Hello everybody, welcome. This is Chris Romero, I'm the Senior Vice President on the Ventures team here at MedAxium. We're going to let people start registering here and let everybody sign on. We'll give it just a minute or so, and then we'll get started. And we're just going to give it a little bit of time to let people get logged on. Okay, I think we're, we're ready. This is a, again, this is Chris Romay. I'm the senior vice president on the Ventures team here at MedAxiom. We're proud to have a presentation today by GE Healthcare. It's called 3D Stent, a new era in stent enhancement for percutaneous coronary intervention. And in a minute, Dr. Carlos Collette will be presenting. I'd like to go through a few housekeeping items if I could. So let me just go to the next slide. So in the link, in the chat link, you'll see three items. One is the presentation itself. You can download the presentation and review that or share that with your colleagues. There is also a link to the website, as well as a brochure that you can use and download. If you have any questions during the presentation, you can put that into the Q&A feature. So that button, the Q&A button on the bottom of your screen will be where you enter questions and you can submit those as you like. And we'll answer those at the end of the presentation. So with that, let me introduce Dr. Collette and turn that over to him and we'll get started. Dr. Collette. Chris, thank you very much for that introduction. And for me, it's a pleasure to be here and I have to thank, of course, the team of GE Healthcare for setting up this webinar and, of course, the team of MedAction for all the preparation. So if we start, I'm going to show my disclosures. And let's start. This is the brief agenda of what we're going to discuss in the next minute. And basically, we're going to be talking about a very exciting new technology called 3D scent that, in our view, it's going to really change the way we perform PCI. With that as a background, the agenda of today, we're going to start with what is the current landscape of PCI today, what is happening in terms of PCI failure, what is the role of intravascular imaging in 2024, and then we're going to go to what I see as the next generation of angiography, which is basically how we can use angiography to enhance PCI procedures using this technology that is called 3D scent, which basically allows 3D scent in a very innovative and intuitive way to assess any sort of procedural complications. And again, we're going to discuss briefly how do we see this technology in the future. And of course, we have a session at the end for questions and answers. So, if we start with, this is a fascinating image, and this is a CT scan of a mummy that is actually an Egyptian princess. This is 1500 BC. And the reason why I'm showing this as a first slide is for us to be aware that atherosclerosis, the process of cholesterol deposition, calcification of the vessel, is something that is not new. And if we do a fast forward 3,000 years until today, this is one of my patients in my practice here in Belgium, where I perform, again, a CT scan, and I see more or less exactly the same that we observed in the Egyptian princess, again, a long time ago. So, this is basically one of the most prevalent diseases of the humans. And this, again, we're going to discuss how have we managed this disease for a long time, again, with focus on PCI procedures. Now, atherosclerosis is really something that can affect the whole body. You can have atherosclerosis in practically any artery of the human body, as you know. But there is, again, a high prevalence of coronary atherosclerosis. So, deposition of, again, of lipids, cholesterol and calcium in the coronary arteries. And again, this appears to be higher in men than in women. And if we look at the prevalence of atherosclerosis today, and this is a paper of around seven years ago, show that in asymptomatic individuals that are more than 50 years old, the prevalence of atherosclerosis is extremely high, specifically in male patients. And you see that almost 50% of patients that are, again, asymptomatic have coronary atherosclerosis. And again, this prevalence is also important, but lower in women in the same age group. Atherosclerosis is a process, again. It's a process that starts with a deposition, again, of cholesterol in the vestibule, and this progresses over time until the artery is actually obstructed by the atheroma or by the plaque. And this is when the inside of the artery, the lumen of the artery, becomes too narrow that the blood flow becomes insufficient for what is after the artery, which is basically the cardiac muscle. And when the blood with oxygen is not sufficient for the heart, well, there come the symptoms. And the cardinal symptom of atherosclerosis in the coronary arteries is angina. And if we look at the data today, and this is U.S. data, more than 9 million patients are affected by angina today. Now, we have a very effective method to treat angina, basically, and this is called PCR, percutaneous coronary intervention. And this is basically an invasive procedure that can be done via the radial artery in the pulse. It can be done also via the groin, via the femoral artery. And basically what we do is that we come with very small balloons. These are balloons of two, three millimeters of diameter. We place them in the obstruction, then we dilate the obstruction, and this is how we, let's say, prepare the lesion. The second step of this PCR procedure is what we call stent placement. We have these devices that are metallic, most of them, that are actually used to, again, to scaffold the vessel and avoid, again, subsequent closure of the vessel. And this is what happens. So, we go again, the stent is mounted on a balloon, we deploy the stent in the lesion, and again, the flow is completely restored, and basically, this improves the blood flow to the myocardium. Now, that is a cartoon. Now, I'm going to show you one of my cases in real practice. You see here, again, this is what we call an angiography, a coronary angiogram, and this is the left anterior descending artery. And you see here, clearly, the mid-part of that, the mid-segment of that vessel, that we have an obstruction. It's a 50-60% obstruction, and the way that we have, again, to treat the patient, as I showed you in the previous image, so we place the stent, beneath the stent, you see, between these two black dots, you can see the prosthesis, and then we inflate the balloon, we deploy the stent, and basically, at the end of the procedure, we see what happens, and you will see a clear difference with the previous slide that I showed you. And I showed you a before and after, so before placing the stent on the left side of the slide, after placing the stent on the right side of the slide, and you will see clearly, without being an expert, that the lumen of the artery, of the diameter of the artery, has significantly increased in terms of its size, and you see, again, that the flow now becomes better. Now, this is a procedure that is increasing over time. Again, I brought US data from 2020, showing that in the last year, this procedure has increased around 16%, and this is, again, a trend that has been consistent in the last five years, and again, it's a division between elective and non-elective, but again, both have had a minor, or 10-15% increase over time. How many of these procedures are performed, and again, based on data from the United States, this is about, around a million procedures per year, exact number is around 900,000 procedures per year. Again, this is from the NCDR, CAT, DTI registry, collective procedure from 2009 to 2007. Is this procedure effective? Yes, it is. There's a beautiful study that you have in front of you, that has been recently published in the New England Journal of Medicine, actually showing that patients that undergo PCI, you see here on the left side of the slide, have more, are free from episodes of angina, and you see here that this light color actually means that the patient, 14 days, 28 days, 42 days, doesn't matter when you measure their angina, they are significantly better than those that are treated without a PCI, in other words, with medication that can also offer, sometimes, reduction in angina. So, we have clear evidence that this is an effective procedure for the treatment of angina, and again, this, of course, also improves the health status and the quality of life of the patient. Now, until now, it's a beautiful story, and I think here everybody is convinced that this is a very important procedure in practice, but this is basically the question that we'll try to address today. What can go wrong? What are the potential complications during a stent implantation? And again, if we try to look at this in terms of a tunnel that has been, again, obstructed, and the goal of the PCI to make this, again, broad for the blood, again, or in this case, for the car, to go through the tunnel, then we have a very important, we're going to call it complication, which is the fact that sometimes we cannot or we do not open the vessel properly. In other words, the stent remains underexpanded. I brought a couple of pictures that this is extremely clear to understand, even, again, for a non-expert, what we call suboptimal stent implantation. So, on the left side of the slide, you see, again, a stent that is implanted between these two black dots, and you see here in the middle how the stent has not been clearly well-expanded, well-deployed, and remaining with this sort of waste in the mid part of the stent. And this, of course, creates a lot of problems in terms of the flow, and again, the complications that we're going to discuss in a little while. On the right side, exactly the same, the same type of situation where the stent has been, let's say, well-deployed in the proximal part, in the distal part, but in the mid, you will see here, again, this waste of the stent, and again, this produces a reduction in the blood flow that goes through that stent. Now, if you leave the stent in that suboptimal condition, this is the data that we have. There's a recent publication in Air Intervention 2022 showing that when you have suboptimal stent deployment, and this is seen in the blue bars, you will see, one, that the rate of death after stent implantation is significantly higher, and that the rate of TVR, TVR means the necessity of performing another PCR procedure or another vascularization to fix the stent, is significantly high. In other words, the risk of suboptimal stent deployment for having a major adverse cardiovascular event increases by around 75%. And then comes the next question is, then what is suboptimal stent deployment? How it can be in the red bar instead of being the blue bar? Well, very simple. In this case, suboptimal stent deployment, this particular publication was defined basically as the stent area, so the area inside the stent, the smallest area more than or less than 4.5 square millimeters. This is important. We're going to come back to this number later in the presentation. Now, if the stents are not well deployed and they remain underexpanded, there are two main mechanisms that explain the adverse event. And again, we're talking about two major adverse events. One is stent thrombosis, which is basically an acute thrombosis of the stent that leads to a myocardial infarction. And most of these cases have to go to the emergency department and be immediately revascularized. Or we have another phenomenon that we call that in-stent risk stenosis, in which there is again, a growth of more additional plaque inside the stent, particularly in the segment that was underexpanded. The presentation is different from the cases of stent thrombosis, in the sense that these patients present with chest pain after the stent implantation. Again, they undergo a second procedure to try to fix the stent in a second time. This I tried to divide it, but sometimes these two entities coexist in the sense that sometimes you have an in-stent risk stenosis, so a progressive decrease in the blood flow due to a stent constriction or due to the underexpansion or the new deposition of plaque, and that can lead to a later stent thrombosis. And this again, some cases can be both entities superimposed. Since almost 20, 30 years, we have tried to overcome this complication. And again, we saw this quite frequently with what we call the bare metal stent, so a stent that were metallic alone without any type of drug. And at that time, we had really, really high rates of risk stenosis. If you read the slide, we're talking about 20 to 30% of the patients were coming back with an issue related to the stent segment due to risk stenosis. Then, around in the 2000s, came what we call the first generation of drug-eluting stents, which basically were the same metallic stent, but now they have drugs that inhibit the proliferation of new plaque. And that led, indeed, to a reduction in the risk of having this phenomenon of risk stenosis. The first generation of drug-eluting stents were thick devices, difficult to implant, and they were also associated with late complication. And for that reason, in around 2010, came the second generation drug-eluting stents, which were basically, again, metallic devices. Now, they have thinner stents and the drugs are more biocompatible compared to the drugs used in the first generation of stents. And here's where we are, basically. There have been a couple of other attempts to try to improve the second generation stent, but basically, these are the stents that we keep using in clinical trial. Now, I brought you contemporary data. These are data from four different randomized clinical trials comparing old with new technology. And what I want to show in this slide is the fact that when you see the event rates at five years, these are all clinical trials with five years followed, you will see immediately that the event rate, it doesn't matter if it's for the new stent that's already blue or for the old stent that's already red, the event rate at five years is around 20%. So, this basically means that one out of five patients is still coming back with a stent-related problem. How common is this? And then we're going to focus on this phenomenon called instant risk diagnosis. So, again, the re-obstruction of the coronary artery at the level of the extent implantation, well, this is about 10%. This is one of the final, the latest data. And you see here that for the U.S., this represents approximately 100,000 patients per year that are coming back to the institutions, coming back to the catalog with an issue related to the stent that was implanted. What happened to this patient? Well, this patient, of course, comes back, we see that the stent is not open again, it has a moderate or severe obstruction, and then we re-intervene in those patients. And what we have observed is that those patients that come back and we re-intervene, they have, of course, a higher risk. They now have a double layer of metal in the coronary arteries. They undergo twice the same procedure that had been reached. So basically, re-intervention increased or are associated with an increase in mortality of approximately 40%. So this is not benign. This is not that the stent got the rest of the node, and then we open it again. This comes with a price again, and the price in this case is increased in mortality around 40%. So the question is, well, we can improve angina. This is a safe procedure. Can we prevent the complications associated with stents? We call this a stent failure. And the question of this slide, is a stent failure preventable? And the answer is yes. We can, of course, ensure that the stent is perfectly expanded during the procedure. And this is traditionally achieved by using something that we call intravascular imaging. Intravascular imaging, there are basically two main modalities for intravascular imaging. One is called IVUS, which is basically a technology based on stent. And we have another technology that is called OCT, that stands for optical coherence tomography, that is a technology that is based on light. Both are similar from the technical point of view. You require an extra small catheter that is again, placed inside the coronary artery. And then from the inside of the coronary artery, we see how the stent was deployed. Basically, what we see here, I show you one image on the left of IVUS, on the right of OCT. And for example, in the IVUS picture, these white signals that you see in the image is basically the stent. And in the OCT, it's a little bit easier to identify the stent. Basically, what we do is we trace the circumference of that stent, and you get automatically in any of the software of these technologies, an area. And of course, if you measure the smaller area, we call that the minimal stent area. You see in this case, it's 5.2 on the left side, and 5.0 on the right. Based on this number, we define how adequate the implantation of the stent was. In other words, if the area of that stent is less than 5.5 millimeters, we consider that stent to be underexpanded. And this is extremely important. So in the cartoons that you have in front of you, again, on the left side, you see a perfectly implanted stent. And when you do, again, this IVUS, this miniaturized camera inside the vessel, you see that the stent has been extremely well deployed, and the minimal stent area in this particular case is 10.2. Now, in the right example, you will see again that the stent, specifically in the mid portion, looks like the one I showed you before. So there is areas that look more or less well-expanded, but you see again, in the middle of the stent, there is a significant reduction in the diameter of the vessel, and then we call that underexpanded. And why is that important? Look at this graph. This is a survival curve, or a Kaplan-Meier curve. Basically, what we're seeing here are two groups, and the two groups have been divided based on the minimal stent area at the end of the procedure. And then we have two groups. A group that had a minimal stent area more than 5.5, and these patients have been put in this red line. And then we have the patients that have the minimal stent area less than 5.5, and these patients are in the blue line. So we call those not an optimal implantation. And what you see here on the vertical axis is basically the incidence of three of the worst complications that can occur after PCI, which is cardiac death, myocardial infarction, or ST, and that is stent thrombosis. And you clearly see that when you implant a stent optimally, and again, the criteria is based on this number 5.5 of minimal stent area, you have an 80% reduction in the complications associated with you. So this is extremely important, and this has led, again, to the recommendation to use more intravascular imaging to be sure that the stent, again, has been well expanded at the end of the procedure. Now, there have been many trials assessing the use of intravascular imaging, in particular, IVUS or OTT, to optimize the implantation of the stent. And again, with the goal, of course, to make the procedure safe, to understand what needs to be done in a safe way, to make the procedure also effective, and to make the result, the procedure, durable, and the patient doesn't need to come back for a re-intervention that we have seen that is associated with additional events. So basically, I'll show you data from one of the most important studies. It was published a couple of years ago, and basically, we have two groups that were followed for three years, and we see here the event rate, what we call the angiography guidance, or basically, no IVUS guidance, and you see here the event rates at one, two, and three years. And these were the event rates of the patients that were treated using IVUS guidance. So again, going with the intravascular imaging catheter, and be sure that the stent was well deployed. Well, the numbers are very clear. There is a significant reduction in what we call target vessel failures. So again, this is mainly driven by the fact that some of, most of the patients come back to reopen the stent, and you see here again that this is almost double. So there is a clear benefit of using this technology, IVUS and OCT, to improve stent expansion and improve outcomes. Now, that was one trial. I'm bringing you a meta-analysis that was published very recently, a couple of months ago at DMJ, basically combining all the data that we have available comparing intravascular imaging with angiography. In other words, using intravascular imaging to optimize the stent implantation basis versus using no intravascular imaging, just playing a joke. And what you see here is that the use of intravascular imaging significantly reduces the re-intervention in about, with a reduction of 25%, and also the use of intravascular imaging is associated with a reduction of 56% in the occurrence of stent thrombosis. So this technology is extremely useful in reducing the event rate of patients undergoing PCI. But there is a problem. The problem is that these technologies have not been adopted by the community. IVUS has been around for about 20, 30 years. OCT, almost 20 years. And when we see the adoption rate of either IVUS or OCT, IVUS is in red, and OCT is in blue, this is data from five years ago. Again, data from the U.S. And it shows that the adoption of imaging to optimize for the PCI is approximately 10%. Okay? This is not a phenomenon unique from the United States. I will show you data from France. France, only 3%, 3% of the PCI procedures are actually guided by intravascular. And there is a number of factors that I don't want to go into the details of why we as a community, with the evidence showing that there is improvement in outcomes, have not really adopted these technologies in practice. But basically, it comes to the cost. All these have a cost, an additional cost. They add time to the procedure. You need to have a significant expertise to interpret the images. So not everybody is at their ease with looking at images. And again, in systems that are resource-contrained, well, when you think about cost, price, then these are factors that actually limit the utilization of intravascular. So there are alternatives. So there are several ways that we can look at extent expansion. And this is basically the topic of the discussion today. And one of the things that have been really, in my view, something that has really helped understanding the problem or the potential problem with suboptimal extent implantation is this technology called extent enhancement. Extent enhancement are technologies that are available to all the vendors. Of course, this is also present in the catalog from GE, which basically offers a type of zoom into the stem to understand that the stem has been actually well-deployed. This is extremely easy. Basically, you don't need to do anything else. You put the foot on the pedal. You have to wait for 30, 40 seconds. No extra resources needed. No extra devices needed. And you get this type of pictures quite easily. Now, there have been several studies trying to correlate these so-called 2D extent enhancement with the areas obtained by ILUS. And what you see here on the slide is basically a correlation plot with the horizontal axis showing what was the minimal extent area measured with ILUS. And in the vertical axis, the same minimal extent area, but you derive from this extent enhancement tool. And you see here that the correlation is quite good. Correlation coefficient of 89. So basically, these tools help understanding what would be the area of the extent of the procedure. And not only that, they don't only correlate in terms of the area that you can derive from it, but they also are very helpful in terms that they have shown in several observational studies that the use of these technologies also reduce the amount of patients coming back to the catheter. So we focus here our attention in what we call TLR. TLR is target lesion revascularization. In other words, the necessity of a patient that has been treated with a stent to come back again for another stent or for the improvement of the deployment of the first stent is significantly reduced when these technologies of stent enhancement are used. And again, you can see here on the right side, this actually drives a reduction in the total number of events in the group that is using this technology in blue and the group that is not using this technology. Now, we need to recognize that these are not perfect. It's not a perfect technology in the sense that sometimes you get this type of picture and you cannot really assess what it is. You have sort of blur images that can be affected by the movement of the heart or by the stability of the balloon that is inside the stent. There is no way to really quantify this. So it's basically a visual estimation of the deployment in the sense of if you see or not under expansion. There is a limitation in patients that are obese with high BMI because basically in obese patients the x-rays, the quality of the image of the x-ray is lower. So it's very difficult to really assess the stent in obese patients. And again, this is again extra radiation that we're giving to the patient. So these are general concerns with the use of this technology that we call 2D stent enhancement. But one of the most important limitations of this technology is that 2D stent enhancement, as the name says, is a 2D approach. In other words, they are at the heart and the coronary arteries are three-dimensional structures. So if you have a problem that you can only see in a determined rotation of that stent, you will miss it. And I show you, for example, this is a 2D stent enhancement acquired in a projection. And if I look at this picture, again, visual interpretation, I would say this stent is perfectly deployed. But if I now move the angulation of the CR to a different one and repeat this stent enhancement, this is what I find. A stent that is not well deployed. So again, it requires some sort of attention to the different projections that can be used in order to not miss a potential ulnar expansion that is not detected in one single view. Now, to overcome all this limitation, and again, in this evolution, in the way that we have been serving on how stent expansion can be assessed, is where we're going to introduce this new technology. This new technology is called 3D stent. I'm going to play the video here again. This is an impressive technology because, again, it's based on angiography and it provides a visualization of the stent in 3D. And I will tell you what are, again, the practical consequences of that. So this is the 3D stent technology. It's a very recent technology. I don't think it has been in the markets for a few months. I believe the team of GE can verify this in terms of availability. But basically, the way it works is it uses angiography, but not only one acquisition in one single plane, but something that we call a rotational acquisition. So basically, after we implant the stent, we perform a rotation of the C-arm while having the stent visualized in the middle of the screen. Behind the computer, many things are happening. And there is a detection of the image and motion compensation. And after approximately a minute, you get this in front of you. So basically, you get a three-dimensional reconstruction of the stent that has been just implanted. And I will show you a video that was recorded by the team of GE on how this works in the cat-lab. So basically, this is the cat-lab, and this is just, of course, a demonstration with a rotation. So you go here, you click 3D stent, and then you prepare yourself for what we call a rotation, a rotational angiography. You rotate the C-arm. This happens, again, this is real-time. We're talking about something that takes approximately 20 to 30 seconds. And after that happened, you see immediately that in front of you, you get for the first time the possibility to look at the stent in three dimensions. And not only that, you can scroll through the stent and make measurements in a similar way that you would do with intravascular imaging. And again, you can look at this value that is extremely important. We have this cost that is the minimum stent area. This is one of the pictures that we have from the first experience. And you see here, again, that we can afford to do measurements in the longitudinal plane. We can do measurements in the tomographic plane. And again, what you see here is the determination of the areas at different parts of the stent. And again, here is the cross-section in the middle points to an area of 5.3, basically saying this stent needs to be further expanded. And then, of course, we know what to do with that. We basically put another balloon and with higher pressure, try to increase the expansion. Now, I'd like to bring you a case because one of the things that this technology, in my view, is going to be extremely useful and easy to adopt is the fact that it's basically, it falls within the routine of a daily procedure. So I'll show you, this is one of the, or actually one of the first of the second cases that we did in my cathlete with this technology. I'll show you very quickly the angiography. Again, this is a patient that came with chest pain, we detected this lesion in the mid-segment of the left anterior descending arteries, the vertical lesion, around 70% narrowing. We did intravascular imaging also to demonstrate not only the type of narrowing, but also to confirm the result of the implantation. And then we proceeded with the PCR. So this is basically the stent. You see again, between the two dots is where the stent is actually located. We implanted the stent and did the angiography for the procedure. We then did OCP. So basically we repeated intravascular imaging after the procedure to understand what were the dimension of the stent in each of the segments of the stent, approximately this tall. And then we saw that the areas were very, very low. So then we proceed to use this technology. So this is my cathlete in Belgium. I'm here with my colleague, Professor De Bruyne. And here, what I'm basically, I'm waiting. I'm not doing anything. I'm just waiting that this machine completes the cycle of 20, 30 seconds. And then you will see what I'm seeing on the screen on the right side of the slide. And basically that's it. And after the procedure, this is what you... And this is again, showed in front of you. So this comes on the screen, and then you can basically do whatever you want to do. You can rotate this, you can turn it around. It's basically a 3D geometry that you can play with it and go in, I'm sorry, et cetera. Now, what we have been observing is that the correlation of the geometry that we see with this non-invasive or less invasive technology called 3D stent compared to what we think is the gold standard for this, that is intravascular imaging is extremely interesting. Again, we don't have sufficient data, but the first case is impressive. So basically we're talking about a technology that has a longitudinal resolution of about 100 microns and an actual resolution, again, of 100 microns. And you see how that compared with the intravascular imaging catheter that has to be placed again inside the stent to get these pictures. And again, we are working on trying to correlate what you can see with the technology or the old technology or let's say the gold standard for this, which is OTT or intravascular imaging on the left side and the dimension that we get with the 3D stent on the right side. And again, this is more to confirm the accuracy of this reconstruction. And of course, the next step will basically be the automatization of all these measurements, again, to facilitate the adoption of clinical trials. So this is basically the use that the engineers from GE foresee or saw for this technology when they developed it a few years ago. And we have the chief engineer on this call. She might be able to answer some of the more technical questions related to the technology. But now as a clinician, one of the things that we quickly understood that this technology will also be very useful is in vessels with calcified disease. So calcium is one of the, I call it one of the enemies of PCI. And the reason being that the main factor leading to extended or expansion is the presence of calcium. Calcium, as you can imagine, is very hard. So if the calcium has not been properly fractured, it's very difficult to really expand the stem. And we have a lot of data showing that patients, in this case, that have severe calcifications in the corner of the artery and undergo PCI procedures have a significantly higher target lesion failure rate compared to those with no or mild calcium that are in the yellow line. Here you see almost a twofold difference in the occurrence of adverse events in calcific versus non-calcific lesions. And this is one of the cases. This is a case reported very, very recently. I think this case has been published two weeks ago, impressed by the team in France, Dr. Ben-Emer. And you see here that they treated this right corner of the artery that was very calcific. Again, seeing calcium is not easy within geography. And they proceeded, again, with implanting several stems in this right corner of the artery and this is the final endogastric result. And then they proceeded with this 3D stem approach to understand what was the expansion inside the stem placed in the right corner. And these are the images. And when we saw these images, we were really flabbergasted by the fact that we cannot only see the stem, but we can also see the calcium. So here it is very clear to see the stem. I'm looking at the first cross-section here in blue. You see clearly the stem truss, so here's no calcium. But when we go to, for example, the second cross-section, which is in red, you start seeing these images with high intensity behind the stem, which is basically calcium. And you see that, again, in different parts of the cross-section. I would like to bring your attention to the cross-section number eight, where you see, again, a big chunk of calcium here between 11 and 12. And again, if this technology have the possibility also to assess calcific disease, I think it would be great because so far, the only way that we have really understand calcification in the sense of how severe the calcification was, was either using OCT or NIBRS, or also could have been, or coronary CT, which was, again, it's a non-invasive technology. Again, this is the same case. You're highlighting the potential of this technology also to assess the calcific arc. And again, I just brought the last slide, which is basically the comparison in this particular case of the areas coming from OCT on the left, so intravascular hemelin on the left, and this novel technology, again, 3D stem on the right. And what is impressive to see is that not only the numbers are pretty much similar to each other, but also the distortion of the symmetry of the stem implantation is similar between the one on the left and the one on the right, basically driven by the presence of this calcified disease that inhibited an adequate extent expansion in that particular segment of the vessel. So with that, I would like to summarize everything that we have been discussing. And I think we have to start by stating that PCI is an effective method to treat angina in patients with atherosclerosis, and it has been shown in many trials that PCI improves angina and quality of life in patients with obstructive coronary artery disease. Again, but PCI today is not perfect. There is a high rate of prevalence of suboptimal stem deployment or stem under-expansion. And again, the low penetration of intravascular hemelin, I think, I favor that this remains under-detected. Again, as I showed you with the data, this again results in a higher rate of potential complication for this stem implant. Now, what we are witnessing is that angiography, as a tool that has been developed almost 50 years ago, has evolved now and has a new possibility to really understand the expansion of the stem by visualizing the stem in 3D without the need of any intravascular imaging computers. And we believe that the systematic evaluation of stem expansion with an additional 30, 40 seconds to the procedure without any additional cost will certainly facilitate the detection of the stem under-expansion, will improve the rate of optimal stem deployment, and this may improve, again, clinical outcomes. And with that, I would like to thank you for your attention, of course. And I'm looking forward for the Q&A session. Thank you, Dr. Colette. Before we get to any questions, I do want to thank you and GE Healthcare for this presentation and to our members for attending. So we do have a few questions. Before we get to that, I just want to remind everybody that in the chat section is the presentation, the website link, and a brochure. Some people did indicate that they were having a hard time downloading the presentation. It is a rather large file, and if you're international, it may take even longer. So we will be recording this. We will be downloading this presentation and sending this out, so that will be accessible to you. So we do have a few questions just to get started. The first one is, can 3D stent be used to assess instant restenosis? Definitely. So instant restenosis, again, as I show in the presentations, is the condition where the patient comes back after a previous stent implantation, and we see that the stent is re-obstructed. There is a restenosis. Now, there are several mechanisms that leads to stent restenosis, under-expansion being the most important one. So yes, this technology is actually meant to detect under-expansion, and this can be done either in the acute phase, so immediately after the implantation of the first stent, or when the patient presents again for a second procedure because of chest pain or other clinical situation, and then we detect that the stent is obstructed. Again, this technology can be used in both scenarios to detect the presence of stent under-expansion. Fantastic. Okay, another question that came in. Does 3D stent have any limitation in terms of stent type or brand? Well, no, there is no limitation in terms of stent brand or type or metallic alloy, so there is no limitations in terms of that. What I do need to mention is that sometimes in some particular patients, we are forced basically to put many stents, and that result in stents that at the end of the day are too long. So again, one of the, let's say, the technical limitations of the technology is that you will not be able to assess a very, very long stent. It's a technology that the stent needs to fit, let's say, within the screen, and this is a limitation of the technology so far that cannot assess a very, very long stent. With one acquisition, you're basically required to repeat a 3D stent in the different segment in case of a long stent. Okay, thank you. Will this technology work in bifurcation lesions? Well, I have to say that we're starting the validation, the clinical validation of this technology. This is extremely new. This is novel. There is a couple of clinical sites worldwide where this technology is already available, and in my personal opinion, bifurcation is one of the niches where this technology will make a difference, and the reason being that in bifurcation, we sometimes use two stents, and we need to be sure that the stents have been adequately crushed or adequately recrossed, or we recross the stent again to re-expand them, and having a geographic tool that tells you where exactly I have the recrossing of the wire, which is a very technical part of the procedure, is going to be extremely, extremely helpful. So I do believe that bifurcation is one of the most important lesion stops for this technology. All right. Thank you. If you have access to IBIS or OCT, IBIS slash OCT, which types of patients would you find 3D stent valuable? So the way that I see this as we go forward is that 3D stent will basically be part of any procedure. So you basically implant the stent, you do a 3D stent, and then you get a first glance, whatever, everything that you need to know about the stent expansion. So I think this is going to be just part of any PCI. So I don't see this actually competing with IBIS or OCT. What has to be said is that 3D stent is an extremely useful tool to detect under expansion. But there are other, let's say, situations that the stent can be not optimally deployed, that cannot be detected by 3D stent. I'm referring to a situation that we call stent malaposition. That basically means that the stent is not in complete contact with the vessel wall, and there is a little bit of a gap between the wall and the stent. This is not a big problem in the sense that this situation of not complete the position has not been associated with adverse outcomes, but this cannot be detected with 3D stent. For this, you need to use either IBIS or OCT. A second point that also needs to be mentioned is the fact that for adequate sizing of the balloon, the stent's intravascular imaging, either IBIS or OCT, remain the gold standard, and 3D stent doesn't have any role in assessing the precise dimension of the vessel. Hey, the next question, and Dr. Colette, I don't know if this is for you or for somebody from the GE team that's on the call. How can I get this technology? Definitely not for me. Maybe some of the colleagues from GE on the call may answer that. We can always get that back to them and put that information in the Q&A. That's the presentation that we're gonna be sending. We'll give it another second here to see if anybody has any last questions that you can put in the Q&A section. But if not, I think that was a fantastic presentation, Dr. Colette. We wanna again thank the GE team for sponsoring this presentation. If we don't have any other questions or comments, I'll turn it over to you, Dr. Colette, for any closing comments, and then we'll close. But, Dr. Colette? Chris, thank you very much again to you, to the MedAction team, and also to GE Healthcare. I think this is an exciting moment in the sense that we truly believe that this technology is gonna change the way that we do PCI, and we will increase the proportion of the rate of optimal PCI. That is what we want for our patients. So thank you for having me and for the opportunity. And I do believe somebody from GE was trying to say something. Yes, sorry. Just to answer the question about the availability of 3D Sense. Can you hear me? Yes. Yes. So 3D Sense is available on our last platform that is currently in sale in the U.S. So it's on the Alia platform. You have access to this technology. So yeah, last platform, you can get it. So I want you to answer on that. So it is available right now on our products. Fantastic. Again, Dr. Collette, GE, thank you very much. Appreciate that. With that, we'll close this session out. Thank you for attending.

Dr. Carlos Collette

3D Stent technology

stent deployment

percutaneous coronary intervention

angiography

real-time visualization

under-expanded stents

patient outcomes

calcified lesions