Transcription
A [Music] so I think I think we probably ought to keep the energy in the room and um get started. If if you ever needed a warmup act, I think to have Patrique and Fernando um creating the debate, there's every expectation this is going to overrun, Ben, I'm afraid, but I'd like to start the clock maybe at 15:55. Um, so it's a great pleasure for me as the chair of this next session um on behalf of Cordis to to really extend the conversations we've just had in relation to this very exciting field of drug-eluting balloon um and specifically now to consider maybe drug-eluting balloon use in bicationic panel.
J, I'm sorry that you are the only non-UK representative, but um joined by them, Peter, Simon, and Dave, and actually all of us have been um recruiting patients to the Solution denovo study. If I could just have my slides up just to outline the presentation, so what we're hoping in the next 30 minutes is really to offer maybe some experience from our engagement in that study. Um, there's another damine moment I think with Peter uh who is going to kick off by uh describing his journey to metal-free um and then beyond that, Simon will give some of his uh experience and expertise, but then also very importantly, actually share with us some of the data that was um collected in the first thousand patients recruited to Solution. Solution denovo has now um closed recruitment uh earlier in the Summer with the expectation and the hope that the um primary outcome will be presented at next year's TCT. So I think for the purpose of time we will get on and I invite Peter up to uh present his journey.
Thanks, Tom. Uh, it's a pleasure to be here. Thank you for the invitation. If I could have my slides up, please. We had a very provocative discussion before this session, and I think this would also uh be very similar. So that's my uh necessary slide for conflict. Um, so J, this is really my Journey um and it's going to be similar perhaps to what Dave was just suggesting. For me, I'm thinking going to talk about a decade um and I'm going to talk about how we've gone from simple lesions that we made complex to more complex lesions that we can make simple. So that's the sort of message of this uh next eight minutes. Three components to intervention in my opinion: lesion assessment, and I think without doubt best done for bifurcation with icrone imaging; we don't get that much information from land. The second phase is of course preparing the vessel, and that's the key, and we got to get it optimal. And then finally, destination therapy, metal perhaps for some, but I think let's think about going metal-free and how we can apply this newer technology. We know that this sort of simple lesion we can get a very interesting stent result, and this case uh I'm going to show you was with a Kop. It's a pretty simple lesion. We had a great session earlier about 1, and there's no perfect solution with stenting, and in fact, this looked okay angiographically, and it looked pretty good at 3 months as you'll see in a second with ofdi, but I got obsessed about the carina, and I was thinking that the Kina should be free of metal, which led me on to access.
In 2014, before that we were putting in quite a few access stents, and the key we learned about this technology uh was that you had to prepare the vessel; you could get very nice results, you could get this Kina free as it said on the tin, but but the rest of the vessel they still became full of metal because we put stent distal and obviously they had the access proximally, but the preparation of the vessel was the absolute cornerstone of this technology. It was tricky to put in uh first of all, but if you didn't prepare the vessel you could not get good placement. So if there's calcium, you had to use atherectomy or other tools; you didn't have IVL, then you had to pre-dilate both the main and the side, and you often use cutting balloons to get proper uh effect at those ostial lesions for recoil. The positioning was say a bit tricky, finished off with a kiss, but you get pretty good results, and they were fairly reproducible um and actually you know this was a good technique, but of course the technology was never going to last; expensive to make, and the uptake was uh you know not that that common. There's a few people in the room who certainly using it, but we applied it to many different bifurcations; we even put it into lesions where we had complex CTO, and we finished off with access. We put it into vein graft uh failures in bypass surgeries. We'll see in the next case you know whether it was necessary to put all that metal in; I don't know now looking at it, you know you could perhaps apply a different technique in the modern era, but you know even some of my great companions here on the on the thing they came across and we did some cases together, so everyone was at doing this, and then this other technology was around the same time, and this was even more appealing because it was something in my mind that was never going to stay there for the long term, and Patrick's already made that point. And this is a case from 2014-2015 with uh clear stenosis; this was the only case I did with a double absorbable type case, but preparation again was key. We did a TAP in this case um and I was really worried about this case for a long time, but in fact this is eight years later; patient comes back 2023, it looks perfect; it's got a stent to the LAD; you can see the culprit here was the right coronary, and this patient was randomized in the Solution trial sadly to stent and got a big stent to the right coronary with image guidance. So that's just you know is a a modern era, but we learned today; we've learned at every EBC that provisional strategy is the best, and of course it is; putting minimal metal in has been proven to be more superior to put in tons of metal in, which makes complete sense, but it isn't as easy as we all think; not in the cath lab, nor do you get older; your eyes get less good, and positioning in the pot for instance can be hazardous; you go too far, you shut the vessel; if you go too proximal, you know you have geographical miss, and Niels has already said from October: a bloom the wire, and even in experienced operator's hands you get it in 5% of cases, and if it's not corrected it leads to mace, and this was a case of a colleague didn't correct it, didn't even notice it, and they crushed the stent. So AB wire is a real problem; there's ways to get around it of course.
So here is a case from just a couple of weeks ago; anterior NSTEMI; it looks like a simple lesion; we got some coronary sign; reduced to do this was like a warm-up case; thought it'd be very easy. We do o guidance, cu; the PTI is going to go into the error registry which is Tom is running; o I think again gives us real clarity of the case; it tells us to avoid that sort of bigger proximal vessel; we have a nicer landing zone just a little bit away; got perfect measurement; you see the diagonal is really clean; it's not going to be a problem; very tight lesion in the LAD, so we prepare it, and at this point actually I was very tempted to stop; I thought I got a great result, but we're finished Solution, so wasn't an option to randomize the patient, and this is the oot, and and what we just heard from Patrique about these uh dissections you can see, but it looks fine; I could have easily stopped, but because we're not doing the trial and all the discussions about guidelines, I put a stent in, and I sized it maybe a bit oversized, but it was sized; this this little vessel; the pot balloon I thought put it in the right place, but that simple technique of putting the stent in jails that completely normal diagonal. So I've gone from having a really nice result to having a problem, and actually it wasn't so easy to wire; had to use a dual Len; had to use a Pilot 50; slightly aggressive; a bit risky; chance of perforation so forth; we got it open and I kissed and then pop, and we get a good result, and the patient's fine, but it's gone you know an extra probably 30 minutes or 40 minutes of the case; more x-ray; more contrast; more time and frustration because it delayed the rest of the list and meant it was harder to get to the next conference later in the evening.
So 2024, you know I think we are moving away from this sort of perhaps concept that stent in is the right way forward for all these cases, and perhaps we need to think of Alternatives. So how can DCB make it easier? How does it make it more simple? Well, it makes it simple because we don't have to think about these complex stent techniques; the principles of the case remain the same. So we assess the case perhaps with physiology upfront or with imaging to understand what we're doing; this is an example here of a more complexification than you've seen already; this is very basic basic imaging with eagle eye II's, but it gives us enough information about the plaque morphology; perhaps our landing zones, and I think it's it's fairly simple but effective and quick. We then prepare the vessel, and the preparation as I've already said is absolutely key; we use cutting balloons, scoring balloons much more readily than we would perhaps ordinarily, and when we're we're satisfied that we've got a good result in the main vessel, we think about the side branch, and here this is a a trial patient was randomized to Solution, so independent uh diagonal that does need treatment; CU it's severe, and you know often you get this recoil effect, and we go for that 30% as a sort of the marker from the consensus paper. So we focus a bit more on the preparation with a cutting balloon at the osteum; it's very effective; we move the NC balloon, and then actually that we're kind of almost done at this point; we've finished with our preparation; we're happy; and geographically here looks good; what does it look like on IVUS? Well, we don't know the answer on IVUS in terms of how good we should get it because we don't have that information; I think we need to learn it, but because it's an angiographic study, if it's less than 30%, we're happy to randomize and go with the; we're happy to treat with a balloon at this stage, and then the treatment stage is really simple; it's a balloon to the diagonal with a Solution; it's a balloon to the LAD, and the case is done; so no recrossing; none of all the complexities of having to work out where we've crossed with a a wire, and how does the stent look? Forget all that; it's really straightforward.
Final thoughts: DK crush in that type case; all those steps; you may have modified it with Thomas's talk; provisional; less steps, but still quite a few steps. With DCB it's all about lesion prep, and you go from heavy metal to minimal footprint, and I think that's got to be the way to go. We need data, and Solution I hope is going to provide it, and of course it may not; there's going to be more trials to come in different arenas, but this is where we're at, and I think this is where we need to think going forward, and there's still a lot to learn, but I think we're in a good place to learn it. Thank you very much.
Peter: Thank you. Fantastic presentation. Now this is a slightly loaded question because I think we're relatively aligned, but I'm not sure about the rest of the panel. You you've emphasized quite strongly there a place for imaging; do you think do you think imaging is as necessary for the minimal footprint than it is for heavy metal?
Well, great question. I mean obviously for heavy metal I'm 100%; you have to image because I just don't think you get good results with angiographic even in provisional. I think for minimal footprint it perhaps at the moment seems less so; you don't have to do it, but I think as a learning tool it will help to us to understand because I I suspect there may be a point that we need to create these dissections because you might get cases come back because you didn't prepare enough, and perhaps you have a minimum threshold of what you should be achieving with imaging guidance; try and understand the sizing like we have with stents; I think that could be very useful information, but it may require another study; just throw that to the panel.
So in Gran, what's um so not as much imaging because I'm not afraid about malapposition etc., but um more looking at flow. I think uh I don't know if the QFR post-procedure is an answer, but that's what reassures me when I have a QFR above 0.91, and I don't even know if that's the right threshold for DCB um and just a quick comment also about this journey of yours about scaffolds; we always made this mistake of needing something to scaffold, and we don't actually right and to allow the positive remodeling um you actually don't need the scaffold, which always had a bit restricted remodeling first; so that's a side note, sorry.
Yeah, I would say uh at the moment a lot less imaging in this setting; it's very angiography driven, but angiography has so many limitations; it's quite possible as we learn more we will find out that IVUS or OCT or whatever will will show us okay this this is this is safe to leave; this is inadequate uh this is good, you know; so it may be able to characterize things better than pure angiography um can I just make a comment? Um, so as as an American operator, I I love coming to Europe because I I always learn from the Europeans, right? You guys are always ahead of us when it comes to new technology like drug-eluting balloons, and having done PCI for a couple few decades now um I haven't taken the Journey that David, you and and yourself have taken, and and it does seem you know kind of nerve-wracking to be honest, because if you think about where we've gone with stenting, right, it's that consistency; it's you know the radial approach; you know we have like 90 plus percent same-day discharge um and and so I think until you show me evidence, and obviously you guys are accumulating that confidence, that evidence that you can get away without acute closure with you know what level of dissection to leave behind, what not to, I mean the consistency we've gotten with stents, radial, same-day discharge and then optimization with imaging and you know all the standardization around physiology and imaging it's become standardized, right? We we've reduced the variability based on experience when you add physiology, imaging etc. So I do think that while this is very exciting to me, getting us at least in the United States to get the comfort level and the evidence it's going to take quite a while; it's going to take a lot of learning; a lot of comfort; you guys in the UK and in Europe have are personally going through that journey and getting that confidence; whether it's our medical legal environment, whether it's our financial situation, the expediency of same having same-day discharge it just seems like quite a journey before we standardize things sufficiently; get the data for us to embark on it.
Yeah, I mean I agree that we've got to a standardized approach, but we've just had three hours discussing where the struts might sit in a bifurcation, so the standardization is a standardization of not really knowing. Um, so the avoidance of the metal may be very attractive, but I agree there needs to be data. Just a little comment about a potential endpoint post-DCB uh I think post-PCI physiology is uh an extremely good possible target, and we reflect the same concerns that were voiced earlier that what is the endpoint? How do you know that this dissection can be left and this dissection should actually be addressed? Because we're always balancing the risk of an abrupt closure versus the efficacy in the long term, and I do think that post-PCI physiology actually offers an easy and reproducible endpoint because if you do get past a particular figure, the risk of its closing down is probably a little less. I mean I I don't know; probably this one of the targets that we should look at.
Yeah, I agree with you as well, and there certainly being been when I've had some clinical doubt as to whether it's safe to leave; I have exactly done as you say; I've done usually I've started with physiology and then I've fit it; finish with physiology, and if you got a very normal FFR, I think it just proves that the flow is actually pretty good, but we don't really have a data set to to back that up, but I think from hopefully from Solution there will be a number of sub-studies; the invasive wiring was actually relatively low volume, but there will hopefully will be some opportunity for sub-analysis with the non-invasive uh non-wire based physiological assessment that hopefully will give us some insight into exactly that question you've just asked. Two two more questions. So yeah, Patrique, the the original data from POBA and rosis, if we go back to the original paper by Gary Min in the '90s, 996 I think in Circulation, they showed that restenosis after simple balloon was actually negative remodeling 65-70%; do we have any data that the drug-eluting balloons um improve the uh negative remod or we have neutral or even positive remodeling? Do we know that maybe the way we treat it because I think that's the key; that's the no intimal uh proliferation; we know it was L after POBA than with stenting, but the negative remodeling; have we eliminated that with a drug-eluting balloon? Do we have any data?
Uh, so my understanding of the data related to balloon angioplasty only when that's all we could do was that you would get late lumen gain in about 30% of your cases. No balloon angioplasty only with paclitaxel balloons that have been um investigated a fair bit over the last few years; the ones that work that deliver the drug in a way that has the effect that you want, you are getting late lumen gain in about 70% of your cases. Yeah, and that's angiographically, but also Paul will tell us in a minute on OCT.
Yeah, no, that that's right; it's about uh 70%; what you can do; no constrictive remodeling; it is a stable of increase. I want to come back on on the two statements by Joanna; I think it's correct; velocity of the flow is the key things; so many of these software now I'm measuring automatically the uh front of contrast in the vessel; that's probably enough; I'll tell you an anecdote after that, and I think David is also right; we are going to learn from the imaging; maybe it will not be permanently necessary, but we'll learn I think that when we do an OCT and you don't see any problem with the clearance of the vessel injection of contrast, you can be sure that the flow is good; the the the contrast comes in and comes out; there is not a cul-de-sac of a dead hand where you have red cells staying; that's a good sign; what we should avoid is to have the dissection post-stenting apply to the DCB; don't forget Gonzalo; Gonzalo NES; Gonzalo has described the dissection at the edge of the stent; that's a totally different animal because it's a junction between something rigid and something flexible, and that's very dangerous; so don't apply the the concept of dissection as edge problem; that's don't apply that; that's really; I'll tell you one anecdote because I think it's interesting; in 1982, February 1982, I go to Stanford okay to the course of John Simpson until there; 79, 81, 82; two patients on 10 goes to surgery in Rotterdam; there's nothing you can do about it either at the time of the procedure or at 5:00 okay; then we go to Stanford because there is a guy called John Simpson introducing the long wire, and I go well along with uh John Simpson and I get 150 long wires; go to Skipo; pass the the security and the custom with my 150 wires, and then you know from a success success rate of 80% we went for 100 patients; the 100 and 1 went to surgery, but for 100 patients we didn't have surgery; why? Because my colleague which was much more daring than myself said okay it's dissected; let's dissect it more; so when we have a dissection with a balloon of 2.5 we were going to 3 and dissecting more, and we were avoiding systematically the bypass surgery; that's what has to be done a little bit with the drug-coating balloon and the preparation before; it's not a dilating device; it's an eluting device; it's a delivery of drug, but I think that
There was a message. The other things, if you look carefully in the literature in circulation, I have published a paper which called therapeutic dissection, and therapeutic dissection. That was the line of contrast parallel to the angel; everybody was afraid of that, you know. There were already people saying, maybe we should send the patient to surgery, and I said, okay, I mean, what is this? It’s contrast; who goes somewhere outside sometime? It was disappearing also; you wait a little bit and disappearing. That’s what I call Therapeutic dissection. And if you look at the paper in circulation, that was the best result post-angioplasty. Yeah, so that’s all kind of sign, and I’m sorry to talk about anecdote, but you, you go back to the balloon, so you have to learn what you have, what you have seen in the past. Yeah, great insight, but yeah, so thank, I think let’s um move things up. Thank you, Peter, for a lovely presentation, and um we have Simon up. But Patrick, you make a really important point, and in some ways we need to distill that experience from 20, 30 years ago to re- to to kind of support us on our learning. Because, as you say, you know how much injury is enough? And in fact, once you see injury, the default is to put a stent in because that’s your comfort place. But actually, and maybe Simon’s case will expand upon this, the learning of how you might adapt dissection and and change the the status of that is an important one. But Simon, hopefully you can share some of that experience in your presentation.
Great, thanks very much. Uh, can I have my slides up, please? Thank you very much. Um, so my name is Simon EOL. I work at the North nor University Hospital in the UK. Uh, this is the title I thought I was talking on, not the one that’s in the program. Um, anyway, it comes to the same thing. I’ll be showing you a little bit of the solution work as well. So, uh, I presented this at PCR already earlier this year. We looked at the first 1,000 Deb cases in the solution study, and we divided them into early cases per center or late cases per center. We were just looking to see if there’s any change in practice or any change in how people were working or what cases they were selecting or whatever. So essentially, it’s a little bit like the learning curve or the adoption rate. So as you can see on this slide, the later cases have a lot more type C, more calcification, more bifurcations, more multivessel procedures. So it looks as though people, people are getting a bit more confident in what they’re doing. Legion preparation was pretty much unchanged; slightly less physiology and imaging over time. What happened, what we were looking at was the bailout rate. So there, there’s two points in time at which you bail out in a DCB procedure. The first one I’d call failure of lesion preparation; whatever you do, you can’t get a good enough result that you are happy to leave with a DCB. And most experienced operators who do try to do DCB most of the time would say they DCB being around 70% of all of their cases. These are obviously cases that people think they should be able to DCB, and at the beginning they were bailing out after leion prep at around 12%. As they learned a little bit more, it dropped, not much, down to about 10%. The other time you bail out in a DCB procedure is after you put the DCB in, and that shouldn’t happen very often because, as everybody’s told you already, leion prep upfront is all your anoplasty; the balloon is just to deliver the drug. So the reasons why you’d be bailing out after DCB should only be in that very small percentage where you’re really unlucky and the balloon has done some damage that wasn’t already there. However, what you tend to see is that people either haven’t spotted that there’s trouble before the DC D CB or they put the DCB in and then essentially in the UK would say they get cold feet; they go, okay, it’s a proximal LOD, and I’m really anxious about the fact that I DC be it and I just want to put a stent in. And at the beginning of our study, the beginning of the learning curve, that was running at about 9%. As it went along, it came down to less than 5%, and that fits actually with all the rest of the published data out there.
So what about the DCB approach to bifurcations? Must be an easier way than really complicated stenting. So to my mind, if you’re trying to DCP, you’ve got some questions to ask yourself at the beginning: Am I putting a stent anywhere as part of my initial strategy? Yes or no. And then, am I treating one or two vessels? So here’s the time where you can put your DCB through your stent. This is when you were never planning to treat the side branch; you stent across it; you have to go and rescue the side branch; you rescue it well enough with a balloon that you could DCB it if you wanted to do a planned hybrid or blended approach. The way, the best way to my mind to do it would be: you leion prepare the main branch, you leion prepare the side branch, you DCB the side branch, you stent across it, and then you don’t have to do anything to your stent. That way you’re not affecting integrity of the stent, and you’re not affecting the drug you just delivered to the side branch. If you’ve done good lesion prep and you’ve looked at your angiogram or your physiology or imaging, and you’ll know that it’s safe, it will manage with a stent going across it. It’s very rare you’d have to recross in that situation, and I think that’s what people worry about with the idea of balloon first and then stent across it. However, there are simpler ways. If you wanted to do both lesions, so side branch and main branch, the way to do it, Bruno’s already told us this: you leion prepare the main branch, you leion prepare the side branch, you run a checklist that I’ll talk about in a minute, basically telling you that you’ve done a good job in both branches and it’s safe, then you put your DCB in your side branch and usually then DCB the main branch last. So you do main, side, side, main; no kissing, no balloons at together at any point in time. The other one would be: you’re simply doing the main branch, and the side branch is going to look after itself. Prof Shin has told me endlessly, I use her slides forever; they’re beautiful, showing that if you DCB the main branch, the side branch will get better as well. The last one, and I’m amazed that we had a whole um session on this, surely the answer to the 001 is just a DCB; it’s so much less complicated and fraught with long-term problems. Right, so that was fairly controversial possibly, but those are the five different ways DCB fits into bifurcation to my mind.
So I was asked to show a provocative case. So I’ve got a provocative case for you. Apologies for anybody that’s seen it before, but it’s still one of the most provocative ones I’ve got. 87-year-old lady came in for an elective angiogram with a lot of angina. Based on the pictures I just showed you, she was kept in for consideration of urgent bypass grafting. You know the answer they’re going to say no. She then had an NSTEMI on the ward while she was waiting for the surgeons because she was so anxious, maybe I don’t know. Guess what? The surgeons now have another reason to say no, which is why she’s here. Yeah, so that’s her anatomy. What are you going to do with that? Just in case you’re wondering if the left main stem as well, yes it is. So there’s all sorts of things that you, you could do; any of that lot is open for discussion, I guess. Uh, if you’re going to do it, how you going to do it? Those are all the different ways that are open to you. Obviously, I’m going to show you one that I think means you don’t have to put any stent in, and that was the approach that we took. Two wires, you’ll be pleased to know, I do believe in two wires for these sorts of things. Two, pardon, it’s good. Um, two non-compliant balloon left main to L, same balloon to the circumflex, slightly bigger balloon into the LAD. We’re just trying to make some space and work out what’s going on really. So in DCB land that would be called an inadequate result. You’ll be pleased to know I’m not that provocative. This is the checklist that we run in our lab: lesion preparation; are you making the vessel big enough? Are you giving them a load of nitrates? Have you got rid of the recoil? Can you deliver your balloons so that you know you can deliver your DCB safely? How’s the patient? What’s the ECG like? They must have TIMI 3 flow. What luminal compromise have you got? And is it progressive? If it’s progressive, that’s an intramural hematoma; you have to deal with. Is the RV vessel threatening dissection? Is the contrast in the wall? That’s hanging around; if it’s hanging around, it’s getting in; it won’t get out when the patient leaves the lab; bloods will get in; it won’t get out; they’ll be back with an occlusion. Last bit: you then have to think about your DCB; it’s got to be 1:1 balloon to artery ratio; angiographic the same as your leion preparation balloons, little bit longer, and then you obviously need to know your transit time for your DCB, how long from the wrist to the heart, and then your, your delivery time, usually 30 seconds. So we haven’t done enough work here. Is a 40 nsse Alpha, so that’s a semi-compliant polymer bladed scoring balloon. You can see that big chunk of calcium; it’s always in the same place at the ostium of the Circ, hiding on, on the underneath. Same balloon pushed around the corner, bit higher still, a big junk of calcium; bit higher still, less of a chunk, but doesn’t look perfect, does it? That balloon inflation. Well, then use the same balloon as the LAD. What do you think of that result? Are we allowed to take a vote? Who thinks, based on that one view, that that is enough balloon angioplasty? Thank you; I’m not alone. So you could take some more views, can’t you? That’s the checklist again. So we’re now thinking that there’s a bit of contrast underneath the left main stem around the circumflex; maybe there was a load of calcification in there; it’s quite difficult to differentiate; that’s a therapeutic dissection. Thank you. And um, otherwise it’s a pretty good result in that view, isn’t it? So how are you going to do? No, very provocative, huh? So how you going to do this now? You could do your left main stem separately if it’s really big; circumflex first, LAD first; kissing DCBs; so many ways to do it; it’s never one answer for everything, is it? But essentially generally sequential DCBs; you virtually never need to kiss, and like I said, it’s normally main, side, side, main. I’m now going to break that rule because we were most worried about the ostium with the circumflex. So we did left main, LAD DCB, left main, circumflex DCB. This is now the result. There’s the checklist. I think the only problem in this, in the spider view, is the ostium of the circumflex, which it was always going to be, wasn’t it? It was where the rock of calcium was and where the balloon struggled, but the recoil is not that bad; you’ve got TIMI 3 flow; all the contrast is clearing; patient fine. So I applied a rule which is slightly odd one: if I’d stented left main LAD and I’d done everything I could in the ostium of the circumflex look like that, would I be happy? That’s another way of saying yes. So let’s leave it.
So she went from that to that. 14 months later, she comes back with angina. She’s now 88 and a half; she had a lot of angina; it looked like this. Ostium with the circumflex looks worse, doesn’t it? One of the things we’ve learned from all our DCB work is: don’t just go on the angiogram at this point; think about the physiology. So she’s got some diagonal disease that was there before; the ostium of the circumflex looks worse. So we pressure wired it; it was profoundly negative; the answer was the right coronary artery this time. Thanks very much; the music came on at just the right time; it was kind of triumphant finale. Yeah, very dramatic. So I mean, that time it was a lovely case, and it is provocative, and Fernando would absolutely accept the guidelines um being out of kilter with this. But what strikes me in terms of the presentation is a very systematic approach; you went two, you went three, you went four, you then went for nsse Alpha; so you’re creeping up on lesions, right? Is, is that in that case? Yes. I mean, you know that stuff was so tight you couldn’t go straight one to one. I mean, I tend to feel those lesions a little bit, so I don’t inflate the balloon as quickly; I actually watch it the waist disappear and do it that way. So I massage it a bit. And the other little point that I wanted to make is that um the drug-eluting balloon is not a, it’s only a drug delivery, but it’s also something that you can tuck up your dissection with. So if you inflate it at 7, 8 atmospheres for more than one minute, then you actually reduce your dissection sometimes. I think maybe shock wave would have helped, at least for the, for the long term. Did you say shock wave? Yeah, this case was so long ago; shock wave didn’t exist; didn’t exist. Maybe just to see the, the inner, the circumflex ostium, or maybe just 1.5, 7, 1.75 rotation just to crack some of the calcium for the long term, if you don’t want imaging, and if you insist on just using balloons or Dr Qued balloons. So I think maybe that would have helped. And with the help of the imaging, I, I think um imaging and rotation would have been absolutely mandatory if you’re putting stents in. I think with balloons it’s a lot more forgiving, although that calcium was on the outer curve, wasn’t it? So rotation may not have had an impact. And so putting a stent in there regardless of how aggressive your modification has an ongoing risk.
Reas, not to put a beautiful case. Don’t tell guidelines to make no beautiful, beautiful case. Simon, I mean, is, is, is a striking result, and perhaps it’s the way to go now. I do remember very well when we started with stenting the left main because we were doing balloon angioplasty, and there was a major recoil. So when we started with the stents uh the left main with all the elastic fibers, I mean, you were able to get a beautiful result, and with balloon we were getting only a suboptimal result. And the other issue is in the left main used to be plenty of calcium. In your patient, there was some calcium, and of course it is possible that, you know, the outcome of the circumflex coronary artery with DCB in the two arms is better. But my point is we don’t have a significant series of DCB alone in the left main including bifurcation. I mean, these papers are not there. So beautiful case, but we needed the data. So there’s, there’s two papers that I’m aware of; small. Shin, Shin three, now, okay. Yes, you told me you published. Uh, we’ve, we’ve published ours, uh, and Thomas WR has published his as well. We are all trying to get together to put the data together for a bigger series. Okay. So I think fantastic case. Just if I might, I’m sorry to remake the point here in the back. So you used physiology at the end when the patient came back with angina. If you’d used it right in the beginning, you would’ve been a little more confident about, don’t you think? That would have been the case after finishing the DCB if you could have used physiology right at that time. Uh, yes, and we do that now, and I’ve learned that from Prof Shin as well. I agree entirely that, you know, physiology can really help, and actually one of the lovely papers that she’s written tells you that if angiographically it looks as though you should stent it based on DCB guidelines, that if it’s non-ischemic then it’s fine to leave it. Anyway, Simon, can you say a little bit more about the calibration of the drug-coating balloon? Because, you know, uh in the Transform one, we used the OCT to be sure that the drug-coating balloon was perfectly, perfectly sizing. So at the end of the study, we had a ratio of one between the drug-coating balloon and the reference diameter based on OCT; that is the only reliable technique. When you use QCA, you systematically 0.3 mm below; you underestimate. And IVUS is tricky because it’s overestimating the big value and underestimating the small value. So how do you do that? You, you just use your last drug-coating non-compliant balloon and say, I will use a drug-coating of the same size of, yeah. So, so we’re working generally and geographically one to one, and I think maybe if you’ve been doing it for a long time, you’re probably a little bit bigger than most people would think they’re working at one to one angiographically. So yes, the last leion preparation balloon is one:one; your DCB should therefore also be one:one. And I think from the point of view of worry about are you under-sizing it? If the vessel truly is four and you’ve put a four in it, it should touch the sides. But actually if it’s four with the amount, cuz you’re never going to get a 4.0 result just with a balloon anyway. So a 3.5 DCB will touch the sides anyway, but you might then be slightly underdosing. And the, the 2, 1, 2 scoring balloon and cutting balloon is that still the number today or is that much higher? Uh, in the solution it was 30%; I’m, uh, we haven’t looked again; we were just discussing whether we should look again or just wait and do the big paper, but we, we’re going to, we are running. So over time, I think what this demonstrates is the need for even more time to discuss this very exciting um, you know, evolution that we have in practice. I’m sorry, T, but we’re going to have to probably move on to the next session, but I’d like to thank Cordis, thank uh colleagues, and thank you all for uh stimulating debate. [Applause]