Dr. Allen Jeremias and Dr. Ziad Ali are both key opinion leaders in interventional cardiology as both hold key positions within CRF’s core labs and both participate in a variety of clinical trials and society presentations.
have. Ah, pretty interesting case today. What I would suggest is we can't actually see the questions. So if they are questions, maybe you can filter them and then occasionally feel feel free to interrupt us and be happy to answer the questions. So with that said, can we have the slides up and let me introduce the case that we have today next slide. So this is, uh this is a test of my eyes. Actually, you know, the screen is pretty far away, but the younger guy a in the world does it say, Come on, Gramps s. So this is a very, very complex ation. But in his mid seventies, I should say he has advanced corner disease history. Off bypass surgery in the past with known included vein graft patent lima multiple pc ice. In the past, he has an ischemic cardiomyopathy is F is around 25% or so, and he also has a number off capabilities in student including, um, advanced chronic kidney disease. Stage five. This crap minus 5.6. Aziz. Well, as a couple other probabilities. Hey. Came in with some chest pain, but predominantly heart failure. About two weeks ago, at which time he had a diagnostic angiogram. And the way we do this in these patients with advanced renal disease is to always separate the diagnostic procedure from the PC I and the goal of the P C. I is to do it with zero contrast. But obviously you can't predict for sure. Which is why What? Separated. Andi, that's gonna be the step. Today I'm going to show you the diagnostic that we did a couple of weeks ago. If you can go to the next slide. So we basically take two pictures off the less system one cranial and one coddle Ziadie. Wanna Doc, Doctor Ali, As many of you guys, I'm sure aware, um, kind of pioneered this technique off zero contrasts as well as ultra low contrast angiograms. So you want to guide us through how this Sure. So the first thing to do is to understand, um, what? Your limit is two. And set yourself a target on how much die you can use. And that's a contrast. Volume two E jafar ratio of one. So you for E. Jafar is 13. You got 13 mills to use. You can kind of split it amongst your coronaries Once you go above one. Multiple studies, including our our own as well as from Jeremiah Brown, show that you just have an increasing risk of of kidney injury and contrast induced a prophecy. So what you're seeing here is relatively dilute shots because this patients post cabbage. So with a credit of 5.6 sorry GF hours around 13. And so what we have is 13 mills. We diluted a little bit with some sailing so we could fill all the arteries. And what we're really getting here is a silhouette of the arteries. And if there's any ambiguous lesions, believe it or not, we have these wires that can measure flow and pressure and determine if there's ingredient. It's incredible. Let's do it next slide, please. So go back when I'm sorry. So if you wanna look at the anatomy, it looks like the lady is included in the mid vessel. Just go back, and, uh, there's not much else in the left made approximately laid back one and then 41 And then the Circum Flex has a previous stent, which is the right screen, which has maybe some mild, diffuse disease the whole vessel has mild to moderate abuse disease. You know it. Maybe it's something worthwhile investigating a little bit later, next slide. And then his Lima was Peyton, actually. Yeah. If you go back to the Lima shot one back, one back, and then go forward. One back. Here we go. Let's play it possible. All right? You all have toe. Here we go. Okay. Patently Metella d again. A little dilute, but enough to for us to visualize the coronary artery. And that's important. Frankly, in this case, what you want to know is is anything you can intervene on. And there's really nothing that can be done. And then the target for today is if you go forward and show the right. Go forward, please. Here we go. So that was the extent of the right. There is kind of mild, diffuse disease, you know, with understand, in a pretty high, great diagnosis of the proximal r p l, which really is the major vessel in this right system. So we brought him back today, um, for for that And so what we have done so far is Really we kind of waited for you guys to kind of watch the whole procedure. We haven't done much. The first step was to measure the L V d p um, which we have done. It was 10. So obviously it's low. And even though he has ah lo e f we hydrate the patient and you wanna talk about the protocol? Sure. So we're gonna let Alan get starting a second. But essentially, we measure We do not pre hydrate patients with CKD four or five outside the cath lab. Remember the one piece of evidence from this The Poseidon study in 2014. But the mean Jafar on the Poseidon study was 46 our patients. CFR is 13 there in diastolic pressures are typically very high. So if you aggressively hydrate them outside of the lab, you can bring them into the lab with a GDP of 25 or 30. And then you're looking for a situation where the patient is short of breath. There you could get flashpoint oedema. So what we do is first step is always across the aortic valve measure. The diastolic pressure we saw it was nine. We're gonna gently hydrate. At the end of the case, we will re measure the GDP, but we've now got the guide engaged, and we're ready to determine whether or not we're actually able to start the procedure. So of course, the first thing we want to know is Is the guide actually engaged or not? There's two ways to determine that. And if you can go and show our e k. G, we're going to show you something interesting. And that is that by injecting about eight mills of normal sailing down the coronary artery and looking for E k G changes. Yeah, here we go. So what Alan is going to do here looks like I'm close enough. Looks like he's close enough. And so what he's gonna do is just keep your eyes peeled to the E k. G. And so what we should do, because we know that the sodium chloride is going to conduct. If we inject, you see those E k g changes. That is a typical indicator that we're engaged in the coronary artery now. There are, If that didn't work, of course, the patient is now Hepburn. Either we could use a wire, but this is a nice sort of proof of concept that we don't even in the diagnostic angiogram need to take lots of puffs. In fact, the puff should be completely eliminated. So are planned for this vessel for the zero contrast PC is actually going to be to create a metallic silhouette of the coronary artery. So what we're gonna do is put wires into the p d. A and another wire in the pl branch. And there we go. So I'm gonna Allen's already got a little cranial, right? So that's the PL there. And so what we're gonna do is but one branch of the P t A. And what that's gonna do is allow us to know where the bifurcation is, and then we're gonna use the Omni wire. So, as you all know, we've been waiting for a pressure wire that actually has the handling characteristics of a workhorse wire but also provides us the ability to measure physiology with very minimal drift, as well as high precision and accuracy. And I have to say, I'm Alan and I did it just like that. It sounds magical. Well, I don't imagine this. It's even comes with two talkers Way s Oh, I think I mean to be honest when Allen and I had the pleasure of doing the first time you are Case live. Um, honestly, I was blown away. And it's not easy for me to say that I'm usually a tremendous skeptic because I'm a scientist at heart. But the handling characteristics of this wire is pretty much as close to ah, work course wire as I could imagine. In that case, we used it over and over again. And I'm gonna test Alan skills here by making him do some repeat wiring. And so, um, you can see that we're almost at the point now where we can get started. So what do you have right now is just gonna dio I'm gonna blow your mind right now. We're gonna use the second talker from the Omni wire on the BMW. Unbelievable thing this comes so free. It's free. It's free. It's I'm not. I mean, maybe that's just for you, because you need to talk because you're wiring. That could be one possibility, because mind that not only has one tour E, I think, but so it doesn't hurt. So we flushed it, right? The first step is, can you just zoom up my hand. Yeah. And zoom in here. Yeah. All right. Good. So the first step is always to flush these wires, and obviously, the second is to connect it right once. That's the case. Whoa, Greg, Did you Did you have a couple drinks this morning? All right, close enough. Maybe zoom a little more weaken tilted towards them. Okay, Good. And then we take it out from the back. As you see, the wire is connected here, so I usually dont disconnected unless I have trouble wiring it. And the possibility which is, which is a good possibility. Although you promise me that's why I would be fine, right? Yeah. Even you can learn with chicken wire with this. Okay, e Just want to show you guys this, um, the new structure, which is really a lot more user friendly than the previous doc. And afterwards, when we wire and rewire and reconnect, I'm going to show you some of the features of this device that make it a lot more easily able to connect. So what we've done so far is we've sort of We re equalized the aortic pressure. We equalized by flushing inside of the hoop, and now we're going into the artery. And so what we're gonna do is we're gonna actually you can see that we're gonna go ahead and put this third wire right next to a little bit to be able to normalize this kind of in the very good. And now one of the advantages of having multiple wires and can normalize this is that we can very easily disengage the guide to make sure that we're not ventricular rise because we have two wires air anchoring the guide catheter in. And so this step, of course, is very critically important. And now we're Azzawi always doing physiology studies. We take out the introducer because that would decrease artificially the guiding pressure, What I like to do in a situation like this, where it was actually a pretty large difference. Frankly, between the two measurements when we went in, I usually wait a few seconds, just gonna give a little sailing just to make sure we get a good democratic notch. Not that we used any die, but it's always good practice to flush, but it seems like it's it's holding the normalization, so I think we can go ahead and And why are this So you can see that you know, the handling characteristics of this is really I'm really nice, So picking up a little bit. Understand? But let's see, it goes here. This is a pretty tight lesion, by the way you guys saw. Okay, there we go. Well, I would have been faster, but that's okay, right? It's no problem. You know what we have in our I I need to fill the time. Okay. Great. Uh, let's go the other way. There we go. Alright, good. So just for those who are interested about, um, what the impact of the second wire in is probably between 0.12 point 02 units. Of course, it's moot in this situation because you think it doesn't matter. It probably doesn't matter. I'm just gonna go out on a limb and say Thistle is a schematic. Let me just point out a couple of things, you know, being interested in physiology, Obviously, as you know, also directing the CRF core lab. This is something that we typically look for when we get those measurements in the core lab where you basically see complete ventricle ization off the distal pressure. You make sure that the oil pressure obviously is nice and still has a Democratic march. And you can be pretty assured that this is a very, very critical lesion. When when you see that, um, that kind of behavior and under pressure tracing So what? We're gonna try to dio eyes this. We're going to do an I f r pullback, but first we're gonna bet on the dot How many dots? Well, and then what we're gonna we're gonna get just let's just let's just, uh you know, we hope we're gonna get Stack is not for sure. So normally, how this works and I'm a big fan of this is a system called the ignition algo registration. And how that works is that we basically do arresting I fr pull back very, very slowly under continuous Fluoroscope E. And when we reached the guide, we inject contrast, one shot of contrast. And then the system basically, um, translates the pressure loss that occurs during the pull back onto the angiogram angiogram. And basically each unit off fr loss is one yellow dot That's what you're referring to when you're saying how many dots are there. In this case, obviously we're not going to give contrast. So what we try to do is to do a dry sink vision, if you will. We're going to try to co register without injecting contrast. And I would say in our experience we have done a few cases together. It works about half the time, so it's a 50 50 shot, a little bit challenged by the fact that there's a previous bypass. There's multiple astronomy wire. There's an I c D. But I'm still confident we can. Let's see if we can at least give it a shot. So what we're gonna do is this. We're gonna start to pull back. Let's do that first. That's gonna help us, no matter what, and then if we can call registers even better. So when we started the pullback, go ahead. We always wait for the blue line to come up, which is now and then we're going to slowly pull back, saying on continuous flora now and again. What we're looking for is where this pressure. So we're pulling back pretty slowly, sort of five millimeters a second. That's the type of rate that we're considering, and there's a big jump, which is a good news. We're already at 0.90 which means that the rest of the vessel is probably got diffuse disease and nothing focal for us to fix. But nonetheless, I think it's worthwhile for us to pull back slowly to gather all that information. In all fairness, when you have a lesion like this, which is really overwhelming, right, the rest of the vessel becomes a little bit less accurate. So we might have to do another I far pullback after treating that lesion. So that points very important. Remember, cross talk and you stop. It is much more evident when you have a very, very tight legion. When you have 90% lesion, the ability of to create that the accuracy of the step up is indeed reduced. So normally, I said, right now, the next step would be to inject contrast what we do instead of some re advancing this wire because it helps us to have the radio opaque part in that vessel to kind of outline the vessel. And I'm going to go on sinning without injecting a nice long Senate helps and let's see if we can do it. Okay, so now what we're gonna do is on the go on the screen and oh, you can read this. All right? That's a lot of yellow. There's only one problem. It's on the face of wire. Okay, so let's go ahead and see if we can manually correct it. So outside we have Craig Porter, who is ah, master of correction. So also, let me give you a few other hints. When When people do this at home, right? This is how it's done. Even with the injection of contrast, it's very, very important. Thio do a few things first, make sure before you start the pullback under ferrous Copy that the entire vessel, um, is outlined in the shot. Sometimes you have to de Mac for that and also make sure that the guide tip is visible because the system uses to both the guy tip as well as the distal wire to recognize the landmarks. So those are really important things to do. Obviously the table cannot be moved. So no panning, bagging out and making sure both distal vessel and the guiding catheters are visible. When when we try to do distinguishing cases, okay and it's, you know, this never happens. Really. When you inject contrast, right, it almost always identifies the vessel. Um, even when there is other equipment in the chest, if you will. But obviously in this case, it's it's a lot more challenging. So let's see if this manual correction is going to do the job. I have to say that Craig Porter is doing a masterful job of tracing this line. It's incredible skill and accuracy. Why don't you never say such nice things about me? Well, I was gonna wait for you to say that. Okay? Thank you. Okay, so let's see the moment of truth. That's it. That's it. Right. Okay, So how do we interpret this? There is obviously a massive pressure loss in this one legion in the proximal r p l, which corresponds to the angiogram. There's two dots in the distal R c a. And then there is some single dots approximately, basically indicating that there is one single focal lesion. And so if we just go across that and do even our tentative planning by putting a very short stent, we're going to get a Delta I fr 0.51 which is obviously an enormous gain. Alright, so although it's Ioffe are estimated to be 0.84 that's slightly gonna be inaccurate. Um, but what we're gonna do now is we're gonna go for the big shebang and see if we can try. You know what we're gonna do with this? I think we should pre. This is a very tight leash and was actually hard to wire. Let me just read the latest. I don't think exactly. So that's what I was about to mention. Next we have a 2.5 by 12 balloon, and also we'll take the office catheter, please. And let's take this out for now. So, you know, one of the questions now is Could we take the Could we just keep the Omni wire in? Well, we absolutely could, but since we already have wired with a very through a very tight lesion, we'll just use the Omni wire later on to do our post PC II fr. Alan knows a thing or two about post PC II. Afar's. Certainly we're excited for the results of the defined PC I one year data coming up presented by Menashe Patel is a T c T connect late breaking clinical trial. I won't ask Alan to divulge any secrets, but what we did learn from to find PC I was that we leave Ah, lot of ischemia behind. About 25% of patients have ischemia. Um, that's by angiogram. We kind of basically miss a third of that is within the stent. A third is distilled the extent, and the third is a proximal to the stent. And the idea is that if we could maybe capture those, we can improve target vessel failure. And Dr Jeremiah's here is the P I of an upcoming very large multi center international randomized trial called Defined GPS. Allen, do you want to talk a little bit about defined GPS? Yeah. So as you mentioned the fine PC, I was kind of the pilot study. If you will to kind of test the hypothesis, how many times do we still leave behind significant ischemia? Even though we think and geographically we did a good job and then we did a blinded, I fr pulled back, just like with it now, But it was obviously blinded at the end of the procedure and what we're looking for is Do we leave behind? Refused to these focal lesions. And just as you mentioned, 80 plus percent of people had focal lesions, which we think we can fix with about a 3rd, 3rd, 3rd mix in between, you know, instead, distal proximal. So based on that data said what we said. Well, what if we did the pull back before? All right, so, just like with it now to guide the procedure. If this was a patient, let's say in GPS, we would have a pretty clear cut answer. Okay? You treated with one, send an. In theory, you should leave your ischemia. So, um, the idea there is that we're gonna randomize patients, Teoh a sick, vision based strategy. What? We do this full back ahead of time. We planned the whole procedure would decide how many legions need to be treated. Hominy sense that we need for the procedure. We decide we decide all of that versus the standard and a graphic guided PC I strategy. And the primary outcome is gonna be mace in. Um, you know, hopefully around 3000 patients at the two year end point, which we hope will give us some clarity whether this guidance with ST Vision will make a critical difference. So I think they finished manufacturing the balloon. We manufacturer manufacturer balloons and house. By the way, just I thought we were soldering and welding and way do have a balloon. Wait a long it takes to get a sense So So here's an important point. Let's in all seriousness talk about pre dilation. So, you know, I think that ramming the Ivies through this because it's so tight in this situation doesn't make a lot of sense. We have the I f. R co registration and the angiogram. We haven't moved the table, so we shouldn't end up missing this legion. And in general, however, if you don't have a completely inclusive lesion, we do try to do a pre PC II vis without pre dilation so we can understand the plaque morphology. Having said that, as you know, at San Francis, we have 80 86% of our p C. I is his image and guided a little forward, I think. Yeah. There we go. Okay. So we're gonna go up slowly so you can see a waste jump forward. Okay. We'll come back to a tiny bit. And so our philosophy is that you don't have to necessarily do it at baseline as long as you do it before the stand. Here we go, because that really determines what type of stench you use where the landing zones are the sizing. All of that is important. So I think it's okay to pre dilated still, maybe one more. So while we got our you know, our fr car registration to work, which I'm very excited about the office is a little harder. Okay, so I have it captured. But nonetheless, we're gonna talk to you about some of the tricks, uh, tips and tricks about how to use the office, irrespective of which I have a system you used, even if the core registration doesn't work. So we're gonna go ahead next with our I vis try to do a trial registration, but nonetheless, we're gonna mark or distal reference by the I vis. And then the advantage, of course, of the trial registration if it works, is that we can determine the length based on the trial registration. If not, you already saw that when we did an I f. R co registration. We were able to determine by putting in a 15 millimeters stent, we were actually able toe get a delta of 0.51 on our fr. So we won't call for a stent just yet because we don't know what size the artery is. I'm guessing it's gonna be a to five. But then what's the point of guessing? And the whole point is to use the imaging. Okay, so we're gonna going down. Okay, let's do this before we start recording. This is basically a normal vessel down here, so I'm gonna come down. Not quite yet. Let me just find the landing zone, and then we consider that. So as I come back, it still looks reasonable. Right? But maybe we should cover. There's a place a black so we need to go forward to. Basically, I think this is a nice landing zone here. What do you think? So I'm gonna take a city of this so we know, or to lend it. And remember, the lens is a thicker part, so we know exactly where we're gonna lend our stand. Now, if can you are start recording, please. And so, just like the i f a pullback. We're going to come back very, very slowly. It's a manual pullback. Its's not. Ah, so the calcium here and it's also under continued Doris, Copy. The way we want to get close to here is a distance with a double layer layer, a little undersized. But I would like to leave all of that, absolutely treating this if we can avoid it, right? A lot of calcium in this vessel for sure. And we're back. All right, now let's do this. Let me put the Ivies down again as, ah, as a landmark, if you will, and we'll put it right here. And then let's do the same thing. We're going to send a So if you just think for a second to the key step for your contract can get this done this to re advance your gear, Whatever it is, you're I far wire or your I vis back into the vessel so that you have a marker. Alright, it again Look at the at the lead at the Pacer lead. Can we manually adjust? That really likes that place? The lead, huh? And we can We kind of knew that, right? We expected that to happen. Yeah, it's a little, you know, labor intensive. If you have to do it by hand, if it doesn't, if it doesn't register. But obviously that's a function off. You know, it's not injecting contrast and and, like, you know, this is a post cabbage case. I think it's a lot easier for sure. It is not a post cabbage case. You know, Pacer. It has. Really? Or I c d Whatever this thing is, it has, uh, a lot of challenges. Now, if it does not co register, what I'm gonna do is I'm gonna go back life, and I'm gonna actually dry, sedated bifurcation. So I know where the beatification is, and then we can deduct, I guess, between the two Sydney, um, frames. And, of course, we have the bifurcation wire as well. What's that? Pl Yeah, I get the house out. No, I want to put it back in when you know if, uh, it doesnt call register. I'm gonna I'm gonna look at the distillery landings on. So we just checked our a c t. Obviously, you don't want to leave the office, Catherine for too long. Um, yeah. All right. Great. Let's see if it works. Let's see. Moment of truth. I think it did. Okay. Very good. Wow, That's amazing. All right, so let's go ahead toward the still reference. Go to the last frame. Wow. Right. So there's our last frame now, this critical first time that's ever worked with the I this this could be the first. What do you think of that? Okay, so we're at a We have a 30 by three. Okay. So when you want to talk a little bit about sizing one second, that's good. Let's let's do let's do the following before. So the first step is identified, basically the landing zone. And we identified the email of the landings. Only talk about sizing in a minute. What I would like to know right now is, though, is the mark the Bible? Where is the modification here? So scroll back for us on the office until you see the bifurcation. And there it is. There's your wire. Right? Keep coming back a little bit more. More, more, more, more until you see the wire joining. There you go. Okay, So that's the It's already in the distal in a bit. Let's just go a little bit more distal. More, More, More, More, More. Right. Keep going more. We don't have to come back. Here is That's probably what should landed. Right. Okay. What is the distance between those two? So bookmark there. Now the other way. 24. So can you just go to back to the proximal edge of that drawing? I think you might be a little slightly bit. Yeah, right there. Show us that vessel. Thank you. Little your little, Too deep. Too deep. Good. Modesto, Go Modesta all the way. Keep going. More distal. More distal. That's it. That's it. Go from here. And can you measure the distance between that? There you go. 23. Okay. I don't know. I don't think this is right. I think you're going to this toe. The not to this or the proximal market. I don't think is accurate that I say we buy it. Really? Yeah. 24 years approximately. You know, in general and zero contract cases, it's okay to go a little bit longer. So you don't miss the lesion? Because, of course, you got your guy coming in. No, the other way. More distant, more distant and then to be a little bit more or does generous. Okay, here we'll do one more time or a little bit more conservative. Yes, it is. It is what it is. So we'll take it to 75 23 7. Perfect. So why two? 75? So can you Goto representative Greg, let's go back and talk about that measurement distantly. So what we try to do with with the any image ing right is to identify the e l off the distal reference. If the vessel is healthy, I mean, honestly, you won't. You won't get a more healthy vessel than this in most circumstances. And we know that the e l in this case is three point. Oh, right. So if the measurement was 100% accurate, we would take a 300 other techniques like O C t. We know it is accurate. Right? So in the know city case, we would take it throughout with this. We overestimate a little bit by 8% actually. Right? And so the way we do it is that we undersized by that number by about 8% what we do e l measurements and I and in general, rounding down from your L is always a safe approach. As Alan said, if you're using either 60 megahertz scientists or O. C. T, you could go ahead and be right on because their precision and accuracy is really very high. But if using 20 megahertz Avis or 40 megahertz Avis, it's a good idea to round down to your closest device eyes. But what we could do is probably go ahead and take a 30 by 12 n c balloon for post dilation, please. Well, and and we think right. And I think there is some data indicating that we are using larger devices when we do imaging on a routine basis because we almost always underestimate the size of the vessel. Based on the angiogram, Bill Lombardi has some really nice really world data of when they sort of mandated I've issues in their complex cases. And just by simply looking at their stock, they were able to determine that they're putting half a millimeter to a millimeter larger. Stenson's in over 2000 patient. That was the day when been Labadie learned how to land a plastic. That's great, but we had a question from the That may be an opportunity. If you're planning on doing this car registrations. That's with any specific X ray setting that you've changed this no well, except to say you cannot do it on 7.5. So when you dio the fluoroscope e the steady pull back on the floor a Skopje, you want to make sure you do it at least 15 frames. You put your friend up here so they could see. So what we're gonna do is just go back toe one shot and we want you to say if the core registration didn't work, what we're going to do is save our frame from the manual. Sydney. Okay, so that our stent should land right where the thick part of that dot is. Let me just see. And we are right on it. Let me just see. I want to see one more time on the on the sink. Instead, off this view, go back to the other view and show me one more time the proximal landing zone, because I'm more concerned about landing it too close to the beautification. I think we're going to more, much more. You see, you remember, the wires will separate. Yeah. Okay. So I think this is I think you're really good. Should I come back? I know. I feel like I should come back a little bit. You know, you can come back a tiny bit. Yeah, this is a science. Tents were right on the dot. I'm really to take this. I'm happy with this. Okay, we're going up. Okay? We're just going to nominal. That's 12 atmospheres. Just because it's my habit, I'd like to go up twice for good luck, superstition. And then what we're gonna do is go ahead and take our 30 N. C. So the other lesson is when we do imaging before we place to stand, we basically know the entire strategy, right? We know the landing zones. We know the size of the stand. And we also know the tapering. And we know in this case that we can go with a 30 N. C. And so there's no point in repeating either the an angiogram, even if it wasn't zero contrast or repeating the inter vascular imaging because we have the whole strategy laid out, so we know that we're gonna post it with the 30 So obviously, we're gonna go ahead and do that right now. And after that, we're gonna repeat the imaging. And so one could argue, You know, what's the value of the re imaging? Should we just do the Army wire and be done with it? But I think the key is to make sure that you don't have a distal edge dissection. You could make the argument, I guess if you were, um, you know, injecting contrast. But in the absence of that, it's hard, right? Exactly. So I think you know our plan will be Thio. Just post dilated, then re image. Make sure there's no distillation section now for under expanded. We have two things we need to look at. We're gonna then re measure the vessel at the distal reference. And because this vessel was so tight, there is a possibility that the artery will grow. If it doesn't then and we've already posted island with a 30 a 20 atmospheres, then there's gnome or for us to do Now Here's another great feature bit. Um, if which is basically, uh are, uh, stent boost or stent viz or whatever you wanna call it, uh, the ability for us to see our our scent detection software, which is now gonna allow them a little bit away from the distal edge, which I think it's fine because it lands a normal tissue. This is where the calcified lesion was, and we're up in 18 guys a bit more aggressive, I think, in this area and 20. And I think we have a bit more room back right back just a little bit. You can see that. We're just probably a few dots away from See if the sand booms. Helps us on the way back. Okay, Now, our stent detection. That's pretty good. I think you were right there. Yeah, I'm gonna take that. So right in the proximal edge of the stent. We're up at 18. Yeah. Okay, we're down. Okay. We'll take the iris, please. So, so far, just to summarize, what we did is we did a try registration. The I f r told us that the Legion was significant. It didn't just tell us whether to treat it. Told us how to treat that. The rest of the vessel didn't have a lot of disease. We then used IBIs to determine how big our device was. And now we deployed our stent based on the Irish. Try registration, which we could have done manually or using the try registration we stent and post dilated, based on measurements from our IBIs, which was a 275 stent rounded down from a three vessel. And because we stayed within the edges of the stent in a calcified plaque, we used a 30 n C balloon. And now we're going back with our I vis. We don't really need to do any trial registration or any of this anymore. Um, because we can streamline. We're gonna look for this alleged section some, you know, see whether the vessel has got a lot larger. If it hasn't, we're done because we've already postal where the biggest balloon we can and then we're gonna do a final I fr GPS style. Let's see what this shows patients human dynamically stable. Cross is pretty easy. And then vessel. Okay, start recording, please. Okay, so we're just gonna pull back now. It's a good point to really spend some time at the distal edge and sort of study it a little bit more than just peruse it. So the distal edge looks really good here. A little underdone here. Yeah, there's some calcium there, but I'm not sure unless the arteries has not gotten significantly bigger. We've already posted. Elated with the 3 20 atmospheres will be chasing our tails. You could go a little higher. Yeah, maybe appear nicely, right? Right. The proximal vessel. And here's my application. Perfect. I'm pretty happy about that. The rest I think we don't need Oh, let's look at the stop it. I'm inclined to go back. Wait one second. Can you dio a measurement one more time? Go more distal. Just measure the distance Reference for us outside the stent because if the stent has grew, arteries grown will use a bigger balloon, Go to the e l distantly and re measure it, please. So from our research, 40% of the time after you post dilate the distal vessel reference changes by one device size. It's still the same. It's the same. Okay, so in this situation, that's not the case. Let's go back with the 30 and I really want to go to, like, you know, 28. 30. So here's where Al and I are different. I wouldn't go back to beat up this vessel because I think we've posted there with the biggest bull. Impossible. But I'm not taking a big I don't think you can take safely a big balloon. I think we should take the same three your balloon, But just maybe go a little bit higher atmospheres. And that's I must say one thing that if you do physiology on Lee, as you know, I like physiology. But if you only rely on physiology, you know, likelihood you have normalized the physiology at this point, right? Versus when you do imaging, you can optimize ascent, maybe a little bit more on. And maybe that will reduce your TL are you know we did them? We did some research on this. Yeah, We find that if you've post allied with your maximum size balloon to the E l that this further post dilation doesn't give you more than a 3% increase in stent expansion. No matter how you go, doesn't matter E. I mean, the plaques got nowhere to go at this stage unless you go a little bit more distal. Well, I'm gonna go a little bit more to still not all back on our detection. All right. I think we're You want to sit in and use the stent detection? Yeah, I'm good. Okay, so we're going to go up there. Let's go to 28. Uh huh. For as high as the data goes. All right, let's do one more a bit more proximal. And then let's just repeat it just to see you will still have a few minutes, right? Let's just see what made a difference. Yeah. Can you give me a minimal stent area from the previous run? That's great. A minimal stand area. And so I guess one thing here that the Irish showed us is that we may not have been distal, um, just to protect the stent edge, which we might have hit now. All right, let's go back with the I vis one more time. Yeah, 4.1. And can you just measure our distal reference area? So just outside stent. So what? We're gonna, as you all know, there's, like, 100 different stent expansion criteria. Um, and so what we're gonna do in this situation is see if were greater than 90% of the distal reference. You're going to do the math you had. I could do the math in my head, but let's just make it greater than 100% of the distal reference. Live like I have sex pl And so if we manage to do that, then we know that we're fully expanded because the artery should be a cone. Uh oh. If you're done with okay, just do this and then we're gonna go back Life on the six. Okay, so we're about 66% expanded. Okay? Fourth. Well, maybe we'll get a little bit more bang for a buck. All right, let's start again. And honestly, I don't actually have to floral this now because we're not political. Register it. So I was kind of very slowly at the distal edge. It looks good, actually. Right? Yeah, it looks better, don't you think? Yeah, maybe here. I think overall it's a little better. No, I think that's the tightest spot there. Here somewhere. Right? Right. There you go. Alright. Fair enough. Right. And this is the distal RC. Take it out. Well, what I wanna know is what's the post pc? I fr Alright, let's go back with physiology. Okay, So a few things I want to show you guys about the omni wire and that Is that the connection? Thank you is a little different. So what I want to show you guys is that can you just zoom in on my hands for a second? Perfect. Okay, So unlike before where it was a little bit hard to hook in, right at the end of the box is a very sharp hook. Which means you really can't miss this from hooking in. That really aligns all of the markers very easily. So eliminates this problem that we used to have some time of not getting these in the right sort of alignment. We got the 5.3, right? So that's pretty good. That's great. So that's a significant improvement. 5.3 from six is we're almost 90% 85 88%. So it's kind of optimal, right? Yeah, that's that is great. Yes. Okay, let's hope the physiology confirms that, right. And it does not mask new lesions, So why don't you just show them reshaping the tip? But this is one of the advantages of this wire, right? The nightingale tip. So it's much more shape. A ble. I dont know. Can you zoom in on my hands? So I think you all live this right. You've used a pressure wire the second time. It's impossible. It, like, turns into like curly hair, actually, how the shape it's held the ship beautifully, a little bit on. And to be honest, isn't this one of the problems that it makes it difficult to do a post PC physiology when you banged your wire up on you don't want to spend the money to get another one. It doesn't seem like that sensible to do a PC. Physiology my hands. So getting in everybody's hands this one is especially your especially line. But that's a good point, right? That the wire really holds its shape. And to remember, just think about what it was like toe what it is like tow wire through Ah, sort of, you know, 300 millimeters of stent. I'm exaggerating a little bit, but, you know, probably 10 centimeter. Understand. Um, look at this. It's almost a full week. Realized it was 100.95 point 98 That's pretty amazing, right? Just sitting outside all right, let's do with the normalization one more time. And not only that, you're you're disconnected, right? I did. This gonna be you sitting outside for half an hour, Disconnected, reconnected, and it didn't lose anything. Really. This is ah, really high quality wire on, and I think is going to become the sort of, you know, the standard for for wire technology in the future. Okay? Caught somewhere a little bit. Eso he's really trying toe to take it to town here, trying to get it into that biggest vessel. So we have the best kind of flow separation, if you will. Here we go. Okay. I can Let's see. Oh, it's OK. All right? It's better. It's not better. Yeah. So this is a sort of a five pc pc i k spot measurement. Now, what will be interesting to see is, Well, let's do Let's try. Let's try to do another. We're gonna do a pull back and let's try to do another sink vision so we can see this is all diffuse disease, Or is there some kind of lesion that we might be able to? So, you know, if I'm gonna bet right now, I think the very proximal part of our stent. Still might be a little underdone. All right, wait for the blue line. Right. And then we are starting so far, it's pretty flat. Right? Let's say maybe it's a proximal edge. No, it's not, huh? Uh huh. So now we're back in the distal. So remember we talked about this before? What a what a beautiful example of why to do the physiology Eso remember we talked about before? The predictability is much lower when we, um when we have a 90% stenosis. Distantly. So what we've done is now unmasked a new lesion in the distal r c A. And so we'll go back with arrives and actually take a look at it. Okay, let's do this first. Let's see if we can sink it. So let me send it this one more time and let's try to sink one more time here, but I think it's pretty clear based on the pull back that it was at their image. Yeah. Can you Ah, yeah. Fix our sink for us, please. It's right at the end of that. What? I think one of the two layers extends that looked a little bit under expanded. I think that's what the issue. So maybe Well, he does. Because we got that many times goes, Let's do the iris. You want to put the I was just look at the obvious. We have Sure. I don't know if we got it. We stopped early, didn't we? We have from the beginning to me. Yeah. Did we get the distance? And the first thing is this. And then and then we can go to the sink with the IVF because then we we have everything there. What we do, we have the same time. Let's use the sink I vis and then figure out. I think what we should do is just violated with the high pressure balloon. Agree? I don't think we should put another layer. You wanna do it on the arm? You are Sure? Yeah. Lets dilate and see if we get the pressure drop. Let me put this back in, and then we'll just gonna get a team one second. Let me just put this back in. This is how it hangs up. It's getting caught. There's there's clearly something someone to expand extent or something. Ah, yeah, I think he's trying to go retrograde. This is an epic cardio collateral. I leave it here. Okay, I'm gonna get in a C T. Take this guy out. Could you just show us our sink vision? I've us run. Please. Got a three cc syringe. Thanks. Right. Thank you. This is the Beamer. A city. The universe is, uh all right. Keep coming back. Yeah, right here. Okay, good. I'll give it back more, but more. It's weird. It doesn't really look like there is a the problem. This is We already passed it. Okay, go back. But I guess this this must be it right here. Give us go a little bit, proximal and give us an area off the vessel. So we know what the yell is. There. Keep coming, proximal a bit more. Let's see if we find the an area that is healthy enough. Yeah, How about here? So this is a pretty big artery. So maybe they just put the two small understanding that Yeah. So the Stanford us there, but the vessel is a 55 millimeter vessel. 440 no. Five. You're right. So let's go on with what I think about 35 So just do one thing first, go to the distal edge of the stent. This alleged where the double air is all the way to the end. Right before the branch point box, we're getting some intimated blinking image of inter side. I'm okay right there. Why don't you go ahead and measure here for us? Just from stent to stent, So probably a little bit bigger. Go to the the outside. To the outside? Yeah, there's the vessel wall yet. Too big. So just if you can, just outside the stent. That's it, right there. Yeah, that's it. Good. Perfect. Okay, so that's 39 so we can round down. Could we have a 35 etc. Balloon, please. So you see, the way we did that is because you can't really see the fibrous layers because of the stent in the way. So what we did is just go outside of the stent because we know the arteries gonna be at least that big. And we know that the reference vessel size should be like this. So I think what we're gonna do is take a 35 15 NC balloon posted late this on the Omni wire and see if we could get an improvement. It's It also shows you what I said before. If you have a 90 plus percent legion, you basically overwhelmed the physiology to the degree that you can't really assess Syria legions, even when you do resting Pullbacks, right? Absolutely. Which makes sense. Makes sense. So we know we only have one minute left. We're hopeful that you guys can stick around for a few minutes just so you can see what happens to this improvement in this pressure as soon as we do this post dilation. So we're testing the wire a little bit here again. It's obviously not meant to do high pressure post dilation on it. Great. We'll get these Phillips engineers to sweat a little bit. That's it. What is it? What is it Israeli time anyway? They all awake. Okay, Okay. Hold the way. Underwear. Now, let's see if we can connect it up, and then we're gonna go to a life pressure. And so again, this very easy to connect, because what I'm gonna do is just hook it onto the back, and it just literally hooks almost automatically. Uh huh. So I think this is where the issue is, right? Yeah. So I'm gonna go up here, get the pressure tracing up to see what the balloon across. And so we're gonna go up to 20 atmospheres here. Maybe I'm gonna come down a little bit. I'm gonna go forward just a little bit, okay? Let's do it a little bit more distant. You go, you can see our Okay. Good. It's just like this is actually FFR if you think about it, because now we're inducing hypothermia with. Although I gotta say I'm not convinced about how much high premium that actually, cause it does. Maybe we're gonna guys we're going to do in FFR when? When the balloon goes down. Okay, I'll tell you. And okay, I have got no f f f What, you wanna do it with hypothermia. Pseudo high premium pseudo hyperthermia. We're gonna come back with the balloon and check out so far, please. All right, now look, our pressure. Great. It's got better go hit that for far. Mhm. Well, at the very least, well above the scheming threshold 0.8 with FFR. Uh, you still measuring I fr though I don't know why so ever Far should be higher. So, e, I think what you want to do is you wanna wait a little bit, You see how it's now going up. So that's a typical example that when you have high premium you do wanna wait. This is interesting. Is it that our PDP is completely, almost normal now? Uh, so you wanna wait 30 seconds a minute after after you did the last balloon inflation hype arena should be gone. And now let's repeat the I f r. Oh, yeah, look at that. So you do have a pretty significant improvement 00.94 Well, the point that for that was the PDP. Uh huh. So we're right at the ischemic threshold. Fine. OK, but we went from 0.7 point 76 for basic 760.39 point 76.89 for a pretty beaten up vessel. I think that's not a bad result. Absolutely. So we should just, you know, the other thing that we could be impacting this slightly with the balloon. So, Alan, just want to just take this balloon out and see if things actually correct a little bit even further. Yeah, Okay. Go ahead. I think that just might mean. Okay, that's about the same 0.9. Well, 0.9. Better than 0.89 Where you going? Alright, e. Think it's good what we should maybe do Because we're not injecting any contrast. Just one more. I this run just to make sure things are good. And I think that we haven't disrupted anything. So what? We don't want to keep you If there's no other questions, you know, we're gonna finish it with a with a final lives run. And, uh, okay, if you guys want to stick around and we'll have that this is gonna be extra. This, by the way, was all of the on the obviously. It's gonna be extra guys. You can't just, you know. Yeah. Yeah. You're like a lawyer. You billed by the minute, Uh, no, by the minute, huh? Okay. All right. I'm making this a little sticky here. Okay, but in honesty, it shows you this was literally the example of the fine BC I or you think everything is good. You're right, and you're done normally. You would have just ended the case, and you go back in and you fix the problem. That is and then emerge super easy to fix. And you get it. You get 15 points off, but and imagine this guy goes out and starts complaining against the chest pain again. You have been like I just fixed you. Maybe it's his heart failure. And it's a classic example of what we would have just literally left behind. Most people would have done this by Angel. Put a stent to five stent into the PDP l and left, and we would have ended up with a really a result. Perfect faction. Ah, so this is a nice 35 dilation here. This is what we Yeah, dilated it. Look at this. Wow, the perils. It's huge is the word that never heard here. It's huge. Alright, guys. Okay, I'm pretty happy with this. So we were above the ischemic threshold. We're not quite at defined GPS levels, but we improved the ischemia. We made sure we didn't leave any problems behind. We didn't. Imaging and physiology got a P C. I. And most importantly, we didn't use a single drop of die. Now, let me ask you one final question, which is okay, we're gonna remove the wires and we're done right. The Onley. Other complications. So we know we relieved ischemia. We know we don't have a dissection of major problem within the vessel. The only thing we're not, we don't know for sure. Do we have a distal wire perforation? Right. So without injecting contrast, how would you assess with that? So the only way to do that is really to do a delayed echocardiogram before the patient leaves the hospital. So we have the small spots, the sort of echoes that air handheld, and we quickly do one at the end of the procedure, make sure there's no problems. Nothing has been accumulating. Human being has been stable. And right before discharge, we put the probe back on, make sure there's no problem. And when we have, I've seen two out of probably about 350 0 contract PC ice, and both of those present to within four hours. But the patient's symptoms also look, the patient hard to 60 s pressure is 100 40. Nothing changed in a dynamic case. I think there was also somewhat reassuring science, right? So I'm going to remove the wires. And so this is the part where Stefan Winfrey likes to say. It's like having decaffeinated coffee because there's no final picture. It's fun to do one final picture, but we're not gonna do that with a crab. 5.6 were not. So what we'll do is we'll take some questions. We're gonna do a final GDP. You'll be surprised that the IGP can actually drop because the patient's face so dilated has been sedated. And it will help us to determine what a guy with any F of 20 or something percent can actually get in terms of hydration and recovery. But in the meantime, if there's questions, we're happy to take them. You started to make your questions on the asked the question. Washington a great case, a great workflow and using all the technology to do this. We really appreciate it. I think it was informative, not the registration, but a lot of PC I inside. I think when you guys ecstasy, appreciate with certain yeah, we know our attendees or a priest or any other questions that way have understandably, I'm not saying anything new. So crystal clear, huh? There's no clear already got work well, understanding of physiology. The three workflow hi Knowledge. And every day coming. Yeah. Great work from the from the team. They're your lab. We appreciate all the hard work from everybody there. Questions. Nonsense. Writing Siri's is not going to be a final injection. So this is it. This is it, folks. So the final the final injection is the e. P. For those of you are excited by that, this might be the hardest part of the case for Alan. It's not easy. You might be here while guys, guys, just get a break. Is gonna take a coffee. Could take a while. There we go. Don't do this with the Langston. Yeah, yeah. Okay. All right. I always check the zeros there on and let's do it. Okay, but just what we predicted, right? The ADP is lower than when we started. And the reason is the patient is now basil dilated pictures lost a little bit of fluids and as a result, that GDP is even lower. So most people would not check this and then, as a result, very hesitant to rehydrate the patient. But now we know that we've got more room, so we're gonna give another 2 50 bolas and Then we'll gently hydrate the patient and let him drink freely before discharge. Now, having said that, we gave zero contrast. So it might not be as important if you have always important. If you have given contrast, I think it would be critical. Absolutely ready to pull. So it just took you a long time. There's no Yes. Oh, yes. Okay, very good. Well, welcome again. Thanks for for having us. It was fun to do this. I will see you guys soon. We'll see you soon. Thanks so much. Dr Ali. Dr. Jeremiah's trip. Pleasure and honor to us be watching us and having you, Alba. So thank you, everybody. Thank you from ST Friend. Appreciate it.
