Chapters Transcript Video Current State of M-TEER and T-TEER Dr. David Adler discusses transcatheter mitral therapies updates and enrolling trials. This is the final talk and I promise you this will be the most exciting talk because my unbiased opinion, transcatheter therapy for Mitral and Tricuspid valve is the most exciting thing in cardiology, perhaps in all of medicine right now. So we're gonna have a great talk. Um We're gonna talk about transcatheter edge to edge repair or tear. We've been doing tear for a decade now and it really has been a decade of blood sweat and tears. And I would like to acknowledge all of the people who have been involved in building our program from performing a small niche novel therapy to what is now a main line therapy for mi regurgitation. And there's too many people to name today, but it's been a tremendous team effort we've been doing here for a decade. Our first implant was in 2014. Uh It was FDA approved in 2013 based on the landmark trial, the Everest trial based on that the FDA approved the MitraClip for primary mitral regurgitation, realized this technology was in development for a decade before those trial results were available. And we had that data. The other very important landmark trial was the co op trial. And you'll realize there were six years between 2013, 2019 when the FDA approved tier for secondary mitral regurgitation. Now, why is that? Well, the results for primary mitral regurgitation with tier are, are quite apparent when I see a primary Mr patient for follow up in the office after a tier procedure. I get a hug. I mean, those patients, they're, they're feeling better and I like getting hugs. It's, it's a good feeling. They really do. Well, it it wasn't very hard to show that that works for secondary mr patients. Those are patients with sick ventricles. The mi regurgitation isn't the only problem with their heart. So we'll get a beautiful tear result. They come back to see me in the office and I ask them how they're doing. And they say, man, and so it took us a little bit longer to understand the benefit that those patients were driving the co op trial, randomized patients to guideline, directed medical therapy or medical therapy plus tier. It demonstrated improvement, heart failure, symptoms, improvement in hospitalizations and more importantly, decrease in mortality. So now when those patients come and see me and they say, man, I say you're going to live longer, you're gonna feel better. Just trust me, hang in there. And those that data have panned out, we'll talk a little bit about where we're at now with uh with tier uh we now have five year data from co a trial. And our program is currently doing 100 and 25 to 100 and 50 tier cases a year. There have been 100 and 50,000 patients treated worldwide with mitral tear. I want to share with you a case. Uh This was a patient that we treated recently. The 78 year old. He had a prior stot, he had primary Mr with a flail P two and uh we had a heart team evaluation and I want to stress every single patient that comes to us with their primary secondary. We have a heart team evaluation. We have our surgical team, see the patient, our interventional team, see the patient, we have a heart team discussion and we make recommendations. Um We decided that tier would be the best treatment for this patient. You can see this is clearly degenerative or primary micro regurgitation. Uh That flag flapping in the wind on the left side of the screen is the, the P two segment of the posterior leaflet that's partially flail with severe Mr. Um There you see a 3d view of that and you, you see the severe Mr on the right side. Um So how did we come to the decision to treat this patient with the? Um There are trials underway for transcatheter mitral valve replacement. Uh So we have the full Armamentarium within our system to treat patients with trial uh TMVR or TIER. Uh We have two systems to treat with tar. There's, there's been a tremendous amount of resources uh spent developing treatment for micro regurgitation. Over the past couple of decades, every device on the screen has been explored as a treatment for micro regurgitation tier has become a first line standard therapy. And the reason is the transcatheter mitral valve replacement is more complicated than transcatheter aortic valve replacement. Uh We are enrolling in a couple of trials now and I'll, I'll allude to those. But the, the difference between tver and trans cather micro valve replacement is really the anatomy. The aortic valve is very well suited for uh for deploying a valve. Basically, the LVOT and the aortic root form a tube. There's usually a calcification there to anchor the, the stent valve and the valve goes in, it's round, it stays there. The mitral valve is very different. Mitral valve is a lot more complicated than the aortic valve. It's a dynamic structure. It's not round, it's crescent shaped, it's saddle shaped, it moves, it's got a very complex subvalvular apparatus and all of those are hurdles to implanting a new valve within the mitral valve. We do have several trials that are ongoing and um there, there's been tremendous progress in overcoming the complex anatomy of the mitral valve. The intrepid valve has a, a skirt that fits the annulus and supports the valve. Uh The uh encircled trial is studying the SAPIEN M three valve which which uses a novel technique of anchoring the valve with a dock that wraps the leaflets and uh so valve of corte and we are enrolling patients in these. There is a need to develop this. Even though tier has been very successful, there are still some patients, especially those patients with some degree of mi stenosis and and thickening of the leaflets that would probably be better suited with a a true valve replacement. So it's important that we, we continue to pursue those developments. But transcatheter edge to edge repair derives from a procedure developed by Doctor Alfieri. Doctor Alfieri was a surgeon who really appreciated the complexity of the mitral valve and understood that less is more that the more you leave that valve intact, the less you mess with the valve, the better off a patient is going to be. And so he developed a procedure called the A stitch where he simply stitched the anterior leaflet to the posterior leaflet. And it worked. Nowadays there, we have more elegant repair techniques. It's not performed that often. But this was the basis for developing a transcatheter system that could replicate this without the morbidity of sterno and car excuse me, cardiopulmonary bypass. So, mitral tear it's performed from the right femoral vein. We come, we do a trans puncture, come from the right atrium to the left atrium, come below the valve, grasp it with our device and we clip the anterior and posterior leaflets together and it replicates that ALPH or stitch with a simple uh groin puncture and patients go home with a band aid over the groin. Um So this is the patient that I showed earlier. We actually performed this as a live case. Uh Some of you may have actually watched it. We, we did this recently as a as a teaching case. And you can see on the left hand side of the screen that flail posterior leaflet on the right side is our delivery system. And we've grasped both of the leaflets. You can see there where we've, we've grabbed that flail portion of the posterior leaflet and clipped it to the interior leaflet. And then in this, on the left hand side, you can see we have not yet released the clip. Um but we're, we can see where we've uh very got a very good grasp of weet. And on the right hand side, that's after we've released the clip, the clip is in good position here on the left just to remind you what we started with and on the right, that's our resolve. And so he has come back to see me in the office. He's feeling great. I got my hug. Uh It was a successful tier procedure. So over the past 10 years, we have accumulated knowledge, skill base. Uh We've gotten much better at performing Mi Mili and Pascal tier. Uh We have now four sizes of micro cip devices, basically long arms, short arms wide arms, narrow arms. There's a also a pascal device. Now that's on the market, there's two sizes of pascal. So we essentially have six devices to choose from when we're treating patients. Um We've accumulated a lot of data over the past 10 years and have come a long way from the Co op trial. We've had recent publication of fiveyear data from the Co op trial, which has shown that that's a durable result. And perhaps more importantly, there was a crossover arm of the Co op trial where patients who initially were randomized to the medical therapy arm after two years crossed over and were treated with tear and had the same outcomes as those who were originally randomized to the clip. Uh class two D trial show that Pascal was effective. Uh We have a postmark registry, the expand trial which is confirmed uh that in the Real World Theater is effective. Recent publication of the Co op uh pas uh is this postmark registry but Real World experience always a question of well. Yeah. OK. It worked in a clinical trial, but how is it going to work in the real world? And I have to mention the Mitra Fr trial. It was another trial published about the same time as a co a trial uh which was similar in design but did not show the same results as the co op. Uh I have sat through many, many sessions at meetings debating why that was um it's beyond the scope of today's discussion but, but probably boils down to patient selection and, and picking the right patients with what we call proportionate or disproportionate. Mr to their left ventricular dysfunction. But really with the, the data that we've accumulated since those two trials, people aren't talking that much about Mitra fr versus Co op anymore. Uh So where do we go from here? We're enrolling moderately uh sorry, moderate risk patients. So all of all of what I've discussed applies to patients who are at high risk for cardiac surgery. We now need to know how does this compare in moderate risk patients? So, the repair ira trial is enrolling patients with an SDS of two or greater or age of 75 or more. We'll randomize them to surgery or to tar and uh we'll, we'll learn that. So tar effective on the mitral valve. Can we treat patients with tricuspid regurgitation? Can we take that same tier technology that clip and put it on the tricuspid valve? Well, the tri iIn trial answered that, uh that was a trial we participated in and uh results were published this year. Uh Tricuspid regurgitation is a little bit different than mitral regurgitation. We don't expect to have that sort of mortality benefit that you would have with the mitral tier. But we, but treating tricuspid regurgitation is all about treating symptoms and quality of life. And the truma trial did show number one, it was a safe and effective procedure. Uh At 30 days, 98% of patients were free from any adverse events. We showed that the patients who had a significant reduction in tricuspid regurgitation had a significant improvement in quality of life and that improvement in quality of life was proportional to their improvement in tricuspid regurgitation. So we are anxiously awaiting an FDA decision on this. In the meantime, we're enrolling patients in continued access trials um to continue to learn about tricuspid regurgitation at tier but very optimistic that this is going to be um uh therapy for patients with tricuspid regurgitation going forward. So, in conclusion, we have uh a team of experts, we have structural heart cardiologist, surgeons that evaluate every patient. We have a multidisciplinary heart team that will evaluate every patient and we have a full Armamentarium to treat patients with mi regurgitation and tricuspid regurgitation with both tear and transcatheter valve replacement. So, thanks for your attention today and I think we finished on time. Published October 19, 2023 Created by Related Presenters David Adler, M.D. Sentara Cardiology Specialists View full profile
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