Chapters Transcript Video Venovo Venous Stent 8 Year Data Back to Symposium All right, thank you, Doctor Ray. I appreciate it. OK, we're in the home stretch. I appreciate everybody hanging in there. It is my absolute honor and privilege to welcome Doctor Michael Lichtenberg all the way from Arnsburg, Germany. Uh, he's gonna be talking about his experience with Vinovo over the last 8 years. Immediately following that, we're gonna do a question and answer session, and then we're gonna head over and get some food. So please stick with us. Hope you're taking notes throughout so that we can, uh, get your questions answered for you. Doctor Lichtenberg, thank you so much for being here with us. We appreciate it. Thank you very much. Thank you very much for the introduction. Thank you very much for the invitation. I don't wanna keep you too long away from your, um, lunch. Good evening from Germany. It's a pleasure to talk today about our 8 year follow up on the Vinovo venous stent, our long term data on this stent in patients with, uh, nivel and post-thrombotic syndrome. This is a disclaimer slide, my conflict of interest, my disclosure slide. So many dedicated wind stents are on the market. Many of these stents are available in Germany and Europe. We actually have now 13 stents available across Europe. I don't know if we really need so much, but I think what is important is that all these approved stents show positive data in terms of efficacy and safety in well controlled trials, and these trials were definitely done in the past for the already very well known stents which are shown here, Wii stent is unfortunately not any longer available, but anyway it was a great IDE trial, and you all know the other existing Wiener stent trials which are important. But I think beside of these very well controlled prospective uh trials we need Acoma registry to learn more about the behavior of the stent and different indications and this is why we set up um this Vnovo analysis over the years. So from my perspective it's important uh to highlight that the Venus stent attributes are always a balance between strength, flexibility, and lumen quality. So if you are treating a proximal iliac vein, then strength is obviously more important than distally below the ligament and the conformal vein where flexibility is important. So therefore, a stent always has to do a compromise when it's implanted. Of course there's not a perfect venous stent for the whole system. When you look at the different physical behaviors, the different morphologies of the stent, you can definitely easily assess that all these stents differ in terms of their resistive force and flexibility. So therefore, short message, all these stents need to produce efficacy and safety data in prospective registries in trials. When we look a little bit more in the theory, you can easily see that there is a significant difference in terms of uh stent crush force between the existing stents. Question of course is does this has any importance for all the daily routine practice, maybe especially for the very weak stent like a Cook-Silver venous stent. I would not place such a stent in the Maurna patient, but maybe a good idea to plant such a stent in the confemoral vein or below the ligament. Because what we want to have is always a perfect shaping after standard implantation, that means we all need and want to see an aspect ratio somewhere significantly less than 2. If we have an aspect ratio close to 1, I think we did all for patency in the future, and we could show the importance of aspect ratio in the past year in this publication from 2018 already. Uh, with decreasing aspect ratio, so more circular and constant perimeter, the area increases, the flow increases, so that means that in theory, patency rate and long-term patency, patency rate of course improves in these patients, but if a stent is crushed and bringing the lumen shape, the area and the flow down, then of course we can anticipate a re-stenosis or even a re-thrombosis. Therefore, um, we aim to analyze the bonobo venous stent, which is very well known, and I heard today already a couple of very interesting things about the bonovo stent. We know about the self-expanding stent design. We know that there's a very unique flaring of this stent, and we know that this is a tri-axial system. There are not so many on the market which favor a tri-axial delivery system. You can see you can, uh, in terms of diameter and length, you can treat all the indications in the venous side. Um, so iliac and IVC can be treated with the stent easily. So in terms of the product design, um, I think you're all familiar with that. Um, I think the most important aspect is the, the, the strength of the stand on the one hand side and the flexibility on the other hand. So a good compromise stand also for below the ligament and conframal vein, so a stent which you can use for all indications in the. Um, iliac vein system. So therefore I want now to emphasize a little bit more, especially on our data, on our experience using this thumb wheel delivery system which especially also our younger interventionalists like very much and appreciate very much because the precise implantation, I think is one of the. Major key aspects for successful revasculation, you don't want to have a stent in the IVC looking too much in, and you definitely don't want to miss the Methanna. So with this triaxial delivery system, I think you can easily implant a stent absolutely accurately in the place where you want to have it. The vernacular trial um already showed us in the ideal prospective way, um, the efficacy and safety of this uh device, um, with a very independent analysis in terms of vinographic and radiographic assessment, drex ultrasound, and of course the CS CSC and DSMB. So I think you're familiar with the patency data through 36 months for the different groups of patients which were treated. Patients with PTS and NBL, and you can really appreciate, I think, the very good patency rate, especially in the NIL patients, and a very low re-intervention rate, meaning a very good patency rate in patients with post-thrombotic syndrome after 3 years of 84%. So our Annsberg registry was already um set up many, many years ago. Uh, this Annsberg Venus registry includes all venous stents, and what we are doing is that we are doing subgroup analysis for the different stents and also in terms of patency, um, re-stenosis, and clinical events analysis and for the Bonovo we defined 8 years ago an 80 patient cohort. Um, we published already our two year data which I'll show you in a 2nd. 80 of these patients had, um, 50% of 50 patients of these 80 subjects had a post-thrombotic syndrome, so meaning 63%, and 30 patients in typical nivel syndrome. You see the demographics of these patients, of course, quite young. I highlighted a little bit the history, medical history of the patients in terms of previous DVT. Um, I highlighted as well the left limb was more affected as typically in these trials, and you can see. Also that these patients had a quite high RVCSS, especially in in the in the PTS group, um, overall 9.1, I think it's quite high, so we included also very challenging clinical patients here in this registry. You can see here the areas where we implanted these stents in these 80 patients. I want to highlight the mean stent at length of 134 millimeters in mean, the means um this is, I think, a typical daily routine cohort sizes and diameters are typical and length of 134 millimeters I think reflects a daily daily routine practice. When we look at the already published two-year primary patency data, you can see that in overall we had a patency rate of 95.5%, um, NIL patients, 95.5%, and patients with post-thrombotic syndrome, 96%. So you can see that we lost patency, especially in the 1st 6 months. This is typical for re-stenosis and rethrombosis rates in these patients, especially in PTS patients. This was also reported in many other trials, so I think we're on the same level with that. But if these patients come in a chronic phase, you can see that the patency rate stays very stable over time. And these are the patency rate analysis up to 8 years, which I would like to highlight as the main slide here tonight, 91.8%. You can see after 8 years, which I think reflects first of all the efficacy and safety of this device, but also on the other hand, clearly shows that these patients can benefit from revascularization. Um, overall, if we revascularize these patients, so don't be afraid of a loss of patency after a short time. This is the first time that long-term data really could show, um, for the Vinovast a very good patency rate. And when we divide the, uh, the, the patients into two subgroups, you can see that PTS patients also performed very well. Uh, close to 91%, uh, patency rate and the novel patients 93.5%. In terms of the clinical symptoms, and this is definitely what we want to see and also the payers want to see that these patients improve in terms of their symptoms, you can see a significant decrease of the VCSS score. Right after the intervention, this is follow up one, and throughout the years you can see that this VCS score stayed very stable over time, so the patient had a significant and chronic improvement. Of their symptoms, taking them, bringing them out of their post-thrombotic syndrome, uh, disease, improve the quality of life and the quality of life I will show you in a second, more in detail. This is the CAP score which I, we are all not a fan of, but we have to report it, but also the CE score showed a very positive, um, um, decrease over time. Um, the patient improved also in terms of the CAP score. This, I think, really reflects in this radar char the quality of life improvement over time um for these patients, especially um a significant decrease in terms of the venous edema, skin pigmentation, I think it's important in duration. This is all what patients definitely um influence. During their daily routine, and I think this radio show can nicely illustrate you that these patients benefit in terms of their clinical symptoms and then improve of their quality of life. So in conclusion, I think these final data at ASIS reflect the efficacy and safety of the stent. The patient improved in terms of their pain from baseline, improved in terms of their quality of life, in terms of patient comfort. And the primary patency was also very good with uh 90, close to 92% in the overall court. Thank you very much. Published Created by
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