A Real Conversation, About Real Patients: Redo Aortic Valve Replacements
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Good evening everyone. Thank you very much for joining. Uh Tonight we're gonna talk, have a real conversation about real patients. Um Our faculty has presented a couple of great cases for you. We're going to really talk about aortic valve replacement, including redo aortic valve replacements and considerations for that. So I hope you will enjoy the next hour. My name is Tracy Wong. I'm gonna be moderating this discussion. I'm a professor of radiology here at Duke University. Uh let's do some housekeeping things first. So next slide, you guys can go ahead and read that and then let's go on to the next slide. Amy, you want to take us through the housekeeping? Sure. I'm happy to do so. Hey everyone. Good evening. Just so you know, everyone is muted by default. To avoid any interruptions during the program, please feel free to participate in the audience polling and please use the Q. And a function to submit any questions you might have. Our faculty will be responding to your questions and comments within the Q. And a function during and after panel discussions along with your question. Please include your full name, City and country. Thank you very much. The floor is yours dr wang. Thanks. Um you know we intentionally designed this to be a interactive program, especially interactive among our panelists. Um but we look forward to interactions with you all as well, so please feel free to use the Q. And a function. Dr Toronto will be monitoring that function and submit questions. Read out the questions. I'm joined by three colleagues that are excellent. Um and let me have them introduce themselves first vino, would you like to introduce yourself? Yeah. Thanks. Thank you so much Tracy. Um We don't throw him a cardiac surgeon at Piedmont Heart and student Atlanta Georgia. Um and really pleasure to be here tonight. Great, thank you Chris I'm excited to be here tonight. Thanks Cryolife. Thanks Tracy. My name is Chris Melissa rima, cardiac surgeon at Northwestern Memorial Hospital and professor at Northwestern University. Fantastic. And Hector. Yes. Crazy. Thank you very much. Pleasure to be here. Hector Michelin, a professor of medicine at Mayo Clinic, cardiologist and the chair of research for eco and structural heart disease. Great, so looking forward to our discussion here. Let's get right into it. And first I want to thank Chris dr melissa Reform, providing a good chunk of the imaging and case reports here um that we'll be talking about. He provided all three cases and we might have a few extra bonus cases as well. Um So thank you very much. Let's go with our first case. Excuse me. So we've got a 55 year old gentleman here who had a tissue valve implanted 10 years ago was 23 millimeter Edwards valve. Now comes in with moderate to severe aortic stenosis, Not much past medical history. And there's quite a bit of information on this slide. But generally what you see here is that he is considered mostly lower risk for surgery with an sts core of 1.12%. He's uh and then there's some information on frail to here at the bottom right here. That suggests that um he's pretty active and not too frail. B. M. S. 28 crab means 1.0 with the G. F. R. That's nicely intact piece by new york heart association class to some. So when we go ahead and look at some of the basics like his E. K. G. What you see is his in sinus rhythm. He does have a right bundle um For conduction disturbance here. As you can see in the E. K. G. Here. Let's take a look at the echo. Um and you've got the gradients on the right but you can see that the uh as noted on the left the ejection fraction is pretty well preserved. The a. the indexes .48. You've got moderate to severe A. S not much uh aortic regurgitation and uh not much vegetation either. I think Tracy it's it's important to note there that the that the alignment of the cursor with the flow of the aortic valve is not appropriate. And therefore this likely severe aortic stenosis which is which is underestimated. Good point. Thank you. All right after you want to continue and talk a little bit about this. The echo the these Doppler images. Yeah I mean I think I think I think it is important number one to know that he has a preserved LV INN and RV function and uh and also when we have this type of I mean you see the alias in going through the aortic valve which basically clues you in into into into obstruction. But but critical thing with these patients is perhaps to take a look and and make sure that it's not from boast and make sure that it's degenerated and and the best way to do that is either by T. E. Or C. T. Great. Here's the ct pictures chris do you want to chat a little bit about the ct images here? And this is one of our this is a real patient and the ct scans taken for a couple of reasons. The first it would be a re operative a VR. So I'd like to get a ct scan to see anatomy for surgical planning. But for this particular one we're getting a CT scan to see candidacy for tavern valve in valve And a couple of things on this slide. You can see that we know it's a 23 stent, bovine pericardial valve, but with real dimensions there the inner diameter is running 18-19. Yeah, chris I think this is important because, you know, a lot of surgeons, the most common valve put in by surgeons as a 21 valve. It's not really 21 23 is measuring 18 by 1921 is measuring a lot smaller than that. So, I think this is an important thing for people to appreciate By CT really, that there is not really a 23. When you look at the dimensions by CT Scan by the effective Orpheus area, that is good point. You know, the instructions, their reconstructions are pretty good volume rendering. Here's some mips. You can see the posts in relation to the coronary arteries, which which are really important. Um you can see the bulges of the sinuses because there's got to be room for both. The old surgical valve in the new trans catheter aortic valve. That's that's the route we're going to go. Here are some of the heights, especially the left and right corner fights, which you might want to comment on as well. Yeah, this is um Trying to determine what sort of risk of coronary obstruction with valve in valve this patient is going to face. So if you look at the coronary heights, there are eight and 9 mm a little bit lower than we would want. But there's gonna be there's gonna be a next slide I think. Tracy that measures a virtual valve that is in the surgical valve and measuring From that frame to the coronary arteries. And uh with these measurements I think it's a little bit Iffy. Right. You have 5.1 mm to the left coronary artery and 3.3 mm to the right coronary artery. And uh vii note is an expert and tabby of course. Uh you know what sort of numbers you're looking at for these virtual distances from the tabby valve to the coronary arteries. I think this is a very important and these is a little bit on the shy side. I'm looking for a little bit more than that. But what's important is your science of al salva diameter, it's 30.3 millimeters. And so the post is not going to believe this is going to go much past that. So, I think that even though the heights are a little bit on the lower side, I think your science of Al Sabah is actually nice and I'd feel relatively comfortable moving forward with something on this patient if Tavern was the pathway that was being chosen all because of the S. C. O. S. O. V. If the s. o. v. was in the 24 range 25 range, I'd be very concerned about coronary occlusion here. Hector. You agree or what are your thoughts? I agree. Yeah. There's actually a great question from the audience. Why was this procedure 10 years ago? Not a Ross or a mechanical valve? I think this is one that we also debated when we were going over this case before. Yeah, that's a great that's a great question. Yeah. It sounded like this patient had had a strong aversion to orphans and and so preferred a tissue valve at that time. But I think it brings up a good 0.10 years ago, this guy would have been 45, um and confronted with many, many years ahead of him. Bishop valve is probably not the best option uh for for for that patient, given the what we know to be the durability. But let's keep going here. Uh go back one, keep missing this. Okay, so just a quick look at the coronary angiogram, seeing some lumps and bumps as you might expect, but consistent with his age. Nothing really that uh that requires uh cabbage per se. So let's get to our first um whole question and Justin if you could line us up for the whole, I'd love to get a sense from the audience. What do you based on what we've presented so far? And again, this is a guy with severe as he's 55 he's sort of bio prosthetic valve. 23 with the dimensions now that you're seeing on um uh echo and ct imaging. What would you do next for this gentleman? Would you do a transaction for a br Calvin bell? Would you take the guy to the O. R. Redo his valve with the bio prosthetic belt? Or redo his belt with a mechanical valve? Or think about a br with homa craft. Here there you go. C61% of folks, we've got um quite a few respondents. So 61% of folks would prefer to do a redo surgery with a mechanical valve. And then the second choice was reduced surgery with a bio prosthetic fouls And then 9% thought about doing trance capital valve themselves. Let's open this up to our panelists. What do people think? I personally think and dealing with bicuspid aortic valve and knowing that bicuspid aortic valve is so prevalent that that we have to be very clear in our shared decision making with the patients. Yes. It has to be a bidirectional communication with our patients. But but we also have the responsibility of Showing our patients what the data is and making sure that they can make a well informed decision. That is based not just on on on fallacies and opinions but that is based on data. So I think this guy at 45 years old when he had his first problem, he was done at this service basically he's now again for for the same problem and we have an opportunity to do a service for him. So I have a question for you Hector and also chris What when you see somebody like this, when you put a tissue valve in them, what do you tell them their durability is gonna be? I tell them that I plan to see you in 10 years. Um I don't tell them, I have some people that I've heard surgeons say this at national meetings, where they go, I will see you back in 20 years. This valve is gonna last you 20 years. And I do not tell them that if there are over the age of 60, I say 10-15 years under the age of 60, I say I'll see you back in about a decade. And so I'm very honest with them Hector, because I do think that people, the patients are gonna listen to you, you're an authority. And so I think that you can guide that direction in a variety of different ways. And I think we have to be very honest with the patients on what we think the two she volunteered to last, especially under the age of 60-65. You know, I I usually give them a range and it's somewhere between seven and 15 years. Um so um So um and for some people they may be quite unlucky and you know, refer them to a surgeon seven years later and for others the luckiest individual be 15 years. So like 45 confronting Surgery at 60 and possibly if we do the same thing at 60, another one at 85 uh sorry 75 can do master. uh so so at least 3-4 surgeries over the course of the Yeah, I mean I would tell this patient 45 that they're going to have 3-4 surgeries, three or four interventions, however you want to call that? Yeah. Um I know chris or Hector, do you want to weigh in? I just want to make a point that there's two big questions that need to be answered in clinic when this patient comes to the first is the valve choice. And I think the audience hit on it right there. Mechanical versus tissue and the second is the approach. And I think patients come to us um Um asking the wrong question 1st. They come to us asking should I have a tabby or should I have surgery? When I think the first question that should be answered is should they get a mechanical valve or a tissue valve? Because that determines everything else downstream. Because if the right answer is a mechanical valve then it has to be reduced surgery. You can't get a trans catheter, Mechanical valve. So only after that decision is made mechanical versus tissue. Then do we start talking about approach? I agree with that Chris. All right, let's keep moving here. Um So chris um what happened to this patient? It looks like uh as part of the evaluation you also looked at some virtual valve imaging. This is the advanced imaging that we get and I think most people are used to getting this. Um It does require additional software to draw this virtual valve in and I just have to make sure that every understands that aortic valve and valve for low risk patients is not currently FDA approved. This particular patient was being considered under an investigational protocol but here you can see the trans catheter valve drawn in and uh pretty good distances to the coronary artist. So we felt pretty good about enrolling this patient in an investigational trial. I think chris did you did you model this also uh for um self expanding. That was the only balloon expandable because it was part of a trial. It was only this particular valve as part of the trial. Right. Right. Um Here's some additional images of what these beautiful C. T. Scans can offer us here. You can see the silhouette of the valve there. Tracy, nice pictures and then this patient I think ended up getting a um Well actually you had an access picture first. Right. Thank you had talked a little bit about trans several versus other accesses that might change your mind. Well I think Vino Vino remembers when we started to be about 10-15 years ago that it was 5050% chance you're going to get a trans femoral access. But now with She sizes down to 12 and 14 French about 90% would be a candidate for a transfer Meral. And for these cT scans which have to be taken and looked at. This is a good transferrable case in the United States. When I looked at all the tv T data for 2020 96% of patients in the United States have done transform really, That was in 78,000 taverns in the United States. So it's now up to 96% Chris but this seems like a great transfer Meral case here. So um chris you can tell us a little bit about follow up imaging here too. We're actually um Pretty happy about a couple of things with that right Bundle branch block that puts the patient at a higher risk for pacemaker. Um didn't end up with a pacemaker. The gradients a little bit better than expected. Previous valve in valve trial showed the gradients of about 17 or 18 after valve in valve And this patient end up getting a 16 millim gradient. Still not great, but better than what would be expected and looks like it persisted three years later. Yeah, So that's that's three years later. Uh echo results from three years after the procedure is shown on the right. So it looks like you had some pretty decent durable results too. The third issue there, we put the anti platelets anticoagulants here because one more thing that is showing up in the trans catheter vows is the risk of valve thrombosis and um, you know, I forget the exact numbers for valve thrombosis. For both vales. Yeah, You showed it in a couple of trials. Yeah, there's not it's not great data on the valve and valve, nearly as much as it is for the day. No votes in the 20 to 30% range. But the only thing that I would do differently on this, uh at least for this component is that we would put them on Coumadin and not aspirin. I mean I'm sorry I'm not Plavix, we would do aspirin Coumadin For 30 33 months. Of course in in therapy. Uh The no x have not shown decrease in from us nearly as much as a full anti coagulation with Coumadin. Um eloquence. And the other ones have not shown it. So we're a little bit more proactive with Coumadin for these patients, at least for the first three months. So one thing we would do differently with that. Yeah. So you know it it makes you it makes you wonder and I want to ask vino and and and and chris you know with these patients, how many valves can you put in? You know in a inside a 23 millimeter valve? And and what's going to happen to the future of this valve in valve? But before I ask you let I'll show you, I'll show you later. Okay? So so but in the meantime I just want to say a couple of things on because you know everybody has opinions. But the bottom line is that is what you think you know for sure that that gets you in trouble. So so so if you can go to the next one in the and you can bring them all down in the in the era of tavern. There are some facts and there are some misconceptions. There is increased popularity of bio prosthesis. Patients don't want to take Coumadin but they misunderstand Coumadin. Like for example, I have to change my diet to accommodate Coumadin when it should be the other way around. You should change your Coumadin does to accommodate your diet. For example. Industry suggests that the third generations by a prosthesis are perfect. No referring no clots. The cardiovascular community has accepted as given that valve in valve is the long term solution. And then the partner three trial in low risk patients showed initial outcomes better with Tavern than with Sovern. Let's go to the next. With that being said. Of course you can see that for all age ranges. The use of mechanical valves in patients 50-70 years has decreased. Let's go to the next. And I just have to show you here, 56 year old two years status. Post aortic valve replacement with the bio prosthesis coming due to thrombosis and having had to have the valve redone. Let's go to the next. And the truth is let's go to. And the truth is that by caspit that by a prosthetic valves not only encourage the generation over time, but they also encourage thrombosis. And we say, well we'll put the patient on Coumadin for three months. Well, it turns out that thrombosis can occur late in these patients. And this is very important to know. You can have a 34 patients, 3, 4 year out patients from the surgery or from the tavern that comes with a completely thrombosis valve. Let's go to the next and I want to show you something very interesting. Go to go to the next. Yeah, if you look at the aortic valve, Estimated incidents of bio prosthetic thrombosis in the early position is about 0.5%, uh 0.5%. And I want you to look at the next line and see that the same risk of Trumbull embolism Of .5% is for the mechanical valves. So there are two important lessons that we have to learn. Number one trumbull embolism and even by all trials has been proven to be the same with bio prosthetic or mechanicals and the same has happened when all these big trials have compared endocarditis, the rate of endocarditis in mechanical versus by a prosthetic is the same. Let's go to the next and here's what has happened. And in this regard, I I am very, very respectful of the of the of the partner group because you know, they have they have, you know, come out with with with with with very, very clean and transparent data. And you can see here that the initial results that favored server over Tavern in terms of death or disabling stroke in low risk patients are offset at the end of two years, noting a higher incidence of valve thrombosis in Tavern versus surgery with the result of increased gradients through Taber valves and not Sabir vales. And this is an important thing to note. Let's go to the next one because this is real data when we look at by a valve in valve, evidently it is a great solution, especially for older patients and high risk patients. You better believe it can save a life. I mean, let there be no doubt, but if we look at the data a little further, let's let's go to the next to the previous. Yeah. So so if we go, if we go and look and look at the data, we can see that there are issues with valve in valve. One of the issues is the size of the prosthesis itself. As as as my surgeon colleagues were mentioning, note that there is a significant difference in survival that is related to having a large bio prosthesis versus a small bio prosthesis. Let's go to the next. Sorry about that. And very important to know that mortality was very strongly associated with every millimeter of decrease of internal diameter. And it was also associated with re intervention using balloon expandable travers. Of course there's a call there for surgeons to implant valves that are that are more than 23, which I'm sure for Vino and Chris who are very experienced surgeons. It's not such a big deal. It is difficult, but not such a big deal. But I don't think all surgeons all over the place are well versed in annual or enlargement techniques that are easy for them to do so you have to take all of this into consideration. And then I asked, you know and chris so how many valve in valve can you put in number one and number two. What is the risk that a valve in valve will give you for future coronary artery interventions? How are you going to get into the coronaries with a couple of valve in valve When this guy comes with an acute in mind, you know, I think you're up. So Hector. I think that you're absolutely right and I agree with that. And I think that the data is out there for us to look at. I think we have to be uh we can't just look at the data that we want to see. We have to look at all the data and be very um honest with our patients about this. So, I'm going to show you something because you're absolutely right Hector. So here's a patient um 65 year old now comes into me with uh progressive distant exertion, bilateral leg, a demon for the last six months. And he does he is young, 65. But his COPD with a home oxygen atrial fibrillation, diabetes, hypertension, bad ph d with prior stents in a chronic anemia At age 49 Hector at age 49. Okay. This patient underwent a tissue a VR When a coronary bypass Times two Patient, then comes back later. Seven years, not 10 Tracy. Not 15. 20. Okay, patient comes in seven years and says actually at that time, 2012 hours at Emory. So he came to me after the first region wasn't done by us. Um And I ended up at that time, the home oxygen. He was in a bad shape. He was in acute heart failure. We did a valve and valve on him with a balloon expandable valve. He did okay with that in 2017. He came back to me now, he has federal access was completely gone And he looked even worse. So we did a trans cable tavern valve and valve and valve. So the guy's got a surgical 23 balloon expandable Fallon valve and we put in core valve valve and valve and valve. Now now he finds me, I come back to Atlanta, moved away for two years. I come back and my guy, he found me. I'm not sure how he found me, but he found me and now he comes to me like this. He's still smoking by the way, a pack and a half a day, he just won't stop. His Ef now is 40 to 45% severe A. S being graded at 43. He also has some severe mitral regurgitation. We diarist and we got him better. We got the micro negotiation down to moderate, take a look at this Hector. So there's a there's a there's a tissue valve, there's a there's a SAPIEN valve, there's a core valve and then we end up putting another core valve. It um so this guy at age 65 has two core valves, balloon expansion valve in a surgical valve. So he and we had to do him as a redo trance cable. Right? So he's a redo transcriber tavern valve in valve in valve in valve, self expanding th v mean gradients 25. Albury is 11 That was in April 2021. I'm scared to get his Echo in April of 2022. So he's symptomatically better. But my in my opinion, he's not in a great situation and I don't expect him to live more than one or two years. Yeah, I think he bought him a little bit of time but he's not helping himself. And Lord knows that this guy comes in with a stem E. I feel sorry for whoever the intervention, luckily that's not going to be me. Yeah. And I'm not going to operate on him for a coronary bypass. But Hector, your point's well taken In my opinion, that patient in his forties should have been coaxed as much as possible to go into a mechanical pathway and mechanical valve pathway. And I think we need to do as physicians a little bit better job. Not talking about the glory of what we can do with valve valve. But also talking about these type of cases where we're struggling now on a 65 year old that I don't think we'll make it to 67. Great, great case be no thanks so much for uh for showing that that was our little bonus case there. Let's go on to case to case two is a really cool case too. Um, so let's quickly go through a 48 year old gentleman modern aortic stenosis, StS score of 0.38 And then not see if I can advance to the next slide. I am controlling the slides. Let's see. Let's go back on. All right. Um So you can see the gradients. Um Here, Calculated a via as 1.6. Uh indexes .9 again, might be underestimating here. F is pretty preserved here. Uh Hector or or chris do you wanna go over these pictures quickly? Well, I mean, you can you can you can clearly see on that on that echocardiogram that there's significant decreased mobility, systolic mobility of that aortic valve. And you know, evidently we know it's a unique caspit valve and you know, in that short axis, basically the differential diagnosis would be between a right left bicuspid aortic valve fusion And the unique hospital valve. And it turned out to be one. One university valve. All right. Um mm. Sorry it's jumping ahead. I'm not sure what what I'm doing differently but let's see if I can get back to where we want to be. All right chris here's the cardiac M. R. Results and maybe you can take us through the next few and the unique custom valve is visible there on that cross section. MRI looks like a toilet seat. Just one leaflet all the way around. You'd definitely be concerned about doing a tabby and something like that um worse than a bicuspid I think. And the second reason that uh this is not a great tabby cases that aneurysm there and you can see it on that right panel. Some rotational images. Midday sending orders 5 to the Bicuspid. That's a Class two recommendation for surgery just by itself. With the aneurysm but definitely indication for surgery if they've got a would extend. No sis you need to do something anyway. What? Mhm. We get some um these are investigational mars time resolved. M. Rs 40 flow colloquially and you can see the manner of the vertical flows and um uh wall shear stress that we can measure there through the aortic stenosis that hits the aortic wall. We think that contributes to um aneurysm growth on top of the on top of the B. A. V. A. Or top of the, yeah great picture is really showing why that aneurysm is some asymmetric here. So what happened? So this case young patient aortic stenosis aneurysm. Um The biggest question is what sort of valve they would have wanted and that's where I always start mechanical versus tissue valve. And um despite H. A. C. C. European asian japanese recommendations to take a mechanical out, the patient did not want to be on Coumadin. So The patient would have received a tissue valve at 46 a senator with replacement. So that opens up I think a great option for this patient which is uh pulmonary autographed a Ross procedure. Mhm. I think it's important for uh the general cardiologist and probably some cardiac surgeons to be able to explain what a ross procedure is. It's very difficult to um send this patient for referral. If referring physician can't even explain what a ross procedure is. And um there's some diagrams on the web. Cryolife us has these um these diagrams that can be accessed through that website. The next slide shows that the procedure involves taking the pulmonary valve and trans locating it into the aortic position. So it's an aortic valve replacement using the patient's own pulmonary valve and route. And uh in the place of the pulmonary valve goes a pulmonary hama graft. So that's a alan graf, the cat, a very calm a graph from some from from from another, from a cadaver and that's used to replace the pulmonary valve. And the reasoning here is that you want something native, um something autologous in the left side of valve. And although the home a graft um is um a substitute for pulmonary valve, it's much more benign in the pulmonary position than in the left side of position. This particular one shows a full root replacement technique. There's a couple techniques to the ross procedure. When Donald ross first described it, he described it with a sub coronary technique. So that's not a full route. It's just an aortic valve replacement. Sub coronary future line. Um I don't think people have to concern themselves too much with that. Most people do it with a full root replacement. That means the coronary arteries have to be reimplanted into the pulmonary autographed. So that's a couple more future lines. Um Take a little bit longer to do. I think the most compelling thing about the ross procedure and young patients is the survival advantage. And you saw some survival data that Hector showed for patients who get an artificial valve And uh their life expectancy was not good. 40%. I thought I saw five years Hector. So patients definitely do not return to expected uh survival after accepting an artificial valve. Still much better than living with politics stenosis. They'll be dead in two years but not not the same as the normal population. And um this uh this jack state of the art reviews shows uh and summarizes some of the data on the next slide showing 15 year survival Not just 10 years but 15 years survival Of greater than 90%. So that's a lot better than the patient receiving either a mechanical or a tissue valve. And beyond that, the next slide shows what's the what's the what's the re operation rate chris Yeah the re operation rate is better than having a tissue valve and almost as good as having a mechanical valve. Not quite as good as having mechanical valve. Uh risk ratio is about 1.7 when you compare Ross with the mechanical valve but still definitely better than taking a tissue valve in already is told me when I tell the patients the same thing, tissue valve at 45 years old, expect to be back in less than 10 years for another procedure. And um this is the final slide that I think will show for the raw survival. Um in case people don't believe it, I do believe it. This is 25 year data now and um with the expected survival of 75.8%. That um that confidence interval you see in that panel is not statistically different from the general population. So um the hypothesis that ross procedure can bring people back to their normal expected life expectancy I think is uh could very well be real and chris maybe you can speak to a little bit of the selection factors who are ross candidates versus not. I think the hardest thing about getting the Ross procedure is finding a center that will offer that procedure and even finding a center that would talk about the Ross procedure. I think that first case the person who got a tissue valve at 45 probably was never offered a Ross procedure at all. So I think that's the hardest part about patient selection. Um In terms of anatomy we get M. R. I. S. In order to look at the pulmonary autograph to make sure that also isn't bicuspid. A lot of these patients are bicuspid and make sure there's no P. R. P. S. Just don't want any surprises. I mean we can quickly change to a mechanical valve at the time of surgery, but I'd like to know these things pre operatively so we can counsel the patients. Chris, I have to Tracy can ask two questions of chris course. So so when you say chris that ross procedure can be done in people who are relatively healthy, right? You're not going to do it on a sicker patient who's on some home oxygen or so their survival curve automatically by patient selection therefore makes them a little bit more likely to recover and take a hit of a larger or longer cross clamp time. What do you say? Yeah, I think so, I think and uh I think that was sort of a pitfall that we ran into 20 years ago as people are doing Ross procedures and risky patients, even patients with endocarditis, I'm not saying you can't do it in endocarditis that those aren't the patients that you want to be starting out on And the patient has to have an expected life's life expectancy of 20 plus years for the Ross procedure to be worth it. Yeah. And the second thing is, you know, to me a major impact is going to be the product in a trial that both Tracy and I are on the steering committee for and I think that would that change? Because I think that will change that bar Hector social, nice slides of bio prosthetic and mechanical valve. If you said to the patient, I'm not going to give you coming in after 90 days, you can switch over just like we do for tissue valves or whatever. Tavern valve valves, we can switch over to a non war from based therapy. Do you think that would change your decision where you do less ross's if that study becomes positive, I think the product in a trial is gonna be a groundbreaking trial Tracy is going to talk about it at the end as well. The opportunity to have almost an ideal valve. Right? So it's a durable valve that you don't have to be on Coumadin for but you will have to be on a pixel band at the trial is positive um, is extremely, extremely attractive for doctors and the patients. So I think, I think, I think it is important to recognize that that that for for the younger healthy population ross procedure and bicuspid aortic valve repair in the appropriate valve leaking bicuspid valve with the appropriate surgeon procedures. The ross and bicuspid aortic valve repair in young low risk patients done by the proper A surgeon and done on the proper valve can give a patient a 2025 years of having their own tissue, having their own tissue, not needing anti coagulation. And then and then and then you know there will come a reckoning moment where where something else will happen. But I think I think that that is an important thing to know. Great point Hector and chris you can take us home on what happened with this patient and I'll add the Hector as well. Freedom from endocarditis of the autograph too. I think it's a powerful motivating factor for the ross procedure. So this is the post op echo for this ross. Um uh deep implantation of the autograph. You can see it's seated well in the L. V. O. T. I think that protects the proximal future line. Um Next slide and chris just a quick point about that endocarditis. Do you do antibiotic prophylaxis after after us? Right. I do. So we do pro flex ross procedures but not for the autographed weep reflects it for the pulmonary home a graft. But even if they get endocarditis on the home a graft which is on the right side. We know that's a lot more benign than having endocarditis. Endocarditis on the left side. There's some more cool pictures for you to show. Yeah. There's a 40 reconstructions. We followed up with more 40 reconstructions afterwards and the left sided panel. You'll see that the ascending aorta is completely replaced with the background graft. So all that's left of the pulmonary autographed is 2.5 centimeters of the pulmonary valve. So the autographed is protected approximately in protected distantly at the S. T. J. To keep it from dilating in the future. Blood pressure control is also important for for the first six months afterwards and the four D. M. R. Shows resolution of the wall shear stress and Boris's of blood flow secondary to the aneurysm. Hopefully predicts good durability to. And some more pictures here. The four D. M. R. Previously also showed a nice flow to the pulmonary pulmonary home a graft. We typically use a 28 or 30 millimeter home a graft. Um Just so we don't get pullman home a graft. Dysfunction afterwards. Pulmonary stenosis specifically. Mhm And I'm really excited for this patient. Um I think not doing the aneurysm would be a mistake. Um That wall shear stresses ominous. We're gonna have more data correlating wall shear stress with aneurysm growth and probably able to catastrophes. But just looking at that wall shear stress hitting the outer curve of the aorta makes us not want to leave that they would alone that they would should be replaced. Well, great case and um really complex anatomy here but great result in the interest of time since we've got about 12 minutes left. Let's move on to case three here. So this is a 58 year old lady who had Hodgkin's and underwent mental radiation before. And we all know that this is associated with Uh thoracic pathology here who now comes in with severe aortic stenosis has an SPS four of 3.08%. Creatinine is a little high g frs. 55. Okay, take a look. Uh This is her E. K. G. Not terribly concerned about conduction issues here. This is her echo severe A. S. A. Via index of 0.38 F. Nicely preserved. Although I suspect she'll have some diastolic dysfunction. Not much um Are but a little bit of aortic regurgitation. Yeah I think I think this is this is a beautiful eco for for for all echocardiography. Echocardiography is present. If you look at the left side on that purse turn along you see the typical appearance of radiation disease. It's almost pathetic Hamonic when you see a calcified aortic valve and a tremendous exuberant classification of the aorta metro curtain going all the way almost to the to the a little bit beyond the belly of the anterior leaflet of the mitral valve. And you can also see very importantly that in short axis as well the classification is exuberant so such that this patient likely has calcification of the L. V. O. T. As well. And this is another category of patient that the STS doesn't cover. Well I mean that's the risk or three for a post radiation patient. It's not true because these patients have damaged their lungs, their mile cardi um valves, coronary. Yeah. Yeah I can't wait to see the ct on this patient Hector. Have to be honest with you. It's concrete. It's a concrete wall. So I mean again I mean there there's there's there's calcium accretion on the left there all the way below the annual list of that of that of that valve and that and that that is something that that a cardiologist imager cannot let go by and you know without discussing with a surgeon because there are dangers to having this amount of calcification and doing tavern and I'll let my colleagues explain that. And this is um so this is native aortic stenosis. Um radiation heart disease is bad. All the reasons that sway you away from surgery also leads to problems with tabby. So these severe LV. OT calcifications put the patient at risk for annular rupture at the time of tabby. In fact, you know, I don't think we enrolled any patients like this in any of those trans catheter tabby trials that we did the past decade. I think that's really important chris to mention that. Is that Hector shown some data on will show some data on p. three and and these are not the patients that are represented in those trials. You show that it's not representative. You have to be you have to look at the trial patients and equated them for real life. You can't just assume that these are the type of patients that are considered low risk. It's very that's a very important adjunct about looking at randomized trials for your own specific patient population. Okay, so heavily calcified coronary heights are are shown here. You can see the sinus of el salva diameter as well, coronaries wise, small coronaries. Um but uh fortunately nothing uh that uh looks by possible. So let's do a quick audience poll here based on what we've shown so far so younger patients uh Well somewhat young patients um mantle radiation heavily calcified including L. V. O. T. Calcifications uh severe A. S. What would you like to do for this particular patient Tracy? I think you listed all the potential options. I can't think of any other options that the patient would have to decide upon. Yeah, let's let's see what the poll results show. Yeah. So a little over half want to do a surgical A VR. With mechanical valve. I have to say that. I agree with that. Um There's some thought about surgical A VR. With fruit enlargement. Um and uh maybe a tissue valves. I think the tissue valve. If we're going to crack the chest I probably would would not favor a tissue valve. Given that this is a chest you don't want to get back into again. Um And then um tabby is as an option here. What is the panel? Thank after. What do you think? So? I think I think that these are very difficult patients and and my recommendation from seeing and having many patients many radiation patients is that you have to pick the right time for surgery and you have to try that. That surgery is the only one that they have as best as you can. So if you need to do the aortic and mitral valve, you better wait. You're better off doing it in one sitting. Because a redo operation in these patients is like behaves as as chris was saying before as a as a 73 operation because all their tissues are are extremely scarred and classified. And I also have to say to my cardiology fellows colleagues out there that that it is critical in these patients to make sure that before you send them for whatever you're gonna send them. Look at the, look at the aorta. An echo is not very useful for that. You either have to do it by playing old chest x ray or ideally by CT scan. Because some of these patients may have a porcelain aorta which would put you in in in real trouble because then then the only thing potentially you can do is a tavern or a more complicated operation with with replacement of the aorta and they already valve replacement. So so so these are very tough cases. Yeah 100% agree with that. I think that you've got one shot at this mantle radiation is an absolute bare and the and the you have no lines of demarcation within the chest. So you got I think you actually have one shot. One shot for this patient. You better take it. Um And you know it's gonna be very difficult operation because you have the debris to a lot of that calcium. But you get one shot and I think that's the appropriate spot. Is trying to do a mechanical valve wants to be done with it chris any final words on this case? I think I think this brings up one topic that we should discuss is minimally invasive cardiac surgery. That's what M. I. C. S. Means for the cardiologist. Uh Usually these patients come in looking for a tabby and they're very disappointed. We tell them you're not an animal. An atomic candy for tabby. Just too many too much calcifications. We take on a huge risk of rupture here. You're gonna need open heart surgery. So then if we can offer patients minimally invasive cardiac surgery either. Minister Anatomy mini thoracotomy. I prefer to I prefer mini thor economies. Then all of a sudden that becomes a little bit um easier to swallow for the patient. Well we've got four minutes left so Hector I'm gonna turn this over to you to kind of give us a little bit of a recap here. Yes and again. You know I mean we all speak about prosthesis and and bio versus mechanical and and we believe those facts. But what does the real data show? And you know there are many studies. Let's go to the next and I just want to show you a couple of them. You know, first of two big randomized trials that began a long time ago. One is the Veterans Affair which the follow up. No, no that's that's good. So the so the and this was of course bio prosthesis versus mechanical. And you can see that what turned out happening is that actually survival was better in the mechanical patients. And somebody You know from a company might tell me that's because they used all buy a prosthesis. I don't know the answer to that. And clearly of course there was more bleeding with mechanical prosthesis and that's the final results of that study published in jack in 2000. Let's go to the next. They also noted that if you're less than 65 years old, that degeneration is quicker and as you can see the degeneration in these patients, as we have said, started, started occurring, you know, at 89 years. You know that that's that's where the business begins. Let's go to next. This is the other Edinburgh randomized trial, which was a much smaller trial and again, also showed no difference in Colombo embolism or endocarditis between bio and and mechanical. And these were very young patients 45 year old. Again, death of re operation better than better with mechanical A VR. Death alone was not better, but death and re operation was this is Yeah. Sorry, please. 50. And this is just one to show you this is now an observational study with many patients but it is very appropriately perspectively matched and you can see that the survival between mechanical and bio prosthesis in 50-69 year old is about the same. Let's go to next. And basically the differences re operation in bio prosthesis and major bleeding in mechanical. Let's go to next. This is an important one. This is uh this is a paper that was published in 2017 in the New England Journal of Medicine by Goldstone 2017. It's a retrospective study but very well perspectively match and with inverted weighing and all possible statistical methods to try to make it as clean as possible. And You can see that the probability of death is larger in biologic valve patients, particularly in the 45-55 years of age. Let's go to the next. Not very significant for for older patients. A little difference in the curve there, but not enough. Let's go next And again. Very important. The risk starts to begin or or starts to increase when you are about more than 60 years old with bio prosthesis. Let's go to the next. Therefore, I mean, I think, I think it is important to recognize that of the of the 11 or 12 studies that are out, some of which show equally nobody has shown that bio prosthesis are better in big outcomes and most of them have shown that mechanicals, better. particularly for the younger people. Yeah, and I think vino really alluded to this. I'm very excited to be part of this trial and actually all of us are, all of the faculty are involved in this trial, um, either in the Syrian committee or as a site. Um, we think that this will be a big game changer for us because clearly one of the biggest messages we're hearing from patients is that they don't want a mechanical valve because they don't want Warfarin. And so if we're able to show that a drug like a picks a van could be as safe as Warfarin for these patients. Um then I think we really will change that very first decision that patients and their surgeons are making, which really changes the landscape of these redo conversations uh that we've been having a dialogue about tonight and um in our in our practices. So just a quick reminder that proactive in a trial is just, is a randomized trial. It will take patients with an on expel. These are patients that many of whom already on a lower iron. Our target with the annex fell. But we are randomizing them to best Warfarin. So as FDA required, I and our 2 to 3 versus a pick the band five mg twice daily. And we are looking for non impurity. Um as well as his uh, Oh PC criteria for thrombosis, embolism and for valve thrombosis. We're currently enrolling, we're at about 300 patients enrolled across 53 sites so far. Um and uh, we hope to be able to complete this trial. We're trying to get to about 1000 patients and 800 patient years of follow up on each arm. So stay tuned. Um, and uh, for those of you who might be with us in this trial, um Thank you so much. We just had a great site investigator meeting today and we hope to really push up our enrollment now that uh, we're seeing a covid hopefully behind us. So I think that is our, our last slide for the, for night. Um, I hope you've enjoyed these cases were a little bit behind eight o'clock. I really want to again thank chris vino Hector for some amazing cases. I think I learned a lot from these cases. I hope you felt like these were uh, instructive and helpful for context as well. I like this kind of case based discussions we're really talking about, you know, what decisions we're making, um, as we're seeing the patients.
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