So we'll be talking about when to use OCT in 2022. I believe it's every single day, and over the next couple of minutes, I hope to convince you as well. So based on the latest data, 10 percent of all PCIs in the U.S. are for ISR. That's the why we need to do a better job. Every single time we implant the stent, we can do a better job to try to minimize instant restenosis. So two-thirds of centers in the U.S. use less than 5 percent intravascular imaging for PCIs. I think this is completely unacceptable. Fortunately, there's been an uptake of this, and this is increasing. You want to join us out here on the right where we have over 80 percent intravascular imaging. I think that is something that is achievable, and I hope to show you why it's impactful. So most people would agree if this isn't something you do every single case with intravascular imaging, this would be a case you wouldn't bother imaging. Type A lesions, most people think you don't need to do intravascular imaging. Short stent is probably adequate for this. Because we use systematic imaging in all of our PCIs, we find it's ruptured plaque. It's actually a 38-millimeter lesion, and you wouldn't know that unless you do baseline intravascular imaging. This is the case. You implant the short focal stent, and you get a short focal edge dissection with haziness. When you stent into lipid with TIKVA, you end up with no reflow. And you can predict this with intravascular imaging and avoid it by covering from healthy landing zones. So it changes your management, and I believe you don't know it's a Type A lesion until you've done intravascular imaging to determine if it's actually a Type A lesion. Also, because of systematic imaging, when we have discordant angiographic findings, non-obstructive lesions, but patients with real clinical presentations, when you do systematic imaging, in 22 percent of cases, we found high-risk clinical findings, plaque rupture, thrombus. It doesn't mean all lesions need treatment with PCI, but it does change your management, not with PCI, with pharmacotherapy. Systematic use of intravascular imaging, we know, changes your management. The Light Lab study looked at systematic OCT. When you use it routinely in every single case for a defined period of time, and you ask the physicians what their plan is based on the angiogram, then they image, what's your plan based on the imaging? Eighty-eight percent of the time, it changed management, different stent, different PCI strategy. So this is just one study, but different year, different continent, same study design, iOptico, showed the exact same thing. Ninety percent of the time, nine out of ten times, it changes your management when you use systematic imaging. So what's systematic imaging? MLD Max, if you haven't heard of it, it's a stepwise approach. This isn't just pass an imaging catheter. It's actually analyze it, just like you look at an EKG and you have a stepwise approach. It's a pre-imaging, post-imaging. It's not one or the other, and we utilize all that information to make the best decision for how to treat that patient. We use the morphology of a lesion to determine what our PCI strategy is. We know it's more than just, is it calcium? Calcium, there's multiple types of calcium morphologies, and now we have lots of tools available so that we could treat each type of calcium in a different way, and you only know what the most appropriate treatment is if you actually know what type of calcium there is. With calcium specifically, OCT has an advantage. It's the only modality where you can measure thickness, and that's the largest predictor of stent expansion. We have an algorithm for determining when it's a prediction model, when you need to do lesion preparation modalities. So if it meets this criteria, the rule of fives, we know you're unlikely to get adequate stent expansion without arthrectomy or lithotripsy, and you need to crack the calcium, creating calcium fractures. In 2022, we have AI that's incorporated with our OCT, so with the Ultreon system, there's automated calcium detection. You don't need to take a picture of the last slide because the system does this all for you. In the orange on the cross-section on the right, you see the calcium's automatically detected and highlighted for you. It tells you the exact arc of calcium and the exact thickness, so you can make your decisions based on this, and it takes a fraction of a second to look at the screen and know exactly what you're dealing with. You can then incorporate this information into an algorithmic approach where you're systematically giving the best prescriptive treatment for that specific lesion. It's more, though, than just a morphology. In every single case that you implant the stent, you can take precise measurements. When you see your elderly female patient with severe AS, you don't take a look at her and say, oh, she probably would do well with a 23-millimeter valve, and we shouldn't just eyeball an angiogram before you implant a prosthetic device in someone's proximal LID. We have the tools for precise measurements, and again, using intravascular imaging and modern techniques, you can glance at this, and these measurements are all automated. So I can look at this and say a 275-23-millimeter stent post-dilated with a 3-5 proximal is the best devices for this patient. It's not just guessing anymore, and that allows us to get the best treatment for that patient. Visual estimation for stent sizing based on an angiogram is limited, because an angiogram, it's a two-dimensional luminogram. So even with QCA, you're underestimating the size, and that gives us potential for greater areas. If you can do larger stents, you get larger final areas, and the final MSA is the biggest predictor of what future stent-related events are for that patient. Moving on to ISR lesions, another great application for intravascular imaging, particularly with OCT. It allows you to look inside and see exactly what the morphology is. All ISRs should not be treated the same, because what the mechanism of that ISR dictates really what the appropriate treatment is, and I don't believe you can figure this out from an angiogram. So I don't believe anyone can tell me what the primary mechanism of that ISR is based on an angiogram. And this was a patient who was referred for brachytherapy. Fortunately, we did intravascular imaging. So if you look in the middle, there's no tissue. Brachytherapy will only harm this patient, because it will prevent endothelialization. There's four layers of severely underexpanded stent with an MLD of 1.4 and a distal reference of over 3.5. That dumbbell appearance on the longitudinal profile is honestly what you'd be as an operator if you put in another stent for this patient. You need to address the underexpansion, and you need to identify that there's severe underexpansion to properly treat a patient. All ISR, I believe, can benefit from intravascular imaging to dictate what the appropriate mechanism is. And again, we have intravascular imaging-based algorithms to guide what the appropriate treatment based on that lesion morphology. And if this isn't part of your systematic practice, these cases get missed. And that's why that patient didn't end up with four underexpanded stents because the operator was malicious. You don't know. With the angiogram, it looked like it was an adequately expanded lesion. And you often see this due to the limitations of a two-dimensional luminogram. The intravascular imaging has significant benefit for post-PCI. Every stent you implant, there's post-PCI findings that you can determine that will actually help their outcomes acutely and long-term. It can be achieved with IVUS or OCT. One of the advantages of OCT, it's very easy to recognize. You don't need to be an expert. With a brief overview, you can understand all these post-PCI findings that are treatable and addressable and will actually improve outcomes. And with current Ultreon OCT, this is all automated for you. Again, this is what the software looks like. You glance at this, and you can see exactly where there's malapposition, which is highlighted in the yellow bar at the bottom of the screen. We get our expansion, which is automatically calculated. It's no longer a subjective measurement. It's an objective finding. We know there's 59 percent expansion. We want to have 90 percent expansion, so we know we need further optimization. Before this patient leaves the room, we're able to optimize and improve the likelihood that this patient's not going to come back with instant resynosis. So the reason most people don't do routine intravascular imaging is it takes too much time. I hear that every day. Disrupt CAD3, it was the shockwave study that led to its approval in the U.S. So all complex coronary calcified lesions. There were two arms, an OCT arm, non-OCT arm. The OCT arm was mandated minimum of three OCT runs. Some had as many as six runs. Minimum of three runs, it didn't add a single minute to the procedure. No significant difference, and actually saved two minutes, because you know what you're dealing with up front, and you can have a thoughtful strategy to achieve the best outcomes. Now, in current situation, contrast is of concern. So I hear a lot. I had a lot of questions, are you abandoning your OCT practice because of the contrast shortage? I think it's actually the other way around. We find using routine intravascular imaging, we're able to mitigate our contrast use. Saline OCT allows for as low as zero contrast PCI. Here's side-by-side representative views where we did OCT with both contrast and saline in identical vessels in the same vessels, and you have the matched images here. And I challenge you, if we didn't have the labeling of contrast and saline on the left, you probably wouldn't know which one is which. So you could get high-quality images with saline that's available today. It's off-label, but it provides high-quality images and allows you — it's not always about zero contrast PCI, but you can incorporate these techniques into low contrast PCI. And even when using contrast OCT, I take less angiographic images because I get a 360-degree view from inside the vessel, so we don't need orthogonal views. So you can actually be very efficient with your contrast use if you're using systematic OCT. If instead you take your normal angiographic views and add OCT, then yes, it adds contrast. But if you do this up front as a systematic approach, you can be very efficient with your contrast. There's a number of really exciting OCT studies that are on the horizon that you'll be hearing more about over the next five years. The most impactful is probably the first one here, Illumion IV, which has completed enrollment and is in the follow-up phase, will be presented in the near future, and hopefully will shift the guidelines to make this more routine. So we know intravascular imaging, two decades of consistent data showing that it improves outcomes. It helps with procedural planning. I believe it only will help you each and every time if it becomes part of your standard practice, and you need to use a systematic approach. It's not just passing an imaging catheter, and you want to ensure an optimal endpoint has been reached before your patient leaves the room. So I think the question in 2022 is when not to image, rather when to image. Thank you very much. Thank you.

intravascular imaging

optical coherence tomography

interventional cardiology

stent selection

in-stent restenosis