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CTO Devices for Crossing, Re-Entry & The Future of Chronic Total Occlusion Treatment

Author Caleb Solivio covers CTO Devices for Crossing, Re-Entry & The Future of Chronic Total Occlusion Treatment on BackTable VI

Caleb Solivio • Aug 13, 2023 • 261 hits

Clinicians working with peripheral artery disease (PAD) and critical limb ischemia (CLI) populations should be comfortable with different approaches to CTO crossing and true lumen re-entry, and be aware of the myriad tools that can aid in such cases.

Interventional cardiologist Dr. Jihad Mustapha shares his view of modern CTO devices, including the Outback Elite, Pioneer, Stingray, and Wingman. He explains the role that these tools service in in his practice as a PAD / CLI specialist, with each device offering its own benefits and drawbacks. His review also looks forward into the future of re-entry devices that he feels will make navigating subintimal dissection easier, offering significant benefits to both patients and providers.

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

• Each CTO re-entry device has its own advantages and disadvantages that make it ideal for specific situations. Some of the most common devices include the Outback Elite and Pioneer. Operators that become familiar with such devices will learn their own tips and tricks for re-entry success.

• Companies such as Reflow Medical have developed CTO-crossing devices that can also serve as re-entry devices, making interventions more cost-effective by decreasing the overall amount of equipment used.

• Outside of CTO-crossing-specific and re-entry-specific devices, some companies, such as Asahi and Terumo, are also developing new catheter technology that may better support revascularization.

CTO Devices for Crossing, Re-Entry & The Future of Chronic Total Occlusion Treatment

Table of Contents

(1) Re-Entry Devices

(2) Future CTO Devices

Re-Entry Devices

Crossing CTOs is never a straightforward process according to Dr. Jihad Mustapha. Though clinicians can do their due diligence in properly identifying CTOs by their CTOP (CTO crossing approach based on plaque cap morphology) classification, complications such as subintimal dissection can always occur. Thus, it is important that clinicians understand different approaches to true lumen re-entry and the tools available for them to accomplish successful re-entry while avoiding vessel perforation. Re-entry tools include the Outback Elite, Pioneer, Sting Ray, and Wingman which all have their own specific operational nuances.

[Dr. Sabeen Dhand]
And then go and finish off the case, right. Where in that algorithm do re-entry devices fit your-- I'll be honest, we do a ton of CLI in my practice. My practice is mainly diabetics and I have a lot of tibial disease, but I have plenty of SFA-Pop disease but using pedal access, I have felt no need to take a re-entry device out because we tend to be able to cross it with a wire and catheter. I want to know for myself and for audiences, what re-entry devices are out there and why should I use them?

[Dr. Jihad Mustapha]
The most commonly available now, two devices that we're all familiar with are the Outback Elite and the Pioneer. There's actually some tips and tricks to them if you're going to use them. The Pioneer, when you've taken it up and over around the horn, you have to always respect it and I tend to use it with a 7 French sheath you can push it through a 6 French sheath is fine, and these they use a 7 French braided sheath because when you go around the horn, you have to actually rotate the needle angle of the Pioneer that is facing down.

Basically, it kind of rides the horn of the aorto-iliac junction, so you can advance it down and smoothly. Otherwise, actually, you will be looking up, so the vector of force will be going away from the contralateral iliac artery. With small rotation, you advance and take it down to where you need it to be and then when your get there, also, be patient because when you rotate in the Pioneer, you have to wait for the forest rotation to get there because the going around the horn, and many of us including me don't do that.

This is one check about the Pioneer. The other thing is please always remember to use a non-hydrophilic wire with it because if you use a hydrophilic wire, you know the consequences of that. That's another thing that's very important. The Outback is similar to the Pioneer. Make sure you always look at the different shafts that come in because you don't want to be going up and over and then you have an 80 centimeter shaft versus 135 and then you want to re-enter at the popliteal then you won't reach.

Again, when you're taking the IVUS catheter of the aortoiliac junction at the horn, the tips can break. For the Pioneer you can lose the value of the IVUS if you break it. For Outback, if the tip bends, then you can lose the functionality of it because it takes it away from the re-entry component or the lumen comes at a distance. These two things for them-- and besides these two, there's not that many out there that actually will give you the good outcome that these two can give you.

When you re-enter, make sure you're not too far in the adventitial space because then you have an angle re-entering and you don't want an angle to [crosstalk].

[Dr. Sabeen Dhand]
That's a good point. The angle can really mess things up. What are some other devices? I believe there's Reflow out there, what are some other ones?

[Dr. Jihad Mustapha]
There's devices that was used in PQ Bypass devices with Limb Flow, but these are not on the market yet. These are re-entered devices, and they'll be in the market soon. There is the Sting Ray which is-- if you're treated just subintimally when it would get back in the lumen and it's more effective when you use it in the tibials, popliteal. It's not very strong, kind of penetrating type of device because it's not a needle, it's a wire that comes out.

The last thing that we use, something called the Wingman, and the Wingman is made by a company called Reflow, and it's got a needle on it. It's 035, 018, and 014. The value of this device in our practice, it's actually cool because you can actually bend it, shape it, and then use it to-- so you don't have that 45-degree re-entry or whatever, you can actually enter it maybe 30 degrees if you want or 15 degrees based on the shape that you make.

[Dr. Sabeen Dhand]
It's designed for like to cross the CTO right? That's what the [crosstalk].

[Dr. Jihad Mustapha]
It's a CTO Catheter.

[Dr. Sabeen Dhand]
It basically centers you and then you can push through, but you've used it in a-- That's neat. You can bend it.

[Dr. Jihad Mustapha]
Yes, because if you shape it, it retain the shape that you put on it, but then with retrograde access and the ability to use two angled catheters, and two angled catheters as we put them next to each other and you start to rotate them back and forth like this, what they do is they break the cap and based on the CTOP analogy of the type of cap you're dealing with, it doesn't matter how complex the cap is, nothing actually crosses the complexity of the CTOP caths better than two catheters come from two different directions on it. They're both in the lumen and they just keep just shaving out--

[Dr. Sabeen Dhand]
I call it like battling of the wires and eventually-- to be honest, we barely even do a car-- it's very rare. I'll put a balloon up and try to make a space. I think, two wires and angled catheters that are lubed and they're going around whatever circumferential subintimal plane you're in, eventually, you're going to connect the two planes, you just have to work at it right?

[Dr. Jihad Mustapha]
We were very fortunate to be able to see under ultrasound. As you know we use ultrasound intra. You can see the catheters actually demolishing the cap and getting closer to each other and you can see sometimes one penetrating the other. If you ask me about the time it takes to do this, it's actually a lot shorter than anything else. Long CTOs right now, no matter how long they are, our time to cross them is less than 10 minutes.

It's not because we're good, it's because we use the technology that is available to us and allows us to see what we're doing and we use the CTOP. You have data, you have technology, all you have to do is tie the two together and then you can cross intraluminal a lot quicker.

Listen to the Full Podcast

Tools for Crossing Challenging CTOs with Dr. Jihad Mustapha on the BackTable VI Podcast)
Ep 305 Tools for Crossing Challenging CTOs with Dr. Jihad Mustapha
00:00 / 01:04

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Future CTO Devices

As the field of treating CTOs in PAD continues to evolve, more advanced devices will enter the market. Some upcoming CTO devices aim to offer both crossing and re-entry functions within a singular instrument. One such design includes a ‘one-way valve’ mechanism, enabling a shift into re-entry mode when necessary. Others propose a stent or spring system, aligning closely with the artery to facilitate re-entry. The development of these tools is guided for their potential benefit to patients and clinicians both, by increasing operative safety and cost-effectiveness.

[Dr. Sabeen Dhand]
Do you see anything on the horizon in the future for other devices to help crossing large occlusions? Do you think they're going to be so easy to do five years from now? Is there going to be some evolutionary, revolutionary stuff?

[Dr. Jihad Mustapha]
There's a few actually that are coming out. There's one from Europe. It's a CTO device and a re-entry device simultaneously together. There's another device being worked at by Reflow. That's also a device that's actually CTO crossing and a re-entry device. Companies are starting to get smart. They're going to give you not just a CTO crossing device, but also if it fails, it becomes a re-entry device. That's kind of cool.

[Dr. Sabeen Dhand]
That's cool. Very cool.

[Dr. Jihad Mustapha]
If you're there, and if you're stuck, then you pull back. It's almost like a one-way valve, and then you advance your needle, and then you're in re-entry mode now. Once you go into re-entry mode, you can't go back into the CTO crossing mode. Which is fine because you may have crossed [crosstalk].

[Dr. Sabeen Dhand]
Maybe you might enter into the occlusion, and then you need some more stuff. That's very cool. That's one of the reasons I think all of us love endovascular work. There's just technology left and right, all sorts, and CLI, and neuro, everything. It's just so cool to be a part of this.

[Dr. Jihad Mustapha]
The last one that is being worked on right now, this one is really cool. When you un-sheath it, it has a spring system or a stent that takes the shape of the artery, so hugs the artery and basically, it pushes the re-entry-- It's a CTO crossing device first but if you want to re-enter, you unsheathe that and that releases the crescent stent and that pushes the re-entry device, which is a CTO device now, closer to the artery.

Actually, the distance to travel to re-enter is much shorter than any other devices. That one is-- I'm not sure how far it is. The company is working on it is-- they come and talk to us about it and then we will try it, actually, in cadavers. That one is going to be a cool one when it comes out. The one from Reflow is really cool. Actually, all of them are really cool because I like how everyone is thinking like we're thinking.

We have a CTO device, trying to cross, we didn't. We have a re-entry in the same device. You don't have to exchange, no new device, cost is down. Cost-effective methods.

[Dr. Sabeen Dhand]
Well, I think, Jihad, you've been doing some amazing work. It's so nice to have you back on after so long. It's really helpful for the entire CLI, CTLI community to learn from what you, Fadi, and all of ACV, what you guys are doing.

[Dr. Jihad Mustapha]
Appreciate it.

[Dr. Sabeen Dhand]
I really commend you guys for driving this field on. I learned so much from you and I know everyone else does so I just wanted to thank you. If you have any parting words of wisdom for our listeners, you guys always have such good things to say.

[Dr. Jihad Mustapha]
I do actually have a couple of things to say. The CTO crossing is the most important part of treating a patient with CLI. In the vascular revascularization really depends whether you get flow to the target organ, the foot. If you don't get flow to the foot, you really didn't succeed, and no matter what you do. I just want to mention few catheters coming out.

We still have some catheters that help CTO crossing. Actually, the catheter itself, the catheters are coming out from different companies right now. They have CTO modalities. They're not CTO catheters, but they're good for support. We still have one, and a company called Asahi. This kind of things would like to leave our colleagues with to think about these devices because when we got them, and we use them was like, "Wow."

Reflow, and Asahi is a company now they have theirs out. Other two, there's 035, 018 only, at this point by Terumo and Asahi. The 014 is on the way. Kudos to these companies. By the way, there is no connection with them. I just really appreciate the fact that they give us what we need. There's not much to use in CTO crossing of the tibial pedal arteries, so I always appreciate the effort they put into it.

As you know, it's complex, and you don't want to mess the target organ vessels. That's the most important thing. Look for these catheters, if you're working in the tibials and tibial pedals because I'd like to say, a couple of papers were published the CTOP showed 67% conversion from antegrade to retrograde. And retrograde was more successful. Another paper published that the highest mortality rate for patients with CLI is the CTO that's present at the distal tibials or tibial pedal arteries. When you see that CTO over there, you got to go out there and open it. I'd leave you with that. The highest mortality rate with CLI patients are patients that have a CTO present at distal tibials or tibial pedal arteries. It's published in a CLI journal. [crosstalk].

[Dr. Sabeen Dhand]
That's great. Those are the hard ones to-- those are hard. If it's distal AT/DP/CTL, they are very hard. That's great that we're having these devices to come and help us and all the techniques like you mentioned Janali, being more, opening our methods for pedal and everything. I think it's been a really good time to be treating endovascular work.

[Dr. Jihad Mustapha]
Absolutely, it's really helpful to show that there's hope for patients that don't have hope. I'm talking to you about patients that come to us with an occlusion in the SFA and then there's no reconstitution. These are the ones that are worth discussing one day.

Podcast Contributors

Dr. Jihad Mustapha discusses Tools for Crossing Challenging CTOs on the BackTable 305 Podcast

Dr. Jihad Mustapha

Dr. Jihad Mustapha is a practicing Interventional Cardiologist and CEO at Advanced Cardiac & Vascular Centers for Amputation Prevention in Michigan.

Dr. Sabeen Dhand discusses Tools for Crossing Challenging CTOs on the BackTable 305 Podcast

Dr. Sabeen Dhand

Dr. Sabeen Dhand is a practicing interventional radiologist with PIH Health in Los Angeles.

Cite This Podcast

BackTable, LLC (Producer). (2023, March 27). Ep. 305 – Tools for Crossing Challenging CTOs [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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