Computer generated transcript

Warning!
The following transcript was generated automatically from the content and has not been checked or corrected manually.

Okay, we're live. Hello. Hello, good evening, everyone. Thank you so much for joining us tonight. I'm Tim originally trainee in Oxford and to get together with legit and I are trainee in Birmingham. Have the pleasure of co hosting this general club organized by the trainees section of the British Society of Interventional Radiology. And I are juniors. I'd like to start off by introducing our distinguished speakers who kindly agreed to contribute to training, education and evidence based practice on this late Wednesday evening. Instead of catching up on the latest bake of episode, representing team I are, we've got Doctor Catherine Lewis Ir consultant from Somerset, Dr Raghu Laxminarayan and I are consultant from Hull, Doctor Rahman Oberon and I, a consultant from Oxford and then representing team vascular surgery. We've got MS May not li a consultant vascular surgeon from Oxford and shortly joining us, Mr Mathew Thomas, a consultant from Newcastle. Lastly, I'd like to introduce doctor Indeedy Eddie Osaki radiology trainee in Manchester who was given the impossible task of presenting today's behemoth of a paper. Uh The trial and question is the recent groundbreaking publication in New England Journal of Medicine entitled surgery or endovascular therapy for chronic limit threatening ischemia. The results of the study initiated a lot of debate in the I R and vascular surgery communities and we're fully expecting some heated discussions as part of this session as well, especially given the seemingly contradictory results of the basil to trial published just yesterday in the land set. Indeedy. The floor is all yours. Thank you. Thank you, Tim for introducing me. So, hi, everyone. I'm in a, a radiology trainee based in Manchester. Um ST one level. Um So just to recap, we're going over surgery or endovascular therapy for chronic lymph threatening ischemia published in the New England Journal of Medicine. Um last year in December. So the link to the paper is there if anybody would like to refer to it as we go along. So just a little bit of background for any medical students or juniors joining us. So, chronic limb threatening a scheme is the most severe form of peripheral arterial disease defined by ischemic foot pain at rest ulcerations or gangrene. And it's associated with severe health outcomes and a very large cost burden. So treatments can be divided into surgical or interventional interventional as the primary revascularization therapy. So in the background of the paper, the relevant literature is introduced, the article also highlights a gap in the literature. They're stating that there's great variability between choice of endovascular therapy there. Surgery as the initial treatment for chronic lymph threatening ischemia and the extent to which variability affects outcomes is largely unknown. So in terms of the methods, it was a prospective randomized control multi center study. 100 and 50 sites were enrolled in America, Candida, Finland, Italy and New Zealand. And two parallel studies were done based on pre procedural assessment of the availability of an auto Jenness conduit vein bypass. So that they were split into two groups, cohort one had a single segment of great sadness vein cohort to had a need for an alternative conduit. For example, an arm vein, a short saphenous vein or prosthetic enrollment start in August 2014, cohort one were followed for slightly longer than cohort to you because it has slightly more funding for that cohort patient's were enrolled into the cohort based on the duplex ultrasound and they were then randomized to receive either endovascular or surgical treatment. All the patient's were expected to receive their treatment within 30 days after randomization and an investigator with expertise and surgical bypass procedures had to agree with another investigator with expertise in endovascular revascularization that clinical expose existed in the randomization of each patient group. So in the surgical group, surgeons were allowed to choose any bypass technique that they were using in clinical practice. And in the endovascular group interventionalist were allowed to choose any available endovascular technique. They were then followed up at 30 days, three months, then six monthly until 84 months after randomization. So the major inclusion criteria included being male or female age, 35 years or older, having arthrosclerotic imprint, inguinal peripheral arterial disease. Um So, below the inguinal ligament, um chronic limb threatening ischemia um including ischemic, breast pain, tissue loss, ulceration or gangrene. So consistent with Rutherford categories, 4 to 6. Uh and the candidate needed to be eligible for open or endovascular treatment adequately. Also, I like inflow and adequate target, defined ear's an arterial segment distal to the area of stenosis so that it could support a distal anastomosis of a surgical bypass. And then of course, the willingness to comply with the protocol attend follow ups, etcetera, exclusion criteria included limited disease only to the femoropopliteal segment. Presence of an aneurysm, low life expectancy and excessive risk for surgical bypass planned above ankle amputation on the apps electoral limb within four weeks of the procedure. Um renal dysfunction, dialysis history of renal transplant presence of a documented hypercoagulable state pregnancy lactation um or any prior input inguinal stenting or sent grafting. This is just a schematic of the child design. So um the patient's was initially screened for eligibility. They underwent vein mapping, informed consent was obtained and then they got split into cohorts. One cohort too randomized, half the group had surgical revascularization and half had endovascular revascularization. So in terms of the outcomes and the statistics, so that null hypothesis for this study was that there would be no difference in time from randomization to a primary outcome event between the surgical group and the endovascular group. The sample sizes were large enough to allow determined for crossover lost follow up, etcetera. Captain mayor plots, we used to evaluate risk of an adverse event and they also use SCS statistics. So overall they use appropriate robust statistical methods to analyze the data and considered multiple sources of variability in their analysis. So outcomes measures. So the primary outcome was a composite of major adverse event events or death from any cause. So major adverse event were defined as above ankle amputation of the index limb or a major index, Lynn reintervention. So a new bypass graph revision, thrombectomy or thrombolysis. The need for and timing of the reintervention was determined by trial site investigator based on clinical assessment. Um in addition to the primary outcomes, key secondary safety outcomes included the occurrence of a major adverse um event um uh any time or post operative death within 30 days. So slightly different timeframe to the primary outcomes also major adverse cardiovascular events. So, eh my stroke and and serious adverse events um these are also adjudicated by the Clinical Events Committee. Okay. So moving on to the results between the cohort. So, okay. Hot one with a selection of candidates that had a single segment of great stiffness pain and there were 1431 of these candidates. Um They're randomly assigned to receive either surgical treatment or endovascular therapy. The medium follow up time was 2.7 years in both groups. The patient characteristics are generally well balanced. Um And the time until the index procedure was four days in the surgical group and one day in the endovascular group, the surgical group had 85% of the procedures performed with a, with a single segment of great saphenous vein. And the type of endovascular procedure varied depending on the arterial segment that was treated interestingly. Um it was done across many sites all over the world. So, endovascular procedures were performed by vascular surgeons in 73% of cases, interventional cardiologists in 15% of cases and interventional radiologists in 13 kind of cases, the technical success of the index procedure was 90% in the surgical group and 80% 5% in the endovascular group. Um There was 66 cases of early technical failure um in the endovascular group, for example, not being able to get past the diagnosis and that was treated with a bypass operation within 30 days. So just some more um stats on cohort. Um um So the primary outcome of major adverse um events or deaf, many cause occurred in 42.6% in the surgical group and in 57.4% in the endovascular group, major interventions occurred in 9.2% in the surgical group and 23.5% in the endovascular group above and co amputation of the index limb occurred in 10% 10% of the surgical group and 14.9% in the and the vascular group. Um and the insist incidences of death from any cause and Periactin death was similar in between the two groups. Um So it suggests that a treatment forget effect across most pre specified groups favored the surgical group compared with the endovascular group. There were some exceptions. So patient's that were older than 80 black patient's patient's with previous limb revascularization on the same side or grade three, um be on the skin wounds. Patient's than the surgical group have the lower instance, rate of new or recurrent chronic limb threatening ischemia events and those me and the vascular group, there wasn't much difference between the instance of major adverse cardiovascular events um at 30 days. So am I in stroke, perioperative death was slightly higher in the surgical group than the end of vascular group and length of stay was longer in the surgical group. So just moving on to the results in cohort too. So in cohort to patient's without a single segment of great staff Innisfail were randomized with 100 and 97 receiving surgical treatment and 100 and 99 receiving endovascular therapy. The technical success was 100% in the surgical group and 81% in the endovascular group. 26 patient's underwent a surgical bypass within 30 days after technical failure. In the endovascular group, 37 candidates had a technical failure. Um And the primary outcome of major adverse limb events or death occurred in 42.8% of patient's in the surgical group. And 47.7% of patient's in the end of ask a group with no significant difference between the two groups. The time until major read prevention favored the surgical group. Um but there was not much difference between the times until a Burbank amputation or death from any cause adverse events was similar between the two groups. Um And um as expected, the lump of state was longer in the surgical group. So the city um highlights and has some obvious limitations. So one of those being selected and operated bias. So non responsive, certain individuals, individuals possibly from disadvantaged backgrounds, the local eligibility varied in different countries. So it's determined by the principle investigator. Um and investigators use their preferred techniques. For example, in intervention, stents balloon angioplasty may have been used another variation. So there was heterogenic et between the techniques that we used. And then another limitation was judgment of individual operators in determining Sabet successful revascularization. Um Although there was sort of a percentage advised um decrease in stenosis, there was no defined reduction um to determine successful revascularization. Um Also co morbid patient's that have renal dysfunction, poor life expectancy within the exclusion criteria for these patient's. And the vascular therapy would be a safe and probably last resort approach. So these patient's were excluded from the study. So just to summarize, um overall, the study found that in patients with a good quality, great sadness, famed for conduit initial surgery associated with the 32% lower risk of major adverse live events or death, then was the endovascular strategy. However, in patient's without a great saphenous vein for conduit, overall efficacy and safety outcomes appeared to be similar in the two treatment groups. The study also highlighted the importance of individualized patient level decision making in patient without an appropriate bypass conduit. Um And the findings suggest that pre procedure planning of treatment and patients' with chronic lymph threatening scheme, you should include a surgical risk assessment and as we know and determination of staff in spain availability. So thank you for listening just to the summary of the paper. Um If we came now just to move on to the discussion. Okay. Thank you. Indeedy. That was a really good summary and deconstruction of the paper. So we're ready to move on for a panel discussion now. So we'll bring up a different set of slides which will structure that part of the session. If there are any questions uh either for indeedy or for any of the panel members feel free to just put those in the chair and one of us will pick them up as we go along. So I think we have our panel online. I think one of our panel members is still having some connection issues. Uh Tim, should we, should we carry on? I think maybe let's carry on for now and hopefully we can add Mr Thomas somewhere in the background. Maybe Christian class. That's right. And I think MS Notley is also. Yeah, Mr Thomas has made it onto the stage, I believe. Uh, he's just got to turn his camera and mic on the field. Uh Okay, fine. And can you see this lies added? Yeah. Okay. So the first point of discussion we want to touch on was, you know, was there anything that you found either unexpected or surprising in this study? That's what challenge our way that we think about CLT I treatment. And sort of a, a sub question to that would be, you know, how do they, how do these results actually fit in with the current evidence base and our understanding of surgical versus endovascular treatment uh for these patient's. So perhaps we can start with Dr Lewis to start the discussion on this. Um I think uh the low technical success, I think we're often is quite surprising to see sort of 80 85% and that, that's significant difference in that. Um I think so initially, when you read that, and you think, well, actually we still think, you know, we're generally being safer within the vascular first, the patient's going to be having less invasive procedure, they're not gonna be having a general anesthetic um and all those outcomes. So that was quite surprising. And I think, um I think there's a lot to be said about that, you know, the different cohorts, the actual really selection of the vein, the Great Southern Spain and cohort one, they're using Great Southern Spain. Um And I wasn't surprised to see that actually, then there wasn't a significant difference with the prosthetic limb because um the alternatives because we do often, I mean, that kind of mirrors our practice. I think patients have vein and they're fit for surgery. Um It's a very pragmatic approach. I think so. Um And obviously we are as, as it was just highlighted then indeed, they just said that actually, there are quite, quite a lot of our patient's who we exclude, weren't included. Um And I think it's really good that it has challenged kind of thinking because I think sometimes when the trend goes too much, one way towards actually always go into vascular, always go open. It's never right and we've seen that with Eva as well. So actually, it's really good to have a, a paper which just challenge that thinking. Okay. Mhm. Great. Thank you for that. Perhaps it would be good to get a vascular perspective on this as well. So is Mr Thomas available to uh offer some thoughts? Can you guys hear me? Yeah. So I think looking at the best cli paper, it really just depends on whether you're someone that looks everything like the glass is half empty whether the glasses are full. Um If you look at life through the glass is half full, then this is a level of one randomized trial. Um It does add to the evidence based by which we practiced. It is uh Doctor Lewis has mentioned, it's, it is a pragmatic trial um as was something like the improved trial. Um And in its pragmatism, it mirrors our practice. Individual surgeons were left to choose their um their preferred surgical technique, individual either open or endovascular. Um If you look at go through last uh last is half empty, um it has a lot of limitations and again, often Lewis pick up like that. One of the, one of the surprising findings is not their overall conclusion. It's the very low technical success rate um of endovascular treatment, which is much lower than other uh serious published in the literature and it's probably much lower than most units were grown up. Um And there are some potential reasons for that. Um I think it's one of the questions a little bit later that you've put together. Um So it, it challenges current thinking a little bit, it adds to the evidence that we have available. Um I personally wouldn't describe it as an earth shattering paper. Um I think the limitation is unfortunately cloud um it clouds over all conclude. Yeah. Yeah. Thank you. Yeah, we're definitely gonna touch on the limitations and another point. Um But before we move on any other further additions from the panel? Uh October. Yeah, thanks Agit and, and thanks for, for the comments that we've already had. Um I mean, there's a lot of questions for this study that that and I think the things that been highlighted, the low technical success, the operators, clearly, we're mainly vascular surgical, which uh there was an interesting papers some years ago looking at the technical success and costs of IR versus surgery and and there was a big discrepancy between the two groups when they're undertaking these procedures. And that's something that may be worth looking at a sub analysis within that cohort. So to look at why that might be, um I think the problem with random my studies of any sort and the basil sadly, which goes gives completely diagnose opposite suggestions. Um is the fact that we are excluding a large cohort of people, there has to be echoed points in order for you to enter these studies. And um when you really start looking at the numbers of patient's that are being entered, it would be really interesting to see how many were excluded. And I can tell you locally for, for basil, we entered a fraction of our patient's, we really struggled to enter patient's because getting echo poise is really quite tricky. So what we're ultimately looking at is about a 5 to 10% of the population that were actually treating and therefore, the results are really not translatable So I think in terms of answering your question, it's not really surprising finding given the limitations as Matthews lose too. Uh And I think the practice currently, most centers certainly in the UK is we try and under vascular first and that even if it fails, there is a good option for a surgical bypass, then that's what they have. If there is a patient who has a good surgical option from the outset, then okay. That's, that's often a good way to go for that patient. So the findings are a fine because effectively you have to look at the individual patient and individual factors and then plan the treatment on an individual basis rather than generalizing from studies like this, which which are always have these confounding factors. Thank you. Uh Dr Laxminarayan would like to add some thoughts. I I just, I just want to bring some spice into this discussion because uh everybody is trying to talk about the the low um endovascular success rate, initial success rate. If you look at the cohort, want of this group, the end of our success rate was 84.7%. And I was searching for the endovascular success rate on basal to which was predominantly done by interventional radiologist, of which I am one and we did put patient's through and that's 87%. So it's not, it's not hugely different, you know, between, between the two groups. When you look at it, I think um the point, the strength, I mean, the, the weakness that, you know, some, some endovascular first or endovascular only strategy, which is flawed. I think that bit is debatable in our setup because most of our patient's go through an M D T. One of the things that we don't know with this group is, you know, what kind of task lesion's were, they, were, they, you know, were they just noses or they were task see or tasked the lesion's which are being picked up. That is something that we don't know, there was no angiographic whole lab adjudication of any of these patient's. And I think that will come, you know, when you unpack it'd to come. And another interesting thing, you know, you say, how do these results fit in with the current understanding of our patient's of CLT I, if you look at the average age of the cohort one patient's of the best cli, it's 67 years. Whereas when you, when you suddenly look at your M D T and what you're going to look at, there are much, much older set of patient's. And the second thing is when you actually look at what was the percentage below the knee uh which were treated in the best cli trial that was only 40% compared to the entire thing. So, you know, what the best cli is doing is somewhere between basil, one and basil to basil to, we were looking at more below the knee patient's so it's an interesting trial. And, uh, like what Matt said, I mean, a huge number. It's pragmatic randomized. It's an extremely large data set. It's evidence. Nonetheless, we should take into consideration. And I think what it has done in our own unit is at the M D T S a more serious consideration of whether a vein bypass uh is a suitable option for the patient really considered at the moment. Thanks. Yeah, I think we're gonna touch on basil to in our next discussion point as well. So I think Tim's going to lead on that question. Yes, I mean, to be honest, I have nothing to ask because we, I feel like we've covered many of the discussion points already. You've made some, some excellent points. Um But the one thing I want to focus on straight away is the trial being accused of having a low technical success rate. As many of the speakers have already um touched upon and specifically the cohort one had only had a technical success rate of about 84 85%. And just to remind you, I included the definition of what a technical failure was in this study on the right hand side of the screen. Now, the whole story of this trial, you could argue begins with the basil one trial which was published over 20 years ago. And I think one of the main issues with it was again, the low reported technical successor, about 80%. And our colleagues, particularly across the pond. When discussing this paper, I have a feeling that perhaps it doesn't quite capture real practice. Um That's not quite what we should be aspiring for in terms of treatment of CLT I uh in 2023 has nothing significantly changed in terms of the outcomes of our patient's, despite technical developments and the accumulated operator experience over the past, you know, almost 20 years. And especially if you look at as, as Mr uh Thomas um uh touched on there's, if you look at the data from the other large publications of vascular literature over the past decade, the technical success rate was generally much, much higher. So what's what's happening? And we can't discuss this paper in a vacuum like we have to talk about the elephant in the room, the basil to trial, which was published on the gym yesterday. And despite showing a seemingly different. Uh so we know that the primary endpoint of the study was different. We can't compare apples and oranges here, but it does give an edge to endovascular first. And yet the technical success rate was as Dr Laxminarayan mentioned was only 87%. So perhaps the low technical success rate is not um wrong, maybe it just reflects real world data now. Lastly, yeah, looks Uberoi. Yeah, kind of since checked. I was going to comment when rugby was talking but as ragweed answered in his own sort of answer is that the numbers of bolognese treatments were significantly higher. So if you look at the two different papers, the numbers are more technically challenging patient's was higher in the basil two studies. And I think the the other thing to, to, to factor in is that actually when you looked at the overall numbers in best cli it was actually 80% when they looked at. Uh So when you start looking at more complex cases, complex patient's, um then actually you start to see that there's a bigger disparity between the, the end of end of techniques. So I think it's, it's probably greater than when you think about it. Because when I was looking at the numbers of femoral and isolated femoral and property lesions that were treated, there's actually quite a lot and most of our cli patient's virtually never have single level disease. They're mostly multilevel disease. So they're quite complex. Um So I would argue the technical success is actually much, much better than we is much more disparate than, than one can see. But I, I think that the important point is is there is an important role for surgery. And I think if a patient is young has got good veins, I think nobody would argue with having a bypass option. Um But I think most of the patient's as *** alluded to is actually not in that field. They've got comorbidities, they're older, they're higher risk and having an endovascular strategy first makes sense. But, but it's not the only technique. And uh there is another elephant in the room. I think we didn't kind of allude to is the technical expertise in doing firm distals various hugely, I think because of way practices are developed. The numbers of surgeons uh worldwide if not nationally has who can do from distals, well, who are doing large numbers of them is not that great anymore. There are some centers that fantastic experience. These, there's others that have very limited and then you're, you're not comparing apples and apples. Again, you're comparing different uh expertise with those different techniques. Thank you. There are some excellent points. Um Absolutely. Like you have, we can't um we can't ignore the these issues especially when comes to below the knee revascularization. Um Something that Dr Laxminarayan also alluded to in his in the points he made earlier was the task classification. So we know that we failed in some proportion of these patient's, but we don't know which sort of patient's we might have failed in. We don't know how severe these lesions were the reasons why we were not able to, to cross them. And I think I'd just like to open the discussion here. Um Do we have any ideas at all why the technical success was perhaps lower than expected? Both from like a technical point of view, population point of view. Um Perhaps we start with MS Notley. Yeah, sure. I was just gonna speak the side that you have on the screen at the moment because um I think uh the authors were actually asked this question about the high rate of just plain billion angioplasty. And they said that actually they confessed, they felt that they didn't represent particularly this table as they should have. So they say that they represented this in terms of segment treated was actually if they presented it per patient there, plain balloon angioplasty rate was much lower. They haven't actually stated what it is. And I think they're publishing their sub analysis to try and correct that. But they, they're quite open about the fact that they feel that the way they've represented the this data in the paper is misleading. So they've said that the actual plane balloon angioplasty figure was lower, that doesn't really help us very much. But it doesn't really the answer the question is why there might be some lower technical success and, and what proportion of newer techniques was used. Um So that does bring into question a little bit um exactly what is going on in the data. And I think they're, they've got about four million dollars further funding to publish all the sub analyses that I think it'll be interesting to see what comes out from that. Yeah. And I think reading the basal to paper, I think they've also the office will collaborate and try to bring all the data together. So to, to create a meta analysis of patient level data. So I think that's definitely something exciting to, to look forward to. Uh Thank you. Thank you, MS Notley. Um Doctor, do you have any other points? Oh, sorry doctor, doctor. When I was raising, I'd let you speak first. No, I was just, I was just saying, you know, which, which you mentioned the cats honest thing, you know, this trial started on 2014 and uh after that, the honest paper ended up skewing things a little bit differently. And I think uh what maze refering to, I was listening to, I think Dr Farber and, and he was saying the actual total number of plain balloon angioplasty was actually 19% and uh drug techno biology was used at 40%. The skewing that happens is when you look at below the knee work, the standard of care for below the knees playing balloon angioplasty. So, I mean, people don't use drug technology in CLT I below the knee as yet. So, um that's, that's probably the reason that uh it has skewed one way or the other. Um Once again, when it comes to one of the interesting things that we should uh discuss is, you know, the mortality is similar in both groups, but the composite endpoint is different and whether the, the, the way in which, you know, the technical success has been running down the composite endpoint. But even though the mortality of both groups have been different and heterogeneous et of the endovascular strategies is a key thing, two key points heterogeneously of endovascular strategies across the board in the 1000 outpatients. And the fact that, you know, things have moved on now with the presence of uh you know, shock wave technology, the presence of arthrectomy and the the presence of recapitalization technique from below, like, you know, using the Dorsalis pedis approach and the pedal approach. So things have things have moved on from when uh this paper was or the study was being developed. Thank you very much. Do you have any other thoughts about the uh technical outcomes in the study? Yeah, Doctor Uberoi, I would look Catherine uh speak first ladies list. Unfortunately, sorry, I'm not able to see all the speakers at once. I'm sorry if I'm hurting anyone. Apologies. No, I think it's about, I mean, we've talked about hydrogen entity to head genetic technique but also head regenerative different patient populations. So quite diverse patient populations. And within that, you've got quite a lot of heterogeneity of different operators in different countries and, and different approaches. Actually, I think, you know, some of the approaches in in Europe, there will be more intend to inclined to put jog alluding stents below the knees and while our practice may not not be that. Um and it's quite interesting with the Bologna work is really critical. And actually, when you look at basil to there's been a real shift again. And it's not only if we shifted our own techniques, I mean, I'm sure we all know that since, you know, my technique, since I became a consultant in 2014, and my technique now has completely significantly changed over that time. Um But also the idea that Angie's because own concept now, often people only shooting one vessel and now we're moving to cheating to, we're seeing basil to that actually, often two or more in for property or vessels were reopened and revascularized so that there's a very sort of headliners population operators working different systems and also in the technique. Um And when we come too, basil two were saying again, even within, I'm sure our patient populations in our own it within the UK for basil to we're also seeing a different in where you're where you live in the number of patients you have with diabetes or renal failure. Um So all that's going to sort of add in and, and um make this quite, quite difficult. And I think, you know, Tim's mentioned the individual patient data meta analysis which is planned, which is going to a lot of work, someone between best cli and basil too. And looking at the angiograms between those two studies, which I think is also planned is going to be a bigger piece of work. Really give us, allow us to drill down into that data. One Yeah, thank you very much. Um If there are any keen junior doctors and medical students on this call, I'm sure there's plenty of work to be done. So, yeah, 10 guys one month finally. Uh Yeah, thanks. I agree with Catherine. Uh Because uh what I was doing 25 27 years ago is very different to what I'm doing now. I'm much more aggressive in terms of interventions and even in the last decade, I think it's changed. Uh And the techniques have become much more refined. We've got more tools which is great. Some tools have been around for ages. Arthrectomy. I think rugby mentioned uh didn't work 25 years ago, didn't work 15 years ago and they're still trying to see if it'll work now. It's one of those things that uh these things keep coming back and forward, back and shot. But we are quite fortunate in Europe because we get access to far more tools than they do in the US because of the FDA regulations. So we get them earlier and quicker and we get to try these things out much more quickly and we're much more aggressive. I mean, some techniques such as D V A we've been doing uh started only 55 or six years ago. And the things with D V A s is just highlight how aggressive we are becoming in terms of trying to salvage limbs, which we wouldn't have tried in the past, we had just said that's fine. We've had one go at angioplasty, one go extending and then that's what we're going to give up. Whereas now we're much more prepared to intervene again and again, as long as we think there's a viable option to try and keep the legs on. So there is a very different emphasis and different approach. So it will be interesting to see when we compare the data directly with angiographic evidence between the States and, and the basil studies. Um whether there's a real correlation, whether it's dealing with the same cohorts of patient's and we're dealing with the same pathologies and uh task. I'm afraid nobody's used in practice uh ever since its inception, but we use it for a tool when it comes to research, there are other markers that people might use. It comes out to in practical terms, we will uh if there's not a good surgical option for a patient, then we will try and uh and we'll try it more than once or twice because the alternative is amputation. And uh even if it's below in the amputation, that's a pretty poor outcome for the patient. Uh And we know in the long term, they, these patients do really, really badly. I think I'd also just like to add um I think that would be very careful to compare the population for kind of basil one best cli and basil too because I think as we all know infrapopliteal disease tends to affect, you know, more diabetic or the renal population and they're, they're far more weighted towards, um, those are diabetes and renal disease. Um, so I'm not sure that they're a comparable group and I'm, you know, all aware of that, but uh that might be reflected in the results that you see between the two best. Seelye and basil too. Thank you very much. There was some excellent points. I think we could keep going for another hour, but I think it might be time for us to move on to the next question and continue at the discussion from a slightly different angle. Legit. Yeah. On a similar note to some of the comments that we've just uh touched on. Uh and that is, you know, do you feel that there any sort of new techniques or approaches or anything already used in your practice that could further improve the end of vascular outcomes for these patient's? Because we know enrollment for the study start in 2014 and that's almost 10 years ago. And nowadays, we've got, we're using more advanced, you know, adjunctive techniques like intravascular ultrasound, intravascular lithotripsy retrograde approaches, all of which help us improve our technical and clinical success. So, with that in mind, do you feel that the outcomes from this study are representative of the outcomes that you're getting within your own practice? And maybe we can start with uh Dr Laxminarayan with this one? Thank you. So um in answer to your question, which I did briefly touch upon is that newer technologies, not just new technologies, new approaches to revascularization. For example, you know, we used to do only the transfemoral approach, but we got into a practice using pedal approaches. Political approach is to try and improve recapitalisation. The second thing is we've also got into having reentry devices, very nice reentry devices which are 23 French which you can even use uh from appeal approach to try and get through. So that improves your immediate technical success of revascularization. To top that the use of intravascular lithotripsy that you said the use of intravascular ultrasound to optimize the balloon diameter because sometimes there is a general feeling that you under dilate and you don't get the Luminal gain that you need to get and follow that up with the presence of drug technology. The newer sirolimus drug alluding balloons that have come into practice and certain stents that have changed our practice. Uh like the three D bio meme extent that have come into practice, have all improved outcomes. I feel having said that, you know, one of the great advantages that we have in our practice is it's not patency that we're after. It's what we're after is clinical outcomes. In fact, one of the I was asked talk about success in P A D and the answer to that question is asked, the patient, the patient felt uh the ulcers healed and stuff like that. So we use certain different parameters. But I think on the whole, I echo what Ramen and Catherine said over the last decade, there are a lot more technologies that are available that a improve our ability to cross calcific and difficult regions, improve our ability to modify plaque and improve our ability to keep the vessel patent for a lot of the time. That's great. And could we get a vascular opinion on this as well? So do we feel that these outcomes are representative of today's current practice and our techniques that we use today? Do I think like all of the dollar techniques my colleagues have mentioned, used a unit hours. We use, we use it as a threat to me. We started insulin to use IBL when we failed solution and we've had a solution and great in an attempt to be more aggressive. Um Well, uh retrograde approach. So I think, I think in terms of the advancement of endovascular techniques, um uh there's really a lot of units and so coming in, creatively more requested, we've already talked. So perhaps that is the quiet, reflecting the best killer, like um uh data on on the techniques they were using. Um I really appreciate you talking to them this, they argue on the I think it is important. Just uh your specific question there is about what uh and the vascular treatment uh techniques are available. I think it's important to highlight something like uh studies quality improvement framework for I want to just feel tired. Patient's because getting better outcomes for the stability eyes has a bit more to do than just what we technically due to them, whether we're a construction lender, regular surgeon or interventional radiologists. It's about improving the standard uh patient facility I received and the goals and the targets that were set by the society. Quality improvement from work to try. And after I Zarley inpatient spend five days are out page within two weeks um to improve multidisciplinary working um etcetera, I think is equally as important when considering how we manage these patient's. Yeah, just to add to that point, if you look at the medium time to bypass um for cohort one like the medium time to bypass or endovascular therapy for cohort one versus cohort to medium time to bypass for cohort one is one day versus four days for endovascular and cohort to the medium time. It's completely opposite. The medium time, two bypasses, four days versus one. So if you think of that in the context, Mr Thomas has just talked about the, you know, the sequin pad where guideline is to we've afterwards within five days, those are both within five days, but they are opposite in two groups. And does that I was thinking the same has that actually affected um the outcomes there? Mhm I suspect that anyone else like had some comments on that just say, I agree. I suspect it has that effect of the outcomes. And I think I agree with both the surgical colleagues have said this is a lot more than just, you know, what we do to patient's. This is the whole package and the times to get in the patient's revascularize is going to be with a significant okay. Doctor Uber has got his hand just a very, very quick comment again. I, I entirely agree. I think um there's also the other uh management strategy for the patient's managing the diabetes, the anti coagulation, the infection. And we set up uh along with my surgical colleagues and diabetologists and microbiologists about 67 years ago, a sort of uh multidiscipline team looking specifically at diabetic foot. But uh cli patient's and that's uh that's something that has evolved and lots of centers are doing as well. I know um to a variable degree, but it does make a huge difference in terms of having that much more team based approach, uh getting really good outcomes and it much and speeds up throughput of patient's from uh diagnosing uh imaging treatment, follow up re interventions and uh and improving the foot care through good nursing care and podiatry. So all these aspects are crucial to getting good results in the patient's. And I think the point that my surgical colleagues have made is really good that uh it's not just about doing the technical bit and just incurring what Ramen has just said, you know, the medical optimization in the best cli trial uh is not, is not that great. And they're just looking at their unpacking that it's only about 75% of those patient's were medically optimized at the time. Yes. So, you know, for instance, the statins and the S G L T two inhibitors, you know, both have, have been going to have an effect on the risk of major limb amputation. So I think we need more detail on, on the medications. And there's a lot because, you know, there's a lot of it's so multifactorial and so much playing in, into limb salvage and limb salvage rates and success failures. Great. Thank you. I think we can move on to the next point of discussion. Tim Sergeant. Again, this is something that we've sort of touched upon a couple of times already. And specifically, I'd like to discuss the population studied. Do you feel like it was representative of the patient's in your practice in the UK? And particular point I'd like to draw your attention to is the rate of end stage kidney disease, a renal dysfunction in general. What you can see from the subgroup analysis in this paper is that although the results were that the signal significant this of the hazard ratio, um that wasn't the case in the group that was politically much smaller, only about 10% of the general population of the study in the group that had a renal dysfunction at the time of treatment. And also if you look at the more general sort of population, the very small rate of female participants in this study, the average age being, as I think Dr laxminarayan mentioned earlier quite young for, for what we generally tend to treat or often tend to treat. Um and then the other population differences in the UK. So what do you think are the main issues with the study in terms of uh drawing conclusions uh about managing patient's in the UK? And what do you think we could change in the future? Should we start with? Um Doctor Lewis? And yeah, I mean, the it's interesting spousal to also had a very small number of female patient's. And I would think that is well, most are predominantly male patient's. I don't think it, I have more female patient's than that retreat. I mean, the kidney disease, I think it's going to, it does depend partly on again where your base, I don't work in a renal unit. So perhaps I might not be treating as many in stage renal patient's as colleagues um in renal units. Um We have, I think it gained were but if I look at my practice maybe from 2014 and now with newer techniques and abilities to give less contrast days and use things like I've us and big outside the box, there are also um patient's, you, you can teach, teach with that, with that data. Um I think it's, it's very difficult. I mean, I did touching it earlier and I was saying actually, I think where you're based in the UK, the patient population is very different. I have a very elderly patient with a lot, we have a lot of calcified legion's. And um, whereas if you're um, somewhere, um more, um, you weigh in the bigger cities, you know, I have a younger population, but potentially more uh diabetes and more ethnically diverse populations. So it is quite difficult. I have looked at this until it doesn't reflect it and it's not hugely far off, but a lot of, a lot of patients are still currently smoking and tell you that my patient. So, um it is hard to kind of take such a big study and then put that into your own sort of patient population, you know. Thank you very much. Can you hear from the vascular perspective as well? Yeah. Um I think there is a ways in which do those presidente seven populations that we look after? Uh Maurice would have been mentioned is the age of the patient's over included. And again, the trial deliberately excluded those patients'. It describes the farming, excessive risk of open surgery. Um um uh the guidelines on which they're based definition excessive high risk for open surgery, just crops. Every patient I see with the FBI even the population of the. Um I do think that's important um to bear in mind when you've already made a decision to include those high risk patient from a trial like this. Um It makes it very difficult to extrapolate that was also into those patient's um that are considered um to be high risk. I think that's uh I think that's, that's an important uh point. Uh Thank you very much. Um Do you have any other thoughts on, on this? Maybe from doctor like me and Ryan? I think, um you know, uh in our own practice, um the, the, the end stage renal disease would be reflected, but much, much more smoking. If you come to the northeast, you have to kind of, you know, raft your smoke through when you enter the hospital in a Rahman doesn't have such see such problems. But on a serious note, um I think the timely referral of the patient's, uh you know, people were talking about the sequin and, and, and within a five day revascularization strategy, be it uh bypass or uh the bit that happens before that the timely referral into the system, I think we struggle a bit, at least in our place that, that sometimes reflects on the outcomes. Um But on the whole population, I agree with both matin uh Catherine, our population is definitely much older than what is being, what is looked at in this study. And the fact that Matt brings up the, I think about 1000 patient or where were not taken into the study. So it's not all comers that have come in. So, even though it's a large population, it's not a complete reflection and that's a problem with it. Many are cities ramen brought that up with basil and trying to get patient's into the trial. So it is, it is a reflection of the fact that uh it doesn't give you the entire spectral view of, of the population you're treating. Thank you very much. And Doctor Uberoi from a perspective of, you know, working at a center that was involved in a one of those large studies recently, like what do you think can be done at a at a trust level, hospital level department level to make sure that the cohort that we enroll or try to recruit, it's representative is inclusive of all the patients that we actually see. Like what are the major barriers when it comes to recruiting patient's to clinical trials? That's, that's a great question. Um So as I said, we've got this um one stop clinic where we see uh patient's cli and they basically assessed with duplex and can have treatment instigated best medical therapy from diabetologist, microbiologists, etcetera, etcetera, dietary uh and have discussions with IR and surgery about what to do. And that's a really important tool because it means that you can speed through patient's for treatment. So from decision making to investigation treatment and follow up and that then allows you to recruit patient's uh much more accurately. So, you know, who you're dealing with because you're seeing that, that, that big Cohen population don't see everybody. But it seems pretty much most of the patients who are risk of, of Lim, Lim lost and having those set up for every center means that you really start to see the whole population. And then you can do better selection the problem with randomized trials And it's, and it's just not something that can be easily dealt with. And I'm, I'm much more in favor of registries. Now, having previously talked to thought registered, you know, randomized trials with the bees and knees. Um, we're setting up a registry for shockwave, for example, through uh Cersei, which will look at a large cohort of patients and that, that look at all comers and look at, you know, really start to give us answers because we start to look at the whole population rather than as soon as you start saying, well, they've got to be suitable surgery. They've also got to be sort of a endovascular. They've also got to be fit in. Are you start than introducing a whole tranche of barriers which don't reflect real life and real practice and it gives you some important answers, but it doesn't really tell you what to do with an individual patient that's in front of you and that's the floor, I think with randomized studies. Um And they're incredibly expensive and very uh and take a long, long time to set up. Um So there are things we can improve to help recruitment. But I think um we may need to think differently about how we do studies and how we collect data, a well run registry which has funding to ensure adequate follow up for those patients'. What I think would do far better in answering our questions. Uh And then we wouldn't be having this discussion again again because of criticisms because of patient selection bias. Um uh you know, do we use task or not? You know, we, we get a real world, real life picture, what, what works and what doesn't. Yeah, I just like to add to that if you listen to the, the authors of this paper talk about how the level of organization and almost cajoling. They said that at some point they felt like they were going around different centers, almost like salesman because it was very hard to get equipoise from clinicians because you have to remember the way that things are practice outside of the UK. You know, a lot of, a lot of the clinicians were cardiologists, interventional radiologists and vascular surgeons who see patient's independently. And some of them have endovascular only practice. So they truly believed that endovascular was going to be better and they only practice endovascular. Um And so getting them to have equipoise on patient's or persuading them to essentially give patient's away to the vascular surgeon in a randomized fashion was quite difficult for them. So, you know, the practical that the practical details of trying to actually recruit to a trial like this. I think we're very, very difficult and I guess it just goes on to show the importance of like a multidisciplinary approach and how lucky we are in, in many regards in the UK having have, having that as like a first step before we decide on any kind of treatment, I'm sure that's not the case elsewhere. And it's going to have that especially dialogue part, even as part of this uh small forum for trainees to know exactly what the perspectives of different specialties are and how we can, they can complement each other. Um Yeah, and I think you're absolutely right that the is very, very key to have a good working relationship between vascular and I are in close conversations as, as the patient's come in. Um So that, you know, that in your unit, you can offer both equally either within different teams or as, as a single clinician. I think it's very hard as, as Raymond was saying to be very good at both open and endovascular. I, I certainly am happy to admit that my endos is a definite weakness. Um You know, so I, I rem and I work basically together, we, we did a case yesterday. Um And I, I'm really grateful that I have have such a good relationship with my ir thank you very much. I think we're looking at the time we might move on to the next question. Although I'm sure we could be discussing the, uh, these issues for, for another hour or two. Um, just go back to the last question that we planned for today. Yeah, I think that's, that's the one that we like to finish on a Gyn. Yeah. So we'll just end with a sort of a broader question in terms of what the future landscape is going to be. So what, you know, where do we think the results of the study are going to take us going forward in the treatment of CLT? I given that we've got basil to that's had a slightly different conclusion and how are I ours and vascular surgeon's going to coexist and, you know, in the space in the future in terms of delivering care to these patient's and lastly, from a training perspective, how do you think that's gonna shape specialty training of both I ours and vascular surgeons? Um Maybe we can go back to MS Notley first for this. Gosh, I was thinking to be quiet because I feel like I've spoken to. I think, I think I just say I said again and that is that I think it is truly, very hard, genuinely to be good. Both. You know, if you're from vascular trainee point of view on our curriculum, you know, we have use that cover both end of vascular and open. But, you know, I think I've been a record number of years and like I said, I am very conscious that my end of vascular skills are a week. My open skills are not. But I think being aware of your weaknesses and your limitations is important wherever you land in your, you know, your training landscape. Um And I think, like I said, again, I'm, I'm kind of repeating myself but being aware of those limitations and being aware, the skills and valuing the skills of your colleagues is the most important thing. So that even if you don't have those skills yourself, you know, that you can consult your colleagues who do and still be objective enough to offer the correct treatment for the patient. Yep. Thank you very much. It's great. Would anyone else like to add some comments on them? Yeah, doctor. Yeah, I'm sorry. I, I'll try not to talk to me very briefly. I just want comment. I've tried to put stuff in the chat and I haven't managed and I don't know if that's a unique problem to me or uh people perhaps dialling in because I haven't seen any questions in the chat, but maybe I'm just missing them all. But, but I, I couldn't use the chat function but just a very quick comment. I just come back to the point we made earlier that it is a big team and I think we've got to use the strengths of, of the whole team. And um you know, uh we, we should embrace sort of the diversity of skills that we have. Uh And that comes everything from, from uh colleagues are skilled in poor dietary to Diabetologia uh to the technical skills that we bring to as interventionist with our vascular surgical colleagues and having an open frank discussion about what, what's most appropriate for patient's is, is ultimately uh you know, what's going to get the best outcome for that patient. And sometimes it's a combined approach or a surgical or endovascular loan approach. And it's just being able to uh yeah, be brave enough to say, look that, that, that's not a good one for us or maybe that that's something that should be done in a different way or a hybrid or combined approach. Uh But it means uh it's not just surgery and I are, I think we've alluded to that before. There's, there's a whole other team out there that we need to include, which are equally important and uh and sometimes more so in getting the best outcomes for those patients'. Great doctor lose. Did you have you 100%? Yeah. Really? Really from a training perspective. So I'm, you know, I'm now educational supervisor and clinic supervisors. I our trainees, clinical supervisor to vascular trainees doing endovascular training. And I, I think we are seeing a shift now towards more collaborative training as well. We've got um more interaction, uh compasses, speaking to a vascular surgical colleagues, they're really keen to see more interventional radiologist, sort of training with them things, more linking between things like be set and BS IR and really bring those together and uh basket surgical compasses and you're seeing that all the way through and there's no way, there's no reason why we can't train people together that you learn a lot. I'm learning lot from vascular surgeons who are endovascularly trained um because they've had different experiences with different techniques. So it's really the time now. And I think any sort of trainees watching this, I don't know if you've got any vascular surgical trainees, you know, we were really good to see actually the trainees leading on this and actually really collaborating at registrar level with their colleagues and understanding it because there's slight different skill sets which really complement each other when you're doing shared, working either in discussion's or actually in cases. And I think that's my final comment. So thank you, Phil. Um this thing from it to me. Thank you. Any, any kind of perspective to say. I completely agree with all of the comments and it's been made by the rest of the consuls and panel about training and looking back to the to the eye visual paper. Um It's something that will shift the way we'll be bringing together what this is what the SCLC our cli papers and it's not a paper that says that every patient is, it, it just feels like it's well for surgery has used, what should it always have? But that's not what the paper, what the results like. Uh, we have to be able to work together. We see an increasing number of patients with our pastor's who uses with most of our interventions are hybrid. Um, they need open hands, they need to end, uh, and that needs clarification. Um, It's uh working relationships that needs a robust MDT. Okay. Yeah, I think uh from, from my side of what, what this study is brought focus is that the endovascular only approach is a flawed approach. The there are patient's would benefit from specialists who can do excellent bypasses, distal bypasses and there are patients who will benefit from endovascular approach. And these specialists, you can call them by whatever name you want to call them vascular surgeons, interventional radios, whatever. But those specialists need to be trained to do uh to an excellent outcome when it comes to either a bypass or an endovascular approach. And those, those trainings I think done in a very collaborative way. And we, we are very lucky uh this side of the point that we work extremely collaborative with, with, with our vascular surgeons and try and increase our uh technical capability on both fronts. And uh thanks to Ir Juniors for uh bring you a fantastic program. I think this is, this has been an excellent discussion Yeah, I think we've had a great discussion and we've covered a lot of ground on this topic that's going to be hugely beneficial and, and relevant for both eye ours and vascular surgeons. I don't think there are any further questions in the chat. I'm just conscious I wear sort of overtime now. So I think that's probably a good place to draw the session to a close. So, thank you indeedy for the excellent presentation again. And thanks to all our panel members for their expert discussion and giving up their time for this educational meeting. We really appreciate you all for coming on. And thanks to both be S I R and R juniors for supporting this session and for everyone else that joined us this evening, um I think Chris has put a link in the chat to fill out a feedback form and um you'll be able to claim your uh certificate of attendance after filling out that form. So thank you all once again and we'll hopefully see you all at the next Journal club. Yeah. Thank you very much. Stay tuned. We'll be announcing the next Journal Club shortly. Uh This time, continue the collaborative theme, something related to interventional oncology. So I'm sure it's going to be hopefully as exciting as this 1 may be even more exciting. Who knows? Yeah, congratulations. Needy. And, and the guy is a great job, great job. And uh yeah, see you soon. Keep well, thank you, uh, yeah.