Chapters Transcript Video Structural Heart Case: Mitral This is uh I have no uh direct disclosures, but this will include some uh off label uh discussion. So this is a 72 year old with long standing persistent a uh a FIB and CKD. She came in with progressive shortness of breath resulting in three prior heart failure, admissions at another hospital and had uh this echocardiogram. And so um Doctor Cohen uh looks at these all day, both in three dimensions and in two dimensions. Um The higher points here, Doctor Cohen. Um what are you seeing from an advanced imagery standpoint? Yeah. So I mean, just, just looking at these images, obviously, the the micro valve is significantly calcified. There's, there's a a significant inflow gradient. You see a peak in a mean of 38 and 18 there um at a heart rate of maybe 100 and 12 or so. So a little fast uh which is probably contributing a bit. Um Yep. Yeah. So uh small LV, um like you said, terribly calcified mitral valve, uh There's two different variants of mitral stenosis that we typically talk about. Rheumatic and non rheumatic. The nonrheumatic is what we're seeing more and more of So, these are the, the CALC or mac related mitral stenosis patients. And this really is our last treatment gap within valve disease. We have therapies, both balloon based uh percutaneous and surgical therapies uh for all different valve uh disease and disease subtypes. Um The remaining ones that we don't have percutaneous therapies for established ones are the mitral valve, particularly when it's stenotic from non rheumatic disease. So, these are a common uh patient that they come into our structural heart office. Uh They tend to be people with renal dysfunction, renal disease and also people that have survived their initial valve problem, which is aortic stenosis. So, this disease uh state is really a manifestation of us being able to keep a large percentage of patients uh with valve disease alive for longer, having treated the aortic valves. And so this is uh this phenomenon is becoming more and more present as far as pathology because uh we are now 15 years into transcatheter aortic valve replacements. This is a tee that the patient subsequently got. Um Doctor Cohen. Uh these are some of your images during uh the the procedure itself that we ultimately end up doing and and beforehand. But, but similarly, you see the mitral inflow, not a whole lot changing here. But what you can see on the on the right is is something that Doctor Cohen does during these imaging uh procedures uh called 3D multi planar reconstruction. Um And I guess I'll, I'll ask Dave. Dave, you do a lot of uh mis and mitra repairs, but from a percutaneous strategy, uh I know we talked about there's limitations here, but there's a decent amount of mitra regurgitation. You take care of a lot of Mr what do you think about MitraClip? That's what our audience uh probably commonly sees us do for percutaneous therapies. What do you think about that in this, this kind of disease? Thanks, Matt. Um Yeah, my general bias is that almost anyone should get a MitraClip. But uh this is one that should not uh clearly this is a calcific stenotic valve. And if we put a MitraClip on that valve, we're gonna worsen the stenosis. So, MitraClip is not an option. Um This is really Mat's showing a case where he's really pushing the frontier of what we can do with transcatheter therapies because this is a, a very challenging anatomy to treat with transcatheter therapies. Um You can see there's, it almost looks like the patient has a surgical ring, the amount of mac and calcium that's on that valve. Um Transcatheter valve replacement is very challenging for the, for the mitral position. Unlike the aortic valve, which is essentially in a tube with the LVOT and the aorta, there's a landing zone for, for a valve in the mitral space. Uh We have to be number one certain that there's enough calcium in a, essentially a ring to anchor a valve and also, we need to worry about things like LVOT obstruction when we put a valve in. So, um, the transcatheter therapies for this patient are going to be fairly limited, I think. Um, but certainly a clip, anything that's gonna worsen stenosis is completely off the table for this patient. And then, and then that's great. And then Deepak, um, we do a lot of balloon based therapies for aortic stenosis. Um, I know Dave and I have done uh quite a few, a few balloon mitral vop plasty in mac patients uh with varying results. Uh but but can you walk us through why? A ABMV wouldn't be a good idea in this scenario. And so you got the structural heart team has tremendous skill, great guidance with the imaging. The problem with doing a balloon here is you have no control over what you do to the valve. And with that much calcium, you could easily tear and leave the room with much worse. Mr, you can see on the left side how much Mr you're starting with. If you leave this patient with four plus Mr and a torn valve, at the end of an attempt to make the stenosis better, you've really hurt them rather than help them. So a lot of places in the country there, there'd be no option for this patient. Exactly right. It was perfectly said by everyone. This is the heart catheterization uh that uh came as part of the work up, I have arrow signs there pointing to the, the mitra annular calcification that you can see. It's not the focus of the study. Obviously, um We will get back to the coronary angiogram in a minute. But the, the calcium is so dense. You can see uh just as Doctor Adler said, it almost looks like a surgical ring on 3D. There's no obstructive coronary disease. Uh The filling pressures were relatively normal for uh the disease state that they had some pulmonary hypertension, obviously, in a transmitral gradient, estimated by a wedged LVDP with borderline index by thick. And so, as uh Doctor Adler mentioned, our, our therapies for this uh really for, for MitraClip are are limited. That's our only commercially available uh transcatheter mitral valve therapy, but it's really reserved for mitra regurgitation because we're, we're trading stenosis for regurg uh the other way around. We're trading regurgitation for some degree of uh stenosis. And before we release those clips, we're commonly measuring and we're always measuring actually the trans mitral gradient. And so we have access and have performed several of these uh TMVR uh uh uh procedures through clinical trials. We have access to two of them. The Apollo trial is the Intrepid valve which is a trans valve which we've done a few months ago. Uh It's large, it's 42 French. Um And so it's a, a very large device. It is uh going down to 29 French. So it increases our options for folks. Uh but it is just like a tver transcatheter aortic valve only. It's designed for the mitral position, which is much more difficult uh to design because the anatomy is so variable. And on the right is something called encircle. It's probably gonna be the first commercially available device we have for transcatheter mitral valve replacement. And you create a dock with catheters first, it's all transept as well and then you deploy a tor inside of that dock upside down. And so we've done several of those, but the, the take home from those is that the screen fill rate, meaning our excellent research team, that is fantastic at getting people into trials. Uh If we screen 100 people, 80% of them, uh don't qualify. And that's nationally. And the reason for that is something that Doctor Adler mentioned is outflow track obstruction. So this gets down in the weeds uh with, with structural heart. But you'll see us comment on these things in our notes and they're not just made up acronyms. Well, they're made up acronyms, but they're based on procedures that are very important to mitigate some of the risks of doing these valve procedures. And so when we talk about outflow track obstruction, that seems to be the theme of the, the whole conference so far, even with the PC I, we showed a, a decompensated ho and patient, these patients don't have ho but we create subvalvular stenosis and what we call dynamic outflow tract obstructions, just like hom by putting a mitral valve uh into the ventricle. All of these designs require some uh part of the valve frame being below the mitral valve. And so the struts in the actual valve, uh obstruct flow out of the heart from the LV outflow tract. And so there's this is a life threatening problem. We can get through the entire procedure and plant the valve and the patient dies. It's usually a sudden thing where they have a significant outflow obstruction. Um but they die with a normal mitral valve usually, but we created a bigger problem than we were intending to solve. So that's why this comes into play so much to mitigate this neo LV outflow tract obstruction. If you look at that middle picture there, you can see where the flow increases along the thickening of the septum there. That's what we're talking about. It's creating a tighter space between the mitral valve and the septum. We can mitigate that in two ways. Just like we talked about earlier, we can do an alcohol ablation and, and reduce the size of the septum. This is in ventricles that are not thick though. So it comes with even increased risk of uh uh uh ventricular septal rupture or we can do an electrocautery based catheter procedure much like something you've heard of called basilica called a lampoon where we lacerate the ant mitral leaflet and as you're looking in the upper right, what that actually does by creating that linear laceration is that when you implant the valve, this was developed at the NIH about close to 10 years ago. Now, as you implant the valve, you can see its splays where that frame of the stented valve uh would otherwise block the blood flow. And so there's two ways to mitigate these. And so we worked, worked on those with this lady. And so uh Doctor Cohen, uh you, you also help us uh plan and are gonna be a huge part of our, our program planning for some of these more complex valve procedures. This is uh my rather rudimentary prep planning through terror recon of the, the CT. But can you just describe what, what we're, what I'm trying to do uh here with the virtual valve? Yeah, absolutely. So, um you know, as, as everyone has mentioned that the kind of dreaded complication of all of this is a, is a neo uh lvot obstruction. Um And what you can actually create is either a fixed or a dynamic um outflow tract obstruction. And some of that depends on where the valve falls and what the leaflets do. But you're essentially creating a, creating a covered stent um in that area. And so if that, that area is not big enough, you can create an obstruction. What we're doing here is um you know, so we take full phase or retrospectively um uh acquired CT scans where we can get all of the data from, from all phases of the cardiac cycle. Um And then what we do is we actually simulate with a virtual valve implantation. What that valve area would be um We tend to do it in um in mid to late Sicily. Um And we put the valve in the size that we think would be um optimal. And then with uh 3D reconstruction and multiplanar reconstruction, we measure the outflow tract in the area where we think it would be narrowest. Um And I would say this is this is kind of standard in terms of what we've been doing to screen these patients. Um Anything less than about 200 you'll see various cutoffs, um 200 centimeters squared. Um You'll see various cutoffs for trials and whatnot. But we tend to worry then and, and think that we may require some sort of um either leaflet modification or septal reduction therapy. Um Perfect. Yep. And, and so I tell folks, uh just as you mentioned that we're doing the procedure virtually several dozen times before we ever touch them with, with uh numbing needles. And we really are. But the, the, the simulations um have been rather rudimentary. We're taking static embedded geometry and putting it inside uh the CT scan and measuring the surrounding structures in multiplanar. Um You see on the top row, the third from the left uh right under the Neo LVOT. That little sliver is something we manually measure called the out neo LV outflow track. And as doctor Cohen said anything under 202 150 is severe. Hers was 100. And so we have a lady that's at 72 screen failed for TMVR trials. She's been in the hospital three now four times if we try to fix her mitral valve. First of all, we don't have anything through clinical trials. So she's either going to pass away from this and, and not in a good way with her current heart failure admissions, we're gonna have to figure out a way to treat this lady. Um And that's what we did. So the first consideration uh is, is that we, we would have to do a valve and Mac and so Mac is mi annular calcification and on the spectrum of things we do in uh structural heart, this is the most complex procedure. Uh We typically do. Um but we're a basically anchoring. We've traditionally in an on label now treat degenerated surgical mitral valves. So when someone gets a bioprosthetic surgical mitral valve and it wears out after 10 years, which is the, the median we put in a tover upside down, we deliver it trans separately, it's the commercially available TVER, but we turn them upside down and deploy them in the mitral position. That is the standard of care for degenerated mitral bioprosthetic mitral valves. And it's now on label for degenerated rings as well. So we have apps and a lot of off the uh on the bench testing to guide which, which ones we do. But Valve and Mac is still off label and it's only considered in situations like this where we don't have any other options. Now, unfortunately, with her, she, she's gonna have an outflow track obstruction and we talked about leaflet modification, which we would plan to do in this scenario, but we don't have good candidate septal for sept ablation. And so really, they're too distal, you can see it's beyond the calcium ring. And that first septal which is highlighted by the, the uh yellow arrow there first before it pans down is a little bit too distal, a little bit too long, a little bit too big of a territory. So now we really don't have a way to fix this lady. Um But fortunately, we have excellent colleagues at our uh center like doctor Doctor Patel who are capable of doing uh things uh beyond the standard. And this was the sixth case performed in the country for this all five. You can see in that case report, there were done at Emory where they developed a way to do an endocardial ablation of the septum for more targeted reduction in outflow track. And that really allowed us as you'll see to do this procedure and help this lady who's alive and well and at home and has not had a a heart failure admission. Since what we're doing in Alvin Mack is we're taking it to tavern, we're turning it upside down. This is the next step of what we're incorporating into structural heart. So this is the most advanced preprocedural imaging and simu simulation that that's currently being done in the country. And instead of static embedded geometry, we're actually incorporating tissue deformation and a lot of uh artificial intelligence and machine learning into the predictions of some of these out uh complications that come with all of our catheter based therapies. This is their company which we've aligned with pretty closely. And on preprocedural simulation, actually putting in a 29 S3 valve with three CCS of fill volume. They know exactly what radio force that has on it by, by biophysical uh simulations. They know exactly what the leaflets are gonna do and simulate what the leaflets will do and they can simulate it with and without basilicas. And after the scorpion procedure, we, we started working with them closely on our bowel and valve tor in our complex uh cases and we sent this to them. And after the scorpion, the Neo LVOT was now 330. And so we actually did not have to take electrified wires into this, this lovely 72 year old lady's tiny heart and risk all the complications that could come with that. Uh because we did the endocardial ablation. Doctor Patel did. And because we had more advanced uh preprocedural simulations. So this is the actual procedure and this was Doctor Cohen's uh literal first day. Um But this is what this looks like uh on Fleur, what I used to see and what I see now. So, um on the left screen there, this is a, a catheter in the left ventricle. I'm just doing an LV gram. So you can see the calcium uh on axis uh there in the, the, the plane, basically the A V groove and the, the dye coming out of the aorta. I've got a catheter across the intra septum. On the right there is a is live 3D multiplanar imaging of the trans seal. And then a septostomy to get the catheters in, we have to create a hole and then dilate it um across the intra atrial septum. And so you can see those balloons going up there in the upper left. This is live, I have to cross that narrowed valve with the pig tail. And I can literally with these 3d M pr, I can see my catheter, I can clock and counter clock and I immediately see the catheter move, waving the catheters at uh the imagers and and the procedures because the resolution is so good nowadays. And in the bottom left is the actual deployment of that valve inside the calcium. And what that looks like on fluoroscopy. So we shoot for a 9010 ventricular deployment. And that's because the migration forces and, and a closed valve are towards the atrium and we want to flower or uh um flower pot, the valve out and flare it. We ended up with an excellent result, zero PV L no leak, a grading of four. And as predicted by the simulation, we had no LV, outflow track obstruction. So on the left there, you see no gradient between the aorta and the LV, we had to close the uh in atrial septum after the septostomy. I just thought that was a great picture of, of in uh 3d M pr doing uh the transept closure the two months follow up. Now we did this case in, in uh August, she's completely asymptomatic. We saw her back in the office. She's doing incredibly well. She was in street clothes, uh makeup on, she looked wonderful and so all good news there. So to summarize calcific mitral stenosis and mixed MS Mr are really our largest treatment gaps. Now in in structural heart, it's the things that those patients typically do not have surgical options because they're high risk and prohibitive uh from comorbidity standpoint. Uh but we also don't have any purpose-built treatments for them just yet. Um We have trials but they are plagued with high screen fill rates. And that's because of this concept of outflow track obstruction, which again is the theme of this conference. We can address that by leaflet modification or septal reduction and TMVR with TVER devices can be used on label for valve and valve and valve and ring in uh extreme scenarios where we literally have no other options for patients that are gonna die otherwise or struggle suffer. Otherwise, we do have the capabilities. Thanks to our, our multidisciplinary teams and how collaborative this process is amongst interventional cardiology, ep and CT surgery to tackle these very, very complex problems. Thanks. Published November 14, 2024 Created by Related Presenters Matthew Summers, M.D. Sentara Cardiology Specialists View full profile