High definition IVUS-guided treatment strategies in calcified stenoses - EuroPCR 2026

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[00:00:05]Good afternoon again. High definition ivos guided treatment strategies in calcified stenosis. That's a tools and technique session. So it's a practical session um with these learning objectives.

[00:00:17]People sometimes ask me what the learning objectives are. Actually it's the reason why we here. We are here to learn how to recognize the value of high definition ivos in assessing calcified lesions and guiding leion preparation.

[00:00:32]We are here to discuss with peers the use of DCB or drugaluting stands or both in a hybrid approach in heavily calcified lesions and we are here to understand how to implement IVOSG guided drugaluting therapies to optimize short and long-term patient outcomes.

[00:00:52]What's in the box? We have a fantastic live in the box from the team in Colin, Germany. You can you can do whatever you like with this team. You can tell all the bad things about them. We won't tell them. They're just here in the first row, but we won't tell them. We have an outstanding faculty. So, don't miss out the opportunity to contribute and interact. So, be part of this team.

[00:01:17]together with me my good friend and co-f facilitator Neves Gonzalo. We have um two uh speakers uh Tom Johnson's and Eval Christensen and we have two uh discussants Neo Salvatella and Roberto Dleti and of course our two operators Yam Mining and Yan Pulz with this I'd like to invite the first speaker Tom Johnson where a has a very easy task to explain us the role of high definition ivos and automated legion assessment in calcified leion. Don, >> thank you.

[00:01:54]>> I've just been told by Roberto that my picture reminds him of high school. So, um, with that, the gloves are off. I think so. Um, the role of highdefinition ivvis and automated lesion assessment.

[00:02:05]Uh, these are my conflicts. I am conflicted by virtue of being an imaging believer and I have to um acknowledge that in terms of my continuing pursuit to to understand where both IVIS and OCT actually might be implemented in complex disease. So my task is to consider how we might use HD IVIS to enhance detection and characterization of calcium and then to think about how we might use new technologies like Aviggo and the the automated elements to that software in in helping us with our treatment.

[00:02:37]There's an elephant in the room. We have returned on the basis of ACC and uh optimal and IVIS chip to an uncertainty within the community about how we should be applying and using intravascular imaging and particularly IVIS on the basis of those two studies. And this is a challenge. It's also an exciting one because I think there's a huge amount of information we need to to dive into in those studies to better understand the outcome as we were faced with and Roberto has been living this for the last couple of months. An outcome that I think surprised many of us which is that the IVIS and Angio um comparison out to two years for the composite of cardiovascular death, target vessel MI and clinically indicated TVR um was non-significantly different.

[00:03:26]My challenge and this isn't a criticism of the study. This is an observation I think of how we use imaging in everyday practice is that we can't consider just simply opening the packet of an IVIS catheter as being good for our patient.

[00:03:41]Imaging is not a therapy like taking a tablet. You know, ultimately we have to react to the imaging. And so it's it's interesting to observe how we used imaging in these studies and have to acknowledge rightly that this was highly complex disease. You know the reason we have 63% prepci imaging was because many were CTO's we couldn't cross the disease but then imaging was done subsequent.

[00:04:06]The issue is how do we react to that imaging and I think that's an interesting one and specific to calcium which I've been tasked with we identified that in IVIS chip there was a huge amount of calcium 45% identified in IVIS 42% in angioarm of severe angographic calcium I would put to you the angiogram is an ass and what we want is actually to use imaging to better determine the complexity of disease specifically in relation to calcium Now actually here when we look at the adaptations as as Roberto tells us actually you know there are high levels of adaptation we have high numbers of non-compliant balloon we have about 30% overall with modification balloons with the use of rotablation IVL but interestingly we don't see a difference between the two groups so the imaging hasn't resulted in a greater use of those modalities so we have to question that I think now we're undergoing a study here on Cyclops at the present time which is about an algorithmic approach to how we center the decision- making on imaging and we use that to then define and then modify calcium and I'll show you a case example of an osteial circ here which is challenging the angagram does suggest calcium and actually we've had to p-ilate as was seen in um a third of the cases in ivvis chip prior to importantly imaging both the LED and the circumflex we define calcium actually less than I expected but even here my interpretation of that calcium is I want further modification.

[00:05:36]So actually take Wolverine into the that vessel into the circumflex to gain further lumen and then we start to use the software to really identify the nature of this disease. And this is where the ALA tool becomes so important in terms of giving us this robust and very rapid determinant of both the lumen and the external elastic membrane. Now I'm making a measure of where to place my 32 megatron stent and importantly identify an area where the plaque burden is less than 50%. The optimization criteria most commonly failed in IVIS chip was a plaque burden over 50%. Now that may well be due to the complexity of disease but it also is required upon us to identify those areas of landing and the tools are now available to help us with that. So the stent, the pot, the wire recross is done and then importantly the recross is telling us both about stent expansion again with this rapid um review where we have an area of six which against a reference gives us a persisting stenosis of 28%.

[00:06:37]That's not good enough. And at the same time when we look proximally we see that the stent the wire into the LED confidently is within the lumen of the stent and not abinal.

[00:06:48]Here we go about then post dilotation and actually gratifyingly see an inc an increment in our lumen from six to seven and a half with a persisting stenosis of less than 20%. Within the left main we've achieved an area of 12 and we've just reported a new consensus identifying new metrics 10 to 12 would be the range we want in the left main.

[00:07:09]So again the imaging gives us that confidence. So I would put to you that the role of imaging in calcified lesions is quite central in my in my view that the angagram doesn't help us in the way that we historically have felt it does but that the implementation of this technology can't just be taken for granted. It requires our interaction and engagement with that and it may well be that these types of algorithms to guide our treatment will become important but undoubtedly the technology particularly the ALA function of Avo assists us in getting rapid results and understanding of what we're achieving in the procedure. Thanks for your attention.

[00:07:52]Thank you very much uh Tom for kicking off the session with this interesting um uh reading reading out of the data and and practical implementation of the messages um accured. Uh perhaps one question um that we should ask is moving away from the setting of randomized clinical trials but to the real world practice. We all are aware of the fact that corrogram can and is limited in accurately um uh predict the presence of moderate to severe calcification. When it's obvious, it's obvious but most of the times the severity of the calcified lesion is not that at all clear on the corendrogram and we'll find it out sometimes when it's too late. For example, when the stand is already in and we are unable to expand the stand. So starting from this consideration perhaps Neos can address this um what is the uh your attitude in your daily practice really on a day-to-day basis in terms of IV implementation and in the setting of calcified coronary stenosis as long as you can see them or as long as you can anticipate them on the basis of a clinical predictors or or something else.

[00:09:06]>> Yeah, thank you. Well, first thing is I try to do imaging up front. So if the probe doesn't cross, you know that you're facing a severely uh stenotic calcified lesion and then you go I go for a threerectomy. If not, if I manage to do baseline imaging, then I try to apply to check all the all the features of calcified disease like the length, the the calcium burden in general, the thickness, although with EVOs we cannot measure the thickness, but the absence of reverberations is a sign of a calcium thickness more than 0.5. the the arc if it's below or above 270 or full full calcium ring the presence of uh bifurcation as well is important because it can make you decide one technique over another one.

[00:10:01]>> Thank you. But can you do all this? I mean um how the question is is uh also about when are you opening up an ivos probe? you see an androgram you say okay this is the moment I need intravascular imaging and that's what I want to know from you >> when classify disease almost all cases >> all almost all >> in STEMI maybe not in STEMI I try to open the vessel and see what happens but in most stable patients I do if if I see significant calcification I'm much more confident using IOS 4 you know from the beginning I have no limitation in my institution for that I know that in some places reimbur person is an issue but I think that we do have many sub studies showing the value of of ivos in calcified disease.

[00:10:50]>> Yeah, I completely agree that we should bring on the table the ivos catheter very early in the procedure. It's both the pre-run, it's the consequence of our calcium modification. Have I done enough? And the post and a lot of guidelines just say you should go for this minimal stand error. You should not land a stand in these areas. But it's sometimes difficult to correct afterwards. So the pre-run is the most important one for me and I completely agree. It has implication if it's in a bifurcation area, is it a nodular calcium, how big is the arch? So the pre-run to describe the calcium is very important because it's difficult to correct afterwards.

[00:11:28]>> So one question to to Roberto because of course the the calcified cohort in I was chip was uh quite large. So a big proportion of patients with calcified lesions and imaging was performed in a significant amount I would say of these patients pre however there are not very uh significant differences in terms of um the plaque modification used. no between the these two arms. So what do why how can you explain that Roberto?

[00:11:55]What do you think is the cause of really not big differences in between the two groups in terms of plaque modification techniques is in the end that these were not super classified lesions is because um this was uh identified in a different way in the two arms. What do you think is the cause? Well, this is an important question because uh actually what we have seen in the IV chip and those are corlab data is that the calcification rate so the heavily calcified uh lesions were u very high percentage even 45% in the IV group so extremely high uh I I think is it's really another scale compare what what we have seen with the majority of uh other trials so we I would define this patient comp really really complex patient um this has implication of course uh we discussed the fact I love the what what Tom said in his presentation that we couldn't cross the uh the lesion in a lot of patient this is true because those were really complex patient first of all more than 20% they were CTOs so by definition you cannot cross in the other uh in the other portion of patient the the catheter could not cross the lesion because it was heavily calcified and this is happening when you have a he have heavily calcified lesion. So this is an important point to understand what what kind of population we are we are dealing with and the other point that we have seen is that they use the same strategy in both arm. So when you use the same strategy, of course you expect to have same results and that's what happened in the in the trial. Now why they use the same strategy? We need really to understand that because it could be that they did not react properly to the iOS imaging. So they did not increase upscale their uh their strategy in terms of uh devices for plaque modification or might be also that they were very experienced operator and they actually applied what they learned in in years making also a lot of IV procedure because those operator were chosen also in terms of IVOS volume and they applied what they know also in the arm and doing also a great job in the ano arm. So we we might have different explanation. We need to have more granularity in our data to really understand what's the reason.

[00:14:34]>> Yeah. One one final comment before we move uh I think Emanuel to the case. Um very practical comment for for the colleagues here is um we always talk about pre-imaging.

[00:14:44]For me pre-imaging is not baseline imaging before you do anything.

[00:14:48]Pre-imaging is imaging before standing.

[00:14:51]So that's that's the that's the pullback that you always need to acquire. I mean it's there are many cases not only CTOS where you cannot cross with >> with the IUS uh pro initially the important thing is that before you decide to go for a standing etc you do an anus pullback in the moment you can cross with your catheter. So Emanuel >> shall we go to Colin >> and specific >> bonjour par a warm welcome here from Keflap number one in St. Vincent's Hospital in Cologne. Um it's our pleasure and honor to present a case to this interesting session which is about HD IV guided um calcium modification modern PCI. Without further ado, I would like to hand over to my colleague Yan Pulz who's going to present the case. Hi colleagues, welcome in our case lab in Cologne. Uh the topic today is HDI with guided treatment strategies and calcified stenosis.

[00:15:46]uh our potential conflicts of interest and I start with the medical history uh 55 years old female patient with stable angina and disperure with a lot of cardiovascular risk factors it's diabetes hypertension high cholesterol active smoker obesity and a very very complex peripheral atal disease with graft stenting and neuro stimulator implantation non-invasive Ive diagnostic the echo it's a normal normal ejection fraction hypertensive heart disease the ECG and lab parameters are normal and we start in the case lab with the left coronary artery in the mid part of the LED you can see intermediate LED stenosis and distally there's a epicardial collateral to the RCA on the right picture there's a circumflex CTO situation.

[00:16:48]Uh today our aim is to treat the RCA.

[00:16:53]The RCA a lot of stenosis from the mid part to the distal part. It's a long distance and we mean it's calcified. On the right side you can see the nor stimulator with the dots.

[00:17:10]And now this is our uh aim today. And we have discussed um the case in the heart team. The syntax score was 27.5.

[00:17:22]The treatment recommendation was a cabbage procedure. Uh but the patient refused a cabbage.

[00:17:30]Medical summary in the case lab chronic coronary syndrome reversal disease with long calcified RCA lesion with intermediious uh CTO and intermediate LA stenosis echanormal stable angina and dispure and today we planned I was guided RCA PCI and in a few weeks a stage um circumflex PCI and DFR L.

[00:17:58]>> Yeah, thank you Yan. Um that's the situation as it is and we already prepared a little bit and um sometimes things are a little bit different from uh what we want things to be. Um as Yan nicely pointed out we have a extensive peripheral arterial disease we have to deal with in this young patient. So we decided for a biraial approach.

[00:18:25]Okay. Now we start with 180,000 rounds per minute and advance our rotational etherctomy catheter with slight movements pecking motion and every time we encounter decelerations we retract the bur a little bit.

[00:18:49]So we're increasing back up with a second operator a little bit in this scenario.

[00:18:56]Now we see can some decelerations at the console.

[00:19:00]We track the bur. This is our second run and you see how easily we are able to cross this super tight and very calcified leion. And important in this case no rhythm abnormalities. We don't see any AV block um or uh whatever. So this is very stable and in these days you don't need uh temporary pacemaker anymore. Um especially in this case we didn't want to touch the groin. So this is a big advantage.

[00:19:32]So the third run.

[00:19:41]So now we are through.

[00:19:45]We are already in the PLLD with our burr um with our third run. Um finally, that's something we can debate. We're always doing a polishing run with 120,000 rounds per minute just to make sure that the lesion is um modified and it's much easier to cross this lesion with the material we need uh um in addition. So let's go that down um to 120. advantage and all.

[00:20:17]So we don't see any decelerations anymore.

[00:20:21]>> What means that we have at least with this versides adequately prepped the lesion.

[00:20:28]Please so remember we are here in the PL a negatively remodeled vessel for sure.

[00:20:40]There's not so much disease. Now we can see some calcification.

[00:20:47]So this is um the crux cordis and here we can see the original diameter of the right coronary artery. So there's still a lot of calcium with some reverberation. What means that we already modified the vessel. We can see a slight dissection but we are still in the true lumen. Something we were a little bit concerned about. This is still true lumin circular calcification here at this part of the vessel. A lot of um firotic lesions again a tight and severely concentrically calcified lesion. also some eccentric calcium. So actually we will do a detailed analysis of this calcium um distribution pattern in a second but actually in this case we see all the variations of um calcium in a coronary artery. For doing so, we first have to know the original vessel diameter. And for this um automated lesion assessment really was a gamecher with this new art artificial intellig based algorithm to see how large the actual um reference vessel diameter is.

[00:22:17]Here we can see a little bit more of disease as in the PL. Here we are in the distal right coronary artery and you can see nicely the cracks in the concentric calcium and also some dissection uh membrane so that we in my opinion at least the distal part of the right corner artery um prepped sufficiently.

[00:22:45]There you can see again some cracks.

[00:22:47]Remember we had lots of um ring calcium concentric lesions there. We can see everywhere these cracks and remember before we did the post dilation with a 3.5 balloon we had already some reverberations meaning that we um did some kind of debulking to these concentric lesions um making this a lot easier to crack them. And here also now we're back in the gilla.

[00:23:15]So what we have achieved so far is the following. Let me summarize for the benefit of everyone. Um rather younger patient 55 year old female patient with several risk factors. We heard the patient has uh also peripheral artery disease. So it's a predictor of very complex procedure in the coronary artery as well. Preserved in ejection fraction.

[00:23:38]The left coronary system has some disease in the LED. a CTO of the circumflex plus this uh uh heavily calcified and long lesion in the RCA. So they gave it a try with ivos and they didn't cross. So by the way and Roberto will confirm this much like fits with the ivos chip patient right. Uh let's remember in ivos chip twothird of patients did I at before stand implantation so at the baseline let's put it like this and they were forced to do plaque modification advance. So to Roberto we asked if you can go to the smart screen to guide us through the IVOS images and teach us how to recognize an efficient effective plaque modifications after rotational and you heard colleagues in Colum did also non-compliant balloon dilotation.

[00:24:27]Roberto, >> yes, >> can you take the hand microphone? Thank you.

[00:24:32]>> Yes, this is a very important point because uh the plaque modification that you have is giving you the variation in vessel compliance and then is having an impact on the expansion of the stand. So this step is particularly important if you want to have a very good a very well expanded stent. So we we selected some uh frames from uh this case uh after the lesion preparation and uh we want to have a look now uh what we did to the vessel. Uh starting from distal to proximal. We can see here a couple of frames where we can observe first uh here the reverberation that we was already mentioned uh during the case and this means by the way here you can observe probably what was the action of the of the rotablation and this means that the density of the calcium there is reduced. So the um uh the uh the echo can go through the layers of the ve of of the tissue and create this reverberation. On the other side uh in the steel frame is more difficult to see but we appreciate it during the uh pullback run. We saw a dissection a large dissection in the uh in the vessel. Maybe I can I'm able to give you the more the uh the the profile of the dissection. Those are two things that are letting us think that we did something to the plaque. We are modifying the plaque. We are having uh some action in terms of uh vessel compliance. If we go more uh uh proximally, we can uh still see something else. Here we see a fracture again in the steel frame is sometimes more difficult to see. Here uh is a fracture in the calcium and on the other side we see again here a fracture maybe you can you can see it and reverberation again on the other side.

[00:26:42]So it means that in this frame we are having an impact of our strategy uh on the calcium.

[00:26:52]Let's have a look also to the next here I think is the one of the first frame after post deal. So we used a an important balloon and a 3.5 and we have here a large dissection. We saw that there is the disruption of the media. We and we have a a bigger lumen. So we are having again uh a modification of the plaque.

[00:27:22]Again another example going more proximally. Here again we see plaque rupture. Here is the side where we observe some circular calcium. And here we see that there is an interruption of the calcium. And again in the other side same story we have an interruption of the calcium. So we go more and more along the vessel and we have the impression that this vessel is quite well prepared. So we go for the last uh portion. We see again here a big fracture in the vessel and in the calcium. here is not very clear in the in the steel frame but there is an opening really large uh what we call fracture but is also a dissection and in the frame that it was moving we can observe that the dissection is going all the way like this and also here but it's not very evident in the steel frame. So we modified a lot the vessel. Uh here we have a large dissection involving the media and we have extensive uh fracture in the calcium. So if I look at these images I would I would um hypothesize that the lesion has been quite well prepared that my stent is going to be well open when I'm implanting.

[00:28:47]>> Excellent. Another question that normally we try to address with IV images is about the size, the length. I don't know if you had the opportunity to to look at those images and to give us an idea what would be your stand choice in this or or drug looting balloon choice.

[00:29:05]>> Yes, we have seen a vessel that is a bit tapered at the end but overall is quite a big vessel. So it was spread deal with a large balloon and we can just count one, two, three, almost four. So what I would do is to think about a four stand and more proximally even probably a post deal to 4.5. That's actually a very practical recommendation from Roberto.

[00:29:31]The RCA unlike the L doesn't taper down much. So most likely we might need one size of stand fitting at least most of the RCA and if we need something different that would be in the very proximal segment. Neves shall we elaborate a little bit more in this section of the live in the box?

[00:29:52]>> Yeah. So um we have seen here and I agree with Roberto that they have achieved a very good um preparation. Any of you could have chosen a different strategy. For example, the Jan and Jan here they decided to go for NC balloon after ROA. Is for example more your practice to use cutting balloons? I know for example this is very no a very common practice for you after ROA try to use cutting and what is the what is the purpose of that?

[00:30:21]>> Well um we we do have some trials showing that it is an effective strategy.

[00:30:26]The rota makes some room and makes the calcium um smoother, thinner. And then with a cutting balloon that you can under size a bit and go to high pressure, you can and you see it with with imaging that you you create a lot of cracks. So this is quite a safe strategy and we do have some data from from uh the shortcut trial showing that it is as effective at not inferior to to rot shock and and cheaper. So I think it's a I cannot say that it is better than using a non-compliant balloon but I say that it is effective and safe to do so.

[00:31:03]>> An intermediate way to do is to keep the rotor wire and do a parallel wire and then you have the scoring effect and if you have a waist on the balloon you can go back with a bigger bur. So that's a way to stay in place.

[00:31:17]>> Yeah. Hold on. Uh since you you like this topic of rotablation, why don't you help us addressing this question from one of our colleague is it true that if you're doing your final run with 120 140 so we alluded to the polishing run you get more lumen gain.

[00:31:36]I heard that theory but I'm not seen that in practice that some is even doing with um the Daglide to go down in speed and they say they can have a kind of orbital effect but I have not seen documentation for for that.

[00:31:50]>> Manuel I I'm I am an advocate of that.

[00:31:52]Uh there's some Japanese truly Japanese data in the sense of pre and post slow slower run. They went down to 100,000 revolutions but showed a 200% increase in gain by by measurements cross-sectionally by intracoronary imaging. I mean the orbital effect it is a reverberation. You say polishing but actually you hear acoustically it it changed. I mean Yam went Yamalta went down to 120 and and you get a similar issue. Clearly the concern is around the risk of burst stall and you're only doing it after multiple runs where you've you've debulked. though you'd undertaken three four runs by the looks of it before having come down to that slow speed but conceptually there may be more to gain rather than taking an additional burr in that in that first instance >> we need to address another question before moving to the lecture of Evald why does a dissection seem black on iOS how to diagnose it and this question goes right away to Roberto because you you showed us this dissection the colleague wants to know how does it come that it seems black on iOS the dissection.

[00:33:00]>> Yeah.

[00:33:00]>> Yeah.

[00:33:03]>> So, uh basically the difference is when we have calcium the the acoustic wave cannot cross it and we see >> sorry for again.

[00:33:13]>> Yeah.

[00:33:14]>> Sorry.

[00:33:15]>> Yeah. Go ahead.

[00:33:17]>> They cannot cross it. we see uh as a as a white layer in the dissection we have basically blood going into there. So we can we have basically the the the black image that we have there.

[00:33:32]>> I mean I think you beautifully outlined it on the smart screen that the still frame is is not a good way of identifying these kind of dynamic structures and so within the system it's critical that actually you put dynamic review on. So there's a button that allows you to toggle between a series of frames which gives you then a much better appraisal of it. So I routinely will have dynamic review on for the assessment of of those tissue elements dur during the review of the of the IVIS run. If Nos doesn't have really a burning comment, I would like to fine.

[00:34:06]Okay. I would like to move on to Evald's lecture to whom we ask um what are the option available in treating heavily calcified lesions. We have seen the strategy of the colleague from Colon. So rotational arterectomy non-compliant balloon but that's nicer summarized what is now available. So yeah, calcium modification strategies in modern PCI have these potential conflicts of interest.

[00:34:33]So the key insight of this short talk is that calcium is a major predictor of adverse events. Imaging used to assess and decide strategy is proven to improve outcome and optimal use and device selection reduces complications. So why is calcium a problem?

[00:34:51]It's a problem because it impairs equipment delivery. It requires specialtity modification devices. It may damage the desks and impair drug delivery and may also lead to suboptimal desk expansion.

[00:35:05]To succeed, you need to modify and prepare. Use intervascular imaging to assess the lesion and decide do I need modification and if yes, you should select the right tool for the modification.

[00:35:18]What can intravascular imaging tell us about the calcium?

[00:35:24]And what characteristics of the calcium matters? It's the arch as also already mentioned is the depth of the calcium, the length, eccentricity and compliance.

[00:35:36]And we have calcium in various morphologies. We have concentric all the way around, eccentric and nodular.

[00:35:45]I will focus on eccentric calc because it's difficult to modify. Conventional balloon don't modify eccentric casm. It tends to bulge towards the side where there's low compliance. It can be the vessel walling can even be the side branch and the calcified part often sits opposite to the side branch and this is where we get the karina shift when we put in a stent if we don't modify it. So your objectives in modifying the calcium arch below 180 is to get a calcium dissection and detachment. Because if we can get a detachment of the castle, we have much more of the circumference of the vessel that we can stretch when we put in our stent. That means mobilizing vessel compliance to achieve a larger minimal stand area. Here's an example of a small dissection in the transition zone between the calcium and the normal vessel giving this minimal stand area.

[00:36:44]If we can achieve cracks in the calcium and a big dissection behind the calcified part, this part of the vessel can be stretched and we can achieve larger dissection. A way to achieve that is to use the bull ring cutting balloon.

[00:37:02]It can give a high force in the transition zone and contribute to dissection but also to cracks in the calcium. So it can mobilize vessel compliance and achieve larger minimal stand area. So in this case we are seeing here wolverine would not be a bad idea if we didn't see cracks in the calcium.

[00:37:22]So when to consider advanced calcium modification?

[00:37:27]Now we are moving up to above 180 and I think we can learn about rule of five and rule of three. I would recommend the rule of five when we are in a circumference of 180 to 270.

[00:37:40]So if we have an arch that's above that a half of the circumference a length above five and a thickness above 0.5 we should use advanced calcium modification that could be IVL.

[00:37:53]What if we have an arch that is above 270?

[00:37:58]There is not the maximum thickness that's important here. It's the minimum thickness because the minimum thickness drives you to have the possibility to crack the calcium with conventional non-compliant balloon. So please remember rule of five and rule of three.

[00:38:16]This is really actionable.

[00:38:20]So this is a conclusion of that. If you have eccentric calcium below 180, NC scoring and Wolverine cutting balloon are good options. If we have eccentric calcium above 180, use the rule of three or the rule of five and IVL is a good solution.

[00:38:38]And the advantages of IVL is it's easy to use, it has a good efficacy, it's safe, and it's selectively working on calcium in the vessel wall. We don't need these super high pressures.

[00:38:51]I'll give you an example from a case I did in the fracture trial that was presented yesterday by Margaret.

[00:39:00]This new device has four emitters. That means it it's it can easier modify eccentric calcium and nodular calcium. This case I had had very high calcium burden with a lot of nodular calcium. I was able to bring in imaging catheter after a small balloon. I had eruptive calcified nodule in part A.

[00:39:25]These small cracks in circular calcium was from the small balloon to deliver this new IVL catheter. And there was also nodular calcium in this region.

[00:39:36]What's the lumen here after IVL alone and no ballooning? What's the lumen? It became bigger. So we had lumen gain with this new IVL device alone. So this lumen gain may uh also be a predictor of having a good stent expansion because it's achieving compliance in the vessel wall. So this minimal stand error of 7.6 was a good result in this fracture case trial. The result I'll just make a short uh introduction of the result. there was a treat performance goal of 86 and the performance goal for the primary safety endpoint was 93% and for the success rate also 94%.

[00:40:19]So I think we'll hear much more about this new device that will be presented to us by Boston soon. Thank you.

[00:40:33]>> Thank you very much. So I think it's time to go back to Colon and see how they concluded their case.

[00:40:39]>> Lovely presentation.

[00:41:09]Nice. And even though these are semicompliant balloons, they perfectly stayed in place during this kissing balloon inflation. And we will give the balloon catheter some time to deliver the drug to the vessel wall.

[00:41:24]60 second.

[00:41:27]So we're going down simultaneously. One, two, three, and down.

[00:41:38]>> It's only first with 12.

[00:41:41]Okay. Nice. So there's the super smooth stand expansion of the balloon.

[00:41:49]And down, please. Down. there's a dissection in the um PDA. Um I wouldn't be concerned about this because we saw in Iowa that there's a lot of negative remodeling and as long as this is not flow limiting even though this might seem provocative. Our practice in Cologne is to leave it as it is and um do a control and geography in three to four months. If there's a remaining um dissection um we can stand it. If not, most of the times the vessel heals and gets a lot larger. We leave it as it is.

[00:42:38]As we're still waiting for automated stand assessment ASA so far, hopefully it will be introduced this year, we have to use a trick and bookmark the most distant part of our stand as reference.

[00:42:51]And then we can see by um retracting in the panorama view um our pointer that we have a stenosis degree. And if this stenosis degree is um with a minus in front then it the stand is overexpanded. If there is um something like 10 or 20 that means that there is some slight underexpansion. So maybe advance the pointer a little bit. We saw in the pullback already that there is some kind of a vessel. We are now approach approaching this part where there's still remaining uh calcium. um the minimum stand area is sufficient already but we would decide to post dilate this with a 4.5 u millimeter balloon and um with the rest of the stand we see according through the um Ibis 123 algorithm no mosition no edge dissection distally but before the stand we have seen some kind of intramural hematoma which uh occurred after um post-dilating the stand um a little bit more aggressively with our 4.0 balloon. In my opinion, this is something we shouldn't leave without um a stand in these days. I mean, we're creating data so far. I wouldn't be concerned about PDA and PL, but this proximal right coronary artery has to be treated. We will probably need another 4.0 by 38 mm synergy shield stand, but would post dilate this first with a 4.5 mm non-compliant balloon.

[00:44:46]It's 14.

[00:44:51]Also nice expansion of the balloon.

[00:45:09]We can appreciate again this slight dissection. Here we see the bifocation.

[00:45:15]Some remaining disease we treated with kissing balloons with kissing drug coated balloons. Now we are in the first stand in our distance standy 4.0.

[00:45:28]Very good stand expansion. Remember we post dilated with a 4.5 mm non-compliant balloon up to 20 atmospheres at this part where we had the most difficulties actually to wire this lesion as well because it was so super calcified.

[00:45:46]But I have to say even without measurements just from an eyeballing perspective it's significantly larger than before also this part of the um stand of course there is some calcium left but the minimum stand area is much better than before here we can appreciate between 12 and 3:00 a remaining intramural hematoma and I wouldn't push the limit too far this part of the vessel a slight underexpansion again in our second stance I would leave this here as well as it is because our IVL balloon catheters are up to 4 mm and that's not enough. Um, and I wouldn't dare to do a more aggressive post dilation as we post dilated this part of the vessel with a 4.5 mm non-compliant balloon up to 20 atmospheres over 20 seconds. You can appreciate the calcium cracks in the circular calcium. And now we approach the proximal um edge of the stand.

[00:46:44]would like to check whether there is an edge dissection according to the IV 123 algorithm. That's it. This is hopefully our last IVIS run just to reassess the proximal stand edge.

[00:46:58]Flush the catheter.

[00:47:00]Okay, perfect. No stand deformation. That's really important. And um very good opposition. This was really long work and of course we can still appreciate this dissection membrane in the PDA and also at the distal PDA some collateral flow from this nice epicardial um collateral um originating from the um L.

[00:47:29]I think having shown you um that here we can be happy and are totally satisfied for our patient. And I mean it started complicated uh and the most important and most difficult thing was to getting access in this biraial approach preventing her groin groin from getting punctured. That's what we achieved with a nice and beautiful um angographic result and even more important with a very good uh um result in intravascular imaging and um having said this we wish you a good day in Paris and hope to see you soon. Thank you Dr. P.

[00:48:06]>> Thanks.

[00:48:12]>> So there are lots of questions here but before moving uh to that part I'd like to ask to still NOS to guide us through the IV interpretation of this stent implantation. How was the quality of the stent implantation? Teach us how to read the IVOS images.

[00:48:30]>> Well thank you. Well quality was good as you saw. So in the IOS 123 algorithm that you're probably familiar with otherwise you can check it through the educ platform. This is a a stepbystep algorithm that was um designed to help us being systematic when using others to guide our procedures. So there are three steps post stenting that should be addressed.

[00:48:53]One is we check both this um stand edges. So in here on the left we have the distal um stand edge. So we have to check if there is any residual plaque version or um dissection that should be addressed. So as Tom mentioned for this it's very useful when there is no stent to use the um oh what's the name >> dynamic review >> the dynamic review that goes a few frames back and forth. So it's much easier to check where our lumen starts.

[00:49:28]Okay it's here. That would be so this is more or less what the the ALA would show but we have to know how to do it and this would be our lumen and this would be more or less our toal. So we also have from ALA the automatic calculation of our residual plug burden that would be below 50% that there is no geographical miss here and then we move to the proximal stentage and we check um the same if there is any proximal dissection or any any significant plug burden. This is the final um final um proximal stand edge. That was okay. But in the run between the first and the second st there were some some things that were needed to be addressed. So we checked both edges. Then we have to measure stent expansion. So that was explained in the video by Yan that if you set a reference using the the the distal stage after just after the stent we have an automatic calculation of the stenosis. So if this residual stenosis is um below 10% it means that we have more than 90% stent expansion and this is quite this is automatically calculated by the ALA. So send expansion is a second step and third is stand opposition. So center position suppososition is different from expansion. A position is a contact between our stand and the vessel wall.

[00:51:05]And there was a frame there's no major malaposition but there's a frame where we could see some malaposition in here.

[00:51:12]So my stand is and this is also useful to check with a dynamic review. This is my stand and this is my vessel wall.

[00:51:20]And if we do have maloposition on the especially in the proximal part of the stand this should be corrected.

[00:51:27]There's a increased risk of stentrombosis but there's also an increased risk of going under the struts when you wire again the vessel though.

[00:51:35]So we should try to address and correct malaposition.

[00:51:40]We also saw um on the um run after the first stunt implantation that there was some some hematomas on dissection proximal to the stent and this this can be visualized of course quantitatively but it was we could also um check the the plaque burden there and because of the pens of hematoma we had more than 50% let's say stenosis in here you see this is our lumen And this is is our vessel. So this also needs to be covered. We have some dissection and ematoma that was covered with with an extra an extra proximal stent.

[00:52:25]And finally we could see here oops.

[00:52:30]Well I think that this is all.

[00:52:36]>> Thank you.

[00:52:38]Thank you very much.

[00:52:39]>> That's it. Thank you news. So actually there was a question of one of our colleagues about uh how to assess the MSA when you have a long segment like in this case if you need to use of course the distal reference and proximal reference and and use um this to calculate your stance expansion but I think it's very clear now with the explanation from both Jamal in the in the video and and also um from uh from NEOS. So there's a question here that I'm going to address directly to you and is how long did the whole procedure take? It was a complex case.

[00:53:14]>> Yeah, just join us.

[00:53:15]>> Of course, >> join us on the podium.

[00:53:19]>> I mean you have seen uh taking a look at the radiation do it was a super complex case. So you made it the case look very easy but believe me or not I mean she was a very young lady had an issue with anxiety and it took us 1 hour and I mean we are not doing that the first time to do a CTO like lesion in a biraial approach but was super complex and backup was also not u um so optimal I would say >> um actually we plan to do it with a um AL1 but that was not possible to get it in and then the next step we thought there is a lumen and some kind of micro channel but um that's the part we skipped out and also took us again 55 45 minutes um we had a super super hard way down so we had to do an integr wire escalation and finally even used a GIA next three to get to the distal part of the RCA that was also the reason why I told Jan we're still in the true lumen because we had some doubts during this procedure I mean that's the way it is we planned as a life in a box case and So 1 hour plus 55 minutes >> and what else?

[00:54:28]>> Yeah, I mean I mean IS and stand implantation 2 and a half hours only 45 minutes. So 2 and a half hours 2 and a half hours part was the easiest part before all the everything before.

[00:54:39]>> Okay. Um so there is um there are also some questions about um potentially other plaque modification techniques.

[00:54:47]For example, uh there's a question about the use of orbitaltomy. I don't know if any on the I don't know eval if you um are using oridctomy. Do you think it's that could have been also for that?

[00:54:58]>> I I had the slide in my presentation but it became too long. We had the eclipse trial but that was a trial that was also for patient that could be treated with balloon alone. So this was not a trial of um of uncrossable lesion. It was a trial of patients with severe calcification and it was neutral. It was not in favor of using orbital artctomy.

[00:55:22]>> But but I mean that brings us back to that comment around the angagram being an ass which I feel responsible for in being particularly persecut.

[00:55:34]It gives us a hint but beyond that it doesn't really tell us more. And yet the angagram is essential for understanding expansion of our devices. So you shouldn't lose angio completely but it shouldn't be the determinant of your approach to the calcium modification.

[00:55:48]That's where imaging is essential.

[00:55:50]The other very interesting aspect of this case that of course in the end was a CTO uh no then we do that very often I think nowadays no is the typical findings no you have a distal vessel with a lot of negative remodeling very small and then you have a huge vessel proximal and also so a vessel that changes so much so much the size no along the vessel it's very difficult really to size the stand etc so I think it's it's been a great explanation by by John and also um by Roberto about how to measure here it's not easy but also the combination of devices is is in this case the operators decided to go for a hybrid strategy with distal DCB plus uh extending the proximal area. Is this something um you you think um are you also doing that in your in your practice? In this case there was some dissection in the in the PDA you would feel obliged to to stand this Roberto.

[00:56:41]Can you let it like this? What do you think? No actually I like the strategy that they had because there are some data that are saying that in the distal portion of this CTO like uh lesion you might have uh negative remodeling but also u some sort of uh spasma. So the these these vessels they are growing over time when they reacquire flow. If you make an at 3 months you might see a very different vessel. uh if you make an ius at 3 months, you might measure very different uh measurements. So uh we when we uh reopen CTO's and we have a distal vessel that is uh like that, we tend to leave it and when we ask the patient to come back, we very often see a a different distal vessel, very different vis distal vessel. So I must say that I agree with your strategy. Mhm. Just a final question before uh we wrap up is um so you use kissing DCB. There's a colleague uh here asking is this a standard if you do kissing DCB and you're not diminishing somehow the drug that is going to to the vessel wall. I don't know who in the panel want to take this question.

[00:57:52]>> I I was interested Tom I was interested by that technique. It's been discussed obviously the EBCDCB trial is ongoing in terms of denovo treatment of of bifocation and it it has actively avoided that strategy due to a concern that I mean the balloons as expanding there will be a portion of the vessel that may not have contact with drug and at the same time the the requirement of maintaining geometry may be different in the absence of a metallic scaffold. So potentially blowing a balloon up in one arm and a balloon in the other may provide similar or more efficient transfer of drug, but it's not been tested. So I think it was a reasonable thing to do, but it was certainly something that piqued my attention.

[00:58:34]>> Yeah.

[00:58:36]>> Okay. So I think um Emanuel that we can wrap up the session if you if you agree.

[00:58:41]I would take the these take-h home messages. Um I think that the clearly the case demonstrated how IBUS enables accurate calcium detection and pattern characterization. So it's not only that we see calcium, we characterize this and we can guide the selection of optical optimal plaque modification strategy.

[00:58:58]Following preparation also IBUS can provide very significant information about the plaque modification and can support us in this decision making. If we decide to go for extending, can we use hybrid uh treatments? Can we go for DCB only? And finally, these automatic measurements in this case LA enables precise vessel vessel sizing and evaluation guiding again device selection and procedural optimization.

[00:59:25]With this uh Emanuel, if you want to close.

[00:59:28]>> Well, a big thank to the team in Colin for the great job and a big thank to the colleagues here in the panel for the excellent discussion. Good continuation of Europe PCR. Thank you.