Chapters Transcript Video Special Challenges: Lifetime Management in Low Risk AS Patients paul gave a nice grand rounds on this recently and he's been kind enough to share some of his slides and then I'll enhance some of the themes we heard from steve a little bit earlier. So Lifetime management, you know, it's interesting Elizabeth mentioned that 2011 we started the structural heart program and that was we were involved in the first of the Taber trials and that was a different era altogether. The catheters were huge, more than double the size of what we're using now. The patients were frail, inoperable older patients. And the real goal was to get one or two cases done on a good day and get the patients safely off the table. We weren't thinking about lifetime management at that point, the average age was in the late 80s, we were doing patients in their 90's. Now we're still doing those patients as well. But the spectrum has moved. And if you look from 2011 now to 2019, what you see is as with all technology, the technology that originally is designed to help us take care of a unique population expands outward into lower risk populations, more frequency. And so what we're seeing is that the average risk of the population we're treating now has gotten lower and the age has gotten lower. And that brings with it. What we discussed in the first part of today's meeting, which is that's going to bring the challenge of more patients that live long enough, fortunately that they need subsequent therapies. So this topic of lifetime management strategy has been brought up and we alluded to this earlier. We have surgical tissue valves, surgical mechanical valves and a variety of Taber valves. And if we use any of those as our first treatment at some point, in fact, with all of these at some point, there's the possibility they might need another valve. Even with the surgical mechanical valve, they can develop panis and need another surgical valve, for instance. But that has brought up a lot of debate and discussion without a lot of trial data to guide us on what's the right strategy for the 1st, 2nd and 3rd trial. We're getting more information on that, but that's what we're thinking about. So this is a nice case that was presented at grand rounds that is thought provoking. And it brings up some of what steve talked about earlier. This is a 53 year old female long standing on hemodialysis with severe symptomatic prosthetic aortic stenosis. The V max was clearly high at 5 25 m per second. This patient had a first surgical valve. Young patient. First surgical valve was 2010. Again, what we talked about today, a relatively smaller valve. So five years later the patient went on to develop recurrent aortic stenosis and that's early for sure. But we see these patients and after careful team discussions Again, the decision was made to put in a tavern valve that was a 23 millimeter core valve. That's a super annular valve. Like we discussed in 2015, we didn't have a lot of the things that we've talked about today that are available today, for example, basilica, which you'll hear more about that in the afternoon sessions. Under hot topics, fracking or fracturing the old valve frame when we put a new valve in to expand it a little further than it was at the baseline. And again, we have to think about issues like pacemaker, need coronary obstruction and we'll talk about that. This patient again. The thought was even though now we're looking at a third valve that would be a valve inside a valve inside a valve. There are surgical risk. The sts risk or is quite high patient with multiple risk factors including the dialysis. So what do you do in a patient like this? I'll cut to the chase And after careful team discussions. We thought about surgical options. We thought about valve options. You see a surgical frame with a core valve inside it. And now a SAPIEN going inside that. So three levels of valve. First surgical valve, then the core valve and now a SAPIEN valve, you see being expanded and on the right, what you see is after putting it in the gradient is still pretty high at 26 millimeters of mercury and that frame on the left. And so at this point now, the third time around, we have that technique of fracturing the old valve. We use a Kevlar co high intensity balloon that we can put in. And if you look carefully at the image on the right, you'll see at the end of that sequence, pop where the surgical valve actually fractures and expands to allow the inner valves to expand even more. Watch now and it's going to come up in one second. If you just look carefully at the screen, you'll see a little pop there and often we say we can feel that as much as see it. That was the pop right there if you want to play one more time because it is dramatic and nice to see that we come up with differential solutions for problems that exist right now, you're going to see it in a second and pop. That's where the surgical valve opened further. So what do patients with any level of risk, low, medium or high really want at the end of the day and we've alluded to this in steve's talk. So they want us to fix the problem in the safest way possible. They want the best clinical and human dynamic result they can get for a new valve. They want the lowest risk of death and complications. And sometimes their understanding of that isn't perfect. This patient steve described, he came in with a lot of understanding of what was going on. But even those who do their research really need that heart team discussion. So we can put all the risks in the right context for them. And of course they want as quicker recovery time as possible and the least disruption of normal life. The discussions we have on the, on the, on the medical side of things is what you heard already. Durability, functional status and the freedom from complications that are associated with implanting a device which you can see with any form of replacement. Those are commonly pacemaker. We talked about lowering pacemaker rates, access to the coronaries because especially as we take care of younger patients, they'll go on to develop heart disease, arterial blockages, acute mes and then valve in valve suitability for the next procedure. Again, this is really highlighting some of what we've heard today and that really is the discussion nationally. What's been nice to see is compared to the first generation of valves as we look at the later generations and most recent generations, the clinical results across the platforms. We have have really been tremendous again 10 years ago we were looking at the patients safely off the table. Now we're looking at optimizing results and getting really low gradients so patients can have good functional outcomes and be able to exercise and get back to regular life. Our tools for assessing patients are sometimes limited with ct we've been able to eliminate a lot of the older procedures we did, like using T. E frequently using peripheral IV's and so that streamline the procedure. But these are two patients who if you just look at their surgical mortality. The numbers are very similar risk or of 2.2%. But these are clearly very different patients, even though they would both be classified as low risk on the left patient. A The 74 year old. Little bit older. But no previous surgery healthy patient. And when you see the measurements on the CT including the peripheral anatomy, they're very favorable for federal access. This is a patient who takes care of her husband with dementia. She wants to get home back to him as quickly as possible. That's a great patient for tavern. That's as good as it gets on the right patient. B again, they're calculated risk isn't that high? The calculations for the sts database have limited numbers of features that are entered in them the ages clearly younger than the last patient. And so that's helping bring the risk down. But this patient has other comorbidities, diabetes renal dysfunction. They have a bicuspid valve with a calcified rafei which is going to give a more elliptical orifice. That's going to be harder to seat a valve as cleanly. And although it certainly can be done, the coronary heights are low. That introduces a little higher risk of coronary obstruction and they have other non valve related issues ascending aortic aneurysm that if it's large enough should be repaired at the same time as opposed to root enlargement, we're going to decrease the size of that. And so that's a patient where surgical options really really have to be thought about very carefully and are almost always going to be the better choice. So that's part of the conversation as you've heard alluded to in figuring out what do we do for this patient? And that's where the team approach really makes a difference. So who does well with Tavern? The perfect patients tend to be those with calcification. Try leaflet aortic stenosis. There is data in bicuspid, but some bicuspid valves are harder to treat, especially because of concomitant anatomical abnormalities like aortic root enlargement or calcification patterns that really put the coronaries at risk. And here you're going to have an even more difficult time potentially with alignment of a valve. A good aortic valve are complex. Again, talking about aortic root size small, large. We prefer per catania's federal access and in the afternoon again, you'll hear some of the alternate routes back in 2011, our routes were either going through the femoral arteries or going through the wall of the chest. We almost never do the transactional approach anymore. But there are a lot of other approaches that have become possible and help with these patients. But the data is best in those patients that do well with cutaneous femoral access and then thinking about other unfavorable anatomy's multi valve disease, coronary disease that should be managed surgically. Sometimes we can stand it. But there are times really a bypass makes the most sense for that patient. And that's when you want to avoid tavern. So the things we talked about our hostel, aortic roots, lack of transferrable axis, surgical grade coronary heart disease. And then issues around patient age, durability and lifetime planning might make you favor a surgical approach in those patients. And that's why each discussion is individual, taking into account each of these features with each patient. And that's why the work up is as robust as it is. Many patients I know when they get sent over to one of us think they're going to have on that day of the first cat there valve put in and it's always a little discouraging for them. When they here we've got this, then we've got dental x rays and cat scans and then we're going to start the real discussion. But that's important. One other thing that's been alluded to a couple of times is in older generations. The data we had was when someone had a surgical valve, especially as they were frail and older and we didn't have to have our options. We looked at the time to death. Nowadays, a really more relevant met is when the valve has to be intervened on. And if you look at that metric, we find that we often quote 10 to 15 years as the average survival for a bio prosthetic valve. But in reality we're intervening a lot of times, even before that with both surgical and trans catheter based valves generally, if you asked five years ago, six years ago, I think age was one of the main selection criteria and that still remains the case. But it's gotten a bit more complicated as technology has evolved in general. Younger age concomitant disease have favored severe and Tavern has been favored in the older frailer patients who can get a good result with. But that has evolved. And this is the 2020 american College of Cardiology american Heart Association and Society for thoracic Surgery guidelines. It's too small to read. But again, we see these guidelines and the year later, european guidelines say the same thing which is look at age as a key index. And in fact calling out in these guidelines, they say for symptomatic and asymptomatic patients with severe aortic stenosis And any indication for a VR who are less than 65 years of age or have a life expectancy greater than 20 sava is first recommended. But this is a moving target. And again, that's where the heart team becomes essential with representation from both the world of severe and travel to figure out what's the right answer for this individual patient. That's where longevity and durability become important. This is a slide you've seen again. And I think the reason you're seeing it again is it really doesn't inform the success of aortic valve interventions. We've seen and specifically tavern. This data from the notion trial at eight years out shows us incredibly favorable human dynamics. I think when we started doing these cases in 2011 again, we we're looking to just keep patients safely off the table. It would have been a dream to have a valve that performs as well as a surgical valve. And we clearly have that now. And in fact sometimes the super annular data again shows we can get gradients that are even better than with traditional surgical valves at times and that translates into less structural valve deterioration and better long term survival and outcomes. So this is kind of a reasonable algorithm that's kind of out there again, this is simplifying a lot of complex dynamics. But in the younger patient we may say we start with severe, although Tavern is an option for the right patient and go on to Tavern severe or Tavern. Tavern. And on we go and you've seen that first case. That's a nice example. There are patients that will get through that three rounds or maybe even more in time to come. And as as steve alluded to as well. What's really amazing is in this era with cT scans and T. E echo cats guiding us. We can do pretty amazing pre surgical planning to figure out to the level of to a few millimeters. How high are we implanting a valve to get the best impact on things like valve leakage, pacemaker rate, not obstructing coronaries and so we're really individualizing to the level of the individual patient with both the first and with subsequent procedures. When we look at what matters to them and what matters to long term outcomes, patients want a good result. And we've talked about some of these issues already. We want good human dynamics here. PpM doesn't mean permanent pacemaker. It means patient prosthesis mismatch and that's become an increasingly important area steve focused on this and really making sure we have great human dynamics. One of the real key principles is when you're doing lifetime managing of patients of course we have to think about 2nd and 3rd valves but the most important consideration is getting a great result from the first valve. So we may not have to worry about a second or third valve down the road. Coronary access was brought up and this is a patient. I had to include these slides because I actually did this on monday. This is a nice lady. We did tavon five years ago and she comes back now and on the diagnostic shot we can see she's developed she had no coronary disease before and in five years she developed a very critical lesion in the proximal lady. And so we've talked about getting into the coronaries aligning the valves. That's where all the action is right now in this. What we have to do with the tavern valve is we have to get into that coronary and there could be things in our way in the world of interventional cardiology. Within paellas with reimplanted coronaries, we've gotten better and better at figuring out unique anatomies and that's what we've done here. So in this patient, I ended up putting in a guide and then using a guide liner to get further right into the corner and get nice pictures. We can wire that we can balloon it and get a nice result. And after stenting, we see in a second view that in the majority of cases with the techniques we've developed now we can get into those coronaries in the majority of patients, but it does require attention and thought and that's part of this lifetime strategy of thinking for each patient. What's the right answer individually. Thank you guys. Published Created by Related Presenters Deepak Talreja, M.D. Sentara Cardiology Specialists View full profile
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