Chapters Transcript Video IVL Expanding Options for Calcified Lesions Back to Symposium Good morning, everyone. Uh, We will advance slides here and so I'm gonna transition a little bit and cover a few things in one talk, uh, mechanism of action, a little bit of the data that's gotten us to the devices that we have available on the market, and then just, uh, a brief, uh, concept or thought on treatment algorithm. Um, this will go relatively quick, I think, get us back on time. Um. And so, we obviously with the issue for us is calcium, right? And calcium is The bugaboo and PAD, we, we know this, this continues to be a problem in all vascular beds, but who are related to PAD, the most severe forms of PAD CLTI tend to have even greater amounts of calcium at multi-level. And as we get further down from the SFA or iliacs to the SFA pop and below the knee, it becomes even greater as far as degree of calcification. And so we have to find ways to manage that and we have over time. We've tried to do that with um uh increased balloon inflation, higher pressures, uh, but with a uh a sacrifice, sacrifice in primary patency and late lumen loss and overall successful interventions as well as some early data to suggest anti-reinotic therapies are less effective in dense calcification. So this is a problem and for the longest time, we tried to manage that by removing that calcium, um. As I've mentioned uh before, when we Uh, treat these lesions, whether they're in the iliacs, SFA, um, or tibial below the knee, calcified plaques are generally much more associated with higher failure rates, right? You have increased rates of dissection. Increased rates of perforation showed a case in the last talk, and of course rest stenosis and overall stent failure largely related to poor stent expansion and that presence of calcium really necessitates you as the operator to then try to do something to either remove that calcium or overcome that burden of that stiff vessel with higher balloon pressures. And so that plaque debulking has increased risk of disembolization and other challenges, um, and ultimately we've also identified that dense calcium has a decreased uptake in drug coated balloons or drug, drug coated efficacy is diminished in those patients as well because of that, um, dense calcium. It's not the same as which we were treated and studied, uh, in those patients. So IVL intravascular lithoplasty. It was a paradigm shift for calcified lesions, right? We, we had, uh, up until this point undergone plaque removal largely or atherectomy with the same issues that I've mentioned previously, dissembembolization or, or inadequate results, frankly, to now a plaque modification approach. And so what's the concept? What are we modifying in these patients? And we're modifying the calcium, but more importantly with the vessel compliance. That's the issue here, right? So we're modifying and improving the vessel compliance to allow improved luminal gain. Following the angioplasty, uh, that, that's done with a low pressure, usually followed with some kind of adjunctive therapy like a, a DCB or perhaps allowing for improved luminal expansion. So what's the mechanism of action? Let's, uh, uh, let's look at this. So there's multiple devices on the market. Uh, most of you are familiar with Shockwave. There's a new one, that's entered this year now, um, a seismic one from Boston, and these are all fluid-filled catheters that have an energy source. So for generically speaking, what's your energy source is generally the generator. Um, the generator can deliver energy of a different mechanism. We can talk about the differences of the devices, and that's like largely where they will differentiate. Uh, but that energy travels from that source, that generator down that fluid-filled balloon, and you get this, uh, rapid energy absorption that creates this acoustic pressure wave, this plasma discharge, if you will, which is what you're seeing on the video here, uh, which is a, a tabletop model. That discharge causes a vapor bubble that propagates from the balloon origin or where the emitter is out to the vessel. So it's critical that you have wall contact with the vessel with your balloon. So sizing is important here. If you have that air gap or gap in between, it may not be as effective, and then ultimately that discharge will. Cause a crack because there's an acoustic impedance difference between um the water filled balloon and the discharge that's happened to the calcium. That acoustic impedance difference is what causes that fracture and ultimately preserves soft, healthy tissue that has a similar acoustic impedance uh to the water in the balloon. So that's not damaged to the same degree. And obviously, um, with that in mind, then you have to figure out how much of energy source or how, how effective or how strong do you want this to be so you can minimize injury to healthy tissue while preserving the effectiveness to calcium. And of course, repeat pulses then cause more fractures, more fractures of that calcium without removing it and without dissembolization, uh, which ultimately needs to be proven in studies. Will allow that vessel compliance to improve to thereby get a better balloon inflation without low high pressures or improved stent expansion. So overall, that's the mechanism of action of all these devices. If you look at the balloons available right now, Shockwave and seismic, as I mentioned, this is the new player in the market with others to come. Um, largely similar setups here, uh, similar number of, uh, emitters, similar balloon lengths with some differences, you know, obviously there's a few more offerings of Shockwave. They're first to market, and they've been the, the leader in this space, largely 014 platforms. I would say the ultimate significant difference between these two is the energy, right? The. Generation of energy that I mentioned from your generator either comes from an electric energy source or from a laser energy source. And so that's the difference, you know, from an engineering point of view between these devices that can provide some benefits with regards to the effectiveness of your treatment to be determined, obviously, as these are compared head to head or in your own hands. Ultimately, you have a set number of pulses that you can use with that balloon and then therefore that balloon is no longer usable for that purpose and would have to be a new balloon if you have a new location or if you've run out of pulses. The other thing that to mention is, is, uh, the newer devices are starting to develop selectivity with your emitters. So you can choose which emitters you want to, um, pulse from as opposed to the entirety of the balloon, um, and, and the last piece is directionality and that becomes a challenge in, in, uh, lithoplasty because, uh, oftentimes the calcium we're treating with isn't fully concentric, but it tends to be more eccentric and those challenges, uh, remain if the balloon emitter is not directly opposite or opposed that eccentric calcium. So, uh, just a, a quick look and comparison of the trial between, uh, for these two devices. If you look at the restore ATK and the disrupt, uh, pad 1 and 2 early trials for both of these devices which were prospective non-randomized multi-center studies, um, a few sites, a handful of patients, upwards to 100 patients, um, uh, in, in the, in the two if you compare them, and really we're looking for safety and efficacy. We wanted to look at freedom from major adverse events in the early time period of 30 days. And these are fairly similar overall residual residual diameter stenosis less than 50%, and they wanted to look at, you know, typical lesions seen in the SFA distribution, SFA pop if you will. And so these are very similar diameter stenosis, perhaps a few more CTOs in the restore ATK, but overall I'd say similar length lesions and similar dense calcification, uh, between the two, and if you look at final lesion characteristics, um, pre-dilation, successful IVL delivery, or technical success, 100%. Um, post dilation, uh, needed for, for these and stent expansion, very, very similar, um, ultimate treatment therapies or destination therapies, if you will, in these two groups. And then the final lesion characteristics, which is important to look at was what was the mean luminal, uh, diameter gain and ultimately diameter stenosis between these two also very similar. So comparable, uh, results in these patients with these devices in their early, uh, safety and efficacy type trials. Um, if we look at, uh, primary effectiveness endpoints here, uh, residual diameter stenosis, again, minimal in both of these, uh, lesion patency, excellent as well, and overall primary safety endpoints. The critical piece here is that there were no cases of perforation. Distal embolization, which is the point of concept that needed to be proved that with lithoplasty that we're not only modifying the calcium, but we're not causing similar complications like we saw with atherectomy with distal embolization, no abrupt closures, no reflow, um, or dissections meeting their, their, uh, adverse event criteria. Uh, but non-randomized data alone isn't enough usually to get this stuff approved. Uh, peripheral IVL, um, uh, further supported by randomized controlled trial. Shockwave did pursue the disrupt pad 3. This was published like midterm outcomes were published in JSky just a couple of years back now, 2 years out, and randomized from PTA to IVL over 300 patients with severe calcification. And what they were able to accomplish was improve luminal gain and improve primary patency out to 2 years with lower pressures utilized with the IVL as you might expect compared to plain balloon angioplasty with fewer limiting dissections, fewer lesions needing or requiring stents, and that sustained patency lasted out to 2 years. So significant improvement with lithoplasty compared to plain balloon angioplasty, even with bailouts considered in both treatments. So, uh, extended out to 2 years and that I think ultimately with the prior data. And support experience is now allowed for reimbursement for this type of device now in 2026. These are new add-on codes. This was talked about last night, so I won't get into this, but there are two specific add-on codes for the IIAc and SFA, uh, pop distribution if you use lithoplasty in addition to. Your additional lower extremity revas codes, they've all changed, obviously, and I think the talk yesterday was meant to highlight that for many of you in your practice. There's a fundamental shift, a huge change in lower, uh, extremity revascularization coding, um, that occurred in January 1st of this year. So I'm sure you're, uh, familiar with that. Uh, so, let's look at, um, Lesion assessment. So, if you go into kinda like how you might approach using IVL in your practice, or many of you have already used this, of course, you wanna determine if in fact the a lesion is a candidate for IVL does in fact have calcium. You know, some of it's pretty easy, uh, like Sean, we tend to use a lot of CT in our patients. And clearly that bottom right image shows dense calcification. There's no, um, signs here. This is pretty clear. This patient will likely benefit in some locations in, in revascularization if you're gonna pursue that, whether it's in the iliacs or in the SFA, uh, for some IVL. Might might need an endarterectomy too there, Sean. Um, but ultimately, if there's a question, we'll use IVIS, uh, IIS for early and post, uh, assessment for our treatment. You can see clearly, uh, on the IIS images, um, you can see that dense calcium and shadowing, uh, and the stenosis related to that, and then ultimately on your angiography as well, very evident. So any of those, uh, can be utilized. I just wanted to put a plug in for, for intravascular imaging as well. Because I can not only assess the calcium burden, the eccentricity of it, but help you determine if you've got a good outcome overall. And typically IVL is used when you've got more concentric calcium, um, extending out to half or 2/3 of the, uh, the vessel circumferentially or some degree of calcium thickness or in long lesions. And that's what most of the trial study, um, uh, patients, uh, look like as far as lesion characteristics. And so, um, a case example or a typical case in a heavily calcified, uh, multifocal fem pop lesion, this is kind of a typical patient I think any of us would see, uh, patient with, uh, CLTI, um, has some tibial disease as well, but just really showing the multiplanar reformatted imaging showing the degree of calcium circumferentially as you rotate around that vessel, um. You see it again on angiography. Unfortunately the, the videos here aren't playing, but I think even if you didn't see the videos, if you look at the, um, the, the non-subtracted imaging, you can see areas of stenosis that are largely related to the calcium that we saw on the CT either in the, uh, proximal, uh, uh, femoral SFA or in the uh above knee pop and beyond. Furthermore, this is supported by intravascular ultrasound, so we saw that as well in this patient. Um, with various, uh, uh, imaging, intravascular ultrasound, uh, and marking different areas of calcium that, that would be a potential concern. So now you've identified your lesion and where do you wanna treat that, whether you're gonna use, uh, angiography to mark the area of stenosis, the visual, uh, appearance of the calcium, or perhaps the intravascular ultrasound, then you wanna decide on your device. Um, and so you wanna make sure you have size your vessel or your balloon choice, of course, and then your emitter locations. Typically your IVL is recommended to be at 1 to 1 or slightly above, which is what I would typically do to your reference vessel. You wanna make sure you've got good wall contact with the balloon upon inflation, but this is occurring at a very low pressure. I wanna, uh, emphasize that the emitters need to be at the position of the calcium. So if you have a, uh, quote unquote geographic miss with your emitters to the calcium. You're not going to have the same effect. And so you wanna get that optimal shock at that location, um, and, and dense lesions that tends to be less critical because you're probably gonna treat it and probably shift the balloon a little bit here and there to try to get, uh, more pulses and more fracture, but essential calcium, that's very focal and targeted. You wanna be very clear about where your emitters or visualize that and you may need to adjust if it's not particularly, uh, a wall opposed or emitter, uh. Diametrically opposed to the area of of calcium because you will not get the same effectiveness of shock even if you're right at that same location. And so, um, we'll go ahead and place our, uh, IVL balloon, uh, and go ahead and, uh, begin our pulses. What might that look like? Um, obviously I said early on with low pressure inflation, generally subnominal, we'll typically start about two atmospheres, and we're looking for that wall contact because you're seeing that because you see a waist. Obviously at the lesions, so you know you've got wall contact and we're not gonna try to cause any barrel trauma at 2 to 4 atmospheres, very low pressure. We're not causing the same degree of injury that we see with balloon angioplasty and typical plaque lesions or with high pressure inflations as you need with, um, uh, in, in the absence of IVL. Then you deliver your pulse, activate the generator, whether it's electric or laser pulse energy. And typical pulse cycles are about 30 overall and then we'll continue that or increase inflation up to about 6 atmospheres but again, not, not too high a pressure that's the intent or the benefit of this type of treatment is we can accomplish luminal gain without a significant high pressure inflation and after sufficient pulsing or or we see that waste go away, then perhaps then we can go and either deflate, repeat, or readjust the balloon location to another lesion. You obviously only have a certain number of pulses, so you want to potentially utilize that same balloon in multiple locations. And so that was what was done here. You can see the waste around, uh, different calcified lesions, eccentric in nature, and we're trying to do our best to, to treat them. And we may, uh, do some, um, um, oblique and, uh, uh, angiography or, or imaging to sort of identify where that plaque, eccentric plaque is and where these pulses are. It can be hard to identify this, and this is one of the challenges, and I think newer devices coming to market will do a better job perhaps of being able to identify where those emitters are and, uh, directing that to these types of eccentric plaque. And then post-treatment assessment, um. You want to do a visual confirmation, as I said, usually the balloon waste, uh, will, will no longer be present. So that's obviously a positive, uh, feedback. Uh, imaging confirmation angiography is obviously, uh, nice 2D imaging. Oftentimes a single view doesn't give you the whole story. So, uh, oblique angiography to confirm there isn't anything, particularly in this area of eccentric, uh, stenosis or calcification, and ultimately often we'll use iVIS, uh, as we used it in the preoperative or, or planning setting. We'll use that in follow up to see if we got good luminal gain. Um, but if you don't see that, you may need some additional pulses or perhaps a larger IVL balloon because you, you just didn't get the, the lesion to its nominal size. So how might that look? This is a, the pre-lesion. You can see the stenosis. These are all from eccentric calcium. This is post IVL and then the, the run. Not sure if it'll play. You put that in the back, the image. Yeah, so then a, a DES, typically this is a stand, not a standalone therapy, and I think that's the intent of uh Of of part of my messaging here at the close is that IVL is a, a great, uh, uh, initial therapy, but it's not a definitive therapy. So typically following IVL, um, well often does not stand as standalone therapy. You'll do that plaque modification followed by a definitive therapy in our setting, it'll be DCB or drug eluting stent, um, and I think because of the lithoplasty we get a better stent expansion overall and a couple of examples, um, I think side by side that, uh, illustrate that, uh, pre and post lesions, um. In a few different stations here and then uh intravascular ultrasound showing the difference in luminal gain, uh, pre on the right and post on the left. With that give us a little time for questions or discussion. Thank you. So Published Created by
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