AVR Options for the Bicuspid Patient: Case Based Discussion
Wednesday, October 14, 2020 | 7:00 PM - 8:00 PM EDT | 6:00 PM - 7:00 PM CDT
Aortic valve replacement is going through a paradigm shift. Innovation in the type of intervention and valve options has opened up new opportunities for patients and clinicians. When it comes to valve choice for long-term outcomes, durability and antithrombotic therapy becomes the crux of the discussion, as patients question the impact to their lifestyle after undergoing an aortic valve replacement. This webinar brings renowned Cardiologists and Cardiac Surgeons at the same table to have a case based discussion on AVR options.
Faculty:
Dr. Edward Chen, Cardiovascular Surgeon, Emory University School of Medicine, Atlanta
Dr. Hector Michelena, Cardiologist, Mayo Clinic, Rochester
Dr. James Stewart, Interventional Cardiologist, Emory University School of Medicine, Atlanta
Dr. Katherine Harrington, Cardiovascular Surgeon, Baylor Scott and White Heart Hospital Plano, Plano
Dr. Tom Nguyen, Chief of Cardiac Surgery, McGovern Medical School Cardiothoracic and Vascular Surgery Department, Houston
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My name is Edward Chen. I'm a cardiac surgeon at Emory University, and I wanna welcome you to they live weapon are sponsored by car lights. Today's topic is ableto replacement options for the by Customs pal patient. Uh, the point of the nice Webinar is to provide a case based discussion for you to, um, come away with more insight into various options that, just off these types of patients, the intent is not to, um, have a Knauer long didactic session, but it is intended to learn by practical discussion on we want to encourage you in the audience to submit questions through the Q and a feature of these of the Webinar link. I'm just I want to thank CryoLife, uh, for its on going commitment to physician education and the betterment of patient outcome and treatment options. I'm just I'm joined by a distinguished panel, a recognized expert in the treatment structural heart disease. So we have Katharine Harrington, who is a cardiac surgeon at the Baylor Scott and White Heart Hospital, Plano, Texas. Dr Hector um Messalina, who's a cardiologists at the Mayo Clinic in Rochester, Minnesota. Dr. Tom Win, chief of cardiac surgery at the McGowan Medical School, UT Houston Medical Center, Houston, Texas, and Dr Jim Stewart, outstanding interventional cardiologists, that Hamilton Medical Center in Dalton, Georgia. This is just some housekeeping rules for everyone. We ask that you mute your cellular devices to avoid interruptions in the program. Please participate in the polling questions After each case. Example. We will have two cases tonight to discuss. And, of course, your input is very valuable. And knowing what? What? The community at large, Um, has thinks about these types of these cases. Uh, please. Again, uh, not be shy and use the Q and A chat function to send in your questions, because we certainly will review those and read those off during the audience question discussion portion of the of the program. We will respond to those, I said, and when you submit your questions, please state your full name, city and country along with your question. You know, the first portion of this is just to get some basic background into understanding the by Castro Val patient and internal, including principles and conundrums. And with that, we'll have a short introductory discussion by Dr Hector Misha Lena actor. Thank you very much. Dr. Chen, before we begin our discussions tonight, I think it is important to look a little bit about what principles and conundrums are currently governing the issues of my custody. Eric Bow. I have ah, no disclosures. Except for I am co p i for the product tonight trial here a manual which is a, um CryoLife sponsored trial. However, I my interesting it is purely academic. I stole this light from my colleague Dr Hartal chef, and I think it's it's very important, particularly when discussing what types of valves we're gonna use for these patients. 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. Which to me is a tale about being beware on being very careful with bias dogma. Andi, with information that it's sold to you on that it's just not true. So we need to be in this area checking ourselves all the time, and I cannot find a better quote for the bicuspid aortic valve conundrum. And it's a hardtop Kathy. Then everything should be made. A simple it's possible, but not simpler on the truth is that the congenital by casting a critical condition is ah, complex one and it's a heterogeneous one. On it is the most common congenital heart defect so common that even, uh, DaVinci in his studies off the aortic valve and flows with the aorta etcetera, actually was able to see a on brecca g'night eyes a bicuspid aortic bell. But if we jump ahead to 2020 you I I wish to show you this is a complete issue in progressing cardiovascular diseases where Dr Serrano and I were editors. And, um, it basically has a number of chapters that cover everything from genetics, embryology to interventional cardiology and surgery for bicuspid aortic valve patients. So I'm going to so that I don't put so many references. I'm just going to refer to the chapters off this, uh, just published issue. The first principle to noise that bicuspid aortic valve is a value low aorta apathy. It involves the aortic valve in the aorta in many of the patients, and it is very heterogeneous in its presentation, and we have recently gotten together and try to reconcile the clinical and prognostic heterogeneity of this condition on. I want you to pay attention to the typical presentation, which is by far the most common. And it's the typical young adults or adult that has a progressive valvular apathy and or a Rato pithy that requires surveillance and usually requires subsequent treatment on the life expectancy is usually preserved, as I will show you in in a coming slide. They are, of course, at risk of in the prodigious and Eric dissection. There's another group that is a complex presentation valve below aorta apathy. And these are the bicuspid patients that have associated genetic syndromes associated severe congenital lesions. Associate. It's very recordation where the bicuspid valve is really not such a problem. Perhaps, but the other associated problems are possibly worse. These patients, their life expectancy may be diminished. As we know in Turner syndrome, for example, or patients with severe quotation, it is diminished. And then there's a group of an diagnosed or uncomplicated, which we will not go into now. Recently, as you know, there are many classifications for bicuspid aortic valve FINA types, including the FINA types off the valve itself in the aorta. We have actually, um, got together with an international group of bicuspid experts. Andi, come up. Come up with a new consensus nomenclature. Classifications, which is based on the English language and not numbers on, is very straightforward, Okay, and the first type of by custody really well is the fuse type, which is 90 to 95%. And it has the three common FINA types that we know right left fusion right, non fusion left non fusion, and it's characterized by having three Sinuses of ball. Salva, usually the non few Sinus, is a little bit bigger sometimes on it is very common up to 70% to see a raffi in these patients, as you can see in the scheme there, the other one is the two signers bicuspid aortic valve, which, as its name says it has only two Sinus and not 31 Sinus. Another Sinus on bacon. Bi lateral, lateral, anterior posterior. It's very interesting that these types usually the cusp, so it is very difficult to tell who's fused. That's why there's no calling right, left or left on here on. They are very symmetric, and they are almost the same size. This is the two Sinus bicuspid aortic problem. Finally, there's a new player, which is the partial fusion bicuspid aortic valve, which indeed has been shown to exist. Andi, it's early in the study and then we also must reconcile the hydrogen. 80 of your top of the okay. Our topic is very common in my custody. Already grab them. By far the most common phenotype is still irritation of the ascending portion that does not affect the route too much, up to 70%. However, there is one presentation that affect predominantly the route, which is called the root finna type. And it's more associated with right left fusion, young males with aortic regurgitation and potentially associated with more risk of aortic dissection. And then, of course, there are extended FINA types that are mixed with the lactation off the entire order. It is critical to talk about the complications. What complications does a patient with the bicuspid value our top of the face in their life? Well, if you look if we look at a population based study for a very long follow up, we will realize that surgically speaking aortic valve replacement is by far the most common surgical complication on aortic valve replacement due to aortic stenosis, as the cause is the most common complication. So this is the bread and butter off the typical bicuspid aortic valve valve below your top Kathy. Off course. We also have aortic regurgitation, and I want to get your attention to the age distribution off this valve. ALopez here is not like the tavern in Try leaflet aortic valves that you know are mostly in their seventies and eighties. This is a whole different story because, as you can see as you go down in age, aortic regurgitation predominates as you go up in age. Aortic stenosis predominate, but you can see that they're about the same or close to the same at that age of 50 to 70. So we have an ample distribution of valvular apathy. And indeed, the two largest population or regional based studies have shown one in Canada, one in the US that the survival of the typical patient with bicuspid aortic valve, not the complex one, is not different than the general population. Perhaps when you take a tremendous amount of patients 2000 Year 2000 here and you look at tertiary referral hospitals or when the patients are tertiary referred for a VR, then you can probably because of statistical power, get a little bit or observe a little bit off penalty in survival in these patients. But in general, these patients have a very good outcome. Now the treatment conundrums air Very interesting. Here we have a bicuspid aortic valve stenosis by transit off. Do you like? Oh, here we have one. Regarded them with the typical eccentric jet. First thing to know tonight is that a BR substitutes one disease for another. And what I teach my fellows about the and or principle that if you're thinking about doing something to a patient, be it for Catania, slee or surgically, that might hurt. Um, you better be sure that you're offering on improved mortality and or improved morbidity and or improved quality of life. If you are not offering those things, you're in trouble now if we look at bicuspid aortic valve stenosis, current options include surgical Erica replacement and Tavern on. If you look at the regurgitation, they include surgical, Erica, replacement and repair. Now, when we talk about surgical a VR immediately, we think about mechanical versus bio on. The first thing that comes to mind is committing on for the mechanicals and the generation for the for the bio prosthesis on That's what the old studies the V. A trial on the Edinburgh trialing in the seventies and eighties showed that there was a significant difference in pleading versus degeneration. But now we know that the Trumbo's is risk is about the same for both. That is a fact. And of course, one has to ask, Should I promise my patient the valve involved, tell them to get a bio prosthesis and that we will do about involved in the future and there's gonna be no problem. And then, of course, there's Tavern that's coming up on Day one has to immediately position your mind into Is it gonna be a balloon expandable or a self expandable situation here with the tavern on? Is it ready to be used in bicuspid valves? And is it better than surgical? Or if you have replacement Now, when we're talking about a are we're talking about a much younger population population that runs in the mean age off in their forties mid forties, while bicuspid aortic stenosis runs in the mid sixties or so. So we have, of course, the surgical A VR, which has the same issues, as we have discussed here, but in a younger patient. And of course we have surgical repair, which I have to say, and this is this is very important. It has made tremendous strides, particularly by groups in Germany and Belgium, um, on the success of repair. But it's limited because you can't do it on every valve. And there are conditions that you must meet, including the training of the surgeon. And don't forget just to end that. In addition, we're dealing with a tremendous age, a spectrum here. Remember that the patients with bicuspid aortic valve may have a or top A T. And if you look at trials evaluating Tavern, for example, in bicuspid belt, sometimes you see exclusion of patients with more than 45 millimeter Eoraha's etcetera. And then, of course, the question pops up. Do we need a bicuspid? Sabir versus Tavern Randomized control trial? Yes or no? Is there a key poise to do this Yes or no? And finally, the patient's wishes, which at the end, the well informed patient is the one who is going to make the final decision as to what type of treatment they want with that we will begin our cases. Thanks so much, Hector, for that comprehensive overview of the spectrum bicuspid valve disease and the surgical options. So our first case is a 62 year old gentleman that was referred for progressive dismount exertion. He works at a liquor store. He could not. Hey began to help symptoms where he could not carry heavy boxes, smoked about half a pack a day at about three or four drinks today lived alone at class three. Uh, N Y h a symptoms His past maker history. He had severe a s, a Seaver's type one bicuspid valve with right left fusion. His E f was about 40 to 45% and this was a new finding, a new decline in his particular function. And he had hypertension practices. Um, a fib. He had been on a picture banned for two years, but no history of bleeding. Mild COPD Ah, preoperative calf of the focal mid led lesion. And in a sending a order measuring about 4.3 centimeters in diameter, his pre op echo images have shown here again is F is about 40 45%. His max velocity was 3.9 m per second. Mean grading about 38 you can see on the right hand panel on the long axis. You of the route heavily calcified with minimal excursion of the leaflets thick l ve seen on the left side of the panel and because of the inability to adequately visualized the left and trigger outflow track valve area was not it would be calculated, but is But using see, anecdotally, it is pretty small. His dimensional velocity index was 0.17 consistent with severe A s. So on CT imaging, he was confirmed to have a Seaver's one by Castro Valley with right left fusion. You see the calcium burden on the on the cuss and all those kind of small. There's the the annual dimensions and vot diameters air shown in the slide there. I think the uh, valve area based on this emerging was 0.62 square centimeters on the intercom material distance was 33 millimeters and you can see the center to the junction. Diamond was about 34 and the Sinuses were about 41 millimeters or so. His his left, uh, coronary height was about 22.3 centimeters in the right corner. Height was 2.4 centimeters. This is a three D reconstruction of his access vessels. You can see adequate, um um iliac caliber through the femoral arteries. Um, some mild torture rossi of the abdominal aorta, but minimal calcium or a theocratic burden, Um, through the distal aorta and the common iliac. Mhm. But so doing using the STS risk calculator, his risk of isolate a VR carried immortality 2.4% 3% risk of renal failure. Uh, small risk of stroke and small mobility. More talked. About 14% linked to stay about 6.4 shortly to stay about 33%. And Onley over 6% chance of a longer leave the state. So based on the data, we thought we had pulled the audience and and give four choices. So based on the patient details in the emerging that's presented in case one, which procedure would you choose? The following options one trans catheter a VR to isolated surgical, a VR with a tissue valve see isolated, a VR with a mechanical valve. And the surgical a VR with either tissue or mechanical valve. Combined with a sending York replacement. So I think as we give ah, minute here to let the, um the audience vote will go to the next slide and and touch on some of the key discussion points that we felt were important as part of this. Um, this case, remember, I want to remind you, if you have questions, please channel those to the Q and a session of of the link. So, in terms of discussion points, obviously what type of Sabra va would you use? Would you use a tavern valve tissue versus mechanical in a relatively young patient? Implications for future intervention, either through redo operation surgically or valve valve intervention? What do you do about the aorta? And and, of course, the the pitfalls or things that one must be cautious self when performing tavern by Castro valve anatomy. So the poll here, um, shows that about half of the audience is favoring isolated or mechanical valve. Um, a small, the least favorable is trans catheter A VR, some favorite tissue valve in about a core of the patient, uh, prefer surgical you've got with a Senate replacement. Um, what, what kind of based on his an atomic features What do you considering in him is? You weigh out the various options. Yeah, thanks After you know, it's funny, actually. Had this exact patients in my clinic today. He was referred for cardiologists for a tavern. I think that's a really important for us to understand just because we can do something. Just because we can do Tavern doesn't mean that's the right thing to do. You know, we know there's a green light to do Tavern, this patient cohort, but actually would argue there's actually very, very little data to do. Tavern in this patient cohort and just a quick reminder. You know, the all the randomized trials we have for Tavern versus Sabir by Customs were excluded. The low risk trialing for Tavern, the average age of 73 74. This patient 62 I believe, to have very little data for a 62 year old tavern, so I don't think that's even should be an option. It all and then even it was an option. Even the patient was 73 ish. The longest follow up we have for low risk patients is roughly two years, intermediate risk patients, five years, so we will have more than two years data comparing Tavern versus Sabir for lowest patients, so of options we had to choose from. No, I think B, c and D A very reasonable options in the way I approach. I have a very kind of honest, transparent conversation with the patient. Now. I think it's reasonable to a tissue valve in a in a 62 63 year old knowing that there's a good chance that he or she will probably need something to be done down the line. I probably would prefer a mechanical valve, the Miss efficient coal port. But you know something you can't forget to the patients, A settings for three and a bicuspid. We know the guideline intervening by customers 45 We also know those guidelines are very, very loose. So I think it's not unreasonable. And a very healthy, robust 62 year old who doesn't wanna worry about his a Senate getting larger to actually go in there and fix it. And he could just call it a day so not to worry about it. So that's that's what I would I would have a very honest conversation with the patient on Give them the option of either B, C or D. It was my It was me. A loved one. I probably choose, I think option. I think C was one where you do Mechanical valve? Uh, no. A sending That would be my my my choice. Catherine, you know, with your experience in Plano, are you I mean, 4.3 is probably slightly below some of the guideline recommendations, and even those are have mixed opinions within a B A B patient. Would you take aged into consideration, considering a sending replacement? Or how would you approach this patient terms of a sending replacement at the top of Yes, thank you. Yeah, Um, I tell the patient that it's always going to be kind of a game time decision. I will, um, also take into account, like when you cut into it for a autonomy, how thin it seems. Or if it's it's good tissue. Um, but I think, um, I also like to look at their, um, kind of index to their b s A. In the next to what they're put, uh, proximal descending sizes, you know, sometimes afford to on someone looks drastically bigger than the rest of the aorta. Sometimes it looks the same, so it depends on the size of the patient and the size of their other normal aorta. Um, but say, if this patient was choosing a mechanical valve, I would be more likely to replace it, because the reason that there choosing a mechanical valve is because they never want to have open heart surgery again. Essentially, that's the trade off for coming in. So if they choose a mechanical valve in this, they want this to be their last ternana me, then I'm much more likely to replace 30 sending to try to give them that. You know, payback for that. If they're choosing a tissue valve, especially if we think of a younger patient, we know we're gonna be back for a reduced ternana me. Then I would be more likely to leave it because that would give it time. You know, at our next anonymous it would be an easier redo without any sending graft, and you could replace it at that time if it's grown. Hector, when you look at by custom balls and and consider, um, the application of tavern um, irrespective of the patient age, what kind of factors are you looking at to tell you this is gonna be more successful? Uh, tava procedure or I'm a little worried about this one. Maybe we should send this from the surgery. You know, things like what kind of clinical and and come back to. You know, I think I think we have been pushed to do tavern on bicuspid aortic valve patients, particularly those that are very high risk for surgery. And we do have er for these patients, you know? And there are other more lose societies, perhaps Europe and so on where they are using it, perhaps in lower risk patients as well. That being said, I think I think that 11 has to be very careful. Andi, there is new data, some of which we're going to show in in a minute explaining or or are discerning. What are the important aspects to take into account when you are going to consider Tavern for patients with, like, a superiority bath? Now, sometimes, I mean, I do have to say this tavern can save somebody's life. Let there be no doubt, specially a very high risk patient, and then you just go with what you have, you know, on do and do and do the best. Thanks so much. Let's some There's a few questions from the audience, but I think before we answer those, let's go ahead. And this was Dr Stewart's patient, Jim. Maybe you could just go through the treatment, um, plan and what you did for him. Sure. So you know, all of the points in favor of surgery in this case are well taken. Um, and that's that's quite honestly the way we were trying to lean, but the the patient was resistant. Hey, had a brother who died on the table with with open cabbage. Um, you know, we were also because of his young age, 60 is roughly kind of the crossover point where we would, um, generally considered doing a mechanical valve. Um, but the patient really didn't want to do Coumadin. His physicians were nervous about cumin, used with his alcohol intake that we thought was probably more than he told us. Um and then ultimately, um, uh, even though the STS certainly puts him in a low risk category, he is low risk. Um, people thought that he was higher risk than you might, you might appear on paper. So, um, you know, I agree with everyone's points of this, The specifics of a particular clinical situation important. This happened to be a very simple lady lesion, Certainly more. An atomic complexity would have pushed us towards, uh, a Lima to the lady in addition to his valve surgery. And then his a fib is well, is worth mentioning to. Had we been considering a bio prosthetic valve, you would also probably be more likely to choose surgery because of being able to like it has left a trail dependence and maybe Obviating from being on any blood thinner. Um, that being said, the decision was made and we we elected to use a self expanding Taber valve. Um, this speaks to some of the heterogeneity and in particular, an atomic points Hector's mentioned. But this was a very heavily calcified valve on it was in sizing lives. It was actually even outside the recommended upper limit for balloon expandable valve. So, um, here's what we did. Here's how it turned out the fluoroscope e. You can just appreciate how, how just a tremendous amount of calcification this year, Um, the valve was actually, when we crossed it had an invasive peak to peak radiant, pushing 70. So our echo image we knew was for quality but definitely underestimated the severity of the stenosis. Here we pre dilated the valve we wanted Thio. We were concerned that are self expanding valve may not fully expand if we didn't. So we performed a valvular plastic ahead of time, which is not something we we always do in most cases. And our initial placement of our uh eh veloute was a bit high. You can see in this Elliot View or kind of above the non coronary Angeles there and our second attempts. We were very happy with our our placement attn least our debt for the valve So we released evolved and the patient was very stable. The valve position was stable. What concerned us, however, was a view in the r E O. And in the area of you, the D valve was just absolutely pancaked. So even though in the 90 degree Elio View it looked well expanded, we could appreciate that even though we had pre dilated it, uh, this the inflow of this self expanding valve hadn't expanded. So we were, we were stuck figuring out what to dio. We knew We need to do at least post delete the valve. The question was, Could we even withdraw with nose cone of the deployment system safely without pulling the valve out? And as you can tough these pictures, three answer is no way. Probably, of course, Hindsight's 2020 should have, you know, stuck the other leg and put up a a value of plastic balloon and dilated it without removing the nose. Come. But we thought we could sneak it through. We caught the bottom of the frame of the self expanding valve, and we ended up dislodging it and immobilizing it. Um, thankfully, at this point on the right panel, even though the valve is above the native valve, we're not obstructing the coronaries. The native valve is still closing and competent. There's not severely. I the patient was actually completely stable, So we again revisited the surgery question. Things is a patient still Ah, we felt like we made the wrong decision in choosing tavern. Uh, could we now reverse course and go to surgery? Ultimately, um, that's not what the team thought would be feasible to accomplish. So we brought up a balloon expandable valve position that deployed it and, uh, essentially hoped for the best. And as you can see on the final, a photographer here on the right of the screen, at least in the acute situation, Um, we were able to bail ourselves out of trouble. No one, I think, will argue that this is an ideal outcome. Um, with a with a core bell floating in the ascending the order there. But the patient was actually stable. There was no way I There was very little Grady in across the valve. Um, and we decided to stop there and lived. Lived to fight another day. So Dr Chen, can I kind of comment real quick? It's a subtle point that I'm not sure the audience can fully appreciate. And Dr Stewart Kind of comment. And Dr Mitch Elena, No. So this patient has bicuspid valve that severely calcified. And the trans catheter options are either a self expanding valve or balloon expandable valve and the pros and cons of both. And the option chose the self explaining valve and the advantage of a self expansion valve in a valve that's really calcified is you have a lower risk of annular rupture, right? And but you do have a risk of PBL and you have Ah, a little higher risk of of the valve, not seating, which which happened here with the balloon expandable valve which they ultimately did. You have less of a risk of the PBL but you have a higher risk of of having issues with the uric ambulance. So can you explain a little of your thoughts, Dr Stewart, on how you chose balloon expandable versus self expanding And it looks like in the end you did self expand a balloon expandable and things worth okay, you Do you regret the the that balloon expandable to begin with Sure that the chief reasoning was just a degree of classification. The the C T scans that we showed without being able to manipulate him don't do quite enough justice in my opinion, toe how heavily calcified this valve is. And that is really the single greatest factor to predict annular rupture risk. Hey had both heavily calcified leaflets as well as calcium that extended down into the l b O. T, which, and you can even see this bulky calcification just get physically pushed out of the way as we do the balloon expandable valve in these two videos. But we were really way ultimately to a self expanding because of our just fear of the catastrophic complication of an annular rupture. Um, and and typically, I sort of use sizing. The other thing that gave us a bit of pauses that the inter commercial distance there for this fairly avoid opening bicuspid was much greater than the largest diameter of of the biggest balloon expandable valve. So calcification, degree of calcification, location of calcification is the the biggest factor I use. Besides, ing can configure in his well on this really large valve, I wasn't entirely sure 29 uh, sapi involved would would fit. Ultimately it did. But there's just no great way to model that ahead of time and and predict, Um, so you know, each, as you pointed out, each valve has its downside. Um, you know, and we certainly found out the downside of the self expandable valve in this case 11 last. Really? I think important teaching point is any time the valve doesn't get deployed where you wanted to go, you maintain bar access what you did, because then you have control to do other things. The last thing to do is lose more access and development around. Yeah, we got a couple of questions from the audience Margaret Rogers, and is asking, how would COPD impact the selection of Al choice? And Catherine, I wonder if you could comment on that. Say, this guy had, you know, sort of marginal, moderate, severe COPD versus, you know, no long disease at all. How much you would you lean more toward a teaching vow and someone who's long sicker? How would you post? Sure. I mean, if he has moderate to severe COPD, you know, depending on his FB one that certainly could push him out of the low rest ranges, STS would probably be higher. Um, we currently strongly discourage, um, tavern and bicuspid that low risk people, but we certainly will consider them and people that are high. Hi, intermediate severe COPD, especially on home attic. Taber candidate for us. There's good data with home oxygen use. Um, and then, um but if we like to do surgery, that would certainly push me more towards a tissue valve due to his life expectancy with moderate, severe COPD and, um, Hector, I wonder if you know. So we I'm gonna forward to the next slide. You know, we we talked a little bit about the calcium burden of bicuspid valve aortic stenosis. And and this is just to follow up on the patient. He's on eloquence. He's back feeling well. He's being graded in six. He's really long doing well. But e would like you toe you have some of the data that you shared with us in our discussions about the use of tavern, the success of Tavern. The outcomes in, um, this was based on calcium burden. Bottom line is that we know a lot about the calcification patterns on quantification of calcification by C t for for Tricastin aortic valves. But we don't know much for bicuspid aortic valves because, as Tom said, they have been excluded from prior studies. So so The first lesson here is is that C T needs to be the gold standard for evaluation of these patients prior to undergoing prior to undergoing cover on what they did in this study, which was just published by Yoon in Jack on by Rash. Marker is they did a systematic and blind C T core lab. Evaluation off 1000 bicuspid patients, or so okay with a combination of qualitative and quantitative assessment off pattern of calcium distribution, presence of Raffi and amount of calcification of Raffi on. As you can see, they divided the the patients in No no Raffi non calcified graphic calcified graphic. But they also in a quantitative manner, used the amount off total off total calcium or excess calcification on what they find out. If you see here in panels E and F or particularly in panel Left, this is a patient with exuberant calcification, including the Raffi and the belly off these cusp So and what they showed is that all cause mortality. Waas waas significantly increased that two years in patients that had both a calcified Rafic and in excess of leaflet calcification on. I think that that this talks a lot about the case that we just saw. There needs to be number one, in my view, studies off calcification patterns and calcification, accretion and quantitative studies of calcium by C. T. With the core lab to determine who are the candidates or who are not the candidates for Tavern in my custody rebel. And if you go to the next slide, this is another study that has been recently published from the Beat International registered with a lot of patients as well. And you can see that the death off balloon expandable versus self expandable there, on your right in match in a match cohort. Okay, it is about the same. Okay. However, as we have discussed, there was higher annual rupture in balloon expandable. And this was, uh, significant. And there was a higher increase off march severe proverbial league in self expandable. Such that, you know, way have I believe, before we attain state of the art travel, treatment and recommendation for patients with bicuspid aortic valve such that we can do a state of the art tavern randomized trial versus State of the Art Sabir, which we already know what it is. We need to improve these aspect. I think we'll move onto the next case. Thanks so much for that very thorough answer. Actor. Um so case number two is a 58 year old gentleman, 6 ft three B s, a 2.32 Had a navy are and eight years ago for with For by Kosovo stenosis. It was a 23 Edwards Magnitsky's hey was having severe symptomatic Prosthetic A s. He works on a ranch on one, initially chose a tissue valve because of lifestyle considerations with injury working on the fence lines. And he was somehow told when he had his original surgeon age 50. The vow with last 20 years he presented with class three class four symptoms continue working until he had a single absolute collapse and critical A s is STS Predicted risk of mortality was 0.7% and no risk of frailty. This is the echo images, and you can see the, um the cyanotic valve sitting in the order position. Reasonably good ventricular function, Pete grading of 101 mean of 60 the V max of 5 m per second. So clearly this confirms again the tourney leaf off the post and a lot of a I and N A s. This is just ah, coronal view of the C T scan showing the vow sitting in the native aortic root. So, based on this particular case presentation of details, we'd like you to answer from the audience. What option would you choose for this otherwise active, previously active person with a history of a biologic? KBR trans catheter valve valve replacement re Duke Surgical A VR with a tissue valve redo surgically mechanical valve or redo replacement with a stent lis bomb, prosthetic tissue valve. And so these were some of the discussion points that we in the faculty felt were important. Um, it was the one was the the application of Sabra versus Tavern? How does age affect longevity going forward? The likelihood for ppm in a patient that was already of large stature and and and the the implantation of about previously 23 size, um, tissue vow the management of cumin and young patients and and and ultimately, you know, over a life. So, Tom, when if you saw this patient, how would you What would you What are your thoughts on as you think about the options for him? Yeah, you know. So, first of all the disclaimers, I actually been a big fan of trans catholic technology, but I think we have to know the data behind that in in similar to the the last kind of message. I think a valve valve is not the right option for this patient, particularly because he's still relatively young and relatively low risk. I think there's not enough data out there. There's not a durability data out there for valve in now for us to make a, uh, the right decision in someone who's relatively low risk. But there actually is a fair amount of durably data under the redo, uh, Sabir on this patient and knowing what to expect. Eso So we know from the valve valve registry. About 30% of patients who get a valve valve have being great and greater than 20 but we know that we do a redo operation. We do writing and the necessary route margin. We can get the greatest down to at least less than 10. So I have again honest conversation with this patient. My inclination would be to do a redo. I'd probably put a mechanical valve in again because he's relatively young on and try to get the largest about possible in, uh, when I can and not have to worry about, uh, the operation or not to worry about a redo operation in the future. Jim, if you saw this patient, um, would you attend Val Val Tavern, would you send this patient when your surgical colleagues for redo a PR Well, I think solely based on age, I mean, age alone. I almost don't have to see anything else before I ask myself, Why can't the patient have surgery? I mean, I I agree with Tom that we we can valve involve tavern is relatively easy to do their a few. It would be nice to see that some of the c t planning to look out for a handful of an atomic pitfalls. But, um, especially in a what was a 23 surgical valve in a 58 year old you're gonna you're not going to end up with optimal Grady INTs regardless of the technique you use, regardless of fracturing the surgical valve frame, Um, and your you're kicking the can down the road. In my opinion, if you did evolve, involve tavern rather than solving the problem, hopefully lifelong for the patient Doctor, do you agree with Jim? I I agree big time with Jim, and I think, and I think that it is, it is critical because the audience was asking this. You know how how do you convince the patient to do the the right thing? Well, I think the younger the patient is this guy's 15 years old. The lower risk the patient is, the more you have to go to the truth and be honest and tell them what you really think you know and that then it's when it becomes important to put yourself and say, this is what I would choose for me. This is what I would choose for my father. This is what I would do because of this and this and this, and you show the data to the patient so that they understand. I would definitely try to percent aortic valve replacement with the mechanical valve as potentially a definitive solution for this patient. Yes, And so I think the important points from the audience are that are coming from the Panelists are that one? Just because you can do something doesn't mean necessary should do something. I think one of the nice things about the palaces we've got both surgical and interventional viewpoints and and all seem to be in agreement, at least for this particular patient that surgery is the better option. We know from large Siris of national databases will single institutional studies that redo a VR in otherwise healthy patient. A young patient is associated with low operative of risk. So in terms of the panel of the audience, I think the majority feel that that this patient should have a redo a VR surgically go with mechanical. About two thirds of the of our audience. A low percentage on Lee. One patient, 11 person voted for a VR with a stent ID about prosthetic valve. 13% voted for a stent lis Bob prosthetic valve and 18% chose valve, valve, uh, tavern the channel. Can I add something real quick? You know, I think what we really don't know is, uh, Taber valve in Val versus redo surgery and maybe intermediate risk patients. I think it's a high risk patient. It's pretty obvious we should do a valve valve in the pace is not gonna be around very much longer. And I think there is a huge opportunity for research in this arena. We don't have really any data comparing reduce surgery versus tavern valve in valve in a non meta analysis observational type study, and I think there is a huge opportunity to try to learn more from that. Absolutely. And And I think that, you know, one of the things we do know is that in some of these, um, uh, Taber Publications, we do know that the the leaving a patient with ppm is associated with worse outcomes. So that's extremely important. Especially a robust, active person. Catherine, maybe you. Could you You were the observation of taking care of this patient. Maybe we'll talk through the treatment options or what you did here. Yes. I think you know the key point. I obviously agreed with everyone in the panel and the attendees. I was really trying to push him towards a mechanical valve. And I went about that three different ways. One was the longevity of a tissue valve. Obviously, he was kind of erroneously told that it would last 20 years. But we all know that younger patient unless it's gonna last. So I think once he had only gotten eight years out of the valve that that helped. Um, because we're not just looking at two more valid. You're looking at three or four in him. If he continues with the same pattern, um, in terms of ppm to I think it's important to mention that if we had gone back and put another tissue valve in a 23 is still relatively small for a man of this age on DSO a mechanical valve also offers, Ah, hire a away for the same size. And then, um um, you know, I talked with him about human Coumadin management with her newer valves like the Onyx about a lower in our, um he was really pleased about that. One of his main issues with getting a mechanical valve. We're in Texas here Was that when he was deer hunting, he was afraid that the deer would hear the ticking. I'm not joking. And so I had to get a valve and bring it in his room and and click it at the door on having figure out if you thought the deer could be able to hear that or not. So that was the final straw that we had to get to get it in. So we did indeed do a, um, I do all my reduced through many, too. So he was pleased about that less pain and get back on the ranch earlier So we did him through a minister Anatomy radio and put in a 23 Onyx. So a straight 23 for 23. But again, that has a better e o A. Than a tissue 23. And then hey was discharged on post update for no problems. So, um and then obviously we'll keep him at a 2 to 3 I in our for three months. And then we will go down to the 1.5 to 2 and I'm also a p I in the proact trial with Doctor Misha Lena. So hopefully we will maybe enroll him in that trial after three months as well. And one of the nice things about the product. 10 8 trials and you could random. You can re roll patients retrospectively e I said eight yards. I think it's, uh, we all look forward to those results and the onyx filed Aziz you alluded to as great human dynamics and one of the nice seasons FDA approved for Einar 1.52 after three months. Gentlemen, if this patient had previous cabbage, would you have gone through really do many because I've done that and gotten into some bank graphs. I'm just curious is just redo isolated. Er what? What kind of do? All my readers, even cabbages through a mini. So far, so good dog, then, um you know what about Tom? I just let the memory beat. What? Tom the You know, one thing we haven't talked about is the Ross procedure. And and, you know, where does the Ross fit into your overall treatment paradigm? And I'm gonna ask Captain the same thing in terms of treating patients like this that you know, robust person, potentially lifelong solution. A suit. You have excellent survival. Otherwise healthy patients. You might be a little bit of older side, but certainly there's centers in Canada and other places in the world that have used the loss into an outstanding results in patients over 50 years. Raising. There's, um uh there's I think there's publications for coming on that, But would you consider the Ross in a patient like this? And if so, what criteria you to include exploitation? Yeah. Thank you. You know, I think the theme is for us to know the data and then really kind of have a shared decision making process with the patient I think the Ross is an excellent option for was an excellent option for the patient. His first go around because you have some data. Pretty good data in younger patients. Get a Ross and some durability data. Um, there's not as much data for Ross and redo operations on, and technically, it's gonna be a little more challenging as well. So this patient, I probably would not do a Ross redo, but the first time go around and relatively young patient, I will definitely entertain that option. Catherine, how about do you heard that? Was the Ross ever part of the discussion with you on this page? Yeah, we do Do select redo Ross's as well at my center Were pretty aggressive with the Ross. Um, I find with that, like Dr Nguyen was saying, it is a little risky or I tend to save it for say, you know, the younger females who are still trying Thio. You know, Conceive, I've had a couple where they put in, like, a 19 tissue valve, and they had ppm after two years, and we switched out to a Ross when they were still in their child bearing years. Um, so I think that's certainly an option. But it definitely the technical aspect is much harder in a radio, and it should be reserved for, um, experience centers. We also I should note that as he is old bicuspid valve, you know, the air top of the extends to the pulmonary artery is well, so when you do a Ross and a bicuspid patient, we do all of our supported. So we put the Allah graft in a Dacron graft, kind of like a pre David before we saw it in. And we've had really good results with that. I think one of the challenges eso I think significant portion of the Rosses I've done have been in reduced previous tissue, a VRs that then became cyanotic and there was no evidence of a auto pithy. One of the challenges is digging out the AP window. I think the autonomy, depending on how I was done, basically they use pledge it's can erode into the poor majority. You can injure the cotton autograph potential autograph conduit, so that's something to be very mindful of. Yeah, I definitely take note of pledge. It's on the C T scan. The little cotton forest you can see sometimes, right? Yeah. Um, Hector? What? What do you in a patient like this? Um, do you have, ah, mechanical valve or tissue value of choice for these type of a mechanical valve? A choice for patients like this, That that we're gonna have a mechanical valve. You always use the onyx valve. And you what is your institution? Paper, You know, to be to be very honest with you, I work a lot with bicuspid aortic valve patients on with patients with the autopsy and patients that are going to require, you know, specific treatment for these things on. I worked with two surgeons that are bicuspid, and you're a specialists, Andi. And the reason why we're participating in the trial is because we have so many patients with chronic Stop. You know, Catherine, we have Ah, One question from the audience I think would be very useful for the surgical attendees. And if this patient had, you know, in a redo, many, um, in this patient has severe ai. And you know, how would you How did you end up initial protecting heart Did use retrograde anesthesia place retrograde catheter. Or how did you protect the heart. Yeah, we have. Ah, very good anesthesia colleagues here. So, on all of our minis we placed both they and a vascular pulmonary event And, uh, Onda Vascular retrograde coronary Sinus catheter through the right eye J S O. I do have a retrograde in. Luckily, eso I like to give maybe one or 200 cc is just to get some some ai down or some an a grade down at least the colonel branches of the right coronary that are going to get good, Retrograde Onda As soon as the heart federal later, start speaking, I switched to retrograde that normally only takes one or 200 And then I give hand held down the right Corrine areas well, after I open my autonomy And what what were the Grady INTs at after the at the end of the day? You should ask I have a slide right here. So here is the post up is actually t e t t. And as you remember, we were 106 max and, uh, 60 to me. And now he's down to 12 and seven on DSO. You know, if we had used a tissue Val we probably would be closer to 10 maybe above 10 when he was awake. So, you know, that's another thing that I look at when I look at people. If they're on the border between tissue and mechanical and they're asking for me to push them one way, we do Taber cts on everyone pretty much. Who's getting an aortic valve so I can see what they're annular sizes pre up. And if I know say they have a higher B S a but a smaller Angeles and they're on the border, I will push them towards mechanical valve. Just a maximize anyway. Yeah, absolutely. And you know, how would you? So in the mechanical valles, um, chicken, onyx Or another time, I like the an atomic or the conform cuff of the onyx. So those were designed to be put in Nani burning or ventricular toe aortic as opposed to the thicker inner tube cuffs, um, on excessive stuff like that in the ST Jude's that are meant to be put in intra annular and so e burning. But I like the conform or the an atomic cuffs so I could do it. Nani burning and not lose, essentially a size by that diverting, so that maximizes your size as well. How about pledges versus no pledges? I'm no pledge. It's E u pledges and no budget. You know that. That's a good question. I've been transitioning to know pledges. There's a paper I've read somewhere recently, um, showing that there's lower ingredients. If you don't use pledge, it's Andi. I think you know now that a lot of us you guys use corn nuts, you know, I think now they're using corn nuts. I think it's actually rare. Very, very, very, very, very, very well to get PBL. There's been studies with that, too cool study people using corn, not people tying if he's core not from medical student does on the not are consistent pressure and a higher pressure circle French Lee. Then you tie. As many of the surgeons out there know when you're tying, especially around the post, especially to have a resident fellow do it sometimes behind that post, it's a little bit hard to get that not to really sit. So to answer your question, I I'll use court not, and I'm increasing not increasingly not using pledges because I feel pretty comfortable that I could get a nice tight seal. E. Just expose them to Panis later down the road and mechanical valves. Although the depends on the which valve you're putting in the hinge, Dr Tender used budgets we have e do not use players at all, because for the exact cause, I the pleasures caused turbulent Eddies. And that means we've taken out valves that have had the core. Not that has some pants on it, although it's on the aortic side. You know, one of the things is very. It's very interesting when you operate on the patient that's had a previous A VR either tissue versus mechanical and and and you cut the knots and pull them out there Sometimes, as you said, time, they're very links. So that means sometimes they were air knots and not since down all the way, and sometimes they were done just right. So sometimes the knots of this long, sometimes there, that long on the same patient. So you felt a lot from the bottom up how the work was done when you go back in and effective. So, Hector, you had some shared some nice slides about we all. I think a lot of us are aware of the New England Journal paper from a couple years ago looking at teaching for mechanical valves. Ah, large California database. Maybe have that data real quick with Look, I think I think it's important to remember to remember the audience that when you are when we're giving patients valves, we're giving them another disease. It's just the disease that it's lesser than the one they have right now and that hopefully will not kill them. Okay, so So we need to look at what the data is out there. And if you and if you go to the to the to the next slide, that New England Journal of Medicine article from 2017 should be there. But But I would like to remind the audience that too big randomized trials where, of course, the V A trial on the Edinburgh trial on those showed, of course, more bleeding with Coumadin on more degeneration with with bio prosthesis, it is now shown that the Trumbo embolism affect both valves about the same. And this is a interesting study because it's an administrative database and, you know, I think I think it's very important because it tells you the limitations off it right off the bat. You know, of course, when you're doing things through through I c D codes, you know you can miss. I see decoding, of course, on it utilized inverse probability waiting, which is a what form off a making. Both groups have the same prognosis, but of course it is not the same as a randomized trial. It covered a tremendous amount off time and Fraley was not fully assessed. But it's interesting what it shows, especially in light of previous off previous data. So if you go to the next now it is important toe. It is important to understand that the V A trial and the Edinburgh trial showed no difference in mortality. Initially, however, one of those trials was followed further into much longer period of follow up and showed that patients with mechanical valves had a survival advantage. Now people may think that I'm showing the slides because this is a CryoLife presentation. Our data from the Mayo Clinic U utilizing matching okay, propensity matches also shows that there is a survival advantage with mechanical valves over biologic. But this particular trial, because you can see showed that there is a a probability of death larger in biologic for particularly the younger people, you know, 45 to 50 to 54 years old. So somebody in the audience was asking, you know, this patient was 50 when he got that that biologic valve, and it's coming at 58. You know, this patient clearly was not done a favor by their physicians in recommending a or being happy with a bio prosthesis when he was 50 years old. Now he faces a reduced anatomy with the risks that that brings, and you can see clearly that the risk of death is increased in biologic, particularly in the younger patients less than 50 year old patients. You can go to the next one, and it is important to know a lot of these. Less than 50 55 year old patients are bicuspid patients because they have early degeneration off the valve number one, and because number two aortic regurgitation presents at a very relative early age in patients with bicuspid valve in their forties, you don't goto the next one. I think that's the last. That's the last one. Um, well, that's that You know, that's very interesting data, and I think it's a very important as we consider all the options, because I think is we think about young patients in their forties and fifties. You know, you're not just thinking one intervention. You must think about the next. The second, even the third potential intervention was you weigh out these options, so that's very important. I'd like to ask the Panelists if there is any other closing comments that you may have related to this case or the previous case. Jim. Well, I think we've highlighted the importance of age. I think those slides were appropriate to end on in particularly younger patients. Um, with surgical options there, that's the proven therapy. There's more data available. Tom highlighted very well earlier that in low risk all the low risk trials all the tavern trials by Customs have always been excluded. We finally got one or two that you know, have some really small, um, continued access availability to bicuspid valves. But those weren't even randomized, actually, so it z we needed as physicians, when we recommend therapies, we need to understand what data is available and then really, uh, take all the factors into account and sometimes what the patient comes for. Ah, you know, if they're asking for whatever, that's not always the right choice and how toe carefully guide them. Ah, towards a decision for what it truly is. A better therapy is kind of an art form. The different techniques you use. Catherine, you have any comment at all? Yeah, I just think, you know, not all by customs are created equal. I think there are some Seaver's ones that are practically like a try leaflet. And there's some like Dr Stewart's case, we have a lot of calcium and a lot of L bot calcium, and that could be quite, um, quite difficult. So I think Dr Michelle and slides about the calcium pattern and the burden of calcium are really important in these decisions. Andi, I'd like to also say I think the heart team concept is key. When we see all of these patients, we see all our NPR patients in the same clinic. And when I tell them the you know, the surgical options to have the cardiologists sitting there agreeing with me that yes, you know, this is the best for you. Um with bicuspid valve at your age is I think it's very helpful for the patient to hear from both sides. Yeah, I think you're absolutely right. You have the heart team concept, you know, I think as we enter um, a zoo, we go forward treating these complex diseases. It should be disease focused. And and it's not. Surgery versus cardiology is how we tackle disease, multi display fashion. I think those are the programs that are really have shown that we have great success and outcome. Tom Love to hear your thoughts. Yeah, I'm gonna go with Dr Harrington said. You know, I think by customer isn't treated equally, and we know that they're different types of my custody. But I think the paper that Dr Michelin highlighted, I think it's worth reviewing again. And us, really, when we see a patient is by custody, we just can't say, Oh, just by customer. We really need to dive deep and figure out how much classifications there and try to stratify accordingly because there could be a difference in outcome outcomes depending on three distribution of the calcification on a bicuspid and the type of by customer disease. ER is the last point you know, I always try to hammer down is kind of what we know, what we don't know. And we don't have a lot of long term data even in these lower risk and intermediate risk patients. I don't think it's wrong to do thes newer technologies by any means, but I think we just need very transparent with our patients and let them know what we don't. We don't know what we do and don't know and then ultimately have a shared decision making process and do its best for the patient. After you started yourself with a little summary, maybe you just have the final word on your loss tonight. Well, I will. I will if I can, if I can share. If I can share my screen, um, I sharing it way. I will. I will just tell you this because I think Dr Harrington's comment was very important. These these valves are extremely different from affirmative IQ standpoint. Andi, if you look at the fused bicuspid aortic about the one with the three Sinuses, you can see that as Dr Harrington said, You know, there, there there, some of them are almost equally in terms of bicuspid ity, and some are very close to attract hospital aortic valves. Well on Do we need to understand these thes fina times? And we need a lot of study in my, in my view, to come to a state of the art use Off Tavern in bicuspid aortic valve, which will lead us to do a randomized trial comparing tavern for suburb in in bicuspid aortic valve. I'm gonna on share. I think it's important that the the anatomy morphology of these vows is on a continuous spectrum, and I think it's discuss intervention, particularly trans catheter interventions. It's important, very specific in terms. What morphology specific AnAnd an atomic features were discussing? Well, listen, I want to thank all the Panelists. It's clear, as hopefully the audience has been able to glean that these air recognized experts in the treatment of by custom album Structural Heart Disease. I want to thank Jim and Catherine for providing great cases for robust discussion, actor for the background and Tom, you always give insightful comments. I always learn something for you every time. I also want to thank wildlife on the crowd. Large staff on the whole team across life for their commitment to excellence and patient care as well as their commitment to education, as evidenced by sponsoring this very nice webinar. So with that, I wish everyone a pleasant evening and we look forward to seeing you guys in person one day either at choir life or it's some meeting. And hopefully we can make virtual platform in the future a supplementary, not the main way that we interact and exchange educational ideas. Thank you very much again. Thank you, everybody.
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