Dr. Summers reviews guideline-directed indications for transcatheter mitral interventions and examine real-world cases from the Sentara Structural Heart Program.
All right, we'll, uh, we'll go ahead and get started, um. I was online. I'm, uh, Matt Summers. I'm the, uh, medical director of Structural Heart, the co-director of Centaura Centera Heart Valve Center, and, um. I'm, uh, happy to show some recent cases and, uh, that, that we'll use as a framework for how we're approaching mitral valve disease here at Centera. Um, this, uh, comes with an incredible amount of work by our team in the background. Doctor Kemp is here as a surgical director, um, and we'll go through some of the data on, on surgical therapies which are really the, uh, the tried and true and established therapies for the vast majority of patients. So a lot of what you'll see here for trans catheter mitral valve therapies are reserved for patients that are at high risk for surgery, although there's newer trials that we'll go through that are sort of tipping that balance a little bit and and opening options for more and more patients, um, but an incredible amount of work done by our cardiac imagers, in particular Josh Cohen, um, where we'll show a lot of cases which um the advanced imaging has really allowed us to. Increase our capabilities by an order of magnitude in this past two years. Um, and so I'll, I'll highlight how we're doing current commercially available therapies like Mitroclip um and Tear, but also highlights how we're taking on cases that still have pretty large treatment gaps, patients that don't have surgical options. I was just giving Doctor Cohen a kudos about the imaging. I'll highlight a bunch of cases he just walked in, uh, but an incredible amount of teamwork in the background. That allows us to take care of these really sick and complex patients that are in our community and provide curative and symptomatic improvement for patients, oftentimes without other options including surgical therapies. So the, the learning objectives here, I, I want to create, um, or provide a framework for how we're, um, classifying mitral valve disease and how we approach it and where trans catheter mitral valve therapies fit within that framework. I'm gonna review what we have as far as guideline directed indications for the trans catheter therapies. Again, it goes outside the scope of this, uh, talk to include all of surgical therapies, but again, they, they remain the mainstay of, uh, mitral valve disease therapies is surgical therapies. Including mitral valve repair, which is really the pinnacle of, of what we can provide surgical mitral valve repair for patients, uh, in particular with a degenerative or prolapse myxomatous mitral valve disease. I want to highlight the evolving landscape of these therapies and examine real world cases that we've dealt with here at Centera to highlight how we're approaching these treatment gaps in patient care, so patients that don't have surgical or trans catheter commercially available options. This is our mitral valve center here that Doctor Kemp and I, uh, co-run. We're one of the largest mitral valve programs in the country, um, both by trans catheter and by surgical therapies. Um, our our surgical volumes increase in relation to our trans catheter volumes. And so as, as we're evaluating more patients, getting more patients referred, um, it, it builds the volumes of both um. When you look at our microclip volumes, our program did, uh, our 1,000th microclip. and Marty, you were involved in some of the original ones, uh, back in the day, uh, but we've been doing this since 2014. Um, we do about 100 a year. Our volume, uh, has, uh, split to include a lot of trans catheter tricuspid valve, uh, tri-clips and, and tricuspid valve repairs. But the mainstay of our commercially available, uh, catheter, trans catheter mitral valve therapy is a micro clip or Mtier. Um, and we do quite a few of those with very, very good outcomes. You can see in 2024 we had two surgical conversions, I'm sorry, two mortalities, but haven't had a surgical conversion since 2021. When you look at this in the scheme of our national standings, this is through three quarters last year we were the number 11th, uh, program by volumes that ended the year with a busy Q4 at number 8, but you can see our, our standing in relation to several other programs, uh, Harvard, Cleveland, um, you do more M tier than Columbia, ECU, Morristown, Mayo Clinic, um, certainly the highest volume in the state. Um, what the takeaway here is, is with the, the our approach to mitral valve, uh, eclipse, M tier. Um, we have an average device time of 40 minutes, which is shorter, much shorter by about 10 minutes than the national average in spite of using more clips, and we get a larger MR reduction than the national average as well. And then of course again outside the uh scope of this talk is our our excellent surgical outcomes um where we do a significant number of uh uh surgical mitral valve replacements and complex repairs. So when we think about mitral valve disease it really uh uh boils down to uh mitral regurgitation, mitral stenosis and the cardiologists understand this framework for the non-cardiologists in the in the uh on the phone and. Uh, in the audience, um, I tell folks there's only 4 valves and the valves can be leaky or narrow, and so there's only so many iterations of, of valve problems that we have to deal with from a mitral valve disease standpoint, a lot of patients sit in this mixed mitral valve disease classification, and that's where a lot of problems come from as far as uh what trans catheter options are available to them. We think about mitral stenosis first. We're thinking about rheumatic mitral stenosis, which of course is a byproduct of rheumatic heart disease or basically an old strep infection where the immune system attacks the M protein on the mitral valve while it's fighting the streptococcus bacteremia or bacteria, something called molecular mimicry, which we've all learned about, and then calcific or mac related mitral stenosis are the two classifications. With an MR you'll hear us talk about primary or degenerative MR. Those are problems with the leaflets themselves and secondary or functional MRI. Those are byproducts of the annulus being dilated. And so I tell people that the mitral valve is a double door that meets in the middle with a doorstop. And you can either get abnormalities in the doors where they don't overlap correctly or come together in the middle to meet correctly, or you can get dilation of the door frames without the door, and so you get leak in between. This is an example of Rheumatic and calcific mitral stenosis, you get this hockey stick deformity for rheumatic, the doming of the anterior mitral leaflet. This is one of our patients from this past 6 months, or you get calcific mitral stenosis, dense calcification, uh, circumscribing the annulus of the mitral valve, this characteristic spectral inflow pattern where you get this top hat appearance and increased mean transmitral valve gradients, uh, typically. This is 3D NPR of those two cases as well. You can see you get a fish mouth deformity, so the, the hallmark of rheumatic mitral stenosis, you get, uh, commissal fusion. So the corners of the mouth, the mitral valve is like a, a smiley face. You get fusion in the commissures and by and large balloon-based therapies and structural heart. Affect commercial calcium that's both in the aortic valve and in the mitral valve. And so when you have a disease that affects preferentially the commissures of the mitral valve, it makes sense that balloon mitral valvuloplasty for rheumatic mitral valve disease is a very effective therapy. But this is the more typical and more common scenario that we're combating older patients, patients with CKD end stage renal disease, circumferential mac that surrounds the mitral valve and basically creates a very tight narrowing that impairs blood returning from the lungs to the LV. When we think about mitral stenosis, our first established therapy is balloon mitral valioplasty or balloon commisurotomy. This has been done since the 80s and we've very clearly defined which patients it works well in. You'll hear us talk about a splitability score or a Wilkins score. This is a 4.4 type classification scale, so up to 16. That describes the complexity, anatomic complexity of the mitral valve of the rheumatic mitral valve. You can see how we score that. And what's important to take away from here is that if you look at the time scale of the results of a balloon mitral valvebuplasty, we're talking about 1520 years in patients that have low Wilkins scores that we get effective result with. And so um we have an established therapy which is balloon mitral valveplasty, but it's not effective in calcific mitral stenosis, which is a much more common problem nowadays than rheumatic heart disease. For the calcific mitral stenosis, we have therapies, but they're very, very difficult. They're very, very complex. We have TMVR trials which are plagued by screen failure. We have almost a 90% screen failure rate for our trans catheter mitral valve replacement trials. So this is us trying to create a TAVR type equivalent for mitral valve disease, mitral stenosis or mitral regurgitation. But one of the unique anatomic problems of the mitral valve is that deploying a new stented valve in that area can really cause a lot of problems with outflow out of the heart, and so we'll talk a little bit about that. It's called uh outflow tract obstruction which can be a lethal problem. Um, to date we've done 3 of these mitral lithotripsy procedures. These are shock wave or lithotripsy balloons across the MC valve, and then we can do valve and mac. We take a sapient, uh, uh, taver valve, uh, turn it upside down, um, and deploy it across the circumferential mac. So those are the options that we have for calcific MS. That's really a treatment gap that exists right now because we don't have effective clinical trials that have, uh, high enrollment or or don't aren't plagued by high screen fail rates. We have some off-label treatments including al and Macine VR and Matrix. For MR, though, uh, about 60% of the total population of MR is this primary degenerative, so when you see prolapse, P2 prolapse, flail, that's what we're talking about, a problem with the leaflets, myxomatous degeneration. It comes in several different types. On a spectrum from fi fibroelastic disease to flail, so FED plus form frust, and then Barlow's valve, when you hear us talk about that, that's bi leaflet prolapse, very complex valves. The priority is, is almost always to repair those, but obviously if patients are in their 80s or 90s, they're not going to be good surgical candidates, good substrates for recovery from a stronotomy. The other problems that are primary in nature, of course. If you think about prosthetic valves when they wear out or repairs when they wear out, that's a problem with the leaflets themselves, even if it's prosthetic material. We have AV canal defects which can be a spectrum of problems from, uh, abnormality and and and uh formation of the endocardial cushions and typically you see that with this with an anterior mitral valve cleft. It's a congenital heart problem. We have manifestations of infective endocarditis, all that fit under the primary degenerative MR category. And then secondary is really like I mentioned, the door frame stretching without the doors. The most typical form of that is ventricular functional functional MR. This is where we have the largest evidence base for mitral clip. It's when you get apical tethering, a dilation of the LV, and it basically pins or tethers the leaflets to where they don't coopt on the mitral valve. But there's this evolving and, and ever increasing, uh, increasingly frequent, uh, concept of atrial functional MR. So the old days of race and affirmed trials where we just. Kept people with rate control afib indefinitely if they weren't symptomatic. What we're seeing nowadays is the byproducts of that. It's massive left atrial dilation and a very difficult subset of functional mitral regurgitation to take care of. The leaflets get splayed out and they're flat and it's very hard to clip an AFMR case. So now we're more aggressive. We have more capabilities with our EP colleagues to ablate and cure AFib in a safe and effective manner. This is our typical uh micro clip case. You can see we take a patient with anterior flail and torrential MR and we eliminate it with a micro clip. And so that's our bread and butter what we do about 100 times a year. Again, uh, 60% of patients overall have uh primary MR 40% have secondary, but of the tier that we do. About 75% are functional and 25% are degenerative, and that's because we push appropriately so the patients that can undergo surgery to mitral valve repair and that's because you can get a 20 to 25 year result with an effective mitral valve repair. Here's our guidelines. We really don't have any guidelines for the treatment of calcific mitral stenosis. Um, it's, it's really that there's no BAV or BMV data. That's a 2B indication for patients that can undergo a very high risk surgical procedure. Again, they're mostly elderly CKD patients with pulmonary hypertension, high comorbidities. For rheumatic MS, the guidelines do preference, especially in patients that have good anatomy, low Wilkins scores. A BMB or PBMC, a commensurotomy as it's called in the guidelines, um, even in patients that are not surgical candidates but have, uh, less anatomically suitable valves, it remains in the guidelines just with a lesser indication. We all know these repair guidelines or the the primary MR guidelines that even in patients that are asymptomatic without negative remodeling, if we can ensure a low likelihood of mortality and a high rate of successful repair, if you do it at a center of excellence, it's still in the recommendations as a two-way, um, but if you get negative remodeling or if you're not a surgical candidate, it's reserved for trans catheter therapies. This is important here too. Secondary mitral regurgitation is now included in the guidelines, and it preferences patients with an EF of less than 50%. Towards trans catheter edge to edge repair is a two-way indication unless there's unfavorable anatomy. And that's because by and large it's difficult to get even in the best hands a patient with reduced EF through a stronotomy through an open heart surgery. And so our guidelines currently established to give you the lay of the land for mitral valve therapies, uh, that we have BMV for severe symptomatic rheumatic MS, particularly with a low Wilkins score and anatomy that's, uh, suitable for BMV. We have M tier for severe symptomatic degenerative MR if high or prohibitive risk for surgery, and that's important. We don't micro clip people that are lower intermediate risk for surgery. They go to surgery. Um, it's reserved for people that are high risk or prohibitive risk for surgery because of that mortality. Uh, are the long term, uh, durability results. Again, we've only been doing clips since 2014, so we don't have the 20 to 30 year evidence base, uh, that, that surgical therapies, uh, do for Mier, um, really with Mitroclip only, uh, we have severe symptomatic functional MR. Pascal is yet to be approved for that. That's, uh, ongoing with CLSP 2F trial. And then we have valve and valve, uh, and valve and ring therapies for bioprosthetic valve, uh, and angioplasty ring failure, but this leaves a ton of patients that don't have established therapies. What do we do about rheumatic patients that have too much MR? That's a very common problem. And what if they're not surgical candidates? What if they have a high Wilkins score and are high, uh, surgical risk patients? What do we do about most calcific MS patients that aren't surgical candidates? What do we do about mixed MSMR? We can't clip someone that has mitral stenosis and MR. We can't balloon patients that have MS with some MR. And so there's a huge group of patients that sit in the middle of that Venn diagram that don't have any options. What do we do about patients with difficult anterior anatomy? Josh will tell you that's increasingly most of our patients, um, and so it's, since it's the only commercially available therapy, we make ends meet, uh, a lot of times with that. Sorry. Is that an edge to edge repair joke or I got you. And then, uh, what will we ever have with the difficult anatomy, something equivalent like we have with TAA where we can give patients options or really tailor the therapies to patients' individual risks and individual anatomies, in relation to surgical or transcaheral therapies. So I want to use that framework to go through specific cases that we've had here at Centera. The first, again, the, the tried and true, probably one of the longest standing structural heart procedures that we have is PBMV or balloon mitral valvuloplasty. This was a 33 year old female that came in with decompensated heart failure. Unbeknownst to her, had rheumatic heart disease. She was getting a uterine stimulation to, to try to have children. And she was found to have a mean gradient of 22 across her mitral valve. You can see the significant mitral inflow, the fish mouth deformity. You can see the Boeing anterior mitral leaflet doming. You can see. The rheumatic mitral stenosis here that we showed already. This patient had a PA pressure of 102/45, so a delicate balance with Doctor Soy who actually took this patient with rheumatic MS and did a vasodilator challenge very, very precisely and proved that we could lower the pulmonary pressures even after we did the balloon mitral valvelasty, which is not a transplant candidate because it would be a combined heart and lung. Um, she didn't have any interest of going to, I know before, so we did a high risk BMV on her. This is her index transmitral gradients. You can see a mean invasive of 20, and post BMV we had 4. So the data again, 1988 was the original Wilkins study. You can see the event-free survival at 5 years from that initial study and then look at the uh the uh primary endpoints of basically event-free survival and event-free outcomes. 24 years, 76.4%, 86.5%, 99% from all cause mortality and so BMV in the right patient. Is better than surgical therapies for rheumatic mitral stenosis and and Doctor Kemp will probably tell you as well that that an open commisurotomy in the old days was really just fracturing mechanically the commissures surgically. If we can do that with a balloon-based therapy that has this kind of outcomes, uh, we should and we do. Again, but we can't do that in a patient with MR or we shouldn't be doing it in patients with high Wilkins score that have good surgical options. So our 2nd and, and most prevalent really nowadays, uh, commercial trans catheter mitral valve therapy is trans catheter edge to edge repair or microclip. The other, uh, version of that is Pascal, which we'll go through. This is a 78-year-old female that came in with heart failure, prior CABG, had an STS of 8%, and has a flail of the anterior mitral leaflet A2. You can see that on 3D NPR. These are Doctor Cohen's images, that clear flail there. You can see this is systolic flow reversal in the pulmonary veins, so quite literally the flow is reversed with systole into the pulmonary veins. It should be coming back into the atrium. It's going away. And this is the sequence of a micro clip in modern days. This is all done with 3D multiplanar reconstruction. This is the transeptal puncture. We're very precisely getting to the highest point in the mitral valve. You can see my catheter tip here. We're going towards basically 2 o'clock and Doctor Cohen can measure. We want about a 4 centimeter septal puncture. You can see us steering this into the left upper pulmonary vein. This is the micro clip folded up. We have this all outlined on live 3D multiplanar reconstruction. This is emming down and clocking down to the leaflet, getting coaxial with the leaflet. In the bottom left you can see us opening the clips and position the clip arms to where we're perpendicular to the annular plane centered across the area of pathology. We cross into the valve. You can see we open the clip arms and come up against these two leaflets, posterior and anterior, and grab them. You can actually see the grippers bouncing as they stapled or pinned down to each of the leaflets. We close the clip. It's still anchored to the delivery catheter, and we assess the mitral regurgitation. It's basically eliminated. We can move that clip. We can add a second clip. We look at the trans mitral gradients before we deploy, but the final result after deployment is you get a double orifice, an edge to edge repair. It's like an old Alfieri stitch, which is surgical therapy. You get a double orifice. We've reversed the pulmonary vein flow. It's now normalized, and we have trivial MR at the end. This was a 30 minute case and so we can take patients with high risk for surgery and put them through a curative procedure that has good long term data now as well. There's two options, as I mentioned. Mitroclip is what we do 99% of the time. It's much more established. It's approved for both forms of mitral regurgitation, not just degenerative, but functional as well. And actually the largest evidence base for any mortality. Improving therapy and structural heart is mitroclipped and functional mitral regurgitation. That's the co-opt trial you hear us talk about. The number needed to treat to prevent heart failure or mortality, heart failure remission or mortality at 5 years of only 4. This is the Pascal. There's some iterative differences you can elongate so you don't get trapped in cords. There's some merits to it technically, but, but by and large, modern day microclip tackles almost all complex anatomies with very good results. We are one of the highest enrolling centers in the expand G4 registry, which tackled a lot of very complex anatomies and proved very good results and durability. The data to support tier again, this is the old Everest trial. Surgery versus anterior and high risk patients, 75% of those were degenerative. No difference in mortality. Surgery definitely reduced the MR more. You had less reinterventions, but as you can imagine, especially in the early goings of it, the risks were much less than a full sternotomy. And so the takeaway from that is that it's an effective therapy with regards to mortality, but you may have more MR than surgery you may have to go back in. That's a degenerative MR. This is co op. You can see the wide separation and the mortality curves both for heart failure admissions and mortality. The number needed to treat at 5 years was 4%. Reduction, absolute risk reduction 57.2% to 33, but that's predicated on CRT, having a patient resynchronize very good GDMT. So this is why it's a heavily involved, uh, team sport, so to speak, between our EP colleagues, our surgeons, and our advanced heart failure therapy, uh, doctors. And then Pascal really was microclip compared to that and showed no difference as far as non-inferiority and primary outcomes or primary endpoints. What's going on now is the primary trial which is set to be completed by spring of 2026. And so that's basically looking at patients over the age of 60 with genderative MR. It's basically taking what we know about that first case I showed you that was 30 30 minutes where we eliminated the TR. Is that as good as a good repair? We don't know because we don't have the durability data and the long standing sort of decades of experience, but this is what that trial is intended to answer, at least in part. The repair M trial which we participated in here was geared at looking at all risk patients, so low and intermediate risk patients, uh, repair, surgical repair versus M-tier. Then of course, as I mentioned, we're we're trying to establish Pascal, the second M-tier device in functional MR which is ongoing as well. For established commercial trans catheter mitral valve therapy, so we talked about BMV for rheumatic mitral stenosis, we talked about M-tier for prohibitive or high risk surgical patients. Uh, as an option for patients without surgical risk or for functional MR patients, uh, that particularly have reduced EF as a primary therapy in concert, with GDMT and resynchronization, but we also have a lot of patients that have been the beneficiaries of good. Uh, historical surgical therapies, prosthetic valve replacements, and mitral valve angioplasty rings. Uh, we've seen in the past month 3 people that had 20+ year repairs from Doctor Azar that just finally are starting to wear out a 26 year repair, uh, that's just starting to leak. And so, um, people are living longer and just because they got a very effective first therapy doesn't, doesn't mean that we won't have options for them anymore. And so. We have options. In fact, Dr. Kemp and I did one of these yesterday, which I'll I'll go through. But when we talk about TMVR, even for valve and valves, one of the big risks is outflow tract obstruction. We mentioned that when we deploy the valve, it protrudes into the ventricle, and when the LV ejects, the blood has to go around that valve. It can actually cause an acute LV afterload problem, and so basically causing acute aortic stenosis from the mitral valve protruding into the LV outflow tract. So we can manage that or deal with that in a variety of ways. Valve and valve mitrals typically are very common procedures now. We have an app on our phone that outlines all of the schematics and the measurements for each of the different surgical prostheses, and it really is the standard of care nowadays if you have a degenerated surgical bioprosthetic valve. This is a case that we did 2 months ago. You can see this patient has fused bioprosthetic leaflets. Two of the three had a mean grading of 18 at a heart rate of 75. Um, what we do is we embed geometry, so this is a 26 S3 that we embed two dimensionally on top of the, the mitral valve. We anticipate a 90% ventricular deployment. It's because the ejecting force on the valve when it's in its closed position is atrial. So to prevent atrial migration or embolization, we deploy partially in the ventricle, but you can see where that would create a problem between here and here is your only outflow from the the uh LV. This is the transmitral gradient, which is significant on TE. You can see the anatomic fusion of those two of the three bioprosthetic leaflets. So this is where there's a lot of lingo and a lot of uh uh acronyms which plague, I think what we do in structural heart. Um, Lampoon, when you hear that, is basically a leaflet laceration. So we take the native leaflet or the bioprosthetic leaflet and we lacerate it with an electrified wire so that it splays on either side of the trans catheter mitral valve. There's a variety of ways you can do that. You can do that retrograde through the aortic valve, which is not really done anymore. You can do that antegrade with two transeptal sheaths, which is the more common scenario. And then more recently is this tip to base which you'll see in some of our notes that's really reserved for people that have a mitral ring where as you electrify this V and lacerate back, it stops at the ring that can come in that can create problems when there's abnormalities or uniqueness in the anatomy relative to the aortic valve. You can get laceration in the aortic valve. And then this is a this is a way that we do leaflet obliteration techniques. So when you hear us talk about Batman or cleave again, um, I didn't come up with these names. I wish we had better descriptions of them, but what we're doing is creating an intentional perforation or fenestration in the bioprosthetic leaflet and then deploying the valve in that. And actually Doctor Prik is the primary author on the paper that described this, uh, technique called cleave, which we've been using. For the past year and a half, Batman is the same idea. It's just using 014 wires instead of 035 wires. We quite literally take the back of a J wire and electrify it and perforate it through the bioprosthetic leaflet and then deploy the valve through that. And then when you have LV outflow tract obstruction, you can modify the anterior mitral leaflet or you can reduce the septum. And so alcohol septal ablation is something we've used in hokum for a long time, so we use it in scenarios where we're worried about alfallow tract obstruction for TMVR. Sesame is a procedure we don't do and probably shouldn't do, to be quite honest with you. It's lacerating creating a linear laceration in the anterior septum. From the mid to the base to splay, it's trying to replicate what the surgeons used to do with some of the initial myectomies and then scorpion procedure is something that Doctor Patel Div has done with me, which is bipolar ablation when you don't have good septal anatomy to do an alcohol septal ablation. So we have leaflet modification techniques and then we have septal reduction techniques back to our case. You can see Dr. Cohen has lined us up very precisely. This is an Aegillu catheter that I've pushed right at the base of the anterior mitral leaflet. We take a 70 watt back end of a J wire and perforate through that and you can see we're working through this fenestration. We dilate with a 40 charger and then we dilate with a 120 charger. This is the balloon inflating across that anterior mitral leaflet in the upper right. See the mitral regurgitation through that fenestration afterwards. Most of the time it's very well tolerated. We typically have a balloon pump in to help with the hemodynamics. Our anesthesiologists are excellent at managing some of these acute valve changes that are required from some of the adjunctive procedures that we do. In the middle panel, you can see us deploying the sapien across that through the fenestration and with the valve deployed here across the bioprosthetic valve. So this is the final result. You can see the new valve working perfectly. There's no MR and a mean gradient of 3, and we have no LV outflow tract obstruction, which is a lethal problem when it happens, uh, intraprocedurally. So it's worth it's time well spent, so to speak, um, in preventing that much like a basilica with valve and valve tara we're worried about coronary occlusion. This is a procedure Doctor Kemp and I did yesterday and so as far as valve and ring, that was a valve and valve example, as far as valve and ring, this is someone that's actually had a valve and ring in 2019 and had an ASD closure. And so their, their valve had degenerated. Doctor Kemp and I had to go through the ASD closure yesterday, dilate the ASD closure to get back to the sapien that was already in a physio 2 ring. It was very difficult, um, but we were able to see this old one from 2019 was deployed a little bit more 50/50. We want to be 90/10, and so we deployed at 90-10. This is with 1 cc added volume. And then we reclosed the ASD. This is the imaging from that case. You can see pre we again have fusion of the sapien leaflets, very little opening here we had severe MR as well that was eccentric and at the completion we have no MR in a meeting gradient of 3. So that was the case with 3 of 5 yesterday was was something that complex going through a prior ASD device and doing a valve and valve and ring. So those are commercial therapies for degenerative prostheses, whether it be repair or uh prior surgical replacement. There are newer commercial therapies that that we don't use here. They're, I mean they're new within the last few months that we do have some experience with through trials but are are really in a limited use capacity right now. Um, this is an M3 case which we'll walk through with this is one of our former patients, 79-year with severe MR class 3 symptoms, poor. microclip anatomy. You can see he's got this cleft almost appearance between P2 and P3 that made microclip very difficult, or at least a good microclip result more difficult. You can see there's probably two origins of the jet as well. It's just not a great clip anatomy. Nowadays. Doctor Cohen and I and Doctor Pri will still take this case on, especially. If there's no trial options, but this patient went through a clinical trial which was the encircle trial you saw us participate in. What we're effectively doing is creating a dock that encircles or circumscribes the mitral valve, and the part of it is a superannular. Most of it is a subannular position. You can see us creating the dock here. Creating the dock. This is above and below the valve. And then we deploy a sapient much like that valve and valve inside of the dock. This is what that looks like outside of the body. It is now commercially available. It's been used at just a couple of centers though. It's quite onerous to deploy that dock. I think the widespread use of it might be somewhat limited, although the data is very good from TCT this last year. This is their animation and how we're actually encircling the valve, creating that dock. Unsheathing the dock. You can see there's a PVL guard that's naturally created with that. And then you deploy the sapient inside of it. It's basically a 29 S3, but it's got a fabric coating to prevent leak. The data is very good, so it was single arm. It's for patients that weren't candidates for surgery or for tier. This was reported and published in The Lancet, but reported at TCT last fall. They had a pre-specified goal of heart failure admissions or mortality based on current M-tier studies, TMVR trials. They estimated a 45% rate of heart failure admissions or mortality, which is fairly realistic. It's quite a liberal. Number, but I think incorporating all the trials, it was realistic to be that high, but they came in far underneath that at 25.2%. So by that measure had met their pre-specified goal of less than 45%. More importantly, the 30 day mortality was only 0.7% and STS of 6.6% patient population, and ODE of 0.1%. And it was the lowest observed mortality both at 30 days and 1 years for all TMVR trials and MTR trials we've we've ever done. We were early feasibility, so we did 4 of the first cases in the country here, uh, and did 6 patients in the pivotal trial and screened 46 patients. The ones that didn't get into the trial all screened failed for anatomy, so you can still, we still have a problem with the applicability of that, that therapy. And then this is tendon. This is commercially available as well, but as you can see, we're coming from the apex, so it's trans apical. It works really well for patients that have high risk of LV outflow tract obstruction, but again, it's trans apical, which, uh, we don't really do anymore. It's, it's a very specific patient population that would tolerate transapical, and they're typically not the patients that have Mac or mixed mitral valve disease that could recover from what amounts to be really a hole in the apex of the heart. Um, but you can see how that's deployed there. There's some merits to it. There's just a few centers that are doing this commercially, and I think it's an important therapy, but, um, probably reserved for a rare group of those patients that sit, uh, firmly in that treatment gap. So that's what we have commercially. We have again BMV for rheumatic MS, particularly with low Wilkins score. We have M-tier, both Pascal and mitral, for degenerative MR if you're high risk for surgery, uh, but again, mitral stenosis trans mitral gradients are prohibitive. We have Mier for. Functional MR, which is microclip only, we have treatment therapies for bioprosthetic valve and angioplasty failure, and then now we have two as of this last few months, TMVR options for the first time, which you'll hear a lot about in the, in the news, but really, um, we still have a ton of patients in this unanswered question treatment gap patients. What about people that don't have trans apical options? And again we don't have access to M3. It's probably gonna be a while before most places have access to it, so we still have quite a few treatment gaps for patients. What do we do with the rheumatic MS patients that have MR, um, or that have high Wilkins scores that aren't good surgical candidates? Um, you can take someone with a Wilkins score of 11 and BMD them and create torrential MR, and then they do really poorly. I mean they, they almost all die and so. You have to be very, very precise and patient selection with the BMD, and there's still a ton of people that don't have perfect anatomy, that don't have any other options, and so it is in the guidelines to be indication to balloon those, but not if they have MR. What do we do with all the calcific MS patients? Most are elderly and have CKD. What if we don't have transapical access? What if we have difficult Mtior anatomy? And will we ever get to the point, as I, as I, uh, questioned at the beginning, to where this is kind of like TAVR, where we go into each specific case and can pour through all the individual unique and the anatomical and clinical risks and make a decision for surgical therapy or trans catheter therapy based on a menu of options really. We have two trials that are ongoing here. One that we're very fortunate to be a part of is the early feasibility for CIA. 20 sites were selected, and we start deployments in the spring. That is something we're live with on a registry and with early feasibility enrollment. The first implants that will probably be in in April or May. This has a lot of merits to it. It's Abbott's TMVR device because a lot of it sits above the annulus and so there's less risk for LV outflow track obstruction. And then we have been doing for a while the Apollo trial. Centera's enrolled 4 patients, 3 of them were transapical. Doctor Kemp and I did a transeptal last year. We screened 66 patients. We have a significant screen fail rate. We almost expect it every time we submit someone to this trial that they're going to come back and it's going to say high risk for outflow tract obstruction, and they're just not candidates. And you can't do leaflet modification. You can't do septal ablation because they still may not be candidates since you could put someone through those high risk procedures and then still not have a commercially available TMVR option. And so I would, I would argue that even though it's a, it's a very nice device when the anatomy fits, the fact that we've screened 66 patients and have put in one transeptal device tells you a lot about the applicability of the therapy. And then there's a menu of other trials that are ongoing with different valve designs. Of course some of these have come to fruition. M3, Tendine, Intrepid is the one we just talked about. CIA is here. There's Alta Valve, um, there's High Life. I don't know who comes up with the names again, but. We unfortunately have to use them. And so what that milieu amounts to be is, is we have a lot of patients that aren't clip candidates that aren't BMV candidates that don't qualify for clinical trials. So what do we do with them? Just watch them get readmitted to the hospital over and over and over and over again. We just let them pass away, um, and so we've come up with a variety of ways, including hybrid approaches. Uh, Doctor Kemp, Doctor Scortino, and I do open valve and mac TMVRs that'll, and Doctor Scortino has developed a technique where he folds the anterior mitral leaflet. Up and creates a ceiling skirt which addresses a lot of the problems with Mac. They still have to be able to go through a sternotomy though, but it decreases the time of chiseling out all the calcification, which is the highest risk portion of that surgery, and allows us just to deploy a sapient open with the heart stopped, and that works very, very well to decrease pump time in older patients, um, but they still have to go through a surgery. It also avoids a lot of the issues that are with inherent transseptal valve and. Uh, we're worried about outflow tract obstruction, um, and worried about significant PVLs. So we've developed hybrid approaches for Valve and Mac TMVR, and then, uh, more recently we've done these mitral lithotripsies which I'll show a few cases of that. This is a case I did with Div Patel. 81 year old permanent afib and CKD had progressive dyspnea on exertion, multiple admissions for heart failure. You can see we have a mean transmitral beating of 18 at a heart rate of 110, was in, uh, afib, um. Actually not there was in Afib, but was in and out of AFib, had 2+ MR as well. See the mitral inflow. This is the TEE that showed significant MR. Again, we have circumferential Mac, dense MC. Mixed patient is very, very common. And so a patient that keeps coming back into the hospital, terrible quality of life, basically ambulatory for heart failure symptoms. When we do her cath, she's got progressive pulmonary hypertension as a consequence of untreated mitral valve disease. That's really what that late stage of this looks like is severe PH and RV failure, which is a terrible thing to die from. And so she doesn't have great septals here is the takeaway, but didn't have any coronary disease. You can see the circumferial mac on the fluoro. She had an STS of 14%. We screened her for Apollo and Encircle, and she screened failed for both for outflow tract obstruction, a very, very common scenario that we, we face when we do her two dimensional screening. You can see we embed a 29S3 in and we get a neo LVOT estimated at 100. So that's the sliver of blood flow out of the LV outflow tract here, and the patient would likely die from LV outflow tract obstruction if we didn't do anything to address that. So that's where we're talking about septal reduction and leaflet modification in this case, uh, had poor candidate septals. And so Dr. Patel did this procedure for us, which is a bipolar septal ablation. Uh, which improved the outflow LV outflow track by about 100 millimeters and allowed us to, uh, successfully perform, uh, valve and Mac uh TMVR. 6 weeks, similar for alcohol septal ablation, but admittedly if you look at this paper from memory, there's 7 patients in it, so it's a very rare, you know, one of the there's a handful of patients that have undergone this. This is one. She's now 1 year out actually, doing very, very well. So when we model this again we can use our modeling to help predict a lot of this as well. You can see that the LVL flow track after that septal ablation has improved significantly with the 29S3. And you can see the three dimensional, uh, geometry of that outflow track has improved as well. We now have an EO LVOT of 322. And no PBL predicted. So this is the procedure. I think this was Doctor Cohen's first day, uh, of, uh, out of, uh, fellowship. And so, um, this is the balloon septostomy. We, we did a very precise TMVR I'm sorry, very precise transeptal puncture. This is 3D NPR showing us crossing the map. You can see how difficult it is to get anchored and, and precise. This was from August of 2024, so she's now more than a year and a half out. Long deployment, usually with rapid pacing. It was a patient before or after? Uh, it was after the septal abortion. You cause heart block just like. So we get a perfect in 9010 deployment as we had planned pre-procedurally. And this is the final result. So again, a trans mitral gradient of 3 it went down from 18, no LV outflow tract obstruction. That's the difference here. That's a peak to peak of 4. So we eliminated that LV outflow track obstruction by doing the scorpion the procedure with Doctor Patel beforehand. And then since we did a septostomy, we closed the septum. You can see a lot of what we do now for Doctor Pree and myself is I'd say it's like playing video games with uh Doctor Cohen showing us in 3 dimensions. These devices being deployed so it's very, very, very precise and the advanced imaging has really improved our capabilities like I said by an order of magnitude. So this patient's 1 year and a half out, has class 1 symptoms, normal prosthetic valve function, no other options, not a clinical trial patient. Yes, it's off label. I'm talking about off label things, but curative therapy in a patient without uh any other options, surgical or established trans catheter. And then this is the newest way to deal with this big treatment gap. This is an 83-year-old female. We've done 3 to date. This is typical calcific MS. You can see the mitral inflow, the circumferential mac. We have an MVA by Goreland of 1.1, a main gradient of 12 at a heart rate of 75 for the cath lab techs, they'll recognize this difference here with fast paper speed as the trans mitral gradient here, which was a substantial. You can see we have a gradient of 23 and a heart rate again of 110 that's elevated. It's important to understand that if you increase your diastolic filling time just with medications we can lower that transmitral gradient substantially. So we try to get these patients down to the heart rates of the 50s and 60s to improve diastolic filling through a stenotic valve. This is how we model again this patient had recurrent heart failure, class 3 symptoms, had screened, failed from both trials. Um, this is me modeling 3 shock wave balloons in that orifice and seeing how undersized we are. We had a max score of 8. These are our anatomic dimensions. Putting in 3 L5 peripheral shock wave balloons, uh, makes us 30% undersized, and so we still have an issue with is that going to be effective, um. The patient also had a protruding bovine arch stent, so we use sentinelbolic protection with this. This is the septostomy with the 14 tie shack. We take 3 wires across the septum. We take 3 Aegilis catheters and cross with pigtails. We take 3018 wires and then simultaneously with 33 shock wave delivery systems we go up with all three balloons at the same time and deliver several rounds of 30 pulses each, so 30 seconds really without blood flow and then given the undersizing relative undersizing for that unique anatomy, we come back and even though BMV isn't. Uh, a good therapy for mitral calcific mitral stenosis in general. After you debulk that calcium, it actually works very, very well, um, to, to do the rest. It's what we do in coronaries very commonly for recalcitrant, uh, calcified lesions. This is the imaging from that case. You can see the 3 agilis catheters. You can see the 3 balloons going across the mitral valve. You can see all three balloons going up. This is the BMV balloon. And this is the ASD closure at the end. And then what are the results? All three cases we doubled the mitral valve area without any increase in MR. See, the mean gradients went from 13 to 5. This is the invasive gradients that matched that. You can see we hardly we have almost complete elimination of the trans mitral gradient. Um, and by planimetry went from 106 to 203, and MVA invasive from 1.2 to 2.1 with no MR. And this has been described, this is just as of July of last year. So there's only a few sites doing these and, and again we're using it to, to fill a treatment gap. So outside of the available commercially available trans catheter mitral therapies we do have options for patients albeit ones that are quite complex um but but very effective, uh, in the early goings of the the therapies. And then to finish things up, uh, a rare cause of mitral regurgitation, and, um, if you have unique patients with different types of mitral regurgitation, it's always worth a call to see if we have something that we can apply to those, those patients. This is a 59-year-old gentleman that had a BMI of 50. Uh, he was blind. He was quite debilitated after a 4 year's gangrene episode in 2020 during COVID. He's essentially immobile with high BMI. He had gotten bacteremic during that 4 years gangrene, and you can see had developed really what amounts to be a weak point in the anterior mitral leaflet and then his AR jet, his eccentric moderate AR jet, basically perforated through probably an area of focal infection from the old endocarditis. Again this was 5 years ago, but had almost continuous pansystolic pandiastolic MR because his AR jet went straight through a perforation in the anterior mitral leaflet. This is 3D NPR showing that area high up on the annulus with MR. Almost systolic going through that leak. This is again the precision that we have with advanced imaging right now, looking at both of these in two different planes by 3D. And because of the precision with imaging, I can take my Agillus catheter and you can see a glide wire coming out, and I can direct that glide wire very precisely through that perforation in the anterior mitral leaflet, prove that we've wired it, not through the central orifice. Advance a catheter through that leak. You can see here it's a glide cath, glide cath, and then we deployed the best plug that fit for this specific hole, this specific defect, which was a ductal occluder. Doctor Vance at CHKD let us borrow one of those from his patients because this anatomy was so unique. This is just deploying that ADO device across the perforation in the anterior mitral leaflet. This is that plug fitting nicely, not impairing mitral valve motion. The important thing with all of this is that you don't have to deploy the plug. If it's compromising leaflet motion, if it's not curing the leak, then. You know we can take the patient off the table and have another discussion about how high risk surgery is, but he was debilitated with symptoms and we had elimination of the leak there. You can see the final pictures this small ADO device. And he had elimination of his MR and he's now a month and a half out and has had a complete elimination of symptoms, not in the hospital anymore. So again, just to wrap things up, the framework in which we approach mitral valve disease here is thinking about things as mitral stenosis and within that subclassification rheumatic versus calcific and then mitral regurgitation, thinking about that as primary degenerative, and then secondary functional, newer ones that you'll hear about and differentiations or or definitions is the ventricular functional versus an increasing prevalence of atrial functional MR from long standing atrial fibrillation or atrial tachyarrhythmias. We also have, I didn't talk about dynamic or hokum related, which generally involves treating the underlying pathology which is septal reduction through surgery, alcohol septal ablation, but we do have quite a bit of available trans catheter therapies, both, both, uh, commercial and ones for reserved for patients without any other options. BMV is the mainstay and the longest established. Mitroclip has the best data for patients with high risk for surgery and degenerative MR, but also very, very good data for functional MR, particularly ventricular functional MR. We have valve and valve and TMBR trials uh that that all are plagued with outflow track obstruction issues and have high screen fail rates, even though we have some adjuvant ways to deal with those outflow track problems with either leaflet modification or septal reduction. We now have two commercially available as in the last 3 months, TMVR options, but their use is limited currently. Um, and we also have ways to deal with things in unique fashions, which is mitral lithotripsy and valve and Mac TMBR which we can do both transeptal and open hybrid, uh, atrial valve and Mac. So conclusions there's several uh guideline based commercial therapies for mitral valve disease and then involving therapies as I mentioned BMV Mier valve and valve TMVR, and valve and ring TMVR is is what we do, uh, most weeks for, uh, bioprosthetic valve and angioplasty ring dysfunction. We have new TMVR devices for limited use. We now can treat patients. A significant treatment gap we've had for several years is calcific mitral stenosis or mixed, uh, calcific MSMR, um. We still can't necessarily treat patients with matrix that have a significant MR, but it's probably a little bit safer than doing traditional BMV in those patients. And then we've got newer therapies with trials coming along. So if you have patients with mitral valve disease, regardless of the complexity of the way that we approach all of these is every single patient, regardless of whether they're 45 and a clear candidate for mechanical mitral replacement. With our excellent surgeons or whether they're 95 years old and uh not a candidate for anything other than a clip, um, every patient is reviewed by both teams, and reviewed at MDVC multidisciplinary valve conference every Monday at 7 a.m. If you have patients that you refer, uh, that's an open conference and you're welcome to, to see how we use this framework to, uh, outline therapies for patients that even a few years ago didn't really have any options at all. Thanks.
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