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The Role of Serration Angioplasty in Peripheral Artery Disease

Author Thomas "T.J." Turner covers The Role of Serration Angioplasty in Peripheral Artery Disease on BackTable VI

Thomas "T.J." Turner • May 31, 2024 • 37 hits

Serration angioplasty is a form of treatment for peripheral artery disease (PAD) that uses interrupted scoring during angioplasty to break down intraluminal calcification. Serration angioplasty, particularly with the use of the Serranator Balloon, can provide significant benefits in treating long, diffuse, and calcified lesions, especially in below-the-knee (BTK) lesions.

According to Dr. Peter Soukas, key advantages of serration angioplasty include reduced dissection rates, minimal recoil, and a decreased risk of distal embolization and perforation. This technology offers predictable and safe lumen expansion, even in challenging anatomical locations, and is recommended for cases where stent placement is undesirable.

Keep reading to learn more about the unique role of serration angioplasty in peripheral artery disease. 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

• Before the advent of newer serration technology, traditional cutting balloons were limited in length and efficacy, particularly in calcified lesions.

• Serration angioplasty is suitable for BTK interventions where stent placement is impractical due to challenging anatomy or mechanical stress.

• Serration angioplasty significantly reduces the risk of distal embolization and perforation compared to atherectomy devices according to Dr. Soukas

• The device tracks well through tortuous, heavily calcified, and aberrant vascular anatomy and provides substantial acute luminal gain at the target site.

• Per Dr. Soukas, the operator should make sure to properly prepare the balloon and pre-dilate at the target lesion in order to maximize the plaque-shearing properties of serration angioplasty.

The Role of Serration Angioplasty in Peripheral Artery Disease

Table of Contents

(1) A Brief History of Cutting Balloon Angioplasty

(2) Lesions Amenable to Serration Angioplasty

(3) Advantages of Serration Angioplasty in BTK Lesions

(4) Safety Considerations & Suitable Cases for the First-Time Operator

A Brief History of Cutting Balloon Angioplasty

Traditional cutting balloons were limited by their short lengths and less practical application in treating long, diffuse lesions commonly found in peripheral artery disease. The subsequent AngioSculpt balloon offered longer lengths (up to 100 cm) but exhibited variable outcomes in terms of luminal gain and recoil. The Serrenator Ballon, the latest innovation in this space, introduces a unique serration mechanism that generates significantly higher focal force compared to typical angioplasty balloons. Dr. Soukas holds that this mechanism facilitates a more predictable and safer lumen expansion, reducing the rates of dissection and recoil observed with earlier scoring balloon technologies.

[Dr. Aaron Fritts]
Let's jump into that, Peter. Today we're going to talk a little bit more about specialty balloons because I think everybody in the audience knows that there's typical scoring or cutting balloons have been around for a while now. You mentioned in the prior episode the Serration Angioplasty, the Serranator. Can you talk to us about how the specialty balloon space has evolved over time? What is the difference between this new balloon and the prior ones that we think of?

[Dr. Peter Soukas]
Traditionally, I think probably the first dedicated Cutting Balloon on the market was the Boston Scientific Cutting Balloon, which was unfortunately fairly limited in terms of lengths that were available. Today, in fact, they're about two centimeters for the peripheral devices, and the coronary devices are even shorter-length balloons. These were basically three surgical balloons that were just glued onto the outer surface of the balloon. When we're talking about below-the-knee disease these are typically long diffuse lesions. It was really not very practical to treat either above the knee or below the knee with these particular devices.

In more recent years, we had the AngioSculpt balloon, which did have the advantage of coming in 40 and 100-centimeter lengths, but the results were somewhat variable in terms of the acute luminal gain, and the degree of recoil that we typically would see. The newest kid on the block, of course, is the Serranator Balloon, which is really, I think, a fairly unique mechanism of action that uses these serrations, which are able to basically have about a thousand times more focal force than a typical angioplasty balloon.

Why is that an advantage? I think it's able to give us a very predictable and safe expansion of the lumen along these so-called fault lines, and our rates of dissection in recoil are much lower than with the traditional scoring balloons that we've used in the past.

Listen to the Full Podcast

New Balloon Technologies for CLI with Dr. Peter Soukas on the BackTable VI Podcast)
Ep 334 New Balloon Technologies for CLI with Dr. Peter Soukas
00:00 / 01:04

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Lesions Amenable to Serration Angioplasty

Novel advancements in serration angioplasty have shown significant success in treating longer and more calcified lesions, which were challenging for prior balloon technologies. The availability of longer balloon lengths (40 and 120 mm) makes modern serration balloons suitable for a wider range of vessels, especially in patients with diffuse calcification often seen in diabetic patients and those with chronic kidney disease. Advances in serration angioplasty technology effectively addresses fibrocalcific and heavily calcified lesions, providing substantial acute luminal gain with minimal recoil. This approach can also be cost-effective compared to intravascular lithotripsy (IVL), making it a preferred option in certain clinical scenarios.

[Dr. Aaron Fritts]
Okay, perfect. You mentioned that for longer lesions, the prior balloons were kind of disappointing. What specific types of lesions are you seeing serration angioplasty most successful with?

[Dr. Peter Soukas]
I think that the advantages of having 40 and 120-millimeter lengths allows us to expand the types of vessels that perhaps maybe we might have shied away from cutting balloon technology, or focused force angioplasty in the past. The nice thing about it is that it really does seem to be quite effective in the more calcified lesions. I think that's really where some of the older generation devices kind of fell short, was that they really didn't do a very good job or a very effective job on these more calcified lesions.

In our practice, a lot of these patients, particularly our diabetic patients and our patients with chronic kidney disease, we know that the further down you go in the tibial artery, the more likely you're going to encounter more diffuse calcified lesions. I think that's really been the sweet spot for this technology, is not only can it take care of fibrocalcific, but even the more calcified lesions, the more concentric calcified lesions. It really does seem to do a very nice job addressing those.

As we discussed in the last podcast, we're very big fans of IVL, however, this technology is obviously less expensive, and for most patients, we can typically get a very nice acute luminal gain with minimal recoil with serration technology.

Advantages of Serration Angioplasty in BTK Lesions

Serration angioplasty can offer significant advantages in treating critical limb ischemia (CLI), particularly in BTK lesions, by addressing issues of recoil and reducing the need for bailout stenting. According to Dr. Soukas, serrated balloon technology has demonstrated excellent outcomes, with residual stenosis rates of less than 23%, low inflation pressures (6-8 atmospheres), and very low dissection rates, necessitating bailout stents in less than 2% of BTK cases and about 4% of above-the-knee (ATK) cases.

The predictable results of serration angioplasty reduce the need for scaffolding, which is particularly beneficial in the distal tibial artery where stent placement is impractical. Additionally, the flexible design of the serration balloons allows them to navigate into distal vessels, such as the common plantar and dorsalis pedis arteries, further enhancing their applicability over traditional rigid technologies.

[Dr. Aaron Fritts]
You mentioned one of the issues with prior technologies was recoil, especially in BTK lesions, and also the desire not to stent in the setting of CLI. How does Serration angioplasty help solve for those particular problems? I know you mentioned less dissections, for sure.

[Dr. Peter Soukas]
Yes, for sure. In both the prelude above and below the knee studies, we saw really excellent final luminal residual stenosis of less than 23%, and a typically fairly low inflation pressures of only 68 atmospheres. The dissection rate was really very, very low to the extent that the need for a bailout stent, for example, was less than 2% in the below-knee study and only about 4% in the above-knee study, which I think is pretty remarkable for a balloon technology. It's that predictable response that I think makes it such an attractive tool in our armamentarium, especially for below the knee, where we really, really try to avoid placing stents.

We know that you can successfully implant coronary drug-coated stents, but that's really limited to the proximal third of the tibial artery. What do you do when you're down near the ankle? You can't put a balloon expandable stent there because it'll get crushed. The ability to avoid the need for a scaffold, particularly in the distal two thirds of the tibial artery, I think is a real potential advantage for serration technology, as opposed to just plain-old balloon angioplasty.

[Dr. Aaron Fritts]
You brought up a good point. I heard a talk by Edward Gifford at the recent sharing cross talking about, there was maybe a study released recently about using it below the ankle. Is that right?

[Dr. Peter Soukas]
Yes, that's true. One of the nice things about the technology is that because it's not rigid, stainless steel blades, it has the flexibility that you can take it around the corner into the common plantar, and in fact, into the dorsalis pedis or the medial or lateral plantar vessel. That's again, I think an advantage compared to the older focused force angioplasty technologies.

Safety Considerations & Suitable Cases for the First-Time Operator

Serration angioplasty offers a favorable safety profile, particularly by minimizing the risk of distal embolization and perforation, which are critical concerns in BTK interventions for CLI. Unlike atherectomy devices, which carry significant risk of debris dislodgement and subsequent acute limb ischemia (ALI), serration technology has demonstrated a lower rate of such complications.

Dr. Soukas recommends that new operators start with fibrotic or moderately calcified lesions where stent placement is undesirable, such as at bifurcations. It is important to pre-dilate if necessary, and to allow sufficient time for balloon deflation and rewrapping to ensure smooth retrieval through a 5-French sheath.

[Dr. Aaron Fritts]
Peter, one thing I forgot to ask earlier, we talked about the decrease in dissection and recoil and spasm even. What about embolization, which is obviously a concern with atherectomy devices?

[Dr. Peter Soukas]
That's a great question. One of the things that can really sync your procedure is distal embolization, particularly, for example, if a patient has single vessel runoff and you send debris downstream, you've now taken that CLTI patient and converted them to an ALI patient. Distal embolization and perforations below the knee are absolutely catastrophic. Anything you can do to minimize that risk, I think is really important.

I think that's another reason why we've sort of shied away from atherectomy devices below the knee, is that the consequences of distal embolization are so dire. I think one of the advantages of this particular technology is that we just really don't see it. Honestly, I can't think of a single case that I've ever had where we had distal embolization. These alternative technologies, I think really not only are they better in terms of acute luminal gain, but the safety profile is, I think, much more favorable as compared to atherectomy.

[Dr. Aaron Fritts]
Great. Anybody in our audience who's looking to maybe try this, what's a good first case to start with?

[Dr. Peter Soukas]
I think for patients who have more sort of fibrotic lesions that are not densely, densely calcified, I think that's probably a very good place to start with serration technology. The balloon, as I mentioned, does really track quite well, and if you have areas where you really don't want to have to bail out with a stent, for example, at the pop TP trunk bifurcation or at the pop to 80 AT bifurcation. We know that atherectomy in that location is particularly problematic in terms of the risk of a dissection or perforation.

Areas where you don't have horrific amounts of calcium, but you have fibrofatty plaque or fibrotic lesions or lesions that are even moderately calcified, I think folks will be pleasantly surprised at how well the device tracks, and the acute luminal gain that you'll gain.

[Dr. Aaron Fritts]
Great. Any other dos and don'ts before we finish up?

[Dr. Peter Soukas]
Again, realizing that you may need to pre-dilate, the devices do go through a 5-French sheath and it's just really important to make sure you prep the balloons very well, and give them time to deflate before you take them out because it can be a little bit snug in a 5-French sheath. If you do a really good job in terms of giving it time to rewrap, then it's usually not an issue.

Podcast Contributors

Dr. Peter Soukas discusses New Balloon Technologies for CLI on the BackTable 334 Podcast

Dr. Peter Soukas

Dr. Peter Soukas is the director of Vascular Medicine and Interventional PV Lab at Lifespan.

Dr. Aaron Fritts discusses New Balloon Technologies for CLI on the BackTable 334 Podcast

Dr. Aaron Fritts

Dr. Aaron Fritts is a Co-Founder of BackTable and a practicing interventional radiologist in Dallas, Texas.

Cite This Podcast

BackTable, LLC (Producer). (2023, June 19). Ep. 334 – New Balloon Technologies for CLI [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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