Paul D. Mahoney, M.D., describes the most up-to-date therapies for transcatheter mitral valve interventions (both replacement and repair) and applies that to specific patient populations.
We're gonna talk about new frontiers in my travel therapy, where we are and where we're going. Um, so just as a brief outline, mitral valve, catheter based microbial therapies is sort of falling out into two buckets. Repair and replacement repair has gotten early jump with micro clip. We've gotten G three now, after a fairly long period of no change in the device that always had rapid iterations with G three G four different sizes, different widths, different ability with the clip in the penalty grasp pass cows, a metro clip competitors, which is still in research phases. And we'll talk about some ongoing trials, including repair March trial, um, replacement eyes the next frontier and in some respects is already here. And I'll talk about that a little bit. We've been doing a fair amount of metro valve valve Alvin ring valve in Mac. It has some limitations. We'll talk about l bot obstruction sides in the analysts risk of Mal Icis, and then we'll talk about pure trance capture mitral valve valve in dinovo analysts with Apollo in the Empyrean Circle trial in some of the challenges we see in that field as well, that's just a now outline of what we're gonna talk about. Hopefully we'll get to all of it. So just how Sentara doing, um, in terms of mitral volumes. As I said, you know, the Trans Catherine mitral valve is still in the infancy, but we've been working on it for a while. Our mitral clip volumes have been steadily growing. Total 434 Mitral clip. Uh, and we showed steady growth. Uh, even this year, we had a little bit of a pause with Corona. We're still in the 92 year to date, and we're we have a lot of people in the queue valve in ring and valve in Valdez air trans catheter, mitral valve implantation in surgically placed valves, a ring We've done photo 64. We've done 14 mitral valve in Mac cases. We've done six research valves Trance, Catherine, much of our replacement about 81 metro value classes over that period of time. In the last seven years, we've done over 600 trans catheter mitral valve interventions, and I tell you, it feels like we're just getting started. So how do we do compared toa regional competitors? Uh, look at the Top 10 regional Mitra clip. 12 month volumes for the For Our region you see on the bottom were essentially doubling up our nearest competitors. Norfolk General. We've got Carolina's in Charlotte and over in D. C, Duke Presbyterian in Charlotte Hopkins U Va. Carilion and Lynchburg, and you could see the operators in the upper right hand. And again, we're doubling up on a lot of the areas. So we've got a fairly robust mitral valve program. We're drawing a lot of people in for catheter based mitral valve interventions. We're trying to really keep abreast and push the envelope a little bit on what we can offer. So I'm talking a little bit about Ed shed repaired before we get to replacement. We had a fairly long period where the device didn't iterated all the first five years. It was it was sort of Ah, a single clip, single size, same platform. And now we've seen rapidly the last couple years. Inter of improvements in much of every pair. The first one came out about a year and a half ago, G three, which gave us two different clips, sizes, the better range of grasp and a lot of small improvements in the device that made it a little more user friendly. And this was tested in something called expand registry span. Registry was 1000 patients with real world experience. We were the number one. US and roller were number two in the world behind some maniac in Germany who did a million, Um, and the Reflects 2018 to 2019 Real World use. We recently presented that data T C T T connected labeling in clinical trials. Sabol Car was the primary author and we were on that paper in the study population again. 1000 patients, 953 people complete roll up way follow up. And then this is really the first look we've had at contemporaneous use of real world Metro clip therapy. And there's some interesting findings. Um, the column on the left. So is the baseline m r. And this was a core lab adjudicated in March, which was fairly strict and was based on Lee on the preoperative t in the room. So it did surprisingly so a little bit more moderate and more than we expected it. This has been attributed to the loading conditions of anesthesia. But how does the clip work in the hand? And these were, you know, granted experience centers, but in the hands of experienced operators at 30 days were able to get em are reduction 0 20% of the time less than 1 90% of the time in less than 2 97.5% of the time. A truly impressive results in a real world population. And this was gratifying to see one year mortality against his A registry. Eso We have the coop data and I remember Coop was functional. Only expand was both functional and and primary mark um the Red Line shows shows the functional group the secondary m R. And those results were comparable to the Metro Clip Co opt arm. So we're still seeing that reduction in mortality. This on CO apt and impressively, the primary Maher was 12.5% 1 immortality, which was good to see single leaflet detachment, which is one of the Bains of this. Procedures continue to improve with rates of less than 2%. Mitral valve intervention was again less than 2%. Stenosis was rare, about one in 200 heart failure hospitalizations again. The co apt would be the reference arm, uh, in the secondary. M r. The functional M R. We saw 26% readmission and again in the primary on March 12.2. So really excellent data from the primary M R and comparable data from the secondary M R reduced annual eyes hard for the hospitalization rate. In the one year pre Mitra clip, we saw 0.8 hospitalization events and then one year post much your clip. It was down 2.28 which was highly, statistically significant across both primary and secondary, um, or groups. So this study represent the first contemporary port of when you're outcomes associate with patients. Both primary and secondary um, are treated with the micro cook, NPR and XDR Systems and UH, M are less than one is achieved Mawr, often with the third generation clip which is maintained it one year significant reduction in Mars. Associate with sustained improvements in quality of life and symptoms, consistent reverse modeling, and we use hospitalization and the introduction of the additional clip size. And the improvements and delivery system resulted in greater technical results without an increase in adverse events. which is what you'd hope to see from a narrative editor of device. That's, however, become a little bit obsolete. G four was rapidly followed on the tail. G three and G four gives us now four clip sizes, small and big, and then different clip wits. Um, in addition, which air the normal one in a wider clip. We also have the ability for independently grasping with the arms. Prior to G four, you close the arms and open them as a group together, and so you had to sort of clothes on both leaflets. This gives you the ability to optimize or open and close one side of the time. You could see the size compared to the dime there. Um, there are competitors. Pascal Edge did repair. There's a class trial, which we are participating. It's a very similar device. It's a edge to edge repair that has a spacer in the middle, and it works functionally very similar to how the Metro clip device works. It's got wide paddle, but now so does Metro Clip and is independently grasping arms. So does Metro Clip, so they're very, very similar devices. Um, we recently submitted for publication in Jack will be authors in This is, well, the role in patients. Interestingly, these were the first three patients any site and they were able to take just those patients. So experienced operators, but new to the device. They looked at results with that and they were able to go from. They saw 98% had moderate or less Uh, M r, which is very comparable to what we saw in the expand registry. So this device works. It works fairly quickly in hands is not a not a huge learning curve on this one as well. So it appears to be a class effect with edge to edge repair. We can now do this with a high degree of success in a low degree of complications. G four has been really nice to work with. I'll also shout out to Amy we in our in our hybrid Oh, are Now we have the ability to fully tape cases, so we've been able to get a lot of good images. Um, and what you see on the screen is what we see in the room. You see the echo image in the upper right? You see the floor image in the upper left him a dynamic, Um, both invasive and a line. And here we are, staring the clip, bringing it down above the valve. And this is just a routine micro clip case. But this is a G four case that we have the ability to open and close these arms independently. Um, and we have, ah, wide clip here, and this just shows a steering down towards the valve. Okay, hopefully will play. There goes here we are open below the valve and you can see us drifting, drifting up. We've lined this up in a couple of different orthogonal views using three D echo. We're gauging the leaflets into the clip arms. We're closing it. You can see our left. Atrial pressure, which we can now measure with G four is in the panel. You could see my mouth's right here. This is our A line, patients. Very well tolerated. This is a very calm procedure. Um, very rarely get humid Amick issues. This was a very floppy valve on DWI anticipated probably more than one clip. They're trying to put the first clip a two p two and then were assessed our results and see if we need a second question. The first clip has been put on. We're just taking a look here to see if we like what we're seeing. If we have good tissue insertion, our echocardiography is our cardiac anesthesiologists are have been excellent partners in this, their critical parts of the case And there, uh, concurrently obtaining images while we're doing the procedure and helping God the procedure from start to finish and communication. There has been one of the real arts of doing This is how to talk to your urine planters. Um, we'll take a look at multiple orthogonal views to make sure we have tissue insertion. Um, we'll do a three d picture to see if we have a tissue bridge that looks like it's getting ready to do a three D picture. We're looking to see if we have both the answer in the poster leaflet in a tissue bridge with a double inlet right ventricle, and I think you can see that on the screen There in the echo images. We also want to know how much tissue, because now the ability with the G force system to let go of one side or open it up in grass, More tissue. We wanna make sure we've got enough in there. We like the trans gastric short access view. We're looking for sort of the bow tie look, and you can see that there. So it's ah, beautiful echo images. Tremendously helpful. Um, during the procedure, Bob. So we released that clip. I believe, um and there's always a little bit of tension on the delivery system from the delivery cable in the clips. There's a little bit more emotion after you leave it. You could see the clip about to come off here being released. We got we got definite insertion of both leaflets. We have a little bit more and more than we're comfortable with. I mean, it was severe before. It's still, you know, a good three plus there. But we got a good clip on there. We know that that leak is going to be, and we're going to buy commercial view. We want to see where the leak is, the lateral. So we know our target for our second clip is immediately adjacent to the first clip. And here we come with the second cliff. All right? And we have a lot of information. Now we know where the first clip is. We know we're going lateral to it. We know our florist OPIC views, um, again, patients tolerant is beautifully their little hypertensive. Actually, during this part, we like to drive the pressure up to assess. Our are a result relying on the clip up just just lateral to the first clip. We'll close and cross and then come up on grasp. Okay, we'll grasp the bubbles air simply. We're flushing through the catheter. So when the bubbles appear, were either opening or closing the clip clippers being pulled up here. Second clip is usually far easier than the first clip, because the first clip is tethering it in close right there. And what really looking to do is get as much tissues we can without creating stenosis and reducing them are more floppy Div album. Or like we already use multiple clips. We average about 1.5 clips at 1.4 clips case. So about half the cases get one half cases, too. Um, and what would want to clip his clothes will reassess our result and, um, cut off there with the end result the result was good. So the other thing that we've been able to do with later generation of clips is we're not tackling more complex anatomy than we would tackle before. We used to like a two p two a lot. We used to, like flail leaflets that we could grab, um, or even in a degenerative goal is usually a two p two. Here's a case we didn't fairly recently, which had I don't know if you appreciate this, but had a very medial c three Swails. Okay, you can see it in the two D images on the right. You could see it over here. Very common. Cheryl, um, and we were not within 100 years and not attempted this with the original couple of systems with the G four, we thought we had a reasonable chance going to swell the medial comic. Sure. Okay, so you brought a clip in, we're able to grab it and optimize it. Usually m r. Here in the three d picture, you can see we're coming in essentially a commission of plastic starting from the edge. And we're coming in so called zipper technique. And you can see in this that we've got the leaflet going into the clip. We're able to optimize that a little bit with the arms. And then here's the Post. Split them are some tremendous reduction m r. And the post implant images with the clip release showing resolution of that oil segment of the commissioner. So we've been very happy with the clip system we've been able. There's a little bit of residual that mark here in the three D, but it's gone from severe down tomorrow and the tea and postoperative day one where most of these people get discharged. Good resolution of the M R. So we've gotten now a third generation fourth generation clip. We've gotten technically good results. We've seen excellent results, especially with primary M R. So the real question is, At which point is this, At which point the surgery, which is excellent, gets great results? At which point do we click over and say that the clip is a better option? We're trying to figure that out. Currently, we're looking at high risk patients. Only with the repair M R trial, which we have just started here, is micro clip versus surgery for patients with primary M R and intermediate risk for surgical repair. Study POPULATIONS PRIMARY AMAAR There's something wrong with the valve judged elbows by the heart team. These all will be evaluated. Cardiac surgery for the surgical Much about repair or catheter based edge repair either have to be older than 75 or if younger than 75 STs greater than two. Or come with formal abilities that increased risk as determined by the heart surgeon. On the heart team 1212 Surgical repair clip The primary end points are all cause mortality, stroke, cardiac hospitalization or acute kidney injury requiring renal replacement therapy. Two years. Secondary point of moderate SMR without replacement without recurring intervention. So excited about that and actively recruiting. So unless there any questions on repair, I want to talk about Metro about replacement for a little while. So the future has been, you know, we've seen in Tavern. We've gone from proof of principle about 10 years ago to standard of care, and we're currently going through a similar revolution on the metro side. Catherine based much about replacement is the next up the complexities and challenges air clearly greater than the tavern side? Um, we have saddle shaped analyst versus a circular analysts. We have a pickle versus transept approaches. How best to approach this? How do we anchor the valve inside? This is a major issue. There's a wide variety of sizes. It's not a three or four sizes. Fits all. And there's a risk of Lvov obstruction, which is when you place the valve that the interior leaflet of the valve itself obstructs flow out of the heart, which in some cases could be immediately fatal so immediately fatal is not something we like to discuss. What, we're trying to fix that out. However, the future has been here for a while. A Z I showed you earlier with the slides and the numbers were at 600 counting in terms of trans catheter mitral valve. And we've done 100 about replacements. The date mostly by adaptation and repurposing of existing equipment using the SAPIEN valve, which is a devolved designed for the aortic valve in a metro position, catheter valve in surgical valve valve and surgical ring and balvin Mac. And to overcome some of the limitations of this, especially the risk of L V. It's the obstruction we have adopted some adjunctive techniques, including alcohol, septal ablation, electric artery laceration of the anti relief with the so called lampoon procedure. And we've been involved in that since the beginning of both retrograde and a great tip to base and integrate based techniques. So valve in valve Alvin Ring valve in Mac, The data on this is lagging. Uh, TV T offers some information. The most recent publication was only from a few months ago from Dr Guerrero It Mayo Clinic. Um, look at registry data, however, that register data was 2013 to 2017, which I'll tell you in trans catheter. Micro valve Replacement field is kind of historic at this point, it's prehistoric, Actually, um, it was favorable, even the valve valve. And actually, this is how trans catheter mitral valve valve was approved by the FDA based on looking at TV T registry data. Interestingly, I there were several trials, ongoing randomized trials, and they simply approved it based on the excellent outcome. CNN TV T registry. So all the work that we're doing with the TV T registries paid some dividends, and we hope for similar results with valve and ring. Shortly way saw in hospital and 30 day mortality for valve in valve. Um was good. Remember, repeat mitral valve surgery is fairly risky even in the best hands, even in the lowest risk patients because of the complexity involved. So these numbers were felt to be favorable for high risk patients. Balvin ring was was also somewhat favorable, although a little bit more risk than balvin valve. And one of the key risk, uh, key issues here is when the surgeons do a surgical valve replacement. They almost always respect the interior leaf, so the risk of elevated to obstruction. It's far less with valve in ring and valve and Magnante. A leaflet is intact and the sale of the interior, the sale like effect that the anterior leaflet causes when you place a catheter valve in the metro position cause L V A T obstruction by wrapping the anti, release it around the valve structure. You can include the L vot, and that's obviously a problem. And valve in Mac is problematic for a lot of reasons. One of the patient population is extremely sick, have a lot of co mobility's, and you're placing a valve inside the heavily calcified but not symmetrically calcified valves. So you can see para the other league analysis seating could be could be troubling. And then sizing is not easy. We did publish our early experience from 2015 to 2018. We are 1st 24 patients, 15 valve, invalid, nine valve in ring, we 100% procedural success with 0% mortality, 0% stroke and 0% need for operative intervention. And that compared very favorably with national averages. Since then, we've done another couple dozen valve in ring and we've added about 15 valve in and back to that. And what's happening with trans catheter valve? This similar? What's happening to valve? Valve? So this was our first valve valve case in 2013. We did it transit quickly. We did it with a very primitive SAPIEN valve. First generation system. Um, this was obviously intubated patient with the trans a pickle 24 French hole, and it worked beautifully. Patient did very well. I spent a few days in the hospital in what home, but we were able Thio Goa trance septal. And since about 2000 and 15, 2016, transept has been our dominant modality. We make a transept, the puncture. Bring the catheter valve into the surgical valve. Um, it's all done through a 20 through, uh, I'm sorry. A 16 French hole in the right femoral vein. We do intubate the patient because he's used useful, but it is greatly expanded Our ability to take care of these patients and greatly reduced the morbidity and mortality. The procedure takes about 30 minutes. Um, valve in ring could be a little bit more challenging. Um, but basically, here's a Here's a video that we did recently. We're bringing the SAPIEN valve up to a transept approach across the ring. We've done a lot of SETI measuring thio. Line this up again. We have eco on the right. We have our video images and left, and we have our human dynamics on the bottom. The valve is placed across the ring. We're trying to line it up. We want to be about 80 20 ventricle, nature and atrial. Um, we're gonna swing the gantry around. We have a couple of technical issues with some hardware on the table. It this particular procedure puts it right in front. So you see me kind of tryingto in an ideal thing, we consider this a wire and the ring at the same time, and that actually takes longer than the actual Val deployment. But eventually we figured it out. We have anesthesia images, which are outstanding. I want you to pay attention when we go to three D here in a second and see one of the challenges with valve in Ring is these rings are all D shape mitral valve, and this is not a It's not a circle. It's a saddle shaped its three dimensional, both oval and then and that has height to it. So as we get set up to do that, we're trying to be cognizant of that, the newer rings of physio to reflect the saddle shape. So we see a figure of eight rather than a straight line, and I think we'll see the three D images coming up here in a second. So as we're trying to place this, um, note the D shape of this. So we oversized the valve. We have two circular rise this ring, which raises some issues of DigiScents and raises some issues of, um, para valve, your leak. If we don't put enough in there, we can end up with EJ Leak. If we put too much in there, we circle rise it too much. We could break the suitors up. Unfortunately, we haven't seen that yet in our experience, but it has been reported, and you have to be pretty careful about that in terms of size and how much value you put in these balloons. We're getting ready to do a valve in ring here again. Patients hollering it reasonably well. There is a little bit of hypertension at times because we caused a lot of equity with wire in the ventricle, but the patients tolerating it reasonably well, we have time to set it up, take lots of pictures, get our angle exactly right. We'll do rapid ventricular pacing. We do not want a cardiac output. When we're putting this in, we want the valve to sit still is possible. So we have a pacemaker in the RV, and this is basically the same technique, by the way, for valve, valve, valve and Mac, and I'll show you some more examples of that here in a second. Yeah, all right. And their rapid pacing has just been turned on, you could see the pressure goes to dust. We have a lot of time. There's nothing really injecting this thing. There's no critic output, so we could blow the blown up slowly to operator. Usually one operator either surgery myself. It's positioning the valve. The other is blowing it up. I'm looking for an 80 25th. Looks like we achieved. We'll put the balloon down. You see all the Stasis in the left atrium in that balloon is up. Um, we'll walk the blue back. See how we did that. We now way only showed this. Okay, now that that was deployed, you see the picture on the right, which is our T assessment. We've circular rise, that valve. You see the try leaflet of the safety valve opening closing night. Silly. There's a little bit of para about early, a little bit of leak at nine o'clock, but that's almost certainly wire related because it doesn't appear to be para valvular. But we'll assess that with Judy Echo. In a minute, we can post dilate thes. We can go with higher pressure if we need to, but again, it's a constant balance of the risk between hissing and damaging the ring and getting full expansion of the valve. Blood pressure looks great. You really likes having a mitral valve that works or she forget. Yeah, all right. And we liked it. So we're simply pulling the wire back to the device so we don't last rate the valve with our curves wire. And we like that result, will assess whether or not we have a nasty that needs to be closed. And that's and that's trans catheter. Mitral valve in ring. If this person had a long anterior leaflet, it could potentially wrap around this device on the GOP side and cause obstruction. So the last thing we'll do is we'll make sure we have no evidence obstruction in the left ventricle outflow track. Look at 1 35 degree view and you can see in this particular case, we have room right here, the valve edge. So there is room for the blood to get out. So this patient, we did not need to do any fancy footwork. The last rate, that leaflet, Um, and the patient did well on home the next day. Ah. So, um, they get progressively more challenging. I'll present one more case of an eight year old female through factory dystonia. She has severe, um, are dilated left atrium heavy pushed your leaflet calcification poorly. Mobility of the grading of four 3 to 4 plus m. R with eccentric jets. You've had a prior tavern. This is a case of Alvin Mack, by the way. And Alvin Mack is a disease that we're seeing more and more of, largely because of successive tavern people heavily calcified aortic and mitral valves will present with symptomatic s usually a few years before symptomatic m S m r. And so our ability to fix the aortic valve in isolation has led to a lot of people progressing to severe valve in back. And so we, uh I would say, out of the 15 valve and max, 70% of them have had prior tavern. It's very common. Um, normal lesson trickles function, practicing fibs, hadn't even of ablation on eloquence has a pacemaker. Here's their previous tavern in 2018, but I can't give a talk without showing a tavern. But also importantly, I wanted to show you the dense, heavy metro annual calcification we saw two years before the procedure. We're gonna talk about today. Um, note. Severe mcis town of in plant and valve in Mac is a phenomenon, a tavern. So these patients are now we're seeing much more of them because they're surviving long enough to have symptomatic that, uh, Mac. The more severe, wide open em are increasing additional shortness of breath. The tavern valve was working fine. This was not present. At the time of the Tavern. 2018 STS score was through the roof. Surgeons in particular find Alvin Mack great challenging operations. They often have to debris the whole levy continuity in this case that have to take the Taber valve out to a double valve so it together and hope that they could. They could somehow salvage the patient, and it's highly more more than time mortality. Peer pressures were not terrible. The cardiac catheterization showed normal coronaries. When did RCT evaluation? First of all, the most impressive thing is degree of Mac in this patient, it z dense. It's thick. Um, the commercial distances 31 the area 6 10, which does put it within the range of something we can treat with SAPIEN valve Sisi modeling for 29 valve, which is the proper size was done. And here's the problem. A little old lady with a small, hyper dynamic ventricle. This is the valve that would go in in this picture. Down here, you would see the left ventricle outflow tract. So imagine an interior leaflet draped around this for predicted. Neo L bot was zero, which means once we put this valve in, she would completely obstruct flow out of her heart. This would be almost immediately fatal if this was done without doing something to mitigate that risk. So we have a couple options available. When it happens, we'll palliative care is one. But this was a pretty vibrant lady. Septal ablation is technically straightforward. And what that does is we try. We try to basically shaved down the inter ventricular septum and improve the size of the left and go out for the track. You can do it. You can assess the results with repeat C t a Priti nvr. So you know what you're getting into. Some sites have been repeating this. They go down and they do acceptable in there wait six weeks and do another stepped on the wait six weeks and do another stuff. It could be, however, very challenging thin septum. If somebody has a normal septum and you're doing an ablation, you might end up with the VSD. It's not feasible in all of that. I mean, not every patient is acceptable amenable to this. And it's off label procedure for an off label procedure for an off label procedure, Um, Lampoon, which is electric artery where we go in there and we split. The anti reliefs of the mitral valve is not dependent on coronary anatomy. It is, however, technically challenging, and you cannot always predict efficacy. Alright, and here's just a cartoon showing the picture of panel on the left, so the entire leaflet, completely covering an implanted SAPIEN valve, depend on the right shows. If you lacerate this leaflet and you create a wedge shape, you can create a neo L bot will flow out of the heart so that the patient can perf use. And, uh, here's the calf For this patient again, there's two sets. There's a there's some large central perforate, er's so we thought we had a shot. Several thickness was okay at 1.5, which looked big enough to tolerate an ablation all right. And when we do this, which several perforated to be target. This patient had fairly large septal perforate. Er's the Red arrow is the one that we would like to get. The purple arrow is one we really would not like to get. We don't wanna infarct her entire septum, just the upper part of it. And so we went back in there a long story short. We did a belt and suspenders approach, and we decided to start with the septal ablation, assess our results and then perform a lampoon so we can see the were wiring the septal perforate. Er here. All right. And this is this is the opposite of what we're all trained to dio We put 15 balloon over there below the balloon up, pull the wire back way infused alcohol. First we infused off the sound. We want to make sure that the echo confirms that where our blood flow is going is where we hope to get. So we put definately down there and hope that the other part of the septum lights up on her. It did. With that confirmation, we go ahead and inject alcohol. 1.5 ccs. Basically one cc Percy Percy. M of thickness of the system. You can see the final result there with a little mouth showing the cut off. The big septal is still intact, the smaller several. Our target is gone and you can see the echo. So this does two things. One is it takes out thins and scars part of the septum, but also makes that part of the septum disconnect IQ, which should make the l v o t a little bit better. You can see on the echo that the upper part of the septum in both the short access in the long axis is a little bit more disconnect. It looks like somebody took a bite out of it. Generally speaking, we can see about 100 uh, millimeters squared of improvement in the L B O. T. With septal ablation. And then you can simply repeat the C T scan and see what what you've done. Put your embedded geometry and you could see one. We got a result, and two, it wasn't necessarily enough of a result. So the panel on the upper left here is our virtual valve. The panel on the upper right shows the valve still contacts except the wall. And we haven't really So if an anti a leaflet drapes over here, we haven't really improved it to the park that we like. If we take it back here, we say, Well, what is just the skirt of the safety and look like If we could make this part open cell architecture, could the blood get out and there's plenty of room there. So the lampoon helped the new L B. T went from zero to about 50 or 60. We hope to get it to about 100. But we decided to combine the septal ablation with the lampoon procedure with electro Kateri of that valve. And that's done. We like the and a great approach. So I just walk you through a lot of stuff. Transept The puncture. We put 28 French of Gillis sheets in the right in the left atrium. We take a swan, floated out they or to snare it and then take a catheter through the A. Jealous. That catheter here holds the snare. The second catheter is what we call our burning catheter. So what we're gonna do is we're gonna We're gonna snare from one catheter that goes through the center of the album. Gonna burn from the base of the leaflet and I'll show you how we do that. Okay, so here's three D images we have to a jealous catheters were looking from surgeons. View from the top. This is the valve. Here's a catheter through the center of the valve. That's our snaring catheter. And here's the other catheter, which we hope to be at the base of A To is what a burn a 2.5. All right, on the on the on the burning view, which is the 1 35 outflow, the Red Arrow shows where we're hoping to lacerate. Okay? And we put the put the other snare catheter through the center of the valve. Okay, so here we are. We burned through, we've snared it, and we basically push and pull. We do a sort of a full body floss. Walk this wire out, scrape the middle of it to create a Kateri surface and bring it back. And the pictures are pretty good. This is a nice system. You can see the sort of the right here. This is a crimped part of the wire were denuded all the installation off here. So we're gonna electrify this wire. I'm gonna pull this electrified wire into the left atrium and cut the interior leaflet in half. How does the patient tolerate this? Not well. They get very sick for a short period of time. So we put a balloon pump. I think you can notice the balloon pump in the background. We have everything ready to go, but it's a little bit of a fire drill. Once we last rate the anti relief of the mitral valve unease patients. All right, so here we are. We have grasped the anterior leaflet. We're getting ready to burn the anterior leaflet by pulling through. I showed this That show this in the last month. Do we actually watch this? Oh, let's have a good part. We play these, there's a loop, and here we are, electrifying the wire. And this takes the village. We have people infusing D 50. We have people holding wires. We have people running the boby. We have somebody, um uh, starting a lawnmower, as we call it. Okay, Well, I guess we'll show you in a second, Okay? So here's the burn. You can see we just pull back the wire easily lacerate through there, and then we immediately follow that with the valve in Mac. Um, usually with the patient who is. The other problem we have is we get ready to develop. And Mac, we put a wire in the L V. And we got all kinds of extra piece of blue pump stops triggering. So at that point, you know, we're just trying to get developing quickly. What the patients is being supported as best we can. All right. And there's our final result. Administration is doing well back to the Eastern Shore. Um, enjoy yourself a little bit higher than we wanted, but we had no leak. We liked it. Alright. Post implant anguish angle. I'm posting plant images you can see in the upper left panel. Here you can see the SAPIEN valve working beautifully. Please note that just as we predicted, the frame of the south comes all the way. The vot, if there was a leaflet wrapped around there, there would be no blood flow coming out with the alcohol septal ablation creating Diskin, icis and water l vot with lampoon We now have a mean l videotape vot grating on Lee six, which was a great result. The higher implant helps a little bit too. Um, you can see the circular rise valve appear in the mac, and you can see the function of the valve with no para valve. They're leak a little bit on the wire, maybe a tiny bit here, which resolved. All right, so here's a little bit more of elaborate. Look, a similar procedure on a different patient. Okay, this is Anna Greene. Integrated, burned through leaflet and sneering line the l B O. T. So we have our two catheters lined up in the left atrium. We have our snare catheter. We wanna put that Neil Bot. We don't want to go put a wire all the way down and get pat muscles and burn to anything we don't want to burn. So the reason that we have this Catholic going out the l V o. T. And going across the aorta is we want to make sure we stay right below the valve. We don't involve in it. So valid instruction that we're getting our We're getting ready to burn here. You turn the sound off. I'm sorry. There. Yeah, They're getting ready to burn here. You can see in our picture in the upper right? We've got our catheters lined up exactly where we want them. There's a little Estado wire, and then we just burn right through the leaflet. You see all the bubbles appearing in the left atrium. That's Kateri. That's from vaporizing tissue. And now we've got a wire through the base of the anterior. Leaflets in the left ventricle were exposed to stare and go get the wire and create that loop to burn. Okay, so we released the snare from the from the jail. 35 Capture that we've got going through the center of the mitral valve. Pull that back. We open up the snare. Mhm. You can set the snare ahead of Tom. It doesn't really have an advantage that wires is totally stable in the L V. It's just one less thing to cause activity so exposed our snare. Okay, we'll pull our wire back a little bit. Um, now, electric artery is still in its infancy. We use a lot of Rube Goldberg stuff when you come into the lab and see us doing this? It looks like it's, you know, Mad Times Lab. I do think we're gonna see the companies and the vendors get involved in better ways to modify these leaflets. It's a huge area of interest in research right now, so I fully expect that we'll get slicker systems and capital their purpose built for. Right now, we're just off the shelf stuff, so we're gonna try to pull that pull down of that. We're gonna take that wire back. That wire is all the way across. Pull it back and just push it through the snare. And again, the patients very stable here. All right, we haven't We haven't lacerated the leaflet yet, so they have an impact. Mitral valve. Pull this wire back eventually. We're gonna scare it. There we go. Freed up the wire. Advanced it. We got it. Snare, we're ready to go. All right. So Alright. So here's the laceration of the interior leaflet. Uh huh. We're getting everything set up. We've got the balloon pump going. Got lots of blood pressure. Okay, We're gonna go back well through the leaflet. It always catches a little bit. The base, which is calcified and pops and you could see immediately human that way just cause, you know, wide open em are the The, uh, blood pressure went from 1 80 down the 50. The facial pressure rose. So we dismantle the soul system, get back in the left ventricle. Okay. Um, it only takes a couple of minutes. It seems longer. So we put a wire in there, you could see our blood pressure is not good. Blue Pump is doing most of the work we bring our valve up around. Okay. The FDP, which makes the blue pump not trigger, is really an enemy because we lose all the augmentation. So we're looking at a blood pressure of 50 to 60 for a little bit. Um, we got all our angles preset by C T. Bring our catheter back. Bring our valve back. We have almost no blood pressure at this point. Okay? We're positioning that. You wanna push and pull? You want to see which is the way you're gonna be more favorably able to move this thing? They were spending a little bit of time trying to get it exactly where we want it. Mhm, because the way that shows up, if you only get one shot of deployment. Yes, we're seeing more and more of these patients, so Well, once we get through this case, we'll talk about sort of the next generation stuff. And what's better? All right, um, again, Rapid pacing. All those patient probably music because the pressure was so low. Oh, that's me talking in the background. Sorry. Not all. Okay. So again, there in the middle of this picture where we go, we caught it. Here goes the valve. Okay. Alright. Again. We're trying to be 50 50 to start in the calcium with the final goal of 80 20 atrial. And you see the valve being deployed in the calcium. Okay. And then we got immediately extend the tea. We have immediately have a working valve. We pull everything back, Okay? What? The pressure recover. You can see the pressure is pulse. It'll patient likes the valve. At this point, we could just relax cause we got a good working system. We're looking to see whether the velvety obstruction there's a little bit of acceleration across that. But I'll tell you, the great it's weren't too bad, and they usually get better. Once the left ventricle fills up. So? So we need a better system, right? I mean, this works, but it's a little harrowing. So TMB are we started with the Medtronic Apollo system. And so this is this is the ability to put a catheter based valve repair and somebody without a previously place about, uh, valve A ring or without dense calcium. Which is to say, most people that need a valve replaced. The first one we looked at was medtronic nbr, which was a very nice system. Um, it was it was transit pickle, hydraulic deployment of the valve. Um, it overcame the limitations of the of the analysts by having two rings and outer ring which conform to the analysts and inter vow that looks very safe and like, um and it worked, It worked very well. There's several problems. One is very bulky for point of reference. You could see in this video you can see a previous surgical aortic valve. Look how small it is compared to the system. This is also trans a pickle. 42 French. You can see the whole that's been cut. You see the operator manipulating the valve outside the body a Z go inside the body. So So several things. The bulk of the valve was an Achilles heel because we had a very high screen failure rate because of L v a. T. Obstruction. You can't modify the leaflets being obstructed. Actually, by the apparatus itself. Um, and secondly, you have to find somebody could tolerate a 42 French trains. A pickle system which can't tolerate a traditional surgical valve replacement. You starting toe threat. A pretty small needle there. We have lots of people that can't tolerate surgery, But this is, as you can see, over from the pan on the left. Even though it's a beating heart procedure without cardiopulmonary bypass. It's a lot like surgery. And, um, devout deploys nicely. Um, we did three implants. All patients are alive and doing well. I will say we screened, I think 80 80 people to get three implants. So it was It was frustrating endeavor. Um, there now have a trans septal system is still 36 but the latest and the greatest one of the M three valve with the docking valve. So the critical issue with T. M. V. R. Is how to anchor the valve right you've got this saddle shaped, large, eccentric, um, annual list, and you want to put a valve in the middle of it and trump and try to get around that by putting in a large, bulky system around the ambulance and then a valve in the middle. Um, but that risk l vot obstruction. So the concept was, let's place a doctor and anchor for the valve and then deliver a SAPIEN like valve transept in the middle. And if we can do that, what's the smallest system we can do? So we have a 21 French trans septal system, which is smaller than Metro Club, so all of a sudden we're no longer, you know, future generations. 21 French is something in our wheelhouse. We do that all the time. There is still a risk, a velvety obstruction, but much less than Intrepids and the design biases with the stock, which I'll show you the second it pulls the valve in the heart towards the poster pat muscle, which pulls it away from the L D O. T. So I'll show you a couple of cases. We have a few minutes left. I go through these, um This is 77 year old gentleman Severe symptomatic M r in a prior cabbage. Chronic a fib. Normal healthy function. Hypertension after academia. Asthma at the fastest. Um, if these were not great, you seem high surgical risk drafts were open. GT modeling showed that within embedded 29 valve that we did not have a significant risk of elevated the obstruction. The govt, in fact, was generous. Okay, at at 34 if anything over 200 it was 347. Anything over 200 we consider acceptable eso party. Graham should severe severe m r. And so this is what the doc system looks like. So we're going to do two things we're gonna put a valve in. And I just showed you how to do that. Valve valve, Alvin ring valve in back. So that's essentially the same. But what we're going to put it into is this Doc, and what we're gonna do with this stock is going to wrap it around the answer in the post, your leaflets in a circle right below the analyst. And we'll use the doc and the valve together toe anchor the valve in place. So the complex of the valve. Native leaflets in the dock. We're going to form a tight seal, so don't see m r. And the valve in the middle is gonna provide an open. All right. Um, okay. This is early feasibility. We're one of eight centers in the U. S. Have access to this technology. Um, we're happy to have it. And here's some preoperative images. Yeah, showing the severity of m r and the breath of the jet of em are with 12 segments. So here is here. Is the system coming in? 21 French? No, I guess that's one fish I had there. Have a better one coming up here. It's 21 French, and the key is deploying the dock, and I'll show you that the second. So we have a curling adaptive system that wraps around the left atrium, and we push this circle out. We go through the anterior commissar, okay? And we push us, I'll show I have a recorded case coming up, and what we do is deployed a circular doc. This is done with T guidance and floral guidance. And here's three in two orthogonal views. And the idea here is we want to be outside the entering The poster leaflet capturing the pat muscles, the analysts is between here. So this is a little bit below the analyst and there's an atrial part. This is a night nol ring that circular route. Okay, we confirm our position to make sure that we have the leaflets. I see, and we're looking to see leaflet on the other side. I will tell you that the vast majority of time of this case has spent looking at echo images trying to make sure what we what we think we have is what we have. And this one shows it best. You could see the three dots and the three dots with valve in between. So we like this. Okay, we could do by plane steering. So again, we learned a ton of lessons with Micro Cliff and your poster medio lateral. We have a language with our echocardiography furs. We could get around the left atrium towards about pretty easily. Um, this This doc comes with a night not with the sleeve to make a little more slick. Pull that sleeve off. Leaving only the knight in all structure behind you can see is just wrapping that backwards, Just pulling it out. Mhm. There's are deployed sleeve. And then the valve. It was right in the middle, just like we've shown you. And here's some eco images. Uh, well, for that, here is the post operative day. Two of the first patient that we did so in the valve intact. Absolutely. No. Um, are we kept these patients often home? Postoperative day, too, Because they wouldn't let me send him home. Post operative day one. But they look great. All right, So, um, the last one I'll show you the last couple minutes I have left is our last M three patient. The 1st, 1st 1 ever done with the surgical ring. This patient had a failed surgical ring. That surgical ring was 40 millimeters. It was too large for any SAPIEN implant. Um, the company was great to work with. This was early feasibility. They took a 40 surgical wing on the bench top, put it in an animal model, and then and then, um, did a couple of implants of this just to make sure proof of principles would work for this gentleman. Um, he had inappropriate neo l v o t with an area that was generous. 3 88. Um, And the surgical ring, you'll note, was put a little bit high as well. This particular surgeon place to bring fairly high in the In the atria, which we learned during the C. T. So again, um, he had had I will also tell you that a previous surgeries I may was inherent right under his sternum. He was just very high surgical risk for for disrupting the I may also to being grass across the midline. So it was felt to be, um, appropriate candidate for transplant their approach. And here we are. This is positioning the doc. So this is what I was trying to show you with the still pictures. We have a 21 French system through that what we're doing is taking a steerable guide catheter, reflecting it. There's multiple dimensions. We can flex this thing. We're trying to cross on the three D images right at the medial commish er and put our device right below the medial. Commissar, we're tilting that there's a serious of maneuvers to bring this down. The ring was helpful in some respects and visualizing where the valve waas. Um but it was also a physical barrier that things sometimes got caught on a little bit of a double edged sword. Um, once we get where we think we're just below the level, the valve will drop this system in cross. The plane of the valve in the ring is very helpful to see that, and then we'll start extruding this circular device. Okay, here's the doc deployment. Yeah, Yeah. What you can see is the device going out. We simply push it out in a circle. It's sized appropriately, Thio. There's a small and large and resizing it. Let me turn that sound off. Apologize to get around the enter in the poster leaflets. All right, We'll sit there instead. About 10 minutes. Confirming by Echo is pretty well tolerated again. We're not messing with the function of the valves. We could take all the time we need to do this. We circular rise that. Okay, If we're happy with it, you can release it. And then it's just a valve in valve. Yeah. We want three full circles. We'll do some maneuvers with the doc to sort of write it. You can see it on the TV images. You can see the night all very nicely coming out encircling, which is the name of the trial in circle encircling the entering the post your leaflets and take the tension out of the system and you go to a orthogonal view, you could look right down the barrel of this. That's our goal for our document plants and then about deployment itself. It's just like all the other valve deployments transept. What you've seen? Yeah, um, the valves and crossed we've got The ring is of no use now because it's pretty high in the atrium. We've got three D pictures showing this We do rapid pacing. The other thing is, the way this works is the ring. The encircling doc isn't fully expanded until the valve inside of it. And hold it in place. Do a full inflation there. Okay, we put the blend down, turn it off and we have a functioning mitral valve. You can see the echo pictures up in the but I started over again on all this. Jump over here. Mhm. We go to the next slide. So So we're running out of time, so we'll stop there, but in somebody trans catheter mitral valve interventions. Air here are being used frequently and improving rapidly. We have both repair or replacement offered. Um, way have the good fortune to be one of leading centers in the U. S. For catheter based metro valve intervention. We're getting access to a lot of early feasibility. And early trials have been very helpful for patient population. And so the last message I believe are go through. Please keep our clinical trials in mind. Where repair Ammar, which is looking at intermediate risk patients. Mitra clip versus surgical repair. We have clasp, which is a metro clip analog. We have m three in circle, which is the last two cases I showed you with the transept all much about replacement And for patients that fit that category. We still running Apollo and intrepid and we hope that becomes transept will soon. So, um, I didn't play with that. I will. I'll entertain any questions if there are, and I know when a little bit long. Are there any questions from here? From the in the audience have adult everybody to sleep, most likely. Okay. All right. Well, thank you very much for your time. I appreciate it again. Remember next week? No grand rounds because it's Election Day and we'll come back in two weeks or grand round. So thank you, Amy. We good. Thank you very much.
