Chapters Transcript Video Lifetime Management of Aortic Stenosis Dr. Parikh discusses the lifetime management decisions that need addressed with the heart team and the patient when managing aortic stenosis. Good morning everyone. Thank you for joining in person and virtually. So I'll be talking about lifetime management of a aortic stenosis, which I think is a very important topic, um, if I can get the arrows to work. OK, no relevant disclosures. So in terms of objectives, I'll try and go over the guidelines for aortic valve replacement and aortic stenosis, evolution of Taver available Taver platforms, data on Taver and SAR, go over some case examples and then future directions and a contemporary approach which we are using here at Centerra Heart. So big question, why are we talking about lifetime management? So lifetime management is important because as we can see from 1960 to 2020, the life expectancy in the United States population has been going up. It is now 77 years, uh, based on the data from 2022. Now life expectancy by age is different than this so if you have a patient coming in at 75, it does not mean that they're at their life expectancy because that was at birth. So if you have a patient coming in at 65 who has made it till 65, they still probably have another 19 years left. If they come in at 75, then they probably have another 12 years left, and if they come in at 85, they probably have another 7 years left, which means. That it's important to think about what we're gonna do with patients who come in with aortic valve disease when they're probably in their 60s or 70s. Thinking about the next 15 or 20 years. So again just looking at the median survival, so at 65, the median survival is around 15 to 16 years at 70 years, the median survival is around 12 to 13 years and even at 80, the median survival is around 8 to 10 years. So again, if patients come in when they're 70 or 80, you have to think about what you're gonna do in terms of valve planning till they reach 85 or 90 years of age. In terms of aortic stenosis progression and intervention, it's important to also know that if we intervene too early, then there's unnecessary exposure to risk of complications of surgery and taver even though the complications for both are low, it's not completely zero. Uh, the patient will have to live with a prosthetic valve for a long time. Prosthetic valves, as we all know, are gonna degenerate over time, so we have to start thinking about reintervention. So again, if we intervene too early, then there are negatives to that. They may be on anticoagulation for a long time and then again repeat intervention for the valve deterioration. Optimal timing is what we're trying to figure out that you wanna try and do this just before the left ventricular decompensation starts and more data coming in that maybe we should be doing this just before the symptoms start as well and then obviously we know that if it's too late then there's already irreversible damage to the myocardium which can cause sudden cardiac death, increased perioperative risk for Tavers and tas both heart failure, hospital admissions, increased mortality, and of, uh of course financial burden as well. So then going over the current guidelines, what do the guidelines tell us? The ACC published guidelines in 2020 which said that it is a class one A indication for symptomatic and asymptomatic patients with severe AS. And any indication for AVR who are less than 65 or have a life expectancy of more than 20 years that they should be undergoing SAR. So they're talking about life expectancy and age if they're between 65 to 80, then it could be either a saver or a tabby. And if there are more than 80 with the life or a life expectancy of less than 10 years, then likely Taver is recommended. Again, these are guidelines, these are not rules, and there has to be a thought process to using the guidelines. So just to recap again, less than 65 with an age, uh, life expectancy of more than 20 years, then SaR is still class 1. 65 to 80, it's Saver or taver, and then more than 80 class 1 for Taver and 2 A for Saber. In 2021, the European Association published their guidelines where they talked about younger patients who are low risk, so they're talking about low risk patients less than 75, they should be undergoing SAR, and then more than 75 or who are high risk should be undergoing TAR. So again, in the blue we have the ACC guidelines in the red or orange we have the European guidelines. Age limit is 65 for the ACC where uh less than 65 should be sever, whereas the European guidelines say less than 75. Now again, as I said these are guidelines, these are not rules there are limitations to guidelines as well. The ACC guidelines talk about age and life expectancy. There's no mention of risk for these patients while the European guidelines talk about risk and age, but there's no mention of life expectancy. In terms of thinking about how we want to go about the intervention, so again less than 65 low surgical risk, they have a low frailty score, uh, if the taber valve morphology is unfavorable if access is an issue, if they have concomitant, uh, other polyvalvular diseases which can be fixed surgically as well, if they have multi-vessel disease with a high syntax score, all of these patients you're gonna tend to favorAR. In patients who are old, high surgical risk with frailty, with, uh, taver valve, uh, morphology which is favorable with good femoral access, with no significant polyvalvular disease, then it's kind of clear cut that you should be going towards taver but then we have a lot of these patients that fall in the orange where there's no great answer, which is where a hard team approach becomes very important. Which is a part of the ACC guidelines as well that it's a class one indication that patients with severe valvular heart disease should be evaluated by an MDT when intervention is considered, and the important part here is not only when it's considered for Taver, but I think it's equally important for patients undergoing SAR as well, which over here we have done a phenomenal job that every Monday we have a structural interventionists, cardiac imagers, heart surgeons, advanced practice providers. Uh, referring providers all sit down Monday morning. We discuss about 20 to 30 patients every week where this there's a combination of patients who are going for SAR who are going for TaR. We have a whole discussion for each patient where the APPs make a slide for us and and list all the issues. And now we're also discussing about lifetime management that if this patient's gonna get a valve, even even if it's sever, what are we doing 10 years down the line? What are we doing 15 years down the line. How are we gonna come across the barriers after the index intervention? Another important part to think about is patient perspective and preference, which again I'll have a couple of cases which I'll show where the valve choice was dictated by patient preference. There are patients who come in saying that I want to have her first. I'm young and healthy right now. I can go back to work sooner. It's less of a financial burden for me. I can get sever when I'm older, uh, when I'm not working, when I'm retired. I look forward to only 2 valve procedures in my life, and I believe that technology is gonna continue to evolve where I can get multiple, not 2, but maybe 3 or 4 tavers in the, in the future. And then we have patients who come in who are of the opinion that they want to get severer first that just do the surgery right now and get done with it. Leavestaver options open in the future when I'm probably gonna get more sick. And then surgery has been around for way more years than Taver. Taver is a newer technology. I believe in surgical aortic valve replacement more than Taver. In terms of evolution of Taver, the first TAVY was done in 2002, and we're now in 2024, so 22 years of doing this procedure. We have had multiple data, multiple trials starting from the partner 1B trial which looked at the extreme high risk population in 2010. In 2011 we had looked at the high risk population. This, uh, the partner trial looked at the balloon expandable valves in 2014 we had data from the high risk for self expanding valve. 2015 self expanding valve in the low risk population. Self expanding in the intermediate risk population then more recently in 2019 we had data on the balloon expandable and the self expanding valve in the low risk population. So we have come a long way from doing these procedures under general anesthesia requiring ICU care, trans femoral or trans aortic approach to now doing it under conscious sedation probably next or at least discharge in two days. I think this is a very important slide which. Is a positive and a negative as well. So in terms of the number of tavers being done, so the first inflection point happened in around 2015-2016 where the total number of tavers exceeded the stas, and then in 2019 there are more tavers being done than all aviars, uh, combined and again we can see the graph here that as time has gone as we have had more data, the blue is the taverse red is sever that. The number of tavers are going up and servers are going down. Now this is kind of a little bit of a more concern to me that in the age group of less than 65, the European countries still, it has been going up the number of tavers, but it's not as significantly rising as it's rising in the United States population. There's an exponential rise in the population less than 65 years of age who are getting taverns right now. And that again raises the concern that we have a great center where we are extremely collegial with our cardiac surgeons. We have a discussion for each patient about their lifetime management. I'm not quite sure whether this is happening in all centers throughout the country, which is where I raised the concern that is this lifetime management of AS or is this mismanagement of AS where the number of tavers have increased to 50% in the less than 65 age group and the avrs have decreased in the less than 65 age group. Again, guidelines, as I said, are not rules, but they should guide us and there should be a thought process that when we're doing. Such a high number of taver in the younger population, are we thinking about what we're gonna do when they reach 75, 85, or 90? Now in terms of trials, I talked about trials which uh have been published so far, but what we don't know is we haven't seen the younger population less than 70 years. Most of these patients were in the 70 to 80 range. We don't have data on the bicuspid aortic stenosis. We don't have data on high risk anatomy, unfavorable femoralis. Most of the data is on trans femoral tavers and not alternate access taver, and then multi valve disease. Now asymptomatic, we have recent data for the asymptomatic AS and taver, and then pure AI as well. There is some preliminary data from the Yenna valve. And then for moderate AS there are ongoing trials as well. So as I mentioned, uh, Taver in the asymptomatic population, we have recent data that was published, so this was published. Very recently, probably 10 days ago, but it was, uh, presented at a conference 3 or 4 months ago where they looked at Taver for asymptomatic aortic stenosis and the composite end point of death, stroke, and unplanned hospitalization for cardiovascular causes. There was a significant difference when comparing Taver to clinical surveillance. Again, this is Taver versus clinical surveillance and not Taver versus Saver that at 5 years there is a significant difference in the primary endpoint. Sure, there can be an argument that when you look at each of the end points separately, which is death from any cause stroke, there was not a difference, and there was probably a primary driving point was the unplanned hospitalization for cardiovascular causes but again it's hard to argue that there's no difference. So in terms of the available valve platforms, I just want to quickly go over this. There's some updates to this as well, but there are self-expanding valves and balloon expandable valves. Currently in the United States, commercially available, we have Evolut. It's now updated to the E Evolut FX Plus. We have Navitor which is by Abbott, and then the Sapien Ultra which is by Edwards. Now, in the evolute, there is an update in the FX plus where they have a bigger cell, uh, which can help in the coronary re-axis. and this is a supranannular valve, so it's above the annulus, so the valve leaflets are higher up while the nava and the sapien are annular valves. So what are the considerations that need to be made during the index tab for lifetime management? Obviously acute outcomes are important, but at the same time lifetime management is important as well. So from an acute outcome standpoint, you wanna make sure that the procedural procedure is successful. There's low PBL, uh, mild or zero PVL. You have the lowest possible gradient and you can get away without a pacemaker implantation. But that's just the acute, that's just the tip of the iceberg. What is more important is looking at all of these issues which are gonna come up in the future. It's not gonna be there immediately at the time of discharge, but what about commissal alignment? When I talk about commissal alignment, it means that how are the commissures aligned compared to the native valve? What is going to be the reiss options? What are going to be the future valve and valve options? How are we gonna treat the degenerated valve when the patient comes back in 8 or 10 years? What is the coronary reaxis if this patient has progression of his CAD or her CAD and then comes in with a stemmi how are we gonna reacts the coronaries? What is the durability of each valve? So in terms of lifetime planning, I think there are two options for an index intervention. I like this in terms of a flow chart that if the patient has two choices they can get a taver or a Saver. If they get a taver at their index intervention, then as physicians and care providers we should be thinking what is going to be my plan for the first re-intervention when this patient comes back? Are we going to do redo taver? Is it feasible or not, or are we going to remove the taver valve and put in a sever when they come in the first time? Once you take care of that, then what are we going to do for the second time because again when we're talking about someone who's less than 65, our hope is to try and plan out at least two future valve interventions for this person hoping that they make it to 80 or 90 years old. Are we gonna do a redo tab and tab versus we have the tavervalve removed, put in a surgical valve, and then do a valve and valve taver Again, there are pros and cons to both of these. As against the patient coming in, you do a surgical AVR the first time, then do a valve and valve taver. And then do a valve and valve redo taver or a redo saber. Versus 2 surgical AVRs and then a valve and valve tavern again there are no right options. I think each patient has to be individualized. We have to take each patient as a separate person and then try and uh plan out what the best step would be in terms of life expectancy after SAR. So this was a paper published with patients more than 60 years with aortic stenosis, isolated SAR with a bio prosthetic valve. And then risk stratified based on low, intermediate or high risk groups. In terms of median survival, the low risk group survived for around 10.9 years. The median survival with the intermediate group it was 7.3 years, and the high risk group it was 5.8 years. So which again says that even if you do a valve at 69 in a low risk patient's surgical valve, they're gonna survive at least another 10 to 11 years at median. In terms of Taver versus SAR 5-year data in the intermediate risk group, there is enough data to show that there's no difference in the 5 year outcome in intermediate risk patients with for disabling stroke or death and death itself in general. When we look at the low risk group, so this was again published in New England, uh, in the low risk group outcomes at 5 years. So this was looking at the balloon expandable valve, which is Sapien, which enrolled 500 patients versus SA 500 patients, follow up at 1 year and then 5 year. Medn age was 73, as I mentioned in the previous slide that most of the trials looked at patients in the age group of around 70 years old. And again their STS 30 day mortality is low 1.9%. Most of these patients had the procedure done under conscious sedation, and you can see that there's no difference in the primary endpoint of death from any cause stroke or hospitalization when comparinga versus taver. There's a trend towards taver being better, but again, the, uh, con confidence interval is 0.61 to 1.02, so it does cross one, which says that it's no, uh, there's no difference. Uh, there's no difference in death from any cause, stroke, or re-hospitalization. Now what about long term data? What about 10 year data? So Tavern versus SA 10 year data from the notion trial, which was, uh, looking at severe AS with a mean age again 79 years. 80% of these patients were low mortality risk in the Nordic region 145 randomized to tavern. This was with a self-expanding valve and then 135 to sever, which was with any type of bioprosthetic valve. 10 year follow up primary composite end point of all cause mortality, stroke, and MI. There is no difference between the two modalities in terms of uh severe structural valve deterioration, which I have put in the definitions here again, there is clearly less structural valve deterioration with Taver compared to Saver. And in terms of bio prosthetic valve failure there was no difference but again what this means is that the mean gradients in these patients who undergo TaverR in the low risk is significantly lower than SAR at 10 years, which we can again see here as well that the baseline mean gradient at 3 months all the way up to 10 years there's, it's still lower than patients who are getting a surgical valve. So considerations during the index t for lifetime management again you wanna look at the low risk patients you wanna go through the guidelines, study the situation, study each patient independently just not base the decision on guidelines itself if it's bicuspid valve, we don't have data on that. This is where surgery is probably still. Better, especially in the younger population, coronary reaxis, what kind of valve are we gonna use for coronary reais? We have three different platforms. One is superannular, two are intraannular self expanding versus balloon expandable. What is gonna be the best strategy for long life expectancy? What are the hemodynamics gonna be of each valve? Each valve has different hemodynamics again with this talk, I'm not gonna try and get into the difference between, uh, ta valves. But they have difference as well. There's a difference in the pacemaker rate for both valves that are available now what are our future valve and valve options? Can we do tavern and saber? What is the uh patient prosthesis mismatch risk going to be? Can we fracture? Do we have risk of coronary obstruction or not? So to go over coronary obstruction, so this is a CT of a patient who had a self-expanding evolute valve where you can see that this is the coronary coming off here. That although the uh VTC, the valve to coronary distance may be low, it's important to see here that the sinuses fill, which means that the risk is low, that even if you did a future valve and valve in this patient, that the risk of coronary obstruction is going to be low. Similarly, a Sapien valve put in and who comes back in for future valve and valve how so you can try and plan out in the future. Now, uh, the person who put this was thoughtful enough to place the valve at a lower position. Where you can see that the coronary and the coronary heights are high as well, which means that this is a sapien here with the struts. This is the coronary. So even if the patient comes in for a future valve and valve and you put in another sapien within this, the risk of coronary obstruction is going to be low as long as you land below. Which is the same on the left and the right, even though the valve to coronary distance is low, so we consider any VTC less than 4 as significantly low where there's risk of coronary obstruction. So even though the VTC is low because whenever the first implanter placed the valve, thought about it, and placed the valve on the lower end. It does keep the option open of a future valve and valve. The trade off again is that when you put in a valve that's a little bit on the lower side that you're risking a higher pacemaker rate and again this is something that you do need to discuss with the patient. Now, this is another self-expanding valve, where you can see that it completely effaces the sinuses. The sinuses are completely obliterated, and the left main is coming off. Where even if you put, so we're here this is the left main which clearly shows that if this patient gets a future valve and valve, then there's a risk of coronary obstruction and we would have to do some kind of technique to modify the leaflets. So to go over coronary obstruction, there are anatomical factors and the heart valve factors. So one is if the patient has a low coronary height which we should know from the pre-procedural planning. And again, which should be thought about in the first index intervention if especially if you're thinking about taver that the coronary heights are low, we may get away with the first taver, but what about when the patient comes back in 10 years? If the sinuses are small, if there's heavy calcification of the leaflet or a long leaflet, so if the leaflet itself is long and you put in a valve, so you're crushing the old valve to the side and the leaflets can obstruct here and completely obliterate the coronaries. In terms of the heart valve factors, high scot and tissue planes, if the implantation is high, as I mentioned in the last case where we saw the sapien that was implanted low, that if it's implanted on the higher side and comes back for reintervention, then there's a risk of, uh, coronary obstruction or there's misalignment of the commissures. So just to again look at the sinuses, so this is a patient, uh, this is a drawing of a patient who has a sever valve, and you can see the sinuses are big, the coronaries come off and there's enough space for the sinuses to fill the sinuses are capacious, so even if this patient gets a taver within the surgical valve, given that the sinuses are big, the risk of coronary obstruction is going to be low. When the sinuses are narrow and the surgical valve completely obliterates the sinus and you put in another taber valve within this, then there's a risk of completely obstructing the coronaries which would be devastating. So over time we have tried to come overcome this with different leaflet modification techniques. One of the commonly used modification technique is basilica, which is bioprosthetic aortic scallop intentional laceration to prevent arogenic coronary artery obstruction. Where again I'm not gonna try and get into too much of the technical details, but you have a catheter, uh, you have a catheter guide catheter that goes into the LV. There's a snare there with another catheter you go into the uh commiser, you perforate the leaflet with electrosurgery. You snare the wire and then you basically lacerate the leaflet here and try and open up the space, so depending on which coronary artery is uh affected. This is one that was done here where the RCA was at risk of obstruction and you can see that there's a perforation here. Uh, with electrocautery through the leaflet snared the leaf, uh, snared the wire, and then this is a balloon augmented basilica where you do a balloon inflation to split up the laceration more so you have more space for the coronary arteries to fill. Another leaflet modification technique is the cleave technique which was developed at in Cleveland and then there's a similar technique called unicorn as well. So cleave is clearance of the leaflet to eliminate valve excursion where you can perforate the leaflet with the electrosurgery again. You cross a wire, you exchange for the wire that we use, which would be a safari or uh 035 wire. You use a peripheral balloon to dilate the leaflet there. Through the perforation which basically destroys the leaflet which would have been causing the obstruction and then deploy a valve through that uh perforation balloon assisted perforation itself. And then more recently this is a device which has received FDA approval although extremely expensive, almost cost prohibitive to be doing this, where there's a device where you can actually just just cut and lacerate the leaflet itself and then place in another valve. There's some safety and efficacy data which shows that it is safe. Uh, 100% efficacious with a technical success of 98.3% increasing the procedural time by around 30 minutes, but again, cost would be something that's prohibitive to using this quite routinely. So then the question comes, what is the data on server after Tavern? So The patient got a taver and now we're talking about explanting the valve, which is one of the slides I talked about that if the patient gets a tavern in the index intervention at probably 65 years age 75 comes back and now we're talking about explanting the valve. So there is some initial data from the international registry where they had uh. Patients enrolled from 2009 to 2020 with a mix of balloon expandable and self expandable valves and again the mortality here in hospital mortality uh is 12%, 30 day mortality is 13%, and then one year mortality is 28%. So again this is not something that's completely benign. And not something that is that oh we'll just put in a to valve and then ask our surgeon colleagues to take the valve out in 10 years because it's not as easy as it sounds. Given that a lot of these procedures were done, 50% of these procedures were either done in an emergent or urgent setting, which means that the patients were sick, but again this has to be thought about that it's not completely safe. Uh, this should be discussed with the patient as well that this is the limited data that we have if you're getting a valve and you're in your 50s or 60s, a ta valve, then we may be looking at this option and this this is the current data that we have. So just an example of a patient, a 56 year old male, severe AS EF of 50%, mean gradient of 50% in 2023, coronary artery disease Afib, he refused savin cabbage in his 50s. Uh, saying that he just doesn't want to get any treatment. One year later comes back in cardiogenic shock, intubated EF of 15%, mean gradient of 43, shock liver, AKI encephalopathy on multiple pressors. Goes to the cath lab, has now a progression of the CAD with a severe uh has disease in the er, a severe tandem lesion in the LAD and as I mentioned in shock with severe AS. Gets a BAV. And then placement of an impella to support his LV. And then the discussion comes up that this guy's 56, he was healthy when he was initially seen by our surgical team, but he himself refused any procedures. Now he's coming in as an extremist and what are our options? So he's after the BAV still dependent on Impela with multiple pressors and dobutamine. Presented at the heart team conference again this is a coronary conference that is there on Thursdays where we have interventional cardiologists and our surgeon colleagues as well join in where we discuss high risk cases again, an important point where we're taking each patient as a hard team approach, not just as an interventionalist thinking that I'm gonna fix and stent and to everything. So here the discussion was that the patient is still an extremist. We're gonna go ahead and fix the LED and try and see. He has already had a balloon done. Try and fix the LED. So he gets a PCI to the LED with a nice result. A few days later, EF. Much better, definitely not 15%. You could almost argue that it's almost close to normal. But his mean gradient is still around 50. Now he was seen by uh cardiothoracic surgery in the hospital, but at that time he was encephalopathic encephalopathic uh his clinical status was terrible, so deemed not to be a surgical candidate. So the discussion was, should we just, his gradients are still high, should we just have him right now? And the discussion was, no, let's just bring him back in a month, make sure he goes through rehab, feels better, and then see how he's doing in a month before we decide on pursuing Taver even though he was turned down by our surgical colleagues. So he comes back to clinic in a month looks great. He, he's then set up on that I just wanna get a tavern done. He looks great. He's young, and the discussion was that what are we going to do when you come back 10 years later? So we decide to send him back to CTS again to see him, but he is adamant that he just wants Taver. He's been hospitalized for 1 month. He's had a lot of financial burden come across. If he undergoes SAR right now when he's 56 and he's out of work for another 1 or 2 months, there's no way he would survive. So we had a discussion with him where we talked about the data that we have that the future options are gonna be kind of difficult although not impossible but difficult and it is a patient perspective as I mentioned in the earlier slide that that plays a role in our decision making as well he's seen by Doctor Newton and again very well documented in the note as well that he himself also talked about lifetime management, the pros and cons of Tavern and Saver. And either going with the tissue valve or mechanical again we recently had data published I believe uh this week in Jack as well where less than 60 years of age patients should be getting a mechanical valve if they have if they fulfill other criteria, but he still continued to wish to go for Taver so he underwent. Placement of a self expanding valve and this is a nava valve with the thought process that one it's intranular uh we talked to our surgeons that in the future if explant is necessary, is there any difference that they have had in their experience in terms of explanting a nava versus a metronic versus an uh sapien. And based on there being limited data and no difference we uh decide on placing a navitor with the hope that at least if he has progression of CAD, then re access becomes easier. Now what about the role of AI in lifetime management? This is, I think, a very hot topic. Artificial intelligence is coming up everywhere. We have TAT GPT coming up everywhere and. I think AI is going to be the future for planning all our valve interventions, so there's a company called DAI where they can simulate how each valve, so this is different valves, they can, uh, based on the CT scan of each individual patient. They can predict how the valve is gonna interact with the calcium, what it's gonna do with the coronaries, what is the risk of coronary obstruction, and you can see that it's being implanted at different depths, and each different depth has some different interaction with the valve leaflets and the calcification. This is the neo accurate so again they have different valve platforms that you can embed the valve in and see how exactly it's interacting. You can also see how it's gonna behave with the calcium itself, whether there are risk of any complications like annular rupture like over here we see the red, it shows the amount of calcium stretched that the valve is having on the annulus itself. Red means that there's a risk of rupture when the valve gets implanted. You can also plan future valve and valve interventions with one where over here you can see that there's an evolute as the first valve and then they put in a sapien and see how two valves are gonna interact within each other. What is the risk of coronary obstruction in these kind of cases? So I think this is an extremely important part that's gonna be a routine part for our valve planning. So in terms of contemporary approach to aortic stenosis, you have a 72 year old male with bicus per aortic stenosis. How are we going to, uh, how is the valve going to interact? What, how is the interaction going to be when we put in a balloon expandable valve versus a self expandable valve? What is the risk of coronary obstruction? So the simulations can predict the risk of coronary occlusion, annular rupture, the risk of needing a pacemaker, PVL having paravalvular leak, and the hemodynamics of the valve itself. So how do we use all of this together if a patient comes in who has a sever valve done and now needs a tab within aever one, what is the data we have on this? So there's a systematic review and a meta-analysis done which shows valve and valve Taver after failed, uh, Saber where it is successful with, uh. I square of 91% and it is low mortality, extremely low mortality. So we have a 78 year old male prosthetic AS. Meets criteria has a 21 millimeter magna has coronary artery disease. EF of 15% cirrhosis, obviously high risk for a redoabr. He's already 78. So how do we use all the available modalities that we have to try and plan the intervention for this patient? So using the AI simulated software. We can put in different valves which is a sapien or an evolute and see how the valve expansion is going to look. You can see what the risk of coronary obstruction is if the number here is less than 0.7, then it means that there's a risk of coronary obstruction with either of the val valve platforms. So based on this, we can plan out our procedure in a very safe fashion and decide what procedure the patient should be getting. So this patient ended up getting a self expanding valve within the server with a great result. And did fine no risk of no coronary obstruction after the procedure. Then the question comes about what about ta and TA? So the first intervention is done as a taver, and now the patient comes back. What data do we have on patients undergoing taver within a taver valve? So again, there's no randomized controlled trial for this, but there's a registry study which was published in The Lancet which showed that they compared Taverredotaver versus indextaver itself where there's no difference in depth. No difference in admission. No difference in death comparing early versus late redo taver. There's no difference in stroke. And again this is just based on difference of the STS risk score. That The risk of coronary obstruction was significantly low 0.3%. Intraprocedural death of 0.6%, and conversion to open heart surgery 0.5%. So again, a safe option but not a randomized clinical trial. So looking at a case example for a tin tab, this is the CT that I showed previously as well that when the implanter placed the first valve, this was placed in 2018, a 26 S3. The patient comes back with a mean gradient of 70, has moderate MR at the index intervention when the patient was probably 56 or 57. Did not have a drop in EF so now comes in with a new drop in EF, a pancreatic head mass which was not there previously, pulmonary hypertension, so all of these things are things that. During the index intervention, we may have not the patient did not have any of this, and we would have thought, OK, we can do a taver the first time and then the patient's gonna come back in their 60s and we'll just do a sever because the patient's probably still gonna be young and healthy, but things change. The patient's not healthy anymore. The patient has a low EF, has a possible malignancy, has pulmonary hypertension, which makes the patient a very high risk for surgical intervention at this point. So here we can reconstruct the CT embed another S3 within it, and as I mentioned that since the valve, the initial valve was deployed on the lower side, it gave us enough room that even though the VTC, the valve to coronary distance was low, there would be enough space for the coronaries to fill, so this patient ended up getting uh. Evolute valve within a sapien and you can just see the difference in the EF as well. This is in the OR just before the procedure started. The EF is abnormal and this is before the patient leaves the OR. So within a within a time difference of 45 minutes, you can see the difference that the procedure can do. Another example of a patient who had an evolute valve and then gets a sap in within that. And this is just the sapient being inflated within the evolute valve and again it's important to plan out on CT as well to see how the valve is gonna behave or using DAI to uh have prediction models to see how the valve is gonna behave and again you can see that the coronaries are quite high here, which is why there's no risk of coronary obstruction and you see the coronaries fill and the sinuses are capacious as well. So in terms of valve and valve data, so surgical valves redo sever. There's a 2.5% to 9% 30 day mortality. In terms of explanting the tavervalve based on registry data, the in-hospital mortality is 11.9%, 30 day mortality is 13%. 27% are not redo have candidates due to unfavorable anatomy. Now, in terms of redota mortality, it is around 0.7% to 4.6%. Again, this is just based on registry data. Now just going over another outlier, so a young patient, 32 year old, severe AI with minimal calcification, moderate MR, end stage renal disease on dialysis, legally blind, generalized weakness, unable to stand without assistance, prior pericardial effusions with pericardial window. So in the most ideal case this patient blindly should be a saber candidate. There should be no discussion, no thoughts, but if you look at all the comorbidities, if you look at the STS risk score, she is high risk for mortality. So we discussed this patient in our multidisciplinary valve conference with a plan that is there a way that we can try and plan out not one but 2 or 3 future interventions for this person? Obviously her life expectancy may not be more than 20 or 30 years given her comorbidities, but still it is our duty to make sure that we're planning it out in the most in the most optimistic possible way. To try and see, so the discussion was that can we try and bridge this patient with a taver to have her get healthier, better, go through rehab process with the hope that one if she comes back in 10 years with valve deterioration or earlier, then if she's healthier we can do sever but at the same time if she's not better, is this a patient where we can do a tab and tab and get another 20 years out of her for her life. So this is just looking at the CT scan which shows that one the barrier is obviously she's young there's minimal calcification so the question comes that for a taver valve to anchor you need some kind of calcification is this valve gonna stick? What if the valve embolizes? This is a young patient, obviously nobody wants any immediate complications. You can only see a small speck of calcium. Is this enough for the valve to stick on, which is rare. One young patient, we talk about this at our conference as a hard team approach we try and send this to uh DAI for simulation to see one if the valve is gonna hold or not which valve looks better. It tells us that based on the sizing if you put in a 29 millimeter valve, you're oversizing by 10%. This looks at the risk of coronary obstruction in the first intervention, which again we're not really concerned about. It's more about the second intervention there would be no gaps so no PVL and stretch analysis of 1.5 now in terms of planning the future valve because we're not just looking at the first index intervention. What if we put in this valve and then she comes back 10 years later she's still not a surgical candidate. Can we put in another ta valve where the thought here is that so if it's a sapien within a sapien, then you can see that there this number, as I mentioned, if it's less than 0.7, it means that there's a risk of coronary obstruction. So there's a less likelihood that this patient is getting two sapien valves. But at the same time if you put in a sapien the first time and then put in a self expanding valve depending on. Uh, where, so if you put in a self expanding within a balloon expandable, then the number is 0.9, which means that the risk of coronary obstruction is low at the same time it can even tell you that if your first valve is a self-expanding valve, depending on which position it's placed at. If you put in a balloon expandable, what is the risk of coronary obstruction? So this is what we use to model to plan out at least two interventions for a patient who's still sick, who may not even get to the second intervention, but we're still being optimistic in her getting to the second intervention. You have animation models which shows how the valves, this is the 2nd valve going in, how the second valve's gonna behave. So this is a balloon expandable within a balloon expandable where as the simulation model predicted that there would be risk for coronary obstruction. This is a self-expanding valve going in. And this is at different depths. So here the decision was made that we would start off with a balloon expandable valve. And then in the future if she comes back she can get a self expanding valve within a balloon expandable valve if she's not a surgical candidate at that time. And again, the point to show with these young patients, as I mentioned that ideally anyone less than 65 should be a server until proven otherwise until there are other factors that are pushing it towards taver but anyone less than 65, if they're getting a taver, then absolutely it is our job to make sure that we're just we're planning out at least one or two interventions in the future. So I've talked about all the pros of Taver. What about SaR now? So this is a 70 year old patient, critical bicuspid AS valve area of 45, mean gradient of 70, prior strokes, but no deficits, hypertension, hyperlipidemia. His risk score is low, so he's low risk now based on this itself, based on the guidelines, you could argue this could beavr versus Taver because there's no other anatomical, uh, definitions that are given by the guidelines. So this patient comes in to clinic saying that he just wants to get tavern now this calcification is something that's of quite a high concern that what about our acute outcomes as well? What about our acute procedural outcomes risk of annular rupture. So again, given to the uh AI model, the CT scan predicts the risk of uh annual rupture as well, and I'll just pause it here that you see the red mark here which shows that this is where there's gonna be a stretch when the valve goes in which is going to put the patient at risk for annual rupture which would be a catastrophic complication in a balloon expandable valve, if you put in a self expanding valve, then there's a risk of paravalvular leak here. So in a low risk patient, you're not getting the most ideal result for this patient by doing tavern. This is where It is extremely important that as a team as a heart surgeon and an interventional cardiologist going in together to tell the patient that no, even though you would prefer Taver you show this, uh, animation to the patient which helps them understand as well that this is where Saver is probably gonna be a much better option which also which leaves Taver as a future option for this patient when they reach 80. So that patient ended up getting a saber with a 25 millimeter magnet ease. Now just going over young patients with low risk group, just the thought process that I think all of us should use is one a shared decision making where we have a hard team approach where we have structural cardiology, cardiac surgery. Valve and imaging cardiologists, valve coordinators or APPs, we take into consideration patient and family preferences and then any other subspecialties that may be involved like if there's malignancy or if there's history of GI bleed or something, then we have those, uh, caregivers involved in the decision as well where you can go for Taver or SAR favoring Taver if they're frail, high risk for sever anatomy, socioeconomic factors which we had in one of our patients. Isolated severe AS noncomplex CAD redo taver is gonna be feasible, so again it has to be planned out. Well, if we favor surgery, then it's high risk taver anatomy again a case example of which I showed the risk of an rupture. There's complex CAD with the syntax score that's high, and the patient has good cabbage targets as well. Small annulus and the risk of patient prosthesis mismatch again, not something that I, uh, touched upon this talk, but if there's small annulus, there's enough data to say that with the balloon expandable valve, the hemodynamics are not great, the outcomes are not great for long term. And then obviously then the decision has to be if they're very young is Ross's procedure a possibility? What are the thoughts about putting in a mechanical valve and they're less than 60, 65 and then obviously if they're older, more than 65 or between 50 and 65 after shared decision making they can get a bio prosthetic valve. So just in terms of considerations, 80+ and you feel that the patient needs a single valve then Taver 75 you need 10+ a year valve results so you need to be thinking about more than one valve intervention. 65 years absolutely 15 to 20 year survival plan. Think about multiple re interventions and less than 65, at least one, at least 2 interventions as long as they have a good life expectancy. So what are the future directions now? So and this is where again lifetime management is gonna be very important because now we have trials going on for intervention in moderate AS. So now we initially were only on symptomatic low risk. We had data more recently published on severe asymptomatic. Now we have trials ongoing for moderate aortic stenosis as well. uh, Progress trial is looking at the balloon expandable. The Evolute expand is looking at the self expanding. And then we have newer valve technologies that are coming up as well which are made of different molecules. This is, uh, made of molybdenium rhenium where the thought is there's early feasibility that has been done that you can deliver this valve through an eight ring system so it's gonna be even more accessible, more smaller and smaller centers are gonna start doing tavers now. And that that is where it's gonna be important that as we start expanding the VA platform to different smaller centers that there has to be a thought process to this there has to be a lifetime management goal through this. And I just wanted to end by showing some of our internal data which I feel good showing that in most of the tars that we have done from 23 to 24 looking at the less than 65 population we have only done 9% of tavers in the less than 65% uh 65 year age population and what I can say is that even when it's 9%. All these 9% patients have been vetted multiple times with a valve plan strategy as I discussed, as I showed two or three cases that we have thought this that uh thought the plan out for not just one valve intervention but for multiple valve interventions for these patients who are less than 65 and getting tavern. So take home messages goal is to treat aortic valve disease for the patient's lifetime and not just the first intervention. The index intervention is most important decision which can affect the lifetime management. Each therapy and valve platform has its own pros and cons, and selection should be individualized to each patient. Guidelines exist, but again, each patient is different. The patient is never going to fulfill each of the guideline criteria. They're always gonna be outliers, and this is where each valve platform, each valve strategy has to be individualized to each patient. Heart team approach has to discuss lifetime management for each patient who's undergoing aortic valve replacement whether they're less than 65 or they're between 70 to 80, each patient who's getting an AVR should have a lifetime management discussion with their heart team. age less than 65, you wanna try and plan out at least 2, if not 3, valve interventions, and one of that valve intervention is likely gonna be a surgical intervention. At least based on the current data and information that we have and the uh devices that we have right now that we will likely have at least one surgical intervention if less than 65 and the patient is getting to then there has to be a discussion not just within the heart team but also with the patient about what the next 1 or 2 future valve interventions are gonna be and what the data we have on it. Older age group with a life expectancy of 10 years, I think it's reasonable to say that Taver should be the preferred strategy. And then EI is gonna become a routine part of planning for aortic valve interventions for us it already has become that over here at Centara. Thank you. Published February 4, 2025 Created by Related Presenters Parth K. Parikh, M.D. Cardiology View full profile
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