Chapters Transcript Video Lifetime Management of Aortic Stenosis: Current Concepts in Valve Selection Paul Mahoney describes the selection process for transcatheter aortic valve implantation for optimal treatment. I'm very excited today to to start off the grand rounds series by talking about current topics and controversies in management of aortic stenosis, I'm gonna present this along with my partner Matt Matt Summers. I'll be talking about lifetime management Matt is gonna be talking about the management of low flow, low gradient aortic stenosis and we appreciate everybody long in or coming in four grand rounds. Amy should I get started? Alright, I'm getting a high sign to get going. So let me uh never control my slides. Here we go. There are my disclosures. So I want to start off with a couple of cases and these are cases done here at the heart hospital within recent time. The first is a 53 year old female with long standing uh hemodialysis, severe symptomatic prosthetic eric stenosis represents with the max of 5 25 which is critical eric stenosis. General surgical valve in 2000 tension when the 19 magma in 2015 underwent valve and valve with the 23 core valve. This at this time there was no such thing as Basilica or fracking. At that point we intentionally placed the valve low to avoid the risk of coronary obstruction of sequestration with the new valve. She came back with very symptomatic severe aortic stenosis within the tavern prosthesis within the savage prosthesis. Her sts was 17.5 and she was referred for valve in valve in valve. You can see here this, he has a sapient core valve inside a surgical valve, you can see us placing a SAPIEN valve inside that valve. Once we place that we had a gradient of 26. So there was still a significant residual gradient. So in the pen on the right we performance called a biological valve fracture, which we took a high pressure balloon and inflate it past the size of the surgical valve. And you can see the waste pop right there and we can actually expand the surgical valve. So we did this through the previously placed surgical valve and then um uh inside the news. So it's a SAPIEN valve inside a core valve. Inside a surgical valve with the gradient of four. And she's done well since that time. I'll show you a second case. This is a failed caravelle. That's an eight year old female nine years ago showing 1 to 23 SAPIEN XT. She has COPD and frailty which he did very well with that valve. She came back nine years later with exertion, fatigue and echoes of the max of 5 50 with severe calcification, static valve stenosis and sts score of 12 according to angiography has shown. And what what you can mostly notice. You can see the position of the left main in regard to the SAPIEN valve and that it's lower than that. And the risk of coronary obstruction with the second valve in here because what we would do. We place the second valve is we take the leaflets, the original valve and create a tube graft. And that tube graft can be inclusive to flow. So there's a very high risk of coronary obstruction with valve and valve in this patient you can see that in the C. T. Scan where you can see the tavern prosthesis which takes up almost the entire route and extends well above the austin of the left main VTS TJ on the left the valve. Um To sign us uh to the sinus of El Salva to the south of the junction. Excuse me. With zero and the right was 3.3. And the BT um BTC developed to coronary was 2.7. These are both very highly predictive of the risk of coronary occlusion. So in an ideal world we might take this valve out into a surgical valve replacement. This lady was not an operative candidate. So we performed leaflet modification within the prior place uh tara valve. Uh We did a what's called a basilica procedure. All right. And so we were able to take a catheter in an electrified wire. We passed the electrified wire through the leaflet of the original surgical valve. We do what's called balloon assisted basilica. We took a five coronary balloon and made a large larger hole in that and then we electrified the wire. We put a second valve in this case an evolution inside the first valve. And with opening up that leaflet we're able to mitigate the risk of coronary occlusion. Alright. And then we placed and when we place that valve, the patient did quite well. And she's been doing well since that procedure I will I will just note that this is all off label. All right. Um So I wanted to show you those cases because the future is as it always is is here before we're ready for it. We are seeing failed surgical valves. Were seeing failed catheter valves. And the lifetime management of these patients. Once we start placing these devices in and what happens is structural valve deterioration is a pretty hot topic right now. And we're trying to anticipate that as we see people in the office. If the structural team sees a patient who's 69 71 in the office. We have to plan for the valve. We're gonna do now surgical catheter and then the valve are gonna do to follow that because many of these people will live long enough. And then what if they need additional procedures after that? So how can we count count both forwards. How can help the patient today? And how can we take care of the patient going down the road? So patient procedures mismatch is a thing and that simply defines the conditions under which you place a catheter or a surgical valve inside a patient. And that valve is too small for the patients. So they leave the O. R. Where they leave the hybrid lab with a gradient um structural valve deterioration is a process. Once you put one of these valves inside a patient, the clock starts ticking, The valve starts deteriorating right away. And so there's a start time. That start time is the date that you implanted coronary access? How am I gonna get back into coronaries? Is there a risk? Is our post in front of the coronary? There's just something about this valve that makes it challenging to get back into coronaries and then coronary obstruction or sequestration. With the second procedure, can we predict this? And if we can, how can we plan the first vowel to get ready for the second valve? Alright, so for young you may have seen the slide before using a lot of talks. But for young low risk patients hypnosis, how do we pick the first valve? These patients are are now different. We're seeing much younger. Much more functional patients, uh patients who are beginning choices but almost always prefer a less invasive approach as you might imagine. And they want to move like jagger. That's the that's the joke there. Um So the lifetime management patients with stenosis, the changing risk profile of Tavern patients in the S. T. S. T. Uh Trans catheter valve registry. The meeting age has been reduced from 84 in 2013 to 80 and 2019 and continues to get even younger. It's in the seventies. Now it's expected. These reductions will continue as more lower risk patients are treated with Tavern. And you can see that group graphically depicted in the in the sts database graph shown to the right catheter based valve replacement become the dominant modality for replacement. They already fouled. Um We exceeded isolated stavros, exceeded in 2015. All servers were exceeded in 2018 and currently 84% of all the valve replacements in the order position are done with the catheter based approach right now. So our dominant approach is still the catheter valve. However, it's still very important consider surgical approaches because for some patients it's still the preferred and the right thing to do. So what when we approach these patients, we gotta ask ourselves, what do the patients want? What do low risk patients want? What they really want us to do is fix the problem. That's that's the captain, obvious thing. But they want us to fix about effectively. They wanna have the lowest risk of death or complications at least disruption of normal life. However, the critical secondary discussions and we as as um interventional cardiology and structural operators and cardiac surgeons need to decide is the secondary discussion. How do we how do we fix them now and how do we give them a good chance to be successful in the future? We talk about durability of the valve platform, functional status of the patient after valve and then importantly, freedom from device associated complications. We need single digit pacemaker rates. We need good coronary access. We need suitability for valve and valve in the future. So in terms of fixing the problem, this question has been asked and answered in low risk patients. Tavern for both evolution and for safety and platforms have been shown to have a 3 to 4 fold decreased risk of death or rehospitalization as compared to surgery. And the reason that Tavern is the dominant modality is because it has better data and low risk patient population. So all other things being equal in an appropriate patient, catheter based therapy is appears to be superior Um in the at least in the 2-5 year range compared to surgery. All right. So when we talk about the conversation about approaching low risk patients, we should know what to talk about what their surgical risk is. What's the Tavern suitability. Okay. Is this a good candidate? Is this apples and apples? And if I proceed with the catheter based approach in this patient um is it in that is in that group that tends to do better? Or there's some that we can peel out that would be better off with surgery. Um So one is Tavern more suitable than Tavern. What patient specific factors lead to saving surgery or catheter based valve replacement and lotus patients? We try to optimize treatment strategies individualized to each patient. Alright, here's to low risk patients. Uh 74 year old. Bestest to no prior surgery, Otherwise healthy primary caretaker for her husband with dementia. She has a very stable um value. A complex good femoral access patient B. Is 59 years old, insulin dependent diabetic of accredited to bicuspid calcified Raffaello, coronary heights and new york aneurysm. Very different patients. They should be approached differently. The one on the left is a Great Tavern candidate that won the right should be operated on. So who does well with Tavern? All right. What does the data show calcify says patients do better with Tavern. Unfortunately, the low risk patients, a lot of the husband um anatomy is excluded. It was not in the intermediate and high risk patient cohort but in the low risk studies, he still weighed additional data, bicuspid patients. Um You need to have an acceptable eric valvular complex and annual size. It needs to be wall matched the valve size availability. You need to avoid surgical patient prosthesis, mismatch, calcium patterns are ascending aortic pathology. Most of the all of the I'm sorry all of the data surviving uh supporting taverns. Better than savages done from per cutaneous femoral access. So when you're starting to look at alternative access, you're you're getting outside of the data. You need to look critically at each patient and decide if they're gonna be better or not. With the Tavern valve and the absence of unfavorable anatomy, surgical corner disease, multi valve disease, et cetera. So what makes Tavern less favorable. We look very carefully at the C. T. Scan if they have a hostile aortic root complex with low coronary heights, narrow sinuses if they need a root enlargement, calcium pattern of large Angeles. If they have lack of transdermal access which I just talked about. If there's a concomitant surgical C. A. D. If this patient would not be referred for a cabbage based on their anatomy then they should be referred for um um Then they should be referred for cabbage and heather valve replaced at the same time patient age and durability is a big hot topic. I want to spend a little bit time on that. Okay because this is one that I think we're still trying to answer. Um I'll talk about some of the other ones. Low coronary heights. Here's a high risk patient that we did a while ago. Um Surgery is favored in situations with increased increased risk of catastrophic complications and low risk patients are present. So this was a high risk patient with a big bulky calcification. We put a catheter based album and as you can see in the panel in the center that big lucent ball is a big hunk of calcium moving right towards the left man and threatening inclusion. This required urgent stenting. The patient developed E. K. G. Changes and hypertension and we had two stents are way out of that. If we see this anatomy ahead of time. This is something we should consider surgery on in the appropriate patients. Okay, hostel calcification patterns. You can see the dense calcification in the C. T. On the right and the left ventricle outflow tract um balloon expandable here could be potentially lethal with annular rupture. We might see a high risk of leak. And we see this type of anatomy. We look at the surgical options and see if they're better or we try to pick a valve that really reduces the risk of an eruption. All right. Um Sabra for large annually or unfavorable calcification. One of the important conditions from in the hybrid O. R. When when our teams go in there is we can't leave with any para volver a league. Alright. More than mild para value leak confers a survival disadvantage to patients. So the calcium pattern is hostile or the annular areas outside of the range of what we can effectively treat with the catheter valve, especially the low risk patient. And surgery is favored. And that comes up a lot with some of these young bicuspid patients. Alright so back to the controversial topics. Should patients age and the valve durability be significant considerations and low risk patients. So the first question is how durable are surgical valves and young patients? You put a tissue valve in a 60 year old? How long should I expect that to last? Okay we'll talk a little bit about that. Yeah. Historically we used to quote 15-17 years. This was based on on survival data and most of the patients getting surgically Bowser in their 80s. So not a lot of them lasted that long. So the number of patients that last up to 15 years was vanishingly small. And it became sort of a natural history study. It might have been symptomatic. But how long could they live when we have an effective therapy for degenerated surgical valve? That therapy is obviously tavern. How how what is the median age of the severe prosthesis, undergoing the valve and valve? And which has been looked at and were published at the vivid registry that the average um Duration of the valve before it degenerated to the point where interventions warrant is only about eight or nine years. So surgical tissue valve has about a 50% um uh chance at eight or nine years of being replaced. All right. I'll show you some additional data to support that. All right. Um However, we still are laboring under the general perception that younger patients do better with surgical valves because they last longer. And here's some from the european heart Journal from the last year. Looking at um strength of valve preference. Sava versus Tavern. Talk about their life expectancy is greater than 20 years, you should have severe because of the survival benefit durability. Pacemaker possible need for annual enlargement. Current valve disease, Tavern, If your life expectancy is less than 10 years in that 10 to 20 year period, that should be a discussion with the patient. Okay. Um But let's look at valve durability if we're gonna if we're gonna hold up that younger patients should get Sabra because the valve durability does the data support that. Um I'll also show you that the guidelines in 2020 that just came out basically said if you're 65 or over catheter based therapy is the better approach If you're 65 or younger surgical valve is the approach however, Okay, there's a very important caveat that was thrown in there for symptomatic and asymptomatic patients to severe severe A. S. And any indication for a VR who are less than 65 years of age or have a life expectancy of greater than 20 years stavros recommended. So if your if your life expectancy is greater than 20 years you should have a surgical valve. Okay. Um a lot of people are under 65 we don't think are gonna live 20 years. A lot of dialysis patients etcetera etcetera. So let's let's look at that and keep that 20 year number out there. The sweetheart study longevity after surgical replacement. Alright. When we looked at um stratification by surgical risk groups in the sweetheart study, I go ahead one slide. I did um If you look at 50% mortality rate. The average high risk patients following a surgical valve last less than six years. Okay. Intermediate risk between 78 years and only the low risk patients really survive more than a decade. So from a surgical valve durability standpoint, we really only need to concentrate the low risk patients. Yeah, sweetheart. Again, this is from Sweden, they look at all patients undergoing surgical valve replacement. Sweden. And again, we're only gonna look at low risk patients because they're the only ones who really seems to survive more than a decade. When you stratify that by age. Okay. Low risk, 80 years of tavern, They only last between 8 to 10 years, 75 years. The median survival is just over 10 years and a 70 year old median survival is 12 to 13 years. Again, less than 20 years. However, if you look at the lowest risk age group, 60 to 64 the average survival is only 16.2 years. So even patients who are 60 and healthy undergo surgical valve replacement, their average survival of 16 years. So this mythical 20 year survival following surgical valve replacement in 25 years is not really supported by the data that we see. Okay, Unfortunately, in paradoxically, the younger the patient is, the less the surgical prosthesis will persist. Younger patients are thought to have a more brisk immunological response and they chew through the vows to generate a higher rate. If you put a tissue in the 56 year old, they're likely to come back earlier than if you put the same valve in the 76 year old and this has been shown this anecdotally. We see this all the time. And you can see this by by these graphs from the sts database. So the chemo of risk of structural valve disease is highest in patients under 60 and markedly accelerated 10 years after Saturn. So durability and surgical valves, especially in younger patients, can be measured in the in an 8 to 10 year window. Well, how do they perform? What's the valve performance to five years for human emmick valve deterioration? Look at all the tavern randomized clinical trials um of Taber versus savor The blue line shows the tavern randomized clinical trials the red line of sovereignty in the randomized clinical trials and at every point and up to five years the human dynamics was better in the Tavern valve and the surgical valves. All right. And how about over time um Human dynamic valve deterioration when these valves developed a grating of more than 20 millimeters of mercury, actually more than 10 millimeters mercury. This definition at five years, 60 months post procedure was 6% of the surgical valves and only 2.7% of the tavern valves. And that's likely because with better E. O. S. And better human damage to start, structural valve deterioration simply takes a little bit longer. The larger the value to put in to start notion looked directly at self expanding valves versus surgical valve platform. And they followed those patients out to eight years and they saw persistent and statistically significant human dynamic benefit of the catheter valve of the surgical valve out to eight years. So in terms of functional status for these young patients, better human dynamics was translate to better, better function. Um when you look at rates of structural valve deterioration, which was defined is developing a mean grading of greater than 10 or a change of greater than 10 from baseline or para valvular leak. At eight years in the ocean trial, 28.6% of the surgical patients at this end point person, only 13.9% of the tavern patients. So lifetime management, bouncing age of implant with tabby valve durability management of very young patients. This was from a recent lifetime management talk that was given to PCR in London Valves and we talked about this mythical 60 year old patient is expected to live 30 years one from a surgical standpoint. We don't see that again. The median survival in this patient is only 16 years. Um, and so planning for that third valve really becomes kind of outside the range of what we're expecting to see. So most of these patients need to valve strategy. So let's let's talk about the ideal Tavern prosthesis. What's as low risk as the patient one. Now we're starting to say, okay, we're looking at Taverna, which is the better valve. So the ideal Tavern prosthesis, you have the lowest procedural risk. Okay, don't leave, we want to leave the room intact. He said the best team dynamics human amex matter. So the lowest pacemaker rate, putting a pacemaker in a 90 year old is different than putting a pacemaker right at the patient, a 60 year old in terms of long term survival and LV and RV function. You want the least interference with coronary access. You want the most durable valve and importantly want to plan for tab and tap in the future. I would I put the picture of the unicorn here because we do not yet have the ideal tavern prosthesis. These are these are still kind of being worked out and a lot of these designs will trade one for the other um optimal aerodynamics, avoid severe patient prosthesis mismatch. There's a lot of back and forth about what exactly constitutes patient prosthesis. Mismatch with kava valves. But you can predict severe PPM. And that is in the surgical literature associated with 32% increase in mortality for severe PPM. And cardiology literature at one year, severe PPM is associated with uh increase in mortality and increase in heart for their hospitalization. So whenever possible, don't give somebody severe PPm. Either the surgical valve to catheter valve. That's a basic principle that we follow their charts. Just like the surgical charts. We have E. O. H. Arts effective orifice area charts based on a patient's body surface area and the annular area there valve is on ct and we can plot out and see which platform is gonna give us which what kind of human and results oftentimes this is differentiating which valve that we choose. And then one thing we're spending a lot of time now, especially in the younger patients is repeat tab and tap like that case. Those cases I showed you at the beginning planning ahead. So one way, the best way to avoid having to have complications is to maximize durability. Okay, um you get a good implant with a low stroke or C. B. A complication. You pay a lot of attention, effective orifice area and you avoid pacemakers. Can we predict according obstruction with the second tavern? Can we plan this with the first implant? And we can All right, we can look at things, you can put a virtual valve inside a patient. All right. And this simulation will give us a different valve to coronary ratio, which is going to predict the risk of coronary occlusion based on the size of the valve plan. And so we can look at a patient, say if we put itself expanding or balloon expandable valve patient today, we have an option for the next one and we can predict this when we look at it and we can all other things being equal, you can pick the first valve planning on the second valve and we do that um routine. Okay. Um if we for example and again this is bench top work, so take it with a grain of salt because this is inside normal valves. But we can we can predict, we've done bench work looking balloon expandable valves inside self expanding valve. So if we put an evolution a portico and is the first valve, What are the options that we have with the second valve? You know Well they believe that overhang and we get coronary access and this has all been modeled and is predictable. Um The modeling is on Evelyn portico is not yet assessed. Okay. And then we can look at the design of the valves when we're looking at a patient in front of us and we have the C. T. With the anatomy we have three commercially available valves and the left is porticos cylindrical valve with self expanding with large windows. Evolution. The middle is another self expanding valves. The taper design a little more radial strength, a little bit higher leaflet and super angular design. And then sapiens balloon expandable with tapered leaflets and all three of them now have skirts, porticos, skirt is in the final stages of of trials. The different designs give us different orifice areas. Looking down in the valves, portico on the left, Evolution the middle and SAPIEN on the right. Even at different even at the same size valves get different effective orifice areas and we can plot that out and you can see that apples and they're not apples and oranges. Blue expandable tend to be the smaller orifice areas and the self expanding tend to be a little. Yeah. Um We can uh we can human actually optimize these two design considerations in terms of the material selection, the geometry and design the components location and where they attach the leaflets. And then look at look at the relative size of the ray of the radial strength as as a trade off for um uh for access to the coronaries in terms of the size of these openings and everyone's a trade off. The larger the the less metal, the less radial strength, the less metal, the greater access to corners. In the future. We can look randomized clinical trials looking at val team dynamics and I'm gonna talk about portico a little bit because it's our newest one. When we look at that versus commercial valves, um we see that every valve is put through a rigorous assessment of the human dynamics compared to the standards, portico versus commercial valve. Okay. And it shows good numbers when we break it down versus SAPIEN and versus evolution. Pro the new valve. The portico has better human dynamics and the SAPIEN which would expect with the design and it has similar to to the evolution. So when we go through, we select the values for each patient. We're trying to we're trying to pick out which patient we think is gonna be the most favorable outcome and how to tailor that value to their anatomy. Um we look at patient prosthesis mismatch in the smaller york analyst. We were steering committee, one of the leading US N rollers in something called the smart trial which is just wrapping up enrollment now, which compared balloon expandable. Self expanding valves and young in in patients with small aneurysms. Looking at human dynamics and structural valve deterioration over time. Yeah, when we look at these this is uh from european data. Inter angle and super angler doesn't appear to matter so much as it does. Self expanding versus balloon expandable in terms of avoiding patient prosthesis mismatch. Again, highly predictable ahead of time based on cT and modeling parameters. And so whenever possible we try to avoid CPM and patients we look at south side, you can look at a particle on the left and evolution the right. Um It's really a difference. Without a distinction. We can get, you know, one we get a 12 french catholic through the other and get a 20.8 french catheter through. Very little coronary interventions are being done with catheters that are bigger than this obviously. So this shouldn't be a consideration with the self expanding platform. Um Alright, so in conclusions, um several things for all but the youngest, low risk patients, initial valves um initial valve should be a tara valve optimized for the patient. You need appropriate anatomy. You need to ensure procedural safety, need good human dynamics, inappropriate access for coronaries. The second valve strategy needs to be thought about prepared. All right. Um I may not be around probably second valves but certainly matt will And we're trying to trying to make his life easier by giving him options. When patients come back, clear discussion with patient regarding the need for a second procedure in the future, A young patient may think the idea of a catheter based valve is great, but they need to know that this is a continuing process. And if you're 65 and getting a catheter valve, the chances you'll need a second procedure, lifetime are very good. We haven't talked a lot about mechanical valves but we do talk about that in a clinic with our surgical colleagues and we see these patients, there's another option. New strategies um evolving to deal with complex situations. Things like leaflet modification, basilica valve fracking have all developed in the last couple of years. So one of our, one of our mantra is is to try to take care of the patient in front of us today and hope that technology is going to keep up with us. So if we have a situation where we might get better human dynamics now but slightly less obvious. Good valve and valve strategies. 10 to 12 years down the line at some point, we have to rely on future technology to help us deal with that. Savage should still be the first valve choice. And it's still very important when the anatomy is unfavorable for cavern. If it's not if it's not a square um old don't try to put a square peg in it in common pathology, Whatever present severe C. A. D. Or the presence of pathology really still favor surgery. And when the surgical risk in these situations is acceptable, then surgery should still be the first choice. Published September 23, 2022 Created by Related Presenters Paul D. Mahoney, M.D. Cardiology Dr. Paul Mahoney serves as the Medical Director of the Sentara Structural Heart Program. He has a particular focus on the diagnosis and treatment of structural heart disease. View full profile