Hands On with the CELT Closure Device

[Dr. Aaron Fritts]
It is pretty neat to be able to place it under ultrasound. Those are the demos that I've watched, just watching that plate come up under ultrasound. I don't know if you saw this, Omar, but recently Duke Duncan posted some comments about the CELT I guess he had just gotten a demo for it and he was sourcing some questions from the audience or asking for feedback, and there was a bunch of questions on there. I thought it'd be actually great to pull some questions from the audience because I think one of the most common questions is like, and I want to get y'all's thoughts on leaving a metal implant behind, which is essentially what it is, right? A small plate. Omar, can you speak to that? Have you seen any negative consequence of that or?

[Dr. Omar Saleh]
Yes, I think that is probably one drawback of CELT like where you have to avoid that. It's changed my practice a little bit. If I know I'm using CELT you don't want to keep bringing patients back if you don't need to. You want to do maximize their angiogram, right? You want to hit, two levels, DCB, whatever you need to do so they don't have to come back. It makes you more conscious. Okay, you don't want to keep bringing them back, but the thing is you can stick the CELT you can deploy the CELT right next to the previous deployment or you can go a little lower. You can use areas that are not being conventionally used for previous access.

What I try to do is I want to leave a little space for anybody else, say if the patient needs something else done by another doctor that they can just go above my CELT and do it and close. I've had that. We have some patients that I've shared with my local vascular surgeons who are not using CELT and they'll just tell me, yes, I went above your CELT and I use Mynx or whatever, because these are like patients with really calcified arteries or things like that, or they're using some other type of device.

I can see that being a problem. If you end up putting like six CELTs in one. I saw one that a angiogram where someone has six CELTs there, and they're doing fine, like on IVUS, everything's okay, it's endothelialized. That is one drawback. I would like to say also that, if you, if you do six Angio-Seals on that groin, it's going to be hard to access, you're going to be struggling putting in like a sheath, huh?

[Dr. Aaron Fritts]
Yes, way worse. I think with the Angio-Seals, given those foot plates.

[Dr. Omar Saleh]
Right. Even with CELT, with CELT at least the groin, when you bring them back, it's nice and soft. You can easily access, whereas Angio-Seal, sometimes it's very hard to even put like a sheet in or you have to use like some other techniques, like a stiff glide and stiff, 0.018 systems and upsize. With that, you're also battling. You may end up holding pressure on those. It becomes a hostile groin later on anyway. That's just a, just a couple of my thoughts on that subject.

[Dr. Aaron Fritts]
Syed, Does it impact the ability to do future large and small bore procedures for you, because you do open surgeries as well, what have you seen?

[Dr. Syed Hussain]
Just to tell you, number one, what Omar said is 150% correct. I think I do the exact same thing he does. The CELT actually guides me for my next CELT placement. I'm able to say, okay, I'm going to put them right next to it or right above it or right below it. I try to keep my CELTs lined up in the same area if at all possible. It does give other practitioners the opportunity to access above or below if they need to. Again, same findings on the IVUS exams I've done with patients with four or five CELTs, I have not seen any significant intimal hyperplasia that causes significant narrowing in the artery. It's well endothelialized on the anterior wall.

I think as far as the Angio-Seal, the Mynx devices, multiple Perclose devices used on these groins, those groins do turn into hostile groins, and they are very difficult to reaccess. Even though you don't have a scar on the groin, you've got an artery that's completely scarred off on the inside. Again, I can't agree with them more on his explanation for that. I think that's really understated as well, because this idea of leaving something behind has become such a big deal.

What people don't realize is that even though you've got multiple CELTs in the groin, the amount of scarring that you get is so minimal compared to what you see with Mynx or with Angio-Seal, or with Perclose devices placed in there multiple different times. Especially if you've got-- My personal experience with Mynx has been a lot of pseudo aneurysms. You've got people with pseudo aneurysms that have been injected, and now you've got these multiple hematomas that are sitting in there that have to be treated.

As far as opening these patients up, I'll tell you, opening up the groin on somebody with multiple Angio-Seals, or Mynxs or Percloses, it's like a bomb went off in the groin. When you get in there, everything is stuck together. The nerve-- You can't tell the nerve, you can't tell the artery or the vein is stuck together. It requires a lot of meticulous dissection. Groin exposure takes like 10, 12 minutes. Can take up to an hour just to try and dissect everything off. I've done the exposures for CELT devices where I've done eventual fem pops on patients or fem distal bypasses. I'll be honest with you, there is inflammation there too, but it's very localized to where you deployed that CELT. It is very easy to get above and below to get control of the artery. You have very minimal dissection to do with the CELT deployment.

The nice thing is when you open these arteries up, you can see the actual CELT device on the artery and how it's literally embedded in the arterial wall. It's really quite amazing to open it and to see that it's on the interior wall. It's much easier.

[Dr. Aaron Fritts]
Interesting. Another question from the audience was how many is too many CELTs? Have you seen that they're-- What's the most you've seen and was it problematic, I guess?

[Dr. Syed Hussain]
I'd say, uh, I've not been overly impressed with number. I don't have a number to tell you, honestly. I've seen some patients who I've done four or five on, I've seen some patients who come from all over the place who've got 10 or 12 that are distributed all over the artery. That's the interesting thing about CELT is you'll see punctures in the mid SFA, you'll see punctures in the proximal SFA, you'll see functions in the external iliac artery. They're distributed everywhere.

The issue that a lot of vascular surgeons and some cardiologists have complained about is large bore access, 12-French, 18-French sheaths, 20-French sheaths, things like that. Honestly, I have not found that to be an issue. I do AAA and thoracic aneurysms, and I'll tell you, typically you'll be able to find a spot on the artery where you can access and do your percutaneous intervention.

The bigger problem becomes where you're doing branched endograft. Multiple branched endograft, the mesenteric, the renals. You're doing thoracic endograft, you're trying to put in complex endograft up in the branch vessels of the thoracic aorta. You need multiple access sites. If at the end of the day, if that's an issue, then the easiest thing to do is just cut down and expose the artery and you're able to do that too. There may be some limitations for that perspective, but ultimately in some, nothing that can't be overcome.

[Dr. Aaron Fritts]
Omar, any concerns regarding plaque? I know you talked about it when you're watching it under ultrasound, but one question from the audience was concerns regarding plaque dislodgement while retracting the device to the vessel wall?

[Dr. Omar Saleh]
Yes, it hasn't been an issue for me because I really-- I'll deploy the first disc, even if I'm under fluoro. I always save where I'm entering, so I'll deploy very close to the arteriotomy. From there, I haven't had any issues. If there's any resistance, I put the CELT device very parallel to the artery, and then usually if I feel any resistance, I can watch under fluoro and ultrasound to make sure I don't hit any plaque or anything like that. Antegrade SFA is much easier. I can see-- I don't deploy it until I can see it and then I can see exactly-- Go against the wall and do the second marker.

[Dr. Aaron Fritts]
Got it. Somebody sent over from the audience a journal, I guess this is an abstract from JVS talking about the safety and efficacy of the CELT from 2022. What was most interesting about it was the median time to hemostasis, to ambulation and to discharge was all under 31 minutes. They only report no major complications to minor complications, which were minor soft tissue bleeding from the access site. Can you guys speak to the time to ambulation and discharge at all? That seems unbelievable, honestly. You'd never do that with any other closure device. Syed, can you talk a little bit about that, because that seems to be one of the biggest benefits?

[Dr. Syed Hussain]
I think in our OBL we would routinely-- Typically when I do an angiogram, I won't give a ton of sedation. I'll give maybe 50 of fentanyl, maybe a milligram of versed, and we'll do our case that way. By the time you're done with the case, the the sedation is essentially worn off. We'll put the CELT in and more times than not, we'll actually have the patients get off the table and walk back to the recovery room.

Then we'll check their groin and that'll tell you everything you need to know. There's no hematoma. Like I said, we give them a little snack and then 20 minutes later they get discharged. Some of the patients who are a little bit more groggy, we basically do the light test like Omar talked about. We'll sit them up in their gurney, we roll them back and then our protocol has always been 30 minutes of bedrest, get them up, walk them in the hallway, and then discharge them after that.

It's worked out great. I try to do that in my hospital now where I'm employed and that's always a shocking thing. The staff is like, "No, we can't do that." It freaks everybody out when they see the patient walking back from the cath lab and they're just like, "Wait a second. The patient's got to be in the chair and they might fall, et cetera. It is a little bit more challenging to do it in the hospital just because of the rules, but it does get the staff-- The look on the staff is always interesting to watch. Watching the patient walk back from the cath lab.

[Dr. Aaron Fritts]
I bet that's pretty impressive to your cardiology colleagues. Are In vitro cardiologists starting to use the CELT at your hospital?

[Dr. Syed Hussain]
That's been a little bit challenging. The arguments that I get back from them is, they don't like leaving a piece of metal behind. That's been their only complaint at this point. I don't know if it's more because they don't want to use it because the vascular surgeon's using it. It's hard to say.

[Dr. Aaron Fritts]
Omar, what about you? What's been your experience with getting patients ambulating afterwards?

[Dr. Omar Saleh]
Oh, it's been amazing. I've had some recent patients that had severe back pain. They can't lie flat on the table and they just we can sit them up right away. That's been great. My mother-in-law had a geniculate artery embolization done, and they did CELT. I actually did it on her. She had the CELT placed and she walked immediately to the bathroom. She didn't want to use a bed pan.

She's the happiest person. From the geniculate artery embo, thank you BackTable for that podcast episode that got me started on that procedure. Also the CELT it's been awesome. She walked immediately and then went home. Fibroid embolizations, they're always in pain. The have that cramping where they can bend their knees and walk to the bathroom. It's been a huge change in our OBL practice or even hospital practice now since using the CELT.