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BackTable / VI / Article
CELT Closure Device: Pros, Cons & Potential Complications
Thomas "T.J." Turner • Updated Nov 8, 2024 • 34 hits
Effective hemostasis after a percutaneous arterial intervention makes the difference between a patient going home the same day or an extended stay in the hospital. The CELT closure device offers a possible solution for interventionalists who want to maximize efficiency in a busy practice while minimizing post-procedure complications.
The CELT device is praised for its effective use in calcified arteries, reproducible outcomes, and ability to facilitate quick patient recovery and discharge, making it suitable for both hospital and outpatient lab settings. In this article, vascular and interventional radiologist Dr. Omar Saleh and vascular and endovascular surgeon Dr. Syed Hussain discuss pros and cons of the CELT device for arterial closure. The interventional duo also explain how to avoid and manage complications that may arise when employing this technology. We’ve provided the highlight reel here, and you can listen to the full podcast below.
The BackTable Brief
• According to Dr. Hussain and Dr. Syed, occurrences of embolization, hematomas, and pseudoaneurysms are rare when CELT placement is guided by ultrasound.
• The doctors agree that CELT is particularly well-suited for highly calcified arteries, offering a distinct advantage over other closure devices.
• The CELT device can help to facilitate rapid patient ambulation and discharge, making it especially beneficial in outpatient settings.
• The CELT device can be placed under ultrasound guidance and, unlike many other closure devices, allows for repositioning and bailout opportunities to ensure optimal deployment.
• Embolized CELT plates can be managed by ensnarement, resulting in less severe outcomes compared to other closure devices.
• Complications with the CELT device are more often due to technical user errors rather than device failure.
Table of Contents
(1) Closure Devices: A Crucial Part of the Endovascular Patient Experience
(2) Pros & Cons of the CELT Device
(3) Managing CELT Device Complications
Closure Devices: A Crucial Part of the Endovascular Patient Experience
Most interventionalists would agree that maximizing patient comfort and minimizing complications are of the utmost importance following an endovascular procedure. According to Dr. Hussain, closure devices regularly require post-procedure bed rest and manual pressure, often leading to patient discomfort and extended recovery times. However, the interventionists here agree that CELT offers a more efficient and pleasant patient experience, especially in the OBL setting, where the goal is to provide a seamless and “spa-like" environment for patients. CELT technology may allow patients to quickly ambulate post-procedure, reducing nursing workload while enhancing both patient satisfaction and OBL throughput.
[Dr. Aaron Fritts]
We touched on it earlier, but let's talk a little about the importance of the patient experience and satisfaction with different closure devices, what you guys were saying earlier, like in the hospital, there's less emphasis on throughput, although that is evolving. Some patients are just going back up to their room, right? Their hospital bed. You think, okay, well put orders in to monitor them closely. Look, laying flat for six hours sucks. Laying flat for three hours sucks, right?
They're not all compliant, right? They're post anesthesia, they can clearly get up and they move around. Also sometimes, pressure for 20 minutes really hurts them and so do some closure devices. I just want to talk about the patient experience and satisfaction. I think that's going to be one of the main perks when we talk about CELT. Syed, can you talk about that a little bit in your experience with closure devices versus, in the hospital?
[Dr. Syed Hussain]
I'll tell you, from the hospital perspective, I think, I think closure devices are nice to have, they definitely get the patient off the table. Again, all these devices besides the CELT that we have talked about, we talk about Angio-Seal, you talk about Mynx , they require a certain amount of pressure on the groin. After you deploy the device, you got to hold pressure. Patient has to be on bed rest for, like you said, between two to six hours, maybe longer. The argument we have from some of the older physicians who don't use any closure devices is like, well, what's the point of even using the cost?
We're adding this cost when they're going to be laying on bed rest for six hours. It's not like they can move faster anyway. We might as well just use manual pressure and do our thing. I think in the OBL setting, I'll tell you, it's a huge difference, because like Omar mentioned earlier, the issue that you're trying to prevent is you want the patients to have a good experience, a spa-like experience, to be honest. It doesn't mean that your OBL has to look like a spa, but you want them to come in. It's a more efficient care model.
The patients come in, they have a really pleasant experience with the staff. They're not walking around a big, million square foot building to try to get around and figure out where they're supposed to go. I think just the moment they walk through the door to the moment they walk out the door, you're trying to give them a specific experience with their angiogram. That's really the purpose of the OBL. You're doing it efficiently. It's more personable. You know the staff. The staff is a small group of people that you get to know over time because they're also the people in your office. There's a lot of crossover from that perspective.
The closure device in the OBL becomes extremely paramount. You want your patients to come in, get the closure device put in, be able to sit up within an hour or two and then get out of there. That's really what you're looking for. Less painful is obviously ideal. Not always the case with every closure device. You put a Perclose in, it does cause a little bit of discomfort. On the other hand, the patients are willing to endure it because they can get out of there faster. From an OBL perspective, it's a different mindset because it's not just about the closure device, it's about the whole OBL experience.
I think that's where CELT really is an amazing device because literally you put the device in, patients get up, they walk off the table, they walk back to their recovery room so you've already done your check for the hematoma so you know that's not going to happen. They're in there for 20 minutes. They eat something light and then they get up and they leave and that's the end of it. They literally walk in an hour before, they get their case done and they're out in 20 minutes. It's no stress on the nursing staff, no stress on the family.
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Pros & Cons of the CELT Device
The CELT device offers unique advantages over alternative closure tech. For one, the CELT device can be placed under ultrasound guidance with reproducible precision. The device's minimal scarring is also a significant advantage for physicians who would like to avoid the development of extensive scarring and difficulty in re-access. Despite concerns about deploying multiple CELTs, Dr. Hussain’s findings on IVUS exams suggest that these devices integrate well with the arterial wall with minimal intimal hyperplasia. CELT can also facilitate rapid patient ambulation and discharge, enhancing patient experience and throughput, particularly in office-based lab settings.
However, operators should be equally mindful of common device challenges. Large bore access sites can be difficult to manage with the CELT device, and there can be issues with plaque dislodgement during device deployment. These issues are generally manageable with careful technique, as the doctors explain.
[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 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 argument 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.
Managing CELT Device Complications
The CELT system, like any medical device, can occasionally lead to complications such as embolization, hematomas, and pseudoaneurysms. However, Dr. Saleh and Dr. Hussain both emphasize that device-related issues are rare, especially when ultrasound guidance is used during deployment. One major advantage of the CELT device is its predictable and reproducible deployment, allowing for repositioning or removal if needed. Even if complications like embolization occur, they can be effectively managed with snares. Dr. Hussain points out that most complications arise from user error rather than device failure, highlighting the importance of technical proficiency.
[Dr. Aaron Fritts]
Similar to this article where they described really no significant hematomas, anything that you guys have had, any issues that you've had?
[Dr. Omar Saleh]
I had one embolize one time, when I was first starting antegrade approach, I was just using fluoro only and I thought I was against the vessel. I had saved it with fluoro and I thought it was against the vessel and it wasn't. Maybe it got stuck maybe somewhere. After that I've not had any issues because I've been using ultrasound.
That's my only complication. No hematomas, no pseudo aneurysms. The only thing I would advise is just make sure you use ultrasound. At least I think when you're going SFA, it's a little different than retrograde. It's just the anatomy's a little different. Really ultrasound, you got to use that and really watch it under real time and then you can-- That was the only time I had a complication, which I was able to fix. That's it. Otherwise nothing like my Angio-Seal and other complications from other closure devices.
[Dr. Aaron Fritts]
Right. Syed what about you?
[Dr. Syed Hussain]
No, I have not had-- I've done a little over 4,500 of these now and I would say I've only had one complication. I know nobody wants to believe that, but that's the truth. My embolization occurred on my second case, and it was a technical error because I didn't-- As I was pushing down on the groin, I didn't pull it up. I didn't hold the interior wall retraction like I'm supposed to.
I started to lighten up on that and I deployed the device and immediately I looked on the floor and it was gone. I'm like, "Where the heck did it go?" It was stuck down the TP trunk. Very easy, took an 8-French sheath, stuck him from the other groin, came up and over grabbed it and took it out. It wasn't an issue from that perspective, but that was my only complication. I guess by the grace of God, I have not had a single hematoma, pseudo aneurysm, late bleed or anything like that. Just like Omar, it's been a really clean cut device which is the reason we switched over to it completely.
Yes. I use it on all my cases now for everything. Actually the best part about it is, we used to do patients with FEM pop grafts, aortal Bifems. I know all of you have done that as well. It works fantastic on Dacron, on PTFE, on vein grafts. I'm able to access a vein graft and then put a CELT in. It's really changed the way I'm able to treat just patients with previous bypass grafts. If they have a FEM FEM graft, now what I'll do is I'll access them in the pubis area with ultrasound through the PTFE graft, we'll fix the right or left leg and then we'll put the CELT directly into the PTFE, it works. Fantastic.
[Dr. Aaron Fritts]
Worst case scenario, it embolizes, it sounds like it's pretty easy to grab with a snare it sounds like. It's not a perfect circle, right? It has edges to it that you can snare it with?
[Dr. Syed Hussain]
You can pretty easily grab it with a regular snare or-- I don't know. Omar, I don't know in your opinion if you feel like a goose snare is necessary, but I'd just use an EN snare that one time and just pulled it out.
[Dr. Omar Saleh]
I would probably have a snare available for that. What else? That's the rare thing you'd have to worry about. In addition to that, I like to say, say you're in the OBL, and you have an Angio-Seal complication. You really don't know what happened. You don't know if it's the collagen plug went into the artery, you don't know if it's just a pseudo aneurysm. The only way you'd know is you'd have to-- you're holding pressure and just so pressurized that you have to go maybe up and over, fix it with a Viabahn. The thing is I always stick low, so I can at least fix it with a Viabahn.
I don't mess with the common femoral artery where you'd have to get it surgically repaired at the hospital, I think. With a CELT if it were to happen, you can at least hold pressure more easily, and you can see where it's going. Then you at least know what happened. You're not guessing where you needed a CT angiogram to see what exactly happened if there is some complication with some other type of device, which you can't see under fluoro. That's one more thing that I'd like to add.
[Dr. Syed Hussain]
I think that's interesting. Aaron and Omar. I think, this is the one device that I have found works on calcified arteries. If you've got calcified arteries, you could totally use it. The Perclose, you're a little more reluctant to use it because you know the Perclose won't work more times than that in that calcified artery. Angio-Seal as you guys already know really well, it doesn't work well on calcified arteries. This thing, it literally works on all calcified arteries.
One of the things that I found interesting about it is the fact that it's probably the only device that is a 100% technically dependent. In other words, you have a complication, it is a pretty good chance that it's because it was a technical deployment issue on behalf of the guy doing the case. It's really hard to blame the device for not performing, would you agree, Omar? What do you think about that?
[Dr. Omar Saleh]
The only one complication I've had with CELT I don't know how many I've done, but I've been probably using it for the last two years. I've done enough to know, feel very comfortable with it. That was the only one time I had a complication. That was my first antegrade access, try to do it. Now it's very reproducible. I was very comfortable with Perclose, very comfortable with Angio-Seal. When that happens, you're like man, what happened? If you get some weird device failure, where CELT it's very reproducible, very predictable.
Also, one thing, you can bail yourself out too. If you're not happy or you think that you didn't deploy against the wall, you can just pull it out and hold pressure. The discs will collapse. You're not done until you pull that trigger. You can check it. If you check it and you don't think you deployed it on the wall or you look with ultrasound, you don't think you deployed it, right, you can completely bail on it and hold pressure. You're not going to embolize it until you pull that trigger, so it's designed where even if those two discs are deployed, you can hold it perpendicular and pull it out and the discs are designed to collapse.
I thought that was nice too. You have some bailouts and options, the only other thing is where Perclose, you can put the wire back in, that's one nice thing about Perclose is, you don't lose your wire access where you would lose it with Angio-Seal or CELT. That one thing about CELT where you can pull it out if you need to and, hold pressure as long as you have a suitable area to hold pressure, that's a nice little bailout where if you're not a 100% sure you don't have to deploy it.
Podcast Contributors
Dr. Omar Saleh
Dr. Omar Saleh is a practicing interventional radiologist with the California Vascular Center.
Dr. Syed Hussain
Dr. Syed Hussain is the chairman of vascular and endovascular surgery at Christie Clinic Vein and Vascular Center in Illinois.
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, November 13). Ep. 384 – New Innovations in Closure Devices [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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