So, my name is Amir Khaki, I'm an interventional cardiologist in Detroit, and I was asked to present an ECP case with bifurcation, and so this is going to be not a typical bifurcation case because you guys could have seen a lot of them, and there's a lot of access to them. This is a little bit unique, focusing a little bit on ECP, and then asking some of our panelists their thoughts about our approach in this case, because I don't think there's a lot of literature support, maybe what we did, and maybe you guys could help us and give us some constructive feedback. So with that, these are my disclosures, did a lot of work for Abumad and was the national PI of ECP. For those of you who are not familiar with the ECP, we did present the pivotal trial data in October at TCT, but this is the very first case actually done, it was a first in man on October 16th, 2020, so just over four, almost four and a half years ago, and that's actually the case that I'm going to present, the very first case, 2020, and I have four-year follow-up for you guys. So next slide, it's not going to the next slide, I don't know why, here it is, okay. So here's how the ECP looks in this animation, if you guys haven't seen it. This is a patient that we borrowed from Dr. Truesdale in the D.C. area, not a Detroiter, and we put access with a 9 French sheath, this is a purpose-made sheath for the ECP, goes above the renal arteries, this blue piece that you see here is actually the crimping tool, which crimps the 21 French impeller down to 9 French, and that's how we crimp it on. We're using the crimping tool, we introduced it into the sheath, it has a pigtail on, interesting enough, no wire, and it hatches, you saw how it hatched in the aorta, it's 21 French at its greatest diameter, and you see without a wire, it crosses the aortic valve. The impeller is on the ventricular side of the pump, unlike the traditional CP, where the impeller is on the aortic side, so this actually pushes blood. Because the impeller is on the ventricular side, obviously it's a very powerful impeller, we're concerned about structures in the left ventricle, like mitral valves, papillary muscles, etc., being sucked into it, and that's why we have that cannula there, so this cannula does not allow any damage to any of the structures that are in the left ventricle. Again, the impeller is on the ventricular side, pumping blood to the aorta, this is a very soft atraumatic cannula, prohibits anything from coming into the impeller, there's small micro-perforations in this cannula, on the aortic side it allows blood to come out, here's where the aortic valve would be, so this is 9 French at its insertion, and a driveline, 21 French at its thickest diameter, with the impeller when it's fully expanded. It's designed to provide greater than three and a half liters of flow, and it did that consistently in the EFS and the pivotal trial, and Avumed has applied for FDA approval with an application or indication of protected or high-risk PCI, and the duration will be a six-hour duration, so not a shock pump. This is the very first case that we did, this is what we describe as hatching, the sheet is up, and then if you'll notice here how the impeller popped open as soon as it came out of the sheet, and there you can see it. The other thing that's interesting is you'll see the wireless delivery, which we talked about, there's no wire in this technology, so you go up without a wire, and go across a transverse aorta, make contact with the valve, and it'll go right into the ventricle. Because wireless crossing can be unpredictable, in the pivotal trial we made a protocol where you would actually put a pigtail into the ventricle from your access, your PCI site, pin the valve open, and then follow the pigtail. Given that this is our first in man, and pinning the valve open with the pigtail was a learning from the EFS trial, we did not do this because we didn't know better. In this particular case, we were very fortunate, and I think it was a matter of luck, you can see it crossed. A hundred percent of the cases in the pivotal and the EFS crossed, the average time to cross in the pivotal trial using the technique of pinning it open with the pigtail was on average 1.3 minutes. In the EFS, it was as long as three minutes for some of the operators, so using a pigtail to pin the valve open makes it reproducible and predictable. This is how the ECP looks inside of the ventricle, a little different compared to what we're used to with the legacy CP technology that everybody's familiar with, so a little interesting. Here's the case that we did. This was a Medina 1-1 bifurcation lesion of the left vein and LAD and circumflex. This is the impella end with kissing balloons. I'll show you the PCI in a minute. After you're done with the procedure, this is what we describe as unhatching. You can see the impella here is expanded again 21 French. You got to get into this nine French sheath to pull it out. I'm happy to report that every single impella ECP case has been done. All of them have successfully been unhatched into the sheath. We were prepared. We have some tips and tricks in the event that this doesn't happen, but fortunately, we haven't observed that potential complication. For those of you who are wondering, does this device provide adequate hemodynamic support, the support that we've become accustomed to with the CP, this patient answers the question. Now, this is not case number one. This was subject number nine, but what you'll notice here, bifurcation left vein in a patient who had a totally clued right cornea artery. I want to go back here and show you this is the impella CP flow, but more importantly, look at the patient's mean arterial pressure. You'll see the patient's blood pressure. It started off 146. You see 150 systolic over 100. As the balloon was up with the prolonged inflation and occluded right cornea artery, in no time, you could see what happened. The blood pressure came down. Eventually, we lost pulsatility. The patient's pulse pressure became dependent on the device. You could see. What's interesting is that this patient maintained a mean arterial pressure, even though it was flat, without pulsatility of 85, the entire procedure, the patient was awake and mentating well. After this case, this is when I was convinced that it does provide the support that we feel that it needs to do. This is a 79-year-old gentleman, born and raised in Detroit, worked on the line. He's retired. He had a history of coronary disease and remote PCI of the mid-circ and the proximal LAD, remote history of carotid disease, status post-carotid stenting. He was recommended for surgery, actually a pretty decent candidate for surgery, but the patient did not want to have surgery because of the prolonged recovery. Again, this was four years ago. Here's the actual lesion. You could see pretty tight bifurcation going into the LAD and the circumflex. Keep in mind the context of the time of this procedure. This is the first time we'd ever put an ECP in a human, so we were trying to be very careful and wanted to declare victory without too much complication. What we did is we imaged both limbs with an IVUS. Here's the IVUS. You could see heavily calcified. It was circumferential in the proximal LAD. This was, again, in 2020, predating IVL. What we decided to do was debulk that with orbital atherectomy. If IVL was around at that time, like if this was a modern-day case, we would have likely had a low threshold to use IVL and mitigate the risk of atherectomy. We used seven French guiding catheters. I know some people like to use eight, and we prepped the vessel. You could see here we did orbital atherectomy to the LAD. If you saw the angle of the circumflex, it was an acute angle. For that reason, because of angulation, we deferred to do atherectomy to the circumflex. What happened is that we wired both vessels. We did orbital atherectomy with the diamond back over the wire, and afterwards, we ballooned a kissing balloon, the CERC, and the LAD. We put a stent, IVUS guided stent, from the left main across to the proximal LAD. We optimized it with the 4-5 in the left main based on the IVUS. This is the part. Here's the part, and here's our final kiss. Here's our angiogram, and this is what we debated. If you look at this angiogram, we have a really nice result, the left main going into the LAD. You can see we have a decent result. This is just with the balloon going into the circumflex. The thought process at the time was, should we do a two-stent strategy? Keep in mind, we did balloon there. We made a decision to try to do less is more. The way we justified it is that we put an FFR wire across the circumflex osteum, and the FFR was 0.92, and we decided to stop. We'll talk a little bit about that PCI. This was the night before where we planned the case, and this is when we did the case. This is the patient six months later. I saw the patient actually in the office in December. Four-year follow-up. He's doing great. The question I have, if you go back to this, I'd like to ask the panelists and the attendees is a couple questions. Is it reasonable to do an FFR to try to avoid a stent after you've already done a kissing balloon at the circumflex? I know we're taught that sometimes angioplasty could be a nidus for restenosis, and we denude the endothelium. There's people who believe that. What is the value and the utility of FFR with somebody who's on Impella? Is there any validation or any studies to support that? I think those are legitimate questions or criticisms that I don't know the answers to, but can be discussed, but we wanted to declare victory as our first case. Interestingly enough, this is our final endographic result, and clinically, he's not needed a cath since then. He's done very well, so I don't know what the right answers are, but those are some things that we debate every day in the cath lab. With that, thank you guys. Looking forward to getting ECP in everybody's hands. Abiumed did submit to the FDA, and hopefully, we'll have commercial availability at the end of Q4 of this year. Thank you for having me, Dr. Rab, and if you guys have any questions, I'd be happy to try to address them. I'm curious what you guys think about that approach that we did. Dr. Rab, do you have thoughts on Dr. Kakhi's case about the circumflex specifically? Well, I think, you know, you're right, Amir. I mean, a couple of things you could have done is, we don't know whether pressure wire with Impella on is valid or not. You could have turned off the Impella for a couple of minutes and done it, maybe. Secondly, you know, the circuit is just too important, it's a large area of circulation that you cannot ignore. And, you know, it's not wrong to just go on, briefly put a small balloon, just protruding to the stenosis circumflex, dilate it, do a kiss, and end up part of the left main. That's not wrong. But I think the chance of putting on a stent and reach stenosis so high that the current thinking in Europe, at least, is if you denuded it, if you ballooned it, put a drug-coated balloon afterwards, and just hope for the best. And I think you took the European approach, it's not unreasonable, and the patient has done fine. But I think beyond just ballooning, you should do something. I'm not in favor of putting on the stent, because remember, the lesion length was less than five millimeters, and it really does not qualify as a complex lesion for a two-stent technique, so it falls more as one-stent technique. But even if you balloon the stent, like pot, side-brain ballooning, and re-pot, nothing wrong with that. You took another angle, beyond the view that you had, you probably would not see it pinched like that. But I think in the future, going forward, probably use a drug-coated balloon, just for completion's sake, and that's what Europeans do right now. What's interesting, Dr. Rav, is I like to challenge everybody on this idea, is that when you look at these bifurcations, everyone does it technically excellent, as we know most cardiologists, at least what they say. That being said, what's interesting, these patients come back, and we don't talk about that a lot. And what happens is when they come back, it's ISR of the circumflex, and the other thing we don't talk about is that we're trained, there's this dogma that we should always treat the left main to the LAD as the parent vessel. My strategy has changed. I think after hearing a lecture from Bill Lombardi, I thought it made a lot of sense. Why do we always, as a default, treat the LAD as the parent vessel? Well, we should be treating the parent vessel as based on the angulation. So for example, in this circumflex that I put a stent in there, and it reached stenosis, it would have been very, very challenging for us to technically wire it. But if we would have made the circumflex the parent vessel and crushed the LAD, then in the setting of reached stenosis, it becomes much easier. So why don't we talk about that? Why do we always make the LAD the parent when the facts are that the circumflex is the most likely to reach stenosis, particularly the ones with hostile angles? And no one comes back and shows us their reached stenosis of their left mains and their osteocerx at these meetings. I haven't seen them, but in my practice, I see them all the time. So what do you guys think about that? You know, the torsion movement of the stent, the interaction of the left main is the reason why they reach stenosis, okay, or have stent fractures. So I think that problem, you know, there are a lot of studies out there currently in Europe about just doing a DCB, and you know, Shaoling's trial that came out, the DCB bifurcation trial, suggests that DCB would be the way to go and reduce reached stenosis rate because you won't have metal-to-metal creating the torsion. So that might be the mute point, make that reached stenosis rate down from 15-20% to 5-6%. I think that's where we'll go in the future. So maybe in the future, we treat the parent vessel that has a favorable angle and then do a DCB on the unfavorable one and always maintain access. But we have always, everybody has awesome acute results, as you saw with, you know, with Alex's case. You saw my case is a little, you know, not perfect, but good enough. But the real answer is, how do these folks look at 12 months, at 24 months, at 36 months, and what do we do for them at that time? A lot of times, I can't even cross some of these, to be honest with you. So... But you know, in China, they do the nine-month follow-up for their trials, and that is very favorable for the DCB arm for osteocyte branch stenosis. Makes a lot of sense. Well, thank you, guys. I was trying to be provocative. I yet to be determined what's going to happen to the poor circumflex. Thank you. I just wanted to ask you maybe one question, Amir, as a person who has not used ECP, is when you scrape up and down the aorta with this device without a wire, and that's trying to keep you central in the aortic lumen, have you noted any differences in the stroke risk or just atheroembolic phenomenon in general as you scrape the outer curvature of the aorta? That's a very good question. As a matter of fact, that was one of the endpoints that we looked at that was pre-specified. Alex was actually our medical monitor, and he would have stopped us if he would have noticed a stroke signal. But I'm happy to report in the 256 patients in the pivotal trial, 61 patients in the EFS, there was no stroke signal compared to historical CP and other high-risk PCI. So no stroke signal, but it was something that we were concerned about. Do you think it'll ever come to the acute MI cardiogenic shock market? I think it's definitely going to be something, for example, who knows what DTU is going to show, but if I hope that DTU is favorable, if DTU is favorable because it's a non-shock AMI cohort of patients, this would be the ideal device. As it relates to cardiogenic shock, I think this would be a wonderful device because if you look at the HQ curves on ECP, it's actually better than CP for the study of cardiogenic shock. The problem with cardiogenic shock in this particular device is the durability of the materials that were used that haven't been tested. But the way I do see it is, let's say you're at a satellite hospital and you need to stabilize the patient and then send them to Sandeep at the mothership. You can do ECP and then send the patient over and they can get upgraded to a CP. Abiumed would love that, but hospital administrators may not.

ECP

bifurcation

atherectomy

calcium

laser

orbital

plaque

interventional cardiology

cardiogenic shock

calcium

laser

orbital

plaque

atherectomy

atherectomy

atherectomy

atherectomy