Paul D. Mahoney, MD, presents on the controversies of bicuspid valve disease and provides two case presentations.
you know, we've done. We just recently hit a milestone of our 2500 tavern Valley community. So these patients are out there. Um, they are you gonna make me a It was. Spaces are out there, and increasingly, we're getting phone calls asking how to approach him. Why would you take a systematic? Got a possible approach like black outlines? Um, way should be in good shape. And hopefully I will be sharing my screen here. Thio It was yesterday. You put valves, and all day it's power pointed to pizza. Um, so all risk indications here, but one of the controversy lingering controversy remains. Our field is bicuspid valves. Um, especially moving younger and younger patients. Um, early data had concerns with higher rates. Excuse me. A parable of your league, especially the self expanding valves and high rates of annual rupture with the balloon expandable valves and by customers, anatomy. And for better for worse, the main low risk trials partner three. Which was what we participated at. Low risk, specifically excluded bicuspid anatomy. Um although I will I will commend Medtronic in the Lotus trial. They did include a bicuspid registry partner. Three did not So, um, so there's still a little bit of controversy surrounding I wanna go over the available data. Talk about strategies. One of the strategies is incumbent on Taber operators to have surgical like results and bicuspid patients. This is a low risk patient population of their surgery. Eligible, eligible. We need to do at least as well as our surgical colleagues. So we're going to talk about the definition prevalence, our registry data on outcomes, the evolution, tourist registry and procedural considerations. I'll show some cases you guys are familiar with this deceivers classification of bicuspid, basically the sort of the classic by custom deceivers type zero with commissions 180 degrees apart is the is less than 10% of these that we see that type zero is 7%. The vast majority views receivers one or two, and what that is is an anatomically try leaflet valve with fusion of the cusp. So all right, either left or right cusp two thirds of the time or any of them can be involved. Type two, which is the rarest, is when two of the costs to the three custom views. This used to be called functional by husband, but currently we've gotten away from that term. So how do you diagnose bicuspid valves? Well, two d echo historically is how we do it. You're going for a fish mouth appearance in Sicily. President Giraffe between leaflets visible vastly. Honestly, when these calcified valves with cyanosis, it's very hard to say, and we've come to rely on C T scans by C. T. By scanning up and down through the analysts in the route, looking at the commissioner's measuring the distance measuring the leaflet Thio Thio Angeles Range has really become the gold standard for truly diagnosing what a bicuspid valve is. Um, if you're if you really want to know. So the other thing to C T scan gets us is the location of morphology of the custom leaflets, the presence of any raft between leaflets, especially heavily calcified raft, which impacts when we go to place of Alvin Extent in the distribution of calcium has been the sub Al Gore, the L D O T space location of the coronary arteries, and I'll show you case where that's important and the site and the shape of super annular um effective orifice area to give us some idea of how the size these valves When should we suspect by custom disease in the population anybody less than 70 asymmetry The Sinuses with one sign, is disproportionately large to the others. Calcium overlapping two leaflets, especially the commercial posts Presidents are at the presence of air atop a fee with vilification of the science under the ascending aorta and then a bovine arch. And these air clinical clues that might lead you to think that the patients by husband, the prevalence of bicoastal disease taking the surgical population, Um, over half of the patients operated between the ages of 15 80 had bicuspid valves, and even 20% 22% of those 80 89 had bicuspid valve. So the fact that someone in front of you 85 doesn't necessary mean they don't have a bicuspid about We still see it all the way out to the eighties and nineties. All right, So how does Tavern doing these stations? Um, the TV T registry by customer analysis. I'll show you both the SAPIEN analysis and the evidence. This is the Evelyn analysis. First, um, they looked force. It all compared the outcomes from 785 bicuspid patients to UM, 11,000 try. Custom patients treated first with the flu are, which is self explaining, that platform and then we're able to pro. And the difference between these 2000 essentially is one has a skirt or a wrap around the bottom. That's the pro and the art does not and the pros what we used exclusively now. And you can see the track husband Patients tended to be a little bit older. Ah, little bit sicker with higher SPS scores. But there's mostly transfer Meral device. Implantation is good. We don't like to stay is probably not a factor of the pressure of the valve. Um and we did see early on you see a signal here in the in the earlier generation of moderate to severe. PBL, I will say, is tavern operators moderate to severe PBL is a bad outcome and it confers a survival disadvantage. So we will not accept moderate to severe PBL and an 8% rate was of concern, um, importantly, with the switch to the evolution pro and again these air, remember, these are patients with elevated STS scores. This or these air high risk patients In the event of pro group, however, we had less than 1% moderate PD l and no evidence of severe pdf. So the the answer of the issue of PBL and bicuspid valves in the self expanding platform has basically been asked and answered that we have very acceptable rates of PBL. Currently, um in the SAPIEN Group that was also recently presented a C C. About a year ago again, they looked at 92,000, shaping cases in the registry and identified 2700 by husband and then did propensity matching for 79,000 taping three and one on one fashion ended up with 2691 in each group covert. They used propensity Match your listed over there The usual stuff. Um, these valves tend to trend to the bigger side. You can see the bicuspid population. It was more much more likely to be a larger valve, uh, than in the tri custom population that makes sense. Annual system. These patients, in general, larger ah, outcomes Procedural outcomes conversion Open surgery slightly higher in the bicuspid group versus the track customer group, all of the annual ruptures appeared to be concentrated in the bicuspid group. We didn't they didn't see any of the tri customer group, and that's an important factor. Need for a second valve trended? A little bit sore there, but so there is still a little bit of a signal with annual rupture with self with balloon expandable valves in this population, thanks stroke slightly higher in the by custom group new pacemaker, slightly higher in the by custom group. Again with the SAPIEN expandable, however, one year mortality was founded, the not significant between the two groups. One year stroke rate was not significant between the two groups. When you combine those end points, there was no difference between the two groups. So the parable of your leak in the balloon expandable, no severe, minimal, minimal moderate and on Lee mild. So that's with the balloon expandable population parallel their elite is also not an issue in the current in the current trend, and then the human dynamics radiant area What you accept after placing the valve. This still is propensity matched registry data. Self reported carries with all the limitations that that does, the sites may under report, uh, data, uh, to their credit, a Medtronic sponsored a low risk by customs study. It was hit by husband vows confirmed by C T. Um, symptomatic symptomatic. Severe es. Predicted risk of less than three says low risk patient population. He exclusion creature. And these are important as we approach these patients, um, age less than 60 or top of the with greater than 4.5 to match the surgical surgical literature in tax for greater than 22. So a lot of coronary disease would push the cabbage air atop a the of not otherwise specified L bot calcification. We're not a bicuspid valve or outside of the treatable range. Primary safety end point was death or stroke. At the same point was success. So you can see that they screamed. 200 patients. 150 got the procedure. One. Converted to surgery. The reasons for exclusion are listed over here. Mostly anatomical reasons. Three quarters. Anatomical regions. Bond somewhere failed to meet criteria age less than 60 or other conditions. And as you would expect, these patients tended to be young. There were 70 there, about half women. Half men. STS story with 1.4, um, receivers class. These were predominantly. I have one, um, Seaver's valve. So these are single fuse cuffs with three leaflets. About 10% were type zero. So this represents the demographics of the bicuspid population. Pretty well, uh, most, most 90% of these patients had a pre tavern balloon. Vilification. That's important from an operator standpoint, and the third has have postal rotations. These valves require a little bit more work intra procedurally, and these tended to be big valves. No 20 threes were used. Ah, handful of 26 is, and then the majority were 29 34 which is again, What would you expect in a bicuspid population? And importantly, even though we know that the rates without the rap with table that are are higher? Uh, 43% of these patients were with the previous generation valve, only 57% with the probe. So how did these patients do little risk by customs studied primary endpoint 30 day all cause death or disabled stroke 1.3%. That compares very favorably with the main cohort of the study and very favorably with published data on low risk. Try custom based outcome 2 30 days. I told you 1.3%. All cause mortality or disabling stroke. Mortality was less than 1%. Stroke was less than 1%. Non disabling stroke was seen about 3% of the time. Faster complications where 1% no deceptions. Zero importantly, zero annual ruptures. Um, and device successful present Val Human Dynamics. Again, this is what you'd expect from a self expanding patient population. Even in these challenging patient subsets, we're seeing valve areas of over two, which is an excellent result from a catheter valve and single digit radiance. So it works. It works well and works with acceptable safety profile. Um, again, PD l thought to be the real risk with self expanding valves on this platform was only mild or trace. All patients and this included a fair amount of Evelyn are patients, and it's thought the aggressive pre vilification, regimens and postal rotation helped achieve, So this led to change in the labeling. Alright, The few indications were modified, and it's just this bottom part I notice is like an eye chart. But the bottom part is limited. Clinical data available for tavern in patients with a congenital bicuspid aortic valve or deemed to be a low surgical risk. Anatomical characteristics should be considered when using a valve in this population. What that means is this is unlabeled. Okay. The FDA has approved the use of Taber valves. Health expanding valves is on label for bicuspid valves. So before we get too far, let's remember that we have an alternative to write surgical valve replacement bicuspid patients works very well. So when we approach a patient with bicuspid currently in our clinic and we spent a lot of bicuspid patients, um, we still have a discussion about surgical valve. Who is it preferred in, well, very young patients. If you're 52 53 you're healthy. We should have a discussion about mechanical valves. Okay, I think surgical tissue valves are are problematic in this population, but a mechanical valve with the 25 to 30 year lifespan is at least worth a conversation. The presence of significant on top of the and that's important because they don't just need a valve that it a valve plus in ascending order replacement. And the literature says it's greater than 4.5. We do look at that carefully with the C t. On a case by case basis. Um, high risk pattern of calcification way could have a low risk surgical patient on a high risk tavern patient that has L B O t calcification just bulky calcification that we don't think we could get a predictably good result from when we have a low risk option like surgical valve replacement that might push us that way. Very large, analyst. Outside of the eye, if you for either device is a relative contra indication, that can be done. And if you're 90 it will be done. But if you're young and you have another option, we should look at it and then lo coronary heights and almost corners. I'll remind you in the yellow box these were the exclusion criteria from the trial. I just showed you, and they sort of mimic what we just talked. So how do we size this again? This is sort of an inside baseball. There's a lot of discussion of where the size of the bottom line is sizes at the annual IHS and you'll be OK, and we The reason we do that is there is a lot of talk about aiming even higher because of the co optation point of the valve. Essentially way. Places like we do the rest of the tavern valves. All right, I'll show you two cases and we'll discuss options with first cases. MBI m b was referred not too long ago. Six year old SPS of 1.0 severe symptomatic. Erickson Mistress Low flow Logue. Radiant Be Max of 3. 60. The F was 25%. Um, left ventricle is mildly dilated. Previous coronary disease with semi in 2013 with drug loading sent to the distal right and drug center, sir. Complex, Most recent Castro Peyton Sense and no other obstructive coronary disease. It had several of, um ablation, hypertension, April academia. The usual. So e k g should've left bundle branch block again. It's important this patient as an ICD, but we're very careful. We don't want to make them pay, sir. Dependent that we want to make sure that we reduce our risk of the pacemaker coronaries, as you can see here and they're still pictures. But there was no obstructive lesions. We elected not to re vasteras this patient. It wasn't indicated the analysts by echo, you can see some of the issues we have with identifying the valve pathology with a heavily calcified valve in echo. There's no way we could look at the outflow tract but identifying the pathologist valve struggling, however, CT tells the story all right. You see very clearly that this is a fevers type one valve. There's three. Com ensures there's a fused Rafic Um, but then there's calcification pretty heavily in the valve, but there's no over to see calcification. What other things do we look at? The ascending aorta is mildly enlarged, but well inside. I'll show you think on the next level show a little bit more detail on that, Um, and it is the perimeters 85. There is 5 63. Both are well within the treatable range of Taber valves. Peripheral assessment gets the Taber operators excited when she access like this. This great access I know it's sad. You can see up in the upper right. The ascending area was 41 by 42 well within the watchful waiting portion of management of patients with our topic and buy custom valves. We've seen a formal clinic with afternoon one of our colleagues. We would bail this patient out and way elected to place a 34 evolution valve. Um, the right federal artery. We did have a discussion with this patient about the the opportunity of mechanical valve. Um, given everything he'd been through, he wanted, uh, he elected to go to the catheter based route. These are just are implant angles. And here's the procedure. Okay, have a curved wire. We do our pre vilification in the first panel. Second panel shows are valve implant. Okay, I think there laws may repeat themselves a little bit, but you see us placing the valve or trying to place those pies possible. Deepak talking about some of the issues with coronary access. We're always trying to place these valves really high, which brings a skirt up and may engage the coronaries. Which is why all these techniques for corner access it becomes kind of important. The reason we're doing that is to reduce the rate of pacemakers, even those guys and I c. D. He's conducting with his native system we want to preserve. That is relatively young 60 year old. Okay, you see us about to release about here, just taking our final picture. We like our depth. It's about one and one, which is good. Okay, we placed it by Grady int by echo was three millimeters following valve implantation. Alright. There was absolutely no pair of out of their league and post imitation. Therefore, given those measurements was avoided. All right? A second patient, I think I have time. I do. Okay. The station was also seen recently. Another 64 year old but SCS have 1.5 normal. Crafting normal ejection fraction. He created the dollar 0.9 p created 74 aircrew 4.5 he presented with acute systolic value of heart failure. Um, you wonder what capitalization was amount obstructive his aorta. Apathy was between 42 and 44 depending on access. We looked at history of atrial fibrillation in hypertension upper lip anemia. Uh, Byron, Natural media saddle module. Um, again, Here's the echocardiogram again. You can see that this isn't that helpful. Deciding that this is bicuspid. Try leaflet. Okay, here is our cast. I'll show you the moving pictures because all that there's something there that is, uh, not normal is anomalous, sir. Complex That rises off the right coronary and courses around. We think of course, is around. But we're gonna get better image and to look at it between the old and the PPA. So when we look at a CT scan, we'll see several things. One is just a very large valve. The perimeters 160 areas 8 23. There's about 20% larger than the published I f. You for, uh, trans catheter valve and buy custom patients. So there's a very large annual is outside of our usual range. The pattern of L V. A few calcification includes dense and bulky calcification that extends into the left ventricle outflow tract, which puts them at higher risk for annual rupture for post irritations needed or or higher risk of conduction disease. Their top of he was not as bad as mentioned only 40 to 42 by the C T. And let's look at that shirt one more time. We looked at the Sir complex and you start in the NGOs. It comes off the right, but it absolutely follows a course between the order and the P A. You can't see it. I've helpfully put some red arrows there. Um, we can actually measure the risk. So imagine putting a valve in here and pushing against this. There's a there's a risk of coronary occlusion, all right, And this has been well published in literature. We could potentially we know that I measured the distance from here to here is about 32 millimeters so we could measure the size of vessel preposition of 38 millimeter stent distantly prepared to pull it back and engage it. What I'm basically describing to you is high risk Tavern Ademi. He's oversized for the valve. We've got the risk of para valor. Leak is high, Do balloon expandable with chunky, bulky calcification has a risk of annual rupture. And he has a risk of coronary occlusion that we would have to actually preposition extent distantly and maybe stent this vessel. So we looked at him. He's had great access. Um, but we looked at him from a procedural plan with a large primary LV, xia codification and almost certain circuit risk for inclusion. This was a patient that we felt was at low surgical risk and high tavern risk. And he referred for bicuspid uh, for valve replacement. Hey, underwent valve replacement. They were careful to look at the circum flexes. You conclude that with stitches if you're not ready for it. The C T was extremely helpful, the surgeon said. It was right. Doc Cabrero operated, so there was right there. He's able to carefully avoid it, but it was been at risk of future. If he wasn't if he wasn't thinking about that and got a valve. Spent four days in the hospital went home is doing quite well. So So. Conclusions Tavern is currently indicated it is on label for patients with bicuspid valves for all risk. So that question has been asked. That question has been answered. Outcomes. Air comparable to patients with Try Husband Valve. We see very low rates of para Val there, leak receiving the latest generation self expanding sense of with pro and we see acceptably low risk of annual rupture in the SAPIEN population. Low risk patients with appropriate clinical history Anatomy, as determined by the heart team, are suitable for tavern s, so we can take a very individualized case. We have both surgery and tavern available for these bicuspid patients and were able thio to go through in the case by case and, uh, pick the most appropriate therapy for these patients. So um, if you do have bicuspid patients out there, just get the word out that taverns absolutely an option for them. It may not be the best option for them, but if they have, they have suitable anatomy. If there's someone we can safely and effectively treat with Tavern, the outcomes have been excellent, and the few in the instruction and the and the FDA has seen, and we've gone forward and had approval for that. So all right, well, thank you very much for your for your time. We wanna talk about some special Consideration Tavern, and if there's any questions, either a mute yourself or we have a few people in the room, there aren't any question. Are there any questions? This one question in the custom? Well, sometimes the predominant issue is aortic insufficiency. Not as much aortic stenosis. Any comment about those patients? I'll repeat the question. It's a good question. The question was, in patients with bicuspid valve, sometimes the predominant pathologies. Eric insufficiency. Not so much aortic stenosis, so they're in order for the Taber valves to be effective and work, they need to be anchored. So if that patient had combined A s and AI and enough calcium devout to anchor it. And the annual IHS was within the range of treatable. Then they would do well with Tabar. Um, it is usually the case in that we see these very large perimeters and we have angular stretch with a I, and it's outside of that range. Then Tara Vales, uh, become a second best choice. And we would only offer those for patients who are not surgical candidates. Does that make sense? Yeah. God, um, thank you very much. Everybody. Is there any? I don't Amy tonight. See if there's questions in the audience. Er, I'm sure there's doesn't, but well, in the interest of time, let's get her. They started. Thank you very much, everybody for your time. I appreciate the opportunity to present to you guys Thank you.
