Speaker 1:
You're watching a ProtectedPCI.com video.

Cathy Jeon:
Hello everyone, and welcome back to ProtectedPCI.com I'm Cathy Jeon, one of the medical directors here at Abiomed and I'm thrilled to be joined today by Dr. Brian Kolski who's joining us from California, sunny Orange County. Thanks so much for being here, Brian. He's going to show us a case. He's going to share a case with us utilizing a new technology called shockwave. Take it away.

Brian Kolski:
Great. Yeah, thanks so much. This is a patient who is a 58 year old who presented to an outside hospital with symptoms of congestive heart failure. In addition, the patient was also a claudicant and had very short distance symptoms of bilateral leg claudication. Very small person who was also a smoker. And due to the poor pumping performance and viability study which showed not a lot of significant viable territory, he was turned down for a revascularization option, either percutaneous or with open heart surgery. And due to the some of the social issues he was told he wasn't a transplant candidate, and he was sent to us for a second opinion. So, this is the patient's angiogram. So there's a proximal LAD, heavy calcium. Other than that actually not a terrible looking vessel. And then in the circumflex it's sort of almost subtotally occluded with some very slow filling, large obtuse marginal branch. And here's a heavily calcified, very diseased right coronary artery, which is obviously an important dominant vessel. So a multi-vessel disease. So this is a pelvic angiogram which shows on the left side a common iliac significant disease.

Brian Kolski:
And actually, you see almost poor filling of the distal left external iliac, and that's also related to significant disease. And on the right side, a similar external iliac and common iliac disease. So very hostile peripheral vasculature. You can kind of see the video here. This is a very low atmosphere, it's a seven millimeter by 60 millimeter shockwave balloon.

Cathy Jeon:
So, let me stop you for one second.

Brian Kolski:
Sure.

Cathy Jeon:
For our viewers out there who don't know what shockwave is.

Brian Kolski:
Yeah.

Cathy Jeon:
Just a brief overview.

Brian Kolski:
Sure, absolutely. So, essentially the shockwave intravascular lithotripsy balloon is just like any standard balloon that you'd use angioplasty and the periphery with, except it has several high energy emitters. Those high energy emitters essentially create sonic waves by creating small thermal reactions, and these sort of micro-explosions that push sound wave in through the arterial wall and help to basically break up calcium. Similar technology that's used in breaking up kidney stone calcium, however delivered in less energy fashion directly through these sort of special balloons, which are sized typically larger than the vessel itself. So, in this case we use a seven millimeter balloon because the energy transfer only works if the balloon is opposed to the vessel wall. So it's real important in these types of cases that you have good apposition of the balloon, so that when these sort of micro-contained explosions occur, the sound waves track directly into the vessel wall, thereby breaking up and fracturing the calcium.

Cathy Jeon:
And it looks like you're at very low atmospheres.

Brian Kolski:
Yeah. Four atmospheric pressures, and this is typical. In fact, with this balloon system we always start at two atmospheres and then four atmospheres, and you really don't need to go higher than four atmospheres. So it's a very safe technology as well. And we actually did this on both sides, the right side and the left side for two reasons. One is we didn't know which side the Impella was going to track up and we felt like we were going to need mechanical support for this patient. And also because he was symptomatic and we wanted when we took the sheaths out, that we wanted there to be good inflow. So that was our rationale for using shockwave in this particular case. So, obviously we got the Impella in, and we used, my choice was a CSI Diamondback atherectomy, because we're going to be using it in multiple vessels with different sizes. And for this reason CSI is versatile for atherectomy. And what you see here is excellent luminal gain and stent expansion, which is the number one thing when we do angioplasty.

Brian Kolski:
I mean, when you talk about the importance of luminal gain at the end of the procedure, it's what predicts target vessel failure and target lesion revascularization rates. So this is, we consider an excellent result. And in our subtotally occluded segment, you can see we also got a nice result just by treating the very proximal part of the circumflex, which opened up that large, obtuse marginal. And then we turned our attention to the more diseased, heavily calcified right coronary artery. Typically, we like to use a deeper seated guide, but because there's ostial disease here, we used a less supportive guide and ended up being fine. And because of some bradycardia we put in a temporary pacemaker and treated the entire vessel and got another nice result with good lesion expansion. We always do IVUS in these multi-vessel cases to make sure the stents are expanded. And for this entire case we used less than 150 CCs of contrast. And the patient had an excellent result.

Brian Kolski:
In follow-up, he was discharged on day three, and on follow-up just about four weeks later, he had an ejection fraction of about 45% with just the lateral wall looking like it was akinetic. And the claudication being significantly improved. So we had a very happy patient, very happy referring doctor.

Cathy Jeon:
Did you end up stenting on your way out?

Brian Kolski:
No. So it's nice. So, we've done a number of the shockwave cases, and in none of the cases have we required a bailout stenting, because generally these patients, it's a very atraumatic therapy. So we have been able to avoid stenting in most cases. And in a guy like this, who's got severe peripheral arterial disease, he was 58, by preserving that up and over option, I think it's great. I mean, if he has ends up with critical limb ischemia down the road, need for an SFA procedure, or procedure and the popliteal, you have sort of left him multiple options, which I think is important is if you leave patients more options, they do better. Especially these young patients. So, I think my takeaways were, in this case, viability is one of those things that's extremely subjective and really clinical judgment. There's no substitute for it. And if you hear that there's no territory that's viable, generally that's an impossibility, that patient wouldn't be walking into your office. And for hostile iliac peripheral access shockwave has become our go to in the algorithm for large bore delivery of therapies.

Brian Kolski:
And as we know with calcium, it's a bad predictor of bad outcomes in the coronaries and vessel preparation is 100% very important in these patients, and mandatory if you're going to have a successful result.

Cathy Jeon:
So that's really a fantastic case, Brian.

Brian Kolski:
Yeah.

Cathy Jeon:
And I'm sure he's feeling a whole lot better, especially given that it sounds like he didn't have many options to begin with. And you gave him complete revascularization.

Brian Kolski:
Yeah.

Cathy Jeon:
And relief of his claudication.

Brian Kolski:
Yeah, exactly. Two for.

Cathy Jeon:
It's just like icing on the cake.

Brian Kolski:
Yeah, yeah.

Cathy Jeon:
So, just in terms of patient selection for shockwave, any patients that you would consider not a candidate for shockwave?

Brian Kolski:
So what I would say is, the shockwave therapy in the peripheral vasculature, we've done this in patients where they've had occluded iliacs, really hostile disease. I would say the only contraindication would be if they're not a candidate for any balloon angioplasty, or there's some type of contraindication to anticoagulation. But for me, this is really becoming a default strategy for large bore peripheral access. So I can't, apart from the sort of conventional no-nos with doing any peripheral intervention, I don't see any real big contra-indications for treating calcium this way. In fact, I think it's a lot safer.

Cathy Jeon:
And in someone with this much calcification, any concern for embolization?

Brian Kolski:
So great question. And obviously with the data that we have, looking at the data right now, that wasn't significant in the clinical trial. It's something that we're looking at and something we worry about. But I think part of the advantage of the lithotripsy is, it really treats the calcium that's embedded in the vessel wall. So it seems to be contained there. We have not seen any signal of distal embolization, which I think has been why it's sort of gotten more widely used, and why people are finding it an exciting way to treat this type of disease.

Cathy Jeon:
Can you tell me a little bit about how this kind of opens your doors in terms of alternative access? Is this something you would choose over something like perk ax, and why would you choose it over perk ax for instance?

Brian Kolski:
So previously our algorithm for large bore access was transfemoral first. If that wasn't an option due to calcium or something else transcaval or axillary as our two sort of next default strategies, whichever was sort of between those two. And I think the safety margin for this is much greater than with transcaval. There's just less that's involved, less bleeding. And from an axillary standpoint, if you can stay away from the upper extremity, typically when we look at sort of large data sets, you're going to decrease your risk of stroke, which is obviously a big thing. So for us in this space where we're trying to deliver therapies through large bore access, whether it's mechanical support, or transcatheter heart valves, I think that if we can keep the procedures femoral, it tends to keep them simpler. And I think it tends to be a better default strategy. And we're actively looking at this. I think we're trying to be mindful that this is a new technology and we want to be good stewards of delivering this type of healthcare. We want to also be studying this. So you'll start seeing some papers, and we're enrolling patients in trials and everything right now. So I think these are very important questions, and we're hopefully going to be enrolling and studying these patients as we're going forward as well.

Cathy Jeon:
It feels like perk ax and trans cable really has been utilized by advanced operators. In terms of a learning curve for a shockwave, your thoughts on this, and comparing the learning curve or contrasting the learning curve from shockwave to perk ax and transcaval.

Brian Kolski:
So I would say the transcaval and perk ax techniques generally are guys and women who have really strong peripheral skill subsets where you know how to bail out of situations with covered stents, using electrocautery, snares, that type of skillset is important. And I think with shockwave, it's much more scalable for general cath lab skills. I mean, it's a wire, it's a typical balloon, and it's used in a fashion that we're all more comfortable with. So I would say from the standpoint of general usability, this is much different than perk ax or transcaval.

Cathy Jeon:
So hopefully open the door to more operators.

Brian Kolski:
Absolutely, yeah. And treating more patients better.

Cathy Jeon:
Mm-hmm (affirmative). Well, it sounds like incredible technology. Thank you so much for joining us.

Brian Kolski:
Sure, yeah.

Cathy Jeon:
And sharing your insights on that. And thank you so much for joining us again on ProtectedPCI.com. Until next time, I'm Cathy Jeon.

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