Mitral valve assessment, diagnosis, and management are rapidly evolving disciplines highlighted by innovations in imaging and interventions. This program is designed to provide a practical, highly case based approach to provide both the fundamentals of mitral valve disease care and cutting-edge approaches to contemporary management. Another focus is defining the role of transcatheter and surgical therapies, with an emphasis on the collaborative nature of these procedures across many cardiovascular disciplines.
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mhm with that. Showtime? Yeah. Two. Mhm. Yeah. Okay. Mhm. Thanks. Mhm. Yeah. One more. Uh or not. Not one more of us. Broccoli? Yeah. Okay, sometimes. Mhm. First this mineral water, not beer. Yeah, I want to give it, Uh, just another minute or so before we started. Uh Mm. Mhm. I see Roxanne Hassan, right? Uh huh. Oh, okay. Okay. Should I start? Yeah. Yeah. Okay, I would. Okay. Good evening, everyone. Thank you for joining us this evening for our three part series on deconstructing the mitral valve. Tonight's presentation is going to be about degenerative mitral regurgitation the next to Thursday's. We're going to be going diving deep into functional mitral regurgitation. In terms of for this part, we have no disclosures to to discuss. Um, the CMI has been produced with no commercial support. I want you to welcome to the Penn Presbyterian mitral valve team. It's a multidisciplinary team that includes structural cardiology imaging, cardiology, heart failure, cardiac surgery, EP. This is the members of the team that has been used to help develop this program and in terms of the discussion of these patients. So why are we here? Why do we care So as you guys all know, mitral valve disease is very prevalent. When we look at mitral valve disease itself, it's actually more prevalent than aortic valve disease. As patients are getting older, we're going to start start to see the incidents increase. If we're looking at significant mitral regurgitation, it actually encompasses 2% of the population, with a 50 50 split between male and female. Unsuspected preexisting valvular conditions in ahead of genius population. If you talk about greater than moderate, is it about 11% of males in 12.5% of females? Based on this, this is a common disease that we're seeing in our practices every day. Yeah, so when we talk about degenerative or primary mitral regurgitation talking about diseases of the mitral valve apparatus, the most common is mitral valve prolapse. But also we talk about endocarditis, conductive tissue disorder, dramatic cleft and radiation changes. Here. The updated guidelines in 2020 the A, C, C and H A, um, discuss the recent guidelines for degenerative M R. And going through this flow diagram. Now I'm going to hand it over to Clark in terms of the surgical aspects of the guidelines and mitral valve disease. Okay, so I'm sure many of you seen this slide. Uh, and I'll try not to try to have death by PowerPoint tonight. Can I write? You run the slides hands next the next. So this was is the American strategy for success in Afghanistan, And you guess why we're still there? Next slide. And you can also say this may be compared to that last slide. That hunt, uh, that Lindsay showed as a h a C C guideline diagram. So we're gonna try to clarify that this evening next line. And of course, we we always remember the words of HL mink independent from from Baltimore Sun Times. For every complex problem, there is an answer that is clear, simple and wrong. So next slide. Uh, so I said, Goal tonight is to simplify, but not too much next line. So degenerative microbiome disease or primary Microsoft disease is a surgical disease. So it's not a question of if, but when we don't need to operate. And although we have extensive experience with minimally invasive approaches, there's not. The decision is the least important one. When we're talking about operating on Damar next slide. The most important and only real question is to obtain a competent, endurable micro valve repair. So if you asked me what I'd rather have a strong economy and a micro valve repair or minimally invasive and a micro valve replacement, I'll take a strain on to me anytime next slide if we look at the anatomy of the micro valve prolapse of middle scallop or P. Two of the poster leaflet is the Achilles heel of the nitro valve, and about 70% of the prolapse, as we see, are related to P two. Obviously, we have all to other areas that can prolapse. But again, if you if we if we just do. If we we get the P two prolapse is we're gonna be talking about 70% of the patients next slide backslide. So this is the spectrum of mitral valve disease is from a paper by, Dave Adams said on the on Malecki, and you just see that we go from fiber elastic deficiency where there's not a whole lot of tissue. But there's there's a flail of a relaxing leaflet all the way up to bar lows. I'll do as you can see here, it turns out, next slide it's actually easier to repair a bar lows than it is a fiber elastic efficiency. Because Barlow XYZ like Children's orthopedics. You just put two bones in the same hitting room and they'll heal the only thing you have to worry about in Barlow. Xyz Getting not having Sam Post operatively next slide. In actuality, the reason I show this slide is Penn Presbyterian. How to keep, uh, role in the in the beginning of mitral valve surgery. Dr. Robert Glover here you see on the right was the chief of surgery at Pym and not also at Episcopal Hospital. And he gave Charles Bailey the permission to do his fourth micro commission. Arata me and I think 1948 after the first three patients had died and it was somewhat controversial. But the fourth patient lived, and the rest, as they say, is history. On his right on Dr Glover's right is Julio Davila, who actually developed the first Mittal Aniela plasticky system, and actually he was given credit for this by Carpentier in his in his book Next Slide. So this is the paper that that started the current era of of micro valve surgery. Uh, it was presented at the 80 s in 1982 and written up in the General Thoracic and Cardiovascular Surgery in 1983. And next slide. Basically Carpentier de Bible eyes. That might be the nomenclature for might regurgitation. And what we're talking about here with degenerative is primarily a type two prolapse where one of the leaflets is prolapse ng and his principles and might provide repair. Still hold today that we classified and get an accurate value of analysis. And he put restore leaflet mobility mainly because he was operating on a lot of patients with rheumatic heart disease from the former French colonies. And he already had to restore leaflet More mobility in these patients with you get a confident repair. The third principle is just reestablished co optation. And the fourth principle is a remodeling annual plastic which fixes the annuals in the systolic position next lot and just again restore my ability. But that's not an issue with PM or next line. Uh, and so here, with the next slide, then here's, uh, the goal of prolapse of the of the post relief it, which we should be able to get repairing about 99% of cases. I was a smooth and regular surface of co optation, long surface of co optation, usually defined as at least eight millimeters located in the inflow track Next slide and just to illustrate patient with with Barlas repair, this is the problem with bar lows. If you don't make if you don't decrease the height of this poster leaflet to make, they're supposed to leave it almost a straight line and then you create, uh, you. You you create an excellent repair without Sam next slide the first few times you C c c Barlow, as you think. Oh, my God, How am I gonna fix that mess? But in actuality, we just have a little patience. You do it systematically. You can almost always get a good repair. Um, and you may end up having to use a an Alfieri, which we'll talk a little bit about when we talk about the micro clip. Sometimes with these patients next line. So in today's world, the way we, uh, we fixed mitral valve is we respect rather than the sick and the old Pontiac method, You did a larger section you put it back together. But did we day? We do smaller, smaller sections. We frequently use cortex neo chords. We occasionally we use edge to edge repair, and we always put in an admiral plastic ring or band. All these techniques and that is the manual plastic reason. Bring a bandage to prevent recurrence. Not not necessarily that you needed might have a confident micro valve. But all these techniques preserve Lee for the tissue and increase the surface of co optation next line. So Theresa Rana and the group at the Mayo Clinic have made the analogy to in the asymptomatic next slide patient with severe rig. Urgent a r m r that has a very high incidence of having a cardiac event within five years. Next slide. And they recommend that we do restorative surgery rather than rescue surgery. Once the patient has atrial fibrillation, pulmonary hypertension or, um, starting to have a dilated left ventricle. You you're you're talking about rescue surgery now, next life. So we should probably be expanding our class two a indicate educations, uh, in the in the patients with, uh, degenerative m r next line. So I don't know You want to present this case jig. Nash, you can go ahead. Clark. Gun. Okay, so this is a man, 57 year old. All right of them are severe enough for sure. Uh, a microwave education and mild elevation of his p A pressures. Ah, and so he would actually have a class One indication for intervention next slide. This is it. So this is the echo showing the flail portion of the poster leaflet in the anterior directed jet of severe might regurgitation. And I'm sure Gina's gonna talk about it. If you've got an anti hero directed jet, you almost always have posterior leaflet prolapse. Whereas opposed to directed jet would be anti relief, it prolapse next slide. And this this just shows the three D image, which is actually on the P three side of p two. But you'd almost call that a Pete P 2.5. I like that next life. So the treatment here was a triangular section Gortex near corn and implantation of 32 annual Flex Band. Next line. This is next line. So this is just illustrating. You can see the mitral valve here. You can see the ruptured cord on the poster leaflet. You can actually see the washboard effect of the mitral valve jet on the wall of the atrium just under the retractor next line. And in this case, we did a small triangular section of the of this, uh, area next slide. Uh, and then, uh, the next slide, This just shows the completed repair. You can see the annual plastic band in place. We always make sure they are attached at the tri guns, but you can see the closure of the super line right here. Um, next slide, and then you can see the finished repair. Good. Uh, no, no, m r. Nice surface of co optation. It's at least eight millimeters next slide. And this is a follow up, uh, with the transfer asking, uh, eco eight years after surgery. So I mean, I have patients that are 25 years out now from a, uh, repair. I actually have one. Sends me a dozen golf balls every year. So anybody wants to do that is welcome to next line. I think that does it for me. Okay, Well, good evening, everyone. My name is Tetanus booster. I'm one of the echocardiography furs. at Penn Presbyterian. Thank you for taking the time out to join us this evening. I'm basically just going to go through the T e for evaluation of the mitral valve for trans catheter H two h repair we all duties. And most of the stuff that we obtain is basic imaging. But there are some particular nuances in particular views that we look for for evaluation for trans catheter interventions, and they don't take a lot of additional time, and they're valuable to us and prevents the need for repeat TVs and things. So I think it's helpful to go through them next life, please. So Clark already went over the mitral valve anatomy. But just to a quick refresher on the left is the surgical view of the mitral valve. So the surgeon looking at the mitral valve from the left atrium, you have your lateral commentary lateral commission on the left post remedial comments. You're on the right into your belief that pusher the leaflet and then have various scallops of the leaflets. So going from left to right, p one p two p three. So from lateral to medial and on the right hand side, you see a three dimensional construct of the mitral valve, the three D zoom view, and you have your aorta at 11 o'clock and you can delineate similar landmarks on three D next light, please. And the biggest and the most important thing for us is really looking at the leaflet Anatomy. The pathology. Where is the mitral regurgitation originating from? What do the leaflets look like at the origin can be grasped those leaflets with the clip and and so those are the things that we're looking for looking for, as we do the T E. So specifically, we're looking at leaflet, thickening or calcification. And the calcification is particularly important within the grasping zone. Because if you have a focal area of calcification and the grasping zone, then we will have difficulty grasping those leaflets in terms of leaflet motion, looking for prolapse segments, flail segments and then similarly for restriction. Whether it's symmetric restriction or asymmetric restriction, it's really trying to define the anatomy. So we know where the M R is originating from and at that location, whether we can proceed with an intervention and grasp the leaflets and then, lastly, mitral annular calcification, usually not an issue. But when it extends onto the leaflet itself, we have to then assess how much free leaf that we have that's mobile and our ability to grasp the least. Grasp the leaflet. Next life, please. Now, these are our basic views of the T E that we all get from mitral valve evaluation the zero degrees to 60 degrees and the 1 20 or the long axis. So on the left hand side you have the three dimensional construct and then the right hand side. We have the T E images, So at zero degrees we get a view of the A two p two scallops at the 60 degrees. So on the 60 degrees view you have lateral is on the right hand side. So you have your left atrial appendage on the right hand side, and then the media would be on the left hand side. So going from right to left on that B screen, you have P one a two and P three, and in the long axis view on the D segment There you have your A two and P two scallops there. Next slide, please. So besides the basic views, what we try to obtain is looking at the anatomy and looking at the scallops and the by commercial views are go to view. That's the view, the use for grasping believe this. That's the view the typically used to look at the different scallops because it really gives us a delineation of the various scallops and and the pathology there. So on the left side and the left hand side of the screen when we're going straight through a two p two, uh, and then you can see the explain image of that, and you have P two or posterior leaflet prolapse with the flail p two segment. And then you have the same thing with color flow Doppler showing a white Jetta mitral regurgitation and then on the explained view. On the right hand side, you see an eccentric enter early directed jet Next light, please. So, just to go back to the previous slide, um, there's one more slide that didn't play, but But we try to see if you can go to the previous one, please. So what we try to do is on this view here, we'll get well, basically go from right to left. So from lateral to medial and look at the P one a one p one scallops, the A two p two scallops and the A three p three scallops. So, basically, if you get if you get this lined up and get three sets of images going from right to left at each different segment, you have a full delineation of what the various scallops look like, What the pathology is. And then you do the same thing with color. You can see exactly where the M R is originating from and at that side. What did the leaflets look like? And whether we can grasp those leaves that so, um, that's important. Next slide, please. And then this is our three D views. So this is again the surgical view, uh, three dimensional surgical view looking at it from the left atrium down. Uh, and we use three d zoom. Uh, so I basically go to the by commission of you do three d zoom and then we get this view here on the left hand side, and then I'll put color on and you get three d zoom with color and a lot of times because of the severity of the mitral regurgitation. The colour flow jet will be very bright, and sometimes I decrease the color gains to really show the origin of the mitral regurgitation. Better next slide, please. And then, lastly, what I do is in the long axis view. I'll do a colour compare, so I'll find it. I'll find the M R Jet, show the most severe portion of the jet and do a colour compare because at the site of the mitral regurgitation, by doing color compare, We can really see the leaflet morphology where the pathology is, and we can see the ability to grasp the leaflets. Apologize. Some of these video loops are not playing, but we'll keep going next life, please. Now, besides looking at the leaflet, morphology and the pathology, the other views that are important is this, uh, four chamber view that we typically obtained. But what we're looking for here is the trans septal height. So we want to see the member in this portion of the septum and the mitral valve in the same view, because that allows us to see what the height is going to be for the trans septal puncture and Jean, as Jean will discuss in a little bit. The transept of puncture is the most important part of, uh, H two h repair procedures. Because if we don't get the transept of right to begin with, it can turn into a very long procedure. The device, uh, the device delivery system is very large, and we have to make some, uh, steering and maneuvering. And if you have medial 883 p three involvement, you need a lot of heights. So long story short, the transept. The height is important, as we know as echocardiography is, Sometimes it's hard to get the septum and the mitral valve in the same view. So sometimes what I'll do is I'll veto the probe a little bit and retro flex. Two. Get a little bit of an off axis view and get that trans septal height, and you can see on the right hand side the measurement of the trans septal height. Next light, please. So what we're looking for is transept. The height of 4 to 4.5 centimeters mean gradient of less than four millimeters of mercury, because we we don't want to make sure we're not starting off with a mitral stenosis because the worst thing we can do in treating a patient is treat their mitral regurgitation and leave them with residual mitral stenosis. Similarly, we obtained Metro Lab area by plane symmetry, either through the trans gastric views. You can do it through the three D full volume acquisition or on a trans thoracic echo, and we're looking for a valve very upgraded than four. Next slide, please. Now things that are unfavorable. So if you have a short transept to height less than 3.5 centimeters, if there's a cleft in the leaflet or perforation, um, if there is calcification within the grasping zone, if you have evidence of mitral stenosis with a small valve area, high gradient, push to your leaflet length a short because we have to be able to grasp both of the leaflets and they enter a leaflet is not an issue. But it's the push relief that that typically gets us in trouble. So we have to have adequate length. And then also, lastly, uh, if there's multi segment involvement with prolapse and, for example, like a bar lows valve, it's going to be hard to get a good result we end up putting more than one clip and may not achieve adequate reduction. Mitral regurgitation. So these are not absolute contraindications, but And we review them case by case and have done some gray zone types of cases. But this is a good guy to decide what's unfavorable. Next slide, please. In terms of m r severity, it's just the typical stuff that we do. We don't need to do anything additional. So effective regards to your office area calculation regards student volume pulmonary vein flow assessment just to determine the severity of mitral regurgitation. Next life, please. All right, actually, uh, I guess I just wanted to interject from quickly. You get all those individually. But what's very important is to be able to put all that together, Um, in terms of looking at the width of it, both location and putting together with the transept, the height, because it helps a lot in terms of planning, because we could take, as you mentioned, a shorter height. If it's more lateral and so forth and things like that, it helps with the planning of one or two clips and so forth. So a lot of that stuff is done beforehand and then the toughest one of the tougher situations that we have not really faced and is, if they have a huge flail gap, I guess would be potentially problematic. So that was the only thing I would put in there. But this is tremendously dependent upon the imaging and takes a lot of time. Okay, Um, my name is Lisa Long. I'm one of the nurse practitioners. Um, that worked with the structural heart group. Um, and I want to go into the case study. And as it stated, all the patients that walk into our office are not that straightforward. Our reality is not always are ideal. Next, we're starting off tonight with, uh, the reality of a degenerative case. We have an 82 year old male presenting for a surgical consultation for mitral valve repair versus replacement versus a, uh, as therapy micro clip. His past medical history includes coronary artery disease, which he had five years prior to presenting to us. Uh, and also a PC. I of the left sir. Complex, uh, following the surgery, he also had hypertension. Hyperloop idem mia, Prior tobacco abuse with with a COPD emphysema. He was under the care of a pulmonologist, for he had a known Michael regurgitation that he was being followed by his primary cardiologist with serial, uh, surveillance echoes and finally presented with persistent Disney on exertion that occurred with walking up and down his driveway or a flight of stairs, as well as his concern of exercise intolerance. Um, when he went for a surgical consult, he was seen by Dr Hargrove, had an STS score for repair of 4.197% and with the replacement of 8.55%. Next, his medication regimen was typical for our cardiac patients. He was on a beta blocker and are a status as well as, UH, 81 mg of aspirin, including his, uh, his inhalers that were prescribed from his pulmonologist. Next uh, T t e transits arpeggio echocardiogram was done at the outside hospital. It showed a mitral prolapse of the interior valve leaflet. He had moderate to severe mitral regurgitation within preserved EF of 60%. His RV was normal. He did not have an ASD, and his left atrium and his right atrium were mildly dilated. His right heart pressures prior to the procedure as we can see, His wedge pressure was 14 p A of 50/60 and a cardiac index of 2.3. The pulmonary function tests were done and, uh, prior to having the surgical consult with the F E V one of 1.23 with predicted of 51% showing moderate, severe obstructive pulmonary disease. Next. So I'm just going to walk you through some of these images here, and hopefully these videos will play again. Our apologies for the technical glitches. So again, by commission will explain, view our home view or go to view. So on the left hand side, we're going through the A to P two. So right in the center, uh, and you can see on the right hand side of that left screen you have a large interior. Leave the prolapse as well as some culturally leave the prolapse with some calcification, uh, mitral annular calcification, but doesn't extend onto the leaflet that much. And then if we go back to that other slide on the right side of that previous slide, you can see the mitral regurgitation originating from a two p two region extending into the A three p three regions. So why jet? Uh, eccentric mitral regurgitation jet? Uh huh. Well, next slide, please. Now, this is a three dimensional, three D zoom view. And on the left hand side, you can see there's a large prolapse of a two a three segments and on the bottom, you can see Also, see, there's evidence of P two and P three prolapse. And then on the right hand side, we have the same image with color flow Doppler, and you can see a white area of, uh, mitral regurgitation. Uh, all right. Can you see if you're able to play those real quick? Yeah. Okay. And then if you can go to the one and right. All right, that's fine. Next slide, please. So at this point, we're going to take a quick poll. Linda, can you put the pole up? And basically, the question is, what type of therapy would you offer this patient? Would you offer medical therapy for cutaneous therapy or surgery? Linda, can you see any of the polls? Yeah. So, um, in terms of the polling right now, 75% have said for cutaneous therapy. 11% surgery, 9% have offered medical therapy. Yeah, well, it's interesting, I guess. You know, it's you know, your audience when you talk about what the topic of the talk is, and so that may have swayed the cutaneous therapy arm or decision. I think that all of them are very reasonable, and especially when you were have access to really world class surgeons with great outcomes. I think it's tough to think about not providing surgery because, as Clark pointed out, this really is a surgical disease that we should be thinking about durable repair and, hopefully lifelong only intervention that these patients will need. But as we know, it's. And as Clark pointed out, it's not just about the incision, um, lot of comorbidities in these patients. Tough recovery, Um, all that needs to be taken into account, and this is a modality in terms of T E. R. That is really right now for high risk or non operative patients, and hopefully we'll be able to move this into the more moderate risk or even lower Allah Tavern. But you can see if you take the polling off, I guess, um, the indications here. Classic indication of surgery and Clark already went through this, and I just wanted to point out that T E. R. Is really a Class Two. Indications has achieved a Class two indication present moment for those that are symptomatic with classroom for heart failure Primary, um, are or Jennifer mahr and prohibit surgical risk. Um, and this patient did meet one of the two STS scores with greater than 8% STs score for much of our replacement, although it was four point, uh, and change for mitral valve repair. Um, it did not have severe pulmonary attention, but it's an inexact science in terms of STS scoring, and it really is dependent upon the evaluations with the surgeons and so forth in a discussion with the patient. And this is where really the multidisciplinary aspect of it comes into play, as we all think about the patients and offer them their choice and see what they would prefer or what they would like to undergo and then again heavily, I can't point out and stress how how dependent I am. We are on our echocardiography firs, uh, ignition. Roy do an amazing job in terms of looking, scrolling back and forth, giving us not only the location, but the width and all the aspects of whether or not could be done. So I think this person, we felt that this person was amenable to edge to edge repair per cutaneous Lee. And I guess the next slide here, let me just say just a second. But I think that the STS score frequently underestimates mortality. I mean, I don't know how they figured this out. I mean, you have an 88 year old come in and you'll be an STS score of 1.5 for Michael operation. And I mean clearly an 88 year olds closer to the end. And he is to the beginning, and I don't want to hasten that process. So, um, and a guy like this who basically would be a redo I mean, it wouldn't be And then he has COPD, so you could do him easily do him to the right chest. But then that's just gonna be a a morbid procedure for him because he maybe end up, you know, with pulmonary insufficiency. Post op. So again, I think this guy was certainly a good candidate for HGH Repair Micro Cliff. Yeah, I think That's what we felt as well. Um, you know, just their high risk doesn't mean they can't have the surgery, Uh, and so forth. And certainly if we have a complication or we're just unable to deploy the device, that's still an option for this individual as well. But as we go through the case next slide, we had already looked at this individual and saw that it was maybe a little bit on the short side, as in terms of trans up to height, as we'd like to get to about 4.5, particularly as you get more medial. But you're limited in terms of the thickness of the crossing sites and some patients. And we're pretty much as high as we could get here. And we got about 4.14 point two centimeters. And I think we thought that was sufficient to do this case next slide. I don't know if you wanted to drive this. Yeah, that's fine. Um, again, Uh, videos are glitch in here, but, you know, and this is why it's important to work through this by commercial explain view, because that's that's the view that we use, uh, most of the time to actually decide where we're going to place the clip and whether it's medial to lateral or anterior posterior. So on the left hand side you can see the clip, uh, coming in through the left atrium. And it's right over a two p two, which is where we wanted to go based on where the pathology was, where there was significant, a two and P to prolapse, and that we wanted to bisect the jet where in the freeze frame on the right hand side, you can see it's it's bisecting the jet. So on on the left hand side, on our by commissioner view, you have so on that side we can move it left to right to orient ourselves lateral to medial so you can see the appendage, which is the lateral side of the valve. And then as we go to the left, it's the medial portion, and then on the right hand side, you see the aorta on the right hand side, which is the anterior portion and then going to the post earlier. So this really gives us an orientation lateral to medial as well as anterior posterior. So we we thought we were in the right position. We were bisecting the jets, so we decided to grasp your next slide. Please. I'm sorry. So the the previous slide was the actual grasping of the leaflets. And you can see we have grasped both anterior and pusher leaflets. Um, and there's a there's a good grasp. And then when we put color on, there was a significant reduction in the mitral regurgitation. But there was still a residual s centric mitral regurgitation jet that's being directed poor Surely, um so we knew we hadn't reduced all of the mitral regurgitation. But once we've had a good grasp of the first, uh, with the first clip, we decided to release the clip. And on the next slide on the three dimensional pictures you can see this is with the clip released and you get a double orifice, mitral valve, um, and nice tissue bridge there in the middle. And then to the right of that, you can see there's still a remnant prolapse segment that's there. And with colorful, you can see there's mitral regurgitation originating from there. So that's on the medial aspect of the first clip your into atrial septum. is on the right hand side in that view. So next slide, please. Just so that's just before we do the best. If you go back to the last slide, I mean this. I mean, it looks like I just want to point out. I mean, all this evaluation is being done before we let go of the clip. So he he's looking at how good a grass we have. The orientation of the clip is extremely important to see about the mechanism of the residual M R. Is it because we've distorted the valve? And, um, would it be like a 93 o'clock orientation or is it classically more of a 12 6 o'clock orientation? So all that is all looked at, and hopefully by the time we let it go afterwards, nothing has changed. So that's the picture that you're seeing here that's actually already released, but that's a lot of discussion and a lot of calculation and time and examination goes into before it's released. Sorry, next line. So that now we sort of knew that we had to go more immediately. And so I don't know Jeunesse if you wanted to. Sorry to interrupt. No, No, that's okay. You can continue. So this is always sometimes we feel at least I have a lot of trepidation because you're going, you've got one clip that's already deployed. Um, and you've got a fresh clip going into the from the atrium into the ventricle, and you're hoping that you go to the right place, hopefully right next to it. Whether it be medial lateral, Uh, I will say that part of the planning process. We like to go more laterally because it's a little bit easier to go lateral than media, as you can imagine from an Internet troll crossing. But you try to hopefully do a lot of things and spend a lot of painstaking time to make sure that you don't interfere with the other clip as we're trying to put it there. So I'm usually listening to generation who's telling me to go a little bit more media, a little bit more lateral, a little bit more of this and that as we go through this, uh, next. So now these are both clips deployed right next to each other, and you can see that on the left hand side, and we were able to get a great result with this patient with trace residual mitral regurgitation, as you can see with colour flow. And then this is our three d at the end of the case. Uh, not not the typical double orifice. You can clearly see that the medial orifice is much smaller than the lateral orifice. But you have a nice tissue bridge. They're good grasp of the leaflets. Um, and, uh, we check gradients throughout prior to proceeding with any multiple clip procedures to adjust to make sure we're not dealing with my presence of mitral stenosis already. And, as you can see in on the next slide, despite the two clips, we only had a mean gradient of three. You can go to the next slide hands. So, you know, we were able to deploy two clips, have trace residual mitral regurgitation, and left the lab with the mean gradient of three. Next life. This is a cartoon or a nice depiction from the Everest to trial publication. But you can see that basically, uh, in, uh, see there in the diagram. It's basically you go up the IBC, you do your intellectual crossing. Um, and then basically you're entering from the left atrium, looking down to mitral valve, trying to find the exact location. And if you go to D can be a little bit challenging to grasp both leaflets at the same time, there is a possibility of grasping them independently. But we do, as in general, like to grasp and simultaneously when you think you have a good grasp will close it and then you'll do all the examinations of the residual gradient orientation, mean gradient and so forth. And then nice depiction in H and G about what it looks like in terms of your Double Orpheus in the old classic Alfieri Stitch type of mimicking, if you will, and then when you let go of it, hopefully it stays there in half. So our patient did really well. His hospital course was unremarkable. He was discharged the following day after his echo was done. He was discharged with Plavix along with the aspirin for dual anti platelet aggregation, uh, for a 30 day period and instructed to take an antibiotic for six months prophylactically for any dental procedures. His six month follow up echo showed uh, an EF 45 to 50%. Uh, post the mitral clip procedure that, uh, there was mild mitral regurgitation. Uh, the mean gradient was 2.5 millimeters of mercury, and there was trivial annual calcification that could be seen. Um uh, there was, uh I think that's supposed to say try custard. There was mild try custard regurgitation with a gradient of 44 millimeters of mercury, and the estimated are a pressure was five millimeters. Uh, three years later, he continues, uh, to big snowbird to Florida and still has some Disney a issues related to his pulmonary issues. But he is currently not on a diuretic. Next. So this is just a historical timeline, if you will. The mitral clip it was the first ones were playing in 2003. Uh, the landmark trial was really the average trial that led to FDA approval in October of 2013 for primary to the general, um, are, uh, are probably all familiar with a splash that came out of T. C T. Back in 2018. With the data from the CO at trial, I received FDA approval for secondary or functional more in March of 2019 and akin to the time delay between FDA approval and CMS reimbursement. Um, in January 2021 Uh, CMS basically approved. Um, uh, the indication for using a micro clip for transit. I'm sorry. Trans catheter edged edge repair in secondary. Um, are so this is a particular device that is fully approved for the basic categories. Um uh, functional and degenerative m r. And there are other devices in the pipeline, but currently, this is the only one this FDA approved next again. I just wanted to maybe spend a second. This was the trial Evers to that really led to the pivotal FDA approval. It was basically a surgical open surgical repair versus proteins, micro valve repair with micro clip. They had to have 3 to 4 plus m r E f greater than 25% and in the stock dimensions of 4 to 55 centimeters. Um, and evidence of pulmonary potential. A fib was a 2 to 1 randomization. It was really ideal in the sense that it was a two p two, uh, area next. And then basically what they saw. This is a m r. Severity between baseline and 48 months between surgery and the clip and surgery was certainly a lot better. You could see in terms of reducing the amount of vegetation on the right hand side, um, in the control. Basically, uh, at 48 months, there was a lot less three and four plus m r. And there's a lot more one plus m r. As opposed to the device where you had about 60% of patients who had 01 place m r. So this is really I think, why this is still a surgical treatment. Back then, I think people have gotten more experience that people have gotten better and, uh, and so forth with experience. But right now it's for high risk or inoperative patients. Um, what I think really led to the approval, though, is the next slide. If you take a look at mortality at four now, five years and beyond, there's really no mortality difference, and it's gonna be hard. As Clark points out, an 88 year old gentleman is going to be hard to show any benefit in terms of mortality with either modality. Next. I think that's it. I want to open up everything to a question and answer. I think I want to put out some kudos to Hans for putting this all together with Linda and Lisa and keeping us on track. We wanted to do a lot of introduction for, um this. There are a couple of other sessions coming up and we'll go into different, functional M R and other questions and answers and other opportunities and other alternative strategies. But I see that there is one question in the in the box right now, and I'll open up to the Panelists. I guess it's basically we can. I'll read it to the group if they are unable to see it. But it's question time. They started to interrupt. But, uh, maybe, um, maybe as we discussed that you can. I don't know if there's a way to minimize the power point and maybe just try to see that will allow you to play some of the previous videos. Um, just in the background. But go ahead. Well, yeah, I think that's great, but it is much repairing the setting of infective endocarditis. Does that change how you approach this repair? And I guess the question is, um, about Michael per cutaneous micro valve repair. I would presume, but I don't know the questions. The second question is, would it make more difficult due to possibility of rupture of the vegetation? Um, so I would say that I don't think anybody is going to do it in the setting of acute infective endocarditis, uh, and so forth. And then I think it would depend upon how it healed and what was left and so forth things like that for at least for cutaneous repair down the road. Um, I don't know. It's vertical repairing. I mean, an endocarditis. I mean, generally, I would Unless it's I know it's an old burned out in the card. I just I would do that to astronaut to me. Just because you have more options, you don't know. Maybe the infections just involved in the annual list. It may be bigger than you know than you know what you're getting into to start with, but I mean, in general, we can repairing the card itis in 85 90% of the patients. I mean, if the vowel is totally destroyed, we we wouldn't be able to do it. But we can use, uh either autologous pair card. Um, that we treat, including Al to hide in the operating room or bovine pericardium and patch these vows just amazing how you can fix in the card itis patients. But in general, I don't think an IndyCar dice patient would be a cannon for a per cutaneous mitral valve repair. So cute face at all right? Yeah, and it it comes down to leave that morphology. And and and that's really key for TransCanada repair. You really need adequate leaflet tissue to be able to grasp this leaflets. And and with endocarditis, you'll have distortion of the leaflets and and that will make it that much more challenging. So, plus, sometimes you could see a perforation, I guess, from the antique arthritis as well. And that would be, as you pointed out nicely in your slide. That would be one of the contraindications for us doing anything pre cutaneous Lee in terms of vegetate Your pair Mhm. Yeah, that's good. One of the there's a question in the chat. Is there anything new for treating severe Mac and severe M. R. Yeah. Uh, well, I mean, we can declassify the poster leaflet pretty, uh, safely. I mean again, in those cases, Well, we would tend to favor a stern autonomy approach, although you can do them through a port access approach if you have circumferential uh, Michael annular calcification, and we've actually use the tavern valve in the micro position. I think we've done six patients. Five have actually done well, the one who did not do well. I used the largest Taber valve, and it was too small at that point. I didn't have any. I didn't have many options, and basically the heart fell apart at the end. So I mean, micro valve and the annual qualification we do approach with some trepidation. We talked to the patient about it, and and sometimes you can, uh, if it's, you know, if it's not terrible, you can actually just replace the valve with usually with a tissue valve and put the suitcases around the poster annular calcification. But it was a younger patient. Then we don't hesitate to d calcify the annuals and do a do a repair. Yeah, and there are other uh, potential T m v R replacement valves in the making to try to do a native calcified valves. And I think the big questions and concerns would be whether or not you have ele bot obstruction with the values that you put in as opposed to just the tavern values. The problem with the other problem of the tavern values is because the morphology is different. It's not really a circular valve like the Eric Ball can be. So it's a challenge. It's a problem. Well, I mean, the prosthetic. My travels are circular. Also not really an issue, but for But you can you can cinch them down. You can't really do that. Prick. Cutaneous Lee, right? Another question is, Jean, what is the risk of it for the second clip for mitral stenosis? Yeah, that's a good question. I mean, I think, uh, it's it's real. We've had detachment, um, putting the second one in and one of our earlier cases that we did a lot of long time ago putting the second clip in. We caused a detachment of the first clip. Um, I would say in general it's under 1% 1% But I you know, it's not something I mean, we do with a lot of trepidation. I will say that if you take a look at, uh, the implants across the world. And maybe in our own experience it was about 1.5 to 1.6 clips per case. So there's a great majority of cases are getting a second clip place. Um, there it may go down because there's a newer clip that's wider, So probably the need to put in a second clip is going to go down. And it's probably, I think, our experience when we looked at it was like 1.3 or 1.4 clips per case, a little bit lower. And maybe just because where you have more trepidation, I'm not sure what the right answer is, but it's it's low. Um, it's not 50% but it's not zero either. Yeah, and I think that's that's kind of as an echocardiography that's always a concern. Will have to replace the first clip. And and after having done many of these, uh, most often, um, if you're if you're starting off with a good gradient and no intrinsic Mitchell stenosis, you can actually comfortably put into clips without ending up with his usual micro stenosis. And and the best thing is, you're able to assess it even after you press the leaflets. What? What your gradient is going to be. And if you're not happy with that, you can certainly decide to aboard at that point. And they don't have to not have to deploy the clip. Right? Follow up question was, how do you d calcify the Metro analysts? Ah, well and carefully you generally have to detach the post here A leaflet and, uh, you use there are you could use this device and neurosurgeon Jews caused the kusa and and get the calcium out. Or you can frequently just actually take it out on block and take the whole thing out and you look at below the Michael annual sit still intact. Now sometimes if you if you if you detach the micro, the ventral from the atrium, you have to put that back together. Usually do that with a patch on the atrial and ventricular side. And then so the leaflet back to that and then finish your finish your repair. So it's tricky sometimes, and which is certainly an increased risk factor in my Yeah, perfect. There's another question in terms of what is your guys thought process in terms of a stress echo Prior to the procedure with the measurement of the P A pressures at rest and peak. Would this be helpful? Exercise capacity and symptoms could also be evaluated. Yeah, so I think that's that's That's a very good, uh, good question. And I think it applies more in terms of your decision making, whether or not to intervene with mitral regurgitation, right. So as as the new guidelines have come out, we're pushing more and more towards early intervention and his, Clark said. It's the timing is key and even the guidelines have have come out and really hard on that factor. So I think if there's any any doubt or any question regarding the timing of intervention, I think those are the people you want to put on the treadmill and assess their functional capacity. See what happens to their P a pressures. And I think it would be interesting to do a study in terms of outcomes of pre and post. But these patients that by by guidelines and by definition they are already symptomatic, they have a need for intervention and we have their human dynamics in terms of their right heart. Cath pressures pre. We measure their left atrial pressures post. Um, so we get a lot of data with these procedures, so that's a good question also. I mean, that's a great as you mentioned. It's great for assessing how severe the M R might be, and so forth, and maybe delineate between the different ideologies that are shortened. Surprise your symptoms, um, but the types of patients, by the time to get in terms of looking at for micro, for degenerate them. Or at least, um, they really can't exercise as much as I did. And I wanted to use that to segue into the evaluation that Lisa does for these patients. I mean, they'll get, um, at the six minute walk tests before they should. As part of it to try to get a baseline. They get quality of life questionnaires that they're doing baseline and then at several time points after. And that's one way we can look at to see how much better the patients have gotten or received. But it's a great idea, and I guess the question would be would you do something like a debut demean echo and some of these patients to see if you had it doesn't really mimic exercise, but and I'm not sure for the patients that can't exercise at all back. Yeah. One of the other questions was Clark, what is what do you feel in terms of the prohibitive risk for micro Riegert for micro repair? You mean STS school an STS score? Yeah. Oh, well, no. You know, I mean, by today's standards, if you're having stf score of five, you're a pretty high risk. I mean again, Like I said, I'm amazed at some of these patients come in the office. And I think that's primarily because they've been so few patients in the database. An 88 year old had a micro repair. Yeah, they've been they've been highly selected to start with. And so the average 88 year old's gonna be a lot higher than they, and they give you at the number. So I I don't think you, uh I'm not sure I have an absolute number. I think we'll Certainly when you get above an STS score of five, you're pretty high risk. And again, I think it's if you have, for instance, that patient they presented had a previous cabbage. I mean, there's a lot of that. There's a lot of, uh, things that go into the equation, What the patient looks like. Are they frail? I mean again, some 88 your 85 year olds, or a robust and active and others are, you know, basically hobbling in here. So I think you have to put all that in the equation, so I don't have a I don't have an absolute number, you know you have. You get a good start about the patient when they walk in the door, and that's usually pretty accurate. Wow. And I think that's where it's It's important because you have the two sides, right. You have the clinical history and the comorbidities and what the patient looks like, and then you have the anatomy and whether it's suitable for any alternative. So that's that's That's the beauty of having a multidisciplinary team. And that's kind of what we do on a case by case basis in terms of review, the imaging, looking at the clinical history, talking to the patient and then trying to assess what's their surgical risk? Is this procedure done? Can be? Can it be doable per cutaneous? Lee? What results are we expecting going into the procedure. And when you put those parameters together and talk about it as a group between interventional cardiology, echocardiography and cardiac surgery, uh, you know, it does become a lot a little easier over time because the patients sort of fall into certain categories. And then and then you pick the best treatment option for them, based on based on those factors. One other treatment that we haven't discussed tonight and I think we'll be discussing one of the future sessions is we're participating in the so called harpoon trial with Edwards, and that is a small left or economy. And you stick up a needle in the apex of the left ventricle and you grab the grab the relaxing leaf right. Now that they're requiring it to be a P two prolapse and they're very selective about who they are, let's do it. But that would be another not not. Let not is less invasive than an open procedure, but not not, but more invasive than a than a per cutaneous, um uh, Alfieri clip. So that's another thing that we will keep in in the reserve for the patients. That's okay. I'm sorry. What What? What what do you attribute for those that people might ask the difference between mitral valve repair and replacement in terms of STS scoring? Well, I don't think there's any question that micro valve repairs a higher risk procedure because one you the micro valve is intricately involved with the mechanism of the ventricle. And, uh so I mean, I don't know. But it's certainly borne out in virtually every study. Ever done the difference between repair and replacement and then in the long term, then what? The long term survival is much better with repair than it is replacement. So, yeah, so I don't know why the scoring so different? Um, it's again. It's based on the patient's in the database. So if you ended up with the micro valve repair, your chances of dying a pretty, uh, probably almost twice as high as it would be with RO. I mean, with the replacement as you as it would be with the repair, do we need to do a re? Do you think we need to re investigate the STS in terms of doing another study or re evaluate? I think it's the biggest surgical database in the world. I mean, it's just an issue of, you know, bias involved in picking the patients. If if I say 88 year olds good enough to be operated on, then they're already less risky than an 85 88 year old. It's not that I don't think it's an operative risk. So again, it's inherent bias in the database, and it's a limited number of patients. I mean, if you had 10,000 patients like that, then you you wouldn't have that much bias. But it's probably a limited number of patients to get that number. It's interesting the the European database. Uh, the euro scored. It tends to be higher than the STS database, So, uh, I don't know exactly. I'm not a I'm not a statistician, so I don't know how they calculate either one of them, but I can tell you that's the case. Thank you guys. Also thank thank you, everyone for joining us today. And then as you guys, um, we kind of pre loaded. There's gonna be two more sessions for the next two Tuesday next to Thursdays. I'm talking about functional m r. And the last one is tear not to tear. Um, in terms of functional m r. And then more discussion in terms of degenerative will be a degenerative mitral valve roundtable. Um, during cardiac surgery, Grand rounds on April 8. Um, I want to thank our Panelists. I want to thank everyone for joining us this evening. If there are questions that you guys have that you know are burning, please send us emails. Um, but I want to thank you guys for joining us this evening. And I hope for for you guys to continue. If there is any questions, please reach out to anyone on the mitral valve team. Presby. Yeah. Thanks, everybody. Thanks. Okay. Tonight, night at all, right?
