Chapters Transcript Video The Future Of Structural Heart I'm going to talk about controversies in tavern and what the future might hold. But I'd rather do this as a conversational style discussion with this panel and see what they think because I hope to learn more about what the issues are than I know already from them. And I really enjoy hearing everybody else's perspective. We're gonna bring up a few things that I think that are important in the Tavern world. And one of the things that I've really learned over time in the Tavern world is that we do lots of these clinical trials. They apply to the populations as a whole. But every patient is singularly important and different. And so here are my disclosures. And so I'm gonna start off with a case. This is 61 year old with hypertension. Hyper lipid. E me a retired federal agent now is a rancher. He was doing triathlons until the last two years or so. He quit doing a little bit of arthritis. Maybe maybe just slowing down a little. His echo shows severe aortic stenosis. Is E. K. G. Is normal. Uh Some of the measurements on his C. T. Scan show excessive calcification, remembers length of 6.5. So paul. What do you think? What would you tell this guy? Um so so it sounds like it needs his valve replaced and we got to start talking about options to replace the valve. Uh in a 61 year old it's a he's gonna need more than 11 procedure probably in his lifetime. Unless the mechanical valve and we know that he'll probably need more than one procedure in his lifetime because durability. The current valves that we have aside from a mechanical valve all suffer from structural deterioration over time. So you draw from a mechanical valve. No no I have a discussion. You know there's I think for this patient we see this patient a lot as I'm sure you do we would sit with them and have a discussion about options. I think the options will be mechanical surgical valve versus a tissue based trans catheter, trans catheter. Okay so here's the sita and he has it's a relatively small annual. Those areas for 46. The perimeter's only 76 sinuses are okay but the ct measurements show that the annuals isn't too bad. He has great peripheral access, a little bit angular ation on his C. T. Scan. Um so he's really into physical activity. Like I said he was probably doing he was doing marathons just a couple of years ago when you're a 61 year old man. Um you probably have on the time life tables. You should probably get to about 82 or 83. Unless there's some other significant medical problem. How many valves to get to the finish line? Deepak how many you think gets him to the finish line? I think I agree with what Paul said a minimum of two, maybe three. And who knows again depending on durability. He's a little bit young on the start and we know younger folks tend to territory their valves more quickly. So for one. All right, tell me that. Well, yeah, I mean Paul opened the discussion with that. And actually can you speak into the mix to make sure we've we've had a patient that's almost exactly. Except I think the patient was 59 who ran marathons. But you definitely have a strong mechanical valve conversation with this guy and that would be one valve probably. But and an athlete. So yeah, you know, everybody gets like I said, we do these clinical trials and then we apply what we know to each individual patient. And I have one of my partners was one of my best friends and he had rheumatic fever as a kid growing up and he was on Coumadin. I hate Coumadin and he died, you know, So I hate mechanical valves. I'll be absolutely honest with you. You know, that's not a data driven statement. It's an anecdotal statement. And we all have friends and relatives and how we treat. But So he's 61 years old. He could have a mechanical valve. He could have a surgical valve. Can can you have a tavern valve of course. So he walked into the clinic and said, I want a tavern valve. I don't want surgery and I don't want a pacemaker. So let's try to go through this. So here's the conduction system, diseases of partner three. Where you get a permanent pacemaker with a SAPIEN valve about 6.5% with core valve low risk it was 17% with a self expanding valve with a new and then new left bundle and mortality with the pacemaker. Is it real? Well, we know that the occurrence of getting a pacemaker is real. We know that there's going to be new left bundle. Branch block does that translate into adverse events and the data is all over the place here. You can see to me mrs eaves analysis that says if you get a left bundle branch block a discharge, your prognosis is not quite as good yet. A jack paper by Chairman D showed that there's absolutely no difference in outcomes in some of our core valve trials, we see that new left bundles have a slightly higher event rate over time but it's not perfectly proven in all of the data registries. And if we look at what the impact on mortality is. The data is also all over the place. If you get a pacemaker, does that shorten your life or is the person who needs a pacemaker? Just the signal of a person who is a little sicker and the sweetheart database, which is one of the largest cohort registries. Well over 12 years of tavern data shows that there's no impact at all on mortality with the use of a pacemaker. So matt, tell me about pacemakers and left bundle is impression that you have that giving a 61 year old man a pacemaker or a left new left bundle detrimental to the rest of his life. Well, I mean, you've shown data here that shows that it's controversial. The fact of the matter is that you have to consider other things. So keeping a device in and a young patient for an extended period of time, you have risks of infection and need for extraction. Can you guys hear okay in the back? Okay, speaking to the mike, maybe you could turn the mix up because I want to hear I'm having trouble hearing him up here. So the answer was, it depends you've shown a lot of data that shows, demonstrates that this is controversial as far as the data being sort of disparate, as far the outcomes for left bundles post have. But the pacemaker issue isn't just how people do with survival. Um, it has to do with uh generator changes, risks for infection, the potential need for extraction if there is infection. And so it's not entirely benign process in spite of what this data shows, I think anecdotally we see a lot of these patients uh year out um or further out that have had a left bundle after after their tavern. And uh there's certainly a percentage of them um that aren't doing quite as well as what we would expect. And so that's where I left bundle pacing and things like that come into play paul. Any other comments about pacemakers. Yeah, I think it's not great to put a pacemaker in a 61 year old. I think we have a long term chronic RV pacing is not an entirely benign thing. If you're 90 we don't really care. If you're 61 we probably care a fair amount. So I think for for us to be competitive in the Catheter side, um, that 17% pacemaker rate and one of the studies you cited is not acceptable. It's got to be single digits because there's a pacemaker rate with surgery as well. I mean, it's not, you know, it's about 4% with surgery. We need to be pretty close to that with a catheter vows to I think be compare Well, I know you're just totally biased against the bicuspid valve. You think the pacemakers ruined? What should the pacemaker Raby? If the interventional cardiologists want to be as good as the surgeons, what does the pacemaker rate have to be for Tavern? I'd say ideally five john comments. No, no, I would say probably that's a reasonable number paul. Great. Alright, so I think that the pacemaker rate with safety valves probably around 6.5%. What would you say that? It seems like it's relatively consistent over time. Not quite joe, not quite close enough to that 5% number, but hopefully we'll get smarter and have better devices over time, paul. You've been involved with the optimized pro data that's about to be published. And hopefully one of our major journals. Tell us about how you lower pacemaker rates with self expanding core valve stems. So steve nationals in that study, we've been actually able to show in that study with technique and a high end plant. Basically you need to keep the valve as close to the analyst as possible. Um, we have a prescriptive implant technique that's yielded a pacemaker rate of about 5.65.7%, which is highly competitive. So technique matters, where the valve goes, matters, avoiding conduction, system matters, and that can be that can be reproduced. And the nice thing is the pacemaker rates have been trending lower over time. So, I do think that it's important when you select the tab a valve that you keep the pacemaker in line. So then he asks another question, Will my Commissioners be aligned? So the Commissioners Commissioner alignments or the posts on the on the tavern valve and the Commissioners in the native valve. But sometimes when we were implanting valves, at least, me and my early experience, I had no idea where the Tavern Commissioner posts, we're going to go. I didn't even cross my mind for several years after implanting these valves that that could possibly be important. And it probably wasn't that important because some of the of the patients that we started with were very high risk or extreme risk patients and their long, they didn't live that long and they didn't live long enough for me to figure out what the problems that created on the initial implantation were. So here's why commercial posts are important and here's why they're important to be aligned in the native artery because you can do a heart catheterization in that tavern valve a lot easier the next time. And as the patients get younger, they will need to come back to the cath lab for procedures like heart catheterizations like angioplasties. And I don't my worst call is when someone is trying to do a heart catheterization on a Tavern patient that I had and every one of these guys has this call at night and they can't get the catheter back through the cage of the valve and how do you do this? Right. So I think if we align the commercial post we have a better chance of going back and doing coronary angiography in the future it may have some impact on how the blood flow occurs in the sinuses. Also, the Commissioner posts are aligned correctly. We may have better wash out in the coronary sinuses and it may impact the durability of the valve. Some of this is unclear, but potentially an issue that we would have to deal with and then if we want to go back and do another valve down the road aligning the commissary post allows us to do valve and valve hopefully not valve and valve and valve without obstructing the coronary arteries. So here's what it looks like. So we do. There's a variety of different devices out there. SAPIEN core valve accurate neon portico. I know that with the new core valve, I could probably align the Commissioner's 99% of the time I think with accurate Neo, I could do it 100% of the time and that's how I learned to do commercial alignment with SAPIEN three. I don't have any idea where the commercial post will be paul. Do you have any comments on that? No. Uh and and this is increasingly becoming important because what you really want to do is avoid commercial misalignment. Don't have a post in front of the left main because that becomes really problematic. And I think the valve companies are on to this right now with the veloute and accurate Neo and portico is something we can do that. I think SAPIEN their next generation will have the ability to rotate the valve. But it's increasingly important as these younger patients come back with recent commission alignment on every patient or to just worry about the left coronary. We try to do it on every patient and again, the current generations of technology are improving in this as paul alluded to. But I think that is going to be one of the really important areas to target in the future. That's where the surgical, the advantage the surgeon has, They can see and line it up? We have to get to that in the structural interventional side as well, joe is it important to have commissioners out of the way on for all of the coronaries or just the left? Well, probably ideally all of them. But the left obviously is the most important one. And I just want to offer one. Aside here, you kind of went anecdotal with the warfarin comment. So, I'm gonna go. So I'm gonna go, I'm gonna go anecdotal with the fact that, you know, I'm seeing in clinic right now, relatively young patient, mid to late sixties who has had to tap valves and now really cannot have another tab or valve because of B two obstructive. And so she's gonna come back in now probably for what's going to turn out to be a complicated root replacement a decade older than she first presented, Which is a much higher risk operation for her. So, I personally am talking to this 61 year old patient would not take off the table a tissue surgical valve. Um, that will uh, that with or without, you know, enlargement, depending on what he needs. Uh, and maybe with a router employment because then you have uh you probably really could do two more taverns and be okay. And he may only need one more tavern. Uh, but I just want to make that point that at 61, I don't think that the only surgical option is a mechanical option? I think a tissue a VR is also an option for that patient. Yeah. In fact, if this patient when they came to the office, I mean, if you if you have a 61 year old coming in for with no comorbidities. Still, our guidelines, as you know, indicate the first option is really surgical aortic valve replacement. Um, I'm one of my purposes is trying to move the needle a little further along. Tavern. Can we get to Tavern for all? But I agree with you right now that the standard of care would probably be a tissue surgical valve I think. But I think I think the reason for that is all the stuff we're talking about. We have to be as good with the Tavern valves as the surgeons are in terms of aligning the posts and reserving access to the coronaries to compare apples and apples. Because at that point then a less invasive approach carries more weight. But we need to do our best possible job in young patients. It wouldn't happen. It wouldn't happen with everybody. But if the patient is going to need a surgical intervention at some point, the younger they are, the better that's going to go. And this particular lady, I'm thinking about her risk now is going to be higher. And I will say though it's not always the case. I think surgeons around the country are increasingly realizing that sometimes when you go back with some valves are a little more maybe prone to this than others. But um, you know, maybe you can take that to val val and just do a straight surgical replacement. That's what you try to do. But you might not be able to sometimes the roots torn up a little bit. And then even in that case, sometimes what we typically do in a route where we create that coronary button, if much of the tissue across that button is torn up. You then have a flush coronary and you don't really have a button. So actually you translated that into root replacement and bypass grafting, which um, gets into another discussion about longevity and issues. Right? So, um, one thing that sometimes we take for granted is Do I think that the coronary arteries come off in the same place every time and they don't, that's why I was asking, we just protect the left or are we worried about both when we do the CT scans on the coronary arteries were taught in medical school and there's a lot of stuff I was taught in medical school that now I find out is wrong, especially about the aortic valve, but the coronaries don't always come off at 120. The angle they're kind of all over the place. So we talk about commercial alignment to make sure that the coronaries are safe, but the reality is we are hoping that we get the left correct and I think the surgeons want that, that you have to get the left main correct and then the valve sits where it wants to for the right. And most of the time it's OK. It's about 95% of the time. We do have influence on where we put the valve. So you can see that these have shown a couple of different valve placements and the skirts that go into the annual is, and if you put the skirt too high, you could influence the degree of coronary obstruction. And we know that the valves that have bigger cages with leaflets that are suspended. And I'm a very big fan of super annular valves with leaflets way above the coronaries. I know that there's a cost to them for potential coronary obstruction, but the human dynamics are better. And hopefully I'll show you that. I think durability is better. So we want the commercial posts in the right way. So our commercial post is not laying right over top of the coronary artery because that makes it very difficult to get back in to do redo redo procedures. We have a way of doing in tab that makes much more sense today. And you have experts like matt who go to the ct scan and they could see where the other valve is. You can tell you where the corner is and you could tell where to put the next valve, which is typically a SAPIEN valve either inside a SAPIEN or a core valve or a neo. And I'll show you some examples of how we could do that safely. But here's where the co ordinary access would be. It is above the ceiling skirt and if we don't pin that, if we don't pin the leaflets back we have access to the coronaries. Now, commercial alignment can be achieved with the core valve by turning the flush pour 23 o'clock. When that happens we look for a hat markers were going up the ascending aorta. The hat has to be to the lateral side of the elo projection so it looks like you're wearing a hat. And then when we go to the to the ascending aorta, the hat is on the other side so it's lying against the greater curve. We typically do these procedures then with that with that hat marker and the correct orientation, we get commission alignment about 85% of the time but that's not quite good enough. And here you can see that if you use the hat marker correctly and you have the C. Tab at the top of the valve in the right spot we can get reasonable coronary access but we want it all of the time. So with our flush ports and our marker we're good. Now there are markers on the valve and if the markers are correct, the markers have to on the, on the left side of the screen and an R. E. O. Coddle projection which is where matt does his cases all the time. He now can probably get to about a 99% commercial alignment. Is that good enough? Does that influence how you what you how you choose a valve for the first time now? It does for the things that we've talked about already potentially durability issues, patients can develop coronary disease after the fact and if you can align the Commissioner's, you're setting yourself up for potential success in the future. Which is I think it's an important consideration when we're making these decisions about choice of first valve. Okay so joe if I give you lower pacemaker rates as paul has talked about in the optimized pro trial where we're getting down into mid single digits and you have commissioner alignment can tab or be the first option rather than surgery. Have I started to convince you yet? I would say that it can be obviously some of this stuff is debatable and you know the patient's gonna have a preference, patients will not always. But you know as most of you know more frequently choose something that's less invasive. But I still worry about a patient like this a decade from now. I don't know. I mean in terms of the Tabard durability. Yes of course we have some data on that but I still don't know. And there's gonna be some of those patients that need That need their operation than a decade or 15 years later and it's going to be a really different risk conversation than if they had a surgical valve up front. So I really still personally would have that type of kind of heart to heart with the patient. Okay, so let's talk about durability. Good leading. Did you see my slide? Alright, so here's notion notions eight year outcomes, core valve versus surgical valves in europe, this is actually out to nine years. But they didn't publish the nine year slide. I was kinda hoping they would do every year slide. And you know, you could, anytime you're trying to follow patients, especially in the valve business, you have the competing risk of death. So nobody lives forever. The patients who get aortic stenosis tend to be older. Some of them can't be followed up because they die of cancer die from some other reason. And sometimes in clinical trials it's hard to find the patients, but notion is our best long term data so far. And if we look at bio prosthetic valve failure, the tabla valve versus a surgical valve. And what I mean by failure is you basically have severe leakage of the valve. The valve has to be intervened upon The valves do pretty well. There's only about 10% of them that have to be intervened at 10 years and tavern um looks pretty good. There's a little bit of a trend toward betterment than surgery. And then if we look at um If we look at the structural valve deterioration, which is a little bit different definition. This definition is a change in the gradient of the valve of over 10 from any time during follow up of the valve. Tava outperforms the surgical valve. Now this isn't valve replacement but it's a it's a marker of potentially of worsening valve function over time. And um the human dynamics for Tavern are always better than surgery. And if you look at the competing risk of mortality from the Sir tabby data, that's the US trial of high risk patients. What we start to see is that there again lower risks of structural valve deterioration with the sea super annular valve. I can't quite say this with an intra annular valve, but with a super annular valve. We are seeing less structural valve deterioration. Now, I know five years. Doesn't a lifetime make right, joe. Okay, so tell me what, tell me how you interpret these data And I'll show you one more slide. The smaller the analysts. The worst the outcome for the surgical valve. The greater the improvement for Tavern. Yeah, I would agree with that. I mean, the gradients are low with the Taber valve. We saw that early on and and that was a pleasing thing about tab are I think. And the durability data. It is what it is. I would just again caution that it's those are factors. Absolutely. But it's also just about if that patients are going to need another operation, the timing of when that patients operation would be. Now, maybe some of these patients, you know, a majority may never need another operation, right? Or any operation. They'll just have their tavern or maybe then a Tavern Tavern. But it's also more about if you need an operation you want earlier, do you want it later? You probably want it earlier. So that's almost more my point durability. I mean all this stuff is known. I I don't disagree with any of that obviously. So, So um deepak throwing caution out the window totally throwing caution out the window if you put on your crystal ball and you look out 30 years from now, what valves are gonna last longer? Taber valves or surgical valves? Great question. So it's obviously a lot of the technology we use is similar between the two valves. Right. The Taber valves were designed based on using the surgical valve as the standard before. A lot of the calcium calcium modifications that are done to minimize calcification can be applied in both technologies. It's hard not to think we've seen so much quick evolution. The Taber valves and that's obvious. A little bit of a bias for me quite honestly. So I would say, I think we're going to see continued improvement in the longevity of tapper valves and and surgical valves too. But I think as as you have valves that last longer and you take this issue off the table of 2nd, 3rd and longer range procedures, I think that preference on the patient's side will probably increase further. Got it. So the problem with the follow up again is the competing risk of death. But we do know that we think we think that improved team of dynamics. Maybe a super annular design may cause even greater longevity of the valve. So, paul, what's your impression of savage durability before I show the bias slides that I'm about to show. What do you think? Let's get anecdotal one more time? I want to get back to our rancher. Alright, so this comes up a lot. We see people together in our clinic Elizabeth's gonna talk about our team a little bit later on. But this would be a discussion we have with each other and then with the patient. And the one thing I would I would talk to to Joseph about is I'd say, all right, we're gonna go with surgery. What size valves can you get in this patient? Can you get a 21 or 23 with a true idea of 19 or 21? And and the reason I said because you look at all these tables and its durability simply a function of the bigger the effective orifice. When you start, if you can start with a bigger area, it takes longer for it to fail. Um and there's a lot of evidence that there's at least a component of that. So if we get a surgical valve that can mimic the human dynamics of a tavern valve, then we're talking so savage durability, I think is predicated a lot by The surgical technique, the size of the valve and and putting the biggest valve possible in a patient. And the surgeon has done a really nice job of kind of keeping up with this. I think the partner three trial there's a 35% rate of root enlargement. Um but I think we'd have to turn around and as hard as a cardiologist don't accept, you know, 19 and 21 valves. And as a surgeon, you know, uh bigger is better. You agree with that? Yeah. Alright. So I answered your question, paul is one of my best friends, but I almost don't agree with what he just said, joe tell me what the root enlargement rate is at your institution for a surgical aortic valve, it's probably not a third. Um But it is something I think that we definitely more actively think about and we definitely talk about trying to get the biggest valve and that we can um And um you know, I don't know, even on the surgery side and and I think the companies are perhaps working on it, although there's been so much growth on the tavern side. I mean, even the design of surgical valves might help us uh reduce some of those gradients um and and and get a bigger internal effective or office area. But to answer your question, probably 5%. So that's really important when we did the core valve, low risk trial. Everybody, all the surgeons were puffing out their chest. We're going to do root and large. We're going to put in big valves. 4% had root enlargement four. You can count them on one hand without your thumb paul 4%. And at my institution we have a 4% annular enlargement rate. Now we'll tell you one thing, no one has ever proved that it makes a difference in mortality. There might be a little penalty to pay when someone's chopping around your heart a little bit more. And I asked one of my favorite surgeons at our hospital. The guy is a prince. He's just a wonderful guy, cooperates with a tavern program. He operates takes great care of patients. He is bold enough to sit in my structural meeting every Tuesday. And I never did a root in large. He's been in practice for 25 years. He just he puts in relatively big valves. I don't know exactly how he does it. But he said, I've never done one. So I think there's variability and the surgeons do a great job. But root enlargements a little bit of puffing out your chest so far. Hopefully it translates into improvements. No wonder he's your good friend. Okay, so let's talk about the durability of bio prosthetic surgical valves. There's a number of trials. And the biggest problem, like I said, was the competing risk of death. Whenever I show survival curves in our heart team meeting about a patient, we're trying to decide which way we're going to go. One of my surgeons always says, the only thing you convinced me with survival curves is that I should retire right now because I don't have that long to live. So I'll try to try to coach this in terms of what a patient's like. But the problem with the bio prosthetic surgical valves is the data is all over the place. It's mostly freedom from re operation and that's where the competing risk of death interferes with how long that valve really is. And I want to point out to you that if you have surgery on your chest for an aortic valve replacement, you never, ever, never, ever, ever get back on the actuarial survival curve again. So that top line the thin line is what a person who doesn't have surgical graveyard, you get pretty close. But you never get there. We think we can get there with Tavern, here's the mortality by age. So the older you are, if you have a surgical aortic valve replacement, just to be a little sobering. If you're 80 years old, you have a surgical valve replacement, five years is the average survival if you're 65 Um, your 10 year survival is about 70% people do not live forever. And the higher your risk is at any age that you have surgical aortic valve replacement. It lowers your survival. And the fact of the matter is no matter what age you get operated on 60, 98% of the people get one valve. Tell me, matt, how many times does paul talk to you about two valve strategies for younger people. Do you guys talk about this all the time in in our conferences that we have for each patient, we talk about these issues particularly how many valves are going to have in a lifetime. We spend hours and hours talking about it. People just don't, What do you think paul people get that many sec? Not yet. Not yet. But they're coming. And I think tsunami is coming. I think it's coming. That's definitely going to see it. It's coming. I think it's easy enough to predict on ct. So we do look at it. But you're right. It's a lot of it's a theoretical exercise as our patients continue to smoke. And clearly we have to prepare for it. And I think what started us to be prepared for it when when we started doing Tavern and Savage and we thought, oh, this is going to happen all the time. But the reality is last year in the United States, 1.1% of, I mean 5% of patients that had Tavern had it for tab and Sav. It's not that not that high and it was 0.7% for Tavon Tavon so maybe the tsunami is coming but it certainly hasn't hit yet. So can Tavern be the first option? Pacemakers are declining comment your alignments improving durability looks promising to have you convinced yet, joe Not quite. Huh? Alright. Let's change the clinical scenario. Alright, Paul. Help me with this 60 year old female with small analysts. What do you do with that person? Make your answers quick. Okay. It's like a chart up there. But let me just see what I can do. 60 year old female severe so small and best lifetime management Just off the top of your head. Tavern. Self expanding valve, not mechanical valve and not surgical route and large. Change it to 50. I'll go with mechanical valve 60. Okay, Joe tell me when your age of this patient starts to click toward tavern. Yeah, I think I think that 60 to 65 year old window is really kind of where the fence is right now in the fifties. Probably go surgical. So 60 to 65. You put a surgical bio prosthesis in there. What if it's a small root and all you can get is a 21 valve. And is that good enough? I'd sure try to enlarge that one. Okay. Okay seven years old paul. I'm sorry. All right, good. We're getting there. We're getting there now. This is this is one of my most fun slides because I can't believe this is one of our journals, european Heart Journal, Stephon Wynn Decker who's really a leader in the field, He proposed this scenario depending upon your age and how long you think the patient's going to live because no one really knows how long anyone's going to live. But he has these three valve strategies, which in my mind are almost totally ridiculous anyway. I just like to show it because the colors are beautiful. All right now we've had better human animals can't have her be done safely. Tavern Tavern. That's his next question. If you give me commissioner alignment, can you do it again? So here's a degenerated SAPIEN valve. We don't know where the commissioners are, but we can dump valves inside here relatively safely. Now, the advantage of the accurate neo when it becomes available is that you haven't given up coronary access, you can get behind these leaflets quite easily. So we've done some modeling on how to do that. And if you have a degenerated SAPIEN and you put a um um if you do a accurate Neo, you could put um uh coronary access is really relatively easily achieved. Do you have to do um Basilica or anything funny with the valve ahead of time. Especially now since we don't accurate for this indication, but for core valve. Do you have to modify something before you do this. Sometimes it's still pretty rare for valve and valve? It's still less than eight or 9%, but sometimes you do need to modify the leaflets. Would you modify the leaflet only if the first valve is a little higher toward the corners? Or do you do it all the time? Only if there's a risk of threatened inclusion. If you're going to either sequester the coronary or include the coronary. And for many of you who don't know, basilica is a leaflet laceration to a lot better access to the corners and paul. Mahoney really is one of the world's expert at that. And I totally defer to anything he says about this. So here's our Commissioner alignment does help you can you can align the Commissioners with core valve FX and then with Neo to the Commissioners of the previous valve. So, the ct analysis ahead of time tells us where the Commissioners will be kind of gives us an idea of how to deploy the next valve. So, what characteristics make an ideal valve durability. Excellent. Human dynamics, freedom from structural valve deterioration and then ease of implantation and use. And currently in the United States, the three is the most common valve used and it's mostly because of ease of implantation. It's important to get out of that procedure as quickly as possible with the best result as possible, but we do have new technology. So there's going to be new SAPIEN valves that allow us to do commercial alignment. Are you talking about that at all today paul? Not specifically, but we're in the trial. Do you want to make any comments about that? So the next technology, SAPIEN valve will have an internal rotation. It'll allow you to spin the valve on its axis and line the commissioner's up so that you can mimic what the surgeons doing bracket the left main and that's going to be important with that valve. And then the next picture is the Jenna valve. We get 100% commission alignment for that. It's being studied for aortic insufficiency. This valve captures the leaflets of the native valve, pulls them toward the valve frame. Do you think that has any other implications or it would be great for potentially a valve and valve treatment. And how about low coronaries or small sciences? Some of the ones we struggle. Do you think that valve may work for that? Yeah, it may be a good choice for that right now. It's only being studied for ai but I think it's got a lot of use takes us a little longer to implant that than most other valves. Um, and then accurate prime, which will be a newer technology with the accurate new, which is still not available but the next gen beyond the one. And this is the one that will become commercially available in the United States has a more robust frame at the annual list to prevent para valvular leak and it's really a very simple valve to get to coronary access. So, um, and then I'm going to talk a little bit about the newer technologies, such as I spoke to my kids one time and I was telling him we were doing tavern, this was years ago and I still had one that was relatively young. Now they're old and he was describing the valve to them and it's a stent frame and we put either porcine or bovine tissue. And he asks, what's porcine means? What's bovine? I tell them it's a pig or cow. And he goes, why do you do that? Why do you put animal tissue on there? And you know, it's one of those things where I'm afraid that if when one of my sons becomes a doctor, he's going to come up to me and say, Dad, why did you hate your patients so much? You gave him Coumadin. So I'm hoping that they don't say that about us using bovine and porcine tissue. Also, I'm attacking all the surgical products. Right, joe. So this is a couple of partners in the audience, some reinforcements. Okay, So what we're working on is a polymer based valve. This is a company called fold X. And what you can see on the left image is the surgical valve. And on the right image will be the the trans catheter valve. And it's a polymer instead of using bovine or porcine tissue. What's why are we doing this? There's lots of supply chain issues you've heard of that term throughout the United States in the last couple of years. But supply chain for animal tissues is also a big deal. And for instance, you could only get the bovine tissue from either south south America or Australia and new Zealand because of bovine spongiform encephalopathy, or mad cow. So sourcing the animal tissue is a little bit tricky and expensive. So we did publish the first initial surgical data in Jack interventions about the first surgical experience in these valves. And what you can see are excellent human dynamics. So the polymer tissue is about a third the thickness of a porcine leaflet. So the human dynamics are excellent. The real question is, will there be thrombosis, and will there be leaflet tearing? And that has caused all of the failures of polymer based valves over history? And there's a true full graveyard of different polymers that have failed for valve technology. So here's what the coronary design looks like. And here's the magic. So, um, when you this is a single robot that makes the valve, so the robot mixes the polymer and a correct blend and then it gets picks a valve frame up from the shelf and then it goes through the process of dipping this and here you can see that it has a valve, a surgical valve frame and I'll let the video play as it's trying to make this valve. But One of the problems that we also have with any type of surgical valve or Taber valve is hand sewing all of the leaflet tissue onto the valve. I think with a typical surgical valve there's over 500 sutures in there and Taber valves, an extensive amount. Also, I don't know exactly quite the number. And of course it's hard to find people with those types of skills to do this procedure with a polymer based valve. You have this one robot that works continuously to make the valve and it takes about three minutes to make the valve. We have a current study in India ongoing in the surgical valve area. It is enrolled close to 40 patients. It's going quite well. The Mitral Valve study in the United States and the aortic valve studies should hopefully resume in the first quarter of 2023. What kind of regulation? So the question is, what kind of anti coagulation do those patients need? We don't know. So, um I think six. What we're doing in India six months and mostly because we have no idea. Six months of anti coagulation with Coumadin, coagulate. Your bio prosthetic. Oh God. What happened in the last two minutes? Because you can't afford you can't afford eloquence in India. So no, I don't regulate any bio prosthetic tissue in the aortic position In the Mitral. I will for about three months just for a little bit of the tissue in growth. But we don't all do that. It's not a it's my personal practice in the aortic position. Nothing ever 30 years because the guidelines are unclear. When we did the low risk study. We wanted to do cT evaluation of the Taber valves in the surgical valves and we wanted to do to look for a halt or hyper attenuation of the leaflets. So we did CTS at 30 days and in one year. And we had a mismatched number of patients in the Tavern arm and the surgical arm. Because the surgeons kept during the beginning of this, when the trial started, about a quarter of them switched to starting them on Coumadin afterwards. Because the guidelines are a little wishy washy, right? It's not like cardiology guidelines where they're perfectly crystal clear. So, final thoughts, Tavern technology is moving ahead very rapidly. And one of the things that I've really learned about this is that we've made great friends along the way. We've learned a lot from each other and I'm always grateful for my friends who are amazing physicians. Thank you Published December 7, 2022 Created by Related Presenters Steven Yakubov, M.D. Ohio Health Institue
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