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BackTable / VI / Article
Endovascular Innovations in CFA Disease: Shockwave Lithotripsy & Beyond
Sophie Frankenthal • Updated Jan 10, 2025 • 40 hits
Common femoral artery (CFA) disease presents a significant challenge in vascular intervention due to the artery’s complex anatomy and its essential role in maintaining blood flow to the lower extremities. Severe CFA stenosis can severely compromise peripheral perfusion, endangering limb viability and overall vascular health. While open surgical endarterectomy has long been the standard treatment amongst vascular surgeons for restoring arterial patency, advancements in endovascular techniques are redefining the approach to managing CFA disease, particularly in patients with heavily calcified lesions.
Vascular surgeon Dr. Mazin Foteh explains the evolving role of endovascular therapies in treating CFA disease. He highlights the impact of cutting-edge tools like lithotripsy and offers insights into integrating innovation with established surgical principles.
This article features transcripts for the BackTable Podcast. We’ve provided the highlight reel here, and you can listen to the full podcast below.
The BackTable Brief
• Although CFA lesions were historically considered unsuitable for endovascular intervention, recent advancements, including lithotripsy and alternative access strategies, are expanding the role of endovascular interventions for CFA disease.
• Intravascular lithotripsy effectively addresses calcified CFA lesions by creating microfractures in calcium, enhancing vessel compliance. It can be used as a standalone therapy or alongside technologies such as drug-coated balloons.
• Lithotripsy preserves options for future surgical interventions, such as endarterectomy, while offering an effective solution for managing complex CFA disease.
• Strategies like buddy-wire placement and dual-access approaches are used to safeguard the profunda during lithotripsy.
Table of Contents
(1) Reevaluating Endovascular Intervention for CFA Disease
(2) The Role of Shockwave Intravascular Lithotripsy in CFA Disease
(3) Preserving CFA Surgical Options with Lithotripsy
(4) Profunda Protection & Device Selection in Endovascular Interventions
Reevaluating Endovascular Intervention for CFA Disease
Historically, the common femoral artery has been considered unsuitable for endovascular intervention due to the limitations of early modalities such as cryoplasty, atherectomy, drug-coated balloons (DCBs), and stenting. These techniques struggled to address the full depth of calcified lesions, often only impacting the intimal or medial calcium, leaving deeper calcifications untreated.
Recent technological advancements, particularly in lithotripsy, have demonstrated improved outcomes by effectively penetrating and treating calcific CFA lesions. Additionally, innovations in alternative access strategies have reduced reliance on traditional CFA punctures, making endovascular approaches more adaptable to individual patient anatomies and clinical scenarios.
While surgical endarterectomy remains the gold standard for vascular surgeons managing CFA disease, these technological improvements have paved the way for growing acceptance of endovascular interventions as a viable option in select cases.
[Dr. Sabeen Dhand]
On that, let's switch gears and talk about the endo approach. Should we stop now? Is there validity to endovascular approach to CFA disease? Should we stop, or do you think there's validity in that?
[Dr. Mazin Foteh]
No. First of all, this is a topic that's very important to me. I know it's a topic that's very important to you, and the common femoral artery has always been the no-man's zone for endovascular intervention, and we've, over the years, have tried everything, from cryoplasty to atherectomy to drug-coated balloons to stenting. You name it, we've tried it, and I've laid, and I know we're going to get into it, but lithotripsy as well.
Today, there really hasn't been a great, useful tool to address calcific disease. Not one that can really affect the entire calcific lesion. Now, some of the atherectomy devices out there have the ability to get into the intimal calcium. Some can even because microfracturation in the medial layer, but none of them have the ability to get into the deeper layers of the calcium, 4 and even 6 millimeters deep, in order to have a great effect on the vessel.
Prior to the last couple of years, I think you included, just have been a little bit disappointed with the outcomes from common femoral and intervention. We didn't do it for a long time. Today, though, I think the tide is shifting. I think we now have some tools out there that seem to be much more effective for that particular artery and are performing much better over time, and I think the avenue for endovascular approaches are getting better. Some things that I think have improved as well is having different alternative access points has made it a little bit easier for us to do.
[Dr. Sabeen Dhand]
That's true. You don't have to stick to common femoral now.
[Dr. Mazin Foteh]
Yes, you can avoid it, so it makes it a lot easier for us to be able to treat these folks. I guess to answer your question, if you asked me 10 years ago, I would have told you, "Absolutely not, common femoral endarterectomy is the way to go," but for the past two years, I think my mindset has changed a little bit.
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The Role of Shockwave Intravascular Lithotripsy in CFA Disease
Shockwave intravascular lithotripsy (IVL) has emerged as a promising endovascular technology for treating calcified CFA lesions, particularly in cases where standard modalities fall short. By utilizing acoustic shockwaves delivered through an angioplasty balloon, the device creates microfractures in the calcium, enhancing vessel compliance and luminal gain. Unlike conventional balloon angioplasty, which often provides minimal improvement in heavily calcified vessels, lithotripsy has shown consistent efficacy across a spectrum of CFA presentations, including short eccentric plaques and long calcified segments. It can be employed as a standalone therapy or adjunctively with drug-coated balloons for patients requiring durable patency. These advancements not only improve outcomes but also expand the scope of endovascular interventions for this challenging disease.
[Dr. Sabeen Dhand]
There's two types of CFA chronic disease, something that's still open. Now, you mentioned that nasty disease with a 2 millimeter open lumen or a total occlusion, but how about this nasty disease? What are some of the tools now that you can use, as long as the CFA is open, to help you with this chunky calcium lipid layer plaque?
[Dr. Mazin Foteh]
The tool that I've been using of late, and I know you're aware of it, is actually Shockwave Lithotripsy. Shockwave has now been available in the US, I believe, close to five years. Initially, it was being used in the SFA and then in the tibials and then eventually the iliacs and now the coronary. Over time, once you start using this technology, you start to figure out places where you think it'll work really well.
We learned over time that it actually can be very beneficial in the common femoral distribution. This is a disease bed that typically is not soft plaque, that typically is dense calcified disease, and doesn't respond to our standard therapies. Doing balloon angioplasty will not work. Doing straight-up drug-coated balloons in this area also will not work due to the dense calcium and the lack of penetration.
[Dr. Sabeen Dhand]
I've done that, where I just do a conventional, like a POBA on a CFA, and I'm like, "I didn't do any--" I tried to convince myself the post-angio is better. I'm like, "Yes, cool," but it's not. It's literally maybe 5% better, when I've used a 7 millimeter balloon, but it doesn't do anything. It's different when you use some other devices, for example, Shockwave.
[Dr. Mazin Foteh]
Yes, I think Shockwave has that ability to crack the calcium, change the compliance in the vessel, and ultimately improve luminal gain, which is really what we want. To date, I think I've used it in pretty much all applications of the common femoral. The short eccentric lesions, the long calcified lesions, the occlusions, pretty much every aspect of common femoral disease that you think you can use it in, I've done it. I know where it works well now, and it's a viable technology. It's one that I think in the future may actually be a go-to first for the common femoral. Lots of reasons for that, too.
[Dr. Sabeen Dhand]
Now, are you using-- you mentioned it to soften the plaque. Are you using it as an adjunctive technique as far as to change the compliance and then do something else like DCB or a stent, or are you using it solely by itself and seeing what the post-result is?
[Dr. Mazin Foteh]
Yes. I think there's two avenues for me, one of which is just using Shockwave alone. Then the other avenue is to use Shockwave in combination with the DCB. Today, not somebody who's going to stent a common femoral. Not right now. I don't think there's good enough data to support that.
[Dr. Sabeen Dhand]
You're not throwing Superas and all those-- [crosstalk]
[Dr. Mazin Foteh]
Not yet. I know we're going to get into this a little bit, but that's not a part of my practice right now. I tend to treat it basically two ways, as a sole therapy, and if I get a great result from that, then I'm comfortable and I leave it alone. If I get a suboptimal result or if it's a patient who I simply never want to bring back to the operating room or cath lab, then I think it's a good idea to use an adjunctive technology like a DCB to hopefully give you more durable patency over time. That's pretty much how I approach it.
Preserving CFA Surgical Options with Lithotripsy
Endovascular therapies for CFA disease, including shockwave lithotripsy, offer an effective treatment option without compromising the feasibility of future surgical interventions like endarterectomy. The technique minimizes risks such as embolization and acute occlusion while preserving vessel integrity and avoiding excessive inflammation. Although lithotripsy does not substantially alter calcium properties to simplify later surgeries, it reliably maintains vessel patency, allowing for surgical correction if restenosis occurs. This strategy provides effective interim management for conditions like tissue loss or rest pain while avoiding premature stenting, which could limit options for future bypass procedures.
[Dr. Sabeen Dhand]
Now, in your experience, has this ever burned a bridge as far as going in surgically after you've done a therapy? Say it didn't work that well, are you already prepping the groin for potentially doing an open approach or you plan for that later? Then, does it mess you up at all? Does it make it more inflammatory to-- like when you postplasty a vein and that vein becomes really crappy and you don't want to do surgery on it, is that the same thing that happens on the common femoral?
[Dr. Mazin Foteh]
No, not really. I've been asked two questions. One, "Does it make it worse? Do you somehow compromise what you can do down the road?" Then two, "Does it make what you do down the road any easier?" The answer to both is no. It definitely doesn't burn any bridges. I've never had an embolic event. I've never had an acute occlusion. I've never had anything where I felt like the lithotripsy balloon was the source of that complication.
Then on the flip side, even if I were to cross and I were to treat and I were to open the vessel, when I go back to do an endarterectomy down the road, it didn't make it harder, but it also didn't help it either. I've had I've had device reps ask, "Well, is the calcium softer at that point?" Maybe. Either way-
[Dr. Sabeen Dhand]
It doesn't feel like a rock. Again, when you go in there, you don't feel-- I don't know, at least the ones I've felt, and I've felt way less than you, they don't feel like-- When I first saw this, I expected to feel a rock or something, but calcium is rubbery.
[Dr. Mazin Foteh]
It depends what you encounter. I definitely had scenarios where the artery was so rock hard I couldn't even place clamps because I couldn't occlude the vessel. In fact, there have been scenarios where it was so densely calcified, when I placed the clamp, what happened is the calcium tore the artery through the intima into the adventitia. I've definitely had scenarios like that as well.
[Dr. Sabeen Dhand]
Yikes.
[Dr. Mazin Foteh]
Yes. It could be quite a challenge. Truthfully, Sabeen, there have been many scenarios where I've done common femoral artery occlusions, I've treated it with lithotripsy, the vessel has stayed open, and maybe one to two years down the road, there might be a restenosis and I have to do a common femoral endarterectomy. Then when I get him to the OR, the vessel is still open. Still open.
[Dr. Sabeen Dhand]
That's great.
[Dr. Mazin Foteh]
To me, that's a testament to a great end result.
[Dr. Sabeen Dhand]
Without the open incision and all that. We're in the right direction compared to 10 years ago.
[Dr. Mazin Foteh]
Yes. On occasion, you're treating somebody for rest pain or you're treating somebody for tissue loss. The only thing you find is a common femoral artery occlusion. You cross that occlusion and you lithotripsy it, the vessel stays open. The patient's rest pain disappears or the gangrene heals. If they're a young patient, maybe you send them to your surgeon and say, "Hey, this worked. I'm worried it's not going to last a long time. Could you do a preemptive endarterectomy for him?" I think that's a great scenario. I really do. I think this tool gives you the option of not having to back out either. If you encounter that in a tough scenario, now you at least have an option of treating somebody.
[Dr. Sabeen Dhand]
Exactly. That's true. That's good. You still can do something. Then it's really important that-- That was one of my big questions, do I burn a bridge or compromise a surgery after if I'm doing something like this? In your experience, you don't, and that's huge. That's a huge take-home point.
[Dr. Mazin Foteh]
Yes. I think one other point we should make from that is that, if you're an interventional radiologist or if you're a cardiologist, don't let anybody tell you that that's going to happen either. I know you can remember this, five years ago when we started getting really aggressive with tibials, the first thing all the surgeons said was, "Oh, they're going to burn all of our bypass bridges. We're not going to be able to do a bypass now." Yes, if you stent the entire vessel, you're not going to be able to do a bypass. If you go in there and you balloon a PT or an AT, you're going to be able to bypass the patient.
Truthfully, as somebody who was very aggressive, I had some of my partners tell me, when I got aggressive with tibials, "Hey, you're going to create a lot of bypasses for us." I said, "No, I don't think so. Maybe you're right, but I don't think so." Luckily, that hasn't been the case.
[Dr. Sabeen Dhand]
That's great.
[Dr. Mazin Foteh]
That really has not been the case. The same is true for the common femoral artery. You can balloon it, you can do atherectomy, you can do lithotripsy. The only thing I would say is, right now in a young patient, if you can avoid it, don't stent it. That's all I'm saying.
Profunda Protection & Device Selection in Endovascular Interventions
Managing CFA disease requires careful attention to preserve the profunda femoris artery. Techniques such as buddy wire placement or dual-access strategies are essential to ensure protection during endovascular interventions. While lithotripsy alone seldom causes plaque shift, addressing spillover disease at the bifurcation, including the profunda and superficial femoral artery (SFA), is critical. Furthermore, embolic events are rare with lithotripsy, reducing the need for filter devices in these cases.
In atherectomy procedures, device selection plays a pivotal role in minimizing complications. Directional and orbital atherectomy devices, such as Hawk and CSI Diamondback, are optimal for targeted plaque removal, whereas rotational devices like Rotarex have limited application beyond occlusions. Employing devices judiciously – limiting passes, avoiding prolonged runs, and tailoring device size to the vessel – helps mitigate the risk of embolization and vessel injury.
[Dr. Sabeen Dhand]
One of the things I wanted to talk about was the profunda. We're talking about CFA, there's no way we can't talk about the profunda. Have you had any plaque shift ever when you postplasty this? Have you compromised the profunda? Obviously, when you stent, you're going to stent across it. That's a big, potential issue. Any issue with your current possible IVL-DCB approach to CFA?
[Dr. Mazin Foteh]
I think one thing you definitely have to be comfortable with if you're going to do common femoral disease interventionally is you have to get comfortable with being able to protect the profunda. Whether that means putting a separate buddy wire in the profunda while you're doing your intervention, whether that means doing a tibial access so you can have one wire across the common femoral retrograde and one wire into the profunda antegrade, you got to protect that artery.
Have I had a plaque shift myself doing lithotripsy alone? No, I haven't. I think that's because we approach the common femoral in a stepwise manner. If the plaque is completely free of the bifurcation, we don't worry, we don't individually wire each vessel. If there was any ever a concern, we take that extra step and we just do it. It's been great for us.
As you know, oftentimes you have to do that anyway because there's spillover disease. The ostium of the profunda, the ostium of the SFA, truthfully, that's the common femoral artery right there. You just have to take care of all the disease. That means doing lithotripsy in the profunda as well as the SFA. No, it's never happened. It is of concern. I do think you need to be careful when you're doing these types of cases because that can happen. Today, I think as long as you're careful, you can do it safely.
[Dr. Sabeen Dhand]
Yes, no, that's great. Yes, and you did mention, too, you haven't had an embolic event, and so you're not typically using filter devices when you're treating the CFA via an endo approach, correct?
[Dr. Mazin Foteh]
That's correct. In the last 10 years, I've never put a filter for common femoral disease, even in scenarios where we were doing atherectomy. We've learned so much in the last decade, where I feel like, although filters are a great safety net, to me, they tend to cause more problems than actually provide any solutions. [crosstalk] Now the atherectomy devices are so advanced. They're doing atherectomy and thrombectomy in combination. These newer devices, I think, are so powerful that if any embolic debris is released, it's immediately suctioned back into the catheter system.
[Dr. Sabeen Dhand]
Yes, and speaking of atherectomy, what's your experience with atherectomy at the common femoral, with devices like Hawk, if you want to go directional, or Rotarex now that's out. They obviously can't go 6 millimeters in, and you can't differentiate going to the media versus-- You're sticking in the intima layer, that's for sure. What's your experience? Do you do it at all, or that's not even on your table?
[Dr. Mazin Foteh]
Yes, so I definitely have done it, and I think I still do it to some degree, but I think it's also important to really choose the proper device if you're going to do a common femoral. The rotational atherectomy devices like Rotarex, which you're mentioning, unless it's an occluded common femoral, that device, quite honestly, is not going to have a major effect because it can't reach the plaque. You're being forced to use directional atherectomy devices like Hawk, potentially Jetstream because it has the cutting blades that can be released, and CSI, a Diamondback. I think those are probably the best options.
I've had some pretty good successes along the way. At the end of the day, it's still the important pieces are choosing the right device, choosing the right size device, and being careful not to create a problem while you're trying to solve this issue.
[Dr. Sabeen Dhand]
Don't embolize.
[Dr. Mazin Foteh]
Yes, don't embolize. Yes, it's easy to say, yes, just don't do it. Of course, it never happens to me. Truth is, just be careful with it. Don't put a [unintelligible 00:42:26] CSI in every single common femoral artery. Small patients use a smaller device.
[Dr. Sabeen Dhand]
No high RPM, all 10 passes.
[Dr. Mazin Foteh]
Yes, don't do 10 passes, and don't do these super long two-minute runs either. Those are going to be issues that get created and probably are self-induced.
Podcast Contributors
Dr. Mazin Foteh
Dr. Mazin Foteh is a practicing vascular surgeon in Austin, Texas.
Dr. Sabeen Dhand
Dr. Sabeen Dhand is a practicing interventional radiologist with PIH Health in Los Angeles.
Cite This Podcast
BackTable, LLC (Producer). (2022, January 24). Ep. 181 – Surgical vs. Endovascular Management of CFA Disease [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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