Dr. Pinak Shah from NYU Medicine and Dr. Gersch with Georgia Heart Institute debate the effectiveness, pros, and cons in how to treat aortic valve issues in patients who require aortic valve replacements for aortic stenosis and structural heart disease.
So, um I think we'll go to the next session, uh which is a debate which I love these type of things. Um The uh first speaker is gonna be um uh Doctor Shaw from uh who is the uh chief of interventional uh cardiology and structural interventions at the Brigham Hospital in Boston and a good friend. Welcome. And he's going to talk about Tar and low risk patients. Great. Thank you very much. Uh It's a pleasure to be here this morning. Uh So I, I think this is a debate and I had to take this uh side that uh should be for everybody uh for uh patients in risk. Um So here are my disclosures and I think probably the most important one is that I am an interventional cardiologist. So I am gonna be biased towards interventional procedures, but I'll be honest and say that I don't necessarily practice and believe the title of my talk. And, and I do think we've heard a lot about hard teams and, you know, it's really important to have a group of people that work with that have similar mindsets about how we approach these patients to come up with a unified decision. So in general, my practice is not based on debate and I'm fortunate to be working with people that we can, we can work with collaboratively. But at least I'm gonna try to convince you over the next 12 minutes. Why should be strongly considered in in all low risk patients? So, uh tar is the most studied technology uh that we have out there now in cardiology, probably in all of medicine, there have been numerous randomized clinical trials comparing tar to surgical aortic valve replacement and uh has been systematically studied with uh first starting with the sickest patients and going all the way down to the low risk patients. And pretty much in all of these studies, tab has been shown to be either non inferior or superior to surgical aortic valve replacement with short term outcomes. And in terms of the two largest randomized low risk trials, I'm sure many people in the audience are familiar with this. This partner three study randomized nearly 1000 patients uh with who are considered low surgical risk to surgical aortic valve replacement versus trans cat that are using the third generation SAPIEN three device. And you can see that uh in the upper left hand corner, if we look at the combined primary endpoint death stroke rehospitalization out to one year, nearly 50% reduction uh with TAR compared to surgery. So in this study, Tar was considered superior to saver in low risk patients out to one year outcomes. And similarly, the volute low risk trial. Now this used devices that we really don't even use anymore. These are early generation devices. Uh But despite that, compared to surgery after the two years, Tara performed very well compared to surgery in terms of death and disabling stroke. This is a non inferiority study and Tara was found to be noninferiority, non inferior to in low surgical risk patients. So, shouldn't we just be doing this in all uh low surgical risk patients? And when I had these conversations with some of my surgical colleagues who, who may not necessarily be fond of the catheter based world and there's a few of them out there. Not, not on this panel, I'm sure. Uh but uh but uh several, several consistent arguments will come up. And I think it's fair to say that we're really looking at short term outcomes here with these studies that led to approval and we're really talking about younger patients who have a long horizon of life and we really need to know what happens in the long term. So what are some of the things that, that um that we worry about in low risk patients? Uh So what are arguments against uh for low risk? So one is associated with a high pacemaker or a higher pacemaker rate than surgery. And if we look at the ST STV T database, we certainly see that early on with our experience and the Green bar, there are high risk patients, which is all that was approved. At that time, we had very high pacemaker rates up to 13%. But you can see that we've gotten better with our techniques. We've gotten better with our technology and pacemaker rates have certainly come down over the years. And when we look at the blue bars, uh pacemaker rate of 6% in low risk patients, I think isn't acceptable. When you look at partner three, the pacemaker rate uh at 30 days is 6.5% in patients who got ver versus 4% in patients who got surgical aortic valve replacements. So very, very acceptable to my opinion, a non clinically meaningful difference between the two groups. Uh Now I will concede that the volute trials had higher pacemaker rates for sure compared to surgery. But we have improved our technique and gotten a lot better at deploying these valves so that we would have lower pacemaker rates down the line. What about valve leak? Surgeons do not get paravalvular leak, uh particularly in low risk patients, but we do with and we have learned that if we leave patients with moderate to severe paravalvular leak, they don't do that well. Uh Now we have modified our devices so that we have a ceiling skirts at the base of our devices that help prevent leakage at the side of the annuls. And when we look at the low risk trials. Again, focusing on partner three. There, you see that moderate to severe per val leak was well under 1% very acceptable. A little bit higher with the core valve eu device. Although again, these were early generation devices and these rates are probably not quite as high in the modern era. What about bicuspid aortic valves? Uh younger patients, low risk patients are more likely to have a bicuspid aortic valve. And the problem with bicuspid aortic valves is that um they are often heavily calcified and the site of fusion between the uh the cusp that are fused. Uh It can also be very heavily calcified. So you can end up with a valve like in the bottom right hand corner that does not, is not fully expanded, uh perhaps leading to worse human dynamics, earlier valve degeneration. But we have shown again, these are just observational studies. Bicuspid um has never been um studied in a randomized fashion and bicuspids were excluded from all clinical trials of tar. But we have shown that in propensity match analysis. If we pick our patients carefully, we can get very nice results with uh tavern and bicuspid patients compared to uh in tricuspid patients. So in this analysis of mortality and stroke were very similar between the two groups and in a similar analysis of patients who were considered surgical risk. Again, we can show that we can get comparable outcomes in terms of mortality. A stroke and the combination of the two and patients treated for bicuspid aortic val with tar compared to tricuspid. What about coronary access? We're blocking the coronaries in a young patient. So when a surgeon places a surgical valve, uh they can uh post the, they can position the commas in such a way that they will not be sitting in front of the coronary artery and we can easily engage those coronary arteries when the patient comes back or if they come back. But uh with the Taber valve, we can't do that routinely. So if a patient does need a coronary angiogram after a tab, or it can be a real struggle. But we have learned ways now of using our devices and markers on our devices as we advance them to increase the likelihood that the the uh are away from the coroner. And now newer valve designs are providing us with markers so that we can actually see where the comers are. So again, we can predictably deploy these valves in such a way that we are not going to obstruct the coronary arteries. And this is probably the biggest argument I hear that Tara valves are not as durable as surgical valves. And I, I would argue that we don't really know that uh question yet. Now, one of the questions is, how long does a surgical valve really last? And I think you get all kinds of numbers from people depending on who you talk to. But this is an interesting analysis from the vivid registry. This is a registry of patients who are presenting for trans cat or aortic valve replacement for failed um uh surgical valves. And the median time to valve and valve tar was only 8 to 9 years. Um So, you know, I typically tell patients who get a bioprosthetic surgical valve here, you should expect to get 10 years out of this, but it's a bell shaped curve. So what do we know about durability? Um Well, uh it, it, it the um intermediate risk trials partner two and sir out to five years show that we have very good effective orifice area and mean gradients with tar valves compared to surgical valves and notion which now has data out to nine years shows the same thing and the low risk trials that I mentioned will be following patients out to 10 years. We may even learn that Taber last longer than valves. So more to come on that. So I'll just close up here with sort of how we approach uh low risk patients, uh whether we consider them for or for. And I think the the easiest group is the uh the eight year olds and above the eight year old low risk patient or even patients in the six in their um late sixties and seventies. We if they have a nice valve tricusp good anatomy, we're generally gonna consider those patients for tar in terms of the great uh patients who are above the age of 80. We, I will tell you that we try to avoid surgery in those patients. Uh So we will most likely consider surgery even if they have a, I'm sorry tab or if they have a aortic valve or if they have concomitant disease, that we would ordinarily think require surgery like coronary disease. Uh If we can uh manage it percutaneously, that's typically what we're gonna do in our octogenarians and older when it comes to patients who are a little bit younger than that, um we will uh consider tar for bicuspid or for situations where they have other concomitant surgical disease. If we think we can treat it effectively with percutaneous options, I think uh this is the group that's probably the most controversial. The guidelines do not even discuss tavern in patients under the age of 65. And that's because these patients weren't really included in the low risk trials. Um So when I see a young patient, uh coming in with aortic stenosis, I generally go in with the mindset. I'm thinking about surgery for that patient. But if they ask, and patients are going to ask, they know about it and this is what they want. Uh We have a very careful discussion about some of the unknowns and as long as they have anatomy that I feel we can treat and get a result that is as good as surgery with the opportunity to potentially think about a redo tar down the line. We will often consider tar for some of those patients. But of course, if they have a bicuspid aortic valve, uh particularly an unfavorable valve, or if they need an aortic root done or they have bad coronary disease, those patients are going to get surgery. So I will conclude that uh the short term outcomes with tavern and low risk patients are excellent. Um But there are, there is a positive data for patients under the age of 65. Um What's clear is that patients are gonna come wanting a ta it's, it's I I can't think of a patient who's walked in saying I really want surgery. It happens, but it's extraordinarily rare. And what we really need is just good, hard team assessments uh to ensure that the best course of action is selected and that patients and families are fully understand the consequences of whatever decision that they go with. Thank you very much. It's been been point. Well, Benny, that, that was a fantastic overview. Ok. So let's make this a debate. Uh Let's have our, our own Karen. Um As many of, you know, Karen uh joined us as, as a cardiothoracic surgeon, what like a couple of months ago, we've, we've been in the works trying to recruit her for a little while though. Um But anyway, we're absolutely delighted. She joined us. She's a phenomenal kind of overall high risk cardiovascular surgeon. Um but um in addition to all that has special expertise in robotic endoscopic lema as well as thoracic work as well as minimally invasive work and in the other valve. So Karen's gonna make the case for that surgical aortic valve replacement for lower risk patients with aortic stenosis. Karen. Welcome. Good morning. I'm clunking around up here this morning. I got up and my Children were yelling at me for clonking around the house with my heels, but they're not my surgical clog. So good morning. Glad to see everybody here this today. Um My uh plan is to discuss uh a surgery as a surgeon. It's the best thing ever. I have no disclosures. Um I do agree with Doctor Shaw. The biggest thing that we all need to take away from this conversation today that this is a cardiothoracic surgery team discussion with our cardiology colleagues, partner trials. We know what the high risk trials and the intermediate risk trials showed that, you know that uh a valve are superior to the standard therapy and extreme risk and non inferior to the intermediate risk. Partner was specifically looking at the low risk people and the inclusion criteria as we all pretty much know high risk or um severe aortic stenosis and their sts risk was less than 4% the exclusion criteria and the tar trial, the partner is quite large. So as a surgeon, we don't always see people with none of these um B A or A valve, severe A R uh severe LV, dysfunction, calcification as syntax score is greater than 32 unprotected left maine not amicable with PC I. So these are all exclusion criteria for, for P three. clinical renal insufficiency for LT is a big one. So when we look at the average age at the very top 73 for the low risk, not 50 not 60 not 65 73. Um the sts score is pretty well matched. Going. Keep going. I'm looking at Doctor Mack did a very good presentation on two year outcome. I'm gonna compare one year and two year for a trans valve and A P three. I think it's good for us to start looking at the longevity of these valves. This is just how the two year um uh uh review of the patients. Uh pretty much all the patients were reviewed. There was a higher fallout review of the surgical patients which may skew some of the data, primary end points, composite end points, death stroke, rehospitalization. There was a significant difference at both but one year and two year between Tava favoring tar over surgery. But look at death at two years. There's no difference as far as uh surgery and trans valve. Looking at the causes of death, we can see that they um the sudden cardiac death, the trans valve uh between one and two years had more deaths and they started to catch up with the surgery group, looking at stroke at two years, there's no difference at death and disabling stroke. There's no difference. So we're also looking at disabling stroke, um, and strokes that were not there at disabling. You can see that tab started to catch up with the, the surgical group at between one and two years for these disabling strokes, rehospitalization. Tar one at one in two years, the trans valves win all the time at 30 days in one year period. Well, let's take that out a little bit further causes of hospitalization. As we can see is usually uh congestive heart failure, secondary end points, we know this, that trans valves have a higher likelihood of of permanent pacemaker and left bundle branch block and surgery has a higher likelihood of a fib down the bottom on the very far, right. You can see that there's a higher incidence of valve thrombosis, albeit that the criteria for val from thrombosis as study for this var two classification has changed. And it may have been a little prickly that perhaps it was just the classification of how we were reviewing valve thrombosis. But nonetheless, trans valves did have higher valve thrombosis between one and two years. And this is just a definition this has changed. So I won't spend very much time on how they define VAR two versus the new var three um as the group as, as a, as a whole, the trans eric valve and surgery, um, category, echocardiographic findings were similar uh and non um, at one in two years. And also the valve area you start to see that uh, the surgery group and the group kind of evened out and were very similar at one in two years. So valor leak something that none of us like to talk about. But is there in this, uh, the P three trial? There's very little trans trans catheter um excuse me, paravalvular leak. And that held true for at one in two years, there was no significant change in the leak on these in these and studied patients. The P three, the P three trial limitations, the results, the results imply really to the only in the enrolled aosis patients. And I'm gonna talk more about the enrolled people because you saw there was a pretty hefty exclusion criteria. Um There was less follow up data in the surgical group at two years than the trans aortic valve group that may have skewed skewed a little bit of the data val thrombosis was an issue. Again, the classification for valve thrombosis has changed. But nonetheless, we did see higher valve thrombosis and in that group of patients and valve thrombosis in the trans valve group, only two of them had atrial fibrillation. One came in with it, one developed it over the 1 to 2 year period. So the val thrombosis um and associated strokes and these folks were not um exclusively related to atrial fibrillation. Um The results of two year outcome, long term assessment has to be performed on these patients. And I'm gonna talk a little bit about doctor review of P two patients and intermediate risk at five years. So, um the uh the, the as for the defined population for P three for partner three, the defined population of severe asymptomatic eros patients who are at low risk ta R as compared to surgery at two years reduced primary end points, 37% reduction in death, stroke and rehospitalization. That's great. But again, we have to look at the population that was studied. There are more deaths and stroke events in the tar population between one and two years than the surgical group and the reduced CV hospitalization still hung strong in the group. So um the there is a question of increased valve thrombosis. There was no difference in hemodynamics and either valve and, and P three looking quickly at Eval loop, which is also a low risk trial. The primary end points are all cause mortality, disabling stroke for tar versus AVA. And so it shows that the conclusions Tava self expanded core valve was non inferior to A R for the treatment of severe symptomatic aosis. In low risk patients, stroke atrial fibrillation and severe bleeding were higher in the SAVR group and permanent pacemaker and moderate to severe para league were higher in the tar group. So, what does that flat mean, I'm just gonna go through these quickly, quickly. So I don't lose my time to get to my point of, of um why um the approach is often superior. We kind of scoot through conversation. P three results are good results are good as well. We cannot in any way argue that. But trans valves are not for all comers, exclusion criteria for P three by sin insufficiency LV, dysfunction, calcification of the anus into the LVOT, high syntax scores, unpredicted, Left Maine. Um Also uh patients who have non amicable to PC I, the average age was 73 and then less than 7% of P three patients were 65. So saying that we can apply a trans cat valve to a 68 year old who wants it is maybe a stretch by C beds. There are two or three times more likely to have calcium, high, high calcium burden and also their younger patients. Um We have a lot of risk for rupture in these patients. And also we know that the LVOT calcification is, is real. Anybody who's had a rupture knows that you don't want to ever have one again, para or leak is a problem. The aorta and bicuspid patients can we not, we can't just ignore the aorta bicu have larger aortic um sizes anything over 4.6 centimeters, we probably should be replacing. And then there is a higher, higher likelihood of embolic event with bicuspids just intuitively. And we know that the protect trial really showed no miss the primary end point of failing to show a significant difference between the threat of stroke. So, protecting the um cerebral vessels don't necessary, doesn't necessarily mean that there's not gonna be a protection in the stroke pacemaker. We know there's a higher risk of pacemaker. Um low risk patients with coronary artery disease oftentimes now, in our a transcatheter group, if you know that a patient's gonna need a PC I down the road, oftentimes you can choose a valve that's more favorable to PC I, that may be a prosthetic mismatch because you may have chosen the wrong valve based on the fact you have to do PC I later then paravalvular I highlighted you. So the five year outcomes in P two, the valves are probably gonna be durable. That's for sure. We think the valves are probably gonna be durable. So the issue with the transcatheter valves is, you know, the um placing it in patients where there are higher risk with bicu valves or analysis that aren't necessarily favorable for transcatheter valve. And you end up with paravalvular regurgitation. We definitely know looking at the five year data at P two, that people with paravalvular leaks have a higher mortality. That's there's no question. So to take a young patient with a bicuspid and a lot of calcification and leave with a para leak, we've done them no favors. Looking at non tri trileaflet aortic valves, severe coronary artery disease, combined mit and valve disease and combine a a uh replacement. There is a Quebec group that looked at their patients from 2020 to 2019, I mean 2000 to 2019. And they looked at every single patient that they had and they said of the 6874 patients that were eligible for, for the low risk trial, only really 202,720 were really truly could be into the trial because the other ones had an excluding criteria by a so to say, try trans are applicable to every patient. It's just the wrong thing to say. Are they good valves? Yes, we put them in all the time. I love putting, I love doing trans valves, but it has to be done with the right patient. And we, that takes a group of us to sit around and discuss, discuss who that patient is. So, in conclusion, I'm gonna have to agree with Doctor Shaw. This is a fantastic approach trans val and we do the same thing. Anyone less than 65 we really discuss surgery over 65 is they have a lot of co morbidities that would exclude them from both safe surgery, transcatheter valves the way otherwise, I don't mind taking very high risk patients to surgery. And a lot of us in this audience, don't, don't mind doing that as well because we do see the outcomes um over a longer period of time as being superior. Thank you. Um Wow, what a what a great presentation. And, and ladies and gentlemen, you might ask yourself, you know why the, the huge emphasis on TAVR versus if, if you think about aortic stenosis, it's one of those conditions that we truly make a difference, we truly save lives. Um And the technology, there's no question that the advent of trans aortic valve has revolutionized the field has offered uh therapy uh to a lot more patients. And now we're not talking about the very high risk, but we're talking about the lower risk. And that was a really, really good discussion. Uh We are running a little bit short on time and as you know, we want to get to our live cases at nine o'clock and I think people are gonna be ready for a coffee break, but maybe um I also want to mention that. Um OK, let me just ask the panel um in two or three minutes. Any thoughts or comments on that. Um Yeah, I wanna make one question for, for Bennie and Karen. Both of you highlighted um the need for heart team assessment. Um One of my roles is, is I'm the chairman chair of the T BT Registry for the country, right? So I have early access to all the data in 2022 97,000 taverns were done in the United States. And Jeff who, who knows a lot of this data. He is a CMO from Metronic. Um So 97,000 it transcends all surgical valves done in the United States by that tens of thousands of patients. However, there's a new component that's um coming up from C MS and potentially from the N CD, that the N CD potentially is going to be reviewed soon. And things that people are talking about is the, the, his, the, the idea of a heart team going away. Benny, your thoughts N CD no longer says a surgeon needs to see the patient. The heart team doesn't need to exist. Are you still gonna do it? You gotta, you gotta answer this really quickly. Are you still gonna do it? Are you not gonna do it because this will change the way that A S is managed surgeons against cardiologists instead of a heart team? I can't, I can't envision that changing for us. Uh You know, we've set it up um really nicely that, you know, we'll generally know what we're going to decide or at least recommend to the patient before we walk in the room, both the surgeon and myself. Um and I think it's just, it's much better for the patients and their families if both of you are in the room with the same message. Uh Yeah, I, I can't imagine, you know, breaking this up doing it in serious it's, it's not gonna be good for patients having to come back to see multiple people multiple times. I think you just said, you know exactly what the right thing for that patient is and you can walk in together and say this is what we recommend. I agree. And, and this swings all the way back for our initial conversation about quality um to eliminate the surgeons from the conversation. Is there for chopping quality of the outcomes of your hospital right in half because you can put a valve in anybody but the durability of it or whether or not it's the right procedure then bring them back to do a route to dig out these valves is not easy. It's not fun and these patients are very high risk and anyone who's had to go in and take a valve out does not live for that day. So the I can't imagine either that we would have no heart team with the decision making in these folks because there's just too much. And then that was, that was a pretty provocative question. I've been, I was, I was wondering if um I I know that Jeff Popma who really led a lot of the uh initial trials on volute and then very recently has been Chief Medical Officer of Metronic is here. Um Jeff maybe just some comments in general but also specifically about this idea of kind of lifetime planning. Well, first of all, um amazing symposium. Great attendance. Congratulations. Um I really enjoyed all the talks about different valves and different strategies or things. But I would want to make a plea to everybody who's here in the audience. That's kind of at a 10,000 ft level. We know that Eric valve replacement, whether it be by surgery or whether it be a trans catholic therapy saves lives. We know that and yet still in the United States we have a tremendous under treatment problem. Patients are in the clinics. They're not getting good echoes, they're not getting referred in. They're not getting into a heart team. And, and it's particularly true in disparate communities of patients of color black and Hispanic and American Indian. And we have to do better for that. We think that the under treatment is about 25 or 30% just in disparate population oftentimes it's determined by the zip codes and you certainly are in the midst of an area here. That's incredibly important. We also have to understand scientifically whether we need to treat patients with moderate aosis and both Edwards and Metronic are running trials in patients with moderate aosis. We have to learn to know what to do with the asymptomatic patients and getting them in. So I think that whether the debates are great about surgery or transcatheter or Edwards or Metronic or Boston scientific report, those are great debates. But before everybody goes home, we still have to recognize that there's a tremendous under treatment of a. There has to be a better awareness, echocardiographer, techs who are in the room absolutely critical that you get good quality studies and most importantly, get the patients referred into a heart team for evaluation. So that would be my 10,000 ft view about. Thanks Jeff, very uh very insightful, especially since you've been on both sides of the uh of the aisle. As far as this goes, we're gonna go ahead and uh take a little break. Now, uh please visit the exhibitors. That's why we're able to have a conference like this. And then please be back sharp, nine o'clock. We'll start with the, uh we'll start with the live cases. Thank you. Great.
