Dr. Matthew Summers and Dr. David Adler performed a LIVE MitraClip procedure, with Dr. Deepak Talreja serving as Moderator. The team discussed how the procedure is performed, which patients are best candidates, and recovery time involved.
MitraClip is a small clip-like device used to stop leaking in the mitral valve. It is placed on the mitral valve in a minimally invasive interventional cardiology procedure. This procedure offers significant benefits over open-heart surgery for mitral valve disease. Patients typically recover more quickly, spending less time in the hospital and experiencing fewer complications. This breakthrough treatment has shown to significantly improve symptoms, slow disease progression and greatly improve quality of life for individuals with mitral regurgitation.
The Structural Heart Team at Sentara is made up of experienced cardiologists and surgeons who take a comprehensive approach to diagnosing and treating this condition, offering minimally invasive mitral valve repair to treat mitral regurgitation (MR).
Hello, everyone that's logged on. Thank you for joining us this afternoon for an exciting session. We're coming from the Sentra Heart Hospital in Norfolk, Virginia. My name is Deepak. I'm one of the cardiologists with the structural heart team. We're coming from Centra Heart Hospital and Centra Valve Center to present a case of Mitr transcatheter edge to edge repair or tear as we call it, the date is August 24th 2023 and I'll be uh introducing the team in a second. I'm gonna give everyone a second to log on and make sure they can hear everything going on. We'll start with a few slides and then go directly to the hybrid operating room at Norfolk. Um, the operators will be doctors, David Adler and Matthew Summers doing a case of a micro clip. It's obviously quite a feat to think about doing a case like this in a one hour period and we'll do our best to get through the entire case. Now, on the first slide, you see the Centra Heart Hospital and this is a thank you to both the structural heart teams and the surgical teams without which all this would not be possible and it, the slide isn't big enough to include all the people that deserve. Thanks for this. But the entire teams uh bring their best and are excited to show you this example of our work. We're gonna cut to the room now and have the team there, introduce the everyone in the room and then go through the case. We're presenting Mount David. Can you guys hear? Yeah. Can you can, can you hear us? Would you like to introduce? Sure, welcome everyone. This is uh Matt Summers. I'm here with Dr Adler. We have a very interesting case of uh severe degenerative mito regurgitation today that we're gonna fix with uh as mentioned a micro clip device. We've got a big team that that is part of this entire process. Uh Doctor Adler is, is our primary operator today. I'll be assisting him. Mariana is, is our P A that is in uh several of these procedures and has been for several years in the room. We also have uh two anesthesiologists. Doctor Sarah Witt is um our imager today, one of our uh best imagers to provide te guidance during the mit clip procedure. And doctor Dusa is here providing the anesthesia, making sure the patient is safe and stable throughout as we work on the mitral valve, the uh technicians in the room, we have Katie and Tin and then uh in the bag, we have Ciro. So a lot of people involved in each of these procedures. Um We're working on getting access right now. Uh We, we uh typically get access in the left femoral vein to, to give a central access site to anesthesia. And then we do the vast majority of these um from the right femoral vein and it's its standard trans puncture process which we'll go through um while they're getting that stuff ready. I don't, Dave, do you want to introduce the case? Sure. If we could put up the summary slide, it, it's up right now and, and I'll play the images as you're ready. OK. We can't see it here. But uh this, this is a 78 year old gentleman who's had a prior sternotomy for cabbage with severe degenerative mr uh partial flail posterior. Uh And um you can see his hemodynamics there on the screen. So, uh we had a heart team discussion and felt that he was an appropriate candidate for transcatheter edge to edge repair. Given his higher risk for reduced anatomy and surgical repair of the valve. Uh He's got the a fairly broad flail segment of the uh uh P two poster leaflet there that we can see on tee and uh discussed an approach here and uh are going to try to clip this with one clip down the middle. Um I don't know if you've had a chance to discuss this with the audience deep, but we basically have four sizes of clips that we could choose from it boils down to long arms, short arms, wide clip and narrow clip. And so we've, we've chosen an XTW clip, which is the widest and longest clip. And, uh, there's a good chance we may end up needing these two clips. Here. We're gonna, we're gonna start with one down the middle and see how that looks. And if, if that's not sufficient, we'll probably move to the medial side of the, of the defect and uh go with the two clip strategy. So you've joined us just as we've gotten access and we're about to go with the trans. Now we'll take our verse across David while you can get that. Let me show them because you put together on this case real quickly and then you can talk through the trans. OK. So you saw the slides that correlate to what Doctor Adler said on the TP June. The patient had a P two flail mild aortic insufficiency as listed here, an anterior directed severe Mr with flow reversals into the pulmonary veins. You see the excellent job the whole team's done in the work up. The patient underwent catheterization. You can see the hemodynamic as Dr Adler referred to earlier with this prominent uh V wave up to 25 millimeters of mercury and you see it specifically called out that a multidisciplinary heart team evaluation was performed with interventional cardiology and cardiothoracic surgery with a consensus decision to proceed in this fashion on this slide. Doctor Adler has nicely pulled some clips on the top. You see the uh valve and you see that flail leaflet on the post here segment which causes the regurgitation you see on this next slide, here's another image from a different angle. You see it's a little bit broad based in this in this uh angle. You see good left and cul no perc cardial effusion, no thrombus in the left atrial appendage and maybe a slightly enlarged left atrium. And this is the image the still frame came for. It's the final one. And what we see is again, on the left side, you see the two D imaging showing that flail post your segment at P two. You see the aortic valve ice, we function looks served overall. And because of that flail, you see that very anterior directed jet with a Kanda effect that makes it probably appear less significant than it really is. It clearly accounts for the severe symptoms this patient has. If we can go uh room screen now, then Matt and David. So we're, we are so deep back. We're about ready for trans, the puncture. Can you hear us? Can we put up the room? OK. Ready to show our screen here in the room. So we're using fluoroscopy and tee to guide our trans seal puncture. Uh We've got right femoral Venus access and are now up with uh a verse across system which is uh it's an RF ablation wire and a Shap dilator within a sheath which allows us to precisely identify our site of trans seal puncture. One thing with micro clip, it's very important to take your time and do a careful trans seal because where we cross on the septum is going to uh mandate where our, our delivery system is after the trans seal. So we're very careful to, to choose the, the best spot on the set of the cross to give us a successful approach to the micro valve. So if you look on the, can you guys see our screen? Can you see, can you switch to our te, can we show our te we see the screen nicely. We see both the uh right side and the fluro on the left. Perfect. So on the left side, yeah, you see our fluro and on the right side, you see our bi cable view and you can see the tenting from the trans sheet and I'm coming inferior on the right side of the screen is the SVC, the left side, the IVC, I'm coming down slowly. You see the tenting and we will watch as we drop into the faucet of Alice right on the premium right there. So I'm gonna come a little bit lower. You can see the tenting on the septum and we're gonna stick in the low inferior and also posterior position on the septum. So I like that position in our inferior, superior uh view here. So Sarah, if you don't mind showing us a short axis view in 45 degrees, we can see that tenting is uh post can come a little bit more posterior. So you can see, as I I'm able with this system, I'm able to fine tune the location of the sheath on the septum and really optimize that. So what we're gonna do is pause at this point and Sara's gonna go to zero degrees four chamber view and we're gonna estimate our height above the valve. We wanna be about four centimeters above the valve. Ideally, we see, we don't have enough height with micro clip. We don't have enough height. We're gonna dive below the valve and not have enough room to maneuver. We have too much height. It's tough to approach the valve. So that's nearly perfect 3.97 centimeters. So I'm gonna take this if we want to go live on our tee. So what Dave is saying is, uh we'll just go back to that 45 degree view, please. Sarah. Well, what we're talking about is that the trans seal puncture is arguably one of the more important parts of the procedure. Just if we're not low and inferior or low and poster enough, we don't have enough room above the valve to navigate and uh orient our clip uh for those. Ok. So stand by on bay list Bayless on. So this is the RF needle that Dr Adler was talking about success will trans up the puncture. We can administer Hepburn, please. And so if you don't mind confirming our wire position in the left atrium, I'm gonna direct this wire up into the pulmonary vein, which is sort of a safe uh parking spot for our wire as we deliver equipment up into the left atrium. For those, for those on the call that that may not know trans seal puncture is a standard technique for working anywhere on the left side of the heart left atrium. So our ep colleagues spend a lot of time doing a fib populations after trans punctures. Uh Dave and I do uh and deep do a lot of my work through trans punctures. Obviously, that's how watchman are delivered and deployed. Um So it's a standard technique that we're deploying here. But in, in our situation because the device is so large and because we have to be perfect above the valve, uh we typically have to be very, very, very precise in the location of trans puncture, which they've, they've uh got it perfect here. Um So we've got a wire into the left upper pulmonary vein. And now uh we're gonna dilate beautiful imaging. You can see the uh left appendage, you see the left upper pulmonary vein matt and Dave. There are a lot of comments coming through with excitement about seeing this case and for anyone listening, feel free to ask questions through the comment box, we'll be fielding those throughout as we go. So if there's anything that we can be more clear about or elaborate on, please don't hesitate to reach out. So, what we're doing right now is just dilating the vein. Uh The micro clip delivery system is a 24 French sheath and so this just facilitates us getting the sheet up. It's uh, it's just a dilator in and out. So we'll come out with that now and then go up with our delivery system momentarily. Now is a good time to talk about the type of mit regurgitation and strategy. They've, they've went through the types of clips and how we approach things. But this is, uh I tell patients the mit valve is like a double door that meets in the middle and degenerative mit regurgitation is when one of the door stops isn't working so the door can swing a jar. And that's what this gentleman gentleman has. He has a poster P two prolapse and flail right now. Uh If you can pan to the uh room, you'll see Doctor Adler inserting the uh steerable guiding catheter, which is uh the delivery system that the clips go through a little bit more minus on that if you can. And uh can I get a wet one? All right. So we're taking our delivery system up. Now, this is uh, as I mentioned, the 24 French delivery sheet over a dilator 24 French is one of the largest sheets we use for structural heart procedures, but again, transvenous and trans. So this is the delivery guiding catheter going up. So this might be a good time to go back to our screen and show the floro. We're on the screen right now. Flu screen is up. So you can see our wire across the septum into the left atrium. So now we're bringing our system from the right atrium over to the left atrium. You can see the dilator and then you see those two marker bands. That's the transition, that's the, uh, that's the transition from the dilator to the, um, to the actual catheter, we're able to flex that. So we had it straightened out to go up through the vein and I'm taking that flex off and Mariana's got the wire fixed as we advance across the septum. So our dilator is across the septum and we're gonna guide our teeth across such, so we should be well across there and we a check by, we may have come into the appendage. And so I'm gonna pull our wire back, pull our dilator back just a little bit, no guide across. Ok. Now, we're in the vein. So our dilator is across and I'm just gonna gently advance the guide over the dilator and it looks to me like we're across, we'll check by tee to confirm, I'm not sure we're across. We look like we're 10, we're tenting. So we're, if you look at our tee screen there, you can see we're tenting and Sarah's providing excellent imaging. I'm coming more posterior with my whole system to try to point us cross the septum and just gently advance this across too much. Uh Yeah, so Matt's got a good suggestion of taking a little bit of that curvature off. Perfect. And so we're across with our delivery system and we will bring the dilator and wire back into the teeth. Move those nice job. Fantastic. Yeah, that was, that was a difficult trans seal for a 24 French sheath. They've, they've made it look easy, but the, the septum is a little bit thick in that area. Uh You know, we're below the fossa and posterior to the fossa. And so he has to very carefully with very little wire purchase in that uh left upper pulmonary vein, uh get a 24 French system with dilator across it. Um But now we're set up very nicely pointing towards the left upper pulmonary vein with the uh guiding catheter system. We'll get some air in there. So, so effectively what we're doing and there's some slides on this, uh the depot can show, but what we're effectively doing with a MitraClip, it's called an edge to edge repair because we're bringing the edge of the anterior mit leaflet together with the posterior edge. Um and it works particularly well in degenerative mit regurgitation where there's a primary problem with the heart valve itself and the and causing the leak as opposed to functional mit regurgitation, which is the mito regurgitation is happening as a result of something else like left ventricular dilation or longstanding atrial fibrillation with dilation of the annuus. From that, there's a variety of different types of functional Mr, but MitraClip was first proven in a degenerative Mr in patients that weren't uh candidates for surgical uh therapies. So Dave's got everything flushed here, Dave, you want to tell him what we're gonna do next? So, uh if you can see our screen, you can see our delivery, our steerable guide catheter delivery system is across and in the left atrium, we're gonna bring our clip up now. So as I mentioned, we prepped an XTW clip and um I don't know how easy it is to go back and forth to the, the groom camera, but we can show the clip going in. That's a good idea. We're able to zoom in on this. We do that guys can, we cut to the room and just show their hands where they are and come back to the video screen. And meanwhile, monitoring the questions, there's a couple is uh what is the recovery time after a micro clip repair? You wanna address that for a second. It's a good question. The vast majority of patients go home the next day. Uh It sort of depends on their tolerance to general anesthesia since this is a te guided procedure. We're, we're very dependent on good anesthesia and we're fortunate to have a really good anesthesiologists here that get people through and quickly uh recovered. Uh But the vast majority of our patients go home the next day. One thing uh about our program here is that we, we are one of the largest MIT clip programs um in the country. I think this last quarter, we were um third behind Swedish and Cedar Sinai. So we have a lot of experience, Dave and I and deep with uh not just the degenerative mit regurgitation cases but a very, very complex functional mi micro regurgitation cases. This one is a little bit more typical to what we historically have seen but uh will come with its own cha own challenges um in and of itself. And so we have our clip in the delivery sheet now and I'm not sure how much the audience can see from that camera angle, but, but what you're looking at is a metal stand that holds our control system and you can see we have knobs to, to steer our clip once we get it up. And so we have this, the clip up and ready to go. If we can cut back over to our fluro screen, you'll see how we deliver the clip into the left atrium and we're on now. OK. So you see our clip coming up and we're gonna bring that out of the guide catheter. She is showing that nicely on the right hand side of the screen, the tee. And so we're gonna very gently bring our guide back as we unsheath the clip. And so we're now in the left at with the clip, Dave, this is called straddling. We're basically trying to make those markers. Uh, the micro clip be between the two markers and Dave is in the left upper pulmonary vein. You want to describe what you're about to do next with the, the turns. So what we're gonna do is you can see our clip on the tee. We're right at the tip of the Cumin ridge there. I'm gonna turn what we call our M knob and that's gonna put some medial flex on our delivery system and you can see it coming down towards the valve. Now, we may be hung up on the ridge a little bit. I'm gonna pull the whole system back. So let us come down and approach the valve and we're a little anterior. So I'm now turning the whole system posterior and continuing to flex with our M knob down towards the valve. And I'm gonna have to reposition this what we call re straddle, bring the system back out a little bit as we put curves on this. It sometimes uh we have to go back and reposition it. It can sometimes move the whole system uh in, in subtle ways but ways that we'll just fine tune as we're moving. So you can see now our clip on the right hand screen, that tee, we're, we're right over the defect. Um We may have a little bit of a lateral trajectory there pointing a little bit posterior. So we're just gonna kind of fine tune our position here a little bit. So can you all see the TE screen right now? We see the, so, so basically, uh Sarah is setting us up in two very important views. The view on the left is called the comal view that's telling us medial or lateral. Um on the right side of the screen is lateral and the left side of the screen is media. Then the second image is what we call our long axis view. So anterior towards the aortic valve towards the right of the screen and post your towards the uh the back wall there. So we have four different dimensions or four different directions here that we can direct Sarah is gonna get us to something called 3D multiplanar reconstruction or 3D M PR, which is a uh incredible way to do these that we can line up perfectly above the value and get everything situated uh before we cross and try to bring these two leaflets together, Dave, do you want to orient them here? Sure. So first thing I'm gonna do in this view is look at the trajectory of the clip and before Matt opens the arms, we're gonna just test that trajectory, I feel like it has a slight lateral dive. And so what we're gonna do is adjust our curve on that and try to straighten that up so that we, we have a straight shot across the valve. And so that looks a little bit better. You wanna test that trajectory test and there's still a little bit less, less though little anterior. So in the bottom right of the screen there, you can see a three dimensional representation of the, the three other planes. OK. OK. We're just a quick technical adjustment here with our imaging. But uh there's a, there's a question about what the clip looks like. Can I show them a picture while you guys are getting lined up and that'll help them understand. OK. This slide, you can see what you all asked for that top image is an image of the Mira clip. You see the delivery system and you see what looks like a stretched open Y shaped um clip and that's what they'll be positioning and you'll be able to see it on the beautiful images they're getting very shortly. This slide. Also a number of other developments that are in the process and we're involved in a lot of these trials at the end. Maybe Matt can talk about some of the trials we're doing once they've completed this so deep back, we're ready to open the arms on the cliff. If you're ready, we can switch back final image of audience. And then let's switch over back to the, the uh fluro screens. So we have optimized our uh trajectory. And actually, yep. So sometimes these uh curves catch up and we're constantly fine tuning and uh readjusting uh in real time to maintain our trajectory. I'm happy with that trajectory. You can see on the, on the green screen, top left hand side, that's our um uh media lateral trajectory and that looks nice and straight across the valve right down the middle, exactly where we want to be. And then the red screen, the upper right hand, that's our interior posterior. You see the interior microvalve leaflet to the right posterior microvalve leaflet to the left and you have a nice straight trajectory in the clip arms look well aligned, but Matt's gonna open those and you can watch under on the left screen as he opens those arms and then look at the bottom right hand screen. You can see those arms uh in our 3d view and he, he's gonna fine tune those uh probably clock counter that a little bit to line those up with the valve, but they look pretty good. I'm pretty happy with that. We, it's very important for us to align those arms perfectly perpendicular to the valve, especially with this larger clip. We wanna to grasp the, the micro leaflets uh with the best grasp we possibly can. And so we try to, to optimize that arm angle. So our lower right, uh what Dave is talking about, the three dimensional image is a little bit flipped, it's flipped 100 and 80 degrees. The aortic valve is on the bottom. So anti leaflet is at six o'clock and now the uh doctor Witt is rotating it here. And so this shows us the view of what we call the surgeon's view from the left atrium going down. And as Dave mentioned, you can see that the uh the clip arms are now open. You can see that in the, we you can see we're right on top of the valves. So we're very careful about the, the uh the clip arms being open. What we're gonna do, what I'm gonna do right now is test the independent grippers. So what happens here is we bring the clip up against the valve and then we drop grippers. And so I'm testing because we can do that independently. It looks like the dot is anterior. So we're unlocked, grippers are up where we wanna be, right? I think we're ready to cross. OK. I think we got a little bit of a media dive. Still. There's a slight medial dive, but I think we will correct that on the fly as we cross. This is excellent imaging Sara. So we'll maintain this imaging view and we close our arms and uh Matt's gonna bring our clip across the valve while I and watching very closely our trajectory and I think we did do maybe a slight mel dive there. One of, one of the nice things about the way that we do this is technically you can do this one person. But uh what we're, we're actually working together right now. We're, we're adjusting things at the same time. He's adjusting the anterior, posterior dimensions and I'm trying to keep the orientation similar in opening and closing the cliff, open the arms here, we're having trouble like we dove a little bit medial and our arms did spin a little bit. OK. So I don't think they've spun tremendously and I think that we can probably correct this position under the valve without coming back up. We just very slightly. That looks nice. Why we clock that? We clocked a little bit. Are we clocked enough? What do you think Sarah a little bit hard to see the, now that the arms are below the valve, our 3D picture as you can see is, is limited, but it looked very good on our two D I think. Excellent. Thank you, Sarah. And you can see how dependent we are on imaging for this procedure. And Sarah's doing a great job of showing us where we are. It looks like orientation is pretty good, right? They've down, we're a little bit on the medial side of A two P two. Is that fair? Yeah, I think that looks like a good position. I'm happy with that. So why don't we go to a grasping view or the N pr that was pretty good. It was either one and there are some questions and we'll, we'll do them after you guys have deployed this because you're in such a key part right now. I'm gonna a little bit of M off. Just, just, just a, we're trying to, we're trying to grab that flail segment right in the middle. And so we, we don't move a lot under the uh there's a lot of and subvalve structure there that we don't want to become entangled in, but we can make some subtle corrections, you know, we, we came a little bit uh media as we Yeah. Yeah. So I'm gonna actually, we're free. We're not on any cords or anything underneath. We're taking a little bit of our, our curve off. Yeah, because we do that. Yeah, let's Yeah. So let's pull up and see if that. Can you guys uh see the screen on the right. Dave's gonna describe this to you as we come up and we can see the image. It's, it, it really is just you guys are doing such a great job in there with uh showing clearly what you're doing and what's going on. Yeah. So if you look on the right, the anterior leaflet is in the clip, you can see that. So we're working on getting the post your leaflet in the clip. Now, uh before we grasp here, I'm gonna comment that we do have a medial dive still. And so our clip, you can imagine if we grasp here and leave it like that, it's gonna have a uh it can't do it. And um, so I'm gonna stop here and question whether we should reposition this and optimize the trajectory. It's not a terrible uh media dive, but it's enough that I'm, I might just try to straighten this out a little bit before we grasp. I would, I would just come down a little bit and let's see if we can take a little M off and pull the whole thing back and just straighten it up without starting over. Does that look more straight? Does as you pull up, we might have rotated a little bit with that move? Yeah, we can still see your arms very well on the LVOT grasping view. Um I really. Yes. Yes. Uh We're gonna check a 3D and just a 3D. Yeah. One of the question a couple of times guys is uh what are some of the potential complications during a procedure like this? A specific question about hypertension is one of those? Sure. Um uh Obviously pericardial fusion is, is a potential complication. Injury to the mitr valve leaflet or subvalvular apparatus is a complication. And that's why we're taking great care uh as we manipulate this in the heart to be careful not to become entangled in subvalvular structures. And uh I think we're straight now long axis few. Again, we look free under the valve. So you can see that posterior leaflet swinging up and over the anterior and that's where the leak is coming from. Dave's got us lined up perfectly, but we're gonna try to capture that pathology with the posterior. So he's gonna swing us a little bit more posterior. I'm coming up here. OK. Once we like the insertion of both of these leaflets, you become a little higher, coming up a little bit higher. A little bit more. P Yeah, I think if you come a little higher, I'm gonna swing more posterior and try to get as much of that. We really gonna try to get as much of that poster leaflet in the clip as we possibly can because that's the flail segment that we really wanna capture here. I can get, I can get even more. Yeah, more posterior. So this is four hands working together all at the same time to try to get this in the right position. You tell me when Dave, I pull up a little bit more maxed out my handle here, then I would drop the grippers. So we've just dropped the grip, what we call the grippers. Um So these are ti uh my uh stabilizers that basically sit above the leaflet and, and hold the leaflet in the clip and matt's closing the clip down there. You can see that on Fluro and you can see it on the right hand screen on the, on the ee that looks like a pretty good graph. But I'm optimistic about this. Uh We corrected our trajectory. You can see on the left hand side of the screen, it's a pretty straight clip now and we can see that we have both leaflets in the clip. And so uh at this point, we're gonna rest and let Sarah do some work. She's gonna look around maybe while we do that deep. Can you show them the animation in the slide set? Because uh maybe conceptualizing it with the animation uh will demonstrate what we just did. You did a lot of things there in a short period of time, Sarah's gonna be doing while, while we're doing that. Just let you know what Sarah's doing. She's, she's confirming that we have leaflet insertion in the clip. She'll do that. First and foremost, we wanna make sure that we've got a good grasp of both leaflets and then she's gonna check for Mr reduction and, and OK. OK. So Sarah's making the comment that she's concerned about the posterior leaflet insertion into our clip. So there we go. That actually right to, to Matt's point and David's Point, this is again the device. Now you see the uh real version and you see that Gripper segment that they talk as well as the clip. And then this is the animation that uh doctor Somers had referred to you see in this, you see the Venus system and you see they did that trans and put the sheet across as we're seeing on the animation now. So that's going from the left, from the right atrium to the left and that coiled wire is sitting in the left atrium, the right word is out and this is exactly what they just did. They pushed the clip out and then they came below that ridge, you see on the left side of the screen and oriented great delicacy making it an post media, lateral positioning to get exactly where they wanted to. This device has tremendous flexibility allow them with the right visualization to orient the clip. So it's facing exactly the spot they want, they can rotate at 360 degrees as you see here and that's the leaking blood. You see now they're gonna identify where the leakage is worse. And here we said it was the P two segment as they pointed out, you bring the clip below the valve as you're seeing in the animation and then you capture both leaflets and then you grip them and pull back. And now that close pin is sandwiched there. If you don't like the original position, you can reposition it and that addresses some of the questions, I'll ask them that you've been asking in the question answer box once they're done. But once the position looks good, it's analyzed in multiple views and this is what they're actually doing on the screens with the ultrasound. You see that view, the surgeon's view where they can see the leaflets, make sure everything is opening enough to let blood flow through there, but not enough to leak and then they will shortly release devices. You see here. One of the questions uh folks have asked is, can they use multiple devices? They can, they can use different size devices based on what they need to do to make sure that they've sufficiently relieved the amount of leakage that's there without producing any additional narrowing or stenosis. And they're very carefully assessed. And I'll say it's impressive that in this short time that we've progressed so far, they've gotten this far. So this is the micro in animation you see from the before to afterwards that leakage can be very much reduced or even eliminated. Let's cut back to where they are now. So deep after looking around, we've decided we want to try to optimize this a little bit, this particular uh interest that poster leaflet and uh optimizing, inserted into the, the clip. So we're gonna open the arms both. If you want to post your listen to both, we didn't have too much trouble grasping that interior leaflet. So I think we can, so we unlock in our clip and we're gonna just open it up and I'm gonna optimize the uh clip is very system there. And see we've got a, I think a better trajectory. Now you look on the left side of the screen, we don't have that medial dive that we had before. In other words, it's coming straight down across the valve perpendicular to the valve plane, which is what we want. And you can see on the right hand side, we can see both arms of the clip nicely. That tells me we're, we're in good position with our arm angle. And so let's try to grasp again here. We're constantly evaluating how much residual leak is left, how much stenosis this causes we can use three, sometimes four, but usually two, you know, 1.5 to 2 is the average in the gripper that up. Now. Now, during or after cycling posterior gripper, OK, maybe put it down about halfway and just kind of let that but that come off with the there you go, you go. It's in and out, it's in and out. Yeah, I'm gonna come anterior. Yeah, all the way. Yeah. OK. So Dave's swinging his posterior, I'm lifting, coming up against the subvalvular surface of the leaflets. Poster leaflet is still to me stuck on the gripper. So let's just redo that whole maneuver there where we cycle the gripper down. Yeah, you can see we may even have some cord there. So we're gonna try to get away from that poster leaflet. Pull up on that poster gripper now. Yeah. And I think we're free. We just come up all the way up on uh that we should be fine now to come up. It looks free now, but this is what we're getting at with. Is it still still on there? Just like, yeah, I think we're gonna be ok. We can try to drop the gripper and see, I think it's gonna be fine, but you can see where you can see how um delicate this is. We're, we're making just micro maneuvers here and adjustments and uh fine tuning the location of our clip. We give it a little bit back. So we're, we, we've grabbed both, both leaflets again. And so, so uh we're gonna reassess again and just make sure that we have good leaflet insertion in the clip. We've got uh you know, we had good visualization as the clip was closing and I feel pretty comfortable with the uh leaflet and search in there. So Sarah's gonna look around for us and uh we're just gonna interrogate this a little further, Dave, do you want to talk about uh you know, sort of we, we put a clip on and we're planning and thinking about subsequent clips and leaving yourself room. And what do we do about gradient increases and sort you walk through the next steps of what we would plan to do a good question. That's important. So obviously, one thing that we trade off when we put a clip on is the gradient across the vowel. And so uh we pay attention to our starting gradient And then as we put each clip on, certainly before we release this clip, we're going to reassess our gradient and make sure that we haven't increased the microvalve gradient significantly. Um That is important for our planning. So if we have residual Mr here and we think that we're gonna have to use a second clip uh the gradient after the first clip factors into that decision, whether we would proceed with the second clip or whether we would try to optimize this clip. Um He's got a pretty uh large valve area and nice uh client leaflets. So I don't anticipate any challenge here with micro about gradient. But that's something we clearly pay attention to if you guys can see the results with this first clip. Uh We didn't get a good view pre other than in the slide set. Maybe we can compare pre to post once we get our full images here. But with one clip on, it's looking pretty good, a significant reduction in the micro, there's a little little chat there and that uh sometimes we will look at this and uh and sort of question our success and then we go back and look at the pre images and realize, oh, we've really made a significant reduction in the Mr here. Um And so, you know, we're not going for perfect. We're going for a 22 point reduction in Mr and we know that clinically patients are, are gonna do well if we can reduce the Mr to that extent, the enemy of good in here is better. So, you know, we do not try to get to zero mit regurgitation. That's, that's not our goal. Uh One plus Mr is, is a win. And so, so far, we're seeing mild. Uh Mr we saw the video that has, that has to do with the, the entire concept of an edge to edge repair, which is based on the sur you know, old old surgical techniques. Um But we don't eliminate the leak, like they've said, we're significantly reducing it. And a vast majority, I'd say probably 80 to 85% of our cases we get down to trivial or mild. But he's right. We've demonstrated in uh clinical data that even a two point reduction in the severity uh for these patients is extremely clinically impactful. And we, we're already more than that right now, I'd say. And if, if you all can see this 3D picture that Sarah is getting for us, it's, it's an excellent example of uh A two P two grasp. We no longer see that flail segment of the poster leaflet that we were seeing in our preprocedural images. We've grasped it. You can see there's a nice uh double inlet uh on either side of the clip, there's a little bit of residual Mr as we mentioned, but the the grasp looks very good so far. So um so far, I'm pretty optimistic about this grass. There's a tiny little anterior Koan. I don't know where it's originating from. It's hard to see in the, it's so small that it's very hard to even see the pizza, but it's probably medial the fair then wraps up an interior. Yes, I, I would agree. I think that's, that's an adequate description of that. And, um, I think one thing that we will pay mine to is, you know, all these pictures we're taking right now are with the clips still attached to our delivery system. So we'll reassess after we let it go. Uh Sometimes when we're tenting up the the valve, we can have a false sense of reduction in uh as the leaflets are able to move in a more natural state, we'll have a little bit more Mr. So we'll be prepared to do a second clip if we need to after we release that. But um I think we uh take a vote on whether we release this one or not, Dave and I are happy you, you're pretty happy with this day. Yeah, I think it looks great. I my vote is you guys have done tremendous work here. It looks so much better than the pre images. We haven't checked the gradient yet. So Sarah's doing uh her. Yeah, she's so, so I don't, Sarah's not mic up, but what she's just told us is she wants to see where that residual Mr Jet is coming from. Uh if it's coming through the clip, obviously, we want to reposition our clip and optimize that. If it's coming next to the clip, then we have an option to go with the, with the second clip. But we, we do a lot of these, but there's an entire process beforehand that that is required and that, that we're meticulous about before a patient gets to this point from Mar Mariana. Do you wanna uh mention how a patient comes in and sort of what the work up is that they get, that gets them to this point? Because we evaluate a lot of patients with my regurgitation. Oh, they can't hear you. I'm sorry. Well, Mariana is uh going to speak through my microphone, but uh the short of it is is that there's an entire process deac outlined and, and Dave showed the slide that we put up um our multidisciplinary valve conference with our, our surgical colleagues and the, the three of us in our A P CS occurs every Monday um at seven o'clock, that's an open invitation. So if you have patients um that are getting evaluated for valve therapies, uh referring can log into that and sort of see and hear the discussion that goes into this, there's a lot of different factors. There's we have excellent, excellent, excellent mitr surgeons here and there's uh obviously um lots of patients that they tackle with the same kind of problem. We also have uh blossoming transcatheter mitr valve, uh replacements and different repair options. Um but the entire process goes into evaluating these patients and determining which therapy is gonna be the best for them. What safest and what's gonna provide the uh longest term benefit. So this patient has went through all of that entire process up to this point, a heart catheterization or preparatory tee uh clearance of their teeth, making sure that um they have good pulmonary function and can tolerate anesthesia. But, but a lot of steps to get to this point. That fair, yeah, absolutely. I can't, I can't emphasize enough the importance of the the team. Uh as Matt said, this is a team effort. Um It, it too many people to name here from start to finish escorting a patient through this process. Um This is the, what you're seeing right now is just the small part of the entire process of getting a patient through a structural heart procedure. And uh I think we have a fantastic team of enthusiastic motivated uh folks from start to finish from the time the patient checks in. So the time they come back for their follow up visit. So uh we're so appreciative of the fantastic team that we have here, Matt and Dave. Let me not for one second. There's one question we have about 10 minutes left in the broadcast and I'm being reminded. And so, you know, I think we've seen the, the critical parts and, and components of it and the next 10 minutes we'll see, uh, the last pieces here, hopefully. Um, then one of the questions that came up is, are, are you worried or is there a potential for clip dislodgement either during or after the procedure? What, what, what does the audience need to know about that? That, that's a great question and something, uh, that we, that, that's part of why we are taking so much care right now to ensure that our grasp is, is perfect because uh what we don't want to happen during the procedure is to let this go and find that it's only attached to one leaflet um that we can recover from that, we can put another clip on and uh put a clip next to this clip. But obviously, that's uh that's suboptimal. So we're taking great care to make sure that there's excellent leaflet insertion and, and we have good grasp of both of the leaflets. If we do that, the chances of it detaching from either the leaflet are quite low. Uh Now, now, do we see some late leaflet detachments? We do? That's a rare event. But um it, it does happen. Uh One thing patients always ask is this is, is this thing gonna come off and go flying out of my heart. And that, that's incredibly rare because if you think about how that's on the valve, when it's attached to two leaflets, there's tension on it with every heartbeat but if it detaches from one leaflet, there's no longer any tension on the clip at all. It's just hang on to the, the leaflet that it's got. And so it embolize from the valve itself is, is an incredibly rare event. Uh, but we are spending all this time right now, uh looking to make sure we have a perfect grasp so that we avoid that single week with scenario. So right now, right, right now we that uh the what those patients that need surgery afterwards are well able to get it. The the clip doesn't damage the leaflet in any way that prevents that for those that need it afterwards. Um Sorry, Matt, go ahead. No, it's uh saying we have this is our sole commercially available therapy for Mitr percutaneous mit valve options. Um MitraClip and Pascal is another similar device. Uh that's newer. We have far, far more experience with, with mit clip up to this point. Uh But the, the philosophy of philosophy of both of those devices is the edge to edge repair, which we're now doing in the Tricuspid Valve as well through clinical trials. Um We also have, we're right on the cusp of several different transcatheter mit valve replacement options. And uh we evaluate all of our patients for those as well if they have mitral disease. Um The two that we're we're doing here are um it's called the trans Apollo, it's intrepid valve through Metronic. And then uh also the M three, which is through Edwards, uh, which is a docking system that's deployed. We've done several of those. Um, so we have more and more options for patients that previously previously didn't have options. Let's show the Floro and tee, we're, we've, we've decided we like this clip and so we're gonna deploy it. So we're gonna go through the steps of releasing this clip from our delivery system and so you can see that on Fluro and on tee as we do this. So Doctor Summers is, uh, is, is gonna release the clip, gonna release the clip. So, so what we've done is we've tested the lock if you can go back to the camera. Um, so you can see there's a lot of steps involved in this, this entire process. Um But what we're doing now is we're testing the lock. So we're going to neutral one full turn. So what Doctor Summers is doing is he's, he's making sure that this clip is locked closed. We don't want to let this go and have it spring open on us. It's testing that lock before we release it. Our lock is good. Increase the drips. There you go. And so he's just gonna go through the process of releasing this clip from our delivery system. Here. There's a, a couple of attachments. Obviously, the first is, uh, the lock mechanism is secured by a, essentially a long string. And so he's gonna release that you can uh go back to the, the video showing us doing this. I'm pulling out the string here. This would be a good time for a camera on Doctor Summer's hands to show the audience what he's doing the process of deploying this clip and coming off of our delivery system. So we're gonna go back to, so we're, we'll keep the camera on Doctor Summer's hands, but just tell you we're looking at the screen as he's testing the lock again and it's stable. There's, there's no change in the appearance of the clip as he tests that. Yep. And so there's a, a pin that he's gonna release and then he's gonna unscrew the clip from the cable to which it's attached. And so now will be a good time to, to go to our, our floro screen if we can show the fluro screen and the tee you will see us release this clip and it's off and the clip looks stable. So now Doctor Witt is gonna look around for us and we'll make sure that uh the clip is stable and our Mr is uh unchanged after having released the clip. If while Sarah is looking to the last couple of questions, one question is, what kind of anti coagulation regimen do we use for these patients afterwards? Good question. Um There's, there's not a lot of science behind it. Um A lot of these patients are already on anti coagulation for atrial fibrillation and if that's the case, we just put them right back on their anticoagulation tomorrow uh for the rare patient that's not on anticoagulation. Uh We'll do aspirin and Plavix short term. So, so far these pictures that doctor Witt is getting look encouraging. I have not seen a lot of Mr so far. So she's gonna do a very thorough look around and assess uh for any residual Mr. The clip looks stable before we uh sign off here because we got a few more minutes. Can we just show the pre images one more time? This is a dramatic reduction. It, it really does seeing the uh pre and post images. Um puts this in perspective. Are you guys pulling up or do you want me to show them from the power point? It might be easier for you to go to Power point if you can. Here's here we go. OK. There's pre we've got it good. So that's pre so you can see that that jet wraps all around the Atria. That's what what doctor uh Adler was talking about when he said there's a Koan effect. Um the eccentricity or the lack of straightness to it um generally indicates the severity of it as well. But, but pretty significantly there that mild uh aortic regurgitation is something we we will watch here, you know, after this procedure. But significant reduction. Yeah. Yeah. Yeah. You want that perfect example of pulmonary vein reversal. That's our pre picture. And so uh we'll assess that now that as the severity of the mito regurgitation gets worse, you get reversal of flow systolic flow in the pulmonary veins. It makes sense, the regurgitant volume is coming back into the atria and reversing that flow. So we, we commonly see a very dramatic reduction uh or reversal uh in that after the MitraClip. And we can also what Dave and I are doing in, in this entire process is we're looking at the blood pressure and how much Mr there is at different blood pressures. We're looking at the left atrial pressure, how much reduction there is what the V waves are, how much those reduce. So it's a a correlation between imaging uh fluoroscopy a procedure and also the hemodynamics. And then the last set of questions are after uh the patient gets out of there. What kind of limitations are there in the next week or so? And once they get home? Yeah, there's not a whole lot of limitations. It's, it, it has to, it's a little bit individualized. We, we take care of a lot of patients that are otherwise very sick with the, the coop data. Uh uh bringing us access to a lot of functional Mr patients that we didn't have previously. There's a lot of, of older folks, a little bit more frail. So it kind of depends on where they're, they're coming from to begin with. But in general, it's a Venus access, a large more Venus access. Uh but people have general uh weight lifting restrictions just like they would uh heart cat a watchman an eight of. So there's no specific instructions and it's a little bit individualized based on how sick the patients are coming in. I'm, I'm getting a, uh, told that it's uh the end of the transmission here. I want to congratulate you guys. This is a tremendous example of a really successful Mitr uh procedure. The mit clip looks fantastic. You've reduced the Mr dramatically and this patient should feel the difference. Congratulations to you guys and the team for this. Thank you deep. We appreciate you moderating and uh we need to show our final slide and uh show our structural heart team again. Uh can't give enough kudos to everyone involved. Uh That, that helps with this uh the whole process. Thank you everyone for, for tuning in today. We appreciate your attention and I hope this was a, a helpful hour just like to also uh welcome. If you, if you have a patient that has a significant mito regurgitation or you have a question about the severity of it or you hear a patient with a murmur and fine Mr um You can reach out to any of the three of us uh or a PC, any can or valve coordinator that uh can field consults and, and help get the patient in to see us. Um But there's a lot of patients out there. This is a very, very untreated problem in the community. If you have uh uh a patient with mit regurgitation, please send them our way. Um You, you're invited to be part of the process with, with uh logging into valve conference and everything like that. So I appreciate everyone joining in today. Great work. And then just one final comment. If you enjoyed this one. Centra does a lot of these broadcasts across the spectrum of cardiovascular medicine. And also I'd put on your radar screen, September 29th and 30th is our annual cardiology conference. It'll be at the main in Norfolk and for full day, there'll be information across the spectrum from EP to heart failure to imaging to structural heart and intervention. Please come and join us. Amy Ross is distributing information on that and we think that uh that's a tremendous opportunity to see even more of this. Congratulations everyone. And thank you for joining us.
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