BEST-CLI& BASIL-2updates
Cost-effectiveness outcomes defy expectations in latest BEST-CLI data drop
A comment from Andrew Holden (Auckland City Hospital, Auckland, New Zealand) conveyed surprise at new cost-effectiveness data from the BEST-CLI trial that were shared at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK). The findings were revealed as part of a series of four podium-first presentations from the landmark BEST-CLI and BASIL-2 trials delivered at the meeting that aimed to add nuance to the ongoing conversation around the best treatment option for chronic limb-threatening ischaemia (CLTI) patients.
Sharing the main conclusion to be drawn from new BESTCLI cost-effectiveness data, Matthew Menard (Brigham and Women’s Hospital, Boston, USA) shared with the CX 2025 audience: “I can tell you that, based on the data that we have—with the caveat that the final results are pending—we would predict that open will prove to be slightly superior to endo[vascular] with regard to cost per life year gained and that endo[vascular] will be slightly superior to open with regard to cost per quality-adjusted life year gained.”
Topline results from this trial were shared at the American Heart Association (AHA) scientific sessions in 2022, with
investigators revealing that surgical bypass with adequate single-segment great saphenous vein is a more effective revascularisation strategy for patients with CLTI who are deemed suitable for either an open or endovascular approach. Both strategies were deemed safe and effective for CLTI treatment.
At CX, Menard added a further prediction that “given the small and statistically insignificant magnitude of the differences in the relevant inputs, it is very unlikely we will detect any meaningful cost-effectiveness difference,” noting that more granular data will be released later in the year.
Holden, who was moderating the session, homed in on these findings during discussion time. “Before you shared these data,” he said, “I intuitively thought that endovascular, while not being successful overall, was going to be more cost-effective and I thought it would be driven by lower hospital stay and certainly lower intensive care stay, but you actually found the opposite, so I find that counterintuitive.”
Holden asked Menard whether he could explain the findings, to which Menard responded that “our goal was to undertake a very comprehensive analysis,” in which all costs associated with the initial index procedure and hospitalisation were captured, along with all of the costs of follow-up reinterventions, hospitalisations, and rehabilitation care. “The challenge is figuring out what’s relevant to the disease,” he said, adding that “this is how the data are looking” when all of the costs that are associated with CLTI revascularisation are assessed in aggregate over time. “Hospital stay,” he stressed, “which is almost always the key driver in costeffectiveness analyses, appears to be the key metric in our evaluation as well.”
BASIL-2 triallist Matthew Popplewell (University of Birmingham, Birmingham, UK) noted that he was “quite relieved” on hearing the new findings. He explained that the length of stay in the BASIL-2 health economic analysis has been criticised for being “really long”, with the suggestion
Continued on page 3
INTERVIEW
Reality check: Study brings “significant” gap between randomised and real-world vascular patient populations into sharp focus
THE RANDOMISED DATA foundation on which clinicians base decision-making for vascular surgery patients is derived from populations that do not represent the patients they see and treat on a day-to-day basis, a new research paper has found. The review, recently published in BJS Open, involved a comparison of 307 randomised clinical trials including 66,449 patients and UK National Vascular Registry (NVR) data for 119,019 patients. Based on their results, authors Joseph Cutteridge (York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK) and colleagues conclude: “There are significant differences in demographic and clinical factors between patients recruited to vascular surgery randomised clinical trials and the real-world [NVR] vascular surgery patient population.”
Specifically, the UK-based research team found that randomised clinical trial patients were younger across all operations and that, for carotid endarterectomy, bypass and major lower limb amputation trials, there were differences in female patient representation. The authors note that further comparisons were limited by the insufficient baseline data reporting across randomised clinical trials, and that there was no consistent reporting of ethnicity, body mass index (BMI) or alcohol consumption in the NVR.
Speaking to Vascular News following publication of the study,
Continued on page 5
14 Profile Jacques Busquet
L-R: Matthew Menard and Andrew Holden moderate a CX CLTI session
NEWS IN BRIEF
n PAD MANAGEMENT:
Welcome to the June edition of Vascular News Europe
Welcome to the June edition of Vascular News Europe. This edition comes off the back of the 2025 Charing Cross (CX) Symposium, which was another exceptional iteration of the meeting. It was of course an opportunity to reflect on the fact that this was the first CX Symposium since the passing of Professor Roger Greenhalgh in which he had not had a direct hand in the programme. However, the board he established—led by Andrew Holden, Dittmar Böckler and Erin Murphy—was able to lay the path for continued celebration of his legacy with a fantastic programme. The contribution of Professor Greenhalgh was celebrated by Gustavo Oderich’s outstanding memorial lecture, and the quality of the discussion is highlighted in this edition of Vascular News Europe.
This issue focuses heavily on the outcomes of several major trials that centre on the treatment of chronic limb-threatening ischaemia (CLTI). As ever, the fight to prevent unnecessary amputation continues, but we now have further data to support decision-making following on from the BEST-CLI and BASIL studies.
There is evidence to suggest that these trials have impacted practice, but we also have the ‘reality check’ of the gap between patients included in trials and the patients most clinicians see in daily practice. This makes implementing trial results more difficult and is an area that needs addressing, as highlighted by Kasia Bera in our second cover story. It seems appropriate that in mourning the passing of Janet Powell we recognise the efforts she made to address the lack of evidence we see for vascular disease in women and need to continue this fight. Future vascular trials need to ensure that underrepresented population groups are actively recruited to ensure we can inform decisions appropriately.
The issue also covers the undeniable trend for the development of artificial intelligence (AI) and robotics.
There is no doubt that we will see both these areas grow in vascular and it is vital we focus on data and evidence to support appropriate implementation. The Sentante robot is discussed in this issue with early data showing promise, but clearly, we need to understand the role this and other technologies will play.
In the venous field, we have seen continued expansion of the evidence base for the treatment of superficial venous disease for varicose veins. The Spectrum study results present some of the most comprehensive randomised data for the role of glue in the treatment of superficial disease. The evolution of glue as a treatment modality has not been without controversy and this was openly addressed during CX 2025 with the Spectrum data serving to address these concerns and provide clear evidence to support decisionmaking for patients and providers. In addition, the treatment of pulmonary embolism (PE) has evolved considerably and again the data to support treatment has expanded with discussion of the STRIKE-PE and PEERLESS studies, among others, expanding our knowledge base.
All fields of vascular evolve due to pioneers who are willing to push boundaries and help develop procedures and care for the benefit of our patients. This issue features a profile of Jacques Busquet and an interview with Gustavo Oderich on his recent move to Baylor College of Medicine. These are both pioneers who have pushed our field forward and they stand as examples for us all to follow.
This issue brings together the most exciting developments from CX 2025 that serve to challenge our understanding, drive consensus and hopefully continue to improve the care of patients suffering from vascular disease in the future. I hope you enjoy it.
STEPHEN BLACK is professor of venous surgery at King’s College London and a consultant vascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust in London, UK.
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Semaglutide significantly improved maximal walking distance in people with symptomatic peripheral arterial disease (PAD) and type 2 diabetes in a trial designed to evaluate the use of a GLP-1 agonist to manage PAD. Marc Bonaca (Aurora, USA) shared this and other key findings from STRIDE during a late-breaking clinical trial session at the American College of Cardiology (ACC) 2025 scientific session (29–31 March, Chicago, USA). Results were simultaneously published in The Lancet
For more on this story go to page 4.
n CO 2 FLUSHING:
In a podium-first presentation at the recent Charing Cross (CX) Symposium (23–25 April, London, UK), Lydia Hanna (London, UK) shared findings from two studies investigating CO2 flushing in thoracic endovascular aortic repair (TEVAR) and transcatheter aortic valve implantation (TAVI)—INTERCEPTevar and INTERCEPTavi.
For more on this story go to page 11.
n LAUNCH PAD:
Vascular News is pleased to announce Adam Talbot (Manchester, UK) as its new Launch Pad columnist, taking over from Sarah Sillito.
In his first column, Talbot writes about “reframing success” in vascular surgery and embracing the increasingly palliative aspect of the specialty. “As vascular surgeons, we are increasingly operating in the realm of palliative surgery, whether we label it as such or not. Embracing this role doesn’t diminish our specialty; it expands it. It reminds us that our ultimate goal is not just to extend life, but to improve it,” he opines.
For more on this story go to page 20.
Cost-effectiveness
being that this could be due to a healthcare system issue. “Clearly it’s not, because it’s happening on both sides of the pond,” Popplewell commented.
Holden added that a “new lesson” to take from these cost-effectiveness data is that the driver of shorter hospital stay in these patients is perhaps not a less invasive procedure but instead making progress with wound healing to facilitate discharge.
Subsequently, Alik Farber (Boston Medical Center, Boston, USA) shared a new subset analysis from BEST-CLI. “We found that primary endo[vascular] may actually burn bridges for secondary bypass,” the presenter concluded, noting that primary bypass was associated with “significantly better” outcomes.
A question from the audience probed whether there are enough granular data available to know how a primary endovascular intervention “actually burns the bridge”. Farber responded: “There are many potential reasons as to how endovascular therapy may burn bridges for a future bypass. It may occur due to disruption of vulnerable plaque, wire injury, compromise to collateral vessels, damage to runoff vessels, compromise of a bypass target, progression of tissue loss and concomitant loss of optimal window for intervention, or it could simply be a marker for a higher risk patient or disease pattern. Which of these reasons are at play is not clear; however, our findings do show that the amputation rates are higher after secondary bypass.”
Here, Farber pointed to future research that might bring answers. He shared that the Novo Nordisk Foundation has provided a grant to the BEST-CLI team to fully unpack the BEST-CLI dataset.
Menard added that the National Institutes of Health (NIH) has granted the BEST-CLI team permission to look more closely at the first major adverse limb events (MALE) data in the trial. He remarked: “We have been
able to obtain the source data and so will be able to look at the aetiology of treatment failures. We are hopeful this will help us understand the important questions related to the need for reinterventions following an initial open or endovascular revascularisation.”
Summarising this part of the discussion, Holden remarked: “I think it’s fair to say that we are learning that endo[vascular] may burn bridges, and I never used to like to hear that, but I think it is potentially true.”
Elsewhere in the session, Popplewell shared for the first time the outcomes of the 61 patients treated conservatively who were screened for BASIL-2 as part of the BASIL prospective cohort study. He noted that this figure represented 13% of those screened for the trial at the lead institution, a proportion that was “a lot bigger” than the researchers were expecting. These patients, he explained, were not amputated, nor was any attempt made to revascularise them due to frailty or lack of options.
Popplewell concluded that patients managed conservatively in this group were “more likely to be older, female and sicker, and less likely to receive best medical therapy” than those who underwent infrainguinal revascularisation.
Initial results from this trial were presented at CX 2023, with the main conclusion being that a patient who needs a below-the-knee revascularisation with or without a femoropopliteal revascularisation is likely to do better if they are treated with a best endovascularfirst strategy rather than a vein bypass-first approach if clinicians had clinical equipoise between the two strategies.
At CX 2025, Popplewell also shared BEST-CLI and Global Limb Anatomic Staging System (GLASS) angiographic scoring data from BASIL-2.
He concluded that over two-thirds of patients enrolled in BASIL-2 had GLASS stage II or III disease, adding that half had mild or minor femoropopliteal disease, while one-third had long femoropopliteal occlusive disease.
The presenter also reported that most (two-thirds) of the tibial disease in the least diseased artery was confined to less than one-third of the vessel or short occlusions of less than 3cm in length and that the majority had some form of pedal arch. He noted that there were no significant differences in presentation between those patients treated with either best endovascular therapy or vein bypass.
Endo-Bentall as standard repair? More data needed but “never say never”
Polling at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK) saw a 60% majority of the audience vote against the motion ‘Endo-Bentall will become [the] standard repair technique for type A aortic dissection’, with the opposing speakers agreeing that future technologies have the potential to address many current limitations.
OFFERING AN ARGUMENT for the motion, Mehrdad Ghoreishi (Miami Cardiac and Vascular Center, Miami, USA) began by highlighting the high mortality and morbidity rates associated with open acute type A dissection repair, especially in elderly patients, frail patients, and those with malperfusion.
Against this backdrop, Ghoreishi considered the alternatives to open repair. He noted that ascending thoracic
endovascular aortic repair (TEVAR) is an option but is associated with a high (25–40%) rate of type 1a endoleak and “very poor” survival, with a mortality rate of 70%.
Other alternatives include the EndoWheat and Endo-Bentall procedures, Ghoreishi shared, explaining that the former can provide a safe landing zone and the latter, a good option if there is a tear in the aortic root.
The presenter added that both Endo-
Discussion following the four presentations considered whether clinical practice has changed following the release of BEST-CLI and BASIL-2 data.
“Anecdotally,” Farber shared, “I can tell you that it has,” while acknowledging that it is as yet hard to give an evidence-based answer to this “important” question.
Panellist Robert Hinchliffe (University of Bristol, Bristol, UK) stated that it should be possible to track any change in practice in the UK via the National Vascular Registry (NVR).
Menard commented that “it seems like people are listening” while noting it “obviously depends on who you talk to”. He acknowledged that there are specialists who are reluctant to change practice regardless of what the evidence says and that there is a “huge educational challenge” moving forward. “Hopefully it’s not going
We would predict that open will prove to be slightly superior to endo[vascular] with regard to cost per life year gained.”
Matthew Menard
to take 10 years, which is the average for guidelines to affect practice,” he said.
Menard noted that within the Vascular Quality Initiative (VQI)—which he recognised is “not necessarily the perfect place to look” because it only represents around 50% of providers in the USA—it “definitely seems like there’s an uptick” in bypasses. Taking a step back, Popplewell stressed that there is a need to “act carefully” and refrain from “blanketly applying” the results of the two studies to all CLTI patients. “I think we have to remember that these are a subset of patients with CLTI where we have genuine equipoise between two different strategies,” he said. Holden shared that he and his team are now “more rigorous” with assessment of conduits. Hinchliffe agreed on this takeaway message, noting: “In terms of the algorithm for evaluation, conduit assessment is absolutely key early in the assessment and evaluation phase.”
Wheat and Endo-Bentall can stabilise patients with acute aortic emergencies that put them at high risk for open emergency type A. In addition, he stressed that these procedures can transition patients from an acute to a stable condition and can even fix the pathology.
Concluding, Ghoreishi stated that, in a significant number of patients with acute type A dissection, an alternative to an open operation should be considered.
Ascending TEVAR for acute type A has “significant limitations,” the presenter said, adding that a better landing zone is necessary in this pathology for a safer, durable endovascular repair, which EndoWheat and Endo-Bentall can offer.
Closing his presentation, Ghoreishi pointed to the importance of future innovation in the space, quoting his debate opponent and mentor, Joseph Coselli (Baylor College of Medicine, Houston, USA): “When it comes to aortic innovation, clearly there are no limits; there are only challenges
to overcome.”
Speaking against the motion, Coselli opined “this is more of a discussion than a debate” and that he “can’t really predict the future or even try to”.
Coselli put forward the argument that the Endo-Bentall procedure has “no data but lots of hype” with the literature centred around case reports and small series with minimal follow-up. He added that there are no clinical trials on the procedure and no devices that are either CE marked or approved by the US Food and Drug Administration (FDA).
Furthermore, Coselli noted that the aortic root is “dynamic”, with a great deal of geometric fluidity and that might increase the risk and complexity of later surgery.
“Open repair of acute proximal aortic dissection remains the gold standard for the foreseeable future,” the presenter concluded, before noting “never say never” and referring to future technology as having the potential to “solve an unbelievable number of problems”.
AORTIC
ACC.25: Semaglutide improves walking distance for PAD patients with diabetes
Semaglutide significantly improved maximal walking distance in people with symptomatic peripheral arterial disease (PAD) and type 2 diabetes in a trial designed to evaluate the use of a GLP-1 agonist to manage PAD.
IN ADDITION TO improvements in walking ability and function, people taking semaglutide also saw significant improvements in both symptoms and quality of life compared with those taking a placebo.
These are the main findings of the STRIDE trial, presented during a late-breaking clinical trial session at the American College of Cardiology (ACC) 2025 scientific session (29–31 March, Chicago, USA) and simultaneously published online in The Lancet
“Even at very early stages of PAD, people can’t walk well, but they often don’t know it’s PAD. They may say, ‘I’ve just slowed down,’ ‘I’m getting older,’ or ‘I have arthritis,’ but they’re actually severely functionally impaired and they often will self-limit what they are doing,” said Marc Bonaca (University of Colorado School of Medicine, Aurora, USA), the study’s lead author.
“The only drug we have available and is guideline recommended for symptoms is contraindicated in people with heart failure, has no benefits beyond improvement in symptoms and causes a lot of side effects, so overall it’s used in less than 10% of people and so we really have limited options to improve function in PAD.
“The [issue] is that as PAD progresses, patients go on to get revascularisation procedures to open
arteries and become at high risk for adverse cardiovascular and limb events.”
GLP-1 agonists are a class of medication currently used to treat type 2 diabetes, obesity, kidney disease, cardiovascular disease including atherosclerotic vascular disease and heart failure.
In the trial, 792 people with type 2 diabetes and early-stage symptomatic PAD were enrolled at 112 medical centres in 20 countries. Participants were on average 67 years old, about 25% were women and 67% were white. All were randomly assigned to receive semaglutide (1mg) or placebo for one year (52 weeks).
Researchers assessed maximal walking distance—the maximum distance that patients were able to walk on a treadmill at two miles per hour at a 12% grade (similar to walking up a moderate hill). Function was assessed at baseline (median maximal walk distance was 186 metres), week 26, week 52 (primary endpoint) and week 57 (five weeks after stopping treatment).
“Despite the fact that people were recruited on the basis of reporting early-stage PAD, we observed that they were actually severely impaired and could only walk about one-tenth of a mile with symptom onset significantly earlier,” Bonaca said. “We saw that the drug clearly worked. There was a
clear early benefit at six months that continued to increase at one year.”
Overall, patients in the semaglutide arm had a median improvement in walking distance of 26 metres and an average improvement of 40 metres, representing a statistically significant 13% improvement at one year.
“To put that into context, we usually think an increase in walking distance of 10 metres to 20 metres is clinically important in PAD, so this exceeded
There is more work to be done to understand the mechanism of benefit.”
those expectations,” he said. The results were further supported by confirmatory secondary endpoints showing significant improvements in quality of life (as measured by the Vascular Quality of Life Questionnaire-6 score), including painfree walking distance and sustained improvement in maximal walking distance at five weeks after stopping therapy. Safety was similar to earlier
New study validates BEST-CLI trial results, “suggesting generalisability”
A new propensity-matched analysis of more than 1,100 lower extremity revascularisation procedures carried out in patients with chronic limb-threatening ischaemia (CLTI)—which aimed to help solve the puzzle of why the BEST-CLI trial did not lead to a pick-up in the rate of surgical bypass in the year after its publication— has validated the landmark study’s results, according to the senior author.
THE RETROSPECTIVE REVIEW SHOWED that, like in BEST-CLI cohort 1, the primary outcome measure of major adverse limb events (MALE) and MALE/death was noted to be significantly decreased following a bypass with single-segment great saphenous vein (GSV) as compared to percutaneous transluminal angioplasty with or without stenting at five years (51% vs. 60% and 75% vs. 79%, respectively). “These findings correlated with a 29% and 20% reduction in the aforementioned events,” first author Jeremy Darling (Beth Israel Deaconess Medical Center [BIDMC], Boston, USA) reported as he delivered the findings during the 2025 Society for Clinical Vascular Surgery (SCVS) annual symposium
(29 March–2 April, Austin, USA). And, similar to BEST-CLI cohort 2, in which patients did not have a suitable GSV for conduit, significant differences in MALE and MALE/death were not noted.
The analysis grew out of a prior Vascular Quality Initiative (VQI) study conducted by BIDMC researchers in which they discovered that there had been no increase in bypasses placed for CLTI 12 months on from BEST-CLI, despite the trial demonstrating that surgical bypass with adequate single-segment GSV is a more effective revascularisation strategy in those who are deemed suitable for either an open or endovascular approach. Darling and colleagues, led by Marc
trials, with non-serious gastrointestinal side effects the most reported side effect among patients taking semaglutide.
Patients’ ankle brachial index, a measure of blood flow in the legs, was significantly improved among those taking semaglutide compared with placebo. A post-hoc analysis looking at time to rescue treatment (the need for revascularisation due to worsening symptoms) or death was also lower. Within one year of treatment, patients taking semaglutide had a 54% reduction in their risk of dying or needing a medication or procedure to open blocked arteries in their legs due to worsening symptoms compared with those receiving a placebo (14 patients vs. 30 patients).
“Taken together, the data support semaglutide for people with PAD and type 2 diabetes mellitus as a therapy that has cardiometabolic, cardiovascular and kidney benefits and improves function, symptoms and quality of life,” Bonaca said.
“There is more work to be done to understand the mechanism of benefit as the population had a median [body mass index] of 28.6 and the relationship between the outcome and weight loss was very weak. This coupled with the increase in ankle brachial index really suggests a direct vascular effect. This also raises the question of whether patients with PAD and without type 2 diabetes mellitus could benefit and that should be investigated in future studies.”
The study was limited in that it only included patients who also had type 2 diabetes. In addition, approximately 14% of the study population was enrolled in North America, while 57% was enrolled in Europe and 29% in Asia. As a result, there were few Black patients.
This study was funded by Novo Nordisk.
Schermerhorn, the analysis’ senior author, theorised that the lack of pick-up could have been influenced by specialists not believing that the BEST-CLI results were generalisable. “We were able to mimic cohorts 1 and 2 from the study, we matched all of the outcomes,” explained Schermerhorn in an interview with Vascular News. “All of the proportions are fairly similar to BEST-CLI. We did have more dialysis patients than they had in BEST-CLI, but otherwise it was fairly similar.” The results, he said, validate the differences BEST-CLI demonstrated, with just one exception. “The only thing that they saw in BEST-CLI that we did not see in cohort 1 was the difference in amputation rates, where we had an amputation rate that was just as low in the angioplasty patients as in the bypass patients.”
The correlation “suggests generalisability” of BEST-CLI, Schermerhorn said. “I do think people should re-think their treatment protocol,” he argued. “They should routinely evaluate the saphenous vein before they go to the angiosuite, and that knowledge of whether there is a good single-segment saphenous vein available should have a significant impact on the choice to attempt an endovascular revascularisation, as opposed to going right to bypass.”
Photo by © ACC/Phil McCarten 2025
Marc Bonaca
Reality check: Study brings “significant” gap between randomised and real-world vascular patient populations into sharp focus
Continued from page 1
lead author Kasia Bera (University of Oxford, Oxford, UK) notes that the importance of basing clinical decisions on the best available evidence, and specifically randomised clinical trials, is instilled in medical school. Often, however, she notes that “the evidence doesn’t fit the patient in front of us,” highlighting a gap between the data on paper and the patients presenting in clinical practice.
“It is difficult to know if the evidence we have— and we have some really good evidence in vascular surgery—applies to our patients,” Bera says. “If I see someone in clinic who is diabetic, might be of Asian origin and might be female, I look at the trials and there are just very few patients who are like this.”
Bera posits that the vascular surgery specialty “needs to do better” with regard to making research more representative of the population, which should in turn help clinicians to “make treatment more personalised”.
Proposing some specific recommendations, Bera and colleagues suggest in BJS Open that minimum reporting standards for baseline data should be defined to allow future randomised clinical trials to represent “real-world” patient populations and ensure the external validity of their results.
Bera shares that agreeing on these reporting standards is the “first step” and one that can realistically be achieved within the next year. The next step is awareness, with Bera underlining the importance of ensuring support from funding bodies and journal editors. “There’s a lot of power in a journal saying we’ll only publish your study if you adhere to minimal reporting standards,” she says.
In addition, Bera highlights the need for clinical units to be active in research. She comments that this is something currently done “pretty well” in the UK, before stressing the importance of “making sure everyone in the country has access to a researchactive unit rather than having a few hubs”. The result, Bera suggests, would be that “no matter where you live, you have the option to participate in research,
and that means the whole country is much better represented”.
Taking a step back, Bera is of the opinion that there is a need to look outside of vascular surgery for some “novel ideas” when it comes to improving randomised trial design. For example, she references the success of adaptive platform trials such as the RECOVERY trial conducted during the COVID-19 pandemic, as well as the concept of randomised, embedded, multifactorial adaptive platform (REMAP) trials that are being used in the critical care space.
experience designing trials: “When you conduct a trial, you have to be quite pragmatic in many ways, so I think it’s very easy for someone to say you should have done better, but you always have to make a compromise and ask ‘what can we do?’ and ‘what’s possible?’”
“I think we should really learn from some of these methodologies and use them for our trials to make them even better in the future,” Bera suggests. “I think historically we didn’t have the computational power to do this sort of thing, whereas now we don’t have that excuse, so we should be able to have trials where the default would be for all patients who want to participate having the choice to do so.”
It is difficult to know if the evidence we have— and we have some really good evidence in vascular surgery— applies to our patients.”
Bera also encourages a move away from the laser-focus on randomised clinical trials. While these have long been considered the ‘gold standard’ when it comes to research, Bera stresses the importance of considering registries too, and seeing both as complementary. “We must not see one as better than the other,” she says, suggesting that artificial intelligence (AI) and machine learning will improve both study types in the future, streamlining data collection and allowing for the more targeted recruitment of patients.
Bera is also keen to stress that the intention of the BJS Open paper is not to criticise the design of previously conducted trials, stating that it is important to consider the context in which many of them were set up in order to improve design moving forward. She notes, for example, that some US trials were historically done in veterans, who were more likely to be male. She also shares some insight from first-hand
Fully robotic system shows early promise in endovascular treatment
Ten patients have been successfully treated using a fully robotic system for peripheral endovascular interventions in a first-inhuman (FIH) study of the technology.
PRESENTING THE RESULTS of the ESSENTIAL study of the Sentante system (Sentante) at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK), Dainis Krievins (University of Latvia, Riga, Latvia) remarked on the ease of use and safety of the technology, as well as its association with accurate, radiation-free procedures. “The field of endovascular treatment has seen remarkable progress
since its inception,” Krievins began, highlighting that diagnostics, devices and techniques have all evolved “dramatically” over the years.
“But one thing has remained the same—the way we deliver vascular treatment to the patient,” he continued.
Challenges such as radiation, a growing need for precision, and a shortage of skilled personnel for both acute and elective cases, all need to
“I think trials are getting better, but there’s still a long way to go,” she says.
In the BJS Open paper, Bera and colleagues home in on some randomised clinical trials that are setting new standards regarding representation of demographic and clinical factors, including WARRIORS. This trial, led by a team from Imperial College London (London, UK), is set to assess whether women with small abdominal aortic aneurysms (AAAs) currently are treated too late in their clinical course.
“I think WARRIORS is a great trial because we will actually get some evidence for women, which has been long neglected, and I think looking back often this was probably a pragmatic decision because lots of the vascular surgical conditions are more prominent in men,” Bera comments.
Finally, despite setting out a clear path forward, Bera recognises a notable challenge in the form of there being limited time for research in a healthcare system as “stretched” as the UK National Health Service (NHS). “We have so many pressures and to deliver research alongside clinical work when we all know that clinical work is so important is often difficult,” she says.
However, Bera reiterates the need to see research as a core component of optimal patient care. “We know patients who are in trials get better outcomes,” she notes.
“I think that’s the biggest change in mindset, that we have to make research an important part of care,” Bera says. “We have all these targets, we measure all the time, and I think how good we are at delivering research alongside clinical care should be a key metric we consider because it will make the clinical care better, I think.”
Here Bera suggests that clinical academic pathways for trainees and more support for academic and research delivery alongside clinical work could represent the way forward.
In the nearer term, Bera encourages feedback and discussion. “I think it would be great to hear from others and see what everyone thinks,” she tells Vascular News. “And I think bringing people together in the future is important, so we can actually decide how we can take this forward.”
“If our paper is a starting point [for] a discussion, that would be great.”
be addressed, Krievins told the CX audience. He went on to state that robotic systems might help to solve these problems.
Homing in on the Sentante system, Krievins remarked: “This technology offers a new approach to performing vascular procedures with potential to improve precision, enhance safety and support more consistent outcomes.”
Going into more detail, the presenter noted that the system is compatible with standard off-the-shelf devices and can manipulate up to three devices simultaneously. He added that the system provides a digital recording of every procedure, offers real-time haptic force feedback, and negates the need for radiation.
The ESSENTIAL trial, Krievins
explained, was a single-centre FIH study to evaluate the feasibility of the Sentante system in peripheral endovascular interventions.
Conducted between 19 July and 30 September 2024, the study included 10 patients (7 male, 3 female) with a mean age of 67.1 years.
At CX 2025, Krievins shared primary outcomes of a 100% technical success rate and no adverse or serious adverse events, as well as secondary outcomes of 100% procedural and clinical success and no manual assistance or conversion.
Following Krievins’ presentation, Andrew Holden (Auckland City Hospital, Auckland, New Zealand) demonstrated the use of the Sentante system live from the CX stage.
Kasia Bera
Bioresorbable scaffold technology has “potential to be a new paradigm for femoropopliteal endovascular intervention”
In the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK) peripheral arterial programme, which hosted several podium-first presentations, lower limb drug-eluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI).
Opening the session, Sahil Parikh (Columbia University Medical Center, New York, USA) delivered an economic analysis of the Esprit below-the-knee (BTK) drug-eluting resorbable scaffold (Abbott) in the treatment of patients with CLTI. The two-year results demonstrated superior long-term outcomes for Esprit BTK compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.
Parikh stated that the incremental cost-effectiveness ratio at two years was determined by the difference in total cost divided by the difference in clinically driven target lesion revascularisation (CD-TLR) endpoint failure.
“Esprit BTK showed a lower adjusted event rate compared to PTA [27.5% vs. 49.4% for primary efficacy endpoint; 10.5% vs. 21.6% for CD-TLR] showing a sustained benefit,” Parikh stated. He concluded that use of the Esprit BTK device resulted in US$3,206 per primary efficacy endpoint avoided, and US$6,068 per CD-TLR avoided.
Michel Bosiers (University Hospital Bern, Bern, Switzerland) shared an update on the three-year results of the MOTIV-BTK trial. The trial sought to evaluate the Motiv (Reva Medical) bioresorbable scaffold in 58 patients, the majority with Rutherford 4 or 5 lesions, Bosiers added.
At three years, the speaker reported 99% technical success and 80% primary patency for the Motiv device, with 93% freedom from CD-TLR at three years. Limb salvage at follow-up was 95%, with a recorded 16 deaths, although Bosiers notes that these were not device- or procedure-related.
Presenting one-year EFEMORAL I data, Andrew Holden (Auckland City Hospital, Auckland, New Zealand) shared that the trial has the “lowest [percent of] residual stenosis in any reported study of femoropopliteal intervention”.
EFEMORAL I is a first-in-human trial evaluating the Efemoral scaffold (Efemoral Medical) for the treatment of symptomatic peripheral arterial occlusive
disease from atherosclerosis of the femoropopliteal artery across four sites in Australia and New Zealand. Concerning maintenance of arterial patency, even after scaffold dissolution, Holden reported 100% primary patency and freedom from TLR at three years. He also highlighted sustained improvement in clinical outcome and walking tolerance at follow-up. Among other outcomes, the speaker shared a 0–15% post-procedure residual stenosis and no acute or subacute thrombosis—the lowest ever reported for a femoropopliteal trial. Meanwhile, Holden reported that the mean minimal lumen diameter of 4.74mm recorded at six months was the “highest ever reported”.
This, the largest study of sirolimus drug-eluting balloons in complex peripheral arterial disease patients, is proof that this technology works.”
“This has potential to be a new paradigm for femoropopliteal endovascular intervention,” he added. The peripheral arterial programme also featured a series of podium-first presentations that sought to demonstrate the graduation of devices past ‘proof of patency’, to evidence of their “major clinical benefit” in lower limb arterial intervention for CLTI.
Michael Lichtenberg (Arnsberg Clinic, Arnsberg, Germany) began with the first report of the 12-month SUCCESS-PTA trial data, which evaluated the Selution SLR (Cordis) drug-eluting balloon in patients with CLTI. The trial investigators enrolled 723 patients from 27 sites across Europe, Asia, and South America.
Lichtenberg reported positive 12-month outcomes, including consistent haemodynamic, functional and clinical improvements, with 91.1% freedom from CD-TLR overall, and 90.3% for the CLTI subgroup. Among other outcomes, the speaker reported sustained improvements in ankle-brachial index (ABI), Rutherford classification, and EQ-5D from sixto 12-month follow-up.
“These data continue to demonstrate the consistency of positive results across this new technology, even for patients with severe CLTI,” said Lichtenberg, addressing CX delegates. “This, the largest study of sirolimus drug-eluting balloons in complex peripheral arterial disease patients, is proof that this technology works,” he stated.
Elsewhere in the session, Edward Choke (Northern Heart Hospital Penang, Georgetown, Malaysia) delivered three-year real-world outcomes from the HOPE registry, evaluating MagicTouch (Concept Medical) sirolimus-coated balloon versus plain balloon angioplasty in the below-the- knee (BTK) subgroup.
“At three years, sirolimus-coated balloons were associated with lower BTK interventions,” Choke reported, showing a 76.5% versus 64.9% freedom from TLR for MagicTouch and plain balloon angioplasty, respectively. He added that sirolimus was superior to plain balloon angioplasty regarding amputation-free survival (AFS), showing 60.9% and 47.4% rates, respectively, in the two groups.
“Survival was somewhat surprising,” said Choke, who detailed that, at three years, sirolimus was associated with better survival, hypothesising that this was due to higher rates of reintervention in the plain balloon angioplasty group, and therefore, “in this high-risk and highly frail group of CLTI patients, any procedures done will confer a risk to life”.
Choke ended pragmatically: “This is real-world data, and there are confounders both known and unknown,” he said. “Although sirolimus was associated with better outcomes, we should wait for the final data to emerge in the next one to two years before making definitive conclusions.”
Next, Brian DeRubertis (New York Presbyterian–Weill Cornell Medical Center, New York, USA) shared 12-month amputation and readmission rates between the Eluvia (Boston Scientific) drugeluting stent versus bare device therapies in a large contemporary real-world peripheral arterial disease (PAD) cohort.
He outlined that their evaluation was based on de-identified electronic health records (EHR) which granted his team access to data for approximately 10,000 patients. Of these, the investigators identified 881 patients treated with the Eluvia device and 5,156 treated with the non-drug-eluting device. They found that race and ethnicity distributions differed between groups, with Eluvia being more frequently used in Black and Hispanic patients.
“This is important because these two groups of patients are known to have worse outcomes in the United States in terms of amputation rates,” DeRubertis told the CX audience. Following propensity score matching to “reduce bias associated [with] device selection”, DeRubertis outlined that above-ankle amputation and any readmission within 12 months occurred “significantly more frequently” with non-drug-eluting therapy versus the Eluvia drug-eluting stent.
Considering these results, DeRubertis restated the significance of reducing amputations to “not only save cost to the patient, but to the healthcare system”. Showing a decline in amputation and readmission rates, the speaker confirmed the dual benefit of the drug-eluting stent in saving limbs and reducing the economic burden that major amputation places on global healthcare.
Vascular trauma: CX debate on timing of TEVAR sparks call for “individualised” management
A debate at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK) saw opponents Ian Loftus (St George’s University Hospitals NHS Foundation Trust, London, UK) and Ali Azizzadeh (Cedars-Sinai Medical Center, Los Angeles, USA) agree that personalised imaging and treatment will lead to the best outcomes for patients undergoing thoracic aortic endovascular repair (TEVAR) for blunt traumatic aortic injury.
THE DEBATE FOCUSED ON THE timing of TEVAR, with Loftus speaking for and Azizzadeh against the motion ‘Blunt traumatic aortic injuries need early repair with TEVAR’.
Speaking for the motion, Loftus first emphasised the severity of blunt traumatic aortic injuries. “These are very sick patients,” the presenter stated, sharing that up to 80% die before reaching hospital and 10% rupture in the first 30 hours. He added that the rate of in-hospital mortality is upwards of 40% and that aortic trauma is the second leading cause of adult death in the USA and the first in adolescents after blunt trauma. Loftus also highlighted the fact that patients with blunt aortic trauma tend to present with multiple other injuries, which complicates treatment. “I most often see patients with an aortic injury but with co-existent head injuries and other injuries that make the management of the aorta very difficult,” he said.
Focusing on the literature, Loftus referenced one study—a systematic review from 2023 on early versus delayed TEVAR for blunt traumatic aortic injury—in which short-term mortality was higher in the early TEVAR group, but intensive care unit (ICU) stay was shorter, and there was no difference in postoperative complications. While the study included 4,177 patients across seven studies, Loftus did stress that the review relied on “quite historical” data.
“Our endovascular techniques have moved on considerably in the last five to 10 years,” the presenter went on to remark. “We’re much better at it, we have much better devices.”
only group where it’s recommended to wait and manage conservatively,” he said. “About 75% of cases we see, the recommendations would say now you should consider early intervention.”
Concluding, Loftus summarised that most patients with a blunt traumatic aortic injury have multiple other injuries and that TEVAR is the “gold standard” for intervention, with endovascular technologies and skills continuing to improve. “Contemporary data suggest equivalent outcomes between early and delayed TEVAR,” the presenter said in closing, “with recent guidelines supporting early TEVAR in most patients.”
I actually agree that there are few that need intervention in the first
24
hours
Sharing some contemporary data, Loftus noted that the most recent paper on the topic supports early repair. In the study, which included 1,016 patients treated in the period 2013–2022, Loftus reported that the research team found no association between TEVAR timing and mortality, with comparable odds of any postoperative complications.
Moving on to the guidelines, Loftus homed in on the new 2025 European Society for Vascular Surgery (ESVS) recommendations for vascular trauma management.
“I would stress how important I think these guidelines are, and they’re very helpful in this area,” Loftus commented. The presenter went on to note that these guidelines advise not to operate in grade 1 injuries in stable patients without significant brain injury. “That is the
[clinical practice guidelines]”. Finally, Azizzadeh shared the results of a retrospective review of the National Trauma Data Bank registry, which involved 2,821 patients with blunt traumatic injury and found a significant mortality benefit for delayed TEVAR. Specifically, the presenter noted that TEVAR within 24 hours was associated with a 9.8% mortality rate, compared to a 4.4% rate with TEVAR after 24 hours.
Regarding guidelines, Azizzadeh called into question the grading system used in the new ESVS recommendations mentioned by Loftus. Azizzadeh remarked: “I do not understand the rationale for combining grade 1 and 2. As I read the paper, the new grade 1 is defined as ‘injury confined to the intima or vessel wall with normal external wall contour’ and if you take a look at the grade 2, it involves the media and there is external wall contour abnormality.”
Concluding, Azizzadeh stressed that blunt traumatic aortic injury represents a “spectrum of injuries,” with prognosis and management varying by grade. Referencing the original grading system adopted by the Society for
“Significant
evidence” to support delayed TEVAR
Putting forward an argument against the motion, Azizzadeh focused on the “significant evidence” that has been accumulated in this area since 2011.
The presenter first showed a metaanalysis from the Eastern Association for the Surgery of Trauma, which concluded: “In patients diagnosed with BTAI [blunt traumatic aortic injury], we suggest delayed repair.”
Azizzadeh then referenced a singlecentre study that found “watchful waiting may be permissible in patients with grade 3 BAI [blunt aortic injury] with other associated multisystem trauma,” which the authors note “ allows for a repair in a more controlled environment”.
The speaker then shared the outcomes of a study from the National Inpatient Sample (NIS), which he said, “really put the nail in the coffin for early repair”. This study found that “delayed TEVAR was associated with significantly reduced mortality” and highlighted “a need for critical appraisal and clarification of existing CPG
More data needed
During discussion time, Loftus scrutinised the question at the centre of the debate. “It depends on what you define as early,” he said. “I actually agree that there are few patients that need intervention in that first 24 hours. The big question is that next 24 hours […] and I do think that we need to be more open to treat more of these individuals, if anything to take out the uncertainty of that injury amongst the other injuries that are present, especially with the neurological injuries.”
Azizzadeh reiterated a point made earlier in the debate that it is common for these patients to present with multiple injuries, which necessitates a personalised approach to management not based solely around timing. “These injuries don’t occur in a vacuum,” he said. “A lot of these patients have concomitant injuries, some of which are more severe and require more urgent therapy […] so I think the treatment has to be individualised based on the patient, but there’s definitely data to support delayed repair for patients who have stable injuries.”
Session anchor Ross Davenport (Barts Health NHS Trust and Queen Mary University of London, London, UK) asked a question about the timing of imaging in these patients, which shone a light on a lack of data in this area.
The big question is that next
24 hours
These injuries don’t occur in a vacuum. A lot of these patients have concomitant injuries, some of which are more severe and require more urgent therapy.”
Ali Azizzadeh
Vascular Surgery (SVS) since 2011, he suggested that, based on the available evidence, non-operative management is appropriate for most grade 1 and 2 injuries without traumatic brain injury, delayed TEVAR is appropriate for most grade 3, and urgent TEVAR should be used for unstable and high-risk grade 3 as well all grade 4 injuries.
“The ESVS guidelines I think have done a great job in highlighting the lack of evidence here,” Loftus remarked. He noted that one of the main unmet needs in terms of evidence, as listed in the guidelines, is indeed surveillance, both before and after operating.
Also contributing to the imaging part of the discussion, CX co-chair Dittmar Böckler (University Hospital of Heidelberg, Heidelberg, Germany) commented: “At the end of the day— or the night—it’s all about imaging, because you’re grading your patients.” He then asked, “Do we really have good imaging 24/7 to make the decision, grade 1, 2, 3, 4, and then do delayed or early treatment?” Azizzadeh responded: “With advancements in imaging, the CTAs [computed tomography angiograms] are very accurate and it is very uncommon for a patient not to have a CTA in their first 15 minutes of arrival in the trauma bay, so that has not been an issue in our centre.”
Loftus concurred but also reiterated a need for more data. “I agree, I think the CT imaging is very good, but a lot of the things that are now being labelled as ‘high risk factors’ […] are actually really difficult to quantify […] so I think the imaging, although vital, I totally agree with my opponent that this needs to be part of a much broader, individualised approach to management, and we need to be much more scientific about it by getting much better data.”
Polling revealed that 74% of the audience sided with Azizzadeh, voting against the motion that early TEVAR is better than delayed repair for blunt traumatic aortic injury.
IAN LOFTUS
From Brazil to Baylor: Oderich assumes
coveted role at cardiovascular “powerhouse”
Following in the footsteps of some of the pioneers of cardiovascular surgery, Gustavo Oderich recently stepped into position as the Michael E DeBakey distinguished chair in surgery, professor of surgery, chief of vascular and endovascular surgery and director for the Center for Aortic Surgery at Baylor College of Medicine and Texas Heart Institute in Houston, USA. Steeped in history, the Baylor and Texas Heart Institute names add to an already illustrious career for Oderich that has crossed countries and climates.
From medical school in Brazil through the Mayo Clinic in Rochester, USA, to his most recent post at the University of Texas (UT) Houston, Oderich has followed in the pioneering footsteps of some of vascular surgery’s most noted forefathers. Now, he has landed at the place where two of its finest— Michael E DeBakey, the name behind his distinguished chairmanship, and Denton Cooley—minted Houston’s status as a cardiovascular powerhouse. In this interview, Oderich tells Vascular News what the Baylor College of Medicine and Texas Heart Institute legacy means to him and the mark he hopes to make through his clinical and research endeavours.
VN: Baylor represents the holy grail of US if not world cardiovascular surgery through its association with the likes of pioneers such as DeBakey and Cooley. What does their legacy mean to you?
GO: I think it’s a privilege and honour to work at the Baylor College of Medicine and Texas Heart Institute. I’m very much attached to the legacy of these giants and what has been accomplished here during the last century. In terms of cardiovascular surgery, Baylor College of Medicine and Texas Heart Institute have consistently been a powerhouse and a lot of the things we do nowadays started here in the late 1950s with the work of Drs DeBakey, Cooley, and subsequentially E Stanley Crawford and Joseph Coselli, among so many other prominent surgeons. I am so grateful for the work of Joseph Mills, our immediate past chief of vascular surgery at Baylor, who successfully established the Division of Vascular Surgery and Endovascular Therapy in the institution. The aorta is where I spend most of my time clinically and is also the focus of my research, so working in the place where the first of these operations were performed, where modern aortic surgery was really invented, is an incredible honour. It is an honour beyond anything I
could have imagined holding the title of inaugural Michael E DeBakey distinguished chair in surgery. Dr DeBakey was arguably one of the most accomplished and influential surgeons the world has ever seen.
VN: What do you hope to bring to the Michael E DeBakey Department of Surgery at Baylor?
GO: The department has 280 full-time faculty and 18 divisions or sections, and under the leadership of Todd Rosengart, has seen the number of clinical cases, research grants, scientists, and high-impact publications skyrocket over the last decade. Dr Rosengart was able to show me a clear vision of what we could accomplish at Baylor College of Medicine and Texas Heart Institute, which I was most excited to learn in the interview process.
Baylor College of Medicine has played a leading role in contemporary complex open surgical aortic repair, largely due to the massive experience of Dr Coselli and remarkable improvements in clinical outcomes. Yet, the endovascular aortic programme had not yet been fully developed into a premier advanced endovascular programme capable of handling most complex cases and leading future developments in this field. That’s the know-how that I can bring to the department, in addition to continuing to advance the work of Dr Mills. The way I see it, Drs DeBakey, Cooley, Crawford and Coselli climbed a huge mountain, they wrote many chapters and formed the foundations for what we do today; I’m here to continue this climb, write new chapters, as well as preserve, maintain and be loyal to the work that they have done.
As with any move, you have to step backwards to go forwards, and I am in that phase now. We are trying to improve efficiency, create a new workflow, change the infrastructure and establish a comprehensive aortic centre that is inclusive of vascular and cardiac surgery, among other specialties. We
know not a single specialty has all the expertise to tackle all aspects of aortic care. We also need cutting-edge imaging and access to device pipeline. I am also working on the implementation of our research programme, which is quite comprehensive and includes the investigational device exemptions, US Aortic Research Consortium (ARC) and International Multicentre Aortic Research Group (IMARG). Once we establish the whole programme, which I intend to do soon, we will go forward, fast and far.
I do think that there is going to be need for centralisation because medicine is becoming hyper specialised.”
VN: We have seen you go from the Mayo Clinic to UT Houston and now Baylor. Could you speak a bit about these career moves?
GO: I’m originally from Brazil and finished my medical school there in 1995. However, after completing two years of surgery in the country, it became clear to me that I wanted to advance my career and become involved in academic surgery and complex endovascular techniques. I realised this would be very difficult to accomplish in Brazil at that time. I was very fortunate to be accepted for general surgery and vascular
training at the Mayo Clinic in the late 1990s and to join their faculty in 2006. Becoming a Mayo surgeon was the highest accolade of my career; only a few are cut for true Mayo surgeon definition. At Mayo, I was trained to be a ‘navy seal’ of open surgical vascular surgery. Later, working with Roy Greenberg, Dan Clair and colleagues at the Cleveland Clinic [Cleveland, USA], I perfected endovascular skills and broadened my horizons to complex endovascular work. At Mayo I witnessed a place that went from offering traditional, classic open surgery, to a hub of advanced endovascular surgery. To give you an idea of the scale of the shift, when I started at Mayo, we were in one or two device trials; when I left, we were in 26. For most of those, we were the number one enroller.
Mayo is the best hospital in the world; it has mastered clinical practice and is very patient focused. But I am a native of Brazil and, culturally, it was very difficult to live in the Midwest. And the weather—if you imagine cold, you don’t know what cold is. We had a polar vortex more than one time, and it’s a very long winter. There are two seasons in Rochester: July and winter. UT offered a great opportunity, but there was not a complex endovascular programme and so I had several concerns. One of them was whether I
Gustavo Oderich (top) and Michael E DeBakey (above)
could reproduce our outcomes from Mayo at UT but I soon learned that we could. And I learned that it’s not only about the surgeon, but also about the team and the infrastructure. We created all that at UT and, in fact, recently published our outcomes, with a 1% mortality for thoracoabdominal aortic aneurysms (TAAAs) both at Mayo and UT among over 600 patients. I now have to reproduce that here at Baylor, but I’m confident we can do it.
I probably could have stayed at UT forever, but I was teased by Dr Rosengart and the stellar Baylor faculty with the carrot of carrying forward the legacy of giants like DeBakey, Cooley, Crawford and Coselli, of which I was very fond and is one of the main reasons I decided to leave UT.
VN: Homing in on your current work, you are at the forefront of endovascular advancements and pushing the envelope with complex devices through the US ARC. What is some of the key evidence that has been coming out of this project?
GO: I was part of the American Heart Association (AHA) writing committee for guidelines on the management of aortic diseases, which were published in 2022. When we started discussions for how to treat TAAAs, complex endovascular repair was not even on the radar of several members of the writing committee. There were several reasons for this, mostly due to the fact that the body of literature was all single-centre experiences, with short follow-up, plagued by reinterventions and by limited access to devices. In fact, there was no commercially approved device for TAAAs in the
USA at the time. All that changed with the ARC. Offering probably the highest level of evidence for complex aortic work, this is a prospective, monitored and adjudicated registry of ten ongoing prospective, nonrandomised, physician-sponsored device exemption studies that annually report outcomes to the US Food and Drug Administration (FDA). The 10 physicians involved are at the top of their game and have well overcome the learning curve. I think it shows the world what can be done when you have an experienced team, centralisation, skill, access to technology and volume, and the work is remarkable.
Some of our most important work to date was published last year in Circulation. This was a series of over 1,100 elective thoracoabdominal aortic repairs with a mortality of 2.7%. That is a three-fold reduction in early mortality compared to the best open surgical series of a single centre and about a five-fold reduction on large data from Medicare.
VN: What’s next for ARC?
GO: There is a lot of room for improvement. There are still many patients who die from other non-aortic diseases and reintervention rates remain an issue. That’s where I think new research has to focus.
Looking to the future, ARC 2.0 is going to be when we have all the digital and clinical data immediately available at our fingertips so that we can use artificial intelligence (AI) algorithms to look at phenotypes of patients to plan appropriate procedures and assess likely outcomes.
There will be several challenges when we reach this stage, including
HIPAA [Health Insurance Portability and Accountability Act]. This currently prevents us from having access to many aspects of personalised data points, such as dates for example, which are needed for time-dependent outcomes. Also, we don’t have easy access to imaging or other personalised data, and given we’re moving towards personalised medicine, that’s going to be a big challenge.
VN: Can you talk a little more about some of the work that’s being done on the journey toward precision care?
GO: AI will be used in the entire patient experience from preoperative diagnosis to treatment planning, operation, postoperative care and surveillance. We could talk about several examples. Randy Moore’s work with the ViTAA Medical technology is certainly landmark, but it does involve access to very detailed imaging data from patients, which is something we have to work on—how we make data-sharing and image-sharing agreements between centres more streamlined. I’m working now with the IMARG, which has 30 sites worldwide and is going to be the United Nations version of the US ARC for the entire world, but it’s a mountain of work to make all the countries and regulatory agencies happy.
I’m also very enthusiastic about the work of David Murdock and Dianna Milewicz at UT with facial phenotypes. Basically, this would involve taking a photograph of the patient and knowing with extreme accuracy whether they have LoeysDietz syndrome or Marfan syndrome, or in fact any genetic disorder. That is going to be very important
Oderich points to “bright future” for vascular surgeons in memorial lecture for CX founder
This year’s Charing Cross (CX) Symposium (23–25 April, London, UK) hosted the first annual Roger M Greenhalgh Memorial Lecture, recognising the legacy of the meeting’s founding chair. Delivering the inaugural lecture was Gustavo Oderich (Baylor College of Medicine, Houston, USA), who addressed 21st century challenges in aortic education, innovation and evidence.
“I THINK THAT VASCULAR SURGEONS OF the 21st century face a bright future with numerous opportunities, new endovascular approaches, AI [artificial intelligence]-powered clinical pathways, research and education tools,” Oderich concluded at CX 2025.
The presenter added that centralisation “must be a high priority” moving forward and is something that will have to be enforced by both governments and scientific societies. He noted that this “will be tied to changes in the education curriculum to train the next generation of complex open and endovascular surgeons”.
Oderich took questions following his lecture, first from moderator Tilo Kölbel (University Heart Center Hamburg, Hamburg, Germany) was keen to know how
aortic devices might change in the future, noting they have “not changed much” over the course of the past two decades.
Oderich’s response first looked beyond physical devices. “I’m sure we’re going to start seeing some medical therapy to try to slow down progression of
We will have the ability to predict the fate of the patient’s aorta early on and alter that with medical therapy.”
because these patients show up in the emergency department and you don’t have time to take the DNA and check whether they have a genetic condition. You need to know right away.
There’s lots of work being done with digital twins too to predict how the anatomy is going to relate to an outcome, which is similar to the work of Randy Moore, but a bit different.
VN: Taking a step back, vascular surgery has been defined by several ‘revolutions’, from becoming its own specialty to the emergence of endovascular therapy. What is the next revolution?
GO: I think that what we foresee in the future is a combination of a lot of work on AI algorithms that will make things more personalised, more accurate, faster, simpler, more efficient, and will allow us to better select patients and have better outcomes. I do think that there is going to be need for centralisation because medicine is becoming hyper specialised. Both the minimally invasive as well as the open surgical parts of it are becoming extremely difficult, and that means a group of physicians must be able to do those procedures. Also, we need to move away from using radiation and I think that, hopefully, we’re going to see more options aside from this initial phase that we already have. We have Philips’ Fiber Optic RealShape (FORS) technology, we have Centerline Biomedical’s IntraOperative Positioning System (IOPS), but we need to go to the next level where this is seamless, can be used in a larger portion of the procedure, and is more effective.
disease, coupled with genetic precision medicine to identify patients at risk,” he said.
In addition to this, Oderich stressed that there are some areas that need attention when it comes to medical device development. He mentioned aneurysm sac management in particular. “I think that sac management should be a focus area, and I’m glad to see the attraction of industry to that,” he noted.
Oderich also shared that “we still use rather rudimentary materials—fabric, stents—which don’t really incorporate into the aortic tissue,” going on to wonder what the role of regenerative medicine in the future might be to improve this aspect of devices.
Another question came from Richard Gibbs (Imperial College Healthcare NHS Trust, London, UK), on what future technological developments such as genomic medicine and drug therapies will mean for vascular surgeons’ role in patient care. “Is there going to be a day when all of us in here are redundant?” he queried.
“I don’t know,” Oderich replied. “I imagine that it’s going to get very close to what you’re saying, that we will have the ability to predict the fate of the patient’s aorta early on and alter that with medical therapy. I’m not sure that it’s going to be down to zero, but we’re already seeing the numbers are decreasing in the order of 30/40% in the last seven years, and that’s probably going to decrease further in another 10 years, which is going to be a challenge.”
“Bringing communities together is what is at the core of CX Aortic Live”
Building on the success of 2024, CX Aortic Live 2025 (11–12 November, Vienna, Austria) will bring together a multidisciplinary global faculty to share the latest techniques and technologies in open, hybrid and endovascular aortic care.
CX AORTIC LIVE IS THE ONLY GLOBAL meeting dedicated exclusively to the standalone aorta—from the valve to the iliac arteries. The CX Aortic community welcomes all who manage the aorta, bringing together cardiac aortic, cardiothoracic, vascular, interventional, and radiological specialists in a multidisciplinary environment.
At the recent 2025 Charing Cross (CX) Symposium (23–25 April, London, UK), course directors Tilo Kölbel (University Heart Center Hamburg, Hamburg, Germany) and Robin Heijmen (Radboud University, Nijmegen, The Netherlands) spoke to Vascular News about what delegates can expect from this year’s meeting.
Inaugural Edinburgh Aortic Summit to showcase “the old, the new and the future”
Orwa Falah (Edinburgh Royal Infirmary, Edinburgh, UK), chair of the Edinburgh Aortic Summit (EAS), speaks to Vascular News ahead of this year’s inaugural meeting.
FALAH EXPLAINS THAT EAS 2025, set to be held 12–13 June in Edinburgh, UK, aims to bring together specialists from vascular surgery, cardiac surgery, anaesthesia, and interventional radiology to discuss “the old, the new and the future” in aortic care. This will involve highlighting advancements in complex endovascular aortic intervention and exploring future developments in aortic care, while also recognising the continued importance of open surgical techniques.
Opening the meeting, Orwa will share insights from the Scottish National Service for Aortic Arch,
Kölbel, who was codirector of the inaugural meeting last year and ran its Hamburg-based predecessor Aortic Live for several years prior, introduced Heijmen as a new member of the leadership team for the 2025 iteration of the event. Kölbel remarked: “[Heijmen] focuses on aortic disease, and he will bring a cardiosurgical perspective to the meeting.”
Speaking on one of the core and unique
elements of CX Aortic Live, Heijmen remarked on the central importance of bringing together all specialties involved in the management of aortic disease.
“I think we should all realise that we are all treating the same patient with the same pathology, but from a different viewpoint, whether you’re a radiologist, a vascular surgeon or a cardiac surgeon,” he said. “I think the patient may benefit most if we bring all these expertise together to discuss the alternative options that exist, learn from each other, see what the pros and cons are of an open surgical versus an endovascular approach, and as always, the truth is usually in the middle.”
In addition, Heijmen highlighted the benefits of listening to the views and experiences of other specialties in the interest of best patient care. “There are a lot of meetings that we go to separately, and you discuss your endovascular ways, we discuss our open surgical ways,” he said, “but I think the goal for CX Aortic Live is that we bring it all together and we learn and listen to each other about all the
Thoracoabdominal and Suprarenal Aneurysms, which is based at the Edinburgh Royal Infirmary.
Falah explains that the service, for which he is lead clinician, was established in 2001, at which point it offered only complex open aortic surgery. Since then, the service has evolved to offer all modalities of treatment for the aortic organ within a single, dedicated national programme— including complex open (frozen elephant trunk; FET) and complex endovascular aortic arch pathology treatment, thoracic endovascular aortic repair (TEVAR) and, since 2017, fenestrated and branched endovascular aneurysm repair (F/BEVAR), innerbranched technology, and hybrid treatment, including the new Thoracoflo (Terumo Aortic) hybrid technology. Orwa notes that the service has grown from 18 cases per year in 2001 to approximately 60 cases annually across all treatment modalities. Outcome data have been collected since the service’s inception and are published in the public domain.
options, because there are so many options available nowadays, it’s getting pretty difficult to choose.”
Kölbel concurred, opining that “bringing communities together is what is at the core of CX Aortic Live”.
“Half of the podium time is reserved for live cases”
The format of CX Aortic Live is another feature that makes it stand out, Kölbel added. “We have live cases and edited cases most of the time,” he shared, noting that half of the podium time is reserved for live cases and discussing the specific techniques and anatomies that the live operators are treating. “There’s no meeting in the world that I’m aware of that does that.”
“CX Aortic Live is the platform where we get the opportunity not only to discuss the evidence […] but really help each other understand what one operator does differently to another and, most importantly, why.”
Heijmen added that a large portion of time is also spent on discussion, which he noted is key to learning. “You learn most from discussing, hearing discussions, interacting in the discussions,” he said.
Heijmen went on to note that the discussion at CX Aortic Live is inclusive of physicians practising at all levels. “There are no stupid questions,” he said, encouraging delegates to get involved regardless of their experience. “We’ve all had the same learning curve at the beginning, and sometimes we forget and discuss at too high and complex a level, but we forget about the audience. We’re really focusing at CX Aortic Live on bringing everybody together, whether you’re experienced or not.”
On some of the topics that will be covered at the meeting, Heijmen detailed that the sessions will cover the aortic arch, the thoracoabdominal and the infrarenal aorta, as well as the root and the ascending aorta, noting this is currently a hot topic in the space.
setup at the Edinburgh Royal Infirmary.
Orwa highlights that EAS 2025 is centred around the concept of the aorta as ‘the 24th organ’, as defined by Martin Czerny (University Heart Center Freiburg–Bad Krozingen, Freiburg, Germany) and colleagues in the 2024 European Association for CardioThoracic Surgery (EACTS) and Society of Thoracic Surgeons (STS) guidelines. Czerny will deliver a keynote on these guidelines during the first day of the meeting.
“The aorta has always been treated in bits and pieces, with interventionists not thinking about what impact the intervention they do will have on future interventions,” Falah remarks. “A multidisciplinary team needs to be involved in the aorta, with the specialties engaged in its treatment making decisions together to ensure the patient journey is as smooth as possible and that patients achieve better outcomes.”
In particular, Falah references a presentation by Stéphan Haulon (Université Paris-Saclay and Hôpital Marie Lannelongue, GHPSJ, Paris, France) on new developments in F/ BEVAR for thoracoabdominal aortic aneurysm repair, including the latest insights on bridging stents. Elsewhere, Germano Melissano (“Vita-Salute” San Raffaele University of Milan, Milan, Italy) will deliver a keynote lecture on the history of aortic surgery; there will be a full session dedicated to the patient voice, including a presentation from THINK AORTA campaign leader Gareth Owens; and the meeting will close with a forwardlooking session on artificial intelligence (AI) and robotics, featuring a talk from Alan Lumsden (Houston Methodist DeBakey Heart & Vascular Center, Houston, USA).
“This is the jewel in the crown of the Scottish vascular and cardiac intervention service, and we need to recognise this,” Falah comments, underlining the inception of the EAS as a way to share insights from this “unique”
He adds: “With the recognition of the aorta as an organ in its own right comes more focused treatment—involving multidisciplinary collaboration and more specialised, rather than haphazard, care.”
Over the course of EAS 2025, there will be sessions on complex open, complex endovascular, and hybrid approaches to aortic treatment.
With the recognition of the aorta as an organ in its own right comes more focused treatment.”
Orwa Falah
Stroke rates see no change with CO flushing in TEVAR and TAVI
Flushing transcatheter aortic valve implantation (TAVI) valves and stent grafts for thoracic endovascular aortic repair (TEVAR) with CO2 prior to their implantation is a technique that has been thought to offer promise in stroke reduction, with the rationale that this will reduce the amount of air emboli that is released during the procedure and potentially limit cerebral damage. Findings from two studies investigating CO2 flushing in TEVAR and TAVI were shared at the recent Charing Cross (CX) Symposium (23–25 April, London, UK).
“IN RECENT YEARS, MANY centres have started using carbon dioxide flushing as a more effective way to de-air the stent grafts in order to reduce cerebral air embolisation. Really that was the stimulus for the intervention with cerebral embolic protection trials in both TEVAR and TAVI,” said Lydia Hanna (Royal Holloway University of London, London, UK), an investigator in the INTERCEPTevar and INTERCEPTavi trials at CX 2025.
The research was designed to test
the hypothesis that CO2 flushing of aortic valves could reduce cerebral air embolisation and cerebral infarcts in diffusion-weighted magnetic resonance imaging (DW-MRI), and whether this could potentially result in improved clinical outcomes when compared with standard saline flushing of the valves.
Hanna revealed that though the results of both trials showed a trend towards a reduction in neurological injury amongst the patients who received CO2 flushing, crucially there was no overall difference in
rates of stroke.
“Because you don’t see a difference in clinical strokes here, and with the recent publication of the findings of the Sentinel device in TAVI—which showed no difference in clinical stroke—is this field still alive in the TAVI world?” session moderator Nimesh Desai (Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA) asked Hanna in response to the findings.
Hanna responded that adequately identifying and defining stroke makes it difficult to study as a hard outcome in trials and that understanding the
There is still much more that we don’t know—in particular how we define stroke.”
Multicentre data show favourable role for FEVAR over chimney grafts
A multi-institutional analysis has demonstrated fenestrated endovascular aneurysm repair (FEVAR) could be a “safer and more durable option” than chimney EVAR (ChEVAR) in elective juxtarenal abdominal aortic aneurysm (AAA) cases with suitable anatomy, offering potentially “greater generalisability to real-world practice.”
CHEVAR WAS ASSOCIATED WITH significantly higher rates of type I endoleak and reintervention than FEVAR in a study of juxtarenal AAA cases carried out at five geographically distinct institutions with high-volume centres, the 2025 Society for Clinical Vascular Surgery (SCVS) annual symposium (29 March–2 April, Austin, USA) heard. In addition, FEVAR patients demonstrated significant sac regression, while those undergoing ChEVAR showed “a concerning trend” of early sac regression followed by late re-expansion. The study data were delivered by Clayton Brinster (UChicago Medicine, Chicago, USA).
Each centre enrolled at least 25 consecutive cases of FEVAR and/or ChEVAR, Brinster explained. Some 130 cases were analysed in total: 77 FEVAR and 53 ChEVAR. Significantly more patients in the ChEVAR group had persistent type I endoleak at one year—15 of the 53 patients, or 28%—vs. 6/77, or 7.8%, following FEVAR. Ten reinterventions were required in 8 of 77 (10.4%) FEVAR patients vs. 20 reinterventions in 16 of 53 (30.2%) ChEVAR patients. Significant sac regression was seen at 12 months (55mm, -7mm) and 24 months (51mm, -11mm) following FEVAR, Brinster told SCVS 2025. Sac regression was not significant at 12 months (59mm, -5mm) following ChEVAR, and sac re-expansion was observed in this group between 12 and 24 months (59 to 63mm, +4mm), he added.
Speaking to Vascular News ahead of the meeting, Brinster said the multi-institutional consortium behind the data was started four years ago and sought to elucidate granular institutional data on two widely used techniques.
“Although FEVAR and ChEVAR have both been around now for over a decade, there is a lack of granular institutional data,” he explained. “There have been maybe five or six solo institutional studies that incorporate some degree of parallel stenting versus FEVAR, but most include a comparison to open surgery or branched devices, or PMEGs [physician-modified endografts], so the data are not so clean. Besides that, it’s really just registry data with short-term follow-up.”
Brinster said the consortium’s strength is not only rooted in the fact it is regionally diverse, but it has also produced “granular institutional data”.
Significantly more patients in the ChEVAR group had persistent type I endoleak at one year
The medical centres involved include the University of Chicago, Ochsner Health (New Orleans, USA), NYU Langone Medical Center (New York, USA), the Mayo Clinic (Scottsdale, USA), and the University of Rochester (Rochester, USA). “The data is therefore perhaps more generalisable to other institutions,” he continued. “It offers that advantage
impact of cerebral injury in the long term will be important in assessing the efficacy of this intervention in improving outcomes for patients.
“It is a really interesting question, and there is still much more that we don’t know—in particular how we define stroke. Most of these trials have not had a neurologist to examine the patients, and that is the problem with how we define stroke and how we look for it, or how hard we look for it. It is definitely still relevant,” she said. “I think stroke is obviously clinically important and we have much to learn about that, but in terms of the impact of the cerebral injury that is visible in MRI scans it is a concern that with all that happens to the brain, we don’t follow the patients for long enough to understand the impact of this for the long term.”
Further analysis is being done by the INTERCEPTevar and INTERCEPTavi team to assess quality-of-life data, sixmonth MRI findings, and to correlate the effect of brain injury with the neurocognitive data, Hanna revealed.
when compared to either national registry data or the US Aortic Research Consortium, because those are very sophisticated surgeons at the very best centers with the very best imaging, with carefully selected patients in general.”
Brinster said that some may argue the fact there were more endoleaks and reinterventions with ChEVAR was “a foregone conclusion,” but noted that there are many surgeons in the field who are experienced with parallel grafting and produce good results. In effect, the study aimed to answer— “for once and for all”—which of the two techniques is better.
“With fenestrated grafting, there are anatomic constraints, and many patients fall outside the IFU [instructions for use],” he said. “ChEVAR has both the advantage of possibly being able to treat those patients and the disadvantage that inherently those patients are more anatomically complex and more prone, perhaps, to gutter leak, endoleak and reintervention.”
Looking into sac behavior, Brinster pointed out the “unexpected” finding of FEVAR inducing sac regression. In the early stage, he said, ChEVAR induced sac regression, “but when we looked out to two years, there was a statistically significant increase in sac size, and that is particularly concerning.”
“I wanted to look into this because it has become an increasingly hot topic in our field,” he added. “It has been linked to late rupture, late intervention and late mortality after EVAR. There are some data out there looking at those outcomes for standard EVAR, but they only go out to one year in those studies—and it is registry data. There are two industry-sponsored registries looking at sac behavior after EVAR at one, three and five years, and that was the basis whereby now Medtronic can firmly recommend endoanchors, or ESAR [endosuture aneurysm repair], in certain anatomic circumstances to improve late outcomes by inducing sac regression. The main pinnacle there was that even stable sac size over time was linked to late poor outcomes.”
Lydia Hanna
Sirolimus implant fails to meet fistula maturation endpoint in ACCESS 2 trial
Results of the ACCESS 2 study, evaluating arteriovenous fistula (AVF) outcomes following use of the Sirogen (Vascular Therapies) sirolimus-eluting collagen implant, have shown that the device failed to meet non-inferiority for clinical fistula maturation compared to control at six months.
NICHOLAS INSTON (QUEEN ELIZABETH Hospital Birmingham, Birmingham, UK) delivered the results in a podium-first presentation at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK)—where he commented that the trial’s failure to meet its primary endpoint may be attributable to the overperformance of the standardof-care arm against expectations.
Sirogen was developed as a means of intraoperative local, perivascular drug delivery at the time of index AVF surgery to improve outcomes in patients requiring an AVF. The device consists of a sirolimus and collagen matrix for targeted local drug delivery, which is bioabsorbable within 12 weeks.
secondary patency in patients with end-stage renal disease aged ≥65 years.
Investigators went on to initiate the ACCESS 2 study to validate these findings and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AVF. The multicentre randomised study enrolled 136 patients across 17 centres in the USA and the UK, with a primary endpoint of fistula maturation at six months.
Despite an earlier randomised prospective multicentre study—ACCESS—showing no statistical difference between Sirogen and controls in prespecified endpoints, post-hoc analysis from the trial showed improved fistula maturation and
Inston reported that 66.8% of patients in ACCESS 2’s Sirogen arm achieved clinical fistula maturation compared to 63.2% in the control— representing a 3.6% point improvement—but falling short of the 18% point improvement goal set for the trial. Comparing against past studies, Inston said that Sirogen performed largely in line with previously observed results, but the performance of the control arm versus historical benchmarks ultimately tipped the dial towards primary endpoint failure.
WAVE trial discussion at CX probes cost benefit of
Wrapsody
Following a presentation on the 12-month WAVE trial results at CX 2025, discussion turned to the cost benefit of the device in question.
The WAVE trial is a multicentre, international, investigational device exemption (IDE) trial designed to evaluate the Wrapsody (Merit Medical) cell-impermeable endoprosthesis (CIE)’s safety and efficacy over two years. Presenting the results at CX 2025 was Robert Jones (Queen Elizabeth Hospital Birmingham, Birmingham, UK), who summarised findings presented for the first time earlier this year.
In the native arteriovenous fistula (AVF) randomised cohort of the study, Jones shared that Wrapsody was found to exhibit superior 12-month target lesion primary patency versus percutaneous transluminal angioplasty (PTA; 70.1 vs. 41.6%) and significantly higher 12-month access circuit primary patency versus PTA (58.1% vs. 34.3%). In the arteriovenous graft (AVG) single-arm cohort, he noted that the 12-month target lesion primary patency for Wrapsody was 60.2%, with the device exhibiting 36.2% access circuit primary patency through 12 months. “The 12-month analysis provides important insight regarding Wrapsody’s anticipated long-term performance,” Jones concluded, noting that data summarising 24-month outcomes will be forthcoming.
In the discussion following Jones’ presentation, Narayan Karunanithy (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) highlighted one of the main findings: “You’re only preventing a third of [patients receiving a graft] getting an intervention out to a year.” He went on to ask whether the study team has conducted a cost-benefit analysis on that result. Jones responded that a costbenefit analysis has not yet been carried out but would be of value and that it is “on the radar” moving forward.
“Unfortunately, we failed to meet the primary endpoint here and it is really due to this freaky outcome from the control group rather than anything else,” Inston said. “It is quite reassuring that the sirolimus group has performed as it has in all the other studies.”
Trial participants saw a 10-day mean time to functional maturation improvement; however, Inston said that a study involving thousands of patients would be required to study this outcome properly.
The trial remains blinded, with 12-month secondary endpoint data collection still in progress, and secondary endpoints, which include time to first dialysis, fistula suitability for dialysis and secondary patency, may provide additional important insights, according to Inston. “I think these might actually be more important than this simple primary endpoint. There will be number of interventions raised to get there, how will these be done, what type of interventions are required to keep this group going,” he explained.
“This result questions whether strict trial design represents real-world experience,” Inston told Vascular News in summing up his appraisal of the trial. See page 1 for more on trial design
This result questions whether strict trial design represents real-world experience.”
“What’s next?”: Podium-first Ellipsys registry data revealed as device leaves market
A retrospective, single-centre study of 1,000 patients has demonstrated an 84.6% rate of successful arteriovenous fistula (AVF) maturation with a mean time to maturation of 9.9±9.7 weeks using the Ellipsys vascular access system (Medtronic). But with the device leaving the market, questions remain around what is next for innovation in the vascular access space.
PRESENTING DURING THE VASCULAR ACCESS SESSION AT CX 2025, Rashid Sharaf (Star Vascular Access Center, San Antonio, USA) shared real-world endovascular AVF (endoAVF) outcomes from 1,000 patients included in the STAR Ellipsys registry who had at least one year of follow-up data available.
The objective of the registry was to evaluate creation of native AVF in the upper extremity using the Ellipsys system in an all-comers population, with the primary endpoint being successful creation of a fistula and time to maturation.
Addressing the CX 2025 audience, Sharaf stated that there is an unmet need in end-stage kidney disease (ESKD) patients for better technologies for access creation, maintenance, and cannulation.
“The Ellipsys device can be a safe and effective way to create an AVF; however, the complexities of building a programme appeared to slow adoption,” he said.
And, with Ellipsys leaving the market, Sharaf put out a call to action for the medical device community, urging healthcare professionals to embrace new devices, regulators to foster opportunities for new innovations—without compromising safety and effectiveness—and the Centers for Medicare & Medicaid Services (CMS) to reimburse devices that make a difference to patients.
“Hopefully innovations are coming, and there will be more options,” the presenter said in closing.
Nicholas Inston
WAVE TRIAL
ELLIPSYS REGISTRY
Why FLEX FIRST?
JACQUES BUSQUET
Jacques Busquet (Val d’Or Hospital, Paris, France) speaks to Vascular News about his life and career. A proponent of endovascular techniques—having co-founded the International Society of Endovascular Specialists (ISEVS) alongside Edward Diethrich—Busquet highlights the need to train the next generation of vascular specialists in “essential” open surgical skills as one of the most pressing current challenges in the field.
Why did you choose to pursue a career in medicine and what drew you to vascular surgery?
I come from a long line of medical professionals. My uncle was a general practitioner in Bordeaux, France, and both my father and grandfather, as well as my great uncle, were maxillofacial surgeons. My sister Anne, who is two years older than me, chose to study pharmacy with a specialisation in biology. So, medicine was very much part of my family heritage.
I also had the privilege of studying at the Université Victor Segalen in Bordeaux, a medical school with a national reputation and a deep-rooted history. Bordeaux has long been a hub for medicine, not only because of its medical faculty, but also as the home of the world-renowned Naval Health School, which trained doctors to work overseas.
During my medical studies, which were interspersed with periods of Olympic training as part of the French national sailing team, I completed my military service at the prestigious Joinville Battalion, known for its elite athlete soldiers. After concluding this sporting chapter, I decided to pursue the highly competitive internat exam at the Bordeaux teaching hospitals, aiming to become a surgeon. Following 18 months of intense preparation, I was proud to place first among over 2,000 candidates.
This achievement allowed me to join the world-renowned department of cardiothoracic and vascular surgery led by Professor Francis Fontan—an experience that proved foundational for my career.
Who were your career mentors and what was the best advice that they gave you?
My first and most formative mentor was undoubtedly Professor Fontan. He is internationally recognised for developing the Fontan procedure, a life-saving operation for children born with tricuspid atresia or a single ventricle.
From him, I learned not only surgical technique, but also discipline: precision in the operating room, strict adherence to schedules, and an unwavering attention to the instruments and the craft. He also instilled in me a sense of striving for excellence, of always pushing toward the highest level of performance.
Another key mentor in my journey was Professor Robert Anderson, under whom I completed a clinical and academic placement at the Royal Brompton Hospital in London, UK. He was one of the most brilliant and prolific cardiac anatomists and pathologists of his generation.
Alongside his long-time collaborator Dr Su
Yen Ho, Professor Anderson taught me how to structure a research project in the Anglo-Saxon academic tradition, and how to carry it through to publication in top-tier international journals with precision, rigour, and deep respect for the anatomical material we worked with.
My most influential mentor was Dr Edward Diethrich from Phoenix, Arizona, whom I first met in 1988 after an initial training period with Professor Rodney White at the University of California, Los Angeles (UCLA) in Torrance, USA. Dr Diethrich decisively steered my early career toward endovascular techniques at a time when many of our senior mentors saw little future in them.
I had the privilege of participating in 27 consecutive editions of his renowned international congress.
Dr Diethrich and I had the opportunity to found the International Society of Endovascular Specialists (ISEVS) in Bordeaux in 1992, during our congress titled ‘Surgical approach to endovascular techniques: Opening of a multidisciplinary discussion’. I remained devoted to this dynamic, determined man of great natural elegance, whose scientific enthusiasm continuously illuminated all the years I was fortunate to spend by his side.
You were president of the ISEVS from 2011 to 2013. What were some of the highlights of your presidency?
Becoming president of ISEVS was a milestone for me, as I was one of the founding members back in 1992, during one of our first endovascular congresses in Bordeaux, my hometown. The society quickly grew, gathering members from all over the world, and later launched the Journal of Endovascular Therapy, which is now a leading publication in the field, currently led by Professors White and Kak Khee Yeung as editors-in-chief.
During my presidency, one of the main achievements was expanding our international network. We launched new chapters, including one in the UAE with Dr Omar Hallek and support from Dr Zvonimir Krajcer, and another in New Delhi with Dr Narendra Nath Khanna, who organised the Asia Pacific Vascular International Course, where I now serve as international ambassador.
We also developed a strong collaboration in Morocco thanks to Professor Amira Benjelloul and Professor Clifford Buckley, and we built lasting ties with leading vascular centres in China, in Beijing and Shanghai, where I had the privilege to perform a live aortic case at Fudan University Hospital.
I succeeded Professor Christopher Zarins from Stanford, USA, with whom I developed
FACT FILE
CURRENT ROLE
2021–present: Coordinator of the vascular service at Val d’Or Hospital–Saint Cloud (Paris, France)
EDUCATION AND TRAINING (SELECTED)
1971: Passed the national medical school entrance exam (Bordeaux, France)
1978: Ranked first in the ‘internat’ exam for the University Hospitals of Bordeaux (Bordeaux, France)
1983: First prize for research from the Cardiology Association of Île-deFrance for a research fellowship abroad (Brompton Hospital, University of London, London, UK)
AWARDS (SELECTED)
2010: Honoured with the Pioneer in Performance distinction at the VEITHsymposium
2017: Recipient of the Lifetime Achievement Award from the Asia Pacific Vascular Society
2019: Honorary Award from the China Endovascular Course
a lasting friendship, and I was followed by Dr Donald Reid from Glasgow, UK, a devoted student of Dr Diethrich and current president of the Arizona Heart Foundation, continuing the legacy of our mentor.
What have been some of the most important developments in vascular surgery over the course of your career so far?
At the end of the 1980s, traditional open vascular surgery was still at the forefront, while endovascular techniques were largely limited to coronary balloon angioplasty, which had only been introduced a few years earlier following Andreas Grüntzig’s invention in 1976.
Several international teams played a key role in the development of peripheral endovascular procedures, in my view. These included the UCLA Torrance team led by Professor White, the Arizona Heart Institute with Dr Diethrich, the Royal Prince Alfred Hospital with Jim May and Geoffrey White, the Ochsner Clinic with Christopher White, the Buenos Aires Vascular Institute with Professor Juan Parodi, the San Antonio hospital in Texas with Dr Julio Palmaz, and the Montefiore Hospital in New York with Professor Frank Veith.
Among them, Dr Palmaz, the inventor of the eponymous stent in 1986, and Dr Parodi, who pioneered endovascular exclusion of aortic aneurysms in 1990, stand out as two major figures who helped spark the endovascular revolution in vascular surgery. Their active collaboration marked a turning point in our field on a global scale.
What are the biggest challenges facing vascular surgery?
Since the endovascular revolution began in the 1990s, vascular surgery has become well established in modern centres, both in terms of techniques and decision-making. But I see two main challenges for the next generation.
First, we absolutely need to maintain training in open surgery—for bypasses, endarterectomies, and revascularisations, which young surgeons are doing less and less frequently, often preferring endovascular techniques. Yet, open surgery remains essential in certain cases where endovascular approaches reach their limits, such as instent restenosis or stent migration. Teaching hospitals must preserve this know-how for the future.
Second, there’s a financial challenge: the high cost of advanced endovascular devices makes access difficult in some countries. Without proper funding or reimbursement systems, we risk creating a two-tiered healthcare system, where some populations are left behind.
How has your background in competitive sport influenced your surgical career? My father introduced me to competitive sailing, which I pursued at the highest level. I joined the French national sailing team in 1971 and participated in the 1972 Munich
Olympic Games.
Over the years, I won several French championship titles, in both double and solo categories, as well as a European vice-champion title and victories in major international regattas like the Hyères Olympic Week.
This passion of sailing competitively has been more than just a sport for me—it has taught me how to navigate unpredictable challenges, a skill that has profoundly shaped my career in surgery. The ever-changing winds and shifting tides of the sea mirror the uncertainties of the operating room, where adaptability and quick thinking are crucial. Beyond the water, I have completed more than 20 marathons across the world, including London and Boston marathons. Each race has been a journey of endurance, teaching me the virtues of perseverance, resilience, and mental fortitude. The discipline required to push through fatigue and doubt on the marathon course reflects the same unwavering determination I bring to my work as a surgeon.
Could you outline one of your most memorable cases?
One of the most striking cases I encountered was a patient referred for what was thought to be a deep vein thrombosis in the left leg. But as soon as he arrived, we performed a venous and arterial Doppler, which showed no thrombus; instead, we discovered a giant abdominal aortic aneurysm. A computed tomography (CT) angiogram confirmed an enormous 16cm aortic aneurysm, along with a 12cm right iliac artery aneurysm.
We scheduled emergency surgery after obtaining informed consent from the patient and his family, given the significant operative risks. The procedure was carried out by two senior surgeons, assisted by a full anaesthetic and intensive care unit (ICU) team, with a cell saver in place for blood recovery.
Once we performed the midline laparotomy and opened the aneurysm, a large volume of blood escaped revealing a massive aortocaval fistula, about 10 by 6cm, which we closed immediately using a Teflon patch. We then performed an aorto-bi-iliac graft using an
"Without proper funding or reimbursement systems, we risk creating a two-tiered healthcare system, where some populations are left behind.”
impregnated Dacron bifurcated prosthesis, successfully excluding both aneurysms.
The patient was admitted to the ICU in critical condition, having lost a significant amount of blood. Over the following 48 hours, the team worked intensively to stabilise him. He developed a post-transfusion hepatic jaundice and ‘white lung’ syndrome, requiring prolonged intubation and ultimately a tracheostomy.
After 30 days in intensive care, he recovered and was discharged. I still see him regularly, and he remains deeply grateful to our team. It is a case I will never forget, both for its complexity and for the outcome.
What are your hobbies and interests outside of medicine?
I have three principal hobbies: sailing, marathon running, and exploring antique markets. Family life is also very important to me. Even though I have been based in Paris for over 20 years now, I try to spend as much time as possible with my three grown children in Bordeaux.
CX responds: Carotid endarterectomy maintains its golden hue
The established ‘gold standard’ approach to carotid revascularisation remained enshrined as the go-to operation as far as the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK) audience, gathered for a carotid and acute stroke challenges great debate, was concerned.
AN OVERWHELMING 76% OF those who voted in the post-debate poll sided with Barbara Rantner (Ludwig Maximilians University Munich, Munich, Germany) after she made the case for carotid endarterectomy (CEA), long established as the gold-standard method of tackling carotid disease requiring intervention. Transcarotid artery revascularisation (TCAR) and transfemoral carotid artery stenting (CAS) each drew 12% of the audience share apiece, with the proposition for TCAR put forward by Michael Stoner (University of Rochester, Rochester, USA) and that of CAS made by Christopher Metzger (Harvard Medical School, Columbus, Columbus, USA).
Rantner, a co-chair of the 2023 European Society for Vascular Surgery (ESVS) carotid guidelines, looked at CEA through the prisms of gender, age and timing of procedure. “There is no gender issue, there is no age issue, there are no limitations in timing of treatment,” she declared, pointing out the absence of a superiority trial showing an alternative revascularisation option that has been proven to perform better than CEA. “Is endarterectomy the gold standard? Yes.”
Among the articles she invoked in support, she referenced 10-year ACST-1 trial results that showed
L-R:
surgery equally benefitted male and female asymptomatic patients. Symptomatic females undergoing CAS in CREST, Rantner said, “suffered from significantly higher periprocedural complications” when compared to CEA. Focusing on age, trial analysis showed that CAS was not a benefit for patients aged 65 or older. “Implementing endarterectomy remains standard of care, and also in the elderly population of 80 years and older,” Rantner added. In terms of timing, data demonstrated CAS “very significantly increased risk when we looked at early treatment onset”, she said.
The case for TCAR, meanwhile, rests in its minimal-access benefits for highrisk patients, the fact the procedure takes embolic risk in the aortic arch off the table, its safety profile, which is “as good—or better—than CEA”, the
Carotid endarterectomy outperforms stenting amid overuse of both procedures in ten-year cohort study
A retrospective, nationwide cohort study has revealed carotid endarterectomy (CEA) performed better than carotid artery stenting (CAS) in France over the course of a decade, while also highlighting the overuse of both procedures in the same period. Based on their findings, the research team calls for the suspension of interventions for carotid artery disease until appropriate studies are conducted.
THE INVESTIGATION—WHICH AUTHORS
Eric Steinmetz (CHU Dijon Bourgogne, Dijon, France) and colleagues note involved the largest cohort of asymptomatic carotid procedures ever
fact that it is “highly reproducible and scalable”, and its “rapid learning curve for contemporary vascular surgeons”, argued Stoner. He led attendees through the three ROADSTER studies which produced data in support of TCAR, and looked at how the procedure compares to CAS. “TCAR is safer than CAS in any trial that has looked at this,” Stoner said. “How does it compare to CEA, the ‘gold standard’? Well, the gold standard doesn’t fare as well as TCAR. We have equivalent stroke/death rates, improved myocardial infarction, pre- and postprocedural hypotension and length of stay less than one day, and you can see a sustained benefit for TCAR.”
“Percutaneous CAS is plagued by procedural embolic risk and worse outcomes over time in at-risk patients,” Stoner summarised. “TCAR solves the
We should individualise our approach and, in 2025, with patient selection and good technique, all of these therapies are phenomenal.”
Christopher Metzger
CAS embolic problem. Hard outcomes are equivalent to CEA or even better, and there is a strong patient preference toward minimal access surgery. As such, I’ll submit that TCAR is now the contemporary gold standard for carotid revascularisation.”
Taking up the case for CAS, Metzger reasoned that all of the carotid revascularisation strategies
studied—was recently published as an Editor’s Choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES)
Steinmetz et al begin by stating that it was their objective to compare peri-procedural stroke or death within 30 days of a procedure in patients who underwent either CEA or CAS.
The researchers used data from the PMSI (Plan de financement à l’acte) hospital database, including in their study all patients who underwent either CEA or CAS between 2010 and 2019 in France.
Steinmetz and colleagues share that, between 2010 and 2019, 164,248 patients underwent a carotid artery procedure in France, comprising 156,561 CEA and 7,687 CAS procedures. They note that asymptomatic women made up around 25% of the total cohort and high-risk patients, 40%.
The authors report in EJVES that the rate of peri-procedural stroke or death within 30 days was 1.5% overall, 1.3% in asymptomatic patients, and 3.3% in symptomatic patients. They detail that, after matching and adjustment, the risk of peri-procedural stroke or death within 30 days was statistically significantly greater in patients who underwent CAS than in patients who underwent CEA.
In their conclusion, Steinmetz et al stress
“are excellent” and that there is no single gold standard for the procedure. Clear-cut gains for transfemoral stenting include no general anaesthesia and less stress on older or sicker patients, he said. Disadvantages, on the other hand, include the fact that not all patient anatomies are suitable for CAS, Metzger noted. The case for CAS includes four randomised trials in which the strategy went up against CEA and, in one, medical therapy. “The last four randomised trials of carotid stenting versus endarterectomy have produced outstanding results for both therapies and their equivalent,” he said. With newer carotid stents emerging and contemporary results in CREST-2, “the results keep getting better”.
The three strategies are complementary rather than competitive, Metzger concluded. “We should individualise our approach and, in 2025, with patient selection and good technique, all of these therapies are phenomenal.”
In post-debate discussion, a comment from the audience took issue with Stoner’s description of the ROADSTER studies as “trials”. “None of the data you have shown are from trials,” the audience member observed. “You need to be careful about terminology and you need to be careful about head-tohead comparisons,” based on nonrandomised, observational data, a point conceded by Stoner.
Another commenter from the floor challenged both Stoner and Metzger to offer the situation in which they go against the grain and, respectively, proceed with transfemoral CAS in the case of the former and with CEA in the case of the latter. “Transfemoral versus TCAR? Based on the common carotid artery, I do think you can cheat somewhat on the length, but you can’t cheat on the quality of artery,” Stoner responded.
that many patients in the study—specifically asymptomatic women, high-surgical-risk patients, and patients undergoing CAS—received procedures that were more likely to be harmful than beneficial, according to the results of past randomised trials.
In addition, the authors write that “despite the huge number of asymptomatic carotids treated in the present sample, there is currently no proven benefit for asymptomatic carotid intervention compared with best medical treatment alone, or for screening for carotid artery disease”.
Based on these conclusions, Steinmetz and colleagues propose there “should be a moratorium on procedures for carotid artery disease until appropriate studies are conducted to determine whether [these procedures are] beneficial and for whom,” adding that studies are warranted to assess whether screening to detect carotid stenosis improves outcomes compared with non-invasive care directed only by clinical risk factors and without arterial imaging.
Furthermore, Steinmetz et al highlight a “tremendous overuse” of carotid procedures and an “urgent need to reconsider guidelines that encourage carotid artery procedures when there is no evidence of procedural benefit, and concurrent ongoing proof of procedural harm and significant cost”
Christopher Metzger, Adnan Siddiqui, Barbara Rantner and Michael Stoner
Robotic vascular surgery: Could robotics be the key to the specialty’s next great revolution?
Can the world of vascular surgery return to the core therapeutic components of open surgery, unite them with the skillset brought by the endovascular revolution, and combine with a robotic surgery delivery system to create a third revolution in the space?
This question is part of a proposition being put forward by Alan Lumsden (Methodist DeBakey Heart and Vascular Center, Houston, USA): that robotic vascular surgery is the next great leap forward for the vascular specialty. Lumsden says only vascular surgery can add robotics to the field’s first two revolutions—open surgery and endovascular intervention—to spark a third. “With the open approach, we have a delivery system that is unacceptable, and so we have sacrificed core therapeutic efficacy for the delivery system, which is endovascular,” he told the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK), in his latest pitch from the podium as he attempts to spur colleagues to join the revolution.
“Can we use robotics to go back and maintain these core therapeutic components, albeit with a different delivery system?” he asked colleagues gathered at the meeting. “Only we can actually operate in that space and it is going to be highly differentiating for our specialty.”
“One of the secret weapons in the USA is we have 100 fellows coming out of general surgery programmes, all of whom are trained in robotics, and the problem is people like me have said, ‘Don’t worry about it, we’ve got this from an endovascular standpoint, you’re not going to need it.’ But I submit to you we need to capitalise on this.”
It’s a pitch Lumsden has been making increasingly more often in recent times. As the recently outgoing president of the Southern Association for Vascular Surgery (SAVS), he used his presidential address at the group’s 2025 annual meeting (22–25 January, St. Thomas, the US Virgin Islands), to lay out the case for robotic surgery.
Only vascular surgeons are capable of being positioned at the epicentre of open surgery, endovascular intervention and robotics, he said, “working in that space where we can integrate these things, which I think is going to allow us to be branded differently, to market us differently
and will fundamentally differentiate us”, he told the SAVS gathering. Robotics are the epitome of digital surgery and are “going to change the way we practice,” Lumsden said, referencing the long-running Pumps & Pipes collaboration between Houston’s major industries, itself sparked by a conversation between Lumsden and an oilfield engineer. A lot of the solutions to vascular surgery’s problems “exist in somebody else’s toolkit,” he added. Late last year, Lumsden also used his turn at the podium of the World Federation of Vascular Societies (WFVS) as he delivered the inaugural WFVS Roger M Greenhalgh Lecture during the 31st annual meeting of the Vascular Society of India (17–19 October 2024, Jaipur, India), to speak about the frontier-pushing topic and artificial intelligence (AI). In the lecture, entitled ‘Robotics and AI: Next revolution in vascular surgery’, the chair of cardiovascular surgery outlined a roadmap for bringing robotic vascular surgery into the fold of clinical practice. Lumsden referenced his moment of clarity around the concept, how he realised major vascular operations were being handled robotically by other specialties, and how vascular surgery must not miss the boat. He looked at ways of evaluating feasibility; selecting faculty with the necessary skillset to carry out robotic procedures; mitigating risk in getting teams up to speed; identifying high-frequency, lowrisk procedures; expanding the pool of procedures that can be performed; using training resources to test in cadavers; and obtaining US Food and Drug Administration (FDA) approval in order to obtain a vascular indication. In London, Lumsden spoke in detail about some of the instances that led him to his moment of clarity around the role of robotics in vascular surgery. One involved a talk at a Society for Clinical Vascular Surgery (SCVS) meeting of several years prior in which Sam Money, at that time the chief of the Mayo Clinic at Scottsdale (Scottsdale, USA), was showing a robotically performed case of left renal
vein transposition. But then Money made a jaw-dropping revelation: “He said, ‘I didn’t do this operation, the urologist did it.’” Lumsden told CX. Another instance went thus: Back home in Houston, Lumsden was called to assist with a bleeding complication during a pelvic procedure being carried out by a gynaecologist. When he arrived, the specialist—performing the procedure robotically—asked Lumsden if he could resolve some bleeding from an iliac artery using the robot. His response was in the negative. The gynaecologist then told him she would take care of the situation herself. “That was the low point in my career,” he said. Yet another involved an encounter with thoracic surgery, where Lumsden witnessed the robotic approach being performed on the left chest—“there was no dissection”—which had the vascular chief considering how, for him, this situation would have called upon his endovascular toolkit. The thoracic surgeon told him, “‘Alan, you guys really need to be doing this.’ I said, ‘Well, I never learned laparoscopic surgery.’ At which, he said, ‘This is not laparoscopic surgery. This is the same operation we have been doing for decades, albeit with a laparoscopic access system.’”
Can we use robotics to go back and maintain these core therapeutic components, albeit with a different delivery system?”
That’s what led Lumsden down the path of developing a robotic vascular surgery programme at Houston Methodist. The team there have gradually added more and more vascular procedures to their list of robotically performed cases, but one of the challenges in robotics, “and why it has such a bad reputation in the vascular world, is we have leapt too early to the aorta,” he said. “I would like to be Lewis Hamilton and drive an F1 car but I want to learn to drive first. We as a group of vascular
surgeons are in the learning-to-drive mode. We have to ramp up, from the safe, to the much more complex as we move forward.”
Another challenge remains that the existing robotic surgery platforms currently do not have an indication for vascular, Lumsden pointed out, pondering how cases of type I and II endoleaks likely harbour “high enough volume that we can actually get an indication for doing this”.
Meanwhile, he highlighted proof of robotics’ emerging purchase in the vascular surgery world in the form of a postgraduate education course taking place at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 4–7 June, New Orleans, USA). Led by Lumsden and his co-moderator Linda Le, also a vascular surgeon at Houston Methodist, the session will hear from the likes of Money and Charudatta Bavare, who is at the vanguard of the Debakey Heart and Vascular Center’s efforts to build out its vascular robotics programme. Titled ‘Surgical robotics in vascular disease: How we can play catch up!’ it will also feature a debate between Lumsden and Frank Arko (Sanger Heart and Vascular Institute, Charlotte, USA) over the specialty’s future and the role of robotic vascular surgery in it.
Back in London, Lumsden sought to define where robotics enter the vascular fray. “It’s not going to be robotic, endo[vascular] or open—it’s how you bring in the imaging systems that allow us to use the endovascular skills that we have used in the past, and then how do we use some of these endovascular tools [going forward],” he explained. “It’s not going to be going away from the things we have learned, it’s how do we combine these things together, work with the smart people in the endovascular world to give us tools that can be delivered with the robot. I think it could be redefining for our specialty.”
Vascular surgery: Palliative surgery?
Vascular News is pleased to announce Adam Talbot (Manchester, UK) as its new Launch Pad columnist, taking over from Sarah Sillito. In his first column, Talbot writes about “reframing success” in vascular surgery and embracing the increasingly palliative aspect of the specialty.
Vascular surgery has long been associated with technically complex procedures and life-saving interventions. Yet, increasingly, we find ourselves operating in a very different context: not to prolong life, but to improve its quality, often in patients nearing the end of life. This shift invites an important question: is some vascular surgery essentially palliative?
Our patient population is ageing. Many are multi-morbid, frail, and have limited physiological reserve. Conditions like chronic limb-threatening ischaemia (CLTI), nonhealing ulcers, or aneurysmal disease often present in those with significant cardiac disease, chronic kidney disease, diabetes, frailty and cognitive decline. For these patients, the goal of surgery is rarely curative. In fact, traditional markers of success, patency rates, survival curves, limb
salvage, may be less relevant than symptom relief, functional independence, and comfort. Take, for example, the patient with severe CLTI and rest pain who is non-ambulatory, housebound, and has a limited prognosis. In such a case, an endovascular procedure to relieve pain may meaningfully improve their quality of life, even if the intervention offers only temporary benefit. Similarly, a major amputation in a nonreconstructible limb may be a pragmatic, palliative choice, trading weeks of pain and repeated debridement for comfort and dignity. These decisions are goal-oriented, not anatomy-driven.
Yet just as often, the right decision is to offer no intervention at all. As vascular surgeons, trained to ‘fix’ problems, this can feel counterintuitive. But when the burden of treatment outweighs potential benefit, non-operative management is not failure, it is compassionate care. For the frail patient with an asymptomatic abdominal aortic aneurysm (AAA), or the bed-bound individual with ischaemic rest pain unfit for anaesthesia, surgery may not align with their best interests. In these cases, conservative management, good analgesia, and support from palliative care teams may be the most appropriate path. This space between ‘curative’ and ‘palliative’ care is complex. It
Study details radiation exposure learning curve among vascular trainees
The importance of radiation safety training for vascular surgery trainees was highlighted by a recent study that detailed a learning curve effect between first- and second-year fellows performing fluoroscopically guided interventions.
USING OPTICALLY STIMULATED dosimeters fitted outside and under lead aprons, researchers detected that median thyroid (82μGy vs. 44μGy; p=0.009) and sternal (89μGy vs. 54μGy; p=0.007) radiation dose was significantly higher for postgraduate year (PGY) 6 (first year) compared to PGY7 fellows.
“When we analysed regional doses, these were significantly higher for first-year fellows in comparison to second-year fellows,” explained presenting study author Antonio Solano (University of Texas [UT] Southwestern, Dallas, USA). “There was a higher DAP [dose area product] for second-year fellows, higher thyroid and sternum doses for the first-year fellows, and the procedure scatter fractions were also higher for the firstyear fellows.”
The data were presented during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting (22–25
January, St. Thomas, the US Virgin Islands, USA).
Solano set the scene by pointing to the existence of better radiation safety training and awareness of best clinical practices for fellows in other interventional specialties. While there is variation in radiation safety training institution-to-institution, he said, vascular surgery trainees tend to learn techniques on the job, “which can result
demands careful shared decision-making, honest conversations about prognosis, and a willingness to challenge surgical reflexes. We must recognise that the patient’s priorities, whether relief of pain, maintenance of independence, or simply time with family, may not align with our instinct to intervene.
Importantly, this doesn’t mean abandoning vascular surgery’s technical advances or becoming nihilistic. Rather, it means reframing success. A well-judged, minimally invasive procedure that enables a patient to walk painfree for their final months can be just as valuable as a complex bypass graft. A decision to forego surgery and support a patient through natural decline, when made thoughtfully and collaboratively, can also be a success.
As vascular surgeons, we are increasingly operating in the realm of palliative surgery, whether we label it as such or not. Embracing this role doesn’t diminish our specialty; it expands it. It reminds us that our ultimate goal is not just to extend life, but to improve it.
ADAM TALBOT is a specialty trainee in vascular surgery based in Manchester, UK, and education representative for the Rouleaux Club—the vascular trainees’ association for Great Britain and Ireland.
in higher radiation exposure.”
The researchers analysed radiation exposure for patients, vascular surgeons and trainees during fluoroscopic interventions according to level of training in a prospective cohort study over a five-month period.
Operator radiation dose was calculated based on a calibration coefficient factor to estimate radiation at 80kVp. Procedural reference air kerma (RAK), fluoroscopy time, DAP and patient body mass index (BMI) were recorded. Scatter fractions were measured with thyroid and sternum counts to DAP ratio and DAP/RAK ratio. Paired Wilcoxon and chi-square tests were performed to identify statistical significance of training stage on radiation dose exposure and radiation reduction performance.
“When we analysed the outcomes for attending surgeon dose, we saw that there were no statistical differences
between when they were either operating with the first-year fellows versus the second-year fellows,”
Solano said.
He acknowledged limitations, including that the study involved just one vascular surgeon at a single site. “We did not control for the amount of time that the fellow performed as the primary operator during the procedure, and we did not include vascular surgery integrated residents.”
In March, this study was published online ahead of print under the title ‘Analysis of radiation exposure learning curves for vascular trainees during fluoroscopically guided interventions’ in the Journal of Vascular Surgery (JVS)
When we analysed regional doses, these were significantly higher for firstyear fellows in comparison to second-year fellows.”
Adam Talbot
New VenaSeal data suggest cyanoacrylate closure should be added to the venous “toolkit”
Twelve-month outcomes of the VenaSeal Spectrum venous leg ulcer (VLU) trial, assessing time to ulcer healing following treatment with the VenaSeal (Medtronic) closure system, have demonstrated an 81.3% ulcer healing rate at one year.
MANJ GOHEL (CAMBRIDGE University Hospitals NHS Foundation Trust, Cambridge, UK; Imperial College London, London, UK) presented the results in a podiumfirst presentation at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK). The VenaSeal system uses cyanoacrylate glue to treat underlying venous insufficiency.
The single-arm study prospectively assessed time to ulcer healing in patients with an active venous leg ulcer classified as C6 as the primary endpoint, and a secondary endpoint of vein closure through 12 months. Gohel stated that studies have frequently evaluated the C2 to C5 ulcer population, leaving “an evidence gap”
where C6 ulcers are concerned.
The Spectrum VLU trial included 125 venous leg ulcer patients with a median ulcer age of 169 days and a maximum of 6,816 days (18 years and eight months). Gohel stated that the chronicity of the ulcers included was indicative of the severity of disease in their patient cohort, representing a “much harder to treat population than most other randomised studies”, he said.
On healing potential, Gohel reported 81.3% ulcer healing, 82% anatomic closure and 83% freedom from ulcer recurrence at one year, after healing had occurred.
Gohel highlighted safety and effectiveness endpoints, which
Manj Gohel
underwent review by an independent committee. He stated that the VenaSeal systemspecific events were consistent with prospective literature, and that events included hypersensitivity (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%).
No device- or procedure-related deaths were recorded; however, eight serious adverse events occurred following treatment. These were identified as four infections, three superficial vein thromboses, and
I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease.”
Pulmonary embolism: New data advance evidence base for thrombectomy
New data presented at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK) and the Society of Cardiovascular Angiography and Interventions (SCAI) scientific sessions (1–3 May, Washington, DC, USA) add to a growing body of evidence on the safety and efficacy of thrombectomy for the treatment of pulmonary embolism (PE).
STRIKE-PE
Presenting interim data from the STRIKE-PE trial at CX 2025, Andrew Sharp (University College Dublin, Dublin, Ireland) highlighted the “remarkable” safety of the latest iteration of Penumbra’s 16Fr Lighting Flash computer-assisted vacuum thrombectomy (CAVT) device in patients with acute PE.
“Speaking to the efficacy of the device”, Sharp shared that the median thrombectomy time was 25.5 minutes and median procedure time was 59 minutes, with no intensive care unit (ICU) stay in approximately 40% of patients. On-table pulmonary artery pressures (PAPs) decreased—systolic PAP from 50.8mmHg to 38.8mmHg (23.4%), and mean PAP from 31.2mmHg to 23.5mmHg (24.5%).
“The device times of the patients within STRIKEPE compare reasonably well against other devices in the space, and—while it’s a little overblown to focus on PAP as a goal for treatment, as sometimes the pressure doesn’t come down and you’ve done a lot of good for the patient, it is a positive predictor for recovery,” Sharp told CX delegates.
Mean right/left ventricle (RV/LV) ratio decreased from 1.34 at baseline to 0.94 at 48 hours (27.8%).
The speaker noted that one composite major adverse event (0.6%) occurred within 48 hours; however, no device-related serious adverse events were reported. Six patients required pre-discharge transfusion.
“It’s remarkably safe,” said Sharp, “at the point of discharge we’re reporting excellent functional
recovery. So, with this device we believe we can rapidly and efficiently improve [patient] symptoms prior to discharge.”
Following his presentation, Sharp was questioned on what gaps in data need to be filled to make this technique standard practice, to which he replied: “randomised controlled trials”. Referencing the ongoing STORM-PE trial, which randomises patients to CAVT plus anticoagulation or anticoagulation alone, Sharp believes that superiority between the modalities will be clear “by the end of the year”.
AVENTUS
At SCAI 2025, Jun Li (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) shared late-breaking results from the AVENTUS trial evaluating the safety and efficacy of Inquis Medical’s Aventus thrombectomy system. The results were simultaneously published SCAI’s journal, JSCAI Li shared that AVENTUS—a prospective, single-arm, multicentre investigational device exemption (IDE) trial— successfully met its primary endpoints, demonstrating both safety and efficacy in the treatment of acute intermediate-risk
one granuloma.
Gohel stated that the high rate of other serious adverse events unrelated to the procedure or device, with 8% mortality within one year of the study, demonstrates the level of comorbid conditions prevalent in this patient population. This fact was also seen via quality-of-life measures, as patients often scored poorly across assessments prior to treatment.
These metrics did improve following treatment—however—providing “good evidence across a number of domains”, said Gohel.
“This is the largest prospective study of patients with C6 disease treated with cyanoacrylate in terms of effectiveness. Healing rates are good and comparable to other studies,” said Gohel. “I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease.”
Following his talk, an audience member queried Gohel on the ulcer recurrence rate in the VenaSeal data. In response, he highlighted that deep venous reflux and obese patients were included in the study, both of which have venous hypertension for a number of reasons. “That kind of recurrence rate is very typical in this population, and these are patients that are always going to be at high risk of ulceration,” he stated.
PE patients. Specifically, results showed significant improvement in RV function, reduction in clot burden, minimal blood loss, and short ICU and total hospital stays with no device-related major adverse events. The trial also reported meaningful improvements in patient-reported quality of life and a significant increase in six-minute walk test (6MWT) distance through 30 days.
“There remains a clear need for next-generation technologies that can address some of the limitations of current PE devices,” said Li. “The AVENTUS trial confirms that this system not only performs safely and effectively but also supports meaningful improvements in clinical efficiency and outcomes, marking an important advancement in PE care.”
PEERLESS
These data follow the presentation last year of findings from the PEERLESS trial of the FlowTriever device from Inari Medical. The company notes that this is the first major PE RCT in a decade and the first ever to evaluate thrombectomy.
The PEERLESS trial found that large-bore mechanical thrombectomy (LBMT) is superior to catheter-directed thrombolysis (CDT) with respect to the hierarchically tested aggregated outcome of all-cause mortality, intracranial haemorrhage, major bleeding, clinical deterioration and/or escalation to bailout therapy, and postprocedural ICU admission and length of stay.
Findings were reported at Transcatheter Cardiovascular Therapeutics (TCT) (27–30 October, Washington, DC, USA)—the annual scientific symposium the Cardiovascular Research Foundation (CRF)—with results published simultaneously in Circulation
Answering the questions of appropriate outcomes measures after intervention for deep reflux as promising venous valve technology
emerges
FEDOR LURIE
There is an old saying that goes, “As surgeons, we change the anatomy to improve physiology”. Correction of physiological abnormality should, then, result in clinical improvement. The assumptions behind such a three-step logic (anatomy-functionclinical outcome) are frequently challenged, modified and, sometimes, refuted when subjected to scientific examination. Recent developments in the field of chronic venous disease (CVD) make clear the need for such scientific examination of several basic assumptions, one of which is the role of reflux.
Epidemiological studies and clinical observations consistently demonstrate that patients with primary CVD have either deep or superficial venous reflux, or both. Superficial reflux is relatively easy to treat. Multiple clinical trials have shown that ablation leads to clinical improvement. Deep reflux data are less convincing. The introduction of surgical repair for deep venous valves generated several observational studies showing excellent long-term functional and good clinical outcomes. this operation requires the presence of a correctible valve, while most patients with deep reflux have valves damaged by the thrombotic process. Since valvuloplasty was universally performed in patients with terminal venous disease, consensus statements and guidelines restricted recommendations for deep vein reconstruction to patients with venous ulcers.3,4 More than 50 years of clinical experience performing deep reflux correction still did not answer the question of its role in the progression of CVD and the degree to which such
VenoValve: Analysis finds similar improvement among both primary and thrombotic
deep venous reflux patients
A new subanalysis of the SAVVE (Surgical antireflux venous valve endoprosthesis) trial found that there was no difference in the level of improvement in clinical outcomes and quality-of-life measures between patients who have either primary or thrombotic deep venous reflux.
the Society for Clinical Vascular Surgery (SCVS) 2025 annual symposium (29 March–2 April, Austin, USA) by Cassius Iyad Ochoa Chaar (Yale School of Medicine, New Haven, USA).
SAVVE enrolled 75 patients with deep venous reflux in CEAP (Clinical, Etiological, Anatomical and Pathophysiological) categories C4b, C4c, C5 and C6 who were implanted with the VenoValve (Envveno Medical), across 21 US sites. The latest SAVVE subanalysis compared chronic venous insufficiency patients with primary reflux to those who presented with thrombotic reflux—with the latter defined as those who had a history of venous thromboembolism (VTE), with 80% of the participants bearing a thrombotic aetiology.
More than 50% of trial participants had ulcerations, with the average ulcer area 17cm2. The subanalysis showed that there was no difference between the two groups. At baseline, the mean reflux time among the entire cohort was three seconds, with a revised Venous Clinical Severity Score (rVCSS) of 16, Chaar continued. “There was no difference between the two groups. Looking at the outcomes of the patients enrolled at one year, there was a significant decrease in the mean rVCSS score in both groups, both the thrombotic and the primary, with an average 6.2- and 8.7-point drop, respectively.
THE DATA WERE PRESENTED DURING
The only “real difference between the two subgroups of patients was that the thrombotic patients were more likely to be on anticoagulation,” Chaar told SCVS 2025.
Chaar concluded: “The VenoValve is an effective treatment for patients with deep venous reflux with no other options for treatment. Improvement starts at three months and is persistent at one year, and improvement in clinical patient-reported outcomes and quality of life seems comparable between patients who have thrombotic or primary reflux.”
TUESDAY
11–12 NOVEMBER
Clinical News
R3 Vascular announces first patient treated in ELITE-BTK pivotal trial
R3 Vascular recently announced that the first patient in its ELITE-BTK pivotal trial has been treated by Brian DeRubertis (New York-Presbyterian and Weill Cornell Medicine, New York, USA). The trial evaluates R3 Vascular’s next-generation drug-eluting bioresorbable scaffold, Magnitude, for below-the-knee (BTK) peripheral arterial disease (PAD).
“The treatment of the first patient in our ELITE-BTK pivotal trial by distinguished vascular surgeon and researcher Dr Brian DeRubertis is a significant milestone as we commence our effort to fully demonstrate the efficacy and safety of our nextgeneration Magnitude scaffold,” said Christopher M Owens, president and chief executive officer of R3 Vascular.
“Moving forward we look to accelerate enrolment, paving the way for a PMA [premarket approval] market application with the FDA [US Food and Drug Administration].”
DeRubertis commented on the importance of the ELITE-BTK pivotal trial, saying: “I am honoured to have enrolled the first two patients in R3 Vascular’s ELITE-BTK pivotal trial, primarily because this type of technology has been needed by our patients for years. I have spent much of my career researching novel devices for vascular disease, including bioresorbable scaffolds, and while there have been some recent successes in the BTK PAD trial landscape, there remain significant unmet needs in this area. We expect the results of this important trial will reveal Magnitude’s unique potential to further advance treatment and improve patient outcomes for patients with vascular disease.”
“The start of this trial marks the continuation of our journey in providing a groundbreaking technology for patients who have suffered from this debilitating disease for many years without effective therapeutic options,” said Kamal Ramzipoor, founder and chief technology officer of R3 Vascular. “Magnitude is a next-generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from chronic limb-threatening ischaemia due to below-the-knee PAD. R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow for superior biomechanical properties with strength and ductility. We believe these properties will drive extremely positive outcomes, especially long-term for real-world
patients. We look forward to advancing our product through its clinical development with the ultimate goal of having a market-leading position.”
Early feasibility study for Velocity pAVF system now fully enrolled Venova Medical has announced the completion of patient enrolment in the company’s VENOS-2 early feasibility study of the Velocity percutaneous arteriovenous fistula (pAVF) system for haemodialysis access.
The multicentre study is being performed under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA) and is intended to provide proof-of-concept and initial clinical safety data.
“Percutaneous AV fistulas provide a minimally invasive alternative to surgically created fistulas and potentially a shorter time to fistula maturation, reducing the exposure to and risks associated with hemodialysis catheters,” said vascular and interventional radiologist Rishi Razdan (Jacksonville, USA), a VENOS-2 study investigator. “The Velocity system is designed to be intuitive and facilitate the user’s ability to rapidly create an AV fistula with minimal learning curve and limited need for additional procedures to achieve fistula maturation.”
Erik van der Burg, chief executive officer and co-founder of Venova Medical, added: “Our next step is to gather the necessary follow-up data and submit an IDE application to the FDA in Q2 2025 for a multicenter US pivotal trial, which will enable us to pursue US approval for the device.”
Cagent Vascular initiates patient enrolment in Serranator vs. plain balloon angioplasty OCT study
Cagent Vascular has announced its first patient enrolment in the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.
This prospective, randomised (2:1 treatment to control) dual-centre study will enrol up to 60 patients. The study will utilise intravascular OCT imaging to demonstrate the mechanism of action (MOA) of the Serranator and compare the serration MOA to conventional angioplasty across a wide range of lesion morphologies in below-theknee arteries.
Product News
PerQseal Elite vascular closure system gains CE mark Vivasure Medical has announced European CE mark approval of the PerQseal Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The company plans to launch the product in select European markets this summer.
Leveraging Vivasure’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore closure following percutaneous cardiovascular procedures such as transcatheter aortic valve implantation (TAVI) and endovascular aortic repair (EVAR). Currently, there are no fully bioresorbable devices available for closure following largebore procedures. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure step, further simplifying the procedure.
“Vascular closure remains a challenge for the growing cardiovascular procedures that require large bore access. The introduction of PerQseal Elite is an exciting advancement for large-bore cardiovascular procedures,” said Mohamed Abdel-Wahab, professor of interventional cardiology and head of Structural Heart Disease Department at the Heart Center in Leipzig, Germany. “Having a fully absorbable, sutureless closure option simplifies the procedure and has the potential to reduce complications associated with traditional closure methods. We look forward to utilising this technology to treat our patients.”
“Securing CE mark approval for PerQseal Elite marks a major milestone for Vivasure and for patients undergoing complex structural heart procedures,” said Andrew Glass, CEO of Vivasure Medical. “PerQseal Elite represents a significant advancement in procedural efficiency and patient care. We’re proud to bring this innovative technology to clinicians across Europe.”
The PerQseal Elite vascular closure system is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques and returning the vessel to its natural state without leaving materials like collagen, metal implants or sutures behind.
Neuro press release.
The company’s carotid stent system is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following a carotid endarterectomy procedure.
The device is intended to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries, or at the carotid bifurcation, with ≥50% stenosis in symptomatic patients or ≥80% stenosis in asymptomatic patients— as determined by angiography.
According to Terumo Neuro’s recent release, the device also accommodates vessel reference diameters between 3.5mm and 9mm at the target lesion.
Gore announces US FDA approval and first commercial implant of large-diameter thoracic tapers Gore recently announced the expansion of the Gore Tag conformable thoracic stent graft with Active Control system product line, following US Food and Drug Administration (FDA) approval of four new large-diameter tapered designs: 34x28mm, 37x31mm, 40x34mm and 45x37mm.
News of the approval comes in conjunction with the first US commercial implant, completed at Keck School of Medicine of USC (Los Angeles, USA) by Sukgu Han.
For Han, the new large-diameter tapers “provide a welcome addition to the available treatment options for patients and expands applicability for the existing Gore technology,” he shared in a press release.
“The right device sizing is always critical,” Han emphasised, “and even more so when treating in a narrow true lumen. These additional tapered designs will help us achieve optimal sizing for a broader range of aortic diameters while continuing to leverage the proven performance and properties of this device system.”
“The Gore Tag conformable thoracic stent graft with Active Control system is an outstanding technology. I found the device to perform with reliable conformability and [a] controlled, staged delivery mechanism. And now, I know that I have the sizes I need for more of the patients I need to treat,” he concluded.
The study will take place at Columbia University Medical Center and Weill Cornell Medicine led by Sahil Parikh and Brian DeRubertis. A press release reports that this will be the first study of its kind, a randomised trial utilising OCT imaging to compare acute outcomes between serration angioplasty and plain balloon angioplasty. Cardiovascular Research Foundation in New York, USA will serve as the core lab.
Terumo Neuro receives US FDA approval for carotid stent system Terumo Neuro has announced that its carotid stent system has received premarket approval (PMA) from the US Food and Drug Administration (FDA).
This milestone marks the first duallayer micromesh carotid stent approved in the USA, offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment, as per a Terumo
CTAG tapers
Serranator
Industry News
VVT Medical welcomes Antonios Gasparis to medical advisory board
VVT Medical recently announced the appointment of Antonios P Gasparis to its medical advisory board.
A press release notes that Gasparis brings over two decades of expertise in vascular surgery, with a distinguished career dedicated to advancing the treatment of venous diseases.
Gasparis currently serves as the system chief for the ambulatory vascular and vein programme at Northwell Health (New York, USA), where he is spearheading the development of a comprehensive venous disease programme across the health system. He previously held prominent roles at Stony Brook University (New York, USA), including professor of surgery, director of the Center for Vein Care, and director of the phlebology fellowship.
Gasparis’ leadership has extended to national platforms, having served as president of the American Venous Forum (AVF). He is also the founder and co-director of the Venous Symposium and has authored numerous publications and presentations in the field of venous disease.
In joining VVT Medical, Gasparis said: “I am excited to collaborate with VVT Medical in advancing innovative solutions for venous disease. Their
Conference calendar
22–23 May
Pacific Northwest Endovascular Conference (PNEC) Seattle, USA pnec-seattle.org
4–7 June
Vascular Annual Meeting (VAM) New Orleans, USA vascular.org/vam-2025
commitment to improving patient outcomes aligns with my passion for enhancing vascular care.”
Erez Tetro, chief executive officer of VVT Medical, commented: “We are honoured to welcome Dr Gasparis to our advisory board. His deep expertise
and commitment to advancing vascular health will be invaluable as we continue to bring innovative medical technologies to patients across the USA. Dr Gasparis joins us as part of a strategic expansion of our advisory board focused on the US market, with additional appointments to be announced in the near future.”
Diality adds Chris Spring to board of directors
Diality, a medical device company that has developed the Moda-flx haemodialysis system, has announced the addition of Chris Springer to its board of directors.
Springer brings 30 years of commercial and strategic experience
12–13 June
Royal Society of Medicine (RSM) Venous Forum annual scientific meeting London, UK rsm.ac.uk/events/venous/2024-25/ vet01
26–27 June
British Society of Endovascular Therapy (BSET) annual meeting Wotton-under-Edge, UK bset.co.uk/meetings/bsetannualmeeting-2025
26–28 June
in the pharmaceutical and biotech industries to Diality. As chief strategy officer for Vifor Pharma, he created a joint renal-drug company between Vifor Pharmaceuticals and Fresenius Medical Care as well as overseeing a series of licensing deals and acquisitions, culminating in the acquisition of Vifor Pharma by CSL for US$11.7 billion.
Prior to Vifor Pharma, Springer also spent time in executive roles with Amgen. He sits on the board of multiple biotech firms, including Adrenomed, Nagi Bioscience, Quercis Pharma and HICT.
“Chris’s commercial experience and strategic focus is exactly what Diality needs as we transition to the early stages of commercialisation of the Moda-flx haemodialysis system,” said Osman Khawar, chief executive officer of Diality.
Khawar continued: “His guidance and input into our growth strategy will help reinforce the unique benefit offered to clinicians, providers, and patients by the clinical flexibility and ease of use that the Moda-flx haemodialysis system brings to the dialysis market.”
The Moda-flx haemodialysis system is designed to empower kidney care professionals with a wide range of variable flow rates, integrated reverse osmosis water filtration, and an intuitive, easy-to-use graphical user interface. The system provides clinicians the flexibility to easily customise each haemodialysis
European Venous Forum (EVF) annual meeting Krakow, Poland https://europeanvenousforum.org
11 September Interdisciplinary Aortic Dissection Symposium (IADS) London, UK aorticdissectionsymposium.com
13–17 September
experience according to patient needs in one integrated system. The platform’s compact footprint and mobility enable seamless integration and transportation within dialysis care settings.
Evident Vascular raises Series B financing to advance AI-powered IVUS platform technology
Evident Vascular has announced the successful closing of its Series B financing with new investors Shangbay Capital and two undisclosed multinational strategics joining founding investor Vensana Capital.
A press release details that the funding will accelerate development of the company’s advanced intravascular ultrasound (IVUS) technology designed to enhance vascular imaging and patient outcomes and support 510(k) US Food and Drug Administration (FDA) clearance ahead of US market launch.
“We are proud to continue supporting Evident Vascular, which is at the forefront of innovation in intravascular imaging that has become the standard of care in peripheral vascular and complex coronary interventions,” said Cynthia Yee, partner at Vensana Capital.
“Evident’s next-generation IVUS platform represents a transformative step forward in vascular care, offering clinicians powerful tools to enhance diagnosis and guide treatment consistent with clinical evidence and today’s medical guidelines.”
Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress Barcelona, Spain cirsecongress.cirse.org
30 October–1 November Venous Symposium Europe Athens, Greece venoussymposiumeurope.com
11–12 November CX Aortic Live Vienna, Austria cxaortic.com
18–22 November VEITHsymposium New York, USA veithsymposium.org
GORE® TAG® Thoracic Branch Endoprosthesis
AN OFF-THE-SHELF ZONE 2 TEVAR DEVICE
A SINGLE ENDOVASCULAR PROCEDURE.
Helping you preserve the LSA without the need for surgical revascularization. Another first-of-its-kind innovation from Gore.
Contact your Gore representative for more information.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.
Products listed may not be available in all markets.
GORE, Together, improving life, TAG and designs are trademarks of W. L. Gore & Associates. © 2025 W. L. Gore & Associates GmbH 25VS2036-EN01 MARCH 2025
