Dr. Matthew Summers discusses current TR therapies for tricuspid valve repair and team approach to the patient treatment plan.
We'll go ahead and get started. Um So um I know I've met everyone in the room, but for those online, I think we got a big audience online. Uh Matt Summers, I'm the program director of Structural Heart and uh I apologize. This is a last minute substitution. So we didn't have to cancel grand rounds. Um So I subbed in last minute, but um this is an adaptation of a, a presentation that uh I've given uh before, but with some updates since we've adapted some of these uh transcatheter, tricuspid valve therapies uh into our workflow. And so this gives a summary of where we're at currently in the field as far as how to treat tricuspid regurgitation and then what the plans are here at Centra for, for how we're going to adopt these technologies. I think it's best to start with cases just to highlight for those who are not familiar with Tier in general, which stands for trans catheter edge to edge repair. Um This is how we've been treating mitral valves percutaneously and it has been the only commercially available treatment for mitral regurgitation transcatheter uh in the country since 2014 through clinical trials initially, but then through Everest and co a commercial approval for both degenerative and functional mi regurgitation. The technology used on the tricuspid side is identical, the clips are actually the exact same four clips. And so the uh the adaptation of what we've learned and have been doing on the mitral valve um has, has set us up very nicely to be able to treat tricuspid valve patients too. This first case is uh Rh 77 year old gentleman with ischemic cardio mop. He had a four vessel bypass in 21. He also had a fib and a cox maze with the ligation. Uh and then had after that ac T I dependent flutter that uh he underwent ablation for. Um but in the context of his ischemic cardiomyopathy and his atrial arrhythmias, he developed progressive functional Mr got several different types now that we've identified in him. Uh there was some annular dilation uh from the atrial functional component of this, from the arrhythmias, but also uh some tethering, relative tethering of the leaflets in the setting of some mild LV dysfunction and and uh ischemic cardiomyopathy, but had clear symptoms uh related to this severe lower extremity edema and right heart failure symptoms, multiple admissions for decompensated heart failure. And he was referred for MitraClip. So this is how we do MitraClip. Nowadays, in the lower left here, this is called 3D multiplanar reconstruction. And so it's a tee image where we set up two planes. Uh typically in the in MitraClip, we get a 1 31 35 ish to get anterior and posterior direction. And then we get a 60 bi commis view to get medial and lateral. What 3D multiplanar does is allows us to set those planes in one image and then in the second plane and it gives us the short axis and the three dimensional image all at once. And so you can see the clarity over here of what we get with transesophageal imaging nowadays and, and some of these micro CPS and it helps us be very precise with our clip planning. And we have we get some image degradation when we add color to it. But by and large with the combination of three multiplanar um in the 3D imaging, we can very uh uh precisely plan the clip procedures. This is how it functionally looks when we're doing the procedure. So MitraClip for, for those of you who are unfamiliar, as I mentioned, it's an edge to edge repair. So what we're doing is taking, I tell patients this is like a little clothes pin. Uh We drop that across the valve usually across a two P two. We introduce it into the ventricle in a close position, then open the, the arms clip arms and then pull it back to where the leaflets, an interior post are both draped across the clip arms and then grippers come down when we deploy them on top of the leaflets, we cinch the the clip together and close the clothespin and it brings the edges together. So edge to edge repair. This is based off an old surgical technique called the Alfieri stitch or in the tricuspid valve position, the case stitch. Um but you can see we get very, very precise imaging and we have to be able to see those leaflet fets insert into the clip arm so that we're not bunching the leaflets. So we're not grabbing subvalvular structures so that we get a good result and reduction in Mr. And so this is after the clip is deployed, you can see there's no Mr left. This is an anti animation or a picture actually of, of what this looks like. This is delivery system, which I'll mention is the same exact delivery system as a tri clip just uh inverted 100 and 80 degrees. And when this is guided with X ray as well, and he had concomitant tricuspid regurgitation. And so this is up to 40% of patients with left sided disease have severe tr and so we've long recognized this, we've been doing tears since. Like I said 2014, we have a therapy that is a adaptation of a surgical therapy um with an Alphie stitch. And we have a tool that we can use in a very similar manner just as the surgeons did years ago for the case stitch to try to B cuspid, the tricuspid valve and reduce the tricuspid regurgitation. But the biggest limitation is imaging. Um We have excellent, excellent anesthesiologist Sarah Wit is, is one of the best images we have and she can get beautiful images as you'll see in one of these cases. Um but we're limited by the modality itself because it's an anterior structure, the tricuspid valve. And so if you don't have perfect te imaging, you can't see those same leaflets insert into the clip arms. This patient had severe tr as you can see, but we really couldn't visualize very well. This is the same attempt at that 3d multi planar. You really can't have any confidence, especially when you introduce equipment into the heart and get shadowing that you're going to be able to see those leaflets. This is a case that uh Dave and I did together and he actually got uh these images. This is two dimensional ice, but you can see beautifully with ice, the leaflet insertion in that same case confirmation that we've actually grabbed the leaflets that they're coming up and into the clip and that we've reduced the tricusp regurgitation. Now, this is just regular ice catheters. So to get each of these planes, we have to put the ice catheter in a long axis view and then actually put it into the valve and look up to get this, this uh longer axis view here to ensure that we have leaflet insertion. So it's not very easy to get these images and you have to be manipulating the ice catheter inside of the valve that you just clipped. And so a two dimensional ice. It was a way that we, when we didn't have tee images that we could use these clips and ensure leaflet grasp. But it's not ideal, but we've been doing these for the past year purely out of a fundamental need. A waiting patients having options for trans catheter therapies. We do them at the end of MitraClip procedures. We've done a dozen of these um MT plus or minus T tier cases. It's only in the setting of patients that don't have any other options. Um And it's using a therapy that has been proven in the left side for a problem on the right side. Uh That's leading to significant symptoms. What I'll show you is in the truma trial, the patients uh that did the worst were the patients that had a concomitant left sided disease or that their tr was from left sided disease. So, treating these uh valves at the time of left sided operations is what our surgeons have done. Uh when the uh tr husband anatomy is suitable for years and we were attempting to do that as well and successfully in these dozen cases. Uh We eliminated the tr and all the symptoms resolved at 30 days. So it's a case that demonstrates an entire treatment, uh modality of transcatheter edge to edge repair again. We've had it in the mitral position or one of the leaders in the country for mitral valve uh tier. Um And now we have a commercially available T tier or tri clip, which I'll show you our, our first case, but it's an adaptation is the important part from a therapy that we've been using for a long period of time on the, the left side on the mitral valve um that has just recently um gained FDA approval and commercial uh reimbursement. This is the second case. This is an unfortunate 53 year old gentleman. He's a retired police chief and he came in with severe tricuspid regurgitation. He had bic cuspid A S and underwent sour cabbage in 2015. He had hodgkins with uh radiation therapy in the nineties. So there was a component of some radiation heart disease. Um He had post op six sinus and ended up getting AC RT in 15. And then with his C ID, he ended up having progressive tricuspid regurgitation. So he had increase in diuretic requirements uh and progressive lower extremity edema and ultimately was requiring per and t uh up to three times a week before he saw us, he had retired from the police force and was having progressive renal and liver dysfunction. He wasn't a candidate for surgery as a redo right sided prior radiation. You can see the degree of the tricuspid regurgitation. Importantly, the RV wasn't terribly dysfunctional and his uh pulmonary pressures were OK. And these are labor intensive. So T TV R is required a tremendous amount of pre planning and simulation um for me to do this in the background through terror recon can take up to an hour of processing time. And so it's an incredibly labor intensive planning process to make sure uh that you pick the appropriate sized valve. The tricuspid an annulus is very dynamic and so measuring it multiple phases, making sure that uh you're going to have a coaptation gap and an aneurysm that's suitable for the tricuspid valve replacement is very difficult, but it involves virtual valve implantation, looking at surrounding structures um including the right coronary artery and then measuring very precisely in multiple phases. The annual this is what a trend valve or T TV R. It's called the evoque valve looks like in an animation. It's very similar to a MitraClip. Uh these, they call this atrial flip, these t come up and grab the leaflets and then the valve expands and this is a 56 millimeter valve. So inside the heart, this thing looks tremendously large, but it eliminates the Tricuspid leak, which we'll talk about may be a good thing and some patients may not be such a good thing and, and some other patients, this is what we see on tee. So in this example, um you can see the leaflets. Now once you get a 56 millimeter device and with the delivery system, all bets are off as far as your ability to see. And so tee is, is, is kind of a hit or miss about 40% of the cases require a different imaging modality for any tricuspid valve. And that's where the three dimensional ice, which I'll show you comes into place. Um But in this case, we had good imaging, this was Sarah Wigan who, who's, who's an excellent imager. We eliminated the tr and the patient ended up, uh not having to have per and T CS. After that, he had some, some improvement in his congestive symptoms, um particularly in his, his uh cirrhotic symptoms in his side. But uh he's done tremendously well. And so those two cases highlight where we've been this past year and that's a nice transition into where we're going to be in the next year and up to five years with the uh now two commercially available treatments for tricuspid regurgitation. A lot of people assume that we've, we've had surgery all along for this disease, but there's only 500 of these performed every year. Tricuspid valve uh surgeries. And they're generally in younger patients that have IV drug use. And in spite of that of them being a younger patient population with isolated tr usually from endocarditis. There's almost a 10% mortality associated with tricuspid valve replacement and repair. And so it's a highly morbid very lethal condition to have without any treatment options other than diuretics which just delay progressive congestive hepatopathy and renal dysfunction. It's very prevalent too. When you start looking for these things, you find them all over the place. People, people don't refer patients with the tr when there's no treatments for them. Um we treat with diuretics for left sided problems and other other uh heart issues. And it also covers the tr for a while. But these patients progress in a va study. One of the earlier studies, if you just took all the screening TT ES and look for the the percentage of patients with who got att E for anything in a va system. Uh 15% of those had at least moderate tr if you look at how many just had mild, it's, it's almost 30% the prognosis tracks very closely with the degree and there's a separation even between mild and no tricuspid regurgitation. So, you know, we've long thought that if you can get people moderate or less, they're gonna be fine by and large. You delay uh problems in progressive annular dilation and congestive symptoms, but you don't take people off that track and it's a volume dependent lesion. So as you get more tr you get more volume, you get more annular dilation, you get more tr and so it's a spiral in the short term and in the long term, the majority of secondary uh functional tr cases right now, it's tracking at about 90%. There are some rare things like Epstein's um and congenital lesions that lead to annular dilation that, that cause this. Um but but a very common thing that we see is patients with leads and the trinate trials, 15% of patients had uh C ID across the tricuspid valve. And um if you look at the published data, the highest, the upper limit of this uh prevalence is 38% of patients with their first device implant developed significantly associated tr at 1.5 years. So it's uh established an entire other etiology to be recognized as far as causes of tr and we do a lot of devices. We have a lot of patients with poly valve disease. So these patients with left sided disease, um patients with, you know, Tors and MitraClip, uh a significant proportion of them have significant tricuspid regurgitation. And again, something that we didn't have treatment for until this year. Again, no treatments other than diuretics which control symptoms, but don't affect prognosis. Um We put Mras sp frontal lactone diuretics increase them over time. Patients come in with her current heart failure admissions. Ultimately, patients, we sent someone to hospice last month, she had terminal annular dilation, had coaptation gaps that were too wide for us to to treat her with any therapies. Um Eventually people die from this and we have not had therapies. As I mentioned over a 10 year period, only 5000 tricuspid valve surgeries were done in the US. This is from 2010 to 2020. The mortality was 8.8% again in a, in a mostly young patient population. This is what the landscape has looked like over the past several years you'll see on the left, several of these therapies, the Coaptation devices, there's basically space occupying devices that will take up that coaptation zone. There's sutra anoplasty which are basically an anoplasty ring that we deliver percutaneously. These are called cy uh cable, uh Tricuspid valve implants, which we have access to uh but it's currently on hold just as these new, new trials came out to, to define their end points better. Um And then we have valve replacements, you can lump them just like we do uh surgically into tricuspid valve repair or replacement. And uh we're learning a lot about which patients need repair and which patients need replacement. A growing field, obviously, but we're balancing um tricuspid leak with pulmonary pressures, RV, dysfunction, which is almost always present in these patients. And so there's a lot of factors to balance in when we're making decisions about repair versus replacement. And these are the trials. And so we were active participants in all three of these trials. We have not done a case yet, but they, they've been delayed by the FDA because these, these two devices leapfrogged them to some extent from the experience in Europe. And um and they're defining their points with FDA to be more in line with the other two trials. Um But this is the new way of doing clinical trial. These win ratios, there's a variety of different ways you can do this. But the short of it is with the take away, there was no mortality difference. It wasn't really expected to see mortality difference at one year for tricuspid regurgitation. It's progressive congestive symptom uh and uh progressive uh congestive pathology. It was safe, 98% were free from ace at 30 days. Kind of makes sense. The right sided uh procedure, it's not trans um the efficacy. I think this is the important takeaway. So almost 50% had at least a 15 point improvement in KCCQ. Uh So for those of you who aren't familiar with this, our heart failure, doctors know about this more than just about anyone. Uh A five reduction in the KCCQ is clinically significant. A 10 point improvement is the ability to walk 100 and 50 more meters on six minute walk test. It's a five point increase in your MBO two. It's an entire symptom class reduction and portends a mortality uh improvement just in and of itself again, a five point improvement on KCCQ. These were 15 and so pretty significant uh difference. Almost 50% of patients had a 15 point improvement in their KCCQ. This was a randomized trial, 1 to 1, 350 patients. Uh This was not a randomized trial. Edwards did uh the, the evoke valve or the trend trial. It was a single arm perspective, uh study with just moderate or greater tr and 100 and 76 patients. The important thing to take away from here, it's almost a 20% major a adverse event rate. The, the vast majority of that was due to bleeding and these patients bleed because they require blood thinners after a valve replacement. And they're also, they have congestive hepatopathy and are prone to, to bleed. And so that's the biggest takeaway is that um even though the device works at reducing tricuspid regurgitation and eliminating it relative to tr clip, which reduces it. Um There are significant adverse consequences to treating the tricuspid valve with the replacement and significant bleeding was was the main one. Um they had a KCCQ again and a smaller non randomized uh patient group of 25. So, treating Tricuspid valve in general with the therapy significantly affects patients quality of life. Um And then this trav, so what we're doing with this, this is actually a very, very straightforward procedure and it's used in Europe. Uh very commonly, we should have access to it uh later this summer, but it's two cable valve implants. So you, you implant the valves, even outside the heart, you allow the tricuspid valve to leak. It's usually in patients that have aneurysms too large to treat with uh transcatheter tricuspid therapies, but we will have access to this um fairly soon and can treat a significant portion of our patients that are too far along the spectrum as far as natural history of tricuspid regurgitation. The past two years, we've contributed significantly. We're leading in rollers in tri clip and in trend we screened and I know because I, I did most of the well, Paul Levine and I did most of these TES um which were very, very complex tees. Uh We screened almost 50 patients for trinate and 34 patients for trend. Um We enrolled five and did three commercial tri clips. Uh but we did 10 trends. These were FDA approved trend, got uh evoke valve got approved before um trinate even though the tri luminate trial was published earlier and was randomized and this was a perspective, single arm study, but both are now approved and tri clip as of April 2nd on April 2nd, it was approved and we had a patient in the hospital, a young 44 year old female who came in with decompensated right heart failure in the setting of of HIV, that was well treated. She was on medications. But then in January, January got COVID uh pneumonia and had progressive shortness of breath thereafter. Uh some moderate pulmonary pressures in the setting of the HIV and uh COVID. But you can see on the left here, we had excellent T images. Again, this is uh Sarah wet the ideology though, as I'll show you here is less functional and, and a little bit more degenerative. The septal leaflet has redundancy almost like a myxomatous valve and is prolapsing. And so what we thought the pathology here was of, of the, the tricuspid regurgitation is that she was set up with some degenerative pathology on her tricuspid valve. And then when she got a little bit of increase in her pulmonary pressures with the HIV and the COVID pneumonia, it allowed it to uh pressurize the right ventricle a bit more and cause this leak. So because there was a significant degenerative component because she didn't have significant RV dysfunction. Um and we had access to tri clip. Uh we elected to treat her. Um This is sped up a little bit, it's not playing correctly, but this is 3D ice. So we can now do the multi planar 3D reconstruction with ice without ever moving the catheter without having to drive it into the ventricle and look up at the valve right next to the clip that we so precariously and, and, and very, you know, precisely placed on the valve. We risk dislodging it with trying to introduce ice catheters. And just to get imaging that requires us to get to see leaflet insertion. So we can now do that same process. And with Phillips, we just flip back and forth and so we get te flip to ice when we, we can't see leaflet insertion, flip back to te and we can seamlessly go back and forth between the two. This was the quality of the ice images though, relative to that other image you saw the two dimensional ice, sometimes it's hard to tell if, if you weren't looking very closely at what's closest to the probe and what chamber is first. Um The left atrium or the right atrium, you, you would confuse which one's the te and which one's the ice. And this is a 10 French catheter. So this is only getting better and having a 10 French catheter introduced through an IV in older patients and not putting them through general anesthesia to get a tee for an hour, hour and a half is a potentially very, very, very big clinical change as far as how we treat older patients. Um and that may apply directly to MitraClip and certainly will, will be about 40 to 50% of TRP patients. So this will allow us to do MitraClip with conscious sedation and older patients. This was the result we don't eliminate tr we're bi cuspids the valve. And so if it's still pressurized, you still get leak. The, the goal is to, to reduce the leak as much as you can, especially if there's any RV, dysfunction or pulmonary hypertension. The concern is, is most people are familiar with on the left side is something called afterload, mismatch or taking off the pop off valve. So if the ef is significantly low on the left side, you have an ef 20%. Um and you eliminate a degree of my trig gurgitation. Uh with a clip. The concern is that you're, you're creating afterload mismatch on the left ventricle. So all of a sudden you're forcing that already weak left ventricle to not have two outlets, one towards a low pressure pulmonary system, but to go towards systemic pressures and it can cause LV progressive LV, dysfunction. This is why in mitra fr patients with an ef of less than 20% and patients that have had a dilated LV had worse outcomes and didn't experience the same results we got from Co op because those patients were more dilated with lower EFS. The concern with tri clip is that you would experience the same thing. The RV is more sensitive to after load and so the afterload, mismatch may be more prominent effect if you talk to the centers that are doing a lot of uh evoke valve cedar sya, in particular, some of these patients, uh they eliminate the TRN but they stay on inotropes and an IC U for a while afterwards trying to recover. And so we've got a lot of concerns about replacement in these patients. But it's a brand new field, understanding what pulmonary pressure is too high for a replacement, which ones need repair, understanding what degree of RV, dysfunction RV, performance matters how much is going to be too dysfunctional to allow for a clip versus replacement these are all questions that are going to be answered by places like this in the next year to two years. And so we've got a lot of work ahead of us. But the short answer here is that we think that TRP is going to have a more significant role on the, on the, on the tricuspid valve than replacement. That's not only because of the size and deliverability of the device and, and how facile we are with it on the left side. But also because I think eliminating tricuspid regurgitation by the time we get these patients, naturally, there's going to be a late referral bias. Um The patients are gonna be further along in their natural history. Almost every single patient we get referred with tr has some degree of RV, dysfunction, has some degree of increase in the pulmonary pressures. Um and that uh may be sensitive to the afterload mismatch issue. Um But this is the 30 day or this is the next day echo. You can see we significantly reduce the tr the apples to apples comparisons. There's still 1 to 2 plus, we gave her diuretics overnight and improve. This is the nature of a volume dependent lesion. Um Tr Photoshop is giving some diuretics uh to, to uh reduce the tricusp regurgitation, but that highlights the importance of making sure that you're entering into these procedures in a UUV state. And so this patient we had in the hospital getting diarrheas down to right heart Cath demonstrated VALIC numbers and just through the procedure which took 3 to 4 hours, these are like the CTO S of of structural heart. Um she did, she got 2 L of fluid just with anesthesia. And so even though we were, we were getting good results, we started getting leaked centrally and we could see uh the volume dependent uh status of the, the tricuspid valve. So just with diuresis overnight and placing clips, you can see here two in the A S com. This is, this is how we quote unquote by cuspids, the valve and create essentially what a case is. Stitch does on the, the right side. There's also uh in the PS canyon here. So the the anatomy here is that this is the posterior anterior septal leaflets and I'll show you that in just a second and the commissures are the anterior anterior septal commis, which is where most of these clips go. Um And then the PS canyon back here, posterior septal can in this commissure is where most of the pacemaker leads fall. So we rarely have to go in there to clip or, you know, I know early experience, but um very rarely go into that area and we had to in her. Um This is the size of the catheter and ice. We, we took her uh 4 to 5 plus tr to 1 to 2 plus, actually reduced her um RVSP. And we don't as most people know, we don't have good measures of RV function, um, echo that tremendous variability taps is no offense to people that use it. It's worthless. And, uh, F AC is probably the best measure we have. Um, and S prime is OK. But this is gonna be a problem with tracking these long term too is what measures we're gonna use. It probably gonna be a combination of multiple ones, probably gonna be a a right heart C at the time of the Tri club demonstrating unchanged RHL pressures and RBN diastolic pressures. Um But in this situation, we had no change. F AC hovered around 30 prime was 1314 taps. He was what what it is, we shouldn't report that. Um So it was a very successful procedure. She got discharged from the hospital and and is doing well. So this is what our anticipated volumes are. If you just take the numbers of devices put in in the pathology in this area that we're currently treating, these are the potential amounts of patients that we have to make room for, for longer procedures that are more labor intensive. Um but that have a significant impact on our patients. So we did 400 IC DS transvenous last year and 711 pacemakers. So if we take that 38% of patients with Cie Ds uh develop significant tricuspid regurgitation means there's 400 patients in our area with clinically significant tr and that's the upper end. It's not really going to be 38%. It's probably gonna be closer. Most of the studies are hovering around 20%. That's what we saw on Tri trp. Um But that's still a significant amount of patients and left sided disease. As I mentioned, uh we did uh 200 almost 250 mitral valve interventions last year, we did 100 and 51 MitraClip. Um And so that's nearly 75 patients in the Tidewater area that have clinic clinically significant tr just from the valves that we treated last year. And in pulmonary hypertension, eggert follows almost 1000 patients in an advanced PH clinic along with Ed and their team, 50% of these have some sort of degree of uh tricuspid regurgitation um in the trials and in some of the studies, uh 16% of patients with primary uh and pulmonary arterial hypertension had significant tr so the number is a little bit less than what we anticipate here. Um But as we mentioned, treatment of these patients with pulmonary hypertension is going to be even more precarious because we don't have good measures of RV performance. And we're not quite sure how the RV is going to respond to the afterload, mismatch. This is the workflow that, that uh I've established for us with tricuspid regurgitation patients. And I think the most important thing is that because this is early experience and because we're translating uh surgical experiences over decades in a, in a surgical therapy that really didn't work very well and to how we treat things with trans catheter, minimally invasive patients and patients that are sometimes higher risk. Um And so I think it's important to loop everyone in. And so because there's significant component of these that are associated with leads, there's some concern about if you trap one of these leads in the ps comme, you can infect the insulation and lose, capture and cause a lead fracture. And so uh keel is involved in our M BC now, um and uh helps us with these lead associated cases and we anticipate that being a significant number of patients going forward loop uh peart and, and sway in from um pulmonary hypertension. Doctor ya uh kindly has, has been attending all of our valve conferences and just another plug for that. It's Monday morning at seven o'clock. Everyone's welcome. And uh you get CME for for every time you show up. Um So we discuss uh every valve that comes through Centa heart valve center. Um aortic are the predominant ones, but Mitra's tricuspid, all those patients are reviewed by both teams, three interventional cardiologists, seven surgeons, all of our A P CS referring are are welcome to join and it's by teams and you get CME we're incorporating all these people in for our tricuspid regurgitation patients. Now, we very likely will not require surgical approval for these because there is no effective surgical therapy. But we want our surgeons involved valve clinicians as well, especially if there's, if there's issues. After the fact, they have the longest experience with treatment of tricuspid valves, at least therapeutically with device therapies and surgeries. And so we've looped them in. We want it to be a standardized process. Patients are going to come to us probably 50% as impatient based on what we've experienced as far as certain consultations, the vast majority of those aren't ready for a Tricuspid valve treatment. They're, they're hyper V, they need to be eval, we need to get right heart CS demonstrating their eval state. And then we need to see the degree of the tricuspid regurgitation left just like mitral regurgitation. When you all consult us for a functional Mr when we say diarrhea and then we'll reassess. That's what we're talking about is, is because it's a volume dependent uh valve lesion. You can make someone with, with pretty normal looking mitral and tricuspid valves leak pretty significantly if you give them enough fluid. And so certainly if there's abnormalities, if there's annular dilation and their volume overloaded, uh you can uh over appreciate the degree of tricuspid regurgitation relative to the volume status. And so we've developed a workflow that involves measures of RB performance, um right heart caths um cardiac CT so that we can capture the ones that would be served uh best by um evoke uh LFTs and liver ultrasound. And then all these patients are going to go through a multi disciplinary valve conference. And then in the early goings of this, we're gonna have a lot of cause and pa uh pause and caution. Um sending patients and doing tricuspid valve replacements until these, these issues of afterload, mismatch are sorted out. And I think what we're getting with uh our early experience and translation of our experience with M tier is that we're going to see a lot more of these patients going to TRP, especially in the early goings. And especially because a lot of these patients have some degree of RB dysfunction and pulmonary hypertension. It's practical tips. If you're seeing one of these patients um outside of the heart hospital or you're doing a te on them or you're grading them. I think this is very important. Um It's a five point grading scale. Torrential is five massive, is four. We didn't come up with these names, but um it's a five point scale is the important thing and instead of memorizing different er oas and pieces and being a contractor areas for all these, these things. Um and memorizing them for each valve pathology. I think the best thing is if you're looking at an echo and your CTR, that's significant, look at the IVC and see if it's dilated if it compresses and then look at the paddock veins. I had to call several times to make sure that we include hepatic vein flow reversal and our echoes. And so for the echo, our echo texts are amazing. But outside of the Heart Hospital, if you're getting echoes in the community, make sure that if they have a degree of tricuspid regurgitation that you're getting systolic flow reversal in the paddock vein that tells us by, by and large if it's severe, if the IVC is dilated and that, that is present from a, an atomic perspective, we, we do everything in a clock face orientation and this is how we procedurally speak as well during the procedure. Three views is all you need two in me, esophageal and one trans gastric. So 60 to 70 is going down the comers. And so you see all three com commissure in this plane and a 150 is the clipping view. So you see your septal and anterior and your septum and posterior and long axis. So 7150 are two views. Um We'd like to put the aortic valve at four o'clock uh by convention. It allows us with 3d to be consistent uh in the location of a S comma. Sure and it speak the same language. Um The mitral valve is up at two o'clock and we put the intra atrial septum at three o'clock. And that gives us a convention that we can work with uh intra procedurally as well. So to summarize uh tricuspid regurgitation is very common, we haven't had treatments up up until now. And uh we know that it's been accompanied by significant morbidity, recurrent heart failure, admissions being, being the main one and mortality at all degrees, even mild. Um If you let it go on long enough. Um And as I mentioned up until now, it has had no real treatment options. Uh We were one of the leading sites in both of these trials. Um And so we're leading participants in transcatheter, tricuspid therapies um both from a research perspective and we're primed very well in the center with the amount of pathology that we all take care of um to lead in this way for our patients as well. Um So we're gonna have access to, to treatments that patients didn't have this time last year and access to treatments that patients outside of this this area won't necessarily have access to either. And there's a tremendous amount of volume, you know, there's tremendous volume of patients locally and regionally that have this problem that are going to be dependent on us to provide a solution. Um We now have commercial availability of two devices and we have uh research avail availability for cy. We had uh ex extensive experience with MitraClip last year. We were the second highest volume program in the country and had outcomes as good as any program in the country. So we're set up very nicely to translate that experience into the tricuspid valve space. Uh We have a unique opportunity for community benefit because of the volumes of other cardiac procedures we do and the amount of pathology we have in this area. And I think the best way to approach things uh in the current day and age of new device therapies is to do it as a team effort. And I'm thankful for all the people uh on our NBC or A P CS. Um and the, the other teams, Doctor ye in particular and Doctor Kiel. So with that, I'll take any questions.
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