Prática de Shadowing: PCI calcium modification: Updated approach, Device deliverability - Aprenda a falar inglês com o YouTube

i want to talk today about the deliverability

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i want to talk today about the deliverability

and crossing profiles of various pci devices we have especially the various specialty balloons we have

and i want to provide updates on pci calcium modification strategy

and i strongly recommend

that you review my pci of severe coronary calcium talk as

my current presentation will complement the prior one i want to

start by talking about the crossing profiles of various tools we have one iv little tripsy balloon

or shockwave balloon it has a thick profile of about 0.45 inch

or 1.2 millimeters and that is the main limitation of ivl is

that it may not cross a severely calcified lesion it needs a big channel typically over that

1.2 to 1.5 millimeters and that's why it needs extensive vessel preparation before you can advance it

and sometimes you need a therectomy before you can advance it the crossing profile of lithotripsy is close to

that of stent except sent have the added disadvantage of less flexibility

and metal encroaching onto calcium pieces lithotripsy comes in 2.5 to 4 millimeter diameters and has a length of 12 millimeters.

Now this is regarding drug coated balloons.

They have a 0.032 inch crossing profile better than lithotripsy.

This is Wolverine cutting balloon.

It has a 0.037 inch crossing profile also better than

IV lithotripsy and it comes in 2 to 4 millimeter diameter whereas lithotripsy is 2.5 to 4 millimeter diameter

and it comes in 6,

10 and 15 millimeter lengths.

Typically I use 10 millimeter length which improves the deliverability of the cutting balloon compared to the 15 millimeters.

now this is the OPN super non-compliant very high pressure balloon it has a crossing profile of 0.028 inch

which is better than lithotripsy and slightly better than cutting balloon

and DCB and that's a major advantage of OPN

and the OPN balloon has double non-compliant layers

and those two layers reducing its compliance and make it super non-compliant

and allow it to be inflated at very high pressure with limited expansion and a low risk of balloon rupture.

And you can see here on that inflation chart that compared to other non-compliant balloon,

the OPN balloon, the red one has the flattest compliance curve and even at an inflation pressure of 35 millimeter

a three millimeter balloon will only expand to about 3.4 millimeters

you can see here the balloon compliance chart three millimeter balloon at a 35 atmosphere will expand to 3.36 millimeters

and And when using OPN balloon,

it's recommended to downsize your diameter by half millimeter compared to the reference vessel diameter.

So if you're dilating it in a vessel that is 3.5 millimeter by your IVUS imaging,

you should use a 3 millimeter OPN balloon

and inflate it to 35 up to 40 atmosphere year

and here is a summary of the crossing profiles

and deliverability of the various tools we have today in our

cath lab one you have the compliant balloon then you have

the non-compliant balloon then you have the super non-compliant balloon opn then close to it

but behind it you have the 6 and 10 millimeter wolverine cutting balloons

and the dcb then behind

that you have the iv little tripsi balloon then behind all

those you have the stand like i said the stent crossing profile is close to

that of little tripsi balloon but it has the added disadvantage of less flexibility from

that metal and the metal encroaching on the calcium.

And to cross with IV little tripsy balloon,

you need at least 1.3 to 1.5 millimeter channel,

whereas you need one millimeter or less for OPN balloon and probably around one millimeter for cutting balloon and for DCB.

Now I will move on to provide an update on calcium modification strategy for severe coronary calcium.

This is my prior algorithm,

and I will provide an update of that in light of the two new major trials.

Keep in mind the fluoroscopic definition of severe coronary calcium,

which is calcium on both sides of the vessel on still images

and the IVUS or OCT definition of severe coronary calcium

which is more than 270 degree arc over more than 5 millimeter

or 360 degree arc for any length or a calcified nodule

which is a piece of eccentric calcium protruding bulging into the lumen

And keep in mind that having severe coronary calcium does not automatically dictate calcium modification strategy,

as has been shown in the atherectomy trials,

such as Eclipse trial with orbital atherectomy,

where MACE outcomes were worse with orbital atherectomy compared to a standard balloon strategy

and as shown also in the rotaxis and prepare calc trial with rotational atherectomy,

where outcomes were not worse but were not improved with rotational atherectomy.

You always had around close to 15% of patients who needed atherectomy because they were balloon uncrossable or undilatable.

And that's why calcetal modification is always definitely required in cases of balloon uncrossable lesion where you need atherectomy

or in cases of balloon undilatable lesion where you need atherectomy or lithotripsy or OPN or cutting balloon.

And we call the lesion undilatable

when it does not yield with a one-to-one non-compliant balloon inflated at high pressure 18 to 20 atmosphere

and it does not yield clearly in two orthogonal fluoroscopic views.

Always verify that the balloon is yielding in two fluoroscopic views.

Now, here are the two major trials presented at TCT.

One is victory trial of OPN versus lithotripsy in severe coronary calcium.

IVL was size 1 to 1 to the reference lumen diameter,

meaning EEL to EEL diameter,

typically average of the proximal and distal reference lumen diameters,

and it was inflated up to 6 atm.

That's how typically we size IVL,

we size it 1 to 1 to the reference lumen,

whereas OPN was size minus half millimeter to the reference lumen,

and it was inflated up to 40 atmospheres.

And in that victory trial,

we achieved the same stent expansion of approximately 85% of the mean reference proximal and distal area with both OPN and IBL.

So they were both as efficacious.

And in both cases, rotablation was required before ballooning in about 15% of the patients.

And there was no difference in perforation rates,

despite using very high pressure with OPN up to 40 atmosphere.

OPN has a lower profile and was easier to deliver than IVL

and required less balloons and less predilatation to allow its delivery.

So the procedure was faster with OPN and similarly efficacious in terms of stent expansion by OCT.

The only disadvantage is that we had numerically but not statistically more dissections with OPN.

And there are two potential pitfalls with OPN in victory trial.

One, the trial excluded osteo disease as well as stent-related issues such as stent underexpansion or instant calcified neoarthrosclerosis.

This does not mean that OPN cannot be used in those two instances.

It's just that it has not been shown to be equivalent to IVL in those two settings.

And the second potential shortcoming of OPN is that since we had more dissections numerically with OPN,

it could hypothetically be problematic when we're planning to use DCB as a standalone therapy.

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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