Chapters Transcript Video QuickClear mechanical Thrombectomy System: A powerfully simple and cost effective solution Watch the QuickClear mechanical thrombectomy system: A powerfully simple and cost effective solution presented at NCVH Digital Education Series Mhm. Mhm. Good evening, everyone. And welcome to this evening's and see VH Digital Education. Siri's Symposium, sponsored by Philips Tonight's moderator, Dr Craig Walker, is the founder and medical director of the Cardiovascular is True to the South, one of North America's largest cardiology practices. Dr. Walker serves as chairman of the new Cardiovascular Horizons Conference, held annually in New Orleans, Louisiana. He is a clinical professor of medicine at Tulane University School of Medicine and the L S U School of Medicine. Dr. Walker is the clinical editor for Vascular Disease Management and has published hundreds of articles and over 30 book chapters. Dr Walker, Thank you, Jonathan and thank you to Phillips for supporting this new cardiovascular, Risen's digital educational, Siri's and specifically for Tonight symposium that we will be hosting on the quick, clear mechanical from back to me system. I'm very pleased to have joining me to experts in this field. Dr Andre Buchanan's who is a vascular surgeon and he's with the Vascular Surgery Associates in Towson, Maryland, and Dr Brian Fisher, vascular surgeon with Surgical Clinic in Nashville, Tennessee, to also serve as speakers on this very important advice. So we're tonight are going to give an overview of what is called the quick, clear mechanical from ectomy system, which I think has many advantages over present systems. This program is not cmi accredited, and we have been compensated for our services for presenting this material for Philips. And we must, of course, stay within the guidelines of use for this device. Now, in tonight's, uh, symposium, we're going to speak about the quick, clear product, give you overview, animation, detailed performance where we speak about high compares to other from back to me devices and try to demonstrate, at least on bench top the power of this device. We'll speak about advantages experienced in its thus more limited release and give impressions, and at the end will be happy to answer any questions that anyone they have. So this is really the device we can see here that it consists of an aspiration pump the white thing in the middle of the tube. It's just a small electric Uh huh, a booster syringe to give additional aspiration power a disposal container. And all of this is connected via tubing to a catheter, and these aspiration catheters come in three generations. A six French straight iteration, which is 130 centimeters long. This is primarily used in the arterial system but also has some Venus applications. There is an eight French shorter device. It's 85 centimeters long. This has a shaped or angled tip, and this is used in similar material but more Venus applications. And finally, there's a tin French shaped tip, Uh, which comes in in 85 centimeter left, predominantly for Venus applications. Both the eight and the tin French devices come with operators to allow us to deliver the device as necessary. Now this is going to be an animation showing the device in use. And there's many things I like about this device, the whole device. There's no capital equipment. The whole device easily lays on the field. We can watch it aspirated as we use it, and it has an on off switch. So here is an angular, ated catheter, and this is a braid so that it does not collapses. I'll show you shortly. This device creates quite a bit of suction, and we would need something that would not collapse. This shows the operator for if we want to straighten this to advance the device and not injure the vessel. So this is advanced to the traumas. And then we would turn on the aspiration and we return this. And by sweeping it, we can aspirate Promus fairly effectively, actually, both old and new thrombosis. And, of course, anything. Rhombus. It's north. Rhombus is a little easier to aspirate now. I mentioned earlier that this develops quite a bit of negative pressure, and I think it's important to look at this and the upper panel here. We're looking at the aspiration pressure, and we can see that this generates almost 700 millimeters of mercury aspiration pressure, which is actually ah, greater aspiration pressure than either the uh Angie a jet salon, eight French system or the are the penumbra eight French system. The Aspiration Pump is a single use disposable device with industrial strength, and it has three times the aspiration pressure of the Boston Scientific Angie Jet. It has faster and greater aspiration pressure than number, uh, number indigo. And with the 60 cc booster syringe, we can achieve additional on demand aspiration power. The container is a 1.4 leader disposal container, and we can look at it as we're aspirating now. This is very important and something we don't speak about often. But it allows us to see how much blood we're removing as well as cloth, and that helps to make sure that we're not removing too much, um, blood in a patient. It's all easily visible now. These aspiration catheters are braided and reinforced with hydro filic coding so that they slide very easily and torque easily. Hence the braiding. The shape tip allows us to have better directional coverage. By turning it, we can reach all aspects of the vessel their operators available with the eight and 10 French devices so that we can advance him easily. In the normal segment of the vessel, there's an in line flow switch, which enables instant aspiration control. Of course, if we turn this off, we could get rid of this and we can see that the tin French catheter delivers 59% greater aspiration volume than eight French catheters and that simple physics flows related to the fourth power of the Radius. And if we apply same negative pressure, we're going to be able to achieve better aspiration. So looking at this quick, clear mechanical from back to me system. This is an animation. And it takes a second to start. We can see in the upper panel the Zylon T eight French. Angie, a jet in the middle panel. The Philips quick, clear 10 French Catherine, these air all clot models and on the bottom, the pin number into go eight French cat device. And what we can see this device very effective in removing from us. It, uh it can remove fairly large pieces of from us. And because we can target and reach portions of the vessel, it allows us to aspirated, clocked very effectively. And at least our initial use of this is confirmed that this is a very effective tool in removing cloth. And here you can see by 22 seconds all of this cloth, these air, all similar panels was gone. I'll let this run for a little longer. Now, this is not a direct comparison of devices, and the body is, of course, very different. But at least this demonstration gives you an idea that this device can indeed removed from us. And I'm optimistic this will be a tool that we find very, very useful in cases where there's heavy from this burden. But notice again. The clock is still running and this has been free of all clock for quite some time now. I think this runs for two minutes before we start to see total resolution of clot. But we can see again, very effective in being able to remove from us and notice this entire system is on the patient. We're looking. How much blood are we aspirating? As we're using this, we can see that we can even see if there's lack of flow of. So this gives you an idea of what we have and its ability to remove caught quickly. So there have been advantages which have been demonstrated thus far in this limited release, which I'm sure will extend in the future. First off, there's a very simplified workflow. The set up time for this device is less than a minute, which is important in these procedures when we want to get rid of cloth cloth begets clot. If we could get rid of clot, it is always advantageous to do so quickly. It has a very small footprint. In fact, the entire system can be placed easily on the sterile field. It's not heavy. It's right in. Our visual field, has a single button activation. You push it, it's on. You push it again. It's off and you can watch the bag filled. And it's a single use disposable device. It has no capital requirements now. It has same or more aspiration power as other from Beck Tomy devices, Uh, and the maximum aspiration powers achieved within seconds, this constant aspiration power during activation to lessen risk of em. Bolic equally. And there's no extra capital equipment or accessory costs or set up no extra tubing, canister or maintenance costs. So quick, clear impressions. What is what interests me most about this quick, clear system is that I've been able to remove cloth very quickly, very effectively on being control of the entire system. I can prime this very quickly. Use this very quickly and effectively remove cloth when, when I use this quick, clear system, whenever I have from us that I want to remove for arterial clot, I would typically lean towards the six French system for, uh, very unusual cases, perhaps in the iliac, the eight French system, and for veins typically, the Tim French system although occasionally for smaller veins such as ephemeral. Sometimes the eight French system. How would I use the quick, clear system? Really simple. As I've shown you, you put it in, you advance it to the clot, and you either just simply advance the straight system under aspiration. Or are we at an operator for the angled systems to deliver them and then steer those so that were sweeping the entire vessel? How does it compare the current from back to me devices? Well, there's no capital equipment that's important. Set up time is very much less than other devices, and you can put the entire device on the field allowing you to easily watch it and see what you're doing. And with that, it's my pleasure indeed to introduce our next speaker tonight. You've heard me introduce him before from Nashville. Dr. Brian Fisher, certainly an expert in the field. He's going to give us initial clinical experience with this device. Brian. Okay, Craig. Thank you. And again, what an amazing opportunity. And a great panel, um, to discuss it, a device that I think will really change at least be a tool in the toolbox for the treatment of acute clock. This will describe again my initial experience with the quickly, er, mechanical drawn back to the system. These air. The disclaimers give a quick, clear overview again. Craig did an amazing job just discussing this at first again. It's a quick, clear, mechanical thrown back to me system. Uh, introduce introduces a simple throwing back to me solution that provides physician within on one single use aspiration catheter and pump system that has the same aspiration. Power or better for the current solutions is used for the removal of soft, fresh promise or M bolic, material from the vessels of peripheral arterial and being a systems. And again, that's a very important thing to highlight when we're dealing with more chronic cloud earth rhombus. It's important that these devices typically do not work as well is when we're dealing with just a cute clients. That's an important thing to keep in mind when it comes to successful procedure, uh, quick, clear and eliminates the need for capital and eliminates the capital equipment and costly accessories. And it offers three sizes of mechanical problem back me aspiration from a six French straight tip to all the way to a 10 french shaped tip with the A French in between those two with the larger sizes having, uh, the shaped tip for improved aspiration and larger vessels. So I can honestly say there was my my privilege and honor to be the first in my experience in the world for using this device and again big shoutout Thio. People like Dr Walker, who played such a law or droll uh, in my exposure on giving me this type of platform. What a great honor. Thio again used this device be the first on the plan to use it and, more importantly, to succeed it, to see its success and some really great outcomes. And patients that had acute Ilia ephemeral, inclusive DVT. So the first of May experience we way we had, of course, in the non cases today, with about half being Venus and the other half being arterial. I'm abused the six French, a French and 10 French devices, and I'm really excited about the eight French and the 10 French experience, uh, in the Venus space. The things that again are kind of highlight are the very quick on the quick set up and its ease of use, Um, and then a couple that with the simplicity you have the powerful aspiration abilities of the device itself with no capital equipment. And for me in someone that works both in the hospital setting and office space lab setting cost is, of course, something that I keep in mind in both of those places, but especially in the office space lab setting where we have the ability to keep our cost down quite a bit. And not having that capital equipment is certainly a compelling argument in that setting. So to give a brief overview again this, uh, case that we did last month on a patient with acute Elio Federal DVT again a very heavy leg and with quite a bit of a demon, our visual visualization tools again being able to see clearly and treat optimally, uh, did a venogram, of course, followed by IBIs both pre and post. And, of course, during the procedure to assess my my progress again, the location thrombosis in the appropriate places to treat this type of disease process, it's Ilia ephemeral DBT uh, there aren't any studies this point that show ah, clinical advantage from reading diseases that is like. So obviously our clinical experience was limited. Thio again, that acute clot that was completely obstructing the alien ephemeral segment. Uh, this, uh, dramas class classification would describe it is acute to sub acute again. Within a roughly 14 day period, the patient had been, uh, in the hospital, have been transferred to me as a consul in consultation on again. He was able to be discharged and treated within a couple of days from discharge. Um, again, being the office based lab setting we did not do lyrics on the patient was not on any previous anti coagulation, though He was started on the once he was diagnosed, hey was, of course, placed on aural anti coagulation, which was held for the procedure again. With this particular case, we had illegal federal inclusive DVT, so it was important to use the largest advice possible. And again, is Dr Walker mentioned earlier? Uh, the great advantage and aspiration capabilities of the 10 French catheter were certainly appropriate in this case. The set up time was very impressive. Even are very early experience having an outstanding rep, uh, like clay available, uh, to explain the set up. It's still only took us roughly around a minute. Thio get completely ready for functionality. We did a total aspiration of for 15 minutes. Um, and ar blood loss was roughly 400 ccs. Again, that's a large amount again, fairly early in the experience. And we've learned some different things about aspiration and of acute plot and limiting our, uh, estimated blood loss. We're now down to roughly 100 to 150 ccs of blood loss. Uh, over the experience from that time and in this case again, you know, we could look at in a venogram and say that we got 100% return of flow and no limitations in and flowing the vein. But with our IBIs finance, we did find that there was roughly 30% residual clock that I was not able to aspirate. But again, we had a fairly large Luminal diameter. And again the patient in the end, had complete resolution of the symptoms in a soft way. So here's a video showing on the left. We have anterior tibial are and this can be also attempted from higher up If those vessels were not particularly dilated, uh, from the disease process so Poplarville Venus access is certainly appropriate. However, I do like to cite Mont the interventional radiology colleagues and emphasizing the treatment of inflow. You can see the evidence of acute clotting where we've given given some contrasts, and you can see there's some mix on the left side. None on the right is this. The the technique and the ability thio aspirated be acute plot appropriately. It's important to note that there there is a technique to aspirating clotting. As you saw on the theme images of the video shown by Dr Walker earlier, Um, it's evident that there is a kind of a two and throw of the device and also rotating of the catheter tip. And that's very uh, very well illustrated on our video on the right hand side on the previous run. Again, this shows the location, the Quran, Isett and characteristics of the clock and then formulation of a treatment plane. Um, I say that may turn is is most over treated and undertreated disease in the country. And here we see a clear example of our mechanical, uh, external extrinsic compression Aziz, we follow along the, uh, iliac being a system, and here's we come back into the common iliac vein again, you see evidence both acute and chronic. In some criticism, E of rhombus is indicated by the wider shadows on the imaging. As we go down, we can see some evidence of flow and then fairly normal vessel. So here's, uh, just a quick video of the set up A zits already all set to go, and you can see our our additional syringe. That kind of gives an additional ability to aspirate when the clock is, uh is being received through the tubing. Um, again, you see a fairly easy set up. You see, uh, dual access both in the being sistemas well again, the Poplarville vein as well to help assist with aspirational plot higher up. And here's, you know, some of the evidence of clot again, you can see there is evidence of both acute and chronic throb us here a Z evidence by again the dark, uh, more malleable clot versus the more solidified plot on the upper right hand quadrant quadrant here on the left hand side. Again, there's evidence of additional clock. You see, there's there's a good amount of blood within the our towels here. Onda again, we really worked hard to understand where we were gonna aspirated. Uh, as far as the clock was concerned. And again, we've worked Thio really eliminate Ah, large amount of this blood loss. The scene here and that's an important aspect to describe, uh, in the in both the hospital setting and the office based lab setting. Um, there could be a tendency to aspirate in areas where there isn't a large amount of clock and you run the risk of again aspirating a significant amount of blood here. But again, you can see evidence of clot on. You'll see that we've got a pretty good result here. Here's our post office run. And again, I didn't show just for sick of time again, we do a fair amount of virus both intra procedural in, uh, intra treatment and then following treatment. And you can see here, uh, that we placed a stent thio treat May Turner's on that extend the extends approximately and again, you can see evidence of some chronic clock that's still, um, still present. Um, but I consider this acceptable again. This is a pullback, as we could go back lower on the leg. We started in the pelvis through the stent and going back into the thigh here. And you can see, uh, this final area of where the There is no evidence of clock. We see normal vessel, and we treated abnormal tau abnormal and bridge from normal to normal vessel with a with scaffold. So just speaking about you know, this particular case and then my experience again both in the arterial and being a system primarily in the outpatient setting, Um, there's several reasons why I'd use the catheter again. First of all, the easy set up was one of the most exciting things when it comes thio device usage. Avoiding complications, a complicated procedure and complicated set up is key to certainly buying to the staff that are available on day. Also, a quick ability. Thio gain an understanding how the device is set up and how to get it ready for use. There's no no access. I'm sorry, no capital equipment, which means it's quite convenient. The set up, as I described described before, it's all in one system. All the components are are fairly small and are able to be placed onto the sterile field. Um when it comes to use, like to say, just press the easy button. There's a single button activation that begins the aspiration process and that could be turned on and off quite easily with the press of a button. Most importantly, of all the things that we describe here, uh, as you guys know throughout each of our careers, we use things that that work, and we certainly stand behind things that do the job and do the things that we say. We say that they could do and again, most importantly, quickly has shown a very easy ability toe aspirated clock, even in large clock burden, where there's been cute and sub acute thrombosis. And that's been a really exciting part of the treatment algorithm in these patients. Uh, with cost effectiveness. That's something again, is easy to speak about. There's no capital equipment or costly accessories. What you have is in one single bag. You pop it open and you throw it onto the field. There's no additional equipment. Um, there's no other generated that's needed to be placed off the field or that has to be purchased by a particular center, uh, to be able to use the device. And finally, when you have the powerful aspiration in the compact and comprehensive package yeah, the same or greater aspiration capacity compared to the current available technology, there's a very small footprint, I believe the small one of the smallest footprints on the market. And finally, everything is included. Once you open the device up, open up the sterile packaging. You can place a ride into the sterile field and get it ready for use in roughly 60 seconds. Thank you, Brian. And next, we're going to ask Dr Andre Bookings to give us his experience with the quick clear device. Thank you very much, Dr Walker. And thanks Toa Phillips for giving me the opportunity. Uh, Thio be on this panel on duh. Give me give you my experience with a patient. These air the disclosures. So I had the opportunity and the privilege of using this device recently on a patient long term patient of mine. Um, she has a history of factor five Leiden, uh, mutation and has had multiple dvt s. So in the past, I have treated her with other modalities. When she had presented with excessive swelling from DVT and Alia Federal system and in fact, she's had previous iliac vein stents and she had presented actually, a couple of years had gone by. She came in with Venus Claude occasion. So she's trying to lose weight exercising, biking and every time her right leg just gets very swollen and painful and she has to stop. So we did some outpatient work up and I thought the next best thing would be for us. Thio, proceed with a endovascular evaluation, so we had booked her for a venogram. The visualization tools I use during that is obviously the venogram and also intravascular ultrasound, which I use very frequently in both my Venus and Arterial cases. We found that the on this initial evaluation that she had new thrombosis, actually in the right common iliac vein, and it was had a combination of it was acute and sub acute, but she also has chronic promised has been there since her previous cases of DVT, uh, did not use any throne politics during this particular case. I just used the quick, clear device and had good success. So it was used. I had the opportunity when asked. I wanted to use the 10 French system, especially in this Venus uh, space. Um, the devices is the one device that has the largest catheter, which I thought is a huge benefit. Then, as everyone's already stated, the set up time is extremely quick. I could tell you my text were extremely excited. They usually never want me to use a new product because it's always this learning curve. It's just it's terrible, but this this product, it was no problem, and they were on it. And with the help of Jason and Jen, and they set it up and we're ready to go, Um, once I had everything. Once I had done my pre imaging, which I'll show you, I brought the catheter up. I used if for about 33 minutes. I'm sorry now that you condemn The nice thing about the pump is it does have the button that goes on and off. But it also has a flow switch, which I I was using more frequently. Eso I set everything up on the back of my table and then right at the catheter, there's a little flow switch. So I put it to where I knew they would be clawed, and I activated it and pulled back, and I turned it off so that the suction would stop and go back and then activated again so I don't have to reach back to the pump. So that's even more convenient. Lost about 200 ccs of blood on Ben. I ended up doing some injunctive procedure because there was some, uh, stenosis in the native vein that was left and I used Ivanova stand ballooning for that, and I got pretty 90% flow restoration. Um, so this is the initial venogram. Basically, you know what I expected? There's really hardly any flow there, some collateral or, and this is kind of exactly the pain she's having. She's also having some lower abdominal pain Thio with her complaints. And then this is the previous run. So I I use I rely on I vis in all my cases, and it always is now seems very odd to me if someone if if I've isn't used because it's just such a valuable tool. So I'm gonna run this and and this is gonna pull back from the inferior vena cava down through the iliac system and you'll see her previous stents, and we'll get to the point and all Stop it. Kind of where I found all the new thrombosis, and it will do the comparison at the end. But it also ensures you're in the right place and you're treating the right vessel. So right here there was some laminar stuff attached here. May perhaps. And then there's this Claude in there, and as soon as you know, we visualized that I said, Okay, well, we would try this. Quick, Clear. Um, quick and easy. Everything's in the sterile field, no cord or cable cables, and and it's it's important. And everyone that does interventions. You're you're moving the patient, especially if you have an entire limb to treat. And whenever you have another machine that's hanging off the table and getting in the way and pulling on things and it makes things more difficult or challenging takes time, knocks things over and having everything on the table is it was a huge advantage, in my opinion and again, the the ease of setting up and having everything right there, Um, after I going back real quick after utilizing the I initially ran it with just the pump Thea aspirations syringe. I think is huge. When I was treating TV t s before all the devices were coming out, I basically used in a French catheter with one of these syringes stuck to it. And I would aspirate, you know, manually on bond adding this extra pressure on top of that to get the final amount of clout or an area that may be more stubborn was I thought was great and I could control that. And then the little flow switches actually up here, uh, Thio that I would make it used to turn it on and off. So when we opened the bag, we kind of want to see it was in there, and it had it had it had acute clots, but also had all this kind of more chronic stuff too, which I was very excited about that. There's something that could actually potentially have some ability to do that, though again, acute clot would be much, much easier and use, uh, in using it. And when we go back, um, this is a picture on subtraction, and I went back and treated this diagnosis with an additional stent here. And flow is brisk through the area and then the post I vis pull back. Um, again. It's like that. The promise that had been sitting in there was gone. You do see some of that chronic there. This is the new stent. And to me, that was a success. Um, so I thought, you know, this was in this device was great because it had good aspiration. It was on immediately the size of the Catherine was appropriate for this particular case. Given that we're in the Ilia federal system, I was able to control it, not get too much excess blood losses on repositioning the catheter. The bent tip allowed me to reposition it. Um, and then I used that booster, which was, which was great, the syringe to boost it. And I could tell you my staff was very happy. And here they are. They're excited because it's something that we can have right there ready to go. And the fact that we could do this was a 10 French case with Venus. But with the arterial application, I mean, pretty much this could be the to go to for any of these types of cases or needs, um, time savings. It's cost effective and and it's and it's worked. So thank you. Very nice case. So one minute set up three minutes run and you had completely Dick lauded clinic from a clinical perspective, that entire iliac Very impressive. And I think very, very important. Brian Fisher. We're going to ask Dr Brian Fisher again to come back up, and he's going to speak to us about intravascular ultrasound, Uh, when using this device. All right, Craig, thank you very much. And I'm sure that the audience is very surprised to hear me talking about IBIs. It's not really something I'm very passionate about. So here we go. All right, These air disclaimers. So one of the things that you know like to speak about when it comes Thio dramas removable again is understanding why I This is really important here. Um, there are four main points. The first thing that obvious has the captain of the capacity to visualize non inclusive promise that may be missed on traditional pornography. I know this sounds quite familiar, Aziz, we see in the arterial system. Um, the use of fluoroscope just is not great at picking up actual inclusive disease because of the physics of the way that we do Arteriosclerosis and pornography. Ah, second it AIDS and distinguishing chronic versus acute dramas. So why is this important again with any of the devices that are currently on the market when it comes to aspiration throwing back to me, it's really important before you go on open advice and understanding if you have a higher likelihood of success. We know that based on the current available devices, the Maura cute the clot is the higher the likelihood of having success with the promise removal as we've seen the two cases that represented earlier, Um, that's an important piece, and knowing again, should we or should we not be attempting to do, uh, aspiration throwing back to me in these cases? Thirdly, it's also demonstrated a role in identifying residual promise burden after mechanical thrown back to me. So why is this important again knowing have you done the job and have you finished what you said that you were setting out to do leaving behind a large clot burden that isn't recognized on pornography, obviously have pretty serious deleterious effects and decrease the likelihood of procedural success in more long term success, which is trying to prevent post from biotic syndrome in these patients and then finally supports populations that are vulnerable to contrast to radiation, such as pregnant patients. We have folks that are very eloquently shown the ability to use extra vascular ultrasound. But we also know that Intravascular ultrasound doesn't outstanding job in giving a clearer picture of what's going on inside of the vessel to help guide therapy. This is a busy slide, just showing obvious first angiography to evaluate basket characteristics and the big highlight here. Eyes looking, obviously evaluation of adherent dramas in X Eyes Excellent compared to angiography. And you can see that here, um, in the characteristics of the vessel. Andi Evidence of adherent promise. The next important point in Table number two is that I have. This is more sensitive than pornography and assessing residual from Mr Burton on again. This has been described very eloquently on again the idea of understanding what you leave behind. It's one thing not to know on things that you completely procedure. It's another to know that you can honestly say that you have a 30% residual promise burden and that you're unable to clear, knowing that you can still get a good result. But you know that when you leave when you leave that case. So when you look at obvious and evidence of promise, there's some important distinguishing characteristics between between acute dramas and chronic promise. On the left, we have, ah, picture of acute promise within the vessel that shows that it has a flecked special appearance on When you're visualizing and there's also mobile and disorganized. Look to it and we often describe it is looking like a blizzard within the Lumen of the vessel. In direct contradistinction, we have chronic promise on the right which has the appearance of a larger mass. It appears more organized and almost like a meatball flat in motion within the Lumen again when visualizing acute promise you can see And from the 10 o'clock 24 o'clock position in this grayscale image, you know the notice the scattered, disorganized appearance of the clock and again on almost blizzard like appearance. Continue along. You throw him to seeing through this run and again notice that it appears like a blizzard. Uh, the images again, I like to use chroma flow here, which is a a unique characteristic for any intravascular ultrasound system on the planet, Uh, where you can make a distance, you could distinguish again between the clot burden and where there is evidence of flow. But even without use of chroma flow, you can see here that blizzard like appearance running from about 12 o'clock to six o'clock, almost all the way around circle ritually along the vessel. So when again selecting chroma flow, which I'm a big fan, you can help distinguish between the promise and the actual aluminum the vessel, and it makes it easier to locate on again visualized when you're attempting treatment and guiding your therapy. Chroma flow is an outstanding, uh, adjunct to intravascular ultrasound. Uh, that is unfortunately not used very much, but is very powerful. And again so now, going back to chronic dramas, you can see the the very clear difference in the evidence that roughly three o'clock in the grayscale image, you can know that there is a very organized appearance, uh, to the lesion, and almost appears again like a meatball within the vessel. Here's another IBIs run where you can see chronic rhombus, Um, between the six and seven o'clock position on gray scale imaging again, there is a There's a mobile appearance, but it also appears quite organized on certain portion. Let's run that back through and just so I can point that out specifically eso again following on the image, looking roughly from 12 to 6 o'clock. Look at the six oclock position. There's a mobile component which may or may not change your treatment algorithm as faras. What faras. Placing scaffolding versus balloon Beano plast in this area with the risk of dislodging mobile thrombosis and causing a complication. Here we have emerging run that begins with acute dramas present between the nine o'clock and six oclock position. Halfway through the run, you'll see the chronic promises known at the six Oclock position again. A good demonstration, as you can see here. All right, this is one of the new things we're always looking to show evidence of promise removal, and again, does it do what we say the device can dio Um, I like. Here's an evidence of running the IBIs catheter, uh, juxtaposed to our aspiration catheter again. This is a 10 French capital, and it again very eloquently shows. And I think we've seen this before. There's now you see it and now you don't just evidence of the simplicity yet the powerful application that we that we see with quickly device and further evidence that we get an opportunity to see here live and direct with intravascular ultrasound so quickly and I vis eso again, I like to say and again, I think, for people that have both attended courses and many of my very close colleagues, um, it's not just rhetoric to speak about the use of intravascular ultrasound. Whenever I enter a blood vessel almost without without fail, I'd like to have that additional energy. And I'd like to echo the previous talk that discussed, discussed almost how it seems abnormal to not have that extra tool for visualization again, I walk away from every single case, knowing exactly what I need to treat on. That becomes very clear with our imaging modalities. And then finally, when I'm done with the procedure, did I do exactly what I said that I needed to the device to dio? So the important part of again about obvious there several points one understanding the morphology of the thrombosis and plaque is acute. Is it sub acute, or is it and does have more of a chronic component, meaning that you'll either have to spend more time with aspiration. Or in all likelihood, the patient may be a candidate for some other type of therapy. Um, it also helps with looking at the characteristic of viscosity in the vessel as well. Of course, understanding sizing eyes vital when it comes to definitive treatment. Oftentimes these patients have some sort of mechanical cause such as extrinsic compression. Uh, that needs to be alleviated and obviously understanding the size of the best of the vessel for balloon Pino plasticky and placing definitive scaffolding is vital. Uh, when it comes to treatment with the under sizing is in all likelihood going to result in recurrence of disease or the disease not being treated adequately in the first place. Uh, or it could result, uh, again, in rare cases with migration of the stent itself up to the heart. We also can understand the degree of stenosis. And it's important, you know, when we're doing these cases that we really have an accurate assessment of the degree of stenosis and should we actually be treating the vessel in question? Um, I like to place my harvest catheter right at the level of the highest grade of inclusion our stenosis and then have the patient undergoing entire respiratory cycle that prevents me from being fooled into thinking that I need to place a stent or provide balloon vino plasticky in a patient that otherwise might not. Also understanding vascular, the health of the vessel and the vessel walls is something that we're able toc quite clearly when it comes to intravascular ultrasound. We love to be able to reduce the amount of radiation again with the busy careers that we have and the amount of time that we're spending using fluoroscope e. That's an important aspect that that is important to minimize as much as possible. And then it also supports our treatment decisions again. Do we perform from back to me after wrecked me stent balloon? Do we stand here or do we use balloons in particular devices and really understanding the sizing of the use? And again, this is described both the arterial and venous system and then finally quit clear is able to drive our outcomes. It's designed to control blood loss, blood loss, which again that is that there's certainly a learning curve thio this portion and something to be mindful of with any of the aspiration catheters that really are able to pull larger volumes. There's consistent and powerful aspiration. And then again, I think, as many of us have emphasized this evening, it supports faster set up and procedural times. And then finally, the quick, clear mechanical during banking system again is intended for removal of fresh, soft and blind thrombin from the vessels of the purple arterial and being system. It really is not designed, form or chronic, uh, more chronic promise. Even though we've seen some success here, just understand the likelihood of on excellent results in the case decreases the mawr that that that promises organized. Okay, So, Brian, thank you very much. A great a great talk. And I think we all agree as Panelists. And I think the world is starting to see more and more that there's an ever growing body of evidence that I was guided arterial and venous interventions fair for better than those simply driven and geographically, we're more apt to treat to the appropriate size, more apt to detect dissections more apt to detect clot, more apt to find areas that are untreated. We could go on and on and on. But the truth is, this is a Goldilocks world when were there Can't be too hot. Can't be too cold. The porridge well here it can't be too small. Can't be too big. Can't lead the sections. It's a Goldilocks phenomenon, and I must allows us to do this and you mentioned earlier in the lower legs we can use external duplex, but it's very difficult to see in someone's abdomen with external duplex. And it's really hard in South Louisiana, where we have a fairly high body mass index is sometimes and really difficulty to see there. And so I This is certainly a great tool. You know, the other point that we brought up. We talked about there being some residual rhombus, and I think it's important for the audience to understand when treating this venous clot. Argo listen to remove 100% of the of the cloth would be great if we could, but if we can establish a nice channel, the body will continue with rumble Isis. If we keep this patient appropriately anti coagulated because blood flow is a phenomenal from politic, we all have tp a within our system, which continues to work as long as we have clot, blood interface and good flow, and we don't have the Stasis. So certainly those air points that I think we should we should keep in mind. So at that point, are there any questions from the audience that we can that we can answer? Yes, We've had a few submitted. The first question. What is the risk of a piece of thrum bus going downstream? Uh, which of you would like to start with that question? Andre, would you like to take that question? Yeah, sure. Obviously, any time you're manipulating thrombosis and acute promise, there's always a risk of ample ization. I personally always make sure if I'm doing a Venus case that I place a filter that I will often remove afterwards or leave in for a short while and then remove it. But it can't break off. I could tell you with a continuous aspiration, though, the chance of it breaking off, in my opinion, would be a lot less because you're actually pulling back as you're using the catheter. And it's extracting the clot as opposed to just as opposed to just, uh, striking it or or or hitting it in more supervising, actually in the vessel. So I think there's always a chance that that's gonna happen. Can never stop it. But be preventive, be smart and how you approach the thrombosis and, yeah, I use a filter. So, Brian in the car Yeah, I'd like to echo that. Those air excellent points in, uh, in our practice, we've done, uh, essentially the exact same thing in these patients. I do like to place and obviously filter on. As you know, there's some devices were, and obviously filter can't be placed beforehand because of risk of, of entailing, with the filter itself we do place, those not often will leave them in place for usually a month or so. And then I bring those patients back for removal. We get them into essentially a registry, and we have 100% removal rate, sometimes taking one or two times for removal. But again, when the filters placed appropriately, this is usually one of the easier things that we're able to do in the outpatient setting. Do either of you think that would be a role for a filter which is removed at the end of the case, sort of like we use in karate AIDS or we use in the purple space. Sometimes a bigger iteration of that where you weigh treat the patient perhaps a slightly bigger pore size. At the end of the procedure, we would consider removing it. Do you think that would be utility to that and work over that wire? I think that would be That's an excellent idea. And I think that that would really work. Well, um, one of the things in one of the reasons I like to leave a filter in place to is those areas were wrong and that, you know, and in most settings, once you've treated the vessel, you know, I think in theory, I don't know if anyone knows this and I have anything scientific Thio back this up faras journal articles. But you've just removed a large clock burden. You're going to inevitably be some of that behind on eso. For that reason, I like to leave something in place for again around four weeks or so on then. At that point, I consider the the residual from is to at least be more organized with a potentially a lower likelihood for immunization. Okay, great. Any other question, Jonathan? Yes, sir. There's a two part question. Are you not using the bag or are you emptying after second part? If you aren't using the bag, did you notice any loss of pressure? Okay, Brian, let's ask you first. Sure. A za part of the set up of the device. The bag is used every time. That's the kind of the collection bin for the promise as well as some of the blood that you end up aspirating because that's left in place the entire time. There is no drop in. The amount of negative pressure is able to be produced by the device. I think the question was a drop in systemic blood pressure, perhaps. Have you? Have you seen that? I have Not again. In the largest volume that we've lost so far, which again, I showed you the first experience of roughly 400 ccs. We did not see any change in the human dynamic status of the patients. Okay, Well, yeah, yeah, the bag is left in place. I think with the examples that I was showing we we cut the bag after the case was over to look at the contents. So the bags never. While you're using the device, everything's intact. Okay, Other questions. How does the Aspiration volume of the 10 French compared to the aspiration volume of the eight French? Uh, I might take that to start with aspiration. Volume is dependent, of course. How much we're going to ask for it is dependent upon the size because we know that effects flow. But it also depends upon the particle size that you're removing. If you're removing, you know some promise in there, and you have chunks of prom bus on your well embedded within the thrombosis you're going to. Even with longer time, you're not gonna be dragging out quite as much fluid at that at that moment. So remember, flow is related to the length of the catheter. The shorter, the better the flow, the bigger the dye amateur, the better the flow. That's a bigger thing, but that's divided. It's divided, it's directly related. It's inversely related to left and inversely related to viscosity. So if you're removing highly viscous substance I clock, which is very big thick, you're gonna be removing slightly less right at that moment. Is that what the two of you have experienced? A swell. Yeah, Absolutely. Okay. Other questions. How does Theus aspiration pressure of quick, clear compare to other devices? I think I showed that in this slide, it waas slightly higher than the number eight French system. And I think three times higher are close to three times higher than the assailant system. Dr. Walker. No, that's absolutely correct. So if you looked at one of the previous slides, I believe it showed the, um does Atlanta achieving roughly two millimeters of mercury and the yep, go back. You had it just a second. Go back right through there. So look at the graphs. Seven slant is shown here in the solid blue line. This is really very substantial. Negative aspirin. Negative pressure. Okay. Any other questions? No. What value does having the entire system in a sterile field provide? Yeah, I think a lot because you can watch it. It's easy. It's one minute set up. These were quick procedures. But let's ask these guys because they've They've certainly done a lot of procedures. Andre, let's start with you or I. A Zai alluded to it during my presentation. I think having it on the table makes it makes everything a lot easier. I am always panning the table back and forth, up and down the leg, and any time I have a device that's not directly on the table that I have control of becomes a hindrance. They can't position it. The cables don't. Don't they overlap that the shield doesn't get in the way. Whoever designs the rooms never designs it exactly right. So it's it's a riel. It's always a struggle and having just having it right there on the table. You can put it to the side when you're not ready to use it. When you're ready, you just pull it over. It just makes it so much easier. Um, in just managing it, controlling it s so I think that's a huge bonus. Plus for this Brian. Yeah, I would agree with that sentiment. Having a device that again, uh, is handheld the generated portion, uh, again you can place again. The amount of area that it takes up on the entire field, uh, is really no different than most of the athletic community vices that we have currently available, and then There's nothing hanging off of the sterile field. There's no issues with, you know, again, those extra cords. And I love that. The previous example, you know, getting our staff thio buy into these new devices and, you know, knowing that the set up is gonna be going to be cumbersome, there's a learning curve. In some places, you have quite a bit of turnover, and each of those folks that come in you now have to reinvent the wheel and teach them how to use Ah, device that has capital equipment. Once you're able to connect the device again in roughly 60 seconds, you just hit a button. And there you go. You're ready to achieve aspiration that his own power better than any other devices on the market. Yeah, I think it's important to be able to see the device. You know it. You absolutely see when it's on, you see what it's often granted. You can say, you know, and you've clicked it, but it's really good to be able to see things and have visual confirmation of where you are in a procedure. And I like that concept. Any other questions? Yes. Ah, number have been coming in, but, uh, I believe will close with this one final question and we will address the other questions offline. Where do you believe? Quick, Clear Will create the most value. Mhm. Let's ask our guests, Andre. Where do you think this has the most value anywhere? Like endovascular work is done pretty much. E think. I think this is a This is a device you could see. I mean, in the O b l you see it in the A S C. You see it in a hospital. I mean, you have an issue with the vessel, and if you're doing any endovascular work, this This is a tool you will use often. Hopefully not too often, unless it's meant for it, but but it's. But you'll you'll is a tool that you'll go to and you'll be looking for. Andi, I think Yes, I'm sorry. Please, Were you surprised with how easy were you Surprised how you see it, Wa e was I was you know, it was described to me initially and I said, Well, that sounds pretty simple, but I say I'll see what it really is like once we open it and put everything together, but it is extremely easy to do to use. And, uh, you know, a Dr Fisher mentioned, you know, the staff, they just They just They just did it. I mean, it was just done. I mean, it wasn't Where does this go? How do you prep this? How do you prime this? I mean, it's like it was just done. So definitely easy, and I would use it anywhere. Great. Dr. Fisher, where would you use this? Well, just to give some background on this important toe point out again that were outstanding talk and, uh, you know, device that we have an opportunity to talk about that does what it says that it can dio, um, I want to start out by just saying that, honestly, I was skeptical, man. I happened to be in Eindhoven and had my hands on the device. Uh, years ago, a z I believe you did as well, Dr. Walker, I know you play quite a role in the development of devices like this, and when I saw it, you know, you have these models, Uh, you know, it's one thing to be ableto pull jelly out of a out of a tube. It's another thing to be able to use a device like this in the human being. And again, does it do exactly what it says that it can do. So I had quite a bit of skepticism, not do quite a bit of work with filled. I was very pleasantly surprised by the ease of use and the effectiveness of aspirating a cute plot from vessels again, both in the arterial and venous system is you seem we've had experience with both, Um where do I find this device to be important again, as mentioned earlier. You know, in the blood vessels, Uh, I in our office space lab setting. Having a device like this is important and like to describe in the event of a water landing, we all do lots of complex cases, both on the arterial and venous side. And honestly, sometimes, uh, you know, there's thrombosis and ends up in places you don't want it to be. And having a jumped of tool like this that doesn't have ah, big capital cost doesn't take a ton of time to set up is really a nice, uh, nice tool to have in the toolbox. Not only for patients that you plan on having to use it on like a cute, alien, ephemeral DVT, but also in patients where you might have a complication from thrombin bolic material from, Let's say, uh in at directly. So that's where I really found. You know the value might not think of right away, uh, in patients where we might have a complication, which really happens again. We're involved. Material ends up distantly. You have a tool that you can easily set up and aspirate that and continue on with your day. So in closing this session, I'm going to tell you speaking with those that have used this, I've heard certain words used, and I think they're important words because whenever we get new devices, initial words that come out tell you a lot often of where device is going to go. Some of the words were easy to use. I think you both said that and shown that another word was cost effective. It's a very important terminology in today's world. That means it's gotta be both effective and not break the bank when we use it. Another word that I heard was transformative in terms of capability of removing from us more safely and hopefully avoiding other issues. And I think those kinds of words are really strong words. And when we hear them around a new product, it's encouraging. And it's going to be interesting to see how this works over time. But, uh, thus far I've been very impressed as well with the device, and I called others who had used it just to get their impressions. And to be fair, I didn't get a single negative impression from those that I've spoken with, which is again, uh, interesting. And we'll see how this works in the long run. But I'm very encouraged by the initial results with this device. So with that, we will end this session. But not without first again thanking Phillips for being such a world leader in terms of education and making sure that they spread education and give us products. It helps us more effectively treat patients. We appreciate the support. Thank you. And thank you to, uh, both Dr Bookings and Dr Fisher, your phenomenal doctors and great colleagues and appreciate what you did. Can you guys pleasure. Pleasure. Thank you. Good night. Okay. Bye Bye. Published December 13, 2020 Created by
