Chapters Transcript Video Recent Advances in Transcatheter Aortic Valve Replacement Dr. Grant Reed from Cleveland Clinic highlights the most recent data in the management of aortic valve intervention in 2023. We're gonna use the next hour to talk about what I view as to be some of the most important recent adventures in uh transcatheter ARIC valve replacement. There's so much you can talk about in structural heart disease. No, I as, as uh doctor Summers mentioned, I I do trans cathe ARIC valve replacement as a structural heart interventionist as well as much about clipping, left atrial appendage, tricuspid valve. We, we could, we could fill the entire morning talking about all these things, but there's been a lot going on in the Taber space and knowing our audience is fairly broad. I'm gonna highlight some with some of the most important things over the next hour. So I have no relevant disclosures. As mentioned, we're gonna try to cover in the next hour. Uh Where do we stand currently for TVER for aortic stenosis? We're gonna talk about how the 2020 guidelines have recognized TVER now, um and how we've progressed from inoperable to low risk indications. We're going to talk about the question of TVER durability and present some of the most recent data that I think answers the question about TVER durability at least after five years for blue expandable valves. And after 10 years for self expandable valves with, with the a blue valve, we're going to talk about pushing the envelope with a reg and whether or not TVER is now an option and then area which is close to my heart. No pun intended is tavern in patients with severe peripheral artery disease. How do we push the envelope? And, and are there patients that we can do that we previously weren't able to do with um with peripheral vascular intervention, we're going to finish out with a focus on stroke. Um Talking about concomitant Tavern and watchmen and the debate over cerebral embolic protection. And then where do we stand with new and upcoming devices? So, um for those of us who are structural interventionists, we, we know this all quite well. Uh However, um tvert has really evolution uh revolutionized the um field of um a valve stenosis. And, and as you can see, we've moved from the uh performing tvert only in inoperable patients with the partner one B and the, the core valve uh ex extreme risk trials um to the high risk patients. These these studies done concurrently um back in 2007 to 2012 to pursuing intermediate risk indications with the partner two and cer cert trials. And then now into low risk with, with the notion um study that was done back in 2009. Uh It now has 10 year follow up data and the more recent uh trials partner three and evolut low risk studies. Um So there's been a wealth of knowledge accumulated over the last two decades because of these trials. And I would argue that we know more about the um about the pathology of aortic valve stenosis um as well as um outcomes after surgical eric valve poison. Because of this, this is really truly um revolutionized our understanding of ARIC stenosis. Um And when you look at the um uh estimated risk per sts score of mortality and, and cardiovascular complications. Um and you look at what's been observed in tver trials, um You can see a progressive um improvement in mortality all the way from around 33% in patients who are inoperable down to less than 1% in one in at 30 days um in partner three. And uh if you were to um you think about this as either improvements of technology and uh the techniques that we're using, I think that's a big part of it. But this also, I think just speaks to what the inherent risk of of doing major invasive procedures are and patients have different risk categories. Um So I I think if you were to put your patients into buckets here and you were to estimate mortality, you can say it's likely better than this. But this is this is what we see in clinical practice, right? Is that mortality is a lot lower in patients who are low risk than that. It is in patients who are extreme risk and things have improved over time. In recognition of these data, the 2020 guidelines now embraced haver as a class one indication uh for the majority of patients with severe aortic valve stenosis. And and just importantly how we triage patients for ARIC valve replacement is based on the epi gradients as we as we appreciate this and also symptoms. And in those patients who are asymptomatic, the question is what should we do if anything we're gonna touch on that later on, but just keep that in mind as we continue. So, moving on from the decision to do aortic valve replacement, the question is, which do you choose, you choose surgical ARIC valve replacement or do you choose trans catheter and the guidelines if you were to really dig into them? Interestingly, there's so much randomized data, but the decisions about the triage of patients for tsar, a lot of it's based on expert opinion still because there's not a lot of data out there to say which one you should choose and patients with different of different risk group. But importantly, the guidelines do and I think fairly use age as a cut point and candidacy for anticoagulation, right? Because if someone's not a candidate for anticoagulation, that's gonna exclude them from mechanical A VR and that's one of the main arguments for, you know, patients to avoid red, reduce cy uh under the age of 65 is that they could get a mechanical a VR they can't get any coagulation and that kind of, you know, crosses that one off. So, um but importantly, these age groups are used and in those patients who are under the age of 65 sr is preferred and those patients who are over the age of 80 TVER is preferred. And it's those patients in the middle, that gray zone, which is where most of our patients fall, especially those patients who are medium and low risk that there is there is ongoing debate. So just to summarize the key differences here in this, in the next slide is that um SR should be preferred in patients who are anatomically unfavorable for tavern. No one can argue that right, unless they're high or extreme risk. In which case, you can take another look at tavern and say, ok, how can I make this work? Especially those patients with peripheral artery disease which we're gonna touch on later on. How do we make TAVR work in the those patients? But otherwise surgical A VR should be preferred, especially if it by cus the valve or concomitant. Um you know, valve procedure needed such as mitral regurgitation needs repaired or coronary artery disease. In those patients who are over the over the age of 80 or have less than 10 years, life expectancy than to be preferred in those patients in the middle. That there is some debate and and this is a summarized in the table uh comparing the old versus new guidelines. So I think we made a lot of progress with the guidelines. But nonetheless, there's still more work that needs to be done. But in recognition of these guidelines and the data that we've seen, we've seen an explosion in the growth of TVER procedures over the years and some stability in surgical A VR volumes which have maybe started to decline slightly. Um However, surgical A VR volumes, importantly, they didn't, they didn't rapidly decline because uh TVER came on the scene. But because we're doing tabor now and more medium and low risk patients, sts scores have fallen and the average age of patients undergoing tabor have fallen. So how do we optimize outcomes in patients who are low in medium risk, especially because we are expanding into those low risk indications. But, but importantly, you can see here that majority of patients that are done are still high risk, they're still intermediate risk. A minority of patients are low risk. So this is, this is not yet what we're doing for all of our patients, but we're doing this in the majority of patients who undergo surgical uh who undergo a valve replacement now in the United States. So importantly, I think the the $1000 question up to this point has been what have been what are the outcomes in these patients who are low risk as uh valve uh technologies have improved as our techniques have improved. What has happened to our outcome? So the partner three study and the evolut low risk study, they evaluated this and now we finally have data out five years which helps to address the questions of outcomes in lowest patients to a medium to long term follow up as well as the valve durability question. And so the S3 valve, as many of us appreciate is a balloon expandable valve, um intra annular. But what you, so it's different than, than some of the other types of valves. It is the most commonly used valve in the United States as you can see here after the five years, really no difference in the composite end point of death stroke rehospitalization. Um actually a trend towards less rehospitalization with uh with the TAVR compared to surgical A VR. But nonetheless, outcomes were excellent at one year and they mean they they continue to be excellent out the five years. There's some convergence of the curves you can see here. And that that was one of the major points made about partner, three trials that tab or outcomes are getting worse over time where surgical outcomes aren't. I I think it's, you know, in the eye of the beholder here because overall you can really just say that outcomes really aren't a whole lot different between tab and surgical A VR and lowest patients after five years and and hemodynamic outcomes are also very, very similar. So this is a big table which the message here is really just saying that there's really no difference between S3 Bloom example, Tavern and surgical if you are at any end point, uh all the way up to five years and when you look at the self expanding valve with the evolut valve, um they uh out the four years. Um there's actually a slight edge to TVER, meaning that TVER is associated with less mortality and disabling stroke at all time points. And if you look at the delta each year, it actually seems to be growing. So, uh composite all causes mortality, disabling stroke or rehospitalization actually lower with t than sr but pacemaker rates higher with TVER than SR and I would argue that that this, this rate is lower now in contemporary practice because of how we're putting in the valves. But tver patients had better hemodynamics at all time points. And if you look at the 10 year follow up data from notion which I mentioned first came on the scene back in 2009, um there's actually less um uh structural valve degeneration with tab or using the evolut valve and surgical A VR in this trial. So, um so I think that there's something to be said about this and um if you look at tab or with core valve, it may offer the best hemodynamics in the class out of all the valves that we put in either to be surgery or with uh or with Tabor. So how we think about severe aortic stenosis, I would argue that our mindset should change. You know, when you see a patient with severe stenosis shouldn't necessarily just be saying, OK, what is the risk for surgical? A VR? But what is the risk for TVER? And if they are good candidates for tavern, then I think that that should be um considered first. However, in those patients who maybe aren't ideal candidates for TVER, either in terms of their root anatomy, needing concomitant surgery, uh age by cuspid valve, then there's surgical risk should be assessed. And if they're low risk for surgical A VR, then obviously surgical A VR should be um uh it should be uh followed. However, in those patients who are maybe medium or high risk, even if they're not perfect candidates retired, then we can reassess and this is where the hard team comes into play. So this is changing the paradigm, changing our thought process. But I think this is what we evolved to. So those patients who were in the gray zone or maybe in the medium or high risk, how do we approach them? One thing that we commonly get um uh you know, face is how do we, how do we take care of patients with significant peripheral artery disease? Um calcification on the valve atherosclerosis. Many of these patients have P AD and what's the best way to treat these patients? And, and, and should those patients who have prohibitive femoral anatomy? For Tabor, should we attempt peripheral vascular intervention and how those outcomes compared to patients with alternative access? So this has been an area in my research scenario that I've focused on quite intensely and I've looked at this with my group at the, at the Cleveland Clinic, both at a population level and at a patient level. So just to take a few minutes of talking about this, what we did is we looked at about 100,000 patients treated in a national database um underwent TVER. We found that the rate of Pipal vascular invention is about 4 to 5%. Um and the requirement peripheral intervention is associated with worse outcomes uh when, when you're thinking about in hospital outcomes. But when you compare those patients who undergo peripheral vascular interventions, when you say mas organization, they still do better than patients who undergo non femoral access, alternative access to have via chest wall access, um or via carotid access. So here are the data and again, a fairly busy slide and, and just wanna, you know, kind of think about it comparing these first two bars to the second two bars. So these first two bars are, are TVER in patients without peripheral artery disease. And um that, that don't require intervention and TVER with P AD um that uh do not require intervention. So bottom line is that here, you can see that the presence of P AD in of itself doesn't necessarily pretend worse outcomes as if you need intervention. So if you need an intervention during the procedure, your outcomes are a bit worse. Um However, it's those patients that don't have P AD that require intervention that do the, that do the absolute worst. And those are patients that maybe have a catastrophic vascular complication. They need, they need a bailout. Most often. I would probably argue that those are perforations. Although it's, it's really tough to tease that out from a national sample. If you just look at this and breaking it down further tver alone versus TVER with peripheral intervention, this is what you see. So there's, there's a higher risk of mortality, stroke A K I and blood transfusions in patients who require peripheral vascular intervention. Um And in those patients that, that do have P AD do a little bit better. And this is very likely the group of patients who experience small agent dissections during tavern and the balloon angioplasty or sending um or possibly those patients who have peripheral vascular intervention to facilitate the passage of the sheet. But when you compare those patients that had P AD or don't and undergo peripheral vascular intervention to alternative access TVER, there's still an edge for TVER. So TF TVER has lower mortality and lower risk of acute kidney injury compared to alternative access. So that's what we see in in hospital outcomes. Uh When you look at large national sample, looking at a patient level analysis, we took it one step further. Um And we, we studied about 2400 patients who underwent tr at our institution and followed them out for about 2 to 3 years. We found similar to the national inpatient sample. About the 6% required intervention of which 90% of them were for bailout and not to facilitate. But when you compare both mortality and mace, you can see that whether or not you undergo intervention, outcomes are fairly stable and similar out to about three years. But those patients in non transfemoral axis TVER had increased risk of mortality both in the short term as well as during follow up and mace which we included stroke and M I. So non non femoral axis t associate with higher risk of mortality in mace. And this is true both in the in hospital 60 day outcomes. Um And um you look at all overall fall after the three years, you know, mace death, stroke, heart failure, hospitalizations and so on. So the takeaway message here is that at least in our patient level analysis, we see similar outcomes for femoral axis TAVR with or without peripheral vascular intervention to facilitate and the outcomes are better than non femoral axis TVER. So this would suggest that if you have a patient with borderline access rather than send them to alternative access should maybe push the envelope or try to do peripheral intervention to facilitate it. If you talk to a patient, they'd much rather have an iliac stent than have a chest cut open to get, you know, either subclavian axis tver or they're crowded. So it's all about institutional comfort. But this would at least suggest that if you're willing to try it, attempting a femoral Axis tavern and doing balloon angioplasty to facilitate, actually may, may allow you reasonable outcomes. So I wanted to show you an example of a case that we did. I'm just gonna play all these at the same time. Hopefully you can see them. I was hoping I can scroll but the computer is not letting me. So this is an example of a patient who underwent a 29 evolut valve that had really horrible peripheral access. And as you can see here, those of us who are structural interventionists are kind of cringing at these images because you can, you can just see how horribly calcified the iliac is and how hard we're pushing. We did balloon angioplasty with a cutting balloon, actually the shock wave. Um And as you can see the evolut chief finally passing with a bit of effort and it goes, but we do get the valve in and we have pretty much a a perfect placement. And then afterwards, we did AJ coated balloon. So we did Deb um, just to give them the best possible result. And you can see now that their iliac looks, looks a lot better in the end. So we're able to do this case with, with careful methodical, um, uh, uh, you know, peripheral intervention, um, did a drug coated wound at the end and left them without a stent. But I heard an oof in the audience because that's about how we were feeling during the case. So um but it's OK to stop, right? You don't, you know, we don't want you to perforate an iliac. But you know, bottom line is that um you know, you can push the envelope and get these cases done with uh with the appropriate uh skill set. So um moving on and I think touching another area that we're trying to push the envelope and expand the indications for tab or is aortic intervention and important for us all just to recognize that A R is, is underappreciated that you should be acting on A R when patients start to get symptoms or all these start to dilate or the f starts to fall. And in the current guidelines, do not, do not have an indication for tab or for aortic regurgitation. And and in recognition of this, many of us totally avoid uh doing tat in patients with they are. Um and you know, part of it is that it's not yet indicated. The other part of it is that it's not yet reimbursed. So, cost considerations are very important and uh it's technically considered off label and being evaluated in clinical trials. So the the limitations for, for tver here that we, we need at least mild air valve calcification uh in order to get our commercially available TVER valves to anchor in to the annulus at the valve level. And without that, there's a high risk of valve embolization, migration and paravalvular regurgitation. So the choice of the valve here is, is quite, is quite important. And I would argue that self expanding valves may have an advantage. And that's because you can, you can choose a self expanding valve in patients who um have a, an annulus which is at the borderline or maybe small for that size, you can, you can oversize it and kind of stuff it in there and then it will hold itself in place. Whereas with the balloon expandable valve, you can do the same thing where you oversize, but um it's uh maybe higher risk of embolization. And because of that tr really only fits a narrow segment of anatomies who are really able to be oversized with a certain valve. And the early data would suggest that um no matter which valve we, we try, the, the risks of complications are quite high for patients who have T for pure A R. And this is a, a registry that was published back now about 56 years ago. And um you know, found that mortality at one ear is upwards of about one in one in three patients um for doing TVER for pure aortic regurgitation. So a more updated analysis in the Pantheon uh registry here um which was just published. Um how if the press is looked at self expanding versus bloom, expanding with contemporary valves. And they, they, they found that the risk of embolization is upwards of about 15% when you do t for par. And I would consider that pretty unacceptable because we all can appreciate that valve embolization could be catastrophic and also risk for pacemakers upwards of one in four patients. So, so tab it can't be done, it can be considered, but you got to be very careful about your patient selection and, and as, as as the Pantheon Registry shows, um contemporary outcomes still have a long way to go that said here, you know, sometimes sometimes you, you do have to bite the bullet though, so to speak and, and do tver in patients with par. And this is an example of the case that we're able to do this safely and succeed. And this is a patient who's 43 had in effective enter carditis had four plus A R numerous comorbidities, cirrhosis with a meld score of 10. And you know, just had a really tough go that here. You can see um A um you know, with dilated LV, which is torrential A R the nose, the surgery again was, was not an option. So, ct planning is incredibly important. Um This is an example of uh the aortic valve annulus here uh measuring a perimeter of 70 which is technically in the range of a 26 evolut valve where you can oversize and put it in a 29 evolut, which would be over 20% oversized for this patient approximately but no valve calcium nowhere to anchor into, but it had an ace sitting aorta which was less than 35 millimeters in diameter. So that upper bulb of the evolut would anchor in there nicely. The other thing to consider is that this was a fairly, fairly vertical aorta. You wanna avoid doing this in horizontal aortas because things can, can, can settle in unfavorable ways. So I'm just gonna play all three of these at once with computer limitation, slow, very careful deployment, landing the valve even slightly deeper. So that in case it does migrate um uh aortic, then you're not in trouble afterwards. Um landing the valve at at least 8020. Um not getting cute with it, I think is very important. Um And then assessing very carefully in both cus overlap and co point reviews to make sure you're under all the cuffs very important. So sitting there when the vowel was at 8020 deployment and just, just watching it for a while, we watch his patient for a solid 10 minutes before we released it, we're able to get a nice result, no aortic vegetation and help this patient out who was 43 and had no other options. There was the echo afterwards. So, and I think one of the most satisfying things is seeing the he with an AMEX afterwards as well. So this is an example of uh the the pret dynamics, almost equalization of dioli pressures. And then afterwards you can see the civic separation. So, so that's a satisfying case. But it's, it's, that's one of the few patients that were able to really fit into that doc. So being able to really oversize a self expanding valve and, and this patient did really well, but you'll hear horror stories of patients that have valves and bolas and catastrophic complications as well. So there's a big need for patients um to be, be treated for a ar that aren't, you know, aren't candidates for surgery. Um But we need, we need to develop a dedicated system for this and, and these hold the promise to reduce complications, improve outcomes. There are a couple of that, I'm gonna highlight here including the Yena valve, uh and the J valve and more on development. So you guys have, have done um several of these cases here at, at at your facility and have had great results. Um But what we, what I wanna talk about here is the Ya so this is a new device. It's actually an old device that's kind of being repurposed and refined for the purpose of aortic a education. Um but nonetheless, we now have some data to support its use. So this is a night now self expanding valve with poor and pericardial leaflets. Um uh it uh essentially expands and eclipse onto the area, valve leaflets to hold it in place. Um So as a flared ceiling skirt, which is supposed to prevent migration into, into the LVOT, but the whole key to this valve is that it clips onto the valve leaflets. This is being studied in, in the align A R and A S trials, the early experience and this is really small to read, but they were published in 2014. So this came on the scene kind of early on and there wasn't a lot of enthusiasm for it and, and now we're, it's being repurposed kind of for this for this reason. And this is just showing it in action which we're, we're, we're gonna show a case example of this later. But the alignment here is such that you need to align all three of these little posts, so to speak, um these clips with native cusps, they get clipped in the place and then it gets held in the place there and it kind of flares outward and gets held in the place. So the align A R study was just uh just presented and looked at outcomes out to one year safety at 30 days and uh efficacy, I mean, freedom from A R at one year included patients with three plus A R and class two symptoms at high risk for surgery. But importantly, did exclude patients that had BSD valves and large aortas. And another reason for surgery. So, rather than randomizing patients to surgery or or um aortic regurgitation uh for aortic regurgitation or tab. Um again, these are high risk patients that really aren't good surgical candidates. So they use the performance goal and the statistical methodology is actually quite interesting. Um If you are so inclined, you can read the paper about how they define their performance goals. Um Some would argue that his performance goals are a little bit liberal but that said, um you know, I think that they're fair when you, when you look at how they justified them. But efficacy meaning freedom from mortality at 12 months, um they basically estimated a 12 month mortality rate of 25%. Um And that uh safety would be a combination of all these things and they included pacemaker in this um for a performance goal of 40%. So, um they had 100 80 patients enrolled. So you can see here going through the screening process. Um you know, a lot of patients ineligible and I would argue that based on how many we submitted and got declined, um there certainly were um quite a few patients who were declined. Um Most of the time because of an atomic criteria based on their CT scan. So again, not, not, not necessarily that you're gonna be able to use in all patients, but nonetheless, um about half the patients that were screened were enrolled. Uh I won't get into the weeds here in terms of procedural characteristics and so on. Um Just to mention though, is that these are not our typical to procedures, the majority of them needed general anesthesia. Um They were long procedures, use a lot of contrast, but importantly, actually fairly good outcomes out to 30 days in one year, no deaths, no angular ruptures, um couple of valves embolized. Um but much less than you would see with commercially available T valves and overall 95% technical success rate. Um Looking at uh 30 day mortality down the line here, overall, I would argue pretty acceptable outcomes. The the only glaring thing here is that pacemaker rates were quite high. So 24% pacemaker rate, despite 17% of them already having a pacemaker. So pacemaker rates are still quite high with this valve. But hey, for these patients who have no other option, I think this is uh this is actually, I think I would argue you'd rather be alive with a pacemaker than, than dying of aortic regurgitation. So this is showing the primary safety endpoint in 30 days showing that it met its safety goal. Actually, you know, quite, quite a bit, um you know, of a margin there. And if you look at pacemaker rates, it actually declined pretty significantly as the trial went on. And uh I think that uh operator um uh comfort with the device is a, is an important feature here. So I'm hoping that we're gonna be able to see pacemaker rates in teens as, as this gets into more people's hands and similar to evolut valves. Now, we're, we're having pacemaker rates in single digits. Whereas in the clinical trials, they're, they're pretty similar to this at first mortality um was uh about 787.8% in one year. Um and heic performance of the valve was excellent. So um here's an example of the case being done um For one of our patients defining the coplanar um angle here aligning the three um you know, pl its there eclipse with the valve. You coin the valve. In this case, we did do a post dilation even though that's that's done the minority of patients in the study and then afterwards having a really, really nice result without any A R. So, so it's possible. Um And uh I think this is something which we're really excited about because we've had no option up until now. Um The J valve is another um I think really exciting possible valve. This is being looked at in an EFS right now, hoping to start the pivotal uh study in spring of this upcoming year. Um The nice thing about the J valve is that it's, um, it treats a wider range of anui very small and also very large. And there are these anchor rings which, um, uh you can see here instead of being kind of these little like kind of posts that go down into the, um, the clips that go down into the valve, they're quite, they're quite large. And this, in, I think in, in practice allows the valve to kind of self center itself. So one of the challenging things about Yena right now is that you're really, you're really scrutinizing and making sure you got all three cusps and it could be kind of painful. You're using a lot of dye and this is, it's hard to visualize what they are. Uh you want a valve like this that may allow it to kind of self center and just kind of find its, find its way. And um the company would argue this is also suitable for BSP valves. So they're being, they're being included, I believe in the pivotal study. Although this is the details are still being hammered out. They had a, a compassionate use experience which um I think outcomes are were, were, were reasonable and the EFS is ongoing and, and they're presenting that now. So, so that, that's P ad, that's A R I want to just finish out by talking about what should the role of re bone bowel protection be in clinical practice? And you guys are doing this, doing this here. Um Are you doing it in all your patients or very, very select? Yeah. So which patients should be doing? That's the question and, and uh you know, what are the data support doing it selectively? We know stroke is a risk, right? We know it's lower in low risk patients, but patients who are medium and high risk have the higher rates of stroke. Um If you look at all of our data up until now, uh the rate of stroke is around 2 to 3% and it hasn't really changed over time. We know strokes are devastating and associated with higher in uh in hospital, 30 day mortality and um and debilitation. So we wanna do all we can to prevent them. But unfortunately, as we talked about the rates of pacemakers and vascular complications going down with operator experience, stroke doesn't really change. I mean, you can do 1000 towers a year and still have the same stroke rate as someone who does 50 towers a year, right? So, um there's not much that we can do to really modify this risk and and knowing how devastating this is, this is, this is, this is this is why stream bone block protection. Some people believe very strongly in it. Um So not to belabor this, it's, it's a the the the only device which is approved right now for Streb bone block protection during tablet is a SAN device. It protects 80% of the brain circulation. It's not a perfect device in terms of its coverage, but it does cover the anominous. So the um right ver right carotid and the left carotid are protected and the left vert is not, but it's a very quick procedure which goes from the right radial artery. If you look at the um uh the data used for FDA approval, it was a safe device, there was a signal towards efficacy, but it didn't quite reach efficacy in terms of stroke prevention and the Sentinel ID E and this was studied more um uh in more detail and protected TAVR. And this was just presented within the last year, looking at 3000 patients randomized 1 to 1 to tver alone versus tabor with rebro protection and looking at clinical stroke after 72 hours, um assuming a 4% stroke rate in the in the control arm and a 2% in the cerebrum bolic protection um uh arm. So again, these are clinical strokes. Patients did not have routine CT scans or MRI S done. All patients were assessed by neurologists and assessed of whether or not they had a T I or stroke and protected TAVR. Um Just to basically show this was 95% of people roughly had successful uh placement. Um But the risk of the rate of stroke was um was not different in patients who had cereal block protection versus those who did um there, there was however, um a signal and I would say sta statistically significant reduction in disabling stroke with cerebral and block protection versus those who didn't have it. But the study was not powered for this. So there's a trend toward reduction of stroke. If you look at patients enrolled in the United States, North America, actually, all stroke was statistically reduced. Um disabling stroke, however, was um was really a selling point of this trial. So it was a secondary end point nonetheless, um not the primary end point. And um if you were to look at patients who did have strokes, um there was less, the strokes were less severe in patients who had sent. And that's what this slide is trying to communicate. So important caveats here that protected TVER assumed a stroke rate of about 4% in control patients and 2% in the Embolic Protection arm. So it only reached 2.9% in the control arm. So this is, this is the, the challenge is that um although the primary endpoint, they enrolled 3000 patients, um it still wasn't a power for the primary endpoint and it wasn't powered for a disabling stroke although, although they did reach significance. So, so there is, there is a need to study this more despite us, um you know, having trial which looked at, you know, 3000 patients. Uh we, we need, we need an adequately powered trial and, and this is being, this is being studied in BHF Protect A which will enroll 8000 patients. It's a European study. Um I think that the British Heart Foundation should be adequately powered for all endpoints and they're going to combine the data from protected T A and BHF Protect A E. Um And uh this will be the Prosper Registry. So this is already pre specified. It's gonna have 11,000 patients in there and this should answer the question. So this should be coming in the next few years. Uh There is, however, there's been an explosion of potential devices out there um trying to um uh you know, solve this issue of of stroke prevention during tor. Um The one that's highlighted here is the only one that's uh from a radio approach. This this device, the prom uh protects all all of this r of vasculature, um left radial six French sheath. So I would, I would argue probably the most attractive option of all these because very few people want to be putting in a 11 or 16 French femoral sheath to protect stroke in patients. And they're going to have, you know, this is, this is a hard sell, but nonetheless, we need to start somewhere and we need to continue to um you know, continue to uh try our best to protect uh patients from stroke during tabor. Um So, uh this is um I think, I think appropriate segue into how do we treat patients with atrial fibrillation, undergoing tapper. Um And as we can all appreciate left atrial appendage lesion is a very effective. Um And um I I would argue um you know, not only from a clinical standpoint, but also potentially cost effective option to prevent strokes and bleeds and, and all of the consequences of, of, of that in patients with atrial fibrillation. About a third of our patients with severe A, are they going and tab or have a fib and have a high chance va score? And about half of them are, are high bleeding risk. So there's a large number of patients who could be candidates for a blood atrial page olu per current guidelines undergoing TAVR. And the question here is, is can we save cost? Can we maximize patient convenience by doing these procedures at the same time? Um And that's what the Watch Tabor trial uh evaluated. So, uh Watch TVER is a child with about 350 patients randomized 1 to 1 uh to tver alone versus TVER plus appendage occlusion with the watch 2.5 device. So, um this the landscape has changed there. Now, the Watchman Flex device, which is um you won't argue uh much uh safer um and easier device to deploy. So the field has evolved. But nonetheless, this was using um the device that was available at the time. Um And uh it uh followed patients out two years and uh basically looked at vascular complications and stroke risk in these patients. And uh this is a busy table. Um just to basically show you that you compared patients who had Tarique appendage occlusion and TV, without there were no difference in outcomes. So the primary endpoint of uh you know, mortality, stroke and bleeding no different between groups. And if you were to look at this split by all the different components, no difference at all um between uh patients who had Tabor and under one appendage versus T alone. So adding appendage occlusion, didn't, didn't add to risk in other words, and, and that's the important message here. And there are no differences in any of the subgroup analyses and overall um overall pretty favorable for, for Tabor plus watching together. The the caveats of that again is mentioned, they used the Watchman 2.5 device and outcomes have improved considerably with Watchman flex and, and, and amulet and you know, some of the other devices upcoming. So um the study was only power for the composite. And I think one of the things that most people who look at this critically are most interested in is um and this did not answer this question is, is how do outcomes compare to TVER with Watchman at the same time versus TVER plus stage Watchman? Because this is what we're doing in clinical practice. And I, I think that is the very relevant comparison because Tabor with Watchman at the same time you're using the same Venus access site you use for Tabor, you don't need to put the patient through another, another um another procedure, right? So, you know, it's one access versus two. If you do two procedures. Um and with the proliferation of ice for watchmen, you can maybe be able to avoid um you know, uh te for patients and get this done very quickly. So, I this is where the fields are moving and evolving to um economic analysis I think is important. And uh we're gonna, we're gonna look at that um in the future, I'm gonna finish out with TVER for severe aortic stenosis in patients who don't have symptoms. This is a surgical trial called Recovery. This is published in 2020 and this is a provocative study that looked at patients who had very severe A S without symptoms, meaning a peak velocity of more, more than 4.5 and a peak gradient of more than 50. So classic, you know, high flow, high gradient A S and randomized patients to surgical A VR early versus medical management and followed patients out up to eight years. And what they found was a significant reduction in the risk of mortality with, with early intervention for eric stenosis, even if patients don't have symptoms. And when one would argue that these patients may even be better suited for TAVR, especially as they get older. And, and, and how do we, how do we conceptualize these patients. Now, the TAVR outcomes have improved so much. This is being studied in the early tver uh trial, which we, we hope to have results in the next few years. Um But I think this is probably one of the next uh next areas of tabor. Um And we're, we're gonna, we're gonna have some information on. So hopefully, I've got you all excited about ERIC valve interventions. I know there's a ton of excitement about mitral valve, tricuspid appendage, everything and, and, and I agree and, you know, maybe in the future I come back and talk about all those things. Um But nonetheless, um you know, there's just, there's a lot of excitement about a valve interventions, especially this year. Um We now have the Abbot Naor Valve which is uh available in high risk patients. Um accurate ne 02 prime is now on the scene. They're hoping to have approval for all levels of risk here within the next year. Evolut FX just came the market. There's gonna be improvements there. X four is being studied in alliance. We talked about the trilogy valve, the J valve and then this valve which we don't even talk about. Um the uh Antero DAVR is a 3D printed valve where the valve tissue is all one piece. So um hemodynamics are actually quite favorable for this, but this is in, in the early studies and they just completed their EFS. So there's a ton of them that needs um touched on all these already. But um nonetheless, I hope you guys, you know, get the point that I, I believe that the future is bright. Um And uh you guys are leading the way here at uh at, at Santa. So thank you so much for having me happy to answer any questions. Published December 13, 2023 Created by
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