IVUS is strongly supported for use during lower extremity arterial and venous intervention. In the Iliac, Superficial Femoral, and Popliteal arteries, IVUS had the highest support for use during intra-procedure and post-procedure optimization and recommended that IVUS be considered the standard of care. In the Tibial arteries, IVUS use is supported and recommended as the standard of care for all three procedural phases for tibial arterial intervention.
In venous, experts agree that IVUS use is appropriate during all three phases for all venous case scenarios presented and is recommended to be the standard of care.
mhm. Everyone we're gonna get started here and I think we're gonna be expecting people to filter and I appreciate those who came on time here. So I'm eric's awesome. Ski, I'm an interventional cardiologist and the director of the vast intervention program in boston at Beth Israel deaconess and part of the smith center who helped arrange this. But really I want to first think phillips and boston scientific for co sponsoring this symposium. Um I think, you know, really this is to me um the start of something that we're gonna be building over the next years to come. I think it's time for us to start thinking more and more about how we're gonna incorporate imaging in the periphery. And we're gonna use this moment really to help understand where imaging can help improve our procedures and there's no better way to do that than with a panel like this which are true leaders in the field of both peripheral vascular mention, but also intravascular imaging. Uh My co moderator for this morning is to help eric from Colombia. Um next time is Sean Lennon, who everyone knows from Cleveland clinic, brian Fischer from the surgical clinic in Nashville and uh Mahmoud mousavi, who is from ST joe's in in California, ken. Rosenfield is getting directions to our hall right now. So he should be here momentarily. But as you can see we've got an array of different specialties here who are coming together to unite over one thing which is intravascular imaging and really uh today is about understanding this technology um and the future of it and I want to engage the audience as much as possible. So we have plenty of time for discussion built in here, there's a microphone for a reason. So please come ask questions, listen to the experts and hopefully all learn together. So to get us on track I'm gonna first have to help reek of our our first talk on arterial I this for the lower extremity. Um so he'll just to warn you I'm gonna be keeping an eye on time so if I'm a little rude, I apologize. No worries. Eric thank you. It's a it's a privilege to be here and I'm delighted to kick this off. We're gonna talk a little bit about ibis uh in terms of an overview, an assistant review of eric systematic review that will be impressed shortly and then brian is gonna show some cases. Um So angiography uh sean you'll appreciate this from the time of stones uh to now really hasn't given us better resolution. And so it's clear that angiography is discordant with IV's assessments in terms of vessel sized lesion length arias stenosis, especially the presence of calcium and plaque morphology and the the presence of important flow limiting dissection. So I would sort of set up the schema as follows in terms of using physiology and imaging for guiding intervention physiology is really good for initial diagnostic evaluation and maybe for subsequent assessment of flow limitation. But imaging really has a much richer matrix of opportunities for the operator to understand lesion morphology, to make pre interventional device selection choices and then to understand the safety of the intervention, How much Luminal gain has been achieved. Is there mala position? Have we expanded adequately? Are their deceptions or tissue prolapse and will allow one to tailor the final result. There's two dominant systems available here in the United States. There's the phased array. I've a system from Philips. Uh There there is a four different platforms, the O. And 408. and then there's uh the hybrid catheter for reentry, the pioneer plus. And then there's the +035 device which is uh for large vessel uh imaging. Then there's the rotational. I've a system for peripheral arterial imaging, which I'm talking about today, predominantly the O in a system is the dominant player has the largest uh working depth uh and uh has uh a uh automated pull back mechanism with the sled. Uh and a typical image looks as follows. Um This is the full matrix as laid out and in print and for those who are novices to ultrasound imaging basically. Uh It's obviously important that academic materials are what we are looking at differential echo gives you the differential imaging. So here's a typical uh image, you can see the catheter is here in this in this light gray circle, this is the loom in uh and then you can see that there's the media bounded by this uh very dark black circular line, which is the uh external elastic lamb. And then the advantages outside of that. And you can see that there's intimate thickening here consistent with plaque. Um So how do you identify these things? Again? You have to look at a lot of them, but really it becomes quite wrote. After a while. You have your catheter artifact, your media, the blood pool and anything in between his plaque. Here's a so called healthy image with with chroma flow imaging sort of helps you identify the blood pool. Here's a disease vessel where you can see there's a lot of internal thickening and plaque with a relatively narrow Luminal area with a really dense vibrated plaque uh and and chroma flow in the in the setting of the Philips system allows one to see where blood is circulating using differential uh Doppler techniques uh and can be helpful in identifying uh complications such as dissection. Post imaging interpretation is also relatively straightforward. Take for example, here you can see these very bright, intermittent structures are struts of stents. This one happens to be well expanded. This one happens to be floating in the lumen thrombosis will be intra Luminal and have sort of a characteristic echo density. And then when you're disrupting the advent isHA. You can see that also fairly well. So to take you through an algorithmic approach, you're going to identify plaque geometry, plaque morphology, know where your guide wire is inside the vessel in terms of pre interventional assessment. So first is it is it concentric or eccentric plaque that helps you? You can see that fairly clearly as you see in these images. one and 2 here you can identify fibrous plaque from fatty fiber, fatty are purely fibrous. You can see that the uh the echo density is correlated with the amount of of fibrous tissue that's there. That may have some relevance with with respect to embolization risk as well as the amount of of energy that is required for pre dilatation or uh lesion preparation, calcification plaque, which is really the enemy for vessel expansion and intervention is seen here with an acoustic shadow. It's quite clearly delineated and it's actually much easier to distinguish calcium from non calcified plaque using ivy's than it would be really with any other modality. Um So if you see a shadow like this, particularly if it's some tens and arc angle of greater than 180 degrees. Um You may have concerns about vessel expansion and also the risk of dissection at the shoulders or at the opposite wall where the path of least resistance might be for balloon dilatation Here. You can see superficial versus deeper calcium here in the media and you can see this arc angle of calcium is almost you know, 240°. Uh it's going to predict that this will be a difficult vessel to dilate guide wire orientation is also helpful. Obviously if you've crossed a occluded vessel and your sub intimate as you can see here in panel C. Um it may change how you do plaque modification or treatment of that vessel. Uh and it will also perhaps mandate that you provide scaffolding to ensure Luminal patton. C. Again, these images, you can see where the catheter is here and you can see that there's perhaps two layers of the intimacy. You're in a sub internal plane. It gets easier and I'll skip through this because eric is starting to give me the wrap up sign. Uh The last thing I think that's really important is Luminal sizing. We have historically um sized vessels, Kenny taught me that you should always size uh a self expanding device plus one to the Luminal dimension. But is it plus one to the lumina lumina dimensions or to the true media? To media dimension. Um and I think that this really depends on the device you might use. For example, a superior stand is not well designed to expand a vessel beyond the Luminal interface. Whereas a self expanding stent, you probably want to use media to media dimensions. And in truth, I would throw the gauntlet back down to the imaging companies to really define a standard for how imaged dimensions should be measured. Uh And again, you have Luminal areas, vessel areas and and plaque burden, which is a percent of plaque of the Luminal area in total post intervention very quickly. Um you want to see how well expanded the of the vessel is. You certainly want to see if there's any uh complications uh dissection being a really important one. We'll talk later about the data about how dissection influences arterial intervention. In brian's lecture, here's a post a threat to me evidence of a sub internal hematoma with free flow in the subs in small plane. Uh And this is obviously something that could jeopardize the true lumen if not treated uh prior to leaving the lab from this obviously also is important, particularly in the diagnostic evaluation but also post intervention. It may impact your pharmacology and or whether you need to use further treatments including from back to me and finally, stent opposition. The biggest cardinal sin of stenting is under expansion. If your stent is under expanded, whether it's ballet, pose or not is less relevant. Then whether the vessel's not expanded here, you can see that this is both under expanded as well as possibly mala post stent, this would be a bad long term outcome compared to the left hand panel where you have good vessel expansion. So to summarize, I would say that as you are well aware, angiography is a two dimensional technique that is limited ibis and perf interventions Has been shown in in a variety of series two lower amputation rates when when used effectively. And to improve patent. See probably by making sure you have the biggest final limit. Uh and I think that clinicians have to be familiar with the techniques of of all the IVS platforms uh and basic image interpretation. And I think that's what we're here hopefully to uh to propagate. Thanks very much. Great. Thanks. Thank you. That's fantastic. I think that last point and just reminding that everybody doing peripheral interventions in this era should be familiar with intravascular imaging is key. And hopefully we're gonna spend some time on today. I just want to round out our panel real quick. Miguel Montero baker from Baylor has joined us at the tail end here and uh ken Rosenfeld from mass General in boston um on my right, so thank you guys also for being here. So moving forward, we've got brian fisher here. I'm gonna give it back to you. All right. Thank you very much. Again for the opportunity to give this talk and talk about something. I'm very passionate about it. You guys all well know. So we're gonna discuss uh you know, practically use of Ibis in the clinical setting and it's a vascular surgeon. How do I advance? Oh, there we go? Uh huh. Okay, disclosures that are relevant. Yeah. Okay, okay, there we go. So we want to understand the routine use of Ibis and how it's changed my approach to lower streaming disease. Um Again, just my background as a vascular surgeon, I'd likely stand alone in the belief that intravascular ultrasound and other advanced imaging should be emphasized should be employed routinely to achieve and often result in lower streaming interventions. Yeah, I'm a little bit out on a limb. So as my journey and doing long term interventions, again, I'm a vascular surgeon finished in 2012. We didn't do a lot of lower extremity interventions as far as advanced techniques. We did a lot of the basic things I knew how to get to a particular vessel bed to treat it. Uh right now, working a very collaborative environment and that's where I really learned about I've issues. And how important was um the centennial heart and vascular system. We've got some outstanding colleagues, both older and young that we're using. I this it seemed like a no brainer to me as I watched them use this in the coronaries. Uh thought about the lower extremity of some of the results I was getting. How I wasn't happy with that. And again, for me, that's what made me really take the lead. Um and I say don't ask me about using Iverson O. B. L. People will say, oh well you're just using because you get reimbursed. I started using it seven months before I realized it was reimbursed. I was using the hospital. So where it's not reimbursed. So that's kind of my last thing. All right, So, um again, the observation that colleagues not relying on angiography alone to drive their clinical decision making. Um you know, looking at uh case discussion and why this is important. And you know, kind of, again, my early experience, I'm gonna kind of fly through these uh, here's a ct angiogram bad disease behind the knee and into the traffic ation. Uh Okay. And the images are sideways. Okay. Um All right. So I need everybody to turn your head to the left uh 90° and you'll be able to figure out what's going on here. But um, maybe I'll go ahead and skip ahead again. That's just showing technique and some of the good results. And I just kind of skip ahead. Um you have to trust me that this is the result that I got and again this was probably eight years ago. So, you know, you look at this and I'm like, oh, that's an outstanding an amazing result. Okay. Um this is after a touch up though where I had to come back because the velocities were in the five hundred's when I finished the case and obviously something we had, I used obvious that I would have had that would have had to come back and do that touch up. Um the other point is look at the resulting disease downstream that you could say, you show this at at a conference and people will be clapping their hands. You do this case live maybe like that's an amazing result. But in the uh realistically, you know that lesion this in the teepee approximate TV trunk could be around 60, cyanotic. When you actually look at, if you look at the hazy, the hazy look at the vessel itself, it becomes pretty apparent that there's likely disease there. And that's just my experience. So again, posted, of course, patient did well, palpable pulses. I'm gonna go ahead and skip ahead. I've got some live cases or not live cases, but some videos uh, just from a time standpoint again, lower streaming disease. Tibbles. Uh pretty advanced retrograde techniques. Again, this is very early in my experience, you know, when I showed this case, I remember, you know, you can see the shock and all in the audience uh in trying to reestablish flow into the, into the tibial vessels. So we're pulling uh oh 35 catheter back, you know, in my experience, not probably in oh 14 or knave across there. And what I'm trying to do is basically connect the dots um from the T. P. Trunk and 80 form a common channel, get up to and connect the dots into the pop a deal. So, again, we're still working here uh, with re established that that try ification area. And as you can imagine, I wouldn't be showing the case if it wasn't actually able to do it. So we did a balloon angioplasty five millimeter balloon and again, it's kind of sideways again. But again, you just have to take my word for it. And uh excellent results. So there was then there was the Eureka and then the shame of it all when I realized what I was missing on intravascular ultrasound based on tibial interventions. That's when something really realized something was right. I finished these cases up have a palpable pulse at the end of the case and everybody's clapping hands and saying how amazing I am. And again, they come back in one month and they've got velocities in the four and 500. That's when I realized that I must be, I have to figure out a way to do something a little bit different here to get better results. So this case shows, uh, you know, a pretty good example of multiple things that you can miss when you don't use intravascular ultrasound. So you've got a leash in the papal teal 80 lesion TP trunk. I mean, this is just basically a bad looking lower extremity, right? So I wanted to pick that first legion. So there are some people that would just treat that, uh, you know, as a, as a drive by per se. So that first legion was roughly 45% cyanotic. And so, you know, we didn't, I didn't do anything to it. And here is the the office run. And this is what really stood out to me. And this is again, kind of that Eureka moment as you file this down sometimes like a little impatient. But if you can count the number of times that I'm in the true and false lumen, true and false, looming, uh, you know, it's mind boggling what kind of, uh, techniques and um, definitive treatment I was using when I didn't even know where I was. And again as an aside, like say from a quality standpoint, we talked about the use and overuse of a directory and how some people use the same device over and over again. I think that intravascular sign is a prime example of how we can improve quality by ensuring that we're treating the right lesions with the right device and and getting getting good results. Um, the other things you can tell here again, uh, he'll really allude to this. Look at the different areas of calcification. Look at the difference in the vessel diameters you move uh, down the vessel moved decisively towards the feet. That's one of the things that really stood out to me. Um, what I learned, uh, you know, when I, when I started using obvious, I realized I'm not where I think I am the vessels and the size. I think it is. There's not as much calcium as I originally thought. I can't believe I landed in that. And then finally, the vessel looks terrible. Well above and below the index lesion. I don't know if you guys caught that, that slide from Zach arthur's, that was in. So heels talk. But these guys back 10 years ago realized that lesion link was a big deal. And we were completely missing the mark when it came to landing stents where we should land them, where we should do our definitive treatment. And so that's kind of where I ended up. So what's the big deal? Well, the diameter here guys, So look approximately uh you've got a fairly large vessel, you know, no one guesses. We got a five millimeter uh anti R tibial. Now you get down farther in the vessel, you know, it continues to taper down. And then finally, we got a really small vessel. Now, how many times you've been to a conference? Someone goes, they do a live case and they do one vessel. Uh They do a single vessel. Single balloon, three millimeters longest. Can be uh for about a minute and a half. Well, you can understand that. That may look really sexy whenever they finish the case and I've done the same thing, but whenever you go at one month, three months, it looks terrible. Again guys, there's there's really no ifs ands or buts about it. So, same thing. Um that's you know, kind of the same idea as you travel down the vessel. There's a markedly different diameter and let's face it guys in the nBl aren't gonna be happy to pull out two different balloons to treat a lesion I do. Um But I'd say that I'm a little bit different. Um So what's my point? You know, again, I would actually say that people would treat this with the exact same balloon for both. Tibbles alright. Some of you are shaking your heads and thinking I can size the vessel without extra tools. Well, you can't. Uh And again, we have many cardiologists here. So I think the attitude is a little bit different, but not necessarily. So, Um and again, in clinical trials to clinical trial, we talked about a residual stenosis of 30%. I can tell you right now, there's no way that we leave in 30% of those lesions. Just based on my experience. And then change the manager of tibial interventions. Nearly 100% of the time again when I'm choosing an African device and I'm choosing balloon when I'm choosing the type of balloon. it's all based on what I'm seeing on this imaging. So, You know, some people look at me and say that's B. S. you know how you're changing 100% of the time. It drives my decision making and it drives whether or not I feel like I'm done with treating the actual lesion that I've I've decided to address. So, you know, again, I'm gonna I'll kind of skip through the rest of this. But, you know, I describe it as the blue pill and the red pill, right? So you can take angiography is the red pill and you can feel like you're doing an amazing job or you take the blue pill do a little Ibis and and come to the reality that sometimes your intervention just did suck and you need to do more about it. So we talk about efficiency with IV's. People complain about taking too long. Well, if you use, the Edward technique is shown on the left hand side, you go retrograde with the I. V. Catheter through a forefront sheath and you go and you come up and over. Uh you can actually get single wire control and do the uh do procedures quite efficiently. So again, this is what it looked like before. And this is well it looks like now. So the astute person will notice obviously that we're zoomed in on the left, but on the right side there is a dissection um farther down here that I probably should have treated. I wasn't using coronary stents materials at that point. Now I do know they're off label they work quite well. Again, here's the runoff and here's our final result. Um, you can't argue with that. And again, I use divers all the way down. I can see that there was still some lesions there, but I know that they're there when I come have to come back or when they're going for their um surveillance study. I know what I'm going to find there there are no real uh no tricks or surprises. And again, here's the final run. Again, obviously I wouldn't be showing if it was an outstanding result. You see the blush down to uh in the wound and here's our final obvious run? So again, you'll notice that there's a uh coronary stent in the proximal tibial off label. But they work quite well. They work better than just about anything else that I can think of the materials and the proximal tibial especially. So follow us down again, you've got between 30 and 50% residual stenosis with some recoil. Uh but I think overall a really good result. So I've run well over my time. Uh I'll challenge challenge you to try and see if if the changes, if it changed your practice. Uh for the better. Thank you very much. Great work brian? We've got a few minutes. We got about five minutes uh for discussion. So again we have a mic up there. So please come up and ask some questions. Um We're playing musical chairs up here. So I'm gonna moderate from up here at the mic. So question please, thanks for the great presentation. So, um one of the cases you saw a large tibial and then it tapered down to a smaller tibial. And so the question is when you're treating this, you say you might need to use two balloons to accommodate that differential. Um But do we have any data that shows that you want to make the size of the loom in the size of the dilated vessel Knowing that in a three sclerosis vessels dilate to a bigger level? Or is the bloomin in the more normal vessel without that big plaque burden the right size of the vessel? That's a great question. So basically you're talking about remodeling, right? So you have either both positive or negative or modeling. And so I think the practical answer is you want to avoid perforation and so you're gonna try to size right for the vessel where it is. Um The data about remodeling however, and any experienced clinician will tell you when you come back sometimes those negatively remodeled arteries will visa dilate. The question is, how much are you going to do in any individual procedure? There isn't any hard data and tibial vessels, particularly where medial calcium no sis is much greater than that. Which you would see in other vessel beds in the coronary circulation. Though, for, for example, in chronic total inclusions, we see this very, very commonly where you have an area that's going to be stent it of course, because it's a coronary and then beyond that, where you have vessels that looks quite dramatically negatively remodeled and had follow up angiography, they're actually right sized because they've got hypothermic visibility ation. So I would anticipate that you would see that, but you you have to be careful about over sizing. Um and and that's the problem is brian alluded to one size will not fit all you you do need to tailor your result based on the actual size that you see in real time, Thank you. One of the, one of the challenges that you have When you want to add, I've s to peripheral interventions is you're going from a coronary that measures three cm or four cm in length, 2 50-60-7 cm in length. And so I think in peripheral interventions you're obligated to also use more aerodynamically significant things. And the combination of ibis with extra vascular ultrasound, I think is exquisite. If you either have a tech that could be around or if you train yourself the same way you're up up here in the morning trying to understand more about avis. I would also invite you to understand more about extra vascular ultrasound because he's a You can scan a leg in five minutes and then I have This comes in the clutch time where you're like, okay, I'm I notice that there's a dynamo dynamic problem here. I'm not understanding. And how do I go about answering that question? Because a lot of times my thought is if you just drop an ibis, you're going to be very unsatisfied all the time. You can see a lot more. But that doesn't mean that we have to overreact to it. But adding I vous to Eavis, I find it at least in my own practice that that's been really useful because then uniquely, you know, okay, here's a human dynamic issue that I don't understand. And then I this comes to help you find the answer to that and I'm not sure if you guys uh I'll have welcomed that but using that sort of thing using pedal acceleration time and you know there's so many thermodynamic parameters that sometimes you'll miss or you over call that I believe that it's very interesting to use the combined approach. Yeah. And the intravascular imaging analog of that will be the future, which is where intravascular techniques we have F. F. R. And I F. R. And other non high perimeter parameters and the coronaries. I think those are likely to become part of our armamentarium in the in the legs as well. Uh and it's it's exactly what you say. Uh Miguel is that you need physiology to complement the the anatomy which you can get from from my voice. You know we're walking in and brian and we're talking about this. The other thing about Davis though is you may see the things that you don't like. You may see things that don't look good. And brian really highlighted in his talk but that doesn't mean necessarily you have to treat everything and you get this algorithm, your head of I'm glad I know this even if I'm not going to cover it. I'm glad I know this even though I'm leaving some residual disease, it changes how I manage the patient afterwards and it changes, you know how I think about the process and so you know I I don't think, you know, I think we all do IVF and get scared of what we're going to see, but you have to walk away from that and just feel comfortable with your procedure and comfortable with what you're willing to walk away with and when you know that you've gotten burned and and that's what you develop over time by doing this time and time again. And and that experience looks like we got another question. Yeah, I've heard that there's some research going on and trying to develop an F F fire indices or surrogate using ultrasound. Is that is that going to be a future possibility? It is it is uh the challenge of course, is to to impute flow or compute flow and pressure gradients from static images is challenging, but there are ways to do it. Um those techniques are in evolution. The different the difference between the coronaries and the legs, the heterogeneity and as a card carrying interventional cardiologist, I think the legs are way more complicated because of these flow dynamic interplay is between different vascular territories, which the hell. To my point, I think that's why this is so important. And I don't care what people use for again, what we call advanced imaging. But if you argue that purple interventions are are far more technically complex just from a lesion length standpoint, then one should argue that, you know, these types of imaging modalities are even more important and the idea of, you know, if angiography is not adequate in the coronary system that should be, you know, it should be obvious that it's a terrible modality to understand our final treatment algorithm uh in the peripheral system. So I like the combination using extra Baxter ultrasound. I know if you guys have heard of P. A. T yet, um but if you have not, I would encourage you to take a look. It's a really exciting uh fairly new technique uh that really is giving additional information and again, kind of give us an idea of when do we stop, which we don't have in the peripheral system yet. Great. So we're gonna switch gears now into the venus side and ken Roosevelt's gonna give our our first talk here on um excuse for venus intervention. We have little bit more time of discussion built in here. So these questions have been fantastic. So we'll have more opportunity for that in a few minutes. Thank you. Um first of all I want to thank uh BSC and phillips were putting together this thing and in particular eric for taking this on and for taking on this challenge. You know, this is so true, we see so much with IV's and the big question is Wendy do. So there's some things we know, you know, you see dissection or you see flow limiting dissections and then you go in with iris and you see the problem, you fix it, then there's a lot, we don't know. And to your point prime we don't we don't know when, when to stop. And that's always been the problem with IV's and we need to figure that out um and standardize it. So this whole effort that's gone under under way over the past years is an effort to do that. Um Just just to hearken back to the beginning, take off my glasses. This is uh this is uh the first article that Jeff is now and I wrote about 30 years ago. Uh 31 years ago when we first put IV's catheters into into peripheral arteries and uh not wire guided and it was just a whole new world is like the fantastic voyage. We were inside the vessel looking out and and seeing all of this, I remember it was like an explosion that got off in that iliac artery. And we had no idea what to do with that information. And and I would challenge us to say we still don't know what to do with that information we do in the iliac artery, but we don't in the table, we don't in the S. F. A. And and in in the veins maybe we're a little bit farther along, but maybe not. Um So I was charged with talking about the principles for venus intervention. Um I have more experience than arterial but I'll try to address this and some of my colleagues can maybe fill in the blanks uh what are the available devices uh, and overview of the data? Uh, the uh obviously we know that geography maybe even more than arteriogram fee, has limitations. You don't see e centric lesions. Occult disease, residual thrombosis that's there after three symbolizing uh, and what the characteristics of the material are that are making up the stenosis, whether it's uh fibrosis or um uh moth eaten material that's recapitalized. What's the accurate vessel size, particularly challenging with veins where, where you can have, you know, small and very, very large. And it's hard to define the size, especially the large ones. Um, clear identification. Where's the normal vessel? Uh and where are your stent landing zones? I'm not even sure it's 100% important with veins, but but it probably is be to be better to be in more normal vessel. And what is that normal vessel? Um And then finally, of course, optimization of stent deployment and paul, you know, should stand up and say what you, I could quote you here, you can't you can't treat what you cannot see. And, and Iva shows you so much more than you can see with just a pornography. Um So I think I this is really the gold standard for treating venus disease. It characterizes the disease, whether it's fibrosis or scar establishes the the absence or presence of a compression syndrome as the ideology and ofttimes? You see dynamic compression and that's actually sometimes a challenge because you don't know? Well is this really is this real or is it not? Um uh is it clinically significant? Um You can detect occult disease, subtle scarring from prior thrombosis. Cept I. And so on. I treat a lot of B. P. A. Uh CTF. And and there's uh those lesions are really interesting if you look with IV's or O. C. T. Um And they they have often cept I that that that really are not well defined by angiography but you can see them by ivy s um elliptical channels obviously e centric lesions uh non inclusive thrombosis that maybe maybe present. And what do you do with that? We still don't know. But we needed to find that obviously sizing the vessels identification or local localization of the confluence in particular at the confluence of the common iliac veins where they come into the I. V. C. Defining where that is often angiography gets it wrong. And I have this really does give you the marker. Here's the here's the beatification which also helps guide in the placement of the stent, both selection of size, position, location, proper placement and so on. Uh proper expansion. So does this all really matter. Well you know who cares? They they're nice images but but what's the difference? Well it does matter if you detect disease would otherwise gonna go undiagnosed And and if that disease may explain the patient's symptoms. Um and and it's often the case that we were we can't figure out why the patient's symptomatic. You put something that you put the I. V. S. And you say ah there it is. Um And and uh again identifying residual thrombosis um you know post on back to me and will that influence the long term patent see of this vein that you've now spent a lot of time opening up? Will it improve outcomes, improve symptoms, improved latency? That's really what matters. I'm not sure we have the data we yet to define that but we need to actually uh you know this this hopefully this symposium and all we're doing over the past year and moving forward will actually charge us with doing that. Um And hopefully reduce the need for re intervention due to misplacement of a standard under that dilation. Um Also uh the the other advantages that haven't really talked about that much of reducing or minimizing contrast utilization and reducing radiation exposure. And this is just a patient that bob Shane felled my colleague did and uh did totally by I've misguided intervention on this vein prior to uh prior to placing a P. F. O. Closure device that Igor Palacios did. Um So the device is I'm not gonna spend a long time you can go to the booths and look at them. That's the boston scientific opt across and 35 035 platform which is obviously mechanical rotation device. I think you may have gone through these um and it's oh 35 based um uh And uh I can't see the megahertz here but you know um I think it's 15. Um and then there's the phillips uh digital system which is also 35 based. Uh They also have an 018 as does boston scientific. So these are the two big players and obviously uh encourage you to visit the boost and see what they what they are. Um uh eric undertook with his with his fellow or colleague I guess. Um a an overview of the data supporting Ivan's during venus intervention uh during a systematic review of the literature. And they looked at a huge number of studies. It's amazing how many studies are out there, how few of them are prospective randomized or anything else that are really truly high level scientific level. So but ultimately they toned it down to 19 total studies that that were pretty good. Um And uh only one of them was a prospective multi center cohort study. And I'll show you that one. And of those 19 studies or 2600 patients um with a with different study folks. I mean they looked at different things but uh and obviously the comparator imaging with pornography and ultrasound and you know, the some of that review and it will be published soon is that ISIS is effective in diagnosing and characterizing and evaluating iliac femoral venous disease. It improves procedural outcomes over Viagra fee alone. and uh the utility over videography alone prior to intervention is that it's more precise and assessment of dramas burden degree of stenosis, lesion diameter. It's effective at detecting cyanotic lesions that were missed or under evaluated by videography. And and that I was provides valuable information that can inform peripheral venus intervention and be used to make clinically relevant treatment decisions, appropriate measures of lesion diameter and length results in more accurate stent placement and reduction in risk of migration and instant restenosis. And that's a pretty all encompassing statement. I'm not sure that the data really totally support that yet. But uh but the it's certainly uh suggests it. Um and I'm I'm not gonna spend time on these uh for the sake of time that the benefits of Davis versus angiography. And just to say that they noticed that a lot of three plus is here. The only thing is, as has been mentioned by Miguel, is that flow is not seen by by I've as you can see some color flow of course, I mean, but it's not really a determinant of accurate, accurate determine of the total amount of flow down the vessel. So um you need to combine these strategies. I totally agree. This is just a summary of the uh the where that data came from. So the video studies, the only prospective study that actually paul I think you were involved in and others that may be in the audience and it's a multi spencer's multi center prospective single arm study with 100 patients that found that I was detected detected 88% more lesions in a pornography and in patients with normal Vienna grams. This is important. I was detected significant disease requiring treatment in in a quarter of them. And that's important. Um So, uh You know, I think that sort of harkens to how important this it will be. So, this is an article that we Jeff isn't. I wrote again almost 30 years ago enough with a fantastic voyage. You know, you're in the artery, you can see all kinds of stuff, but doesn't matter will it play in peoria? It's a great article. I'd suggest you go back and look at it. But Jeff and I quoted that the most critical vantage of ideas for clinical work at that time, we said was derived from its unequivocally superior capability of defining Luminal dimensions, particularly Luminal cross sectional area. And we haven't talked a lot about the fact that in Viagra fee and angiography and arterial grafts in the peripheral artery system, we usually don't do orthogonal views. So I have this actually gives us that orthogonal view and the limitations of of angiography evaluating luminous dimensions have been well documented. So, uh in conclusion and I've gone over to, I'm sorry eric but I was unequivocally is useful in the diagnosis and treatment of venous disease as an adjunct to Viagra fee or even as primary guidance modality. There are some articles about using its primary guidance without a contrast. But there is a need for standardization. There's a need for more data. We got to do this, we gotta bite the bullet and get the data. Do the hard work that shows exactly when and how we should use it when we find what's what we should do with a lesion. That brian says that that that you know looks ugly isn't gonna matter long term. We also need to define the reporting standards and characteristics. Fanatic lesions and get more and more data and comparative effectiveness to show that this is important. I believe it, we need to document it. Thanks. Great things can we'll move on to our next talk by Mahmoud Mousavi is gonna give us some examples while we're transitioning sean, you know, pretty remarkable amount of data that can can show and talk about a lot of experience where if you had to pin one thing to the barrier for use right now. I mean is it is a comfort with the device. How do I interpret the images were to get started? Where's that barrier right now? You know, I think it depends on on what practice location you have and you know, a lot of it may have to do it just the whole capital expense of the device and then and that's just familiar with using it. And I think the hard part is once you actually do use it and see how different of information it gives you it's all agree with brian, it's it's impossible to go backwards. It's sort of like you get that new computer, you know, you had you had a dos computer and then someone gave you a Mac. I mean what kid went back to the dos computer? Nobody. So, you know, I think a lot of it's you know, maybe getting it, they're getting it set up, making sure that you can afford it, making it reimbursable. But once you have it it's it's you know, your eyes are open. You can't go back. Yeah, sure. Well right. Ready. So the right atrium yeah, understand how there's I cannot leave here thinking that somebody should do venus interventions and I can't wait to hear Mahmoud stuck because I think you're going to drive it home. But we need to understand sizing an anatomy to be able to then put the device that we need to use. All right, thank you. Just as a disclosure, I'm not as much or was not as much of an ibis enthusiast and think I'm on the record in the literature someplace saying that the only use survivors that I thought was an aortic dissection, needless to say that I've sort of changed my mind since then. So, so let me show you a few cases here, a potential advantage of venus interventions. You know, we've talked about it improved visualization of vessel lumen clock versus not improved visualization of the vessel walls. This this will become important on the meaner side and especially in a sort of prognosticator. But as as a post development of post traumatic syndrome detection of degree of stenosis. I don't think anybody can argue with that. And more accurate vessel sizing. So let me show you this is an obvious case. Right? So it's a venogram. We've all seen it. You can see sort of evidence of iliac vein compression. How narrow is it? Does it need treatment or not? This is one of those things. Until you look at the pancaking of that vessel. The devis you say your kids this symptomatic patient needs to be treated. This is less obvious. So here's a patient 72 year old. Here's the venogram. Okay. The common iliac vein is included. Lots of collaterals. It's quite possible that there was a main thoroughfare compression underneath that. But is there. But look at the history. So this this is their cotton. There is it Should they just go ahead and put a stent in there because my wife has passed through. Right Or do I need to do from back to me this is a diagnostic dilemma at this point because it does make a difference until you put the I. V. S. In there up at the top. Now you can see clot. Right? And here's the point of making dinner compression. Of course this patient had it to begin with. And there's a bunch of clutch squished in there. And this is down below. Now this is where obviously I just makes a difference. I mean we've all seen it in the tibial vessels. We didn't know how much recall we get until we but I wasn't there. And you look and you said God angioplasty really doesn't do the job looked awful. Things look like the same thing on the venus side. And so here's another patient was extended form a turner elsewhere and the patient's symptoms didn't go away. Here's what things look like. This is what things look like before the stenting. And they put an I. V. S. They put here's what the eye this looks like up at the top for the sake of time. I'll probably just go through it quickly. It looks like just anything else. So symptoms did not improve. Patient came back because the venogram. Is there something going on here or not? So you put an I. V. S. And they're the Tabernacle and Sinica in there that was completely missed. And this is why symptoms patients did not improve. And so that was extended. And so the stent as you can see was extended down to about where it should have been down extended to begin with. And now the patient's symptoms improve. And this is where you see some of the benefits of the stent. Now could this be a prognostic tool, likely we haven't proven it. But like look at these three different scenarios. Okay, this is a compressed stent. Is this providing the same time a physiologic benefit as that. But we just don't know but we can't diagnose this and pornography. I'll tell you this. You have. This is not a man opposition. This is just that one of those iliac veins that from one side to the other side measures 20 and the other one size measures one millimeter. And you put a stent in there. You always get that Egyptian eye stuff. Do we need to make sure that this is all attached and you get opposition. Does it make a difference? And that we have no idea. But the only way to do that is really to do these types of studies with IV's to figure out what's what vessel sizing everybody knows. Okay, so the venogram can't really accurately sized the vessel. But I do want to draw your attention to this paper that was published about over sizing the distant stents have to be appropriately sized. This causes this person phenomena that may lead into this stent creep that we start from the top and then before you know, you've extended all the way down into the common family when she really doesn't need to be if it's not diseased. This is this. I just want to make sure that everybody becomes familiar and reach this because it is important on the venus side. I also want to draw your attention to this as my last slide on the on the sizing. Be careful. And the reason I picked this one because it has a stent in there. So you can easily see what my point is on the vessel sizing. Remember when you put the I. V. S in there, the diameter you get this perpendicular to the lie of your wire. Okay. And so if you do that on the venus, the ibis, you're going to get about 17 millimeters. Okay. But the diameter of the stent was only 14. Okay, that can happen in the actual vessels also. So be cognizant of that, that it's not 100% so that that I was a skeptic of me had to come out at the end. And and so I stopped there and let's open it up for the discussion. Thank you. Well that was fantastic. I think those are exactly the type of scenarios where we know I cannot be replaced and geography is absolutely insufficient. So I'm gonna I'm gonna spend a few minutes in our last talk and then we're gonna end on some questions. But I think this is the right time to kind of go into what we've been working on for the last um year plus, which is how do we really obtain consensus where we have a lot of experience? We have a lot of anecdotal demonstration of where it's useful. But we haven't come together as a specialty in the Purple Vasko space to really point to the scenarios where we need to be using it is routinely. And we've really taken this on over the last year to try to answer those questions. There we go. Okay. So we um as part of this initiative formed a large um consortium of experts to create really the first ideas, consensus document for lower extremity intervention, both on the arterial and venus side. Um and we were really fortunate uh put together a fantastic group of experts, um ken Rosenfield and say hell um worked with me just to oversee this, but um we had a large group of of writing members um who helped with case scenarios um and also nominating our experts, which I'll reveal in a minute, many of which are speaking today. And for the consensus document, what we did was create arterial and venus scenarios where we felt by this had a potential role and the goal wasn't to gain this to only create scenarios where everybody would vote yes, but identify each period or phase of our intervention, where I this might have a role. And so you can see on the pre intervention side more on the diagnostic side, understanding what an inclusion um ideology because it was like what Mahmoud just showed um to biggest lesion or severity and filling defects on the intra procedural side and determining what our next therapeutic step is, whether we need to do further de bulking. If we need to size for stent implantation and then following that intervention, what does it look like before we walk away from the procedure. This is on the material side and very similar on the venus side. We looked at similar characteristics at different phases of the procedure. So this is quite the task for the arterial side that has split up from iliac sF A pop and tibial. Um We wrote five questions personally and I'll show you an example of these and this is reviewed and edited by that exhaustive writing committee. And we ended up with 72 randomly selected questions for this consensus document On the Venus side. We have five questions person Maria, 40 questions written in total to understand the role of I. V. S. And L. E. Ephemeral venus intervention. And we all nominated um experts in the field. Um We had 15 unique independent arterial experts um of all specialties. We had 15 unique independent venus intervention experts of all specialties. Um And they were provided this red Kap survey and some people probably we'll lament to me that it was exhausted and took a lot of time. But it was it was thorough and unique and different and I think important and gave experts opportunity really to grade anonymously where they think the appropriateness is for itis. No one was reimbursed for participating in this. This is all elective. So these are some questions. I'm sorry the text are small but my hope here is just for you to see the type of prompts that people were provided. Really thoughtful clinical scenarios which we deal with in our practice every day. And we have to make a decision whether this is the right time or appropriate time to use intravascular imaging. This is done again for the arterial side and then subsequently for the venus side. So this is a group of the arterial experts that participated in uh this voting an expert consensus. You can see um really an array of different specialties who participated. Um Again, you know on the stage here we have many people who were part of this on the venus side. We also have um just a uniquely diverse um an expert group of panelists who came together to identify areas where we know um I think I just plays an important role in our clinical practice. And again I want to just draw attention to the multi um specialty group here that participated in the consensus document. So what does this look like? It's the first time we're actually going to be presenting these results but these will be disseminated more broadly. So interesting. The most amount of variability in recommendations occurred in the iliac scenting and iliac intervention. And you can see in the pre intervention say side. The M stands for maybe appropriate. Um and we can see an inclusion and plaque morphology for iliac intervention. It was a may be appropriate, but it was pretty unanimous that for lesion severity and ambiguity, vessel sizing and minimizing contrast that I've always had an important role um for our arterial experts in their in their routine practice. When you look at that intra procedure phase. So things like understanding how you're wired across the lesion and also thinking about what your next therapeutic stent uh step is. You can see also there's more consistency in um the rating and again in the parentheses here is the medium value that goes up to nine. Um and then a little bit more variation for the appropriateness for ideas for a vessel sizing for device and moving to procedure optimization. Um Again, we see here that there is uh not really um unique um um consensus that I've had a role for residual diagnosis and plaque de bulking as well as dissection detection, which we know from our own practices is a critically important but less so for stepped optimization which got him maybe and the S. F. A. Pop side, you're gonna see a lot more consistency in terms of appropriateness for for I've issues during arterial intervention. So we can see here in green that filling defects vessel size and minimizing contrast. There was a lot of consistency and the appropriateness for ivy's during the early phase of sF a pop intervention. Similarly, when we're looking at the intra procedural face and I think this is one that I've learned to really use this is the location of crossing track. You know, I will typically drop the knives down before I add the rectum eyes understand how much some internal space I've gotten into, especially for an included vessel. And I think that the panel of experts really saw the same in terms of the role of ideas in this phase for procedure optimization. Again, lot of consistent consensus here that this has an important role as one of your last moves and your sF a pop intervention doing a run of ideas to make sure your stent is well opposed, making sure you have no residual dissections or if you do understanding the severity of them and knowing what you're walking away with. I think this is probably the most surprising part of the survey, pretty much across the board. You're gonna see unanimously that experts feel Ibis has a critical role in tibial intervention. I think brian did a fantastic job highlighting that seal showed areas where we know this plays an important role, but we haven't really spent a lot of time thinking about this space until recently. And so across the board air, you can see green that in the pre intervention phase, the inter procedure phase and the procedure optimization phase all met high consistency for appropriateness for I this during table intervention and and again thinking about Miguel's approach, combining modalities. I think that is where every tibial interventions moving in the future. Um and you can see that from this really unique expert group who voted on this scenario. The Venus side was a little bit less exciting because it was too easy. I think. I think everybody knows that if you're doing venus intervention in 2021, you have to use it. This. We've learned that from step migration. We've learned that um for many of the faults that we've made in the past and there is consistently see and appropriateness for I've issues throughout all phases of venus intervention. Here's the pre intervention phase especially has Mahmoud highlighted vessel sizing and lesion severity, understanding lesion characteristics for the inter procedure stage in terms of vessel sizing for stent implantation and then really procedure optimization and so you can't get much higher than A nine. That means that pretty much everybody voted I let 15 group that these are phases where we need to be using itis. So again, this is one of the first opportunities to really gain consensus on how to incorporate intravascular imaging into our peripheral arterial and venus intervention. We had more than 42 individual experts who are not renominated for this across the country participating this and as well as across the world. And my concluding statements here are as follows, there was a lot of consensus for tibial artery intervention for avis. There was a lot of consensus for venus intervention with avis. We had a little bit more consistency on where and when an iliac and Sf A pop ibis has a role. But overall there are phases where everyone on that expert panel agreed has uh this has an important impact on their outcomes. And I really feel like the next phase of what we've been working on, it's not as much going and trying to dig through the data to show why how um when it's really now is how do we do this in practice? How do we make a difference? How do we get people comfortable using this device as Sean had mentioned, How do we break down that barrier to getting the capital investment, getting the technology in the lab and streamlining it through our procedure. And I think that's really we're gonna be spending a lot of effort moving forward. So I want to thank everybody who participated this and I've saved us some time to discuss this to discuss everything we've been mentioning today. Um and um you know, close out this session with a few questions and I'll let john start. Yeah, back. Right. So, so you know, the interesting thing is with the iliac is not showing as much consensus with sizing. And I think if you give us a few scenarios that altered that. So I think I and many colleagues will get cT scans ahead of time or use ultrasound had time to do vessel sizing. So I'm getting an external image and so I use a lot of I guess I used to use it a ton for Alex because I might have a cross sectional imaging modality pre procedure. I'm not using as much inter procedure because I can I've already measured the outbound vessel size. So I think I wondered if the questions actually had had in there, there was no other pre imaging other than the angiogram and a physical exam, how much that would have changed the scenarios and responses. Yeah, I think that's a great point and you know that there's actually some you know specialty also um differences in in pre procedure imaging and how people use cT imaging. And so uh I bet when we break that down by even just specialty that we'll see where there are some specialties that do more pre imaging planning and not and so probably makes a big difference in terms of sizing, but but that's a really great point. And um you know, we can dig into that without eric. I want to commend you on that effort because and yeah, it was time consuming, but it was worth it. And I'll tell you because it it pushes you sean to your point. Exactly because I'm in the I'm facing the question and the question doesn't say that I have a cT previous. So I'm forced in a way to say of course I need a nervous, you know, and so it pushes you in ways in which you need to be pushed to create that consensus. So I think the effort is phenomenal. The results are great. Uh and I think from this we're gonna build a ton of more information, so good for you and good for you guys. So let me just ask the panelists how many of you guys use Ivascyn every tibial intervention raise your hand. Yeah, because I don't I mean I I use it in well less than 50% and I'm and you know, I'm thinking am I getting it wrong? But you know, we talked about obstacles earlier Eric and I think there are these obstacles in um in uh taking time. Miguel, you just mentioned it's it's time and energy and effort and tech time and you're on a fast track here to get things done and then it's it's a financial one. Sean right? I mean you're the supply chain guy. I mean it costs money for capital outlay and also for each catheter and by the way, the time is also money. And then the third thing is, and I think the most important thing is we really don't know what to do with all the information that we get and you know, um and sometimes, you know, you just look at the flow and say it looks pretty good and I'm done and you know, I think that that's probably representative, we're the we're the outliers here, you know, in terms of how much we use avis. I think the question is how can we get this more um centerpiece like it is in the coronary world where you really you know you're compelled to use. I've it's a lot of times it was like one of the reasons just going kind of at all. Nothing approaches uh I feel like I was missing so much. And again I've kind of I've tried to write down some of the data and really keep track of what we've been doing and the most powerful part of ideas. And the Tibbles is those proximal lesions where you've got a C. T. O. Approximately. It reconstitutes desailly you get through in your sub animal approximately. You know, what do you do with that? And I found that primary patent see in those lesions I've used off label scaffolding. It's significantly better again without having gone through and actually looked at the data hardcore and actually analyzed it. It's made a big difference. Yeah but one of one of the reasons for that is your and the other, the other comment here is, well, with the Tibbles, what tools do you have to use to make it better when you see an eye. This result. That's not so good. And there aren't very many on label devices to use you like I I've been using coronary stents. Drug eluting coronary stents for You know 15 years. But many people don't feel that that's something they want to do or or feel comfortable doing it. So um you know it's what do you do with the information that you have it. And how do you make things better? Do you blue dilate larger? Do you put a stent in materials? But you make an excellent point that you just real quick. I'm sorry to interrupt you. But um, people are reticent to use corn off label stenting in the approximate materials. There's a, there's so much data out there and again, it's not. Are there multiple double blind randomized controlled trials? Absolutely not. But there's some outstanding european data that shows. And again, you guys been using these in heart for a long time and they stay open for a long time. It begs the reason that you're going to see the same. And again, I've seen kind of those same outcome. So that's interesting that So I think the, you know, we stuck at tibial intervention. I mean our outcomes are city like we are patently rates are poor and we also have more tools. I mean we have deep van utilization, we have, you know, you know, complex crossing algorithms now. I mean the age of tibial intervention is very different and you can't do that blind. And I think that that's really where there was resounding evidence in that panels. You can't do apply and we know recoil. We are so bad at treating recoil And that's why we have scaffolds in the in the emerging future here is that this is a major problem. May not be drug, It might be recoil and may not be, you know, sclerosis. So, you know, I think everybody knows when they use this enough how to use that device where it's changed their practice brian. So this multiple times. And I think, you know, I think our outcomes are going to show that over time. Just a quick reminder there. So if if we do have some tools on like we have to act now also. So that's where I found a lot of of utilization. So let's say you do a tibial. Your pedal acceleration time is very low. You don't understand because the angle looks good. You drop the ivies, you're gonna find a couple of big dissections. You put one tack and your P-80 goes up by three times. So I think there's a sweet spot in those combinations of thermodynamics and the use of some devices I think have been made for those. Yeah, because the reason else's raiding the outcomes like you said, are they quote suck. Uh, uh, in, in tibial, it actually probably is the the lowest hanging fruit to actually define the role of Ibis. Honestly, we could do a prospective randomized trial with them without Ibis and um, you know, it would actually probably show a difference. I think with a very limited number of patients. I think also goes without saying too, I need to thank you guys for bringing together the two main companies and get rid of the competition. You know, this is something where we can, we can make a big difference. Uh, and a lot of times you'll see, you know, in disparity, working that kind of thing. One company wants to go in the front and be the shining beacon and the savior and the sea to the big companies really come together to, to make a difference. It's a big deal and I really appreciate that. I don't know if we have folks from phillips and boston scientific here. That's a big deal. Uh, you know, putting outcomes ahead of profits per se is, uh, it's a big step and I'm proud to be a part of it and probably you guys work well, I think we're gonna close this session with that brian. Thank you for that comment. And I wanted to thank all the panelists here and speakers for taking the time to put this together and everybody waking up this morning in Vegas at seven a.m. For our uh, first supposing there's more to come here. You'll be seeing a lot of publications. We're gonna be doing some more of these type of talks and I encourage everyone to reach out to the local reps if they're not familiar with. I've, it's too, you know, explore this technology bringing into the center and learn a little bit more about it. So thank you. Again, appreciate it
