As always, Chris has some great examples, so take it away, Chris. Thanks very much, Peter. So thanks for everybody who are hanging in there at the bar time here on an evening here, and thanks to SCAI for the invitation and our industry partners and friends for sponsoring us. It's an honor to be here and talk about, question aside, does the stent design make a difference in the outcomes of our patients with some cases? Here are my disclosures. There have been some PI for several of the stents, which will be discussed here. It won't affect what I say. Well, we got a question before us that I was asked, does the stent design make a difference in the outcome? Well, I'll tell you, in life, there are some questions that we know the answer is yes, even if we don't have randomized or photographic evidence like our bear friend with what he does or doesn't do, and the truth is the same here. Come on, guys, of course it makes a difference if there's a design outcome. Now, that said, there's limited comparative data for a different stent outcome. Why? We haven't done a randomized trial. We were trying so hard to do randomized trials against endodectomy or medical therapy or IDE or registry trials to get approval, finally obtained, so we haven't done head-to-head stent comparisons. We do have some retrospective data, which I'll share very briefly, a little bit of analysis, and we can make some comparisons between the outcomes of stents with the compounders that we all know about. So the bottom line, folks, is the importance lies in individualizing our choice for carotid stent design. To each patient, their anatomy, and their history. It's an art, not a recipe. Well, there are a lot of stent design, not a lot, but a few, open versus closed cell, some more recent stents with a micro-net or the more hybrid stents, which we'll talk about, and there are tapered versus straight stents. Some are investigational use only. So looking very briefly, and again, we'll get to cases in a moment to highlight these, but open cell stents have a larger free cell unit, and so that gives them some advantages. They're more conformable. They work well in tortuous anatomies. It may be easier to deliver up distal common, or tortuous common carotid arteries. They do have some disadvantages. There's less scaffolding, so the potential for more plaque protrusion. They have less radial strength. Fish scaling is as seen in the bottom, and there are possible higher event rates with these types of stents compared to others, as we'll see. Closed cell stents, they have smaller free cell units, so they have some advantages. They have higher radial strength. They're better if you're gonna stent in calcium. They have more scaffolding and plaque protrusion, and they, at least the exact stent, has a very precise delivery system. The disadvantage that they are a more rigid stent, they're not good for tortuous vessels, they're gonna make a straight line. So when you put a stent in, you make a straight line, and that's okay if you wanna make a straight line. This is an old slide, but just shows you the magnitude of difference between the free cell area of the various open versus closed cell stents, which will be important as we look at. So does that make any difference? Well, there's not a lot of data here, some. Here's Mark Bosier's over in Europe looking retrospectively at a lot of the data. We know from both Bill, some of your work in CAPTURE2, and others that a lot of the strokes happen after they leave the OR or the cath lab, you know, more than half. And if you looked at Bosier's work, looking retrospectively at a lot of European stents, it was found that, overall, there tended to be more events in the open cell versus the closed cell stents, and that was most dramatic in the middle in the symptomatic patients, where it was 7% events versus 2.2 for closed, and that was significant. And it kind of makes sense. If they're symptomatic, you've got a bigger area in between, as we'll look at. The bigger the free cell area, the higher the odds ratio of a stroke, up to six times if you got up into the big free cell sizes in that trial. Another retrospective European analysis was from space. Again, in the symptomatic patients, the open cell stents tended to have a lot more events than the closed cell stents. Why might that be? Well, mechanism for stents, whether in all, is because of probably plaque protrusion as seen in this OCT, where in the more free cell area, the more plaque that can protrude there and potentially later go up to the brain. And this is one of my own patients here. This is a patient I did at what I thought was a gorgeous carotid stent, and three weeks later, he came back with his third TIA event. The duplex was normal. You see, it looks pretty good, the angiogram, but that one little filling defect on the left, when you put IVUS with protection, you can see the plaque protrusion there on the right that we needed to fix in order to prevent future events. Now, I wanna go to some case examples that highlight how you might choose a stent in your lab. Starting with this one. Symptomatic high-risk patient. As you can see, hopefully you'll notice a very significant entry angle and exit angle out of that severe lesion, all right? So if you look and say stenting is best, we gotta look at all options, but if stenting is best, what kind of protection and what kind of stent? Looking at those angles, all right? I would submit that proximal protection is clearly best, and that's what we used here at MoMA device. That allows you to get that sharp curve with a good wire, a floppy wire, and not put a distal filter on there. Here's your predilatation, and this is a situation where I think a conformable, precise open cell, or more open cell stent is better. You can go around those curves, and you can see that at both ends of that tortuosity, it took the turn very, very well, and got a nice result, and the patient did very well. Similar case, you can see again the tortuosity. There's some plaque extending to that curve. You could try to nail a closed cell stent, but again, I think this is another case where putting a balloon in a conformable stent, you can see we went well above the curve. The stent took the curve, and nice final result, done safely, all right? So open cell worked very well if you need the, if you have significant tortuosity you could final cerebral flow. All right, Mammutus one we were talking about on the way here this was somebody who had a left carotid that was occluded, severely symptomatic, high risk for everything, including endoderectomy, and it came in highly symptomatic on the right. Here's that lesion on the right, and it's just nasty, tight, bad, and you can see this is an only arteries to the front of the brain. He didn't have PCOMs, by the way, I didn't show that, but slow perfusion to the brain. So strategies, here it's a little different. I think first you want to maximize protection if you're not gonna do endoderectomy. This guy couldn't have endoderectomy for a variety of reasons I won't discuss, but you're gonna maximize things. So proximal protection and add distal protection balloon. And does stent choice matter? I think so. I think you want maximum plaque coverage for something like this, and this was a closed cell stent, post dilatation and aspiration, and we got a nice final result, and you can see the perfusion to the brain. Now the entire brain is now perfused from that one symptomatic lesion, and so a closed cell stent was far better in this situation. Here's a different case. It's, again, high risk for endoderectomy, collaborative approach. You can see horrific ulceration there and low branches in the ECA, deep ulceration symptoms, you can see all that. So again, here's an idea what stent you're gonna pick. We'll watch. I think you need maximized protection. This is both proximal and distal. Predilatation, and here we took a precise to take both curves, which was done there and post dilated then. That took the curves very nice, but we added, Gary, this is something you've done for years, added a second stent. This is a short closed cell stent inside the open cell stent to maximize scaffolding in that area where there is the ulceration and the best of both worlds use both stents, okay, and got a nice result. Finally, there have been two new stent design study, both designed specifically to add neuroprotection during the most important parts of the procedure and sometimes after the procedure. Both have completed their pivotal trials, investigational only now, and based on the results to date, which we're gonna show briefly, they may further reduce stroke events and give us stent options. The first is a Contigo NeuroGuard. I'll start with a stent. This is a closed cell stent with a unique design. Closed cell, as I said earlier, usually does not imply flexible. This is both flexible and closed cell. I can tell you we put 70 plus in the trial. It's real, and it has the three in one system. It's got a second incorporated filter with 40 micron pores in the second filter and that unique stent with a post dilatation balloon incorporated, so you have less in and out of the lesion. This just shows you the flexibility of that closed cell stent in the middle compared to a closed cell, which would kink, and open cell, which would have fish scaling. This actually works very well with tortuosity. This is a PERFORMANCE II pivotal trial. Bill was a global PI for 300 plus patients, and if you look at the stroke rate, 1.31% at 30 days, none of them were major strokes and low event rates. If you went out to one year, they've completed the one year data, submitting it for PMA. Additional, only big .37 minor strokes, so the total stroke rate at one year, very low, all minor, okay? Here's one we put in the trial, highly symptomatic, and you can see the severe lesion there, so here's wiring it very carefully, putting our NAV6 distal protection, balloon, predilatation, and then the second filter is placed in, and I wanna show you how it works. It's beautiful, there's that second filter that you can see there, so you've now got a second filter, the stent's right there, the balloon's in place, and then you deploy the second. You put the filter up first, the second filter, and then you deploy the stent, that balloon's already in place, you simply open it up, and then you close your second filter, and watch it, and come out slowly, and we had some friends here that joined me in Kingsport for those kind of cases, and you were probably there for this one, and the case did, it went very well. Finally, the SeaGuard from InspireMD, another stent designed for neuroprotective benefits. It's a open-cell design, but it's got a micro-net on the outside to maximize scaffolding, gives us the best of both worlds, potentially. You saw this slide earlier with plaque protrusions seen on the OCT. The idea here is to add a micro-net on the outside of the stent with much smaller pore sizes to mitigate or get rid of that plaque protrusion seen on that second OCT image. This shows you the magnitude of the difference in the pore sizes, and we looked earlier how important that is, and how much smaller the pore size is compared to others, most specifically even the open-cell design. We reported that this is VIVA, a late-breaking trial, the IDE trial, 316 patients, in the 30-day stroke, death in MI, 0.95%. In high-risk patients, 25% symptomatic, just like the PERFORMANCE-2 trial. Here's a trial, a patient we put in this trial, highly symptomatic, you can see why, severe stenosis, diminished flow, I mean, it takes forever to get to the brain. Here's proximal protection, wiring it protected, putting, ballooning and putting a 10x40 micro-mesh stent in, excuse me, post-dialyzing, and nice result there, and he was a lot smarter after the procedure with the flow going better to the brain. So, putting all that in context, this is one of your slides, Bill, and thanks for letting me plagiarize it. This is just putting in context the PERFORMANCE-2 data compared to even the endoderectomy where they were asymptomatic only and standard risk. These were high-risk patients in PERFORMANCE-2, symptomatic and asymptomatic, as good as we've seen in the endoderectomy randomized control, carefully followed studies, same with C-Guardians, 0.95%. And this is a one-year PERFORMANCE-2 data, again, showing as good as we've ever seen in the endoderectomy arms despite high-risk patients. So, in conclusions, does carotid stent design matter? I would say, like the office, yep, I think it does. And for every patient, we just absolutely need to look at an individualized risk-benefit ratio and then match the stent. If we're going to stent, if that's the best therapy, pick the best stent for the patient and their anatomy and their stent designs, I think, will even further improve the game in terms of low-risk carotid stenting. And for all you Steeler fans coming up for a big year here, this is gonna be good, thanks for your attention. Thank you.

stent design

carotid stents

patient outcomes

NeuroGuard

SeaGuard