Originally Broadcast: Wednesday, March 9, 2022 at 7:00 PM ET
Innovation in aortic valve management and future interventions has without a doubt opened new opportunities for patients and clinicians. The right procedure for the right patient can lead to a longer life well-lived. But when it comes to valve selection and ultimately patient impact, are these future “possibilities” being over-promised and under-delivered?
Join our live discussion with renowned cardiologists and cardiac surgeons to have a case-based discussion on patient selection and future possibilities that determine the strategy for a lifetime of valve management for your AVR patients.
Dr. Hector Michelena, Cardiologist, Echocardiographer Mayo Clinic, Rochester, Minnesota
Dr. Katherine Harrington, Cardiothoracic Surgeon Baylor Scott and White The Heart Hospital - Plano, Plano, Texas
Dr. Erol V. Belli, Cardiothoracic Surgeon, Tampa General Hospital, Tampa, Florida
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welcome friends and colleagues to today's webinar. I will act a little bit as moderator. I am a professor of medicine at the main clinic and I play with echo a lot and with intra echo a lot and have a particular interest in bicuspid aortic valve and younger patients with aortic valve disease as well as a utopia. These and also joining me today is dr Kathryn Harrington who's from Baylor Scott and White, the heart hospital cardiothoracic surgery. She is in fact the medical director of inpatient outpatient Tavern service. So um we love Tavern here and also with us today is dr errol belly from Tampa General Hospital. Cardiothoracic surgery is an assistant professor of surgery at the University of South florida and co director of the aortic surgery program. And he's also just like dr Harrington, a surgeon dedicated and with that special expertise in aortic valve and the aorta. So let's get on to business the promise of bio prosthesis. And is it really real. And before we do that we are going to have a pauline question here. So let's bring that up. This is a very important question for today regarding mechanical and biological prosthesis in the perfect position. The following is true biologic prosthesis experience less thrombosis than mechanical ones. Mechanical prosthesis incur more infective endocarditis than biologicals. Mechanical prosthesis have shown survival advantage over biological ones. Biologic prosthesis have shown survival advantage over mechanical ones and we want to take a vote. There's only one that's correct. Okay, so 80% say that mechanical processes have shown a surgical advantage over biological ones and that answer is the correct one. So I'm going to close this and just grab this again and just let you know that evidently this is a sponsored webinar. But You have three physicians um academicians here who are only looking for the truth and have no monetary interest on on on big companies. So clearly the ideal prosthetic valve has no implant risks, no one take regulation doesn't deteriorate, has no clotting and no infective endocarditis. Unfortunately, that the ideal prosthesis does not exist yet. And prosthetic valves really are substituting one disease for less for a lesser disease, but a mechanical valve maybe the prosthesis that has, that offers the lesser disease in the appropriate patient. A few facts in the Tavern area, increasing popularity of bio prosthesis among physicians patients don't want to take and we could have a whole talk about this but misunderstand some facts about warfarin industry suggests better durability of third generation bio prosthesis. And we have accepted valve in valve have as a general long term solution for our patients with aortic valve disease. Moreover, the partner three trials showed a better initial outcomes with Tavern for low risk patients. But just that just takes me to something very interesting that I have that I saw in this um um article in Jama in interventions. And I also saw recently at the Hard Rock Society conference discussions on how to treat a young person throughout their life with by people with severe by a prosthesis or tavern. And although they recognize that Tavern has never been systematically tested in young, low risk patients and that there are unanswered questions regarding safety and effectiveness in patients with bicuspid valves and future coronary access, durability etcetera. They come up with this paper and they do a theoretical um um treaty on treatment of the lifetime of a young patient with bio prosthetic valve, surgical and tavern. So they go suburban Tavern, Tavern, Tavern, Tavern, Tavern Tower, Tower Tower. And apparently the one that is that is that is like the most is to do a Tavern first and then a savage and then and then a tavern but nowhere to be seen our mechanical paths. And that is to me a little bit worrisome when we're talking about younger patients. And it just reminds me of Mark Twain saying it ain't what you don't know that gets you in trouble. It's what you know for sure. That just ain't. So that will get you in trouble. So I just give you an example here of a 23 year old female stars. Post bio prosthetic nvR showing Three year after three years thrombosis of the valve. Same case here with the 56 year old two years status. Post a VR showing significant thrombosis. Well it turns out some colleagues of mine here identified um um by a prosthetic valve thrombosis in our institution and they were able to plot the rate of degeneration of bicuspid of bio bio prosthesis and the rate of thrombosis. And as you can see the rate of thrombosis goes all along And can happen late even 5, 10 years after the aortic valve has been placed. Something very, very interesting interesting. They were able to estimate The incidents of bio prosthetic thrombosis and in the erotic position. That was about 8.6 or so. And if you look at the current guidelines, you will see that the risk of thrombosis, trombone embolism with the mechanical bow Is about the same. It's 0.53 or so. So of course that has to lead me to look a little further and um very appreciative of the of the tremendous transparency and and seriousness with which partner trial has behaved. Once they found that there was a possibility of having a let's go back the possibility of having a subclinical leaflet thrombosis. They immediately came out with it. And don't get me wrong, I love Tavern and Dr Harrington is the director of Tavern at her institution. In fact, I think that the two biggest um um miracles in cardiology, our heart transplant and Tower. So Precisely the outcomes. Two years after that partner three trial in low surgical risk showed that the initial differences in death and stroke. Favorite Tavern were diminished and patients who underwent ever had had increased evidence of thrombosis. As you can see here, the death of disabling stroke starts increasing in the Tavern patients. Well, it remains constant in the surgical patients and there are um structural statistically significant differences because of that. So it is very important for us to know that no study has shown superiority of bio prosthesis versus mechanical valves in the aortic position. A lot of studies have shown that they are about the same or that their superiority in survival of mechanical prosthesis. And I just want to show you the two most important randomized trials which are old but are the largest. There is a third one italian randomized that we will not discuss. This is the famous V. A study which was randomized and found evidently no difference in trumbull embolism or endocarditis versus bio prosthesis Or mechanical valves. And you can see they studied mostly patients between 50 and 70 years And their last report was in jack in 2000 showing of course more bleeding with mechanical prosthesis and more death with bio prosthesis. This is a randomized trial. They also found that of course there was more valve degeneration in bio prosthesis and that this occurred much faster in patients less than 65 years old. The other important randomized trials was the European trial, Which again showed no difference in trauma embolism or endocarditis. And the last publication was in heart in 2003 and it showed that the combination of death of re operation was better with mechanical a VR. Therefore strong symbolism and endocarditis are the same between bio prosthesis and mechanical valves. There's no difference. There are a couple of other studies I want to show you. These are not randomized, but these are a observational studies. There are very large studies which have been propensity matched To try to equate prognosis in patients. And this particular study in patients 50 to 70 years showed no difference in survival between mechanical and bio prosthesis and again, no difference in stroke either between both of those. And of course the main difference between them, which is higher re operation in bio and higher bleeding in mechanical. This is another important um are observational study of 142 hospitals in California that actually made it to the New England Journal of Medicine. Again, with significant adjustment for prognosis so that patients could be compared. And it showed very clearly that in patients 45-55 years old by biological valves were associated with worse probability of death. Therefore, a survival benefit for mechanical valves And that stopped being significant in patients above 55 years old. In this particular study. Very importantly, they found also that the acceleration of the generation of bio prosthesis increases in patients that are less than 60 years old. And finally, this is a study from Sweden which is again an observational study, european heart Journal propensity matched Showing between 50 and 70 years. A clear survival benefit of mechanical valves over biological valves and again the same risk of stroke. Major bleeding. More mechanical and Re operation more in biological. So it seems that survival is better in mechanical if we are at least up to 60 years old and and below that of course with same from vandalism and endocarditis rates as compared to bio prosthesis. So the recurrent theme is bio prosthesis degenerates and mechanical bleeds. So so can we stop the degeneration of bio prosthesis? And can we stop or decrease the mechanical bleed? And in that regard there is a little bit of hope with the onyx valve which is currently a class to be indication to be used in the aortic position with a lower I Nr Of 1.5- two. I personally do 1.8- two. Um and it's based on a randomized trial with home monitoring I NR which follow up of 3.8 years published in JT CVS by dr puskas in 2000 and 14 showing higher bleeding in patients with full dose warfarin and lower bleeding in patients with 1.5 to 2 and no significant increase in Trumbo embolism. This study had further follow up to five years and was published in Jack in 2018 with the same result. Let me just um show you another important polling question if we can pull it up there because this one is even more interesting than the previous one. And this one we will save for the end to discuss with all of us. A 52 year old woman presents with severe bicuspid aortic valve stenosis With a route of 39 mm ascending Aorta of 43 mm. What is the best long term approach for this patient? Suburban with the biological valve and then valve in valve Taverner. Later he's 52 Sabir with mechanical plus minus aorta repaired. Her ascending Aorta measures 43 mm ross procedure, suburb with a biological valve plus minus aorta repair and then valve in valve Tavern later. And we'll hold a vote for that because I wonder what people think. I'm actually very excited to see what people think about this one. And then after that we'll go right onto a very nice case and presentation from a doctor, Kathryn Harrington. So let's see let's see what the what the voting showed interesting Suburb with mechanical valve plus minus I order repair a few rocks procedures. Nobody wants to do something with the biological valve but some may do several with biological plus minus able to repair and Okay. Sounds good. So I will leave you with dr Harrington. Okay. All right, well thank you to our table and for having me and thank you dr Mitchell anna for that introduction and presentation. Alright, this is my case report. So this is a 75 year old with severe symptomatic prosthetic aortic stenosis with a 21 millimeter tissue valve. Okay so he is a 75 year old. He's a tall guy 63 £225. Which gives him a calculated B. S. A. Of 2.3. Actually did this case back in 2020. Just so that we have it relevant for the how long his valves lasted. He has had to surgical aortic valves. He was a bicuspid at a younger age. He had a sabot in 1983 and then a sabbath in 2003. So he got a pretty good lifespan out of both 20 years and then 17 years. His most recent Sabra was a 21 millimeter Edwards magnet magnet. And he did have a root enlargement at that time. He now has um severe prosthetic aortic stenosis on his echo and class two symptoms. If you calculate his sts his risk of mortality is 3.5 and he has 04 frailty. He's a very um he's still working at 75 gets around just fine. So he presented to our Taber clinic, here's his echo. He had severe prosthetic stenosis and just trace ai his ef was preserved. You can see his gradient there mean at 51 V. Max of 4.66. And here's his ct scan. We do uh 40 cts on all bio prosthetic valves that come back into clinic as dr Mitchell. And I mentioned they do have a um we look for halt the thrombosis at any time. And this shows a no clot, there's no pink on the leaflets, just the yellow calcium. And then the non colored views, you can see two of his leaflets are very calcified and creating the structural ballot deterioration. Here is his Tavern ct measurements. So his 21 magna, the inner diameter there is 19 by 20. His ele bot is uh larger than that at 24 with a perimeter of 79. He has relatively large sinuses at 33 33 33. His coronaries are 12.7 and 6.7 although with a relatively large sinus. So um this brings up a lot of discussion points. What should we tell patients the life of a tissue valves? Is that life different in a surgical valve versus the Taber valve? This patient actually had very good results. He had a lifespan of 20 years with his first surgical prosthesis and then 17 with a second. So he is coming into this discussion of what he should get um with kind of a almost a good bias towards tissue valves. I have some younger patients that come back at eight or 10 years and that will drastically change um what they what they want. And then is this any different Savage versus Tavern? I really don't think we know this yet. We don't have the length of the studies with Tavern. And then what's the risk for a redo a br So most people would say, well this is his third time strain on to me. Um He's high risk. That's that's really not true. And especially a first time reader, a br if you put in the patient's um um you know the risk factors into the sts, it shouldn't raise their risk of of surgery that much. What makes people high risk. Is there other, you know, comorbidities? But just you can't just say just because they're redo their high risk. That's kind of cheating. Um We really need to look at the individual patient risk. And then I think one of the main things we need to look at is the likelihood for patient prosthesis mismatch. He's a large man and he has a 21 millimeter valve. I'm surprised he honestly didn't have it at baseline. Um And we're going to talk about all of those in my talk as well. So what would you guys do for this? Can we put up our poll? So the options would be Taber valve and valve. He has 75. It's a third redo third time astronomy. But he has a 21 valve. Would you do a redo redo with a mechanical valve? Since this is already his third string autonomy. And he has a small root. Would you do a redo or small analyst rather? Would you redo redo with a stent in tissue valve. And then either redo their root enlargement or do a different type of root enlargement or do a redo reduced anatomy and then a stent lys root replacement with either a zen a graft or a home a graph to allow you to get a bigger either way for the same Angeles size. So only 13% want to do a tavern 9% want to do a mechanical valve. 39% want to do a redo with a stinted tissue valves and then 39% want to do a stent lys. So that's a pretty even split. I think all of these are probably reasonable in him. Um Except for maybe the first would be successful but I don't think would last as long. So what we did, So I did do a third time reduced monogamy. And um after I took out his 21 Magna, you could see the old route enlargement cleared up a bunch of panties. The 25 freestyle actually uh slid relatively easily. Um if you note on the Taber Scan, his ele bot was much larger than a 21. So um I was able to get a good size step. Listen, um even without doing any additional enlargements and he did find from this and he was discharged on post update six to home without any complications. And here is his post op echo um from his T. E. This isn't dropping being graded of nine. Um He's still pretty revved up from coming off pump. I think this would decrease with time but certainly I think a good result for um you know a pretty tall man with a large B. S. A. Now we're gonna talk and here's a cT scan. This is what the stimulus route looks like, you can tell it's almost indistinguishable from a native route. Whenever I do these stainless roots as well, I try to move the coronary buttons up slightly. Um And so that that um you know, his left main was somewhat low at 6.7 on the preoperative cT scan. So the stateless route will one give them a larger E. O. A. For right now. And then I moved the coronary buttons up a little bit as well. Um And that will set them up for the next valve in valve Taber at this point will have a larger analyst and higher coronaries at less risk for obstruction here and now we're gonna go into my talk. So here's the actual talk appropriate patient selection for either reduce sava or valve in valve tower. This is what I look at when I evaluate patients in the aortic clinic, which one they would be better served with. Um this is a very nice flow sheet from the recent 2028-8 guidelines for any patient with prosthetic valve deterioration uh split up into stenosis on the left or regurgitation on the right. So for stenosis on the left, they recommend obviously an echo for all valve types. Um And then if it's a mechanical valve flora skopje or 40 CT is good to assure that the mechanical leaflets are moving fully. Um That can often be a cause of stenosis is one of the leaflets getting stuck. And then um for bio prosthetic valves as mentioned before we do like to get the 40 Ct to look for that halter um leaflet thrombosis for valve regurgitation. Um I think it's more important to get A. T. E. Because obviously determining whether the leak is intra valvular or parable. That is very important for what thing you would use. So first day notice on the left if it's severe and symptomatic obviously if it's a mechanical valve you're not going to have for that you'd have to go to surgical intervention. Um But we would check and make sure if it's a leaflet movement issue or a um panties underneath issue. Even if it's a if it's a leaflet movement issue even if it is um pretty longstanding. Um We do do a trial of T. P. A. There's an excellent paper protocol from that from New England Journal of Medicine a while ago. And then if it's a bio prosthetic valve then obviously you're looking at um either surgery or Taber valve in valve and the current guidelines say that if they are high risk or prohibitive then Taber valve in valve is a two way indication. But if they are not high risk of their low or intermediate then surgical intervention is recommended for valve regurgitation um either you're looking for him analysis Uh Mostly with a pair of value? Legal heart failure. And then again, um if it is higher prohibitive risk, yes, they can go to either Taverner or para valvular or leak plug. But if they're not high then uh surgical intervention is still the class one indication. So how do you determine if they're high or not? So these are the things that I look at. So obviously you calculate your sts prom. Currently, the tavern valve in valve is only approved for higher prohibitive risk. So if you do a valve in valve than someone who's intermediate or low risk, um it's not following the guidelines, but also most of you will not get paid by Medicare. Um And then you don't just look at the patient's surgical risk. I also look at their technical risk and we'll talk about that in a second things I look at in the ct scam. Then the other thing I would look at is obviously their prior surgical valve prosthesis size. This is very important for valve and valve determining their risk for patient prosthesis, mismatch. And then obviously coronary heights, not just for the risk of the acute procedural inclusion, but also ease of later lifetime access to coronaries in younger patients. If you're doing a valve and valve. So this is my second polling question, what size surgical prosthesis is required for a successful valve and valve tapper. What do you guys think? Either 21 a 23 or 25. I didn't even put 19 or 27 because I think going for the realm of possibility here. What's the smallest size that it could be successful in? Okay, so what people put, okay, so 18% think 21 23, sorry, 43% to 23 and 39% to 25. That's a good split. I'm excited to talk about that more. Okay, so looking at why it's only approved. Here's the data behind it. So uh the valve in valve tower is mostly the indications and the FDA approval is derived from the partner to valve in valve. Uh It's a nested registry. So this was not randomized data unlike most a partner. Um And it was only in high risk patients. Um per their recommendations. It was associated with relatively low mortality, improved human dynamics and excellent functional and quality of life outcomes. Ah The industry data from vivid. So the vivid valve valve registry is a is a a large registry and they showed that uh this is the capital Myers survivor curve eight years. So 38% relatively good. Long term survival if you look at the surgical or the Adjusted population size. But that people definitely do better with large bio prosthesis which for them was 23 and above versus small. Um so the survival is higher um in large bio prosthesis compared to small. This is another meta analysis. Looking at every um paper that has looked at surgery versus Taber. So not truly getting it randomized but a meta analysis to get to it basically procedural mortality here is equivalent between Tavern and uh valve in valve Tavern reduce a 30 day also equivalent. But if you look at the longest follow up that each study has there is a Which is around 18 months on average for this paper there is a trend towards better mortality with reduced Sabir. And then this is the echocardiogram offic outcomes. This is the mean gradient of the valve Valve in Valve Tavern vs Sabra. And this is the percentage of valves greater than 20 millimeter Um gradients of that favorites average. So basically short term procedural and 30 days the same as it gets into longer term in favor Sabra. And then the echocardiogram thick data also favors Sabir. So that led to the statement on the first thing we saw the 2020 thing that although valve and valve um trans catheter valve in valve appears to be safe and feasible alternative to reduce aber who are inoperable at high risk repeats average should raise the standard of care, particularly in low risk patients. So when I look at patients who are not just their sts prom but their technical surgical risk things that I use are obviously the cT scan is the most important thing for me. Basic stuff like prior coronary bypass grafts under sternum obviously if they're lima is running on the midline, if they have a right graft or remote across the midline, but other things that I really like to look at our, if they've had a prior cabbage where their vein proximal to take off because we have to make an air autonomy here and that can be somewhat um um tricky and also the calcification of the aorta or route, if they have had a prior stainless route with either a freestyle or home a graft, these can be technically more challenging. Redus So this is a ct scan, what I'm talking about about the vein grafts. So this person on the left would be a relatively easy redo uh sabbath. For me, this is where we make our air autonomy here, about one centimeter above the native right coronary. You can see their van graphs. First of all, they don't have a right van graft, um but their van graphs that they do have are high up and gives me plenty of room to do an air autonomy and get in and take the sabah out and put a new one in this one obviously has lots of proximal for proximal, but also the right band graft is is quite low down, it would be not undoable, but a little bit of a challenge to free up this vein graft and doing their autonomy. Um you know, sometimes you even have to sacrifice this brand graft and put a new one, it adds to the technical complexity of the case. So these are things that I look at to how to get in. And then these are some examples of stateless graphs. This one on the left here, I can tell you how to home a graph without even knowing their history. The route is completely calcified, that's what they tend to do. Um And this would be technically challenging. You could consider this a high risk surgery, but any calcium doesn't necessarily make it high risk. If you look at this one on the right, all I really care about is my buttons. So you need to cut out the coronary buttons for a full root. This patient, I could probably get these buttons off, there's a rim of tissue around both the left and right coronary. Um and you could re implant that even with this calcium on the non, you don't really need to touch this area. So um you know, there are specific areas that you care about more than others. The next thing that we care about is obviously prior surgical valve prosthesis. That's the poll that we just had and that takes into account patient prosthesis, mismatch because most of us know patient prosthesis mismatches. Just the effective orifice area of the valve divided by the patient's body surface area, moderate PPM is between 0.852 point 65 and then severe is below 650.65 most literature has shown that moderate essentially does not affect your mortality or your readmission for heart failure but severe does this is a very interesting paper from 2000 and 18. This is basically the sts database from 2004 to 2014. There were 60,000 patients under, sorry, over 65 who underwent a br and this is the distribution of valves that got put in. You'll see um mostly 21 20 three's some nineteens and then 7 25 this is the percentage of PPM per valve size. Um You can see you have some nineteen's that didn't have any PPM because they were put in you know an appropriately sized patient. But obviously the 19th had a higher risk of severe PPM 20 one's about 40% of them had severe, about around 40 had moderate and about 20 had none. The 20 three's only 20 had severe 35, moderate and 35 none. And then as we get into the 25, obviously the risk of severe, moderate goes away interesting, 96% were bio prosthetic over 65. Not surprising, 33% were 21 millimeter valves and 34% were 23 millimeter valves. So 70% of the valves that were implanted in the last 10 years are going to be 21 23. So this is going to be really important for all of us seeing these patients in clinic coming up, Only 3.2 of these underwent root enlargement. I think those data are changing now surgeons we've been You know um kind of uh Taber has nipping at our heels and I think we're doing higher rates of re enlargement to help set better up for for tavern in the future. But this is the data from 2004 to 2014. So this is also looking at PPM and Tavern. Tavern PPM happens in Taber too. So about 24% have moderate and 12% have severe and this shows similar to surgical data that um severe is associated with um worsened mortality but moderate is the same as none. One of the main risk factors for ppm and tavern is a valve in valve procedure. Not surprisingly, it's the Russian doll effect. We're just putting a smaller running out of room as we stack more things inside. And the hazard for that was about 2.7 in this tv t paper. So this is same was found in the vivid valve and valve registry, moderate PPM occurred in 36% and severe PPM in 25%. So of the valve and valve registry almost 60% had some degree of patient prosthesis mismatched. Although as we've shown really the severe 25% has an effect on mortality. 28% of all patients had a gradient greater than 20. And obviously risk factors for PPM would be a higher B. M. I. A higher initial gradient, implantation and extended surgical valve and use of an inter annular valve. PpM did not have an effect on short term outcomes or survival at one year in this registry. This is a handy chart. We've seen a lot of these in some of the apps that exist. Um So this is very important for valve in valve. So the label size of the valve is where we so into the cuff to the analyst. But the true I. D. Here. Uh This is the fab or not the tissue which they so to it the true idea of the valve which you can put the Tavern or the flow I. D. Is here. So for a 21 magna the true ideas 19 for the older generation paramount also 19 mosaic 21 to 16.5. Um and then Annapolis and a trifecta here, 18 and 19. Even if you look at a 23 and 25 we're still looking at anywhere between 21 23 23 18. You know, none of these would really even take a 26 valve. Um You know probably we're looking at a 23 valve and valve Taber for all of our um valves 21 through 25. So um I think these numbers shocked people a little bit but um this is what we really need to think about when we're talking about valve and valve Tavern what valves were putting in. Um Before then surgically. I think this matters not just for PPM but also for leaflet thrombosis. Um this valve, this is the fear of the vivid study showed increased risk of thrombosis with valve in valve especially if they're under expanded. So if you put in a 23 valve and a 21 analysts and you don't expand it fully, their rates of halt are increased and then you have to put these people on oral intake regulation. But if you're putting these people on oral and regulation for the rest of your life, you're essentially losing the benefit of the tissue felt that dr Mitchell Lena talked about. They could have just gotten a mechanical valve earlier on. And then the last thing that I look at is the coronary heights. So obviously you care about the risk of acute procedural inclusion but also lifetime access later to the coronaries. There is an excellent paper by Dr Webb's group up in Vancouver for if you're going to do valve in valve tava. You should read this paper and this goes through all the steps of evaluating and a valve and valve. What you should be looking for. Obviously things that increase the risk of occlusion are low lying coronary ostia, a neuroscientist tubular junction, small sinus Isabel salva. Um And then if the valve has a highly flat profile and an internal stent frame like the metro florentine afecta bulky leaflets and then the trans catheter valve, how high the ceiling cuff is and if you implant it higher, obviously you have a higher risk of blocking off the coronaries. They have some lovely drawings here, how it matters, not just where the valve is, but how the valve is canted in the annual is here and what this has led to is most of us now do this Vtc virtual taverna coronary distance. So these are your Tabar Ricans. You take the tip of the bio prosthetic leaflets and you draw the proposed circle of whatever valve that you are planning on putting inside of it. And then you measure your virtual tavern to coronary distance hype. This one is only two. This one is nine. Um Basically they found that less than three is a higher risk for inclusion. 3-6 is intermediate risk and greater than six is low risk. I personally use five as my cut off for intermediate to low but it varies amongst papers definitely under three would be considered high risk. This is during the procedure itself, but also you need to worry about cardiologists getting in later to the coronaries to um So in summary, I would say reduce severity in patients is still recommended for people who are lower intermediate surgical risk being just to redo doesn't automatically make you high risk Tavern valve and valve and high risk or surgical prohibitive prohibitive risk if they are a good an atomic candidate for Tavern, reduce Tavern should be done in patients with low coronary arteries or low vtc distance. If they are high risk or prohibitive, you can still do coronary protection maneuvers um in the valve and valve like snorkeling or basilica, which is beyond the scope of this talk. And then for valve sized reduce sovereign patients with a high risk of PPM. I would say surgical valve size less than 23 or 21 probably depending on the patient's sex B. S. A. And life expectancy. And then um if these people are prohibitive surgical risk, you can do fracking or high super annular replacement. But um this fracking or breaking the valve ring or putting the valve higher um will increase your risk for coronary inclusion and increase your difficulty and later coronary access. So those are this is my kind of flow sheet for how I would look at a patient and I believe that is the end of my talk. Alright, well, thank you so much Catherine. That was fantastic in in showing us just like the cars, the mirrors of the car. Say objects in mirror are closer than they appear. Things, things things in your business and in the aortic valve are smaller than they appear. And I just wanted to take a moment to ask a both. Um um Meryl and Katharine a couple of questions. So, so given all this information, patients looking for suburb should undergo all of them city because you you have to some degree start planning for a potential valve involved, correct me if I'm wrong. Yes I would agree. All my surgical patients get a tavern ct with their full root measurements and if someone has A 19 annual is I'm not even gonna offer them a tissue valve. If they're younger you know I would push them more towards a mechanical valve because there's no way you're gonna be able to stack two or three valves and they're if they're they're young um it'll rule out certain pathways that it helps kind of guide the discussion for me. No I agree. The same same goes for us that you know C. T. You need to we need to be thinking of the secondary operations later in life for 20 years down the road what the next operation is. So you have to think backwards a little bit. Whereas before we just wouldn't put a bio prosthetic or mechanical valve and we have the plan 20 years down the road for each patient. And the other thing is well then people that have smaller ele bot s. Or that you can predict that we'll have patient prosthesis mismatch. You have to then then we need a new generation of adult cardiac surgeons that know very well and are very proficient in in performing a ele bot enlargement. Yeah I agree. I think that's why probably this webinar you know you guys invited to aortic surgeons here because I think we probably face most of the redo operations, you know in the dissection practices and redo roots and we're more comfortable with the enlargement. But no it's definitely gonna be hurt us with the training future cardiac surgeons and the and the and the procedure that you guys use for this enlargement is at the at the back at the close to the to the non coronary task or or or do you go as far as using cano procedures and that kind of stuff? Um I mean yeah but when I to the posterior there's two types of post here. One is the knicks or the Nunez. Um I do that if I just need one valve size up and then um if you do a full Manoukian which is a double patch procedure that will get you two or three. Um so it depends on how much you have to enlarge. So I just need to go from 21 to 23 or do I really need to go from like a 19 to a 25? Um I would say I only used the Kano as um in someone who's already had a kind of a failed posterior like where you know that's a true more adult congenital um Use most of the time with a root enlargement and like a stainless route, like a freestyle or home a graph and you're able to get a good gradient. Um The Kano is I I probably only use that in like true congenital adult congenital who had prior surgeries as a child? Like general bicuspid. So so so patients that are looking for Sabra should should have a C. T. I would I would I would I would agree that 100%. And and do you agree with me that these patients potentially if particularly if they have a smaller L. V. O. T. S should be managed by centers where there are specialists that can do a root you know root enlargement or any any cardiovascular surgeon can do that. Well I think I think any cardiac surgeon comprises is probably facile with with the state of root enlargements and um you know my go to is the Manoukian and I think that most surgeons could can do that. Um You'll probably find that the bigger larger centers were more cognizant of this and with the valve sizing. When we are implanting those bio prosthetics. Um trying to get those 20 threes and above in um with with enlargements than probably the community. But I think the community community guys are quite good at it. Yeah I think I think it's it's it's very important for for for our audience to know that there's literature out there just as dr Harrington suggested that a treatment of patients with bio prosthetic thrombosis with anti coagulation in many cases resolves the problem. So so that should be given a try first before going to surgery now. How do you differentiate thrombosis versus degeneration in in one of these valves. What how how do you guys do it at at your center era? Well I wouldn't claim to be the the expert of that. You know we have a full valvular team with the imaging cardiologist from C. T. And M. R. I. Proficient guys to to the echocardiography vers uh and we look at all the studies together and and kind of come up with a with an opinion on which one we think it is. Do you think? I think I think that's that's that's a very that's a very good good response because it is it is indeed a team you know the way we do it here is either by sea by by by C. T. Or T. E. And I think that both are good enough if they are properly employed and and if if the person who's who's doing it, understand what they're doing but before we go to to to eros presentation um I want to ask you guys a couple of things. So I think you guys are younger than me. So so when I see patients and I and I recommend um you know of this valve or the other relevant so on and so forth. I always do a final exercise which is to say if I were their age what would I choose? You know or if I'm their age you know I will tell him listen if I were you with my experience, you know, knowing that you and I have the same age, you know, I would go for this, you know if I may and respectfully what would you guys choose right now for yourselves? If you needed an aortic valve replacement? First analysis ross. Yeah, I'd probably do a mechanical just avoid any re operation that you know the lowest chance of re operation, you see. That's very interesting. So ross and a mechanical interested ross with a mechanical backup. Okay, okay, well that sounds very cool. So that so that leads me to um dr belly dr bailey, welcome and take it away. Alright. So I think thanks for having me again and I'll show you everything that these guys told you probably what you shouldn't do and I'll show you what happens when when you do that. So the case we have for today it is a 51 year old female who presents with uh tabby uh consultation. And I think now they're trying to tell us we should uh start changing Taber back to tabby because it is a trans catheter valve implantation and not technically a replacement, but she presented um to our center and she had a previous cabbage with a lima L. A. D. And a vein graft to ramos and and a VR with a 21 millimeter magnum, pericardial valve. And this was followed Following what she said in 2017 was a motor vehicle accident that she had reportedly left main dissection. Um She wasn't a very good historian, she couldn't remember. She just said that she was in the hospital for about two months, woke up And they told her that she had had a bowel replacement and had two bypasses. So she presented to her cardiologist with complaints of Disney on exertion with mild activity precinct api with strenuous exercise. She she was trying to wanted to be a bodybuilder. Uh And so when she would work out she said she would almost get presentable. And there was some concern for patient prosthesis, mismatch Or prosthetics stenosis. Herbie essay was too and she was a 75 kg female. So she got a trans thoracic screening but that you know with these bio prosthetic valves they always, you know, we go for better imaging with the trans esophageal echo and that showed moderate to severe Doppler gradients across their valves. Uh And they thought it was either like I said, patient prosthesis mismatch or cyanosis. But no regurgitation For index valved areas or their index valve area uh was 0.41. And the mean gradient was 27 with a peak gradient of 54. And there's a snapshot. So this is the actual T. E. E. And you know we're looking one for you know leaflet motion making sure those leaflets you know are moving that this you know are we thinking PPM or uh you know valved generation and they appear to be moving. She had a preoperative calf with great looking left and right coronaries great looking vein graft there to the ramos and then beautiful lima to lady. And so at this point I wanted to ask you guys what he you know as a um audience polling question, do you offer this patient valve in valve vitality, reduce Sabir or continued surveillance so that the lady has a 21 millimeter magnet, pear cardio valve, previous two vessel cabbage. She's 51 with Disney on exertion and elevated moderate to severe gradients across her bow. Is it valve in valve tabby, reduce average or continued surveillance. See hopefully you guys listen to the last of the previous two talks and we all get it correct. All right. So 93% said reduce Sabur 72 of you said continued surveillance. I'll show you what we and by we I won't say me say what my partners and actually team chose. So they actually chose to do tab and review uh sorry valve and valve tavern. So they decided on a 23 millimeter evolution core valve and to do true balloon fracture of this 21 millimeter valve. So post deployment the peak to peak gradient was 22. And then they did a post irritation with a 22 millimeter troop Lynn And high pressure cracking and they said the gradient dropped to five per the operative report in both operative notes described the audible fracture that was heard with the balloon going up. And we can actually look at the video of the procedure. That upper right one is then placing the tavern valve valve inside the 21. This is us doing some just location and then finally focus on this balloon. I don't see a lot of waste there in it. There is some but on the um when the balloon goes up there was not a lot of waste. But that was where they said they heard the audible fracture. And so the inter operative T. Wasn't available. You know every valve and valve that has to be fractured. You know these patients are done under general anesthetic and under t guidance. But the cardiology notes state that the mean gradient was down to five and the CT surgeon says the mean gradient was only 14. So when I was reviewing this, you know, I didn't know you know what what's right but what can't lie is the post op day one echocardiogram that we do before the patients are discharged. And that was the show that 23 millimeter core valve was implanted with no significant regurgitation. However, the mean gradient was 29 was 56. So much higher and much more elevated than any of the operative notes say. Um and higher than we'd expect. So she was actually discharged from the hospital and sent back to her referring cardiologist who followed her but she had continued symptoms of more dizziness actually even sent the cardiac rehab with no improvement. And so they did a three month post op tavern trans thoracic echo. And that now showed that the trans valvular velocity was 3.8 m per second. The D. V. I. Was 03 and the indexed D. O. A. Was 0.45 suggested a severe PPM. And so at that point I received a phone call from her interventional cardiologist and her referring cardiologist with this sitting on my desk and it's like you know you're staring at the snake, the pit vipers there there's something wrong when they both call you and say hey we got a problem so that I took over this case and I get you know enter the second opinion. So we evaluate all that data we just saw and the plan was we removed both valves in place and onyx mechanical a VR under moderate hypothermia in case the left internal mammary already was unable to be dissected free and clamp for the rest of the heart. And we'd also removed or to breed any panis found. And also do a root enlargement if needed. Which was was highly likely. And by that you know having a modern technology we actually have the photos and this first photo that's the inter operative uh photo of when I've done the aorta sodomy and you can actually see what's done right. I did it right at the top of the medtronic core valve and I put a lot of ice on this heart and there's a lot of ice in the picture. And that's because you know, Mike Reardon over at Houston Methodist wrote a really good article on how to remove these uh catheter valves, which I suggest you all, you know, read because as it will become more and more common in the future. But because this is a night and all stint, we can put a lot of ice and ice slush onto that to try and get it to the stent frame to compress down. And then you take that pin field, dissect er and kind of dissect the valve frame off the aorta, trying not to injure the aorta as much as possible. But there is definitely an inflammatory reaction that we see in the uh you know where the valve is implanted, it's much more thick than I would expect. And another trick to get these out if they're really stuck is to put a purse string suture through the frame and cinch it down and kind of get that valve to, to decrease in size so that you can remove it easier. So this is the what the bow looks like after we've taken that pin field, taking all the the tissue off and removed it completely. And that's the surgical bio prosthesis that was implanted previously next to the trans catheter about. So I wanted to look a little closer at this valve And when I looked at this valve, something I noticed one, there was this valve had a lot of the panda's room that was around the edge. Just because we've got one to get a clear, you know, pictures of this, but it's kind of oblong shaped oval, not circular in in shape. And so when I this is just another tab about. When you flip it over and take a look at it, this is showing that pianist, that's something that was really important to me to look for at that time. So you can see i if I'm not mistaken, this is more, you know, a little oval. But what's important is it's not fractured. So we took this valve apart and looked at this frame and wanted to make sure, you know, if they had actually fractured this valve. If we're doing the things that you say that to patients or or promise them when we're doing, when we try to do these off label valve in valve towers, you know, should we should have a result. But but there was no result here. Um And so here you can see that ring is still complete all the way around and more. It's just it's almost been bent a little bit more than fractured. And so with this patient, you know, we were able to we we looked at her B. S. A. And we can look at the ceo a chart of the onyx mechanical valve in any on any of my valves in the O. R. With the sets. We carry these charts laminated with them so we can you know focus on it. We're we're very cognizant of you know we want to make sure we don't have any patient prosthesis mismatch. And with the Bs 82 we were actually quite confident we could get out of 21 on its very easily without even having to do a root enlargement. Although being prepared to do that is something that you'll you know you'll frequently find um the interop. T. E. Showed the mean gradient down to eight now one year post op and all her signs and symptoms have resolved. She's back to exercising. She's actually you know text us the other day told us she's going to enter a competition with no symptoms. So you know it's successful I guess rescue from a failed valve operation. And I think with that we're getting pretty close to time. But I have any questions. Harold what was what was the what was the diagnosis of that bio prosthesis going into surgery? Was it panis was it patient prosthesis mismatch? Was it degeneration? It was hard to tell they were between pandas and patient prosthesis mismatch. And I you know I you know just for the sake of this I only pulled you know one of the studies I think she's had actually two T. E. S. And um the the things that were guiding us mainly where the it was symptomatic. They thought symptomatic moderate to severe PPM. And I think probably because she exercised so hard and was so active that that was probably um what what pushed her over the edge. But it's quite you know this is my own program. You know I will show our own failures and our own things and you know there's not just one surgeon in our program. You know there's multiple people that make these decisions. You know it starts with I think you know with the referring guys and the images you guys talking to these patients about setting them up for the next operation that they're going to have any comments. Kathryn. No I would just comment. I have you know these I mean that's another kind of misconception with antique regulation. You know I have people come in oh I lift weights. I can't be on a blood thinner like I mean there's no reason why like she's a you know bodybuilder weightlifter like that that's fine with with with you know Cumin and her warfare and you know it's not a contact sport. People assume any sort of activity or like I'm really active so I can't be on a blood thinner. So I have to combat that a lot as well when I talk to younger patients about um you know what kind of valve that they want they just need to know. You know they're actually guidelines for that. You know, what's considered a high risk activity with cumin, you know, obviously I'm from texas, so I tell them they have to stop rodeo um and you know, contact football, but that's really, you know, stuff like basketball even is considered a moderate risk activity. So, um, and obviously weightlifting, I would consider low, so stuff like that is important to talk to patients about, about their misconceptions about Sabra or sorry, sir, my chemical versus bio prosthetic. Absolutely. And that and that takes me to the final question that we were going to repeat. I think we have a very good audience that has stayed till the end. So they deserve to have that question and to hear what what what our colleagues have to say. So. So, so let's go back to my slides. So who so who would you want to do your ross Catherine? I'm just kidding. I have an answer to that, but I'm not going to say I didn't want this morning, can I do it on myself. There you go. So let me see, let me go back here for a second. And just and just and just say a couple of things, you know, It seems to me and I want that both both of my surgical colleagues of opinions that possibly the future in younger patients in particular say less than 60 years old. It's either a mechanical valve with with with another, a better tolerated, a better proposition of anti coagulation. Like for example a could could be you don't need monitoring. You have more stable anti population, you actually have less bleeding than Coumadin with this or a ross procedure. And then the reason the reason I say those two things is so so currently there is a randomized trial. It's called the pro at 10 10 a trial which is randomizing 1000 patients to a pixel von B. I. D. five mg and continued war faring with the goal of 2 to 3. And these are patients who have had onyx aortic valves in the arctic position and our three months post surgery, more than 600 patients have been have been randomized. I am I am I am copy I together with DR Pochettino here in my in my institution and you have there the primary endpoint and secondary endpoint. Um And so far it's looking quite good and There will be possibly results for 2024. And I think this would be a change a changer for for for addressing these issues of anti coagulation in patients with with mechanical valves that are that are younger. And then finally I want to bring this up this jury attention because this is not the only article up there. It is the most recent one but there are several articles pointing to the same facts that apparently the ross procedure is offering a significant advantages, particularly for young patients. Um They um Dr al Haymon Z from Mount Sinai did this landmark study that included adults needing isolated a VR younger and they did a propensity matching. This was not randomized between ross biological and mechanical, you know, I think in my dreams that there should be a randomized trial for young patients and bicuspid aortic valve patients between these three. But in any case they got over 400 patients 12.5 years. I mean, follow up and they found um a a significant benefit in a long term, 15, 20 years, a significant benefit of the ross procedure. Um And um evident evidently as it's shown here higher mortality with both biological and mechanical valves, even though these patients are young, which which was surprising to me, you know, I mean to to to to kill young people, you have to do a lot of bad things generally, you know. But it's very interesting that they compared the survival of of the ross patients to the general population and it was unchanged, you know. So, so so that is that is a very, very promising thing. And I thought um Donald ross who's who's who who proposed this procedure, who passed away a few years ago, would have been would have been really happy to see this. And I wanted to to see what the what the opinion of of um of Catherine and and errol was, Yeah, I mean I I did a ross this morning, I'm a ross believer enthusiast. Can you, can you briefly explain what ross is? Sure. So for the ross we take out the diseased aortic valve and root and then we take the patient's pulmonary valve and pulmonary artery and what we now call the autographed, transfer it to their route and then we put a generally a human cadaver home a graft in the harmonic position um depending on if their by customers or if they have an aneurysm or not. We're also starting to do what are called supported ross's where we'll place uh either a dacron or pericardial buttresses around it to to try to minimize um future aneurysm awhile dilatation. But I think if if Taber, if Taber and bio prosthetic surgical valves are gonna be equivalent then if we're gonna go to surgery and open someone's chest, we have to offer them something better than a tavern. Um so that would either be, you know, mechanical valve or ross or a a david a valve sparing or some something with a root enlargement. Think putting just a simple stinted valve in that has the same results as a tavern. Um You know why? I think if you're going to open someone's chest now, um now the taverns so successful, we kind of got to make it worth their while Carolyn, Yeah. You gotta have either, you know, survival benefit or or something. Something. Yeah, I know I cross is a great operation and you know, I think young people under 40 and think, you know, it's perfect. I mean in the right hands, right in the right hands, she's under 40. Unless you're Arnold Schwarzenegger, he may disagree. You know, that was a specific issue with that. Yeah. So, so there are failures and and redo ross are also seeing at a work centers and and I've done a few of those uh they're they're they're they're fun. But um no, I think under 40 you know, over 40 and things like that, you know, I gauge how much, what what what's the risk of re operation and and do they want to have anything done, you know, later in life? Um and and if they can tolerate Coumadin and and with the new data coming out, hopefully this proact 10 a it's gonna be a game changer. Yes, certainly. If a patient tells me they never want surgery again, mechanical is definitely the way to go. Um But if they're willing to accept, I don't know for sure, tell them they're going to need re operation with the ross. Um it's not to get out of jail free card, but I hope it will be a little longer than ascended. Just not your aortic valve, your pulmonary valve or something? I like doing both. I like David in the rosses, that's my favorite. Well listen, I think, I think things for the future, look, look look more towards um towards the fact that that we need the specialists in in the aorta management and in aortic valve management. And I think that a lot of centers are starting to have aorta programs which of course include the aortic valve. And not only um one thing that we have not mentioned here, which is which is repair of uh bicuspid aortic valve regurgitation and repair of tricastin, aortic valve regurgitation and we can leave that for another day. But for the time being, I wish to thank my colleagues, hey dr Harrington and dr belly for for for being here and remind you that this webinar will be available on demand in two weeks. Yes, thank you Dr Michelle Lena and thank you to to you and dr Harrington and dr belly um for the engaging wonderful discussion this evening and um thank you all for all the attendees for spending your evening with us. Um I think you know, going over a little time is was well worth the discussion. And um if you do want to watch the webinar on demand, it will be at our website heart valve resources dot com. Thank you all so much