Thank you very much for having us. We are glad to be this part of Sky webinar. And without further ado, Kathleen Kearney has a very interesting instant restenosis case in bifurcation. Take it from here. Hey, sounds good. Thanks so much for having me. It's a great group of experts. I'm actually really looking forward to some input. This is a case from a few years ago that I think I would do differently now, but I think there's lots of ways to attack this. So this is a gentleman who presented after bifurcation PCI and had recurrent ISR. His initial presentation was interesting in that he was out playing golf. He really hadn't had a lot of anginal symptoms. And basically he recalled bending down, picking up a ball, stood up and then effectively passed out about 30 seconds later. No prodrome, just had some chest pain at that time and was resuscitated quickly, but medics came to the scene, basically high suspicion for aborted sudden cardiac event. Lots of cell holes of ET when he first got picked up, but nothing sustained at that point. So his neuro status was intact, he was hemodynamically stable, and he was found to have ISR and was transferred to us for further intervention. So for this gentleman, you can see here, he's got basically a focal area that looks quite severe leading into this bifurcation of an OM, his RCA looks fine, he has a prior LED stent that's patent, and so this was really thought felt to be the culprit. We didn't have a lot of information about how the bifurcation had evolved over time. It sounds like he had initial stenting into an OM and then had repeat stenting for ISR the following year, and that was in 2014, this was a couple of years ago. So several years in between that had gone well. With initial ballooning, you can see we do have some trouble here in the lower limb though, and there's a significant waste effectively right at the bifurcation, upper limb was expanding better at that point. So a few other details here, just mentioning his prior PCIs, we had found at least two layers of stent at some point is what was described in the notes. His initial troponin came back at about 0.5 and a repeat was still less than one, it was in the 0.8 range. So not really a rip-roaring sign that he had thrombosed, and of course had flow here at the onset. At this time, we were using the 30 megahertz IBIS, so that's that image here of the upper branch, which we were able to deliver into, I'll just come back so you guys can see that. So distally, we've got the stented portion there, and a pullback through the upper branch through the bifurcation. Overall, not as much calcium as I was expecting necessarily on the outset. Really small stent, but certainly has some in that bifurcation area. Having moved to an HD system now, I sort of recognize some of the issues we had trying to get the image with the pullback, so you're not popping in and out, so I think that's one thought there. But maybe I'll pause, we have such an expert panel, I'm interested to see what people would think at this phase. We did additional ballooning to the lower branch, but were unable to IBIS that at that point. Things I was thinking, just to throw out, we were concerned that there was stent deformation in the lower branch, that the stent from the upper branch might have some impact on that. We were also struggling with several balloons rupturing when we were deploying those in the lower branch segment there. So based on this, I'm curious if there's any thoughts from the panel. Let me start with you, Ron. Yeah, so one word of clarification, the IBIS imaging was done after the intervening with the balloon or before you intervened with balloon? Yeah, afterwards. We weren't able to deliver the, at this point, a volcano IBIS, but we weren't able to deliver that until we had taken a 3L balloon down both limbs. And at that point, we're only able to deliver to the upper limb, which is- The lower. Sorry, balloon delivered to both. We had a waist in the lower branch, IBIS was just to the upper branch. Yeah, so we see here both the under-expansion and we see also tissue. I mean, again, it's hard to appreciate the exact degree of tissue because it was already ballooned before. But I'm going to ask the question first to Fernando Alfonso, how much it's important for you to know what type of stenting technique at the bifurcation was done before, whether it was a cool-out, whether it was a provisional, whether it was a decay crush or mini crush. I mean, does that really matter when you deal with a situation like that? Yeah, thank you for the opportunity to be here in the sky. Well, we all keep saying in every document the importance of understanding the underlying mechanical problem for stem cell stenosis. But in a bifurcation where you don't know how was exactly the prior strategy, this is key. I mean, we need to understand where the stem are, and this can be rather difficult. We don't have the clinical history, and also we don't have further information. And in this case, it was very interesting to see even that using high pressure, the balloon wasn't able to rectify the artery. So that I think it's very important to understand where the stems are because the mechanical problems that can complicate any stem cell stenosis are particularly of concern when there is a bifurcation. You can have a protruding stem. You can have the wire going different places. So it's critical to have a proper understanding of the underlying anatomic substrate. Thank you. So question to Dr. Sharma. First of all, we have to get opening of the vessel, getting a good result before we apply any other therapy. And we can discuss. I mean, we have POBA, cutting balloon, DES, the DCB, brachytherapy. But how do you approach it to get the optimal outcome before you apply the adjunctive therapy to prevent recurrence of the event? Yeah. No, Ron. Actually, that is the crux of this case. And thanks to Sky and Rob giving me the opportunity. But I would say that clearly what has been done, in this case, I would say cutting balloon will not help. Now you need to have some other ablative technology. Some people will use a laser because you need to. It looks like, again, very tough to say. But I think it still looks like a mini crash at that level. And particularly if your stem was able to go, sorry, balloon was able to go easily on the superior branch, that will speak more so that they did probably a kissing balloon in the end. But the lower one, inferior branch definitely got deformed. Now whether it's some unexpansion, various factors, we can't even figure that out. Geographically, maybe. You know, sometimes if I was doesn't go just to the stem boost, that also will give some idea. But here we need to do something. And I think the two techniques which will help here is the rotational arthritis with a very small bar, with a 1.25 or 1.5, particularly 1.25, knowing that it will be a very tough, a very small lumen or laser. So one of those two things have to be done in order to go to the next level. And the next level will be that how else can you improve the lumen of the lower branch? Yes. So I'll pose another question to you, Dr. Sharma. You mentioned rotoblater. A lot of people would be concerned that the bear would be trapped. And this is already seems to be mechanical issue. We're not sure. Maybe it was a coolant. You say it's a big decayed grass. But what are they concerned? Even a smaller bear could be trapped. You're basically in a territory of a lot of metal there. No, that is. I would say this is the kind of case I'm doing. I'm actually predicting the bear is going to trap. There's no question. Very likely. And many times in these kind of cases we did. And I tell my associate or fellow, I say, you know what, we are doing very carefully. We'll go very slow, lower speed, would not push it. But bear is going to trap. But most of the time, even the bear traps, you can really pull it out. Now, can you do orbital accelerator, which has an oblation on both the sides? I can tell you my personal experience of the unexplained distance or will attract me. I tried probably 15 may work in one. So orbital does not work. Clearly, why orbital doesn't make it heat? Why the rotablation work? Not because of oblation. It just heats up the metal and orbital doesn't heat up. So orbital does not work in this situation. I would say the way it looks and knowing that if you have laser available, even my first choice will be laser. Laser may not go. But I know 1.25 bar can go with the chance that it can get stuck. That's no question on that one. With this angulation, as Ron, you pointed out, it's very likely even a small bar, 1.5, some people believe 1.25 get more stuck than 1.5. So whichever one, the very likely the bar is going to stuck in this case. But most of the time, we can pull that bar out by pulling the wire, which is very strong. But rare cases may give you trouble. Then you have to do a Godzilla and other things. Something needs to be done to open the inferior branch, which is also good size, equal size branch. So, Dr. Alfonso, in Europe, you don't use much rotablater at all. I doubt if you use laser. In a situation like that, if you want to keep it simple, what would be your approach? Now you have the imaging, again, we still don't know what was the original technique, but you see a mechanical issue, you have tissue issue, and you have under-expansion. What's going to be your approach, first of all, to optimize the outcome? So just for the sake of discussion, we try to avoid rotablation and also laser, in most cases, with an external stenosis, unless there is a clear case of really undeliverable stent. I mean, if we cannot see a waste, which is impossible to donate, then in those cases that are very rare, we go for these debulking devices or ablating devices. Nowadays, we try to go in this case, I mean, the branches are not very big, so that we will go perhaps with a small balloon, perhaps a 2-0 balloon, and try to, if this is not working, I will go with a high-pressure balloon. And now, most people in Europe is jumping very quickly to little drips, because I think it's safer, it's very easier to use, and in many cases, you got a very good expansion on the stent. Until now, we have very little data on the use of nitrotricin in patients with external stenosis, but now we got plenty of observational study, and I think when there is clear under-expansion that you cannot cope, you cannot address with a high-pressure balloon, we will go for a little drips, rather than use a laser, or rather to use rotisserie arthritis, especially in these vessels, and especially in the bifurcation, that would be my bias. But I found out that little drips will not make a first turn. They put a balloon very difficultly, they went 3-0 balloon, 20-plus atmosphere, and nothing happened. We know that IVL will not make the turn. The only question is open and see, which just came to America, I know Kathleen said this case was done a few years ago, you might decide, might go, but definitely, I mean, this kind of angulated where it's so difficult, I didn't go, balloon went, but could not crack, they went 20-22 atmosphere, other could be maybe 2.75 or 2.5 or 3-0, but you cross the region, but go very 8-millimeter, focus balloon and go 24-28 atmosphere, or existing non-compliant balloon, maybe a shot might be, but key is that in this case, little drips, IVL catheter will not make it. Yeah, so I actually think that open and see is a good option if you can cross, because you can take it to 35 atmosphere. My view is probably, first of all, let's try to do a good balloon job, because I'm not sure that the balloon was optimized, this was done mainly to restore flow, to do the first shot, to facilitate an imaging, but I don't think you're done with balloon work here. So, Kathleen, you want to tell us what, what did you do at this stage? You heard all the options here, I don't think we mentioned. Can I interrupt for a second? So audience, please post your questions in the chat box, because we have a chat moderator who will look at your questions and post it to us. Thank you. Yeah, I think the input, you hit on a lot of the things we were thinking at the time, and certainly I think with the armatorium of OPN balloons, which we just received, as well as lithotripsy actually come into play a little bit later in this case for him as well. Based on what we had had and some difficulty with the expansion, I think those are good points about shorter balloon. We tried an eight millimeter balloon, which tended to watermelon seed, it was kind of hard to bridge there, but it seemed like we made a little headway, went back with the longer balloon, you know, you can very clearly see the waste there. Sometimes I found with the long balloons that they will almost straighten that area and crack the calcium. So I'll try both. If the short balloon doesn't work, obviously it's, it's, you'll take whatever you can get in those cases. But here we went ahead and did work, did a little more ballooning to try to facilitate passing razor, took the 0.9 laser catheter down, did potentia on contrast and did that in both limbs to try to see if we could modify that. I think for all the points that were mentioned, I was a little concerned about getting a bird trapped in him, given the acuity of his presentation. You know, on one hand, typically an OM, we can get away with a lot. Patients will tolerate that. We can get it out with a guide extension and, you know, et cetera. So certainly, like you said, prepared for a bird entrapment. Here we were a little bit more nervous about doing that. Obviously we could have had no reflow with laser, but just feeling that using that leading edge of the atherectomy, that maybe that would facilitate better expansion, not, not too sure what we were dealing with at that point. And based off the other imaging, I was suspicious it was more of a stunt problem or fibrosis as opposed to that he's got very bulky calcium burden, but of course we're still not really too sure based on that. So I think you can see in both views here that it's really just past the bifurcation there that, that is still acting up despite that. So we got slightly better results with a couple of balloons rupturing and then effectively got a 3-0 scoring balloon down and got, you know, marginally better results I'd say there. And then brachytherapy came as, I don't know what Ron's team is like, but ours is based and Dr. Sherma's basically, you know, they're ready to get out by four o'clock. So when they came by, we went ahead and treated the upper branch, realizing we might need to bring him back and we really weren't able to ever facilitate much delivery for the lower limb. He was doing, it appeared better. And I think, you know, part of the question here is, you know, how, if a surgeon's grafting these, you probably, you might even only graft one of those. You know, is it enough to have a really good result in one branch where a post-divus looks good and accept a focal issue in the lower? Do we need both? Or are we going to maybe compromise one by trying to perfect the other? So quite frankly, I think our setup here as we're radial, we figured we were a little bit limited. So we elected to stop for today and then come back and plan to do some more work. He actually did have recurrent symptoms at that time and ended up getting admitted and transferred over for that. And somewhat surprising to me here, he does have some ISR, actually, in the upper branch that I thought we'd had a better result. You can see this is around the time we switched IVA system. So this is our imaging here. But again, we're only able to deliver that to the upper branch. I still feel pretty hampered by some assumptions that we're making and some difficulty crossing the lower. At that point, this looked fairly focal, but it's certainly concerning that that's part of the picture. And we were a little bit on the fence with that. Basically, serial balloon inflations, ultimately, we're able to deliver. At that time, we just had peripheral shockwave. So we were able to deliver a 3040 to the upper limb. But again, just delivery issues being the main crux for the lower. Had repeated blazer atherectomy. We're able to actually had more difficulty getting NCs down before. We had a 3.0 pass with some difficulty, but fairly easily. Now we're basically barely getting this 2.0 down. And long story short, he had a new area of stenosis in a calcific area of his mid-RCA. So had orbital atherectomy and a 4.026 on that side. So basically, kind of similar because he came in on another ad hoc day. I think the team did a decent job patching him up, but really don't feel satisfied that we've got kind of everything sorted for him and had discussed coming back. He actually felt quite a bit better after this. So we figured, well, maybe that focal area will be OK. He did well for about a year and a half and then had recurrent symptoms and comes back with this image. I will say, especially on imaging, we can see he's got some soft plaque in an unstented segment at the proximal circumflex there. So we went ahead and started with physiology of that. The RFR into that upper branch was 0.98, so that didn't appear to be the problem. So I don't know. Any thoughts here about is this worth going after? Would you start by drilling the lower branch at this point? We kind of know delivery issues and optimization there has been poor in the prior cases. Yeah, you brought a lot of points for the case. I would just mention that the one and a half years, the area that was radiated seems to be looks fine. And the other comment that I would make on radiation here that it's very rare to see recurrence of restenosis three months after radiation. To me, if it happens, that means you didn't radiate that segment. I don't remember any case that restenosed after three months with brachytherapy. Dr. Sharma, any thought to you? Yeah, I agree round on that. Yeah, and I think there was a challenge to deliver any of the systems there. So maybe for the audience, you mentioned a lot about the laser. How do we do laser in instant restenosis? What is your prescription? Contrast, no contrast? What is the fluence? Can you tell us a little bit how you do that? Because we want to learn. Yeah, I think it's certainly variable somewhat. In training, we did a lot more of larger lasers potentiated with contrast. But I think our rates of no reflow were quite a bit higher too. So overall, I moved away from that as much. In these cases, when we're really facilitating an under-expanded area or concerned about really calcium modification in particular, usually 0.9 on 80-80 for your fluence in rate and with small puffs of contrast. And effectively, we'll take just one or two cc's of contrast in the syringe. So it's mixed with saline and kind of go from there. From the bench data that you get, you don't get a lot of augmentation really once you're over 30%, 40% contrast mix. So we'll start kind of low there and just try to get some of those cavitary bubbles for that. On imaging, on the other hand, if it's all soft neo-intimal hyperplasia and we're trying to use more of the photo ablative effects, then I usually will upsize the laser and just go really slow, typically on saline flush and see. And I think it's one of those things, it feels like voodoo. I'd sort of convinced myself it wasn't doing anything. But when we started re-imaging these cases while we were waiting for the radiation people, sometimes, especially with better imaging like for near field things like HD or OCT, we do see some difference there. So it feels like if the minimal area is still poor, usually we've done some ballooning to facilitate getting a good image, then we'll go ahead with that. But I'm curious to hear what others do. Yeah, you mentioned a lot of things again. I just wanted, first of all, ask a very quick question, Dr. Sharma, about the brachytherapy. And then I'm going to move to Dr. Alfonso to tell us he doesn't have brachytherapy in Europe anymore. But first of all, there was a question, should you radiate, if you can, both limbs, or you would radiate only one limb, Dr. Sharma? Yeah, so I mean, question comes in. And again, knowing that the area which you need to radiate, and if you overlap with this kind of bifurcation, maybe you're troublesome. And we have done both branches. If the catheter, let's say the lower branch would have opened, so first you do a radiation which was done exactly from top branch. Then the second one, you'll try to do just after the proximal end at the bifurcation and go further down. So not to put additional radiation in the proximal part of the main circumflex. We have done bifurcation, radiation, brachytherapy, maybe like 12 cases. Not that common, but yes. Idea is that, now I still think that most of the data, and of course, Ron knows more of the pathobiology about this, and this is the part of the paper when we published in the circulation intervention, is the dose of the radiation which we talk about was done in maybe one stent and the native vessel. Now we have two layers of stent. Is that same dose? We are still using the same sometimes three layer. So is it enough to go to the vessel wall or it is just too little? So that was editorial also of the, maybe with the multiple layers of stent, the radiation dose which we do, and I know that our radiation guys don't change it. Ron, they don't do it also, repeat. The 10 year, they said less than 10 year will not do the repeated brachytherapy. As a patient, it's so good for five years, let's do it. Before it used to be one year, one and a half year, five years come back, let's do it now. Every time it used to come 12 months and 18 months ago, we will do it, only we can do it. We are doing two cases now, which we did in 2012, 2013. So far, we've got a second radiation of the same segment, but 10 years later only. Yeah, no, I agree. I would make a one comment on this and then we'll move to Dr. Alfonso that the radiation oncologists and the physicists are very, very conservative, but our experience in this case, we probably would radiate both limbs. I will try to minimize the overlap and also repeat brachytherapy. My cutoff is one year. So if you passed one year, I'm okay with doing another dose of radiation because nothing else works. But Dr. Alfonso, you don't have radiation. There was a question from the audience, give us more options. And I didn't hear dry coated balloons. So I'm asking you, where is the dry coated balloon option here? Well, just in Europe, brachytherapy is being abandoned, which we don't miss it, we don't miss it. But in very challenging case, as this one we are discussing, I mean, having all the possibilities, I think is a great advantage. Now, in Europe, we call it dry coated balloons, and this is a typical scenario where these devices are used. I mean, if you review all the documents, I mean, your classification wrong, the Sky document just published, our state of the art, I just look for that before this webinar. And if you look for bifurcation, there is no data. There is no data saying or explaining how we should use that, because bifurcations have been classically schooled for all randomized clinical trials. Having said that, in Europe, we try to select dry coated balloons, and there are some with large experience and large evidence back in the use, small series, but to us, the evidence is good enough to have a 1A indication. For us, this is very clear. And even though data in patients with large branches causing bifurcation are not there, this is a beautiful scenario, because when do you want to avoid a second meta-layer? When there is a major branch, you don't want to jail with another layer. So in this case, I think in most centers in Europe, we will be using dry coated balloons in the two arms, but having said that, I mean, the choices are what they are, and even this treatment sometimes fail. So this is what we will do. Prepare the lesion as best as we can. Another interesting issue in this case is that there was this waste in the balloon, yet the ibus, I mean, showed some calcium, but wasn't massive calcification. I was expecting to see more calcium, and there was calcium there, but no massive calcification. So important to prepare the lesion, very challenging in this case, and then trying to use, I will use the more classical dry coated balloon to make sure that all the evidence is back in me. All right. Thank you, Dr. Alfonso. I think the question was that, Kathleen, we didn't answer what to do with that lesion beyond it. This is not related to instantaneous bifurcation. So for the sake of time, I'm going to pass it to Dr. Raab, but maybe you want to show us one more thing, Kathleen, before we do that? Yeah, we'd love to do that. John, we'll ask some questions, but we can kind of, yeah. Yeah, I think what might be helpful is when we finally actually image, you know, we have a lower profile ibis system at this point, we actually finally image that lower branch. So I think that is helpful. So basically, same story, basically, serial ballooning really doesn't look better until we were able to deliver, get better expansion after repeat laser on contrast. And I think this time we just had better guide support. We had a neat French guide, we used a guide extension, we started to bail on the other wire occasionally, but we were kind of thinking like, well, we're either doing that or we need a Rota down here. We've been fussing around multiple times and this is really all that's left. But so here's the image on the left of the branch. We've seen the upper branch, not quite as much calcium burden as you might expect. This is now the lower branch here. So we see a small stent. This is, I think we, before we use the slide very often, so I apologize, we're going back in and out a little bit here on the more focal segment that we'll see momentarily. So we're coming back to the main branch and then going back in here just before the bifurcation here in an area that is quite small. John, you have a question from the chat? Oh, we do. Thanks, Dr. Waxman. And just to everyone on the panel and attendees, there is an open chat where you could post your questions that'll get asked. So one of the attendees asks, in patients with one or two layers of stent, do you feel compelled to stent laser lithotripsy or rotational arthrectomy months to years after an intervention? So this is a third stent, Dr. Sharma. Would you put a third stent there, Dr. Waxman? So the third stent in our lab is like a class three indication. So don't do it. And that's where the brachytherapy comes in. And many times we just open it with a balloon and bring back knowing that brachytherapy done in a duration time. And now the big problem is, which is now being the, you know, Mad Alliance, the solution, a DCB trial, that if you have brachytherapy and comes back, you cannot use a drug-coated balloon. They don't do it in Magic Touch. They don't do it in Solution DS. So I don't, maybe others, yes, but it looks like in brachytherapy, patients have been excluded and they're so disappointed. I had at least 12 patients waiting for drug-coated balloon to come and comes in and boom. First exclusion is if you have a brachytherapy. Kathleen, any other comments on the case before we move to the next one? Or show the last one. No, you are able to open now, you put eye of us. Yeah, so I think honestly, you know, I was really fixated that there was some bifurcation issue with metal and worried about that. I think it's really just a focal area of calcium and the bifurcation. Circular calcium. There's a full 360 degree calcium at that area. Yeah, so I think nowadays if we had shockwave or OPN, you know, that would be a good strategy to try to avoid Rota if you're worried about burn entrapment. But I think honestly, if we had gone to that earlier, we probably would have saved him a procedure here in the interim. Ultimately, he's done well. It's now been, we got better expansion. Repeat imaging looked better. And I think ultimately this was the final result, but fortunately he's done better. He's coming up on two years and he's felt quite well. So hopefully we've knocked that back for a little bit, but I appreciate everyone's input. But you did the brachytherapy to the lower branch also now. Yes, we did. So, and I will say our radiation team has sort of reevaluated our dosing strategy and all of that. Their feeling is that with calcium stent and plaque, we're probably not overdosing that area of overlap in the proxal segment by much. So even if we don't deliver it distal enough, they're willing to basically do that. So it is technically kind of his third treatment in that upper area. I think it's a good point that first recurrence was so early. It just is completely out of line with what we normally see with typical ISR. So altogether, he's doing better now. On the flip side, we have a lot of repeat brachy patients. We have not seen vessel injury or issues related to that so far. So I think we've tended to kind of convince them to be a little bit more aggressive there. And my experience is that the arteries are much more, the stented arteries are much more forgiven than the biology that the physicists and the radiation oncologists are afraid of. So we published that hundreds of cases, repeat brachytherapy, bifurcation. We have not seen any issues with that, as long as you don't put a new stent. But John, any other questions from the chat? There is another one, Dr. Waxman. So there's been talk of the OPN balloon, and I don't believe a lot of people are familiar with it, just the fact it's a twin-layer balloon that allows you to go to super high pressure of 3535. And the question is also that anecdotally, has the panel had any experience with it? And from a complication standpoint, has anyone had noticed a higher incidence of perforations going to that high pressure? So overall, again, our experience is very limited because it was just released. The balloon actually does a very interesting job. So we developed an algorithm to start with a regular high-pressure balloon, because the profile of this balloon is not that great. I mean, it's not like a regular high-pressure balloon. So you have to do first a regular high-pressure balloon to facilitate this balloon. After that, we're using the OpenNC, we go up to 35 atmosphere. I know some people in Europe go off-label even more than that. The likelihood that this will rupture is not zero, but it's slim, it's not like a very large one. And apparently, interestingly, it doesn't cause a lot of dissection, especially if you are within the stand because of the twin balloon that you go very focal high pressure. Now, if that doesn't work, then the next strategy after that is LittleTripsy. So we have one step before we do the LittleTripsy, and you're not losing it because after LittleTripsy, you may want to do another high-pressure balloon, you can still use the OpenNC. So that is our strategy, but our experience is very limited because it was just released into the market.

instant restenosis

bifurcation

percutaneous coronary intervention

recurrent symptoms

interventions

treatment approaches

individualized treatment plans