Pratica di Shadowing: PCI calcium modification: Updated approach, Device deliverability - Impara a parlare inglese con YouTube
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i want to talk today about the deliverability
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i want to talk today about the deliverability
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and crossing profiles of various pci devices we have especially the various specialty balloons we have
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and i want to provide updates on pci calcium modification strategy
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and i strongly recommend
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that you review my pci of severe coronary calcium talk as
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my current presentation will complement the prior one i want to
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start by talking about the crossing profiles of various tools we have one iv little tripsy balloon
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or shockwave balloon it has a thick profile of about 0.45 inch
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or 1.2 millimeters and that is the main limitation of ivl is
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that it may not cross a severely calcified lesion it needs a big channel typically over that
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1.2 to 1.5 millimeters and that's why it needs extensive vessel preparation before you can advance it
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and sometimes you need a therectomy before you can advance it the crossing profile of lithotripsy is close to
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that of stent except sent have the added disadvantage of less flexibility
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and metal encroaching onto calcium pieces lithotripsy comes in 2.5 to 4 millimeter diameters and has a length of 12 millimeters.
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Now this is regarding drug coated balloons.
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They have a 0.032 inch crossing profile better than lithotripsy.
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This is Wolverine cutting balloon.
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It has a 0.037 inch crossing profile also better than
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IV lithotripsy and it comes in 2 to 4 millimeter diameter whereas lithotripsy is 2.5 to 4 millimeter diameter
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and it comes in 6,
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10 and 15 millimeter lengths.
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Typically I use 10 millimeter length which improves the deliverability of the cutting balloon compared to the 15 millimeters.
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now this is the OPN super non-compliant very high pressure balloon it has a crossing profile of 0.028 inch
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which is better than lithotripsy and slightly better than cutting balloon
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and DCB and that's a major advantage of OPN
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and the OPN balloon has double non-compliant layers
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and those two layers reducing its compliance and make it super non-compliant
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and allow it to be inflated at very high pressure with limited expansion and a low risk of balloon rupture.
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And you can see here on that inflation chart that compared to other non-compliant balloon,
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the OPN balloon, the red one has the flattest compliance curve and even at an inflation pressure of 35 millimeter
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a three millimeter balloon will only expand to about 3.4 millimeters
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you can see here the balloon compliance chart three millimeter balloon at a 35 atmosphere will expand to 3.36 millimeters
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and And when using OPN balloon,
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it's recommended to downsize your diameter by half millimeter compared to the reference vessel diameter.
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So if you're dilating it in a vessel that is 3.5 millimeter by your IVUS imaging,
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you should use a 3 millimeter OPN balloon
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and inflate it to 35 up to 40 atmosphere year
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and here is a summary of the crossing profiles
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and deliverability of the various tools we have today in our
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cath lab one you have the compliant balloon then you have
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the non-compliant balloon then you have the super non-compliant balloon opn then close to it
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but behind it you have the 6 and 10 millimeter wolverine cutting balloons
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and the dcb then behind
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that you have the iv little tripsi balloon then behind all
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those you have the stand like i said the stent crossing profile is close to
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that of little tripsi balloon but it has the added disadvantage of less flexibility from
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that metal and the metal encroaching on the calcium.
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And to cross with IV little tripsy balloon,
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you need at least 1.3 to 1.5 millimeter channel,
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whereas you need one millimeter or less for OPN balloon and probably around one millimeter for cutting balloon and for DCB.
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Now I will move on to provide an update on calcium modification strategy for severe coronary calcium.
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This is my prior algorithm,
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and I will provide an update of that in light of the two new major trials.
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Keep in mind the fluoroscopic definition of severe coronary calcium,
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which is calcium on both sides of the vessel on still images
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and the IVUS or OCT definition of severe coronary calcium
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which is more than 270 degree arc over more than 5 millimeter
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or 360 degree arc for any length or a calcified nodule
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which is a piece of eccentric calcium protruding bulging into the lumen
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And keep in mind that having severe coronary calcium does not automatically dictate calcium modification strategy,
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as has been shown in the atherectomy trials,
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such as Eclipse trial with orbital atherectomy,
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where MACE outcomes were worse with orbital atherectomy compared to a standard balloon strategy
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and as shown also in the rotaxis and prepare calc trial with rotational atherectomy,
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where outcomes were not worse but were not improved with rotational atherectomy.
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You always had around close to 15% of patients who needed atherectomy because they were balloon uncrossable or undilatable.
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And that's why calcetal modification is always definitely required in cases of balloon uncrossable lesion where you need atherectomy
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or in cases of balloon undilatable lesion where you need atherectomy or lithotripsy or OPN or cutting balloon.
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And we call the lesion undilatable
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when it does not yield with a one-to-one non-compliant balloon inflated at high pressure 18 to 20 atmosphere
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and it does not yield clearly in two orthogonal fluoroscopic views.
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Always verify that the balloon is yielding in two fluoroscopic views.
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Now, here are the two major trials presented at TCT.
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One is victory trial of OPN versus lithotripsy in severe coronary calcium.
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IVL was size 1 to 1 to the reference lumen diameter,
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meaning EEL to EEL diameter,
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typically average of the proximal and distal reference lumen diameters,
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and it was inflated up to 6 atm.
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That's how typically we size IVL,
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we size it 1 to 1 to the reference lumen,
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whereas OPN was size minus half millimeter to the reference lumen,
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and it was inflated up to 40 atmospheres.
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And in that victory trial,
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we achieved the same stent expansion of approximately 85% of the mean reference proximal and distal area with both OPN and IBL.
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So they were both as efficacious.
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And in both cases, rotablation was required before ballooning in about 15% of the patients.
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And there was no difference in perforation rates,
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despite using very high pressure with OPN up to 40 atmosphere.
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OPN has a lower profile and was easier to deliver than IVL
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and required less balloons and less predilatation to allow its delivery.
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So the procedure was faster with OPN and similarly efficacious in terms of stent expansion by OCT.
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The only disadvantage is that we had numerically but not statistically more dissections with OPN.
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And there are two potential pitfalls with OPN in victory trial.
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One, the trial excluded osteo disease as well as stent-related issues such as stent underexpansion or instant calcified neoarthrosclerosis.
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This does not mean that OPN cannot be used in those two instances.
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It's just that it has not been shown to be equivalent to IVL in those two settings.
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And the second potential shortcoming of OPN is that since we had more dissections numerically with OPN,
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it could hypothetically be problematic when we're planning to use DCB as a standalone therapy.
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So it is potentially problematic as a prep for DCB,
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where you want to reduce our dissections, especially flow limiting dissections.
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And here you can see in that trial that you needed more device as a preparation for IVL compared to OPN.
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And you can see here that at the level of the stenosis,
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the luminal channel diameter was around 1.5 and at least 1.3 millimeter.
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And that's kind of the channel you need in order to be able to advance IVL.
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And you can see here that OPN and IVL achieved similar stent expansion,
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including a similar rate of stent expansion,
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more than 80% of the reference and more than 90% of the reference
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and you can see here the numeric trend toward more dissections with opn
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but not flow limiting dissections the second major trial presented at
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tct 2025 is shortcut trial of cutting balloon versus ivl in
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severe calcium again here ivl was sized one to one to the reference luminal diameter
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and the inflation pressure was 5.5 plus
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or minus 3.5 probably best to limit it to 6 atmosphere
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as in the prior victory trial the cutting balloon like opn
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was sized minus 0.5 millimeter to the reference lumen diameter
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and it was inflated to a pressure of 16 to 20 atmosphere
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and the mean pressure was 17 plus or minus 3.5 atmosphere
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and keep that number in mind this is different from the traditional teaching
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that cutting balloon should only be inflated to 12 atmosphere
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so here they went higher in that trial and that's key to the success of cutting balloon in that trial.
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Unlike Victory where only 15 percent of patients had pre-balloon rotational atherectomy,
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in this trial 50 percent had planned rotational atherectomy before IVL or cutting balloon,
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the so-called rota cut or rota shock.
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This is an acknowledgement that atherectomy is unavoidable in some cases,
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evidently the balloon uncrossable cases,
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but also some balloon undilatable cases where the channel is not large enough to allow you to advance lithotripsy or cutting balloon.
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And in that shortcut trial,
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both devices, cutting balloon and lithotripsy,
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achieved the same percent stent expansion at the site of maximum calcium.
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They had the same perforation rate.
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And again, we had a trend toward more dissection with cutting balloon compared to lithotripsy.
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That's always an advantage of lithotripsy,
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the lowest dissection rate and a very low perforation rate.
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And this non-inferiority of cutting balloon compared to lithotripsy was seen in patients who received a planned rotation atherectomy,
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but also in those who did not receive
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rotational atherectomy if you adjust your analysis in terms of percent stent expansion compared to the reference vessel size.
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And here again, you can see that little tripsy required more balloon preparation before you could advance it compared to cutting balloon.
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And here I want to show quickly another trial,
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COPS randomized trial, which was a randomized trial of cutting balloon downsized by 0.5 millimeter to the reference diameter versus NC balloon,
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not versus lithotripsy.
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And this trial showed superiority of cutting balloon compared to NC balloon in terms of MSA,
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minimal stent area, in terms of stent expansion,
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including stent expansion at the calcium site.
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However, in that study, we had numerically more perforations with cutting balloon,
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and this was partly attributed to the fact that cutting balloon was downside only 0.25 millimeter in one of the perforation cases,
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and it was inflated to higher pressure,
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18 plus or minus 5 atmosphere in that trial,
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which tells me that to stay safe with the cutting balloon,
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try to limit your inflation pressure to no more than 18,
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maximum maybe 20 atmosphere.
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And this is my updated approach to calcium modification strategy.
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And keep in mind that not all severe coronary calcium requires the sophisticated calcium modification strategies here.
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You may start with one-to-one non-compliant balloon,
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and if that non-compliant balloon yields in two orthogonal in geographic views,
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that may be enough.
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You definitely need the advanced calcium modification strategy if you have balloon uncrossable lesion,
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in which case you need atherectomy typically rotational or orbital
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or sometimes in the most difficult cases you will need laser
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as a preparation to allow you to advance a micro catheter to exchange for the rota
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or orbital wires so balloon uncrossable you definitely need atherectomy and you definitely need some calcio modification if you have balloon
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undilatable lesion, meaning that non-compliant balloon is not yielding properly in one or two views.
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And here you can use either atherectomy or lithotripsy or cutting or OPN balloons.
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Now, aside from that number one,
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which is most important, we may favor planning upfront calcium modification strategy,
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the denser and thicker and longer that severe coronary calcium,
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also the more you have of iris features.
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For example, you have not just an arc of calcium of 270 more than 5 millimeter,
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it's way longer than 5 millimeter,
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or you have long 360 degree of calcium,
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or you have multiple spots of calcified nodule.
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And in those cases, you will need a therectomy or the specialty balloons.
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Now I said balloon uncrossable lesion,
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you definitely need a therectomy.
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Now regarding balloon undilatable lesion,
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meaning the lesion that doesn't yield with an NC balloon.
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Here you can either do a therectomy or you can do those specialty balloon,
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IVL or cutting or OPN balloon.
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They may work if you can create a channel to allow the advancement of those balloons.
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And here is where OPN is more advantageous than lithotripsy,
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particularly in light of its efficacy in victory trial.
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The OPN has a smaller profile and can be advanced probably in a 1 mm channel or less,
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whereas you probably need close to 1.5 mm channel for lithotripsy balloon.
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So for balloon undilatable lesions,
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particularly when you expect a more difficult crossing and delivery,
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you may start with OPN,
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especially that victory trial shows us that OPN often requires less preparation than lithotripsy.
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and if the lesion does not yield with OPN at 40 atmosphere
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or your calcium does not break on the post-balloon iris then you can upscale to little trip C balloon
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or even to a therectomy if you don't have any obvious in geographic dissection type C or beyond.
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You may also start with cutting balloons since its profile is lower than lithotripsy
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and it achieved similar stent expansion and calcium fracture rate in rota cut trial.
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Another idea is that the thicker and denser and longer your calcium
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and the more complex calcium features you have by IVUS or in geographically,
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the more likely you are to require a therectomy rather than specialty balloons.
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And within the specialty balloons,
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the more likely you are to require little trypsy rather than cutting or OPN balloon.
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And the decision to start with a therectomy rather than specialty balloons
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depend on your perceived complexity and length and density of
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that calcium on both the angiogram as well as your intravascular imaging
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and whether you can create enough of a channel to allow the advancement of those specialty balloons,
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starting with a small compliant balloon,
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then gradual sizes of non-compliant balloons,
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and also on how difficult it is to advance your IVUS catheter,
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particularly the lower profile Avego mechanical transducer catheter or the OCT catheter.
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If you have difficulty advancing those lower profile catheter,
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you're likely to require a thorectomy up front rather than specialty balloons.
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You may start in some of those cases OPN or cutting balloon,
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but you're more likely to require bailout with a thorectomy or lithotripsy in those cases.
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Another third idea I'm adding here is that if you're planning to do DCB in lung disease,
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disease, small vessels, distal disease.
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It's probably better to do IVL versus OPN or cutting balloon because we know IVL inherently causes less dissections,
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and therefore you're more likely to achieve a very good balloon-only result
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that allows you to finish the case with DCB as opposed to stenting the lesion.
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Contesto e Sfondo
Nel video "PCI calcium modification: Updated approach, Device deliverability", l'autore discute i profili di attraversamento e la consegna di vari dispositivi PCI specializzati, in particolare quelli utilizzati per la modifica del calcio coronarico. Viene enfatizzata l'importanza di preparare adeguatamente le lesioni calcificate prima di utilizzare dispositivi come i palloni litotripsici e i palloni potenziati con farmaci, per garantire un’efficace espansione e trattamento delle arterie coronarie. Questo approfondimento non solo è utile per i professionisti del settore medico, ma offre anche degli spunti per chi desidera migliorare la pronuncia inglese attraverso la pratica.
Le 5 Frasi Chiave per la Comunicazione Quotidiana
- "Crossing profiles of various tools" - Profili di attraversamento di vari strumenti
- "Needs a big channel typically over 1.2 to 1.5 millimeters" - Necessita di un ampio canale, tipicamente oltre 1.2 a 1.5 millimetri
- "Non-compliant balloon" - Pallone non conforme
- "Super non-compliant very high pressure balloon" - Pallone super non conforme ad alta pressione
- "It has double non-compliant layers" - Ha doppi strati non conformi
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