,"transcript":"Uh, risk of pacemaker, but you can see over time this is more for a variety of reasons we built in commercial alignment. Our surgeons have gotten, uh, more local experience with explants and feel that using a nightinol valve and being able to put that in cold saline and have the valve contract leads to less root, uh, replacements and repairs. Um, that's our local experience and then cusp overlap, uh, techniques have allowed us.","start_time":"904.88","end_time":"929.25","items":[3111,3112,3113,3114,3115,3116,3117,3118,3119,3120,3121,3122,3123,3124,3125,3126,3127,3128,3129,3130,3131,3132,3133,3134,3135,3136,3137,3138,3139,3140,3141,3142,3143,3144,3145,3146,3147,3148,3149,3150,3151,3152,3153,3154,3155,3156,3157,3158,3159,3160,3161,3162,3163,3164,3165,3166,3167,3168,3169,3170,3171,3172,3173,3174,3175,3176,3177,3178,3179,3180,3181,3182,3183,3184,3185,3186,3187,3188,3189,3190,3191,3192,3193,3194,3195,3196,3197,3198]},{"id":40,"transcript":"Um, to get lower single digit pacemaker rates that have really equaled the playing field here.","start_time":"929.51","end_time":"935.08","items":[3199,3200,3201,3202,3203,3204,3205,3206,3207,3208,3209,3210,3211,3212,3213,3214,3215,3216]},{"id":41,"transcript":"We have all of this milieu of decisions, uh, with one head to head trial and that head to head trial was Evolute versus Sapien and patients with small annuli so patients with the cross sectional area of less than 430, that's basically intentionally designed.","start_time":"935.659","end_time":"950.919","items":[3217,3218,3219,3220,3221,3222,3223,3224,3225,3226,3227,3228,3229,3230,3231,3232,3233,3234,3235,3236,3237,3238,3239,3240,3241,3242,3243,3244,3245,3246,3247,3248,3249,3250,3251,3252,3253,3254,3255,3256,3257,3258,3259,3260,3261,3262,3263,3264,3265]},{"id":42,"transcript":"To look at hemodynamics in the patients where it's likely to shine best, which is in the 20 and 23 S3, so 70+% women, they're small valves. You're either putting something in the annual subloon expandable valve and not getting great hemodynamics, or you're putting that valve up a bigger valve up in the sinuses and getting better hemodynamics, and does that matter? And so what you see and what the the naysayers will say is, well, there's no difference in hard end points through two years stroke, MI, uh, re-hospitalization.","start_time":"951.38","end_time":"978.32","items":[3266,3267,3268,3269,3270,3271,3272,3273,3274,3275,3276,3277,3278,3279,3280,3281,3282,3283,3284,3285,3286,3287,3288,3289,3290,3291,3292,3293,3294,3295,3296,3297,3298,3299,3300,3301,3302,3303,3304,3305,3306,3307,3308,3309,3310,3311,3312,3313,3314,3315,3316,3317,3318,3319,3320,3321,3322,3323,3324,3325,3326,3327,3328,3329,3330,3331,3332,3333,3334,3335,3336,3337,3338,3339,3340,3341,3342,3343,3344,3345,3346,3347,3348,3349,3350,3351,3352,3353,3354,3355,3356,3357,3358,3359,3360,3361,3362,3363,3364,3365,3366,3367,3368,3369]},{"id":43,"transcript":"But what we see is that we have significant bioprosthetic bowel dysfunction at 2 years. If I take anyone with an annulus of less than 430, which is about half of our patients, and I put a sapien in them, a balloon expandable valve, I cause BVD at 2 years every time I do that, make that decision 3 times.","start_time":"978.539","end_time":"998.21","items":[3370,3371,3372,3373,3374,3375,3376,3377,3378,3379,3380,3381,3382,3383,3384,3385,3386,3387,3388,3389,3390,3391,3392,3393,3394,3395,3396,3397,3398,3399,3400,3401,3402,3403,3404,3405,3406,3407,3408,3409,3410,3411,3412,3413,3414,3415,3416,3417,3418,3419,3420,3421,3422,3423,3424,3425,3426,3427,3428,3429,3430,3431,3432,3433,3434,3435,3436]},{"id":44,"transcript":"And so sapiens are an independent predictor of uh bioprosthetic bowel dysfunction at 2 years. It hasn't led to outcomes, hard outcomes, but what we see is we see patients back at 1 month in 1 year. What we see is that 1 month.","start_time":"998.52","end_time":"1013.815","items":[3437,3438,3439,3440,3441,3442,3443,3444,3445,3446,3447,3448,3449,3450,3451,3452,3453,3454,3455,3456,3457,3458,3459,3460,3461,3462,3463,3464,3465,3466,3467,3468,3469,3470,3471,3472,3473,3474,3475,3476,3477,3478,3479,3480,3481,3482,3483,3484,3485]},{"id":45,"transcript":"gradients are 18. We took them to taver, you know, for paradoxic low flow, low gradient. The gradient was 38. Now all of a sudden their gradients are 18 at one month. Patients get their echo read and it says moderate aortic stenosis before you even get a chance to see them in post op at that one month visit.","start_time":"1013.825","end_time":"1029.13","items":[3486,3487,3488,3489,3490,3491,3492,3493,3494,3495,3496,3497,3498,3499,3500,3501,3502,3503,3504,3505,3506,3507,3508,3509,3510,3511,3512,3513,3514,3515,3516,3517,3518,3519,3520,3521,3522,3523,3524,3525,3526,3527,3528,3529,3530,3531,3532,3533,3534,3535,3536,3537,3538,3539,3540,3541,3542,3543,3544,3545,3546,3547,3548,3549,3550,3551,3552,3553]},{"id":46,"transcript":"And you're scheduling repeat echoes at 6 months or 3 months you're starting emeric antic coagulation at 9 months because you see those gradients rise. We're not seeing valve reinventions here. We're not seeing redo tavers here. We're not seeing explants here. We're seeing emeric antic coagulation, repeat CT scans, TEEs, all of these things that, uh, are, are premonitory for, um, what will lead to the uh harder outcomes.","start_time":"1029.31","end_time":"1053.109","items":[3554,3555,3556,3557,3558,3559,3560,3561,3562,3563,3564,3565,3566,3567,3568,3569,3570,3571,3572,3573,3574,3575,3576,3577,3578,3579,3580,3581,3582,3583,3584,3585,3586,3587,3588,3589,3590,3591,3592,3593,3594,3595,3596,3597,3598,3599,3600,3601,3602,3603,3604,3605,3606,3607,3608,3609,3610,3611,3612,3613,3614,3615,3616,3617,3618,3619,3620,3621,3622,3623,3624,3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3636]},{"id":47,"transcript":"And it's important to know that 4:30, this annular area of 20 and 23s, you didn't get that absolute risk reduction stopping at that measure. We don't know what happens above. Does PPM? Does BVD happen at the 26 and 29 sapients, and we think it does. We think hemodynamics is a consistent message that, that, uh, that is an outcome measure for post have or that we need to be, um.","start_time":"1053.65","end_time":"1076.609","items":[3637,3638,3639,3640,3641,3642,3643,3644,3645,3646,3647,3648,3649,3650,3651,3652,3653,3654,3655,3656,3657,3658,3659,3660,3661,3662,3663,3664,3665,3666,3667,3668,3669,3670,3671,3672,3673,3674,3675,3676,3677,3678,3679,3680,3681,3682,3683,3684,3685,3686,3687,3688,3689,3690,3691,3692,3693,3694,3695,3696,3697,3698,3699,3700,3701,3702,3703,3704,3705,3706,3707,3708,3709,3710,3711,3712,3713,3714,3715,3716,3717,3718,3719,3720]},{"id":48,"transcript":"Focusing on some sort of measure of completion and in coronaries we have IVIS measurements to say that we did a good good job or IFR measurements that we can say we we had ischemia before and we fixed it and now we have a measure of normalization afterwards with TR it was again in the first era, let's subtract a CC of volume because the annuals looks kind of nasty. um, we'll try to shoot for a gradient less than 10 and then.","start_time":"1076.949","end_time":"1101.17","items":[3721,3722,3723,3724,3725,3726,3727,3728,3729,3730,3731,3732,3733,3734,3735,3736,3737,3738,3739,3740,3741,3742,3743,3744,3745,3746,3747,3748,3749,3750,3751,3752,3753,3754,3755,3756,3757,3758,3759,3760,3761,3762,3763,3764,3765,3766,3767,3768,3769,3770,3771,3772,3773,3774,3775,3776,3777,3778,3779,3780,3781,3782,3783,3784,3785,3786,3787,3788,3789,3790,3791,3792,3793,3794,3795,3796,3797,3798,3799,3800,3801,3802,3803,3804,3805,3806,3807,3808]},{"id":49,"transcript":"You know, the valve is in they're out of the room. Now it's how do we get them the best performing valve? We've got 3 different platforms. There's a lot of different factors that go into those decisions and how are we gonna make all those decisions for each individual patient.","start_time":"1101.78","end_time":"1115.109","items":[3809,3810,3811,3812,3813,3814,3815,3816,3817,3818,3819,3820,3821,3822,3823,3824,3825,3826,3827,3828,3829,3830,3831,3832,3833,3834,3835,3836,3837,3838,3839,3840,3841,3842,3843,3844,3845,3846,3847,3848,3849,3850,3851,3852,3853,3854,3855,3856,3857,3858,3859,3860,3861,3862,3863,3864]},{"id":50,"transcript":"And as I mentioned, we have good data now. I can tell patients when I started, I, I, I said, you know, they would ask how long it lasted. I say, well, it's based on surgical literature where the average is 13 years, but the median time to valve and valve to average is 8 years, um, but it's a scatter plot if you look at the surgical, uh, durability.","start_time":"1115.66","end_time":"1132.479","items":[3865,3866,3867,3868,3869,3870,3871,3872,3873,3874,3875,3876,3877,3878,3879,3880,3881,3882,3883,3884,3885,3886,3887,3888,3889,3890,3891,3892,3893,3894,3895,3896,3897,3898,3899,3900,3901,3902,3903,3904,3905,3906,3907,3908,3909,3910,3911,3912,3913,3914,3915,3916,3917,3918,3919,3920,3921,3922,3923,3924,3925,3926,3927,3928,3929,3930,3931,3932,3933,3934,3935,3936,3937,3938,3939,3940,3941,3942,3943,3944,3945,3946,3947,3948,3949,3950]},{"id":51,"transcript":"And uh reinterventions over the age of 75 re due to uh surgeries were very, very rare and so people did not meet that end point of reintervention just because they weren't offered surgery.","start_time":"1133.329","end_time":"1142.829","items":[3951,3952,3953,3954,3955,3956,3957,3958,3959,3960,3961,3962,3963,3964,3965,3966,3967,3968,3969,3970,3971,3972,3973,3974,3975,3976,3977,3978,3979,3980,3981,3982,3983,3984,3985,3986]},{"id":52,"transcript":"So the data is really, really muddy for surgical longevity, have longevity. It's becoming clear that Taver is uh non-inferior through 7 years now with Sapien, 5 years with uh evolute, but through 10 years we can assess durability in the in the very first iterations of our valve platforms with self-expanding valves, and we know that it's at least as durable as surgery through 10 years.","start_time":"1142.979","end_time":"1165.64","items":[3987,3988,3989,3990,3991,3992,3993,3994,3995,3996,3997,3998,3999,4000,4001,4002,4003,4004,4005,4006,4007,4008,4009,4010,4011,4012,4013,4014,4015,4016,4017,4018,4019,4020,4021,4022,4023,4024,4025,4026,4027,4028,4029,4030,4031,4032,4033,4034,4035,4036,4037,4038,4039,4040,4041,4042,4043,4044,4045,4046,4047,4048,4049,4050,4051,4052,4053,4054,4055,4056,4057,4058,4059,4060]},{"id":53,"transcript":"And so how are we approaching these decisions? And so this is this is designed, uh, this was designed when we revamped our, our valve uh clinic and our multidisciplinary valve conference every single one of our patients that comes through.","start_time":"1166.27","end_time":"1179.589","items":[4061,4062,4063,4064,4065,4066,4067,4068,4069,4070,4071,4072,4073,4074,4075,4076,4077,4078,4079,4080,4081,4082,4083,4084,4085,4086,4087,4088,4089,4090,4091,4092,4093,4094,4095,4096,4097,4098,4099,4100,4101,4102,4103,4104,4105,4106]},{"id":54,"transcript":"That you refer to structural heart or the Valve Center for considerations of what not just TaR versus SAR but which Taver platform they have concomitant coronary disease, how are we gonna manage that is all those 20 decision points are distilled down to one slide and that's important so we can review 25 to 30 of these every Monday morning. That's an open conference at 7 a.m. every Monday, uh, here, uh, med students come to. It's on teams. Anyone is welcome if you want to see sort of.","start_time":"1179.719","end_time":"1206.14","items":[4107,4108,4109,4110,4111,4112,4113,4114,4115,4116,4117,4118,4119,4120,4121,4122,4123,4124,4125,4126,4127,4128,4129,4130,4131,4132,4133,4134,4135,4136,4137,4138,4139,4140,4141,4142,4143,4144,4145,4146,4147,4148,4149,4150,4151,4152,4153,4154,4155,4156,4157,4158,4159,4160,4161,4162,4163,4164,4165,4166,4167,4168,4169,4170,4171,4172,4173,4174,4175,4176,4177,4178,4179,4180,4181,4182,4183,4184,4185,4186,4187,4188,4189,4190,4191,4192,4193,4194,4195,4196,4197,4198,4199,4200,4201,4202,4203,4204,4205]},{"id":55,"transcript":"How the the sausage is made um as far as how we make all these decisions, it's quite complex and I think in good faith we're doing everything in our power and using all the tools to make really individual choices, not just on which valve is gonna perform best for the patient but which one is going to be.","start_time":"1206.359","end_time":"1221.67","items":[4206,4207,4208,4209,4210,4211,4212,4213,4214,4215,4216,4217,4218,4219,4220,4221,4222,4223,4224,4225,4226,4227,4228,4229,4230,4231,4232,4233,4234,4235,4236,4237,4238,4239,4240,4241,4242,4243,4244,4245,4246,4247,4248,4249,4250,4251,4252,4253,4254,4255,4256,4257,4258,4259,4260,4261,4262,4263,4264,4265,4266,4267,4268]},{"id":56,"transcript":"Uh, the lowest risk for each of those individual patients and you can see we've used clinical factors we've used, uh, you know, ileofemorals. There's annular anatomy where we're making these measurements again, CT is still fairly rudimentary. A lot of these VTC and BTSTJ measurements that dictate whether we use leaflet modification are are relatively imprecise and they're based on normalizing a measure to a wide variation in annular anatomy.","start_time":"1221.81","end_time":"1246.739","items":[4269,4270,4271,4272,4273,4274,4275,4276,4277,4278,4279,4280,4281,4282,4283,4284,4285,4286,4287,4288,4289,4290,4291,4292,4293,4294,4295,4296,4297,4298,4299,4300,4301,4302,4303,4304,4305,4306,4307,4308,4309,4310,4311,4312,4313,4314,4315,4316,4317,4318,4319,4320,4321,4322,4323,4324,4325,4326,4327,4328,4329,4330,4331,4332,4333,4334,4335,4336,4337,4338,4339,4340,4341,4342,4343,4344,4345,4346,4347]},{"id":57,"transcript":"And so it's not good enough, but this is good enough, I think, and it's only gonna build and get better. This is how we're making decisions now. So this is a 72 year old bicuspid and instead of, uh, just subtracting a CC of volume because we see calcium on a cross sectional axial image of a CT scan and making decisions, you know, that I like sapien and I train on sapien, so I'm gonna use sapien or, you know, evolutes have a high pacemaker rate, uh, even though I've got a, you know, a bunch of EPs that do physiologic pacing and, and, and left bundle pacing.","start_time":"1247.339","end_time":"1276.28","items":[4348,4349,4350,4351,4352,4353,4354,4355,4356,4357,4358,4359,4360,4361,4362,4363,4364,4365,4366,4367,4368,4369,4370,4371,4372,4373,4374,4375,4376,4377,4378,4379,4380,4381,4382,4383,4384,4385,4386,4387,4388,4389,4390,4391,4392,4393,4394,4395,4396,4397,4398,4399,4400,4401,4402,4403,4404,4405,4406,4407,4408,4409,4410,4411,4412,4413,4414,4415,4416,4417,4418,4419,4420,4421,4422,4423,4424,4425,4426,4427,4428,4429,4430,4431,4432,4433,4434,4435,4436,4437,4438,4439,4440,4441,4442,4443,4444,4445,4446,4447,4448,4449,4450,4451,4452,4453,4454,4455,4456,4457,4458,4459,4460,4461,4462,4463,4464,4465,4466,4467,4468,4469,4470,4471,4472,4473,4474,4475,4476]},{"id":58,"transcript":"And the patients come out of their tavern or after the tavern mission with a narrow QRS than they had. This allows us to to try to pick the valve based on each individual patient's anatomy and then also this modeling has allowed us to develop certain risk calculations that are much, much more precise that are three dimensionally uh uh constructed and then validated through machine learning. So AI inputs and finds variables like this coronary inclusion measure DLC over D.","start_time":"1276.469","end_time":"1306.449","items":[4477,4478,4479,4480,4481,4482,4483,4484,4485,4486,4487,4488,4489,4490,4491,4492,4493,4494,4495,4496,4497,4498,4499,4500,4501,4502,4503,4504,4505,4506,4507,4508,4509,4510,4511,4512,4513,4514,4515,4516,4517,4518,4519,4520,4521,4522,4523,4524,4525,4526,4527,4528,4529,4530,4531,4532,4533,4534,4535,4536,4537,4538,4539,4540,4541,4542,4543,4544,4545,4546,4547,4548,4549,4550,4551,4552,4553,4554,4555,4556,4557,4558,4559,4560,4561,4562]},{"id":59,"transcript":"Which is a three dimensional uh stenosis and flow into the sinus and that is uh much, much, much more uh precise of a test than anything we've ever used.","start_time":"1306.599","end_time":"1317.91","items":[4563,4564,4565,4566,4567,4568,4569,4570,4571,4572,4573,4574,4575,4576,4577,4578,4579,4580,4581,4582,4583,4584,4585,4586,4587,4588,4589,4590,4591,4592,4593,4594,4595]},{"id":60,"transcript":"And so again this is what's coming um is that we're gonna very quickly be able to model each of the valve platforms in each patient's anatomy this is a web app that they've developed we can change our implant depth we can look at what the native anatomy does and what the coronary flows.","start_time":"1318.589","end_time":"1335.015","items":[4596,4597,4598,4599,4600,4601,4602,4603,4604,4605,4606,4607,4608,4609,4610,4611,4612,4613,4614,4615,4616,4617,4618,4619,4620,4621,4622,4623,4624,4625,4626,4627,4628,4629,4630,4631,4632,4633,4634,4635,4636,4637,4638,4639,4640,4641,4642,4643,4644,4645,4646,4647,4648,4649,4650,4651]},{"id":61,"transcript":"Uh, maybe we can look at the importance of commissional alignment. We can target our first implant depth, maybe a little bit lower in relation to a mous septum that portends a lower pacemaker rate so that we can implant a sapien in 15 years a little bit higher. And so we're going into procedures much, much, much more precise.","start_time":"1335.025","end_time":"1353.89","items":[4652,4653,4654,4655,4656,4657,4658,4659,4660,4661,4662,4663,4664,4665,4666,4667,4668,4669,4670,4671,4672,4673,4674,4675,4676,4677,4678,4679,4680,4681,4682,4683,4684,4685,4686,4687,4688,4689,4690,4691,4692,4693,4694,4695,4696,4697,4698,4699,4700,4701,4702,4703,4704,4705,4706,4707,4708,4709,4710,4711,4712,4713,4714,4715,4716,4717,4718]},{"id":62,"transcript":"And so to highlight this, the complexity of these cases of these, these decisions, I wanted to highlight two cases first for valve therapy disposition and procedural guidance and how we're, we're going into these procedures now. For the past 3 weeks we've hosted, uh, sessions with this company Medtronic who's partnered with them, and we've done basically 4 or 5 live cases all guided by this, uh, modeling, um, to, to demonstrate the complexity and how we're going into these cases.","start_time":"1354.729","end_time":"1380.52","items":[4719,4720,4721,4722,4723,4724,4725,4726,4727,4728,4729,4730,4731,4732,4733,4734,4735,4736,4737,4738,4739,4740,4741,4742,4743,4744,4745,4746,4747,4748,4749,4750,4751,4752,4753,4754,4755,4756,4757,4758,4759,4760,4761,4762,4763,4764,4765,4766,4767,4768,4769,4770,4771,4772,4773,4774,4775,4776,4777,4778,4779,4780,4781,4782,4783,4784,4785,4786,4787,4788,4789,4790,4791,4792,4793,4794,4795,4796,4797,4798,4799,4800,4801,4802,4803,4804,4805,4806,4807,4808,4809,4810,4811,4812,4813,4814]},{"id":63,"transcript":"This first one is a radiation heart disease uh patient that had been followed for several years, was very, very active and the decision came up um.","start_time":"1380.989","end_time":"1389.829","items":[4815,4816,4817,4818,4819,4820,4821,4822,4823,4824,4825,4826,4827,4828,4829,4830,4831,4832,4833,4834,4835,4836,4837,4838,4839,4840,4841,4842,4843,4844]},{"id":64,"transcript":"About First Tower versus Saver and the goals really were to try to minimize risk achieve durability in the context of being very, very functional, and then preserve redo options.","start_time":"1390.689","end_time":"1400.77","items":[4845,4846,4847,4848,4849,4850,4851,4852,4853,4854,4855,4856,4857,4858,4859,4860,4861,4862,4863,4864,4865,4866,4867,4868,4869,4870,4871,4872,4873,4874,4875,4876,4877]},{"id":65,"transcript":"So this is the echocardiogram. You can see a pretty significant aortic stenosis, some degree of aortic insufficiency of peak velocity of 4.7.","start_time":"1401.859","end_time":"1409.76","items":[4878,4879,4880,4881,4882,4883,4884,4885,4886,4887,4888,4889,4890,4891,4892,4893,4894,4895,4896,4897,4898,4899,4900,4901,4902,4903]},{"id":66,"transcript":"But really what you see here is a a really hostile type of annular anatomy, something that's very concerning this calcium pattern, this nodular calcium, um, you can see that extending down into the LVL flow track. The coronary heights traditionally we use a number of 10.","start_time":"1411.3","end_time":"1425.02","items":[4904,4905,4906,4907,4908,4909,4910,4911,4912,4913,4914,4915,4916,4917,4918,4919,4920,4921,4922,4923,4924,4925,4926,4927,4928,4929,4930,4931,4932,4933,4934,4935,4936,4937,4938,4939,4940,4941,4942,4943,4944,4945,4946,4947,4948,4949,4950,4951,4952,4953,4954,4955,4956]},{"id":67,"transcript":"If it's under 10, we get a little bit concerned. If it's over 10, we don't get concerned, but 25% of coronary conclusions happen with a height of over 10. So that's the level of precision we were doing things just a few years ago. We look at sinus symmetry, we look at horizontal aorta, and ultimately when all things are created equal, um, we have the decision between two very good performing valves that are predicting hemodynamics that are very good for both platforms.","start_time":"1425.5","end_time":"1449.119","items":[4957,4958,4959,4960,4961,4962,4963,4964,4965,4966,4967,4968,4969,4970,4971,4972,4973,4974,4975,4976,4977,4978,4979,4980,4981,4982,4983,4984,4985,4986,4987,4988,4989,4990,4991,4992,4993,4994,4995,4996,4997,4998,4999,5000,5001,5002,5003,5004,5005,5006,5007,5008,5009,5010,5011,5012,5013,5014,5015,5016,5017,5018,5019,5020,5021,5022,5023,5024,5025,5026,5027,5028,5029,5030,5031,5032,5033,5034,5035,5036,5037,5038,5039,5040,5041,5042,5043,5044,5045,5046,5047,5048,5049,5050,5051,5052]},{"id":68,"transcript":"So I would have said 5 years ago we would have either sent a radiation heart disease patient to to surgery and and dealt with all the issues after that or we would have probably taken a sapine and subtracted volume because of the risk of pacemaker with the right bundle branch block and now we go into this with this kind of data so I know that this patient has is between sizes for Sapien 26 and 29 and evolute 29 and 34.","start_time":"1449.329","end_time":"1473.56","items":[5053,5054,5055,5056,5057,5058,5059,5060,5061,5062,5063,5064,5065,5066,5067,5068,5069,5070,5071,5072,5073,5074,5075,5076,5077,5078,5079,5080,5081,5082,5083,5084,5085,5086,5087,5088,5089,5090,5091,5092,5093,5094,5095,5096,5097,5098,5099,5100,5101,5102,5103,5104,5105,5106,5107,5108,5109,5110,5111,5112,5113,5114,5115,5116,5117,5118,5119,5120,5121,5122,5123,5124,5125,5126,5127,5128,5129,5130,5131,5132,5133,5134,5135,5136,5137]},{"id":69,"transcript":"And so really this demonstrates the complexity of the things that we're balancing. I can choose between balloon expandable or self expanding, and I have tweener sizes. There's no real risk of coronary inclusion. This number is 0.7, anything less than that is significant. Stent opposition shows exactly what that stent at 30 days is going to do in relation to the native anatomy, so it predicts PVL. It'll actually tell you where the ear val the leak is going to occur, and you can plan for it.","start_time":"1473.849","end_time":"1499.829","items":[5138,5139,5140,5141,5142,5143,5144,5145,5146,5147,5148,5149,5150,5151,5152,5153,5154,5155,5156,5157,5158,5159,5160,5161,5162,5163,5164,5165,5166,5167,5168,5169,5170,5171,5172,5173,5174,5175,5176,5177,5178,5179,5180,5181,5182,5183,5184,5185,5186,5187,5188,5189,5190,5191,5192,5193,5194,5195,5196,5197,5198,5199,5200,5201,5202,5203,5204,5205,5206,5207,5208,5209,5210,5211,5212,5213,5214,5215,5216,5217,5218,5219,5220,5221,5222,5223,5224,5225,5226,5227,5228,5229,5230,5231,5232,5233,5234,5235]},{"id":70,"transcript":"We know that actually with the balloon expandable valves we don't get a whole lot of PVL. It's up to 0.7. If we undersized an evolute, we would get several areas of PVL. But if we slightly oversized 15% is really within the IFU, we would not get any PVL. But here's what's really important is that the stretch analysis if we just put a sapien in, the risk of annular rupture would be significant.","start_time":"1500.0","end_time":"1522.66","items":[5236,5237,5238,5239,5240,5241,5242,5243,5244,5245,5246,5247,5248,5249,5250,5251,5252,5253,5254,5255,5256,5257,5258,5259,5260,5261,5262,5263,5264,5265,5266,5267,5268,5269,5270,5271,5272,5273,5274,5275,5276,5277,5278,5279,5280,5281,5282,5283,5284,5285,5286,5287,5288,5289,5290,5291,5292,5293,5294,5295,5296,5297,5298,5299,5300,5301,5302,5303,5304,5305,5306,5307,5308,5309,5310,5311,5312,5313,5314,5315,5316,5317,5318]},{"id":71,"transcript":"So we go into this and we have two different sizes as I mentioned.","start_time":"1523.66","end_time":"1526.819","items":[5319,5320,5321,5322,5323,5324,5325,5326,5327,5328,5329,5330,5331,5332,5333]},{"id":72,"transcript":"This is actually showing the sapien expanding and you can see that calcium getting pushed into the annus. This is how annular ruptures occur and so we would have had a significant issue with annular rupture.","start_time":"1528.52","end_time":"1538.65","items":[5334,5335,5336,5337,5338,5339,5340,5341,5342,5343,5344,5345,5346,5347,5348,5349,5350,5351,5352,5353,5354,5355,5356,5357,5358,5359,5360,5361,5362,5363,5364,5365,5366,5367,5368,5369,5370,5371]},{"id":73,"transcript":"You can see the calcium patterns not just in cross section where there's a spicul of calcium and you say ah it looks kind of bad. You can see exactly where every calcium spiculle is and what happens in response to the stents. If we undersize the stents, so even if we go down to a 26, which is 3.4% undersized, we still have that concern for the calcium protruding into the annulus.","start_time":"1539.459","end_time":"1560.51","items":[5372,5373,5374,5375,5376,5377,5378,5379,5380,5381,5382,5383,5384,5385,5386,5387,5388,5389,5390,5391,5392,5393,5394,5395,5396,5397,5398,5399,5400,5401,5402,5403,5404,5405,5406,5407,5408,5409,5410,5411,5412,5413,5414,5415,5416,5417,5418,5419,5420,5421,5422,5423,5424,5425,5426,5427,5428,5429,5430,5431,5432,5433,5434,5435,5436,5437,5438,5439,5440,5441,5442,5443,5444,5445,5446,5447,5448,5449,5450]},{"id":74,"transcript":"So annular rupture, this shows you this is called aerial stretch so it basically takes the point of maximum calcium exertion from the native anatomy in response to the uh stent. So anything over 1.5 is 100% sensitive for annular rupture. So your red spots are where annual rupture would occur, and you can see with 29 significant areas in that that calcification.","start_time":"1566.77","end_time":"1591.02","items":[5451,5452,5453,5454,5455,5456,5457,5458,5459,5460,5461,5462,5463,5464,5465,5466,5467,5468,5469,5470,5471,5472,5473,5474,5475,5476,5477,5478,5479,5480,5481,5482,5483,5484,5485,5486,5487,5488,5489,5490,5491,5492,5493,5494,5495,5496,5497,5498,5499,5500,5501,5502,5503,5504,5505,5506,5507,5508,5509,5510,5511,5512,5513,5514,5515,5516,5517,5518]},{"id":75,"transcript":"And 26 it's still 1.6%. That's 100% sensitive, only 57% specific this, this, uh, aerial stretch, but in in a low frequency event that has high consequences, you want something that's 100% sensitive, um, and then you focus on specificity afterwards.","start_time":"1591.18","end_time":"1608.069","items":[5519,5520,5521,5522,5523,5524,5525,5526,5527,5528,5529,5530,5531,5532,5533,5534,5535,5536,5537,5538,5539,5540,5541,5542,5543,5544,5545,5546,5547,5548,5549,5550,5551,5552,5553,5554,5555,5556,5557,5558,5559,5560,5561,5562,5563,5564,5565,5566,5567,5568]},{"id":76,"transcript":"So when we look at the self expanding valves, this is again a 34.","start_time":"1609.9","end_time":"1613.859","items":[5569,5570,5571,5572,5573,5574,5575,5576,5577,5578,5579,5580,5581,5582,5583,5584]},{"id":77,"transcript":"You can see that the tissue doesn't get pushed into the sinuses nearly uh uh much at all, and that's because the design of this valve, it's night and all valve itself expands it doesn't force itself with the balloon into the native anatomy it conforms to the anatomy. It doesn't exert as much uh uh movement on the leaflets into the sinuses, but you get a very good valve performance higher up in the sinuses unencumbered from all the, uh, annular eccentricity and variations that occur.","start_time":"1614.949","end_time":"1642.209","items":[5585,5586,5587,5588,5589,5590,5591,5592,5593,5594,5595,5596,5597,5598,5599,5600,5601,5602,5603,5604,5605,5606,5607,5608,5609,5610,5611,5612,5613,5614,5615,5616,5617,5618,5619,5620,5621,5622,5623,5624,5625,5626,5627,5628,5629,5630,5631,5632,5633,5634,5635,5636,5637,5638,5639,5640,5641,5642,5643,5644,5645,5646,5647,5648,5649,5650,5651,5652,5653,5654,5655,5656,5657,5658,5659,5660,5661,5662,5663,5664,5665,5666,5667,5668,5669,5670,5671,5672,5673,5674,5675,5676,5677,5678]},{"id":78,"transcript":"If we downsize to a 29, it still looks good we're 5% undersized doing that so there's really no, uh, you know, benefit to downsizing and evolute.","start_time":"1642.55","end_time":"1651.26","items":[5679,5680,5681,5682,5683,5684,5685,5686,5687,5688,5689,5690,5691,5692,5693,5694,5695,5696,5697,5698,5699,5700,5701,5702,5703,5704,5705,5706,5707,5708,5709,5710]},{"id":79,"transcript":"And then if we look at coronary occlusion, I can now see exactly why coronary occlude and there's no risk of coronary occlusion with either of the 2 S3 sizes. I can see 3 dimensional into each of the coronary osteum and it's when these coronaries are low, again less than 10, or the sinuses are narrow and you get sequestration by the native leaflets. That's why coronary inclusion happens.","start_time":"1652.0","end_time":"1672.859","items":[5711,5712,5713,5714,5715,5716,5717,5718,5719,5720,5721,5722,5723,5724,5725,5726,5727,5728,5729,5730,5731,5732,5733,5734,5735,5736,5737,5738,5739,5740,5741,5742,5743,5744,5745,5746,5747,5748,5749,5750,5751,5752,5753,5754,5755,5756,5757,5758,5759,5760,5761,5762,5763,5764,5765,5766,5767,5768,5769,5770,5771,5772,5773,5774,5775,5776,5777,5778,5779,5780,5781,5782,5783,5784,5785,5786]},{"id":80,"transcript":"When I go to the evolut, which historically would have said, well, a young guy that's very functional has some coronary disease, we wanna make sure that we can reacts the coronaries. We wanna make sure that um.","start_time":"1673.66","end_time":"1684.41","items":[5787,5788,5789,5790,5791,5792,5793,5794,5795,5796,5797,5798,5799,5800,5801,5802,5803,5804,5805,5806,5807,5808,5809,5810,5811,5812,5813,5814,5815,5816,5817,5818,5819,5820,5821,5822,5823,5824,5825,5826,5827,5828,5829,5830]},{"id":81,"transcript":"You know, we're we're not causing a sinus sequestration with a superannular valve. We can now see that there's unencumbered flow with both valve platforms into the left main and the right qua of your artery, and you can see the importance of commiral alignment. These are the commiss evolutes the only valve that you can actually bracket your left maine with the commissures to make sure you're equidistant between them and preserve coronary access.","start_time":"1685.329","end_time":"1708.339","items":[5831,5832,5833,5834,5835,5836,5837,5838,5839,5840,5841,5842,5843,5844,5845,5846,5847,5848,5849,5850,5851,5852,5853,5854,5855,5856,5857,5858,5859,5860,5861,5862,5863,5864,5865,5866,5867,5868,5869,5870,5871,5872,5873,5874,5875,5876,5877,5878,5879,5880,5881,5882,5883,5884,5885,5886,5887,5888,5889,5890,5891,5892,5893,5894,5895,5896,5897,5898,5899,5900,5901,5902,5903,5904,5905,5906,5907,5908,5909,5910]},{"id":82,"transcript":"And then looking at stent acquisition, so PBL, there's no gaps we upsize to a 29, but again that's coming at the, the risk of, uh, annular rupture if we downsize, we're still getting some gaps that are developing and then from a 29 there's multiple areas of stent under expansion and risk for PBL with the 34 there's not.","start_time":"1708.81","end_time":"1726.91","items":[5911,5912,5913,5914,5915,5916,5917,5918,5919,5920,5921,5922,5923,5924,5925,5926,5927,5928,5929,5930,5931,5932,5933,5934,5935,5936,5937,5938,5939,5940,5941,5942,5943,5944,5945,5946,5947,5948,5949,5950,5951,5952,5953,5954,5955,5956,5957,5958,5959,5960,5961,5962,5963,5964,5965,5966,5967,5968,5969,5970,5971,5972,5973,5974,5975,5976,5977,5978]},{"id":83,"transcript":"And then we can go even further and say what are we gonna do uh when this gentleman is in his 80s and what are the valvey interventions gonna look like and we can actually show what a sapien had node 5 implant in this 34 would look like and what it would do to the calcium.","start_time":"1728.15","end_time":"1743.41","items":[5979,5980,5981,5982,5983,5984,5985,5986,5987,5988,5989,5990,5991,5992,5993,5994,5995,5996,5997,5998,5999,6000,6001,6002,6003,6004,6005,6006,6007,6008,6009,6010,6011,6012,6013,6014,6015,6016,6017,6018,6019,6020,6021,6022,6023,6024,6025,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036]},{"id":84,"transcript":"We can plan our implant depth of the first procedure based on the risk of that second procedure with needing a balloon expandable valve or self expanding valve.","start_time":"1744.66","end_time":"1753.369","items":[6037,6038,6039,6040,6041,6042,6043,6044,6045,6046,6047,6048,6049,6050,6051,6052,6053,6054,6055,6056,6057,6058,6059,6060,6061,6062,6063,6064,6065]},{"id":85,"transcript":"So instead of going into this procedure saying we're gonna subtract some CCs off of a of a uh sapien, we go into this procedure saying we're between two sizes we like the hemodynamic performance of an evolute. The pacemaker risk is not trivial, got an incomplete right bundle branch block.","start_time":"1756.739","end_time":"1771.969","items":[6066,6067,6068,6069,6070,6071,6072,6073,6074,6075,6076,6077,6078,6079,6080,6081,6082,6083,6084,6085,6086,6087,6088,6089,6090,6091,6092,6093,6094,6095,6096,6097,6098,6099,6100,6101,6102,6103,6104,6105,6106,6107,6108,6109,6110,6111,6112,6113,6114,6115,6116,6117,6118,6119,6120]},{"id":86,"transcript":"Uh, and the membrane is septum is short, uh, but you know what the penalty for a pacemaker in this scenario is not, not all that bad. We can do we can do a physiologic pacer and get through without any issue and preserve your ability to get an S3 in the future with a smaller valve inside the frame of the the evolute. So this is the procedure you can see it's a very high implant trying to avoid that pacemaker. These dots are at 3 millimeters. If we can get 3 millimeters in this cusp overlap at the non cornering cusp, we can get uh single digit pacemaker rates, but again.","start_time":"1772.189","end_time":"1801.27","items":[6121,6122,6123,6124,6125,6126,6127,6128,6129,6130,6131,6132,6133,6134,6135,6136,6137,6138,6139,6140,6141,6142,6143,6144,6145,6146,6147,6148,6149,6150,6151,6152,6153,6154,6155,6156,6157,6158,6159,6160,6161,6162,6163,6164,6165,6166,6167,6168,6169,6170,6171,6172,6173,6174,6175,6176,6177,6178,6179,6180,6181,6182,6183,6184,6185,6186,6187,6188,6189,6190,6191,6192,6193,6194,6195,6196,6197,6198,6199,6200,6201,6202,6203,6204,6205,6206,6207,6208,6209,6210,6211,6212,6213,6214,6215,6216,6217,6218,6219,6220,6221,6222,6223,6224,6225,6226,6227,6228,6229,6230,6231,6232,6233,6234,6235,6236,6237,6238,6239,6240,6241,6242,6243,6244]},{"id":87,"transcript":"The conduction anatomy is variable in each patient as well and so some people have a membranous septum that's 1 millimeter and they're gonna get a pacemaker no matter which valve you put in. Some people have a right bundle on a membranous septum at 10.","start_time":"1801.53","end_time":"1814.42","items":[6245,6246,6247,6248,6249,6250,6251,6252,6253,6254,6255,6256,6257,6258,6259,6260,6261,6262,6263,6264,6265,6266,6267,6268,6269,6270,6271,6272,6273,6274,6275,6276,6277,6278,6279,6280,6281,6282,6283,6284,6285,6286,6287,6288,6289,6290,6291,6292]},{"id":88,"transcript":"And so no matter where you put the valve you if you put it into the ventricle, they're not going to get a pacemaker and so all of this is variable and the old adages of, you know, self expanding valves we avoid them because the pacemakers and blueon expandable valves we use them because the pacemakers are low, it's not good enough for individual patients and so this was one deployment ended up with a peak to peak of 4, ended up getting uh a left bundle branch pacer and was doing great.","start_time":"1814.599","end_time":"1840.479","items":[6293,6294,6295,6296,6297,6298,6299,6300,6301,6302,6303,6304,6305,6306,6307,6308,6309,6310,6311,6312,6313,6314,6315,6316,6317,6318,6319,6320,6321,6322,6323,6324,6325,6326,6327,6328,6329,6330,6331,6332,6333,6334,6335,6336,6337,6338,6339,6340,6341,6342,6343,6344,6345,6346,6347,6348,6349,6350,6351,6352,6353,6354,6355,6356,6357,6358,6359,6360,6361,6362,6363,6364,6365,6366,6367,6368,6369,6370,6371,6372,6373,6374,6375,6376,6377,6378,6379,6380,6381,6382,6383,6384,6385,6386,6387,6388,6389,6390,6391,6392]},{"id":89,"transcript":"The second case is is another use that that we've seen. This is uh one of Doctor Per's patients, um.","start_time":"1841.829","end_time":"1847.359","items":[6393,6394,6395,6396,6397,6398,6399,6400,6401,6402,6403,6404,6405,6406,6407,6408,6409,6410,6411,6412,6413,6414,6415]},{"id":90,"transcript":"That we saw he's 76 so typically would be a taver candidate someone that we would do everything we could to exhaust taver um but what we see in historical measures is we see, you know, some pretty nasty, not at the annuals necessarily, but some pretty nasty calcium lower and up into the leaflets.","start_time":"1848.18","end_time":"1863.66","items":[6416,6417,6418,6419,6420,6421,6422,6423,6424,6425,6426,6427,6428,6429,6430,6431,6432,6433,6434,6435,6436,6437,6438,6439,6440,6441,6442,6443,6444,6445,6446,6447,6448,6449,6450,6451,6452,6453,6454,6455,6456,6457,6458,6459,6460,6461,6462,6463,6464,6465,6466,6467,6468,6469,6470,6471,6472,6473,6474,6475]},{"id":91,"transcript":"And so this is something that we would have taken on in the past, but we're a little bit concerned about the LVOT calcium. So thinking about the 1 in 500, the 0.4% chance of annual rupture every year. This is the the patient we're in historical, uh, planning, we may have missed. We may have, you know, been falsely reassured that the annuals looks OK and we would have maybe subtracted some volume out of out of a uh a sapien and gotten away with it in some scenarios and not gotten away with it in other scenarios.","start_time":"1864.01","end_time":"1892.77","items":[6476,6477,6478,6479,6480,6481,6482,6483,6484,6485,6486,6487,6488,6489,6490,6491,6492,6493,6494,6495,6496,6497,6498,6499,6500,6501,6502,6503,6504,6505,6506,6507,6508,6509,6510,6511,6512,6513,6514,6515,6516,6517,6518,6519,6520,6521,6522,6523,6524,6525,6526,6527,6528,6529,6530,6531,6532,6533,6534,6535,6536,6537,6538,6539,6540,6541,6542,6543,6544,6545,6546,6547,6548,6549,6550,6551,6552,6553,6554,6555,6556,6557,6558,6559,6560,6561,6562,6563,6564,6565,6566,6567,6568,6569,6570,6571,6572,6573,6574,6575,6576,6577,6578,6579,6580,6581,6582,6583,6584,6585]},{"id":92,"transcript":"But when you look at this comparing the sapien and the evolute, you can see we got we have significant risk of annual rupture with a stretch of 1.9, no coronary risks necessarily, but a lot of gaps between the stent and the native anatomy. So even if we downsize the valve, we're creating, we're trading annular rupture risk for PBL and when you look at where this annual rupture is gonna occur.","start_time":"1893.04","end_time":"1916.26","items":[6586,6587,6588,6589,6590,6591,6592,6593,6594,6595,6596,6597,6598,6599,6600,6601,6602,6603,6604,6605,6606,6607,6608,6609,6610,6611,6612,6613,6614,6615,6616,6617,6618,6619,6620,6621,6622,6623,6624,6625,6626,6627,6628,6629,6630,6631,6632,6633,6634,6635,6636,6637,6638,6639,6640,6641,6642,6643,6644,6645,6646,6647,6648,6649,6650,6651,6652,6653,6654,6655,6656,6657,6658,6659,6660,6661,6662,6663,6664,6665]},{"id":93,"transcript":"It makes sense to you that if you're just looking at the cross section at the annulus and making your decisions about BEV versus SEV you're missing all this calcium that the setting of a shallow or narrow sinus can still protrude through and cause issues and so.","start_time":"1916.579","end_time":"1930.06","items":[6666,6667,6668,6669,6670,6671,6672,6673,6674,6675,6676,6677,6678,6679,6680,6681,6682,6683,6684,6685,6686,6687,6688,6689,6690,6691,6692,6693,6694,6695,6696,6697,6698,6699,6700,6701,6702,6703,6704,6705,6706,6707,6708,6709,6710,6711,6712,6713,6714]},{"id":94,"transcript":"When we we try to navigate that with either self expanding valve or we try to navigate that by subtracting volume from a a balloon expandable valve, we're just trading that for severe PVL and so we're trading one problem for another.","start_time":"1930.589","end_time":"1942.489","items":[6715,6716,6717,6718,6719,6720,6721,6722,6723,6724,6725,6726,6727,6728,6729,6730,6731,6732,6733,6734,6735,6736,6737,6738,6739,6740,6741,6742,6743,6744,6745,6746,6747,6748,6749,6750,6751,6752,6753,6754,6755,6756,6757,6758]},{"id":95,"transcript":"And it's not benign even though we, we fixed them on, you know, not uncommonly my first case today is a PVL closure, uh, post taver. um, we go into those PVLs now knowing with this imaging exactly where it's gonna occur, knowing what views we're going to, uh, engage the PVL and and what size it's gonna be and which plugs we're gonna go into. So instead of these being 4 hour PVL procedures, um, they're they're now 30 minute to 1 hour procedures.","start_time":"1942.819","end_time":"1966.619","items":[6759,6760,6761,6762,6763,6764,6765,6766,6767,6768,6769,6770,6771,6772,6773,6774,6775,6776,6777,6778,6779,6780,6781,6782,6783,6784,6785,6786,6787,6788,6789,6790,6791,6792,6793,6794,6795,6796,6797,6798,6799,6800,6801,6802,6803,6804,6805,6806,6807,6808,6809,6810,6811,6812,6813,6814,6815,6816,6817,6818,6819,6820,6821,6822,6823,6824,6825,6826,6827,6828,6829,6830,6831,6832,6833,6834,6835,6836,6837,6838,6839,6840,6841,6842,6843,6844,6845,6846,6847,6848,6849,6850,6851,6852,6853,6854,6855,6856,6857]},{"id":96,"transcript":"So we sent this patient to surgery and this is Doctor Kemp's quote, um, and you can see the correlation between the anatomy and what he saw intraoperatively and so this patient, even though they were 76, I would argue, uh, we gave them the safer therapy by sending them to surgery and so we're making decisions in real time, not just on Saber versus Taver uh but with which valve platforms uh we use with much more sophistication than we were even two years ago.","start_time":"1966.859","end_time":"1992.939","items":[6858,6859,6860,6861,6862,6863,6864,6865,6866,6867,6868,6869,6870,6871,6872,6873,6874,6875,6876,6877,6878,6879,6880,6881,6882,6883,6884,6885,6886,6887,6888,6889,6890,6891,6892,6893,6894,6895,6896,6897,6898,6899,6900,6901,6902,6903,6904,6905,6906,6907,6908,6909,6910,6911,6912,6913,6914,6915,6916,6917,6918,6919,6920,6921,6922,6923,6924,6925,6926,6927,6928,6929,6930,6931,6932,6933,6934,6935,6936,6937,6938,6939,6940,6941,6942,6943,6944,6945,6946,6947,6948,6949,6950,6951]},{"id":97,"transcript":"So the other thing is risk mitigation and coronary occlusion risk is, is probably the most validated of all the measures that have come out of this, but coronary inclusion happens in taver for one of three reasons. So first, you can get distal embolization that can happen at any point in time just from thrombus on the leaflets, but the two mechanisms generally are the native leaflets or bioprosthetic leaflets get pinned up and basically occlude the coronary osteum, or you get sequestration of tube graft in the sinuses such that you don't get any sinus flow.","start_time":"1994.239","end_time":"2023.38","items":[6952,6953,6954,6955,6956,6957,6958,6959,6960,6961,6962,6963,6964,6965,6966,6967,6968,6969,6970,6971,6972,6973,6974,6975,6976,6977,6978,6979,6980,6981,6982,6983,6984,6985,6986,6987,6988,6989,6990,6991,6992,6993,6994,6995,6996,6997,6998,6999,7000,7001,7002,7003,7004,7005,7006,7007,7008,7009,7010,7011,7012,7013,7014,7015,7016,7017,7018,7019,7020,7021,7022,7023,7024,7025,7026,7027,7028,7029,7030,7031,7032,7033,7034,7035,7036,7037,7038,7039,7040,7041,7042,7043,7044,7045,7046,7047,7048,7049,7050,7051,7052,7053,7054,7055,7056]},{"id":98,"transcript":"The rates are relatively low and so in natives, uh, anatomy it's 0.4 to 0.7%. It's sixfold higher in Valve and Valrido tavers, but that's still less than 5% total risk. And every time you see us write basilica or cleave or Unicorn or all these ridiculous acronyms, uh, that people come up with, what we're talking about is these between 0.4% and 3.5% of patients that are at high risk for this.","start_time":"2024.489","end_time":"2050.699","items":[7057,7058,7059,7060,7061,7062,7063,7064,7065,7066,7067,7068,7069,7070,7071,7072,7073,7074,7075,7076,7077,7078,7079,7080,7081,7082,7083,7084,7085,7086,7087,7088,7089,7090,7091,7092,7093,7094,7095,7096,7097,7098,7099,7100,7101,7102,7103,7104,7105,7106,7107,7108,7109,7110,7111,7112,7113,7114,7115,7116,7117,7118,7119,7120,7121,7122,7123,7124,7125,7126,7127,7128,7129,7130,7131,7132,7133,7134,7135,7136,7137]},{"id":99,"transcript":"And the gatekeeper for the decisions and when we're taking electrified wires and lacerating leaflets is often very imprecise CT data and not this kind of modeling and so we're overusing those high risk procedures in a relatively low frequency event that arguably has very, very high complication rates and that's why we do it. If you have coronary occlusion, with the, the old adage is you don't have a coronary occlusion problem, you have a lack of ECMO problem because people decompensate so quickly.","start_time":"2050.898","end_time":"2078.668","items":[7138,7139,7140,7141,7142,7143,7144,7145,7146,7147,7148,7149,7150,7151,7152,7153,7154,7155,7156,7157,7158,7159,7160,7161,7162,7163,7164,7165,7166,7167,7168,7169,7170,7171,7172,7173,7174,7175,7176,7177,7178,7179,7180,7181,7182,7183,7184,7185,7186,7187,7188,7189,7190,7191,7192,7193,7194,7195,7196,7197,7198,7199,7200,7201,7202,7203,7204,7205,7206,7207,7208,7209,7210,7211,7212,7213,7214,7215,7216,7217,7218,7219,7220,7221,7222,7223,7224,7225,7226,7227,7228]},{"id":100,"transcript":"If you can get a stent and they still have a 22% mortality, if you convince the surgeon to open them up and bypass, they have a 50% mortality, but if you can't do either of those things, every single patient dies. And so in the setting of a low frequency event with high consequence, using imprecise upfront data to guide those adjunctive procedures isn't good enough. This is what we have. I mean this is so complex. This is, this is a ridiculous paper. It's trying to define this called the vivid criteria.","start_time":"2078.86","end_time":"2107.649","items":[7229,7230,7231,7232,7233,7234,7235,7236,7237,7238,7239,7240,7241,7242,7243,7244,7245,7246,7247,7248,7249,7250,7251,7252,7253,7254,7255,7256,7257,7258,7259,7260,7261,7262,7263,7264,7265,7266,7267,7268,7269,7270,7271,7272,7273,7274,7275,7276,7277,7278,7279,7280,7281,7282,7283,7284,7285,7286,7287,7288,7289,7290,7291,7292,7293,7294,7295,7296,7297,7298,7299,7300,7301,7302,7303,7304,7305,7306,7307,7308,7309,7310,7311,7312,7313,7314,7315,7316,7317,7318,7319,7320,7321,7322,7323,7324,7325,7326,7327,7328,7329,7330,7331,7332,7333,7334]},{"id":101,"transcript":"Um, it's trying to define, uh, sinus dimensions and coronary heights and giving you risks, uh, base of coronary oclusion based on these anatomic variations, but what it leads to is that you can't validate it. Anyone that was high risk in this complex classification scheme, um, didn't have a coronary occlusion event again because it's a low frequency event, so we're kind of flying blind.","start_time":"2107.969","end_time":"2130.56","items":[7335,7336,7337,7338,7339,7340,7341,7342,7343,7344,7345,7346,7347,7348,7349,7350,7351,7352,7353,7354,7355,7356,7357,7358,7359,7360,7361,7362,7363,7364,7365,7366,7367,7368,7369,7370,7371,7372,7373,7374,7375,7376,7377,7378,7379,7380,7381,7382,7383,7384,7385,7386,7387,7388,7389,7390,7391,7392,7393,7394,7395,7396,7397,7398,7399,7400,7401,7402,7403,7404,7405,7406,7407,7408,7409,7410,7411]},{"id":102,"transcript":"This is not flying blind anymore. This is the variable that AI came up with that basically looks at a three dimensional DLC over D flow into the sinuses and validate against BTC, which is we use 4 millimeters for all patients if they're under 4 millimeters, that's your virtual valve to the coronary on a CT scan.","start_time":"2131.139","end_time":"2149.899","items":[7412,7413,7414,7415,7416,7417,7418,7419,7420,7421,7422,7423,7424,7425,7426,7427,7428,7429,7430,7431,7432,7433,7434,7435,7436,7437,7438,7439,7440,7441,7442,7443,7444,7445,7446,7447,7448,7449,7450,7451,7452,7453,7454,7455,7456,7457,7458,7459,7460,7461,7462,7463,7464,7465,7466,7467,7468,7469,7470,7471,7472,7473]},{"id":103,"transcript":"You can measure that 10 times and get 10 different answers and we're making decisions about basilica based on that. If you validate that this new measure against that, it's uh got ROC curves that are 2.5 times better. It's 100% sensitive and 95.7% specific.","start_time":"2150.159","end_time":"2164.169","items":[7474,7475,7476,7477,7478,7479,7480,7481,7482,7483,7484,7485,7486,7487,7488,7489,7490,7491,7492,7493,7494,7495,7496,7497,7498,7499,7500,7501,7502,7503,7504,7505,7506,7507,7508,7509,7510,7511,7512,7513,7514,7515,7516,7517,7518,7519,7520,7521,7522]},{"id":104,"transcript":"So we have much better measures and predictors of these low frequency but high consequence events in Taver and that's how we make already low complication rates even lower.","start_time":"2164.81","end_time":"2174.81","items":[7523,7524,7525,7526,7527,7528,7529,7530,7531,7532,7533,7534,7535,7536,7537,7538,7539,7540,7541,7542,7543,7544,7545,7546,7547,7548,7549,7550,7551,7552]},{"id":105,"transcript":"A case that highlights this. This is a 70 year old female with bioprosthetic AS. She had a Magna E 3300 in 2013 with concomitant repair, severe COPD, and she came in with bioprosthetic aortic stenosis. By traditional measures, you can see we have coronary heights of 6 and 5. They're under 10, so we're already concerned.","start_time":"2175.35","end_time":"2192.35","items":[7553,7554,7555,7556,7557,7558,7559,7560,7561,7562,7563,7564,7565,7566,7567,7568,7569,7570,7571,7572,7573,7574,7575,7576,7577,7578,7579,7580,7581,7582,7583,7584,7585,7586,7587,7588,7589,7590,7591,7592,7593,7594,7595,7596,7597,7598,7599,7600,7601,7602,7603,7604,7605,7606,7607,7608,7609,7610,7611,7612,7613,7614,7615,7616,7617,7618]},{"id":106,"transcript":"We have VTCs of 4.2. We measure it 5 times and we get 3 on one side of 4 and 2 on one side on the other side of 4. We have VTCs on the left that are maybe a little bit more favorable BTSTJs that look OK. So would we, would we do a basilica in this case? Would we do both leaflets? The coronaries are low. The question is, um, is this what we're gonna base this on? Is this imprecise information?","start_time":"2192.52","end_time":"2220.11","items":[7619,7620,7621,7622,7623,7624,7625,7626,7627,7628,7629,7630,7631,7632,7633,7634,7635,7636,7637,7638,7639,7640,7641,7642,7643,7644,7645,7646,7647,7648,7649,7650,7651,7652,7653,7654,7655,7656,7657,7658,7659,7660,7661,7662,7663,7664,7665,7666,7667,7668,7669,7670,7671,7672,7673,7674,7675,7676,7677,7678,7679,7680,7681,7682,7683,7684,7685,7686,7687,7688,7689,7690,7691,7692,7693,7694,7695,7696,7697,7698,7699,7700,7701,7702,7703,7704,7705,7706,7707,7708,7709,7710,7711,7712,7713]},{"id":107,"transcript":"And no, we can use this exact modeling to to be more precise and when we do that we can see even if you dispel a lot of the, the, the AI machine learning sort of biomarkers and these risk factors that have been developed just from a three dimensional understanding of what that patient's native anatomy is gonna do in response to the stent.","start_time":"2220.489","end_time":"2238.81","items":[7714,7715,7716,7717,7718,7719,7720,7721,7722,7723,7724,7725,7726,7727,7728,7729,7730,7731,7732,7733,7734,7735,7736,7737,7738,7739,7740,7741,7742,7743,7744,7745,7746,7747,7748,7749,7750,7751,7752,7753,7754,7755,7756,7757,7758,7759,7760,7761,7762,7763,7764,7765,7766,7767,7768,7769,7770,7771,7772,7773,7774,7775,7776,7777,7778,7779,7780,7781,7782]},{"id":108,"transcript":"And seeing the flow into the coronaries, what you can see is that with a uh with a balloon expandable 23, it's actually the sapien valve pushes the native leaflets up into the right coronary much more and you you actually can't see the right coronary here above the right coronary leaflet. You've got very limited flow into the sinuses so that flagged us uh to coronary occlusion but isolated on the right.","start_time":"2239.189","end_time":"2262.59","items":[7783,7784,7785,7786,7787,7788,7789,7790,7791,7792,7793,7794,7795,7796,7797,7798,7799,7800,7801,7802,7803,7804,7805,7806,7807,7808,7809,7810,7811,7812,7813,7814,7815,7816,7817,7818,7819,7820,7821,7822,7823,7824,7825,7826,7827,7828,7829,7830,7831,7832,7833,7834,7835,7836,7837,7838,7839,7840,7841,7842,7843,7844,7845,7846,7847,7848,7849,7850,7851,7852,7853,7854,7855,7856,7857,7858,7859]},{"id":109,"transcript":"Now we would fracture this valve and so even though we're gonna use a self expanding valve we would be post dilating with a 24 true and so we'd be replicating what would happen with the 23 sapien if not a little bit more.","start_time":"2263.02","end_time":"2274.84","items":[7860,7861,7862,7863,7864,7865,7866,7867,7868,7869,7870,7871,7872,7873,7874,7875,7876,7877,7878,7879,7880,7881,7882,7883,7884,7885,7886,7887,7888,7889,7890,7891,7892,7893,7894,7895,7896,7897,7898,7899,7900,7901,7902,7903,7904]},{"id":110,"transcript":"When we do that with a uh self expanding valve you can see we don't have problems with flow into the sinuses but again this patient had a component of patient prosthesis mismatch so we want to take this old surgical valve and we put a Kevlar balloon in and we fracture the old valve to make the new stent expand more. So if we're gonna do that, uh, we are actually increasing the risk like a balloon expandable valve.","start_time":"2275.889","end_time":"2299.629","items":[7905,7906,7907,7908,7909,7910,7911,7912,7913,7914,7915,7916,7917,7918,7919,7920,7921,7922,7923,7924,7925,7926,7927,7928,7929,7930,7931,7932,7933,7934,7935,7936,7937,7938,7939,7940,7941,7942,7943,7944,7945,7946,7947,7948,7949,7950,7951,7952,7953,7954,7955,7956,7957,7958,7959,7960,7961,7962,7963,7964,7965,7966,7967,7968,7969,7970,7971,7972,7973,7974,7975,7976,7977,7978,7979,7980,7981,7982,7983,7984,7985,7986,7987,7988]},{"id":111,"transcript":"So now instead of going to this procedure and saying OK yeah let's just do basilica on both and exposing that patient to really high risk um we can model the actual basilica this is what a basilica is you see the laceration of the leaflets right here and right.","start_time":"2299.86","end_time":"2314.379","items":[7989,7990,7991,7992,7993,7994,7995,7996,7997,7998,7999,8000,8001,8002,8003,8004,8005,8006,8007,8008,8009,8010,8011,8012,8013,8014,8015,8016,8017,8018,8019,8020,8021,8022,8023,8024,8025,8026,8027,8028,8029,8030,8031,8032,8033,8034,8035,8036,8037,8038,8039]},{"id":112,"transcript":"It's actually here and on the left side.","start_time":"2317.33","end_time":"2319.479","items":[8040,8041,8042,8043,8044,8045,8046,8047,8048]},{"id":113,"transcript":"So that linear laceration is what a basilica is.","start_time":"2320.379","end_time":"2323.0","items":[8049,8050,8051,8052,8053,8054,8055,8056,8057,8058]},{"id":114,"transcript":"And we made a decision to just do the right, and we did something called cleave and so this is a uh multi-purpose guide you can see how low the corner is. This is the back end of a J wire that's electrified with a 40 charger inside of it. It's all guided by 3D multiplanner reconstruction. We create a little pinhole in the the native right leaflet. We dilate that balloon in exchange for a uh LV wire safari wire.","start_time":"2323.53","end_time":"2347.439","items":[8059,8060,8061,8062,8063,8064,8065,8066,8067,8068,8069,8070,8071,8072,8073,8074,8075,8076,8077,8078,8079,8080,8081,8082,8083,8084,8085,8086,8087,8088,8089,8090,8091,8092,8093,8094,8095,8096,8097,8098,8099,8100,8101,8102,8103,8104,8105,8106,8107,8108,8109,8110,8111,8112,8113,8114,8115,8116,8117,8118,8119,8120,8121,8122,8123,8124,8125,8126,8127,8128,8129,8130,8131,8132,8133,8134,8135,8136,8137,8138,8139,8140,8141,8142,8143,8144,8145]},{"id":115,"transcript":"We dilate that with the 12 balloons. So again we're in a keyhole in the leaflet here with the balloon that's inflated, and we're doing that to obliterate the leaflet so that it doesn't swing up and block the coronary and we actually deploy the valve in that keyhole and it's working perfectly even though we're not in the central orifice of the valve, we're in an intentional leaflet perforation.","start_time":"2349.58","end_time":"2368.5","items":[8146,8147,8148,8149,8150,8151,8152,8153,8154,8155,8156,8157,8158,8159,8160,8161,8162,8163,8164,8165,8166,8167,8168,8169,8170,8171,8172,8173,8174,8175,8176,8177,8178,8179,8180,8181,8182,8183,8184,8185,8186,8187,8188,8189,8190,8191,8192,8193,8194,8195,8196,8197,8198,8199,8200,8201,8202,8203,8204,8205,8206,8207,8208,8209,8210,8211,8212,8213,8214,8215,8216,8217,8218,8219]},{"id":116,"transcript":"And then we expand that valve with a post dilation and then you'll see the fracture of the old surgical ring as well.","start_time":"2369.62","end_time":"2376.209","items":[8220,8221,8222,8223,8224,8225,8226,8227,8228,8229,8230,8231,8232,8233,8234,8235,8236,8237,8238,8239,8240,8241,8242,8243]},{"id":117,"transcript":"So there's where it fractured right there.","start_time":"2381.8","end_time":"2383.58","items":[8244,8245,8246,8247,8248,8249,8250,8251]},{"id":118,"transcript":"The patient had no PVL. Um, they had a mean grading of 4 and a peak to peak of 4, so did extraordinarily well.","start_time":"2385.239","end_time":"2392.169","items":[8252,8253,8254,8255,8256,8257,8258,8259,8260,8261,8262,8263,8264,8265,8266,8267,8268,8269,8270,8271,8272,8273,8274,8275,8276,8277,8278,8279]},{"id":119,"transcript":"Likewise, it's allowed us to use dedicated purpose built tools uh to navigate more complex leaflet, uh, uh, modification, uh, requirements. This is a patient that had a 23 S3 in 2018 and again came in with, uh, bio prosthetic aortic stenosis. This is very complex. This is a redo tavern. If you look back at her, uh, imaging from 2018, she had low coronary heights, relatively low corner heights, and narrow sinuses.","start_time":"2393.05","end_time":"2418.389","items":[8280,8281,8282,8283,8284,8285,8286,8287,8288,8289,8290,8291,8292,8293,8294,8295,8296,8297,8298,8299,8300,8301,8302,8303,8304,8305,8306,8307,8308,8309,8310,8311,8312,8313,8314,8315,8316,8317,8318,8319,8320,8321,8322,8323,8324,8325,8326,8327,8328,8329,8330,8331,8332,8333,8334,8335,8336,8337,8338,8339,8340,8341,8342,8343,8344,8345,8346,8347,8348,8349,8350,8351,8352,8353,8354,8355,8356,8357,8358,8359,8360,8361,8362,8363,8364,8365,8366,8367,8368,8369,8370]},{"id":120,"transcript":"So when we see red here on our old uh modeling this means that we were a little bit concerned about hemodynamics with putting in a sapien. The EOAs were predicted to to to have a little bit of PPM, but we made that decision because we were worried about the coronaries.","start_time":"2418.709","end_time":"2431.909","items":[8371,8372,8373,8374,8375,8376,8377,8378,8379,8380,8381,8382,8383,8384,8385,8386,8387,8388,8389,8390,8391,8392,8393,8394,8395,8396,8397,8398,8399,8400,8401,8402,8403,8404,8405,8406,8407,8408,8409,8410,8411,8412,8413,8414,8415,8416,8417,8418,8419,8420,8421,8422,8423,8424,8425]},{"id":121,"transcript":"Now that Valve came back and you know even two years afterwards she's starting to get mean gradients in the 20s since 2020, she's on empiric anticoagulation. So back to the smart trial, this is what manifests at year seven is that those gradients that were 20 and 25, 2 years out from her valve are now, you know, 40 and she's symptomatic. We've got to retreat.","start_time":"2432.82","end_time":"2452.649","items":[8426,8427,8428,8429,8430,8431,8432,8433,8434,8435,8436,8437,8438,8439,8440,8441,8442,8443,8444,8445,8446,8447,8448,8449,8450,8451,8452,8453,8454,8455,8456,8457,8458,8459,8460,8461,8462,8463,8464,8465,8466,8467,8468,8469,8470,8471,8472,8473,8474,8475,8476,8477,8478,8479,8480,8481,8482,8483,8484,8485,8486,8487,8488,8489,8490,8491,8492,8493,8494,8495,8496,8497,8498,8499,8500]},{"id":122,"transcript":"By traditional measures, again, the stent frame actually comes the sapping came up above the leaflets. We have low corner heights, uh, shallow, or narrow VTCs, less than 4, and very shallow VTSDJs, so the risk of coronary inclusion is, is tremendous both by sinus sequestration and by the, uh, tavern leaflets propping up and causing coronary occlusion. So this would get swing swung up and basically block flow into the coronary.","start_time":"2453.01","end_time":"2478.939","items":[8501,8502,8503,8504,8505,8506,8507,8508,8509,8510,8511,8512,8513,8514,8515,8516,8517,8518,8519,8520,8521,8522,8523,8524,8525,8526,8527,8528,8529,8530,8531,8532,8533,8534,8535,8536,8537,8538,8539,8540,8541,8542,8543,8544,8545,8546,8547,8548,8549,8550,8551,8552,8553,8554,8555,8556,8557,8558,8559,8560,8561,8562,8563,8564,8565,8566,8567,8568,8569,8570,8571,8572,8573,8574,8575,8576,8577,8578,8579,8580,8581,8582,8583,8584,8585,8586]},{"id":123,"transcript":"Now we can model this and we can say,","start_time":"2480.489","end_time":"2483.09","items":[8587,8588,8589,8590,8591,8592,8593,8594,8595,8596]},{"id":124,"transcript":"Look, if we do a uh evolute and deploy a little bit lower, we're gonna mitigate the risk of sinus sequestration.","start_time":"2484.419","end_time":"2490.58","items":[8597,8598,8599,8600,8601,8602,8603,8604,8605,8606,8607,8608,8609,8610,8611,8612,8613,8614,8615,8616,8617,8618,8619,8620]},{"id":125,"transcript":"Uh, is the sinus sequestration gonna be all we need to do? Do we, do we still need to lacerate the leaflets? The frame is still above the left main and, and the calcium tip, and are these models valid in in such a unique scenario, someone that has a generated S3 that we're putting an evolute in.","start_time":"2491.11","end_time":"2506.05","items":[8621,8622,8623,8624,8625,8626,8627,8628,8629,8630,8631,8632,8633,8634,8635,8636,8637,8638,8639,8640,8641,8642,8643,8644,8645,8646,8647,8648,8649,8650,8651,8652,8653,8654,8655,8656,8657,8658,8659,8660,8661,8662,8663,8664,8665,8666,8667,8668,8669,8670,8671,8672,8673,8674,8675,8676,8677,8678,8679,8680,8681,8682,8683,8684,8685,8686]},{"id":126,"transcript":"But ultimately we used this purpose built tool so instead of doing 30 of these a year we do 5 to 7 a year and we can use dedicated tools like this device called the shortcut uh that's purpose built and allows us to safely lacerate these leaflets, sometimes lacerate both of them.","start_time":"2506.989","end_time":"2526.34","items":[8687,8688,8689,8690,8691,8692,8693,8694,8695,8696,8697,8698,8699,8700,8701,8702,8703,8704,8705,8706,8707,8708,8709,8710,8711,8712,8713,8714,8715,8716,8717,8718,8719,8720,8721,8722,8723,8724,8725,8726,8727,8728,8729,8730,8731,8732,8733,8734,8735,8736,8737,8738,8739,8740,8741]},{"id":127,"transcript":"In under 20 minutes instead of doing electrified wires, snaring wires, putting a V and a kink in the wire, and then electrifying them and and lacerating the leaflet, which is what a basilica is, or instead of perforating through the base of a leaflet and deploying a valve in that perforation.","start_time":"2526.57","end_time":"2541.159","items":[8742,8743,8744,8745,8746,8747,8748,8749,8750,8751,8752,8753,8754,8755,8756,8757,8758,8759,8760,8761,8762,8763,8764,8765,8766,8767,8768,8769,8770,8771,8772,8773,8774,8775,8776,8777,8778,8779,8780,8781,8782,8783,8784,8785,8786,8787,8788,8789,8790,8791,8792,8793,8794,8795,8796,8797,8798,8799]},{"id":128,"transcript":"We have a device now that that does all this is purpose built and has been demonstrated to be safe. What it does is come down on top of the leaflet.","start_time":"2541.679","end_time":"2548.879","items":[8800,8801,8802,8803,8804,8805,8806,8807,8808,8809,8810,8811,8812,8813,8814,8815,8816,8817,8818,8819,8820,8821,8822,8823,8824,8825,8826,8827,8828,8829,8830,8831,8832]},{"id":129,"transcript":"There's a cutting element","start_time":"2552.08","end_time":"2553.32","items":[8833,8834,8835,8836]},{"id":130,"transcript":"And what's nice about this is you cross the valve, you have an LV wire it goes through your taver sheath and so you can lacerate through over the wire that you're gonna deliver the taver through you can lacerate you can come up and you can turn it and lacerate the other side.","start_time":"2559.949","end_time":"2573.939","items":[8837,8838,8839,8840,8841,8842,8843,8844,8845,8846,8847,8848,8849,8850,8851,8852,8853,8854,8855,8856,8857,8858,8859,8860,8861,8862,8863,8864,8865,8866,8867,8868,8869,8870,8871,8872,8873,8874,8875,8876,8877,8878,8879,8880,8881,8882,8883,8884,8885,8886,8887,8888,8889,8890,8891,8892]},{"id":131,"transcript":"So we've done 8 of these cases thus far.","start_time":"2574.949","end_time":"2577.36","items":[8893,8894,8895,8896,8897,8898,8899,8900,8901,8902]},{"id":132,"transcript":"But more importantly, before we started using modeling for 500 tavers with about 10% being our redo or valve and valve, the highest risk patients, we were doing almost 30 basilica cases a year and so almost half, a little over half of our of our patients were getting.","start_time":"2578.53","end_time":"2596.729","items":[8903,8904,8905,8906,8907,8908,8909,8910,8911,8912,8913,8914,8915,8916,8917,8918,8919,8920,8921,8922,8923,8924,8925,8926,8927,8928,8929,8930,8931,8932,8933,8934,8935,8936,8937,8938,8939,8940,8941,8942,8943,8944,8945,8946,8947,8948,8949,8950,8951,8952,8953,8954,8955,8956]},{"id":133,"transcript":"Uh, extra procedures that are higher risk and we were doing that because of the fear of the high consequence event of coronary inclusion.","start_time":"2597.27","end_time":"2604.51","items":[8957,8958,8959,8960,8961,8962,8963,8964,8965,8966,8967,8968,8969,8970,8971,8972,8973,8974,8975,8976,8977,8978,8979,8980,8981,8982]},{"id":134,"transcript":"Well, now with more precise imaging and modeling we can focus on the patients that absolutely need that the most and use arguably a more expensive device but use it in the patients that actually need it and now we're doing like I said, uh, between 7 and 10 a year instead of 30 a year. This is that case. This is us lacerating the left.","start_time":"2605.06","end_time":"2625.58","items":[8983,8984,8985,8986,8987,8988,8989,8990,8991,8992,8993,8994,8995,8996,8997,8998,8999,9000,9001,9002,9003,9004,9005,9006,9007,9008,9009,9010,9011,9012,9013,9014,9015,9016,9017,9018,9019,9020,9021,9022,9023,9024,9025,9026,9027,9028,9029,9030,9031,9032,9033,9034,9035,9036,9037,9038,9039,9040,9041,9042,9043,9044,9045,9046,9047,9048,9049,9050,9051,9052,9053,9054]},{"id":135,"transcript":"You can see it's just a gentle push on the wire. The cutting element has already perforated the base of the leaflet.","start_time":"2626.26","end_time":"2631.03","items":[9055,9056,9057,9058,9059,9060,9061,9062,9063,9064,9065,9066,9067,9068,9069,9070,9071,9072,9073,9074,9075,9076,9077,9078]},{"id":136,"transcript":"And the leaflet is lacerated.","start_time":"2631.78","end_time":"2633.29","items":[9079,9080,9081,9082,9083,9084]},{"id":137,"transcript":"This is all guided by 3D MPR by Doctor Cohen so he can actually show me if I'm equidistant between the commissures and if I'm cutting through the the largest portion of the leaflet.","start_time":"2634.479","end_time":"2643.129","items":[9085,9086,9087,9088,9089,9090,9091,9092,9093,9094,9095,9096,9097,9098,9099,9100,9101,9102,9103,9104,9105,9106,9107,9108,9109,9110,9111,9112,9113,9114,9115,9116,9117,9118,9119]},{"id":138,"transcript":"And then we just spin it over and do the right.","start_time":"2644.199","end_time":"2646.05","items":[9120,9121,9122,9123,9124,9125,9126,9127,9128,9129,9130,9131]},{"id":139,"transcript":"And this took 17 minutes to do a double basilica with a dedicated device whereas before it would have taken us 2.5 hours so we can also do more cases, uh, and patients wait less.","start_time":"2647.729","end_time":"2658.85","items":[9132,9133,9134,9135,9136,9137,9138,9139,9140,9141,9142,9143,9144,9145,9146,9147,9148,9149,9150,9151,9152,9153,9154,9155,9156,9157,9158,9159,9160,9161,9162,9163,9164,9165,9166,9167,9168,9169]},{"id":140,"transcript":"This is the valve we intentionally deployed a little bit low based on some of that planning and so again we went in with more precision you can see the coronary filling.","start_time":"2661.6","end_time":"2668.76","items":[9170,9171,9172,9173,9174,9175,9176,9177,9178,9179,9180,9181,9182,9183,9184,9185,9186,9187,9188,9189,9190,9191,9192,9193,9194,9195,9196,9197,9198,9199,9200,9201,9202]},{"id":141,"transcript":"And then the final coronary inclusion case is one where we we used uh the shortcut again but it highlights really if if you didn't understand basilica and why it's necessary, this case highlights that you can see the bioprosthetic leaflet all but completely occluding flow into the sinuses and so the DLC over Ds were 0.1 and 0.3 in this, and you can see exactly why you have coronary occlusion. You cannot see into the coronaries on the left or the right.","start_time":"2670.0","end_time":"2695.159","items":[9203,9204,9205,9206,9207,9208,9209,9210,9211,9212,9213,9214,9215,9216,9217,9218,9219,9220,9221,9222,9223,9224,9225,9226,9227,9228,9229,9230,9231,9232,9233,9234,9235,9236,9237,9238,9239,9240,9241,9242,9243,9244,9245,9246,9247,9248,9249,9250,9251,9252,9253,9254,9255,9256,9257,9258,9259,9260,9261,9262,9263,9264,9265,9266,9267,9268,9269,9270,9271,9272,9273,9274,9275,9276,9277,9278,9279,9280,9281,9282,9283,9284,9285,9286,9287,9288,9289]},{"id":142,"transcript":"And more importantly it shows you what a leaflet modification looks like this is what the basilica does. You can see it splays by creating that linear laceration. This is without and the left and the right, this is with and the left and the right.","start_time":"2696.57","end_time":"2708.81","items":[9290,9291,9292,9293,9294,9295,9296,9297,9298,9299,9300,9301,9302,9303,9304,9305,9306,9307,9308,9309,9310,9311,9312,9313,9314,9315,9316,9317,9318,9319,9320,9321,9322,9323,9324,9325,9326,9327,9328,9329,9330,9331,9332,9333,9334,9335,9336,9337,9338,9339]},{"id":143,"transcript":"And we chose an intra-annular valve here which is technically off label because they're they're a newer valve but because we would have still had sinus sequestration.","start_time":"2709.629","end_time":"2716.699","items":[9340,9341,9342,9343,9344,9345,9346,9347,9348,9349,9350,9351,9352,9353,9354,9355,9356,9357,9358,9359,9360,9361,9362,9363,9364,9365,9366,9367]},{"id":144,"transcript":"You can see that laceration beautifully on on TEE.","start_time":"2719.949","end_time":"2723.969","items":[9368,9369,9370,9371,9372,9373,9374,9375,9376,9377]},{"id":145,"transcript":"And then we lacerated the right in the same fashion.","start_time":"2726.449","end_time":"2728.669","items":[9378,9379,9380,9381,9382,9383,9384,9385,9386,9387,9388]},{"id":146,"transcript":"And then we fractured the valve.","start_time":"2730.159","end_time":"2731.82","items":[9389,9390,9391,9392,9393,9394,9395]},{"id":147,"transcript":"And had good coronary filling with a peak to peak of 6 and no PVL.","start_time":"2735.32","end_time":"2738.85","items":[9396,9397,9398,9399,9400,9401,9402,9403,9404,9405,9406,9407,9408,9409,9410,9411]},{"id":148,"transcript":"So this patient had no symptoms at 30 days. This was just, uh, 2 months ago and so we, we, we've, uh, we're presenting this and we're publishing on this is that, uh, our pre-modeling versus post-modeling has dramatically reduced our necessity for the higher risk leaflet modification cases in spite of having a new tool that makes it easier to do those cases, so arguably changing that treatment threshold to lower to reaching for a shortcut any time we have concerns, we've still reduced our total rate of necessary leaflet modifications.","start_time":"2740.469","end_time":"2769.59","items":[9412,9413,9414,9415,9416,9417,9418,9419,9420,9421,9422,9423,9424,9425,9426,9427,9428,9429,9430,9431,9432,9433,9434,9435,9436,9437,9438,9439,9440,9441,9442,9443,9444,9445,9446,9447,9448,9449,9450,9451,9452,9453,9454,9455,9456,9457,9458,9459,9460,9461,9462,9463,9464,9465,9466,9467,9468,9469,9470,9471,9472,9473,9474,9475,9476,9477,9478,9479,9480,9481,9482,9483,9484,9485,9486,9487,9488,9489,9490,9491,9492,9493,9494,9495,9496,9497,9498,9499,9500,9501,9502,9503,9504,9505,9506,9507,9508,9509,9510,9511,9512,9513,9514,9515]},{"id":149,"transcript":"and helped in that fashion.","start_time":"2769.879","end_time":"2771.75","items":[9516,9517,9518,9519,9520,9521]},{"id":150,"transcript":"So what's coming next, so these models are based on.","start_time":"2772.939","end_time":"2776.83","items":[9522,9523,9524,9525,9526,9527,9528,9529,9530,9531,9532,9533]},{"id":151,"transcript":"You know, data sets that are getting broader and broader and more robust and so also becoming more and more predictive.","start_time":"2777.659","end_time":"2783.979","items":[9534,9535,9536,9537,9538,9539,9540,9541,9542,9543,9544,9545,9546,9547,9548,9549,9550,9551,9552,9553,9554,9555,9556]},{"id":152,"transcript":"We can now predict halt by using index echo and looking at flow on the CT scans. Again, you can take pre-CTs is all you need, and you can look at your virtual valve deployments and with machine learning and statistical analysis you can get predictors of uh bioprosthetic valve dysfunction at least by halt, and we can predict hemodynamics. So before we go into a case, we can now say this patient with an evolute is gonna have this gradient through 3 months or Sapien is gonna have this gradient through 3 months.","start_time":"2784.689","end_time":"2812.07","items":[9557,9558,9559,9560,9561,9562,9563,9564,9565,9566,9567,9568,9569,9570,9571,9572,9573,9574,9575,9576,9577,9578,9579,9580,9581,9582,9583,9584,9585,9586,9587,9588,9589,9590,9591,9592,9593,9594,9595,9596,9597,9598,9599,9600,9601,9602,9603,9604,9605,9606,9607,9608,9609,9610,9611,9612,9613,9614,9615,9616,9617,9618,9619,9620,9621,9622,9623,9624,9625,9626,9627,9628,9629,9630,9631,9632,9633,9634,9635,9636,9637,9638,9639,9640,9641,9642,9643,9644,9645,9646,9647,9648,9649,9650,9651,9652,9653,9654,9655,9656,9657]},{"id":153,"transcript":"And so we're now getting the ability to when we're making the decisions about which valve platform surgery versus tava we're now getting the ability and we'll very quickly get more and more uh precision with the ability to see what the result is going to be not just immediately during the procedure but at 3 years, 5 years, 10 years as more data is input into these models.","start_time":"2812.27","end_time":"2831.979","items":[9658,9659,9660,9661,9662,9663,9664,9665,9666,9667,9668,9669,9670,9671,9672,9673,9674,9675,9676,9677,9678,9679,9680,9681,9682,9683,9684,9685,9686,9687,9688,9689,9690,9691,9692,9693,9694,9695,9696,9697,9698,9699,9700,9701,9702,9703,9704,9705,9706,9707,9708,9709,9710,9711,9712,9713,9714,9715,9716,9717,9718,9719,9720,9721,9722,9723,9724,9725,9726,9727,9728,9729]},{"id":154,"transcript":"And then finally we're also using this to guide mitral procedures. These are just a few examples. It's a little bit grainy here, but um we've done several open atrial valve and macs so you can see how dense this calcification is that would take even in the best surgical hands like Doctor Scortino would take hours to debulk in a in a very you know high risk 82 year old patient and instead we can deploy intraoperatively, uh, in patients that have high risk of outflow tract obstruction.","start_time":"2833.429","end_time":"2860.939","items":[9730,9731,9732,9733,9734,9735,9736,9737,9738,9739,9740,9741,9742,9743,9744,9745,9746,9747,9748,9749,9750,9751,9752,9753,9754,9755,9756,9757,9758,9759,9760,9761,9762,9763,9764,9765,9766,9767,9768,9769,9770,9771,9772,9773,9774,9775,9776,9777,9778,9779,9780,9781,9782,9783,9784,9785,9786,9787,9788,9789,9790,9791,9792,9793,9794,9795,9796,9797,9798,9799,9800,9801,9802,9803,9804,9805,9806,9807,9808,9809,9810,9811,9812,9813,9814,9815,9816,9817,9818,9819,9820,9821,9822,9823,9824]},{"id":155,"transcript":"We can deploy intraoperatively a sapien. This is an Arctic procedure where patients had a prior clip we can deploy a valve on the other side of that clip.","start_time":"2861.1","end_time":"2869.33","items":[9825,9826,9827,9828,9829,9830,9831,9832,9833,9834,9835,9836,9837,9838,9839,9840,9841,9842,9843,9844,9845,9846,9847,9848,9849,9850,9851,9852,9853,9854,9855]},{"id":156,"transcript":"This is transeptal valve and Max. We can make sure that there's enough calcification when you see us talking about lampoons just like basilica and leaflet modification. We're worried about that native leaflet or the bioprosthetic leaflet swinging forward and causing neo LV outflow tract obstruction.","start_time":"2870.3","end_time":"2884.689","items":[9856,9857,9858,9859,9860,9861,9862,9863,9864,9865,9866,9867,9868,9869,9870,9871,9872,9873,9874,9875,9876,9877,9878,9879,9880,9881,9882,9883,9884,9885,9886,9887,9888,9889,9890,9891,9892,9893,9894,9895,9896,9897,9898,9899,9900,9901,9902,9903,9904]},{"id":157,"transcript":"And this is an example of of one of those cases. So this is an 81 year old, uh, that we did a valve and Mac TMVR on and had high risk of, uh, this native leaflet swinging in and causing outflow track obstruction. We can now see the LV outflow track in three dimensions instead of just taking a static two dimensional image, and we modeled a 29S3 at a 9010 deployment with three extra CCs of volume filled in.","start_time":"2886.139","end_time":"2910.53","items":[9905,9906,9907,9908,9909,9910,9911,9912,9913,9914,9915,9916,9917,9918,9919,9920,9921,9922,9923,9924,9925,9926,9927,9928,9929,9930,9931,9932,9933,9934,9935,9936,9937,9938,9939,9940,9941,9942,9943,9944,9945,9946,9947,9948,9949,9950,9951,9952,9953,9954,9955,9956,9957,9958,9959,9960,9961,9962,9963,9964,9965,9966,9967,9968,9969,9970,9971,9972,9973,9974,9975,9976,9977,9978,9979,9980,9981,9982,9983,9984,9985,9986,9987,9988,9989,9990,9991,9992,9993]},{"id":158,"transcript":"And with that complex Mac we could also predict where the PBL is going to occur.","start_time":"2910.85","end_time":"2916.58","items":[9994,9995,9996,9997,9998,9999,10000,10001,10002,10003,10004,10005,10006,10007,10008,10009,10010]},{"id":159,"transcript":"This is 3D MPR that procedure. This is us doing a septostomy, so this is the benefit of cardiac imaging and Doctor Cohen and our our advanced imagers have really.","start_time":"2917.879","end_time":"2926.51","items":[10011,10012,10013,10014,10015,10016,10017,10018,10019,10020,10021,10022,10023,10024,10025,10026,10027,10028,10029,10030,10031,10032,10033,10034,10035,10036,10037,10038,10039,10040,10041,10042,10043]},{"id":160,"transcript":"Taking it to where we can we can model all of this stuff, but if we can't do it, it's just pretty pictures. If you can model and you can have interp procedural guidance now you can do those cases and so they've increased our capacity to take on these cases where patients previously and that lots of other centers are just sent to hospice like we used to do for Tavern.","start_time":"2927.31","end_time":"2945.61","items":[10044,10045,10046,10047,10048,10049,10050,10051,10052,10053,10054,10055,10056,10057,10058,10059,10060,10061,10062,10063,10064,10065,10066,10067,10068,10069,10070,10071,10072,10073,10074,10075,10076,10077,10078,10079,10080,10081,10082,10083,10084,10085,10086,10087,10088,10089,10090,10091,10092,10093,10094,10095,10096,10097,10098,10099,10100,10101,10102,10103,10104,10105,10106,10107,10108,10109,10110,10111,10112,10113,10114,10115,10116,10117,10118,10119]},{"id":161,"transcript":"So this is septostomy. This is just deploying.","start_time":"2946.409","end_time":"2949.129","items":[10120,10121,10122,10123,10124,10125,10126,10127,10128,10129]},{"id":162,"transcript":"You can see how difficult these can be. That's the Mac that we're deploying and that's a sapien we're coming transeptal through that septostomy.","start_time":"2950.679","end_time":"2957.31","items":[10130,10131,10132,10133,10134,10135,10136,10137,10138,10139,10140,10141,10142,10143,10144,10145,10146,10147,10148,10149,10150,10151,10152,10153,10154,10155]},{"id":163,"transcript":"And if you're just, you know, a millimeter or 2 more ventricular, it embolizes into the valve and into the ventricle in a patient that doesn't have a surgical backup. So some of the, the, the highest risk cases we do, but we're going into them, at least in my perspective with lower heart rates than we were historically, uh, because we have very, very robust planning and modeling data on the front end.","start_time":"2958.58","end_time":"2980.239","items":[10156,10157,10158,10159,10160,10161,10162,10163,10164,10165,10166,10167,10168,10169,10170,10171,10172,10173,10174,10175,10176,10177,10178,10179,10180,10181,10182,10183,10184,10185,10186,10187,10188,10189,10190,10191,10192,10193,10194,10195,10196,10197,10198,10199,10200,10201,10202,10203,10204,10205,10206,10207,10208,10209,10210,10211,10212,10213,10214,10215,10216,10217,10218,10219,10220,10221,10222,10223,10224,10225,10226,10227,10228,10229,10230,10231,10232,10233,10234,10235,10236,10237,10238,10239,10240,10241]},{"id":164,"transcript":"This case was also done with significant risk for uh uh alpha tract obstruction because of septal hypertrophy and and Div Patel did a procedure called a scorpion where he did uh uh bipolar ablation of the septum to thin the septum because we couldn't do an alcohol septal ablation.","start_time":"2981.62","end_time":"2999.199","items":[10242,10243,10244,10245,10246,10247,10248,10249,10250,10251,10252,10253,10254,10255,10256,10257,10258,10259,10260,10261,10262,10263,10264,10265,10266,10267,10268,10269,10270,10271,10272,10273,10274,10275,10276,10277,10278,10279,10280,10281,10282,10283,10284,10285,10286,10287,10288,10289,10290,10291,10292]},{"id":165,"transcript":"So our main trans mitral gradient was 3, our peak to peak LVOT was only 4, and we did an ASD closure again, even routine things like ASD closures are better with advanced images.","start_time":"2999.899","end_time":"3011.1","items":[10293,10294,10295,10296,10297,10298,10299,10300,10301,10302,10303,10304,10305,10306,10307,10308,10309,10310,10311,10312,10313,10314,10315,10316,10317,10318,10319,10320,10321,10322,10323,10324,10325,10326,10327,10328,10329,10330]},{"id":166,"transcript":"And so in conclusion, um, pre-procedural planning for structural heart is definitely involved. Taver's only about 15 years mature. We went from TE sizing and planning on every single patient just a little over 10 years ago and making uh valve decisions about whether you're a man or a female getting a 23 or 26 or what we had some rudimentary measures on echoed guiding some of those decisions on valve size to then having CTA multiplanar reconstruction and making two dimensional measurements.","start_time":"3012.25","end_time":"3040.06","items":[10331,10332,10333,10334,10335,10336,10337,10338,10339,10340,10341,10342,10343,10344,10345,10346,10347,10348,10349,10350,10351,10352,10353,10354,10355,10356,10357,10358,10359,10360,10361,10362,10363,10364,10365,10366,10367,10368,10369,10370,10371,10372,10373,10374,10375,10376,10377,10378,10379,10380,10381,10382,10383,10384,10385,10386,10387,10388,10389,10390,10391,10392,10393,10394,10395,10396,10397,10398,10399,10400,10401,10402,10403,10404,10405,10406,10407,10408,10409,10410,10411,10412,10413,10414,10415,10416,10417,10418]},{"id":167,"transcript":"To taking patients CT scans and printing them physically printing them to creating virtual 3D prints to now having dynamic computational modeling to guide these, and this allows us to pick the best therapy, not just TaR versus Sab but also which one of the three valves is gonna work uniquely for that patient's unique anatomy, not just with respect to uh durability and um.","start_time":"3040.25","end_time":"3063.03","items":[10419,10420,10421,10422,10423,10424,10425,10426,10427,10428,10429,10430,10431,10432,10433,10434,10435,10436,10437,10438,10439,10440,10441,10442,10443,10444,10445,10446,10447,10448,10449,10450,10451,10452,10453,10454,10455,10456,10457,10458,10459,10460,10461,10462,10463,10464,10465,10466,10467,10468,10469,10470,10471,10472,10473,10474,10475,10476,10477,10478,10479,10480,10481,10482,10483,10484,10485,10486,10487]},{"id":168,"transcript":"Other measures of outcomes but in risk uh modulation and risk mitigation for that patient's individual risk based on their anatomy as patient volumes increase, what we're trying to do is find that 0.4% annual rupture risk in the 1 in 500 tavers every year that's gonna occur randomly on a on a Friday or a Monday is the third case and someone we didn't predict because we had rudimentary ways of predicting and now we have with using this kind of technology.","start_time":"3063.87","end_time":"3092.62","items":[10488,10489,10490,10491,10492,10493,10494,10495,10496,10497,10498,10499,10500,10501,10502,10503,10504,10505,10506,10507,10508,10509,10510,10511,10512,10513,10514,10515,10516,10517,10518,10519,10520,10521,10522,10523,10524,10525,10526,10527,10528,10529,10530,10531,10532,10533,10534,10535,10536,10537,10538,10539,10540,10541,10542,10543,10544,10545,10546,10547,10548,10549,10550,10551,10552,10553,10554,10555,10556,10557,10558,10559,10560,10561,10562,10563,10564,10565,10566,10567,10568,10569,10570,10571,10572]},{"id":169,"transcript":"Much, much more precision to finding that quote unquote needle in the haystack and at the simultaneous point of having to take on more and more complex tavers and reinterventions, uh, we can now plan with so much more precision even in the most complex mitral procedures, um, with these dedicated tools and we can use purpose built devices like Shortcut and the patients that.","start_time":"3092.75","end_time":"3113.409","items":[10573,10574,10575,10576,10577,10578,10579,10580,10581,10582,10583,10584,10585,10586,10587,10588,10589,10590,10591,10592,10593,10594,10595,10596,10597,10598,10599,10600,10601,10602,10603,10604,10605,10606,10607,10608,10609,10610,10611,10612,10613,10614,10615,10616,10617,10618,10619,10620,10621,10622,10623,10624,10625,10626,10627,10628,10629,10630,10631,10632,10633,10634,10635,10636,10637,10638,10639,10640,10641,10642,10643]}]}}
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