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The Serranator Balloon: Tips for Successful Operation

Author Thomas "T.J." Turner covers The Serranator Balloon: Tips for Successful Operation on BackTable VI

Thomas "T.J." Turner • May 31, 2024 • 36 hits

In many cases, successful revascularization of the critical limb ischemia (CLI) patient depends on adequate patency of the lesioned vessel post angioplasty. The Serrantor Balloon is a serration angioplasty device that maximizes axial forces applied to calcified vessels through specialized cutting edges on the lining of the balloon. According to interventional cardiologist Dr. Peter Soukas, the Serranator’s novel technology may be an appropriate choice for a variety of below the knee, calcific lesions that are not amenable or have shown poor response to basic revascularization methods.

Keep reading to find out what tips Dr. Soukas keeps in mind when considering implementation of the Serranator balloon. This article features transcripts from the BackTable Podcast. We’ve provided the highlight reel here, and you can listen to the full podcast below.

The BackTable Brief

• Intravascular ultrasound (IVUS) should be used to characterize the lesion and plaque burden. Per Dr. Soukas, the Serranator is effective at treating both eccentric and concentric lesions, with intravascular lithotripsy (IVL) slightly preferable for dense 360-degree calcifications.

• Pre-dilation of lesions with smaller caliber balloons is recommended before deployment of the Serranator balloon, especially with the longer 120 mm version of the balloon.

• IVUS is routinely used to determine the appropriate balloon size, generally favoring a 1.1 to 1.2:1 ratio relative to vessel diameter.

• Technical success with the Serranator balloon in CLI is defined as 3 months with maintained vessel patency post procedure, though patency is ideally preserved past this timeframe.

The Serranator Balloon: Tips for Successful Operation

Table of Contents

(1) Evaluating Quadrants of Calcification

(2) Delivery of the Serranator Balloon

(3) Technical Endpoints of Serranator Balloon Treatment

Evaluating Quadrants of Calcification

In peripheral artery disease (PAD), quadrants of calcification refer to the division of arterial calcification into four segments, with different patterns of calcification necessitating different approaches to treatment. The use of intravascular ultrasound (IVUS) is invaluable for characterization of arterial plaque burden. Serration angioplasty has proven effective in addressing both eccentric and concentric calcifications, with post-procedural imaging showing clear serrations.

While intravascular lithotripsy (IVL) may be preferable for dense, 360-degree calcification, serration angioplasty offers a reliable alternative for lesions with fewer or more eccentric calcified quadrants, demonstrating good outcomes and visible changes on ultrasound and optical coherence tomography (OCT).

[Dr. Aaron Fritts]
Another talk I heard you give, you talked a little bit about quadrants of calcification, and you just mentioned it works well with concentric calcification. What about eccentric calcification? Talk to us a little bit about those quadrants of calcification, what you see with serration.

[Dr. Peter Soukas]
Sure. One of the nice things about intravascular ultrasound, it really is so helpful to basically identify the depth and the extent of calcification. We all talk about the now, I think, famous Fanelli paper with micro-CT, which demonstrated unequivocally, that the more quadrants of calcium you had, the lower the likelihood that you'd get a sustained improvement in terms of primary patency with drug-coated balloon technologies. We've certainly seen that in our clinical practice as well.

One of the other things that you just mentioned was eccentric versus concentric. I think we have to acknowledge that one of the potential limitations of IVL, is that it requires more pulses for more eccentric lesions. The nice thing about the Serranator is that we've seen when we have done ultrasound post-PTA, that we can actually see those serrations on ultrasound. They're also apparent on OCT as well. Unless it's 360 degrees of dense calcification, in which case IVL might be the preferred option, but for more eccentric and less heavily calcified or less frequent quadrants of calcium, this seems to be a very nice alternative.

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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Delivery of the Serranator Balloon

A good angioplasty device must be able to be navigated to the site of the lesion. While challenges in delivering a longer 120-mm Serranator balloon can arise, pre-dilation with smaller caliber balloons can help to facilitate treatment with the Serranator, according to Dr. Soukas. IVUS is routinely used to determine the appropriate balloon size, generally favoring a 1.1 to 1.2:1 ratio relative to vessel diameter. Dr. Soukas states that this approach allows for more aggressive treatment with reduced risk of flow-limiting dissections due to the lower pressure required by serration balloons. This technique is thought to be particularly beneficial in achieving significant and sustained luminal gain, an important factor for wound healing in CLI patients.

[Dr. Aaron Fritts]
That brings up my next question was specialty technology tends to have a reputation for being challenging to deliver, or bulky. You just kind of demonstrated with that, that it seems not to be, but anything else you can comment on there? How's it typically delivered? How well does the balloon track in heavily calcified vessels?

[Dr. Peter Soukas]
Overall, I think it tracks quite well. Once in a great while, if we encounter a difficulty in terms of delivering the device, and that typically is more likely to occur when we're trying to deliver the longer 120-millimeter length balloon versus the 40-millimeter balloon. Serration Balloons, like IVL balloons, occasionally you may need to pre-dilate with a smaller caliber balloon just to make a little bit of room in there, so that you can then deliver what will hopefully be the definitive treatment to that vessel segment.

[Dr. Aaron Fritts]
How do you decide the size of the balloon? Is it different from your standard balloon?

[Dr. Peter Soukas]
Not really. We are very big fans of IVUS, and we like to IVUS things ideally at baseline and then after each iterative technology that we're using, and then of course, a final ultrasound at the end. In general, if you can pass the ultrasound catheter, you should be able to deliver the balloon. One of the things that we've learned from the DCB trials, particularly for below the knee, as you know, they were pretty disappointing, the IN.PACT DEEP Study and the BIOLUX Study. One of the explanations, I think, primary explanations, in fact, is that we were likely undersizing our balloons significantly.

The other nice thing about a serration technology is that you're not needing to go to high pressure, so your likelihood of causing a type C or greater flow limiting dissection is much, much less. That does allow you to be a bit more aggressive, and so much like an IVL balloon, we're looking more at like a 1.1 to 1.2 to 1 ratio. If I've IVUS ahead of time, then I know exactly what size the vessel is, and I can pick an appropriately sized balloon. I think we've been perhaps a bit too timid in our balloon sizing below the knee.

If we're using specialty balloons like IVL balloons or serration technology, that does allow us to be a bit more aggressive. I think that greater luminal gain will hopefully translate into a better clinical response for the patient, particularly for the CLTI patients, where keeping that vessel open for at least three months is really something that we need in order to be able to achieve wound healing.

Technical Endpoints of Serranator Balloon Treatment

According to Dr. Soukas, technical goals of serration angioplasty are aimed at achieving at least three months of vessel patency in CLI patients, although patency is ideally preserved past this timeframe. The PRELUDE study, published in JEVT in November 2021, demonstrated nearly 98% freedom from target lesion revascularization (TLR) at six months, even in patients with severe Rutherford 5 disease. This high success rate appears to be reproducible in clinical practice per Dr. Soukas. Restoring adequate blood flow to the foot remains critical for preventing limb loss and associated mortality, as well as the psychological and economic impacts of amputation.

[Dr. Aaron Fritts]
You kind of answered my next question, but what's your primary technical goal with this serration angioplasty?

[Dr. Peter Soukas]
Ideally, at least three months. Of course, we'd like to have better patency rates than that for all of our technologies, but if we look at, for example, the PRELUDE BTK study that we referenced a few minutes ago, that paper was published in JEVT back in November of 2021. They had a nearly 98% freedom from TLR at six months, which is really quite remarkable. That particular study included patients with Rutherford 5 disease. That was a pretty remarkable result, and we're certainly seeing similar results in our day-to-day clinical practice as well.

[Dr. Aaron Fritts]
It's that red gold that you're looking for with your podiatry and wound care colleagues? Are you getting any comments back from them?

[Dr. Peter Soukas]
Yes, they're very, very happy that we will go to great lengths. If it takes 2, 3, 4, 5, 6 hours, we'll do whatever it takes to try to get as much red gold down to the foot as we can, because we all know that when a patient loses a limb, their life is in jeopardy. Patients with CLTI have a 50% five-year mortality, and that mortality will be hastened if they lose a limb. Not to mention all the devastating psychological and economic fallout from a patient being a functioning member of society to then perhaps even being required to be living in a nursing home. Anything that we can do to avert that disastrous conclusion is a very good thing.

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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Podcasts

New Balloon Technologies for CLI with Dr. Peter Soukas on the BackTable VI Podcast)
The Multidisciplinary Approach to Combatting CLI Globally with Dr. Jos van den Berg on the BackTable VI Podcast)
My Algorithm for Below the Knee CLI with Dr. Peter Soukas on the BackTable VI Podcast)
Which Dissections Matter, and How to Treat Them with Dr. John Phillips on the BackTable VI Podcast)
Dialysis Interventions with Drug-Coated Balloons, Covered Stents and More with Dr. Ari Kramer on the BackTable VI Podcast)
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