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August 2024 | Issue 95

GEST: Miyuki Sone honorary lecture

Profile: Patrick Haage

Point of view: IR devices in low-income countries

page 12

page 16

page 18

RENAL

GALLSTONE MANAGEMENT

Money-maker or meritable: Is renal denervation out of retirement?

In a paper published in the July 2024 issue of the Journal of Hypertension, Andrew Sharp (University Hospital of Wales and Cardiff University, Cardiff, UK) et al reviewed 16 randomised controlled trials to assess the evidence of renal denervation’s (RDN) efficacy, concluding that, in uncontrolled arterial hypertension, RDN leads to a consistent reduction in blood pressure.

Are scopes within the scope of IR for biliary interventions?

In 2023, the Society of Interventional Radiology (SIR) Foundation awarded the percutaneous cholangiopancreatoscopy (PCPS) registry the largest grant to date to investigate the use and role of cholangioscopy in the treatment of gallbladder and biliary tree lesions with the goal of removing indwelling drainage catheters quickly, treating biliary stones and diagnosing and treating strictures.

Although cholangioscopes are not new and have been used for decades during gastrointestinal interventions and by a small number of interventional radiology (IR) practices, recent advancements in technology have begun to make new of old, drawing scopes to the forefront of a novel era of biliary intervention.

“P

ercutaneous biliary endoscopy has come to the procedural forefront in the past five years,” said Harjit Singh (Johns Hopkins University, Baltimore, USA), lead researcher for the PCPS registry, when speaking to Interventional News. “Prior to that time, only a few large academic centres were performing the procedure.” Since the early 1990s, laparoscopic cholecystectomy has typically been the gold standard for patients with symptomatic gallstones, which involves the surgical removal of a diseased gallbladder.

However, when considered in an aging, increasingly comorbid, and so surgically unsuitable patient population, this treatment option is unviable. For these patients, percutaneous drains can be inserted into the gallbladder, but these require regular changing. Cholangioscopy can improve the efficiency of such procedures and the patient’s quality of life (QOL).

Percutaneous cholangioscopy is a minimally invasive procedure used to diagnose and treat conditions affecting the biliary tree and gallbladder. This typically involves the insertion of a flexible endoscope into the biliary system, enabling visualisation of the gallbladder lumen or bile ducts for the removal of stones, to place stents, treat strictures or perform biopsies. When the biliary tree/gallbladder cannot be approached endoscopically, percutaneous access with the placement of a drainage catheter is usually the first step. For choledocholithiasis and cholelithiasis, percutaneous scopedirected lithotripsy with fragment removal is increasingly being used as an effective minimally invasive option.

Although a smattering of medium-sized studies have

evaluated the effectiveness of cholangioscopy and eventual tube removal, no large studies have been conducted to date. In 2022, to begin filling these gaps in understanding, Singh led the SIR Foundation research consensus panel, identifying crucial priorities regarding percutaneous image- and cholangioscopyguided procedures for biliary and gallbladder diseases.

“Bringing together experts who have performed cholangioscopy was critical,” he commented. They identified three key areas of future research: the treatment of benign biliary strictures, the evaluation and treatment of intrahepatic cholangiocarcinoma (IHCC), and cholelithiasis/ choledocholithiasis in patients not suitable for surgery. Based on the response the panel received, Singh and his team determined that a multisite registry would be the best vehicle to collect these data and—with the sponsorship of the SIR Foundation—

Some people worry about losing their turf, but this is one area that any other specialty would be apprehensive to take on” Peter Mueller

UP UNTIL NOW HOWEVER, RDN had been effectively abandoned, largely due to the influential 2014 SYMPLICITY HTN-3 (Renal denervation in patients with uncontrolled hypertension) trial which found no significant difference between RDN and sham control groups at six-month follow-up. Yet—perhaps supplying the spark for RDN’s revival—in 2022, the Medtronic-sponsored trial published three-year follow-up data which showed that RDN provided a sustained blood pressure reduction benefit for those patients, with the first-generation single-electrode technology.

In Franz Messerli’s (Saint Luke’s Roosevelt Hospital, New York, USA) view, there are still two groups despite the emerging data—the enthusiasts and the sceptics. “In recent meta-analyses—such as Sharp et al’s—we see a fall of 3.6mm of mercury [mmHg], and to many of us, this is simply not sufficient to justify an invasive procedure.”

Although, in an accompanying commentary to Sharxfp and colleagues’ research titled ‘Why the lack of enthusiasm for renal denervation?’ in the July issue of the Journal of Hypertension, Messerli asserts that the authors “correctly conclude” that RDN leads to consistent blood pressure Continued on page 6

Continued on page 4

2

August 2024 | Issue 95

Welcome

INTRODUCTORY EDITORIAL

“Quality of life is the most underrated metric in IR”

Stop and think about that for a minute. For the next few days, as you work, think about quality of life (QOL) as your key metric, writes Brian Stainken, one of the editors-in-chief of Interventional News. Did you and your team make a difference?

L

eave it to one of our titans, Peter Mueller (Massachusetts General Hospital, Boston, USA), to make this statement.

He was speaking to the quiet revolution happening in the field of biliary interventions (see lead story). He was speaking to the patients we all know whose lives were saved with chronic biliary and gall bladder drains, but are now cursed by the same solution. Have you ever met a patient who said I want to keep my drain? The next generation solutions that Harjit Singh (Johns Hopkins University, Baltimore, USA) and the Society for Interventional Radiology (SIR) Foundation have invested in for years are now almost ready for prime time.

Get rid of the stones, lose the tubes!

The patients are certainly out there. Soon the multicentre trial data will be ready, and hopefully by then you will have assembled the multidisciplinary team and the technical competencies to deliver these new solutions and the innovation that will certainly follow. As many of us know, removing a chronic drain is almost guaranteed to get a hug from the patient. Patient hugs are key positive endpoints when measuring QOL improvement. Survival is another positive indicator.

Two stories in this issue take this home. On page 19 you can read the story of a best-selling author, Sebastian Junger, who went public with his near-death experience from a ruptured visceral aneurysm. He was rushed to a local hospital where the emergency department effectively initiated a mass transfusion protocol, and a wise vascular surgeon made the call to refer to the case to the best equipped professional.

Phillip Dombrowski (Cape Cod Hospital, Hyannis, USA) a community-based interventional radiologist, answered the late night call. But why did the surgeon call Phil? Because, over many Brain Stainken

years, Phil built a reputation for excellence, availability and teamwork. Sometimes these teams grow organically, but when not present, build one. Be it a tumour board, trauma or pulmonary embolism (PE) care, the best care is team care.

Work out process and referral plans up front. As Junger notes, it took a team to save his life and survival is a prerequisite for assessing quality.

Patient hugs are key positive endpoints when assesing QOL improvement. Survival is another positive indicator” One more must read article is on page 22. The Dutch COLLISION trial was recently halted halfway through enrollment because it met predefined halting rules. This trial, comparing hepatic resection with percutaneous thermal ablation in the setting of colon cancer found that both approaches delivered similar progression-free survival.

Surgery was associated with a 2.1% mortality risk, there were no deaths in the ablation group. This is huge. It’s the sort of trial we’ve needed to redefine the standard of care.

How about QOL?

If you have fewer than 10 metastases, less than 3cm in diameter, and no extrahepatic disease, you probably don’t need surgery. Do I need to say anything more? But that assumes that you are delivering the solution with the same level of expertise and to the same technical endpoints as the trial centres. If you are, prove it! Others will want to do the same. Be like Phil. Be excellent, be available, build your network and your reputation for excellence. Know your outcomes. Wait for the trial data publication and read it.

Twice. Does it mirror your practice? Interventional News will be covering this important trial in depth in upcoming issues, so stay tuned.

Finally, as I ponder this whole space of QOL as it relates to interventional radiology (IR) care, it strikes me that the subthemes, the importance of teamwork, preparation, professional networking, and awareness of the patient’s needs merit just a few more words. We, as interventional radiologists, benefit from an abundance of opportunity to care. It seems that the field’s growth knows no limits. But, when viewed from the patient’s perspective, what do they experience? Did it hurt? Did anyone show compassion? Did you take the time to explain the imaging when you see the patient afterward in the office? Anyone who has experienced the sharp end of the needle will tell you that these elements matter. Can you and your team be better? From the simplest case to the herculean, pay attention to the impact of your work on your patient. You might just get a hug.

As always, if you have ideas for stories, comments, or an opinion that needs to be shared, email Interventional News via eva@bibamedical.com.

Editors-in-chief: Professor Robert Morgan, Professor Andy Adam, Professor Brian Stainken Publisher: Stephen Greenhalgh | Content director: Urmila Kerslake | Global sales director: Sean Langer Editor: Éva Malpass Design: Terry Hawes, Josh Lyon and David Reekie Advertising: Michael Broughton michael@bibamedical.com Subscriptions: subscriptions@bibamedical.com Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press. Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2024. All rights reserved.

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NEWS IN BRIEF

THE LATEST STORIES FROM THE INTERVENTIONAL WORLD

n LUTONIX AV GLOBAL REGISTRY: In a new post-hoc analysis of the Lutonix (BD) arteriovenous (AV) global registry using investigational device exemption (IDE) criteria, Dimitrios Karnabatidis (Patras University Hospital, Patras, Greece) reports the “highest” sixmonth target lesion primary patency (TLPP) to date when evaluated through IDE criteria.

The Lutonix AV global registry assessed the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional AV fistulae (AVF) and grafts (AVG) located in the arm.

For more on this story go to page 4.

n UTERINE FIBROID EMBOLIZATION SURVEY: A recent survey conducted by The Harris Poll on behalf of the Society of Interventional Radiology (SIR) has revealed that more than half (53%) of women diagnosed with uterine fibroids were primarily offered a hysterectomy. This highlights a “significant lack of awareness” among women regarding uterine fibroids, with approximately 72% of women being unaware of their risk for developing fibroids.

For more on this story go to page 21.

n COLLISION TRIAL: A study evaluating the potential noninferiority of thermal ablation compared to surgical resection for patients with small-size resectable colorectal liver metastases (CRLM) has been halted at halftime after meeting halting stopping rules. The findings from the COLLISION trial showed that the standard of care for these patients should be transition from surgery to thermal ablation based on overwhelming data collected in the trial.

For more on this story go to page 22.

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If you have comments on this issue or suggestions for upcoming editions write to eva@bibamedical.com

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4

August 2024 | Issue 95

Cover Story

COVER STORY continued

Are scopes within the scope of IR for biliary interventions?

Continued from page 1

have enrolled close to 500 patients.

Moving beyond specialised academic centres, Singh stated that percutaneous cholangioscopy’s maturation can be attributed to the technological advancements of recent years. Sharing his experience, Hugh McGregor (University of Washington Medical Center, Seattle, USA) explained that the broader market availability of smaller, disposable scopes “lowered the barrier to entry”, making the procedure more accessible to IR teams. Previously, clinicians would need to buy a reusable endoscopic system or borrow one from another speciality, creating “challenges” for various reasons, he added. “There is definitely a learning curve—it’s a new modality that interventional radiologists don’t typically come across. We’re used to looking at X-rays in real time, not videoscopic images,” McGregor said.

McGregor’s own research has focused on gallbladder cryoablation, having conducted a first-inhuman trial in 2020 which found the modality to be a promising alternative to long-term cholecystostomy tube drainage for the treatment of cholecystitis in nonoperative patients. “When you look at devitalisation of the gallbladder, there was a lot of work done in the 1970s and 1980s, but there seemed to be a gap in the 1990s into the 2000s, perhaps due to the advent of laparoscopic cholecystectomy becoming the absolute standard, despite still being a fairly morbid operation in some patient groups.”

McGregor noted however that the clinical problem has begun to resurface once more, defined by an aging

population with increasingly complex comorbidities.

To meet this need, investment in scope technology applied to minimally invasive IR techniques is increasing. “The growth in the number of patients we’re seeing is outpacing the number of doctors we’re gaining, which has driven speciality crossover and collaboration, each coming toward the centre to act as proceduralists,” McGregor said.

Peter Mueller (Massachusetts General Hospital, Boston, USA) backed the motion for multidisciplinary collaboration, identifying intensivists, surgeons, interventional radiologists and gastroenterologists as key players in the management of these patients.

“Collaboration is extremely important,” Mueller said.

“Some people worry about losing their turf, but this is one area that any specialty would be apprehensive to take on. Treatment options for patients with biliary/

If it turns out that 100% of patients will experience stone recurrence at five years, that changes the treatment equation” Hugh McGregor

gallbladder diseases have little to no long-term data or evidence, but at our hospital we can confidently say that percutaneous cholangiopancreatoscopy to place a drainage catheter is very effective.”

Mueller reiterates that data must be sought, particularly for the sake of patient QOL metrics; “the five-year survival of these patients may not be great, but what about the two-year survival rates—did

Lutonix AV global registry shows higher target lesion primary patency when considered under IDE criteria In a new post-hoc analysis of the Lutonix (BD) arteriovenous (AV) global registry using investigational device exemption (IDE) criteria, Dimitrios Karnabatidis (Patras University Hospital, Patras, Greece) reports the “highest” six-month target lesion primary patency (TLPP) to date when evaluated through IDE criteria.

AS PART OF A POST-APPROVAL study mandated by the US Food and Drug Administration (FDA), the Lutonix

Dimitrios Karnabatidis

AV global registry assessed the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional AV fistulae (AVF) and grafts (AVG) located in the arm. The real-world, multicentre, prospective study enrolled 320 patients from 12 countries across Europe and Asia—the largest DCB arm to date— Karnabatidis told EVA delegates.

At six months, the primary safety endpoint defined as freedom from serious adverse events was reported as 95.5%, while TLPP was 73.9% and access circuit primary patency (ACPP) was 71%. TLPP for stenosis of AVFs was 78.1%.

Karnabatidis then went on to question how key IDE exclusion criteria would affect these results, detailing which variables would affect the patient population. These variables include:

they get cholecystitis again? Did their stents become clogged?” he said. “In fact, I’m going to go to my old hospital next week and encourage the team to look at this.”

“Quality of life is the most underrated metric in IR,” Mueller continued. “It’s all in the decision making, the talking to the family and in the follow-up.” Today, patients are more autonomous during treatment decision-making conversations. John Smirniotopoulos (MedStar Washington Hospital Center, Washington DC, USA) shared that, at his centre, “a new subset” of patients has emerged, self-referring from across the country and internationally for biliary colic secondary stones. In doing so, these patients elect to avoid surgery and undergo organ sparing gallstone removal via percutaneous cholangiscopy.

From a research perspective, Smirniotopoulos stated that the efficacy of such a procedure still needs “bearing out”, and that stone recurrence should also be an area of particular interest. McGregor also touched on recurrence rates, stating that: “increasing the body of literature is going to be important here. If it turns out that 100% of patients will experience stone recurrence at five years, that changes the treatment equation and there may be an argument for a higher-risk cholecystectomy upfront, but we just don’t know yet.”

Primed to bolster or bin scope-directed biliary intervention, Singh et al’s forthcoming registry data are hoped to equip IR with a “whole new set of tools for the diagnosis and treatment of biliary tract disease,” said Singh. “Using what I expect to be proven [via the PCPS registry data], through an adjunctive set of tools, we can accelerate the process of diagnosis and treatment of biliary pathology such as stones, strictures and obstruction.” Singh hopes that subsequently, a “new treatment algorithm” can begin, providing an alternative to the “long, tedious and financially burdensome” treatment algorithms that are available now for these patients and their families currently.

■ Lesions of >80mm ■ Lesions outside the range of 4–12mm ■ >30% residual stenosis ■ Previous graft ■ In-stent restenosis ■ Central veins as target lesions Karnabatidis and his team also identified thrombosis at index as a potential exclusory variable, comparing this to the IN.PACT IDE trial which also excluded patients with current or previous thrombosis events. Other key exclusions include the presence of a stent in the target or secondary lesion, or if more than two secondary lesions are in circuit, however Karnabatidis specified that if a single patent stent is in circuit this was allowed.

Using IDE exclusion criteria to better understand the Lutonix registry results, Karnabatidis stated that the primary safety endpoint of freedom from access circuit-related serious adverse events was 94.9% at 30 days. Concerning the registry’s efficacy endpoint, TLPP was 85.1% at 180 days—the “highest” reported when compared with the original dataset. zKarnabatidis concluded that often DCB trials are impacted by procedural variables such as inflation time, variations in dose when delivering drugs and excipients and patient population differences. For these reasons, it is challenging to compare DCB trials, he said, underscoring the importance of future randomised controlled trials in this area.

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6

August 2024 | Issue 95

Renal Denervation

COVER STORY continued

Money-maker or meritable: Is renal denervation out of retirement?

Continued from page 1

lowering. Messerli however, took issue with the authors’ statement that the reduction of systolic blood pressure of 2mmHg was associated with a 10% reduction in stroke mortality in a middle-aged population, which references the 2002 Sarah Lewington (Nuffield Department of Population Health, Oxford, UK) et al study of age-specific relevance of usual blood pressure to vascular mortality.

“This is a wishful misinterpretation of the Lewington [et al] data,” Franz Messerlli Messerli writes, “all too commonly misused for marketing drugs with paltry antihypertensive efficacy.” He believes that, due to hypertension’s prevalence as one of the most common cardiovascular diseases worldwide, it has therefore become “a money-making” procedure.

“You can simply assume that without industry support, RDN would not survive,” Messerli said.

He continued, describing a term he has coined as ‘gizmo idolatry’, stating that the treatment of hypertension—a disease that has been around for centuries—is “absolutely boring”, but with the development of a new device, “there is a new kid on the block—a gizmo”. In his opinion, following this excitement drawn up by recent meta-analyses concerning RDN, clinicians will realise that there is “very little reason” to use the technique except in “selected patients, few and far in between”.

Hypertension leads to stroke, heart attack, heart failure, kidney damage, and several other health problems, particularly in an aging population. As set out in Dena Ettehad (University College London, London, UK) et al’s 2016 data in The Lancet, a reduction of 10mmHg in systolic blood pressure is associated with substantial risk reductions: 28% for heart failure, 27% for stroke, 17% for coronary disease, 5% for chronic kidney failure, and 13% for mortality. Although RDN is commonly believed to reduce blood pressure to the equivalent of one antihypertensive drug, the minimally-invasive procedure can reduce the issue of non-adherence to medication, as often patients are required to take anywhere from one to three types of medication daily.

Mahmood Razavi (Providence St Joseph Hospital, Orange, USA) commented that compliance with this level of medication is challenging for most. “No one likes to get up every day and take one, two or three medications multiple times daily,” he stated. On top of this, he noted that hypertensive patients will likely have other medical conditions that they will also be taking medication for. He explained that the idea behind RDN was to replace medication with a single

procedure, to reduce the frequency or dosage of medication a patient must take, or to treat patients who cannot tolerate antihypertensive drugs.

The incidence of non-adherence to antihypertensive medication could be why the early randomised RDN studies like SYMPLICITY HTN-3 were negative, Razavi stated. “Patient selection is key—this could have been due to patients who were non-compliant with medication and once entered into the trial, received treatment and therefore their blood pressure dropped.” Despite this, Razavi recounted that, of the patients that his centre enrolled into SYMPLICITY HTN-3, they reported “very positive outcomes”, having observed that even in patients on

Mahmood Razavi

Neelan Das

three antihypertensive medications, blood pressure was reduced by 20mmHg following RDN. Since then, several second-generation RDN trials using multielectrode technology and adjacent ultrasound techniques have been reported to cause a

You can very simply assume that without industry support, RDN would not survive” Franz Messerli

significant reduction in blood pressure compared to sham control groups. Presenting at the 2024 Charing Cross (CX) International Symposium (23–25 April, London, UK), Neelan Das (East Kent Hospitals University NHS Foundation Trust, London, UK)— presenting in a session dedicated to the developing evidence in support of RDN’s return—exemplified the 2023 Recor Medical-sponsored RADIANCE II trial results as proof of this fact.

Das described the study as the largest trial to compare ultrasound RDN to a sham control. The trial highlighted the statistically significant improvement in blood pressure in patients who were taken off antihypertensive medication for four weeks, with a sustained benefit at night to prevent the deleterious effects of nocturnal hypertension. In November 2023, the Paradise (Recor Medical) RDN system used in the RADIANCE II trial was approved by the US Food and Drug Administration (FDA), followed closely by the Symplicity Spyral RDN Lindsay Machan system (Medtronic) in the same month.

Then, Das detailed the current European Society of Hypertension (ESH) and UK National Institute for Health and Care Excellence (NICE) guidance which suggest RDN should only be used in patients who have resistant hypertension, are intolerant to medications, or are on fewer than three medications. This guidance, however, contrasts the findings of the RADIANCE II trial, he stated, which provided a significant reduction in blood pressure “overall, even without antihypertensives”. “I do believe that there is a role for RDN in this difficultto-treat group,” he concluded.

Lindsay Machan (The University of British Columbia, Vancouver, Canada) also presented in the CX 2024 session, and stated: “Looking at the historic headlines, everybody here would think this is a dead technology and assume that it shouldn’t resurface—why is it alive again? The answer is new information. We have new information for physicians who treat hypertension—of the 116 million adults in the USA with hypertension, less than half are controlled and this rate of control is falling off. Nobody entirely understands why.”

However, with the advent of this new information, access to RDN remains a challenge in locations worldwide. As Razavi highlighted, difficulties have arisen when seeking reimbursement—“although two devices are approved by the US FDA, we cannot offer them to our patients as there is no reimbursement from Medicare or from private insurance companies. This means patients realistically have no access to the technique.”

RDN continues to divide opinion. As industryled data emerge to show that the technique can provide a significant reduction in blood pressure long-term, some clinicians remain dubious. “We need more refinement that correlates various physiological characteristics with outcomes— without refinement which tells us who will benefit from which type of technology, we won’t know who needs RDN. But, we are learning and progressing, and over the next several years we will know who responds best,” Razavi said.

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8

August 2024 | Issue 95

CIRSE Preview

CIRSE

Get what you want from your career: CIRSE Women in IR workshop to raise resilient interventional radiologists Taking place at the 2024 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal) the Women in Interventional Radiology (IR) focus session will include a brand-new forum. Taking place on Saturday afternoon, the inaugural Women in IR workshop: ‘Influencing with authenticity and assurance’ wants attendees to leave with actionable strategies to gain confidence at work. Speaking to Interventional News, Alex Barnacle (Great Ormond Street Hospital, London, UK) tells of what may be holding female interventional radiologists back, and the soft and hard skills needed to lead a room and command attention.

the opportunity to deeply reflect on these things. I suspect that we often do ourselves a disservice by being uncertain in knowing how to project ourselves in the workplace and thinking we may be open to judgement. And for whatever reasons, men seem to struggle with this less often, though it is by no means a female-only problem.

IN: The sessions are geared toward mid-career interventional radiologists.

Why is this and do you think earlycareer interventional radiologists would also benefit from this training?

We suspect that today’s mid-career consultants have probably never had any opportunities for this kind of training, it just doesn’t come up. Leadership and coaching themes are becoming more of a thing for junior doctors coming up through the ranks, and there are various mentor schemes available for younger doctors. So there are a few forums where some of these valuable conversations are taking place for our future IRs and that is wonderful. But will focus on three different aspects of how women when I was training, there was never a focus on can be at our best in the workplace. Sarah will join these aspects of building a successful career. I know Alex Barnacle a group of female interventional radiologists on many women who are mid-career and who feel stuck, stage in the morning to look at the role of mindset in who wish that they could be on stage speaking at shaping success in the workplace, building resilience CIRSE, who wish they could be become a principal in high-stress environments and the role of non-verbal investigator on a research study, who wish that they communication. could put themselves forward for a committee or a writing group, but just don’t feel that they have the IN: In the promotional video for the confidence or the ability to do that.

Women in IR session at CIRSE this It’s those women that I am interested in right year, Perugia explains that female now. CIRSE has a huge group of highly talented body language and outward femininity females who are out there doing really amazing work makes it harder to “tell the story of already, but their expertise may be under-recognised power”—do you feel that femininity at national and regional levels because they do not cannot be synonymous with power put themselves forward. They remain very hesitant and leadership in IR? at taking that next step. And we see evidence of this We all know that we should be confident in being quite often, we don’t always get a yes from women who we are and as feminine as we want to be, but it when we encourage them to step up to these roles. is something that many women in a male-dominated I know there are many, many reasons for that and environment struggle with. Each of us need to find some of it may well be work commitments as well as IN: What is the purpose of the Women our own way to do it, and different people will do family life, but there is also a confidence issue that in IR workshop and the new format? it in different ways. Some women are naturally underlies it in many cases. We want those women The annual Women in IR session that is part of more feminine in their style or their outlook than to be flourishing in their careers to the best of their the CIRSE programme every year is always a big others, but it is something that I think preys on some ability and recognised for being IR experts. So that’s success, but we were keen to add something more for people’s minds, especially early in a career when what we are trying to achieve by providing these 2024. This year, the CIRSE meeting will include a interventional radiologists are working to establish building blocks for them. focused workshop for mid-career female consultants their credibility and figuring out how to express their in IR led by a wonderful leadership coach, Sarah professional expertise and fit in with a team.

IN: You have gathered applications Perugia. Sarah is well known to many of us in the All of this is often an unspoken thing, too. When for the workshops, asking potential leadership space. She brings expertise in working I ask female colleagues about this, they often attendees what they would like to take with diverse teams and women in leadership from admit to concerns about feeling less equal than from the forum. Can you share what around the world. Her focus is on empowering leaders others in the workplace or about how to express some of the most common responses to advance their careers, build confidence, enhance themselves confidently at work without being have been? their performance in the workplace and ultimately to labelled as aggressive or ‘bossy’. But there are very We had so many honest and open responses. Many flourish and thrive. few forums that provide space for us to have these attendees hope to gain a better understanding of how During the two-and-a-half-hour workshop, Perugia honest conversations or explore solutions. In the their body language changes how they are perceived will help participants to explore their mindset at workshop, Sarah will look at all this in detail. I think by others and how they can express themselves with work and reflect on how they present themselves it will be really valuable, because women rarely get greater confidence at work. Frequently, responders in both clinical situations and during meetings or reported that they feel unseen in the workplace, one presentations. She will provide tips and tricks to woman sharing that patients often assume her to be help women gain confidence in order to lead with a technician or nurse when male counterparts are in assurance, yet stay true to themselves. There will be the room. Others have said that, although they are opportunities for the workshop delegates to present confident in their knowledge, transmitting this with topics to each other, discuss what might be holding confidence to colleagues and patients can be difficult, them back in their career journeys and reflect on and they are concerned that this then lessens the new ways to approach the challenges every single importance of their viewpoint; this can be critical one of us face at work, male or female. By limiting in emergency clinical scenarios. Several said they this workshop to a small number of delegates and wanted to feel more self-asurred when presenting allowing plenty of time to explore these themes in and wanted to gain the confidence to push themselves depth, we hope to give participants a unique space forward for new roles. To address these concerns, to focus on themselves and their careers in a way we hope to provide the workshop attendees with that is almost never afforded them in their busy constructive, actionable ways to project themselves everyday lives. with more self-assurance, increase their influence in This Saturday afternoon workshop will follow on the workplace and work towards building the careers very well from the morning plenary session which they dream of.

We all know that we should be confident in being who we are and as feminine as we want to be, but it is something that many women in a male-dominated environment struggle with”

Issue 95 | August 2024

CIRSE Preview

CIRSE

From immobility to mobility: 36-month MOTIV BTK results set to show significant clinical improvement “A significant number of patients could clinically improve and turn from being unable to walk, having ulcerations and pain, to a stage without open wounds, less pain and improved mobility,” said Thomas Rand (Klinikum Floridsdorf, Vienna, Austria) in conversation with Interventional News, giving insight into the 36-month results from MOTIV bioresorbable scaffold (Reva Medical) below-the-knee (BTK) trial set to be delivered at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal).

AT CIRSE 2023, RAND SHARED the trial’s “excellent” 24-month outcome data, which showed a 2% clinicallydriven target lesion revascularisation (CD-TLR) rate and 95% limb-salvage rate among their patient cohort. Rand also reported high primary patency of 81.7% at 24 months and presented a 98.3% clinically driven target lesion

revascularisation outcome.

“The positive results regarding patency rates have continued, particularly in regard to clinical results such as improvements in Rutherford stage. This is what really counts,” Rand stated. Having presented specific patient cases to exemplify their results during

last year’s presentation, Rand hopes to once again display those patients who have improved from “immobility to mobility”, he said. “Being able to witness the healing of an ulcer is really impressive and showing this will send a simple and positive message.”

Commenting on the running of the trial, Rand shared that dropouts have been an issue given the long time period and the level of disease these patients are experiencing.

“Most have other severe comorbidities and are in a rather high age group,” Rand said, while adding that

The positive results regarding patency rates have continued, particularly in regard to clinical results”

Minimal IR “survival kit”: What you need to know about trauma care “When providing a 24/7 interventional radiology [IR] trauma service, sometimes our procedures are expected to be concluded in few minutes. That’s why it’s important that we approach patients with a clear strategy,” said Anna Maria Ierardi (University of Milan, Milan, Italy), speaking to Interventional News ahead of her presentation titled Minimal IR “survival kit” within trauma care.

Image_credit

I

erardi’s talk will appear during the Trauma team and with the most unstable and shocked patients without the role of IR session at this year’s Cardiovascular arterial pulses, so it’s important to be familiar with and Interventional Radiological Society of ultrasound guidance.”

Europe (CIRSE) annual scientific congress (14–18 In modern hospitals, the hybrid trauma room is September, Lisbon, Portugal). Setting out her equipped with a sliding computed tomography objectives, Ierardi described what variables (CT) scanner—a feature which she stated contribute to a successful IR trauma is becoming more widespread across service.

European and international centres.

“Our team is often faced “This is the ideal situation,” with unpredictable situations she explained, “with this set up, in which time is crucial,” she specialists don’t need to move detailed. “For us, it’s mandatory the patient for a CT, so when the to have every tool available in patient arrives, they do not need order to choose the most suitable to be mobilised until treatment technique and to go with what is concluded, when they are then we are most comfortable with.” transferred to the intensive Among the devices used in this care unit”. setting, Ierardi defined what is needed to Another crucial aspect of the IR trauma perform resuscitative endovascular balloon Anna Maria team is cooperation between personnel, occlusion of the aorta (REBOA)—a Ierardi Ierardi shared. She believes that cooperation procedure for patients with life-threatening between trained interventional radiologists bleeding not responding to resuscitative manoeuvres. who usually work together on both elective and “A REBOA kit includes a needle, a sheath, trauma cases makes a successful team. “It’s so that guidewire, and balloon. In my opinion, to they know each other and are confident that they work perform REBOA in a trauma setting, it should be in an effective and complementary way. Good results a requirement to be able to get the access with are dependent on the team being tight-knit.” ultrasound guidance,” Ierardi said. “You are faced Ierardi went on to describe the differences in

9

some patients were lost to cancer. He stated however that the vast majority of patients in their cohort remain engaged due to the improvements they have seen in their health status.

In previous data presentations, Rand highlighted the bioresorbable nature of the MOTIV scaffold and its potential to promote a “leave nothing behind” approach. Now, Rand noted that, although this is a “good and strong” concept, it is of course not the only option.

Generally treatment Thomas must always be Rand individually adapted to the vessel status of each patient.

“Uncountable sessions and discussions have been filled with this topic, and yes, I maintain that there are well-established concepts, however I feel that patients and colleagues have had an increasing interest in combined treatment using drug-eluting devices and resorbable stents,” Rand detailed.

In anticipation of his presentation during the FIRST@CIRSE session on Saturday 14th, Rand believes that these data will increase interest in the technique and concept behind it, and predicts that this will once again draw a large crowd.

skillset between interventional radiologists who deal with elective cases and those who deal with trauma patients, stating that the latter, in her opinion, must be “very experienced”. “A good background— equating to long-term experience as an interventional radiologist—should translate well to the fast-paced environment that trauma care demands,” she added.

During her presentation, Ierardi will describe memorable cases from her centre that exemplify the scenarios her IR trauma team often encounter.

Reflecting on how these cases went, Ierardi shared that often, cases that occur during the night are harder to manage.

Good results are dependent on the team being tight-knit” “A big problem in this setting is that interventional radiologists are usually on call during the night.

During the day, when all specialists are on-site, we can all be a part of the decision-making process along with orthopaedics, surgeons and anaesthesiologists,” Ierardi said. However, during the night or over the weekend, interventional radiologists are usually called in and must travel to the hospital when the diagnosis is already finalised and the indication for embolization has been determined by specialists. In most cases, the result is that the delivery of treatment is inevitably delayed, she said.

In setting out the “modern reality” of the IR trauma setting and the crucial elements that make up a 24/7 service, Ierardi invites all attendees to map their teams’ successes and failures to outline where improvements can be implemented to better approach the most critical of cases.

August 2024 | Issue 95

10 Embolization

GAE for mild knee osteoarthritis deemed “safe” with unexpected neuropsychological effect A new study has determined genicular artery embolization (GAE) to be a “safe intervention” for mild knee osteoarthritis (OA), showing a sustained benefit at two years. Published in the journal CardioVascular and Interventional Radiology, the authors state that the “learning curve” reflected in their technical success rates uncovers the “complexities” behind the safe and successful performance of GAE. THE STUDY, TITLED GENICULAR ARTERY embolization in patients with osteoarthritis of the knee (GENESIS) and led by Mark Little (Royal Berkshire NHS Foundation Trust, Reading, UK) et al, is a National Institute for Health and Care Research (NIRH) portfolio single-centre prospective trial which recruited patients presenting to the orthopaedic department at Royal Berkshire Hospital in Reading.

Patients were aged 45 years or older with mild-tomoderate knee OA, defined as Kellegren-Lawrence grade 1–3, who had experienced pain for more than six months despite conservative management.

Little et al enrolled 46 patients with a median age of 60 years, performing GAE using 100–300μm Embosphere (Merit Medical) permanent particles diluted in 20ml (300mg/ml) iodinated contrast (Iomeron). Technical success—defined as embolization of the targeted genicular artery—was achieved in 40 patients (87%) and mean visual analogue scale (VAS) improved from 58.63 (standard deviation [SD] 20.57, 95% confidence interval [CI] 52.7–65.5) at baseline to 37.7 at two years.

The authors also assessed knee injury and osteoarthritis outcome score (KOOS) which they state showed significant improvement at six weeks, three months, one- and two- year timepoints, with

associated reductions in analgesia usage. Concerning complications following GAE, Little and colleagues observed a self-limiting groin haematoma and a single case of deep vein thrombosis due to immobilisation, which they say highlights the importance of early mobilisation post GAE.

Embolization can be utilised in this cohort without being prohibitive of further surgical intervention”

Further, Little et al detail that nine patients underwent total knee replacement following GAE but when followed up post-surgery, no intraprocedural issues or adverse events were experienced by the operating surgeons or the patient. “This

Mark Little

provides further support for the procedure’s utility in those with mild-moderate disease,” the authors state, “as it appears that embolization can be utilised in this cohort without being prohibitive of further surgical intervention in cases of disease progression.”

The authors also carried out functional magnetic resonance imaging (MRI) and psychometric assessments, observing an “unexpected” correlation between baseline catastrophising—maladaptive pain cognitions—and greater reduction in pain post GAE. The authors note that these findings may suggest that patients who catastrophise at baseline experience a bifold improvement.

“The neurological data suggest that those who catastrophise at baseline are associated with higher functional connectivity between pain modulatory and processing regions of the brain, perhaps representative of frequent dependency on pain modulation. These patients could be benefitting from a successful reduction in nociceptive signalling via embolization and an overreliance on pain modulatory circuitry.”

Remarking on the operator learning curve visible in their technical success data, the authors identify that a “thorough knowledge” of genicular vascular anatomy, including a “myriad” of anastomoses and non-target tissues supplied by these vessels, is crucial to obtain good technical outcomes. They explain that improved anatomical understanding and the application of intraprocedural cross-sectional imaging has enabled GAE to be undertaken in more complex cases today.

Of their limitations, the authors highlight their small sample size, the lack of an experimental control group and note a placebo effect which “requires consideration” when evaluating modes of treating pain. Going forward, the team detail the GENESIS 2 randomised sham-controlled trial which will consider the placebo effect “inherent with GAE”. Little et al note that they are currently recruiting patients for this study and hope to build on experiences gained from the current work.

ET

Gelatin embolization efficacy data aims to lift regulatory embargo “Yes, we know that gelatin sponge works, but I believe that these are vital data to show that what we do is safe and effective, and to guide regulatory approval not only in Australia, but internationally,” said Warren Clements (Alfred Health, Melbourne, Australia), presenting preliminary efficacy results using EmboCube (Merit Medical) embolization gelatin to control haemorrhage.

CLEMENTS SHARED THESE results at The European Conference on Embolotherapy (ET) annual meeting (1–4 June, Vienna, Austria), ahead of a further data release at the Cardiovascular and Interventional Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal).

“We know that uncontrolled bleeding is a leading cause of preventable death following trauma, and embolization has become an important facet of the management of haemorrhage in this space,” Clements stated. He described that, over the last 10 years, open

surgery has been common in these patients, but now a “shift” toward endovascular techniques is taking place.

Charting the course of gelatin embolization, Clements highlighted that this technique was reportedly first used in 1967. “Why are we doing a study looking at gelatin when we know it works?” he asked the ET audience.

In response, he explained that, often in interventional radiology (IR), clinicians adopt a technique that works and begin using it without gaining the “right data” to prove why.

“What happens is jurisdictional

and regulatory bodies then step in,” the vessels treated were significantly Clements said. In Australia, Gelfoam heterogenous, pointing out that the sponge (Pfizer) is currently off-label hepatic artery, uterine artery and for endovascular use following an pelvic artery were among the most embargo that was placed in May 2021. commonly treated.

Previously, Gelfoam was favoured for Technical success was achieved gelatin embolization procedures. in all patients with no complications Clements et al, in the introduction to recorded with the use of gelatin. their study, note that this embargo Clinical success was reported did not reflect Australian as 98% due to two IR user experience, patients requiring which largely believed repeat intervention.

Gelfoam to be a “highly Additionally, he noted effective” life-saving a 7% rate of all-cause tool. Providing evidence mortality, which, for their experience, when considered in Clements outlined their this patient population multicentre, prospective which experience multicohort study which enrolled system trauma including 100 patients experiencing neurological trauma, a 7% haemorrhage. Their primary Warren Clements rate of mortality—a rate endpoints were defined as lower than general pelvic safety—the absence of unanticipated trauma management—is a “good rate”, serious adverse device-related effects Clements said. within 24 hours, and effectiveness— He underlined that gelatin foam is technical success and clinical success, safe and effective, despite this being or the cessation of bleeding within 24 somewhat known already. However, in hours post-procedure. collecting these “vital” data Clements In this patient population, the mean hopes to guide regulatory approval in age was 56 years, and 48 patients were Australia to prevent future embargoes reported to be taking anticoagulants being placed which restrict clinicians’ or antiplatelets. Clements stated that access to efficacious tools.

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August 2024 | Issue 95

12 Conference Coverage

GEST

Bariatric embolization deemed relevant in combination with medication for optimised obesity therapy

In a session titled ‘Bariatric embolization: Is it the end or a new resurgence?’ at the Global Embolization Oncology Symposium Technologies (GEST) annual conference (16–19 May, New York, USA), Clifford Weiss (Johns Hopkins University, Baltimore, USA) made a case for “his future” and the future of bariatric embolization, providing the capability to “do surgery without doing surgery” to treat a highly comorbid patient population suffering with obesity.

FIRST, PLACING EMPHASIS ON the severity of the obesity crisis in the USA, Weiss relayed that a dataset collected by Nima Hafezi-Nejad (Johns Hopkins University, Baltimore, USA) et al, found that 22 states reported an obesity prevalence of over 35%.

However, he noted that the comorbid nature of obesity, which causes sleep apnoea, cancer, pancreatitis, diabetes, heart disease, and suicide and depression, is fundamentally “what kills”.

“Minority populations in particular are heavily hit by this disease. We also know that annually, there’s an aggregate of US$260 billion spent on obesity

and obesity-related illnesses in the USA. This is a deadly disease causing significant excess mortality annually.

We need effective treatment options and I think we can all agree with that,” Weiss stated.

He explained that treatments for obesity are most effective and show the highest mortality signal improvement when sought intentionally, “in other words, you don’t seek to lose weight because you’re sick—this is the argument for why we need patients to be healthier and thinner. It’s not to look better at the beach, but it’s to be clinically healthy”.

Treatments can range from extreme,

such as surgery, which is the “least month results also show “soft signs” of accepted but the most effective”, improvement, such as cardiovascular he stated, to lifestyle modification. markers, changes in hunger and qualityHis focus, however, is on the of-life scores, each showing statistically pharmacotherapy treatments which sit significant values post-BAE. in the middle and include interventional Regardless of his allegiance to radiology and gastroenterology devices.

BAE, Weiss stated that the current US When performing bariatric artery investment in anti-obesity medications embolization (BAE), the targeted (AOMs)—such as Ozempic (Novo intra-arterial therapy delivers Nordisk)—is valuable. “I didn’t the embolic to the gastric want to avoid this. We have fundus, defunctionalising it really good drugs on the and causing a mechanical market right now that are shift which affects ghrelingetting an easy 15–20% producing cells, or hungerweight loss, so is there stimulating hormones, relevance to [BAE] still?”

Weiss described. “We downIn Weiss’ belief, BAE still regulate these cells, turning provides a crucial and relevant Clifford them off rather than cutting benefit to this patient population Weiss them out.” as medication persistence—which Weiss went on to provide an update is a prevailing issue with AOMs—can on the ongoing BAE of Arteries be avoided. with Imaging Visible Embolics “When you take these medications (BEATLES) trial—of which he is away, the benefits go away with them, principal investigator. He detailed that almost back to baseline. The current participants with a body mass index AOM guidelines state that these are (BMI) of ≥40kg/m2 with no other lifetime medications, yet that’s a comorbid conditions underwent BAE problem—many patients don’t qualify with 300–500µm Embospheres (Merit and adherence can be as low as 27% Medical), which at six months, show after the initial weight loss. So, can we a 7.6% weight loss or a 60% excess have a combination strategy to mitigate weight loss. recidivism and dependence “What we’re doing in this trial is on medication?” looking at whether this is fat loss or Finalising his talk, Weiss advocated muscle loss, and multi-compartment for the cost-effectiveness and efficacy [magnetic resonance imaging] MRI of combined pharmacotherapy and shows that we were losing subcutaneous embolization, for the dual benefit fat and liver fat, while muscle volume of patients as well as national and remains steady,” he said. Their sixinternational healthcare systems.

Miyuki Sone spotlights women’s empathy as crucial part of any IR team “It’s a boy’s club. If the only examples of success are men, it becomes harder for women to envision themselves in those positions.” These were the words of Miyuki Sone (National Cancer Center, Tokyo, Japan)—head of interventional radiology (IR) and consultant radiologist—during her honorary lecture at the Global Embolization Oncology Symposium Technologies (GEST) annual conference (16–19 May, New York, USA).

SONE’S TALK COVERED A PLETHORA OF position and 55% reported having a mentor, of which issues faced by women in IR, including visibility and 88% stated that their mentor was male. social and cultural barriers. Speaking to Interventional These numbers have remained low, Sone reporting News following her lecture, Sone first and foremostly that in 2023, only 40% of Japan’s new medical emphasised empathy in the IR suite. students were women, and further, only 13% of those “Women are more capable of empathy than men,” with JSIR membership were women. “When women Sone explained, describing the 2023 report published see other women thriving in IR, they can envision in Nature which found women to be superior to men themselves in those roles,” she said. “We need to in displaying empathy and compassion, but found men promote a self-reinforcing cycle where more women and women equal when expressing theory of mind— are encouraged to join and excel in the field.” the inference of others’ emotional status. “If However, women who have gone into IR you include women in your IR team, you in Japan report high job satisfaction, Sone can build an empathetic environment which stated, having conducted another survey is translated to the patients,” Sone said. to measure this regardless of gender.

“This nurturing environment is crucial for Receiving 901 responses from a total of the development and retention of talent, 2,824 recipients, 56% reported high job particularly in women who may face unique satisfaction, which was positively associated challenges in their career.”

Miyuki Sone with a higher number of IR procedures and Recruiting women to the team however negatively associated with salary, overtime remains Sone’s initial challenge. In her talk, she shared and the absence of an “IkuBoss”—a person who data from a 2019 survey carried out by the Japanese manages the working environment and supports workSociety of Interventional Radiology (JSIR) which life balance. compared membership, leadership, and mentorship “My young colleagues have a different mind as they with that of the Cardiovascular and Interventional are of another generation,” Sone explained. “They care Radiological Society of Europe (CIRSE). Of more about their family and believe that if they are not the 304 women who were members of JSIR, 63 happy, the patient can’t be happy. It’s my belief that responded—79% of whom did not hold a leadership happiness should come from both work and private

life, so I always tell my colleagues: ‘your life and your family are your first priority—if you want to go early to take care of your children or go out and enjoy a concert, just manage your time and we can manage the team together.”

To her point on time management, Sone then used the 2017 paper titled ‘Women’s challenges in IR: #ILookLikeAnIR’ as an example of the positive retentive outcomes that occur when work-life balance is prioritised. The paper discussed the six-strong team of women interventional radiologists at Memorial Sloan Ketting Cancer Center in New York, USA, who organise their team according to preferred working hours. Their team channels add-on inpatient cases to prespecified rooms, ensuring that colleagues who require a scheduled finish are able to leave on time, enhancing the quality of life of their male and female colleagues.

Through her honorary lecture, Sone highlighted the crucial “drivers of change” that will be led by “individuals, allies, sponsors, institutions and through organisation structures”.

“I was fortunate to have the opportunity to speak at GEST particularly on the topic of women in IR. The conference organisers were early adopters in terms of diversity and inclusion. It was excellent to connect with people around the world and talk about strategies to increase the number of women in our field.”

We need to promote a self-reinforcing cycle where more women are encouraged to join and excel in the field”

Issue 95 | August 2024

Conference Coverage 13

EVA MEETING

AVeNEW trial shows superior AVF target lesion patency with covered stent placement “Study design is critically important when interpreting outcomes,” said Bart Dolmatch (Mountain View Hospital, Mountain View, USA) in his evaluation of the “disconnect” between target lesion primary patency (TLPP) and access circuit primary patency (ACPP) analysing AVeNEW study data at this year’s Endo Vascular Access (EVA) meeting (14–15 June, Patras, Greece).

A

VeNEW is a prospective and randomised study, which compared outcomes using the Covera (BD) vascular covered stent versus percutaneous transluminal angioplasty (PTA) for the treatment of stenotic lesions in the venous outflow of upper-extremity arteriovenous fistulas (AVFs).

Composed of 280 patients enrolled at 24 sites in the USA, Europe, Australia, and New Zealand, 142 patients were randomised to treatment with Covera and 138 patients to PTA. Alongside criteria stipulating that enrolled patients have a 50% or greater target stenosis and evidence of dysfunction, Dolmatch noted Bart that non-target stenoses were Dolmatch also allowed, but could only be treated with PTA. Primary outcomes were 30-day safety and six-month TLPP, powered to test whether TLPP after covered-stent placement was superior to PTA alone.

Twelve-month TLPP and six-month

ACPP were also evaluated while additional clinical outcomes were observed through to two years.

Dolmatch stated that their results showed comparable and non-inferior safety for the PTA group compared to the group treated with the covered stent, while the covered stent group had superior TLPP and fewer target-lesion reinterventions through to 24 months. In terms of efficacy, he added that they saw a “very significant” improvement of TLPP for the covered stent group, which was 30% more than TLPP for the PTA group at six months. “However, that’s the target lesion,” he said, stating that when they looked at circuit patency, it appeared to be numerically better for patients who received the covered stent, but not statistically superior.

“So you have to wonder, why was TLPP superior, yet ACPP was not statistically better for the covered stent group?” Answering this question, Dolmatch suggested that this is largely related to the study protocol which allowed enrolment of patients with non-

target stenoses that were found in roughly one third of all patients enrolled in the AVeNEW trial. Per protocol, non-target stenoses could only be treated with angioplasty. While this reduced primary circuit patency for both groups, there were randomly more non-target stenoses in the covered stent group. Early recurrence of non-target stenoses after PTA led to a disproportionally greater loss of circuit patency in the Covera group, even though the target treatment site had better patency with the covered stent.

He offered pros and cons for including patients with secondary stenoses in this type of randomised, prospective clinical trial. By including patients with non-target stenoses the AVeNEW study was closer to a “real-world” experience since many dysfunctional AVFs will often have more than one stenosis. Furthermore, faster enrolment was possible by including patients with non-target stenoses. Yet, Dolmatch noted that primary circuit patency was more quickly lost due to non-target stenosis, even though the target lesion had a superior outcome with the covered stent. He recommended treating both target and non-target stenoses with the mode the patient was randomised to, PTA or covered stent, in order to better address the impact of target lesion treatment upon circuit patency.

Dolmatch reiterated the importance of study design when interpreting outcomes, and believes that the markedly improved TLPP with the covered stent reiterates the benefit of using covered stents in AV access circuits. He concluded by stating that more data is on the way, with results from the postapproval AVeNEW study of 100 consecutive patients treated with the Covera covered stent to be presented at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal).

Join us at CIRSE 2024

SATELLITE SYMPOSIUM Sunday, September 15, 2024 | 11:30–12:30 | Location: Auditorium 2

Treating Synovial Arterial Hypervascularity in the Knee Joint: What We Know and What We Still Need to Know. Data, Cases & Research.

The symposium provides an overview of the current understanding, the latest findings and ongoing research in the treatment of synovial arterial hypervascularity of the knee joint. It highlights the therapy’s potential as a novel treatment option and the necessity for continued research to fully comprehend its long-term outcomes and optimal application in clinical practice. Personal clinical experience will complement the presentations.

LECTURES AND FACULTY GENESIS I: Time for prime time M. Little (Reading/GB) To be permanent or not to be permanent? This is the question.

An answer from the GAUCHO Trial M. Picada Correa (Passo Fundo/BR) What does the future of GAE look like? A lens on the MOTION Randomized Control Trial C. Bent (Dorset/GB) Challenges, Efficacy & Safety: from literature to practice Y. Okuno (Tokyo/JP)

M. Little

M. Picada Correa

C. Bent

Y. Okuno

(Reading/GB)

(Passo Fundo/BR)

(Dorset/GB)

(Tokyo/JP)

August 2024 | Issue 95

14 Paclitaxel Controversy

Work still needed to mitigate patient harm, concludes CX 2024 paclitaxel roundtable

“M

ortality is what [regulatory bodies] were dealing with; they had to be intensive and conservative in their process. Now, we just need to move forward and get back to where we were with treating our patients,” said Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) during a Charing Cross (CX) Symposium (23–25 April, London, UK) roundtable. Speaking to CX co-chair Andrew Holden (Auckland City Hospital, Auckland, New Zealand), the pair discussed the salutatory lessons learned following regulatory body restrictions on paclitaxel-coated devices.

This followed Secemsky’s late-breaking presentation, during which his team determined that “unfortunately, we are doing worse for our patients today”, and confirmed for the packed standing-only audience, that more patients in the USA today are undergoing amputation and death than they were prior to the Konstantinos Katsanos (Patras, Greece) et al 2018 meta-analysis.

“It was an exciting year last year, because we had been slowly building mounting data for paclitaxel devices. After the controversy started, the response was: how do we confirm that this is wrong but with the right data?” Secemsky then mapped the “surprisingly quick” beginning of the end for the controversy with the patient-level meta-analysis set out by William Gray (Lankenau Heart Institute, Wynnewood, USA), Sahil Parikh (Columbia University Irving Medical Center, New York, USA) and Peter Schneider (University of

California San Francisco, San Francisco, USA).

“The US Food and Drug Administration (FDA) were swift to respond, to their credit,” Secemsky said.

Holden, in agreement, reflected on the prompt updates the US FDA had provided on the matter in 2023, while the UK Medicines and Healthcare products Regulatory Agency (MHRA) only followed suit earlier this year. “Interestingly,” Holden added, “in many parts of Europe clinicians don’t have that clear guidance covered by those two regulatory bodies.”

“This was shocking,” Secemsky responded. “We know that many global regulators look to the USA for guidance. Typically, the MHRA moves a little more slowly, but they followed the [US] FDA quickly.

We’re still waiting on the rest of the world to catch up.

I’m unsure whether this is delayed due requirements accessing the necessary safety data or whether local data is needed, but we still have room to go to get practices back to where they were.”

Recalling a question posed to challenge Secemsky’s data during his session, Holden asked if there were any unintended consequences in halting access to a “very efficacious” tool i.e. paclitaxel-coated devices.

In his response, Secemsky noted first that, when this question was asked of the US FDA, their response in essence was that mortality is the “ultimate” endpoint.

If it was something “I don’t want to say ‘benign’— but something less terminal, there would have likely been a different approach”, he added. But, Secemsky reiterated that during the period in which physicians could not access paclitaxel devices, patients were harmed, reporting in his presentation that the risk of amputation or death was identified in 40.4% and 43.2% of patients in the pre- and post-paclitaxel period, respectively.

“The risk to patients isn’t only as severe as death and amputation, however,” Secemsky explained.

“Needing another intervention, taking time off work to be hospitalised each time that vessel fails—that’s a risk

Paclitaxel puzzles

Konstantinos Katsanos Point of View Following his recent statement titled ‘Paclitaxel meta-analyses in the lower limbs: Missing the trees for the forest’ published in the June issue of The Journal of Vascular and Interventional Radiology, Konstantinos Katsanos (University Hospital Patras, Rion, Greece) imparts his final word on the paclitaxel controversy, surveying the key meta-analyses data that moved the needle.

M

ore than five years ago we documented an increased longterm risk of all-cause death with the use of paclitaxel-coated devices in the femoropopliteal artery that sparked an intense scientific debate and flurry of research articles pursing to elucidate the actual risk of death associated with such devices in the peripheral arteries.1 Of note, our findings were soon corroborated by an individual patient data (IPD) meta-analysis of US Food and Drug Administration (FDA)regulated paclitaxel devices.2 However, several follow-up observational studies

have failed to replicate the survival detriment in real-world cohorts and the latest version of a similar IPD metaanalysis with more complete followup has found no significant mortality risk.3 Consequently, several regulatory agencies have recently exonerated paclitaxel from the death stigma in the lower limbs.

Certainly, this remains one of the most puzzling scientific questions and one needs to carefully review the design and quality of enrolled studies, the dosage and pharmacokinetics of the devices tested, the patient case mix

Andrew Holden and Eric Secemsky

The risk to patients isn’t only as severe as death and amputation” Eric Secemsky

to the patient. When we look at drug-coated devices, we’re not looking to save the world, we’re looking to get patients out of the hospital, make them functional and give them a good quality of life for as long as possible.”

Holden then asked whether this “sorry event” may influence how meta-analysis data is examined, to which Secemsky replied that the most important aspect when looking at any data is to “take a look under the hood”.

In his opinion, despite meta-analyses sitting at “the top of the pyramid” of clinical evidence, this “doesn’t mean it was done correctly or with the right data”.

“For me, a big part of this is to say—let’s step back, let’s understand why this was done, let’s understand the data that went into it, let’s understand if this is the right approach and not be swift with our decision-making until we’ve done that process,” Secemsky said.

differences, and of course the rigour of the statistics methods employed in the analyses. For starters, cause-andeffect questions (i.e. does paclitaxel in the legs increase risk of patient death?) are best answered by appropriately designed randomised controlled trials (RCTs) alone that by design suffer from reduced confounding and other bias compared to observational studies. To build on this, a recently updated studylevel summary of 27 studies with 5,502 patients produced a significant risk ratio of 1.28 (95% confidence interval [CI], 1.04–1.58; random effects model) at two years, contrary to the reassuring patient-level results of Parikh et al from 10 RCTs with 2,666 patients at 4.9 years (Hazard ratio [HR]: 1.14, 95% CI (0.93–1.40), frailty Cox model).3,4 From a critical perspective, the latter meta-analysis of industry-sponsored analyses are missing a significant number of studies from our original 2018 meta-analysis with selective inclusion of mostly low-dose trials.

Apparently, the latest IPD analysis suffers from selection bias being dominated by the low-dose devices and missing a significant amount of evidence from the rest of the devices. Therefore, the original paclitaxel mortality signal has been obviously diluted, but most likely not invalidated.4 So, how can we consolidate our understanding so far of the relationship between paclitaxel in the lower limbs

and potential risk of death, and what should be the next steps? Certainly, the subgroup of low-dose paclitaxelcoated balloons has appeared to be safe since our original meta-analysis, but the IPD data silo built by the industry (with the exception of Cook Medical) along with the complexity of paclitaxel chemistry, pharmacology and tissue bioavailability still precludes any definitive conclusions. In addition, upon observation of diverse treatment effects between trials and time periods, one also needs to consider patient case mix differences and changes in medical science and practice over time.

Therefore, an informed patient and doctor’s decision remains the wisest choice as advocated by our teachers a long time ago.

References: 1. Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc 2018; 7:e011245.

2. Rocha-Singh KJ, Duval S, Jaff MR, et al. Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis. Circulation 2020; 141:1859-1869.

3. Parikh SA, Schneider PA, Mullin CM, et al. Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis. The Lancet 2023; 402:1848-1856.

4. Katsanos K. Journal of Vascular & Interv Radiol Published:June 04, In press, 2024 DOI:https://doi. org/10.1016/j.jvir.2024.05.018.

Konstantinos Katsanos is a consultant vascular and interventional radiologist, specialising in endovascular, spine and oncology at the University Hosptial Patras, Rion, Greece.

Issue 95 | August 2024

Q&A 15

VENOUS THROMBOEMBOLISM

Thrombectomy gold rush set to follow ATTRACT study, experts argue At the recent Endo Vascular Access (EVA) meeting (14–15 June, Patras, Greece), Ziv Haskal (University of Virginia School of Medicine, Charlottesville, USA) spoke to Timothy Clark (Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA) about what they referred to as the “gold rush” of thrombectomy devices for large-calibre blood vessels.

Haskal: Is this truly the “gold rush” in thrombectomy devices? Or does this landscape hold no promise?

Clark: There is no question that the portion of patients who are treated with thrombectomy is a small fraction of the number of patients presenting with deep vein thrombosis (DVT).

There are differing estimates—we are currently treating somewhere between 4–12% of DVT patients with thrombectomy—you can look at the data and think that that is appropriate, or you can think that that is vastly underutilising endovascular therapy.

In the USA, there is only the Acute venous thrombosis: Thrombus removal with adjunctive catheter-directed thrombolysis (ATTRACT) trial that has level one data, and the ATTRACT trial used a semi-quantitative primary endpoint that the US Food and Drug Administration (FDA) required the investigators to use. So, the Villalta score—like all these symptom severity scores—is semi-quantitative at best, and is still a relatively crude metric to assess and compare outcomes, but it is among the best we have.

Haskal: Clinicians like you had been pushing to treat patients with lysis well before ATTRACT. Has the expanded recognition of thrombectomy driven individuals to design devices that make money?

Clark: There is no question that there has been a huge surge in the number of dedicated thrombectomy systems and devices in the last several years, and that’s just the tip of the iceberg.

There are many more technologies that are in various phases of development and stages of regulatory approval.

Now we are going to have a plethora of devices which will make it difficult to choose. The ATTRACT trial had two devices—AngioJet (Boston Scientific) and Trellis (Covidien; now Medtronic)—one of which is no longer in the market and the other is rumoured to be actively “sun-setted” by the manufacturer at some point in the future. When this happens, we will have no devices that have withstood the rigours of an investigatorinitiated randomised trial, and so this leaves us trying to understand where these currently available and emerging systems fit into providing a treatment solution that doesn’t require

an intensive care unit (ICU) bed, transfusion for blood loss, or lytics and the resultant need to escalate the level of care and deal with lytic-related complications. So, we all can agree on the attributes of what a perfect device should do.

Haskal: Cost is a fundamental question here, given the extraordinarily high price of this class of devices. Out of cheaper, faster and safer, we may be able to do faster and safer. What are your thoughts?

Clark: There have been some medical economic estimates that show that the expensive thrombectomy systems are still cost-effective by reducing length of hospital stay and mitigating, or avoiding altogether, the need for expensive ICU stays. Twenty years ago, it wasn’t uncommon for us to perform venous thrombolysis for DVT and require 72–96 hours of urokinase infusions in the ICU, then also have to transfuse the patient if they had blood loss and manage the puncture site haematomas that would occur.

Haskal: For a long time, clinicians still could not get massive pulmonary embolism (PE) patients treated routinely. Now it is more widespread, there is some cost sensitivity to that, but some still struggle with the idea of 18Fr or larger for leg DVT. Is that a concern, or do you see peripheral devices “amping up” to work with smaller catheters?

Clark: I can remember back when certain vena cava filters were being selected by interventionalists because “it goes through a 7Fr or 6Fr delivery system and I don’t want to put that big 8Fr device in”. Now, endovascular clinicians think nothing of putting in a 13Fr, 16Fr, and even larger devices through the popliteal, femoral and jugular veins. Some people are using a pre-close suture technique to get haemostasis. Others are putting in purse string sutures, holding pressure and hoping that that is going to work— and it typically does. I agree there has been an arms race of sorts in PE treatment with progressive escalation of catheter size. You have one vendor that now is up to 16Fr, another goes up to 24Fr, and newer systems are also very large. There seems to be almost no limit. You can also look to the

structural heart field where there are transvenous structural heart systems that go through a 30Fr sheath. So perhaps the PE thrombectomy systems have the capacity to get even bigger providing they can safely traverse the right heart into the pulmonary arteries.

Haskal: Do you think it is beneficial to move towards devices that have mechanical actuators and energybased systems that might be able to increase efficacy and perhaps reduce blood loss, rather than plain old suction?

Clark: With suction, you are limited because you cannot change physics. If your system is an aspiration system, and the tip of the device becomes occluded by impacted clot, there’s just no longer going to be any movement of the clot. You can’t overcome the force.

Haskal: There is only so much, as you say, that you can do due to physics. We need to see devices that move beyond that. Do you see that lying in the long grass out there for us?

Clark: Yes, I see that. I think the other thing that’s not talked about in this post-pandemic world, is that many practices struggle from staffing

Ziv Haskal

that procedure is going to take an hour, two hours, or three hours, that becomes a problem. It becomes a huge problem for workflow and staffing demands. As these technologies evolve, if there are systems that can improve procedural efficiency and enable you to basically predict—with a high degree of certainty—whether you’re going to be able to get that patient’s clot out and flow restored in under an hour with little to no blood loss, then these will be incredibly beneficial.

Haskal: Coming full circle, do you feel that this gold rush is because of data that’s arisen from the PE intervention world? There is certainly a lot of interest in mechanical or mechanicalassisted thrombectomy. What are your projections here?

Clark: What informs what clinicians are using frequently is what they are most familiar with. They get comfortable with a system, they learn its little nuances, they figure out workarounds for limitations of that system and they tolerate those limitations. We all have our go-to systems that we use for certain disease states. I think that is true with DVT and PE, and I think on the educational front—the awareness front—or you

Timothy Clark

There is no question that there has been a huge surge in the number of dedicated thrombectomy systems and devices in the last several years, and that’s just the tip of the iceberg” —Timothy Clark shortages. There’s a nursing shortage, and a technologist shortage. In the USA, many large health systems and hospitals are, at the present time, financially underwater. Among the most precious commodities we have is time. For example, PE cases aren’t something we schedule. They are add-on cases done urgently and/ or emergently as additions to our already busy schedules. So, if you’re incorporating DVT thrombectomy into your already busy interventional practice, when you bring a patient into the interventional suite for a DVT thrombectomy and you don’t know if

could also say the sales and marketing front, certain stakeholders are looking well beyond the interventional suite to other points-of-contact in the care cycle for a patient with DVT and say “how can we make other people aware of these catheter-directed therapeutic options?” They are looking to get in front of the decision-makers, whether they are in the emergency room (ER), in the ICU, or on other parts of the front line of people who are seeing DVT and PE, where they can be very influential in determining whether or not a patient is going to end up seeing an interventionist.

August 2024 | Issue 95

16 Interview

PROFILE

PATRICK HAAGE

As a champion of innovation and forward movement in his chosen field of interventional radiology (IR), Patrick Haage’s career is no less a reflection of this ideology. With an interest in vascular access, state-of-the-art imaging technologies and artificial intelligence (AI), Haage’s research throughout his career has looked to steer many domains toward progress. Haage is also active in education on a national and international level through leadership roles within multiple scientific conferences and as a founding member of the European Board of Interventional Radiology (EBIR). Set to receive the Distinguished Fellow award at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (14– 18 September, Lisbon, Portugal), Haage speaks to Interventional News to share key moments from his career so far.

What attracted you to a career in IR?

During my medical studies, I developed an interest in less invasive surgical procedures that enable substantial interventions through small incisions. Simultaneously, I was deeply impressed by the scope of radiology as a field and its potential for interdisciplinary and multidisciplinary collaboration. As a radiologist, one has the unique ability to both diagnose a disease and offer therapeutic interventions. The opportunities presented by this discipline appeared to be the ideal path forward for me at that time, and I am happy to affirm today that it was indeed the correct decision. In my view, interventional radiology (IR) offers an unparalleled blend of innovation, technology, patient care, problem-solving, diversity, and constant advancement.

Who were your mentors?

Throughout the years, professor Rolf W Günther, former chairman of radiology at the Rheinisch-Westfälische Technische Hochschule (RWTH) Aachen University in Aachen, Germany, has been a mentor of mine, having previously been my academic teacher and later friend. Professor Dierk Vorwerk Klinikum Ingolstadt in Ingolstadt, Germany, who is the former head of IR at RWTH Aachen University who also supported me in my clinical and scientific development from day one.

Could you describe a particularly memorable case of yours?

There are many cases that have stayed in my memory. Every single event, whether positive or negative, has contributed to my development. The combination of these experiences has shaped me into the person I am today.

I have been very fortunate to never have permanently harmed a patient due to an avoidable complication over all these years, even in difficult situations that I encountered for the first time. Therefore, every procedure that I was allowed to perform as lead interventional radiologist for the first time was memorable—my first dialysis patient, my first gastrointestinal bleed, my first cava filter, my first thrombectomy, my first transjugular intrahepatic portosystemic shunt.

I also had the great fortune to be the first interventional radiologist in Aachen to insert an aortic prosthesis endovascularly.

In collaboration with vascular surgeons at my centre, we spent a long morning

in the angiosuite successfully inserting this prosthesis. I am still amazed at how confidently the team and I took on this challenge. This is not only a matter of attitude but perhaps also the privilege of the young.

Having been involved in several CIRSE committees for many years, how has the programme adapted to scientific innovation and what key developments stick out in your memory of previous congresses?

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has a long tradition of adapting its programmes to scientific innovation by incorporating the latest advancements in IR and related fields into its congresses and events. This includes hot-topic symposia, hands-on workshops, and presentations on emerging technologies, techniques, and research in the field.

Key developments that stick out in my memory from previous CIRSE congresses include the introduction of ever-new minimally-invasive procedures, paired with advancements in imaging technologies, breakthroughs in the treatment of emergency, tumour and paediatric conditions. Particularly exciting has been the implementation of prostatic artery embolization and more recently musculoskeletal embolization and its direct impact on patient well-being.

The integration of artificial intelligence (AI) and machine learning in IR practices will significantly impact the way interventional radiologists diagnose and treat patients. I believe that this technology will ultimately lead to improved outcomes, time and money savings and improved patient care. In the end however, the patient-doctor relationship will remain as an non-negotiable part of the diagnostic, and especially therapeutic, road to restitution.

As one of the founding members of European Board of Interventional Radiology (EBIR), how important is the standardisation of education for IR and how do you feel the EBIR examination has influenced IR practice?

Ensuring that practitioners of IR possess the required knowledge and skills to deliver top-notch patient care is essential. EBIR plays a vital role in this process by establishing educational standards, creating curricula, and conducting examinations to evaluate the proficiency of IR specialists. Since 2010,

FACT FILE CURRENT APPOINTMENTS Head of Radiology, HELIOS University Hospital Wuppertal, Wuppertal, Germany Chief medical officer, HELIOS University Hospital Wuppertal Chair Clinical Radiology, Witten/ Herdecke University, Witten, Germany Member, CIRSE Endovascular Subcommittee (EVSC) Member, ET 2025 Scientific Programme Committee Member, Advisory Board, Next Research Member, CIRSE Artificial Intelligence Task Force

PREVIOUS APPOINTMENTS 2011–2024: Member, CIRSE Radiation Protection Commission 2021–2023: Chairman, ET 2011–2023: Member, CIRSE Executive Committee 2012–2015: Executive Committee, German Society of Interventional Radiology (DeGIR) 2009–2011: President, Vascular Access Society

EDITORIAL APPOINTMENTS Editor, RöFo Editor, European Journal of Radiology Editor, Journal of Vascular Access

the EBIR exam has had a hugely beneficial impact on IR practice in various ways. Firstly, it guarantees a consistent level of knowledge and expertise among IR specialists, throughout not only Europe, but worldwide, fostering uniformity and excellence in patient care.

Secondly, the exam promotes ongoing learning and professional growth among interventional radiologists as we strive to meet the high standards set by the EBIR. Additionally, the EBIR exam offers a respected credential that showcases the proficiency and competency of IR specialists to patients and other healthcare professionals. This has boosted the reputation of IR as a specialised field within radiology and attracts talented individuals to pursue a career in IR. Overall, the standardisation of education through the EBIR exam has positively influenced IR practice by campaigning for excellence, ensuring know-how, and elevating the overall standard of care provided to patients. The newly established European Certification for Endovascular Specialists (EBIR ES) serves as a validation of an interventional radiologists’ knowledge, experience, and competency in performing complex endovascular procedures, and thus not only enhances our credibility and reputation, but also radically increases our visibility for patients, colleagues, and healthcare institutions.

You are also a co-founder of the European Conference on Embolotherapy (ET) conference which just recently commenced. What were the priorities of this year’s meeting and were there any particularly exciting data releases?

Founded by Christoph Binkert in 2019— with a little help from myself —ET is typically focused on in-depth discussion of the latest research findings, advancements in embolization procedures, updates on imaging technologies for embolotherapy, and the management of complex cases using embolization techniques.

At the 2024 ET meeting in Vienna, some of the data releases and presentations included new research on the efficacy of embolization procedures, advancements in imaging technologies for embolotherapy, and updates on the management of complex cases using embolization techniques. Some of the main foci this year were the treatment of haemorrhoids, lymphatics, endoleaks and musculoskeletal pathologies. The newly added “deep-dive” sessions intensified the teaching and learning aspect for attendees.

Several of your recent research papers have considered the place of AI and machine learning in IR. How do you feel these technologies will interact with IR in the future? Should interventional radiologists have any reservations in embracing this technology?

AI and machine learning have the potential to greatly impact our field by improving efficiency, accuracy, and outcomes. These

Issue 95 | August 2024

alisonlang.com

Interview 17

technologies can help in image interpretation, treatment planning, and decision-making.

In the future, AI algorithms and machine learning should play a significant role in IR by automating routine tasks, assisting in complex procedures, and providing personalised treatment options. Interventional radiologists should not have reservations in embracing AI and machine learning technology. Instead, they should see it as a tool that can enhance and improve their existing skills. Nevertheless, it is important for interventional radiologists to receive proper training on how to effectively integrate these technologies into their practice. Plus, they should also be aware of the limitations and potential biases of AI algorithms, and use them as a supplement to their own expertise rather than a replacement.

as breathtakingly positive. Interventional radiologists are constantly reinventing themselves by opening up multiple intelligent and less invasive treatment possibilities that are beneficial to the patient. If I should name one area I find underserved and in need of more attention it is paediatric IR. Paediatric patients have unique anatomical and physiological considerations that require specialised care and tailored interventions. As of now, there is a limited amount of research and few dedicated training programmes focused on paediatric IR compared with adult programmes. In my years as scientific programme committee member and chairman I have tried to push paediatric IR training into attention. This development should be continued.

With decades of experience in IR education, what, in your opinion, is the most underserved/underresearched area of IR?

What piece of advice would you give to early-career interventional radiologists today?

Generally, I find the development of our community and society in the last 20 years

As I’ve mentioned, IR is rapidly evolving.

Thus, focus on continuous learning and professional development is key. Actively

"In my years as scientific programme committee member and chairman I have tried to push paediatric IR training into attention.

This development should be continued”

attend national and international conferences and workshops. Pursue additional training and certifications and advance your skills. Engage in research and academic activities, publish scientific papers and present your work at conferences to contribute to the advancement of IR. This will give you the benefit of expanding your network. Seek mentorship and guidance as you navigate your early career. Finally, always welcome innovation and technology, stay ever curious so that you can deliver cutting-edge care to your patients.

Don’t let yourself be changed, be part of the change.

What are your interests and hobbies outside of your career?

Outside of my work I enjoy spending time with my family (my two sons Noah and Jona, and wife Nadja) or my friends. I like to travel, particularly to Asia and Korea. I also enjoy sports such as skiing or tennis, and driving fast cars—or old ones, (Porsche 911, Volkswagen Beetle)—and going to big events, such as rock concerts and soccer games.

August 2024 | Issue 95

18 Point of View

Building equitable IR supply chains to support training in LMICs: A case study

Chidubem Ugwueze Point of View Chidubem Ugwueze (Oregon Health & Science University, Portland, USA) provides an update on the current state of play concerning interventional radiology (IR) equipment and training in low and middle-income countries (LMICs).

D

eveloping an equitable supply chain for IR equipment is essential for training and encouraging interventional radiologists in LMICs, especially in Sub-Saharan Africa. The need for IR training programmes in LMICs has long been acknowledged.

Over the past five to ten years, various training initiatives have emerged to address this need. Despite the nascent growth of IR training programmes in the region, local manufacturing of IR devices is clearly non-existent, and direct supply chains are scarce. The graduates of these programmes then find themselves in settings where they cannot fully utilise the range of skills which they have acquired from their training. This is

particularly true for clinicians returning to their practice in the public teaching hospitals following completion of their training. One such programme is the twoyear IR fellowship in Lagos, Nigeria.

Established through a tripartite partnership between RAD-AID International, University College Hospital (UCH) in Ibadan, and IRDOCNIGERIA, this programme aims to leverage the growing clinical IR practice in the private sector and to transfer this clinical expertise to clinicians in public teaching hospitals. IRDOCNIGERIA, led by Hammed Ninalowo, is a private IR practice in Lagos offering interventional and neurointerventional services.

In addition to excellent clinical

training, further honed by working as an IR attending at a tertiary hospital system in the USA, Ninalowo’s success in creating a clinical service which is suitable as a training programme is based on creation of a reliable supply chain for necessary consumables to utilise the capital imaging equipment instalments already made by hospitals in the private sector. This strategic approach, detailed in an Journal of the American College of Radiology (JACR) article titled ‘Developing a supply chain for interventional radiology consumable equipment in a lower middle-income country: A strategic approach’, includes leveraging clinical expertise, focusing initially on elective cases, adopting a ‘just in case’ bulk procurement model, fostering self-sustaining investment, and collaborating with multiple hospitals.

The wide range of clinical services offered by IRDOCNIGERIA made the practice an ideal partner for an in-country IR fellowship programme, which aims to train senior registrars or junior consultants from teaching hospitals who pledge to return to their teaching hospitals to build IR practice and train residents. The first trainee, Peter Adenigba from UCH in Ibadan, completed his fellowship in June 2024, having performed up to 936 interventions on 821 patients. He now faces the daunting challenge of securing consumables for his new clinical practice. This is not a problem unique to Adenigba. There is a new generation of IR trainees across LMICs who have put

in the hard work to become trained, with the goal of training future generations, only to find themselves struggling to obtain the required support to achieve this.

Possible avenues of support include national governmental investment in the capital equipment required to grow an IR practice in public institutions and the support of industry to make consumable devices more easily accessible to these burgeoning IR pioneers like Adenigba.

The aim of this article is to add to the voices advocating for industry investment in device registration, partnership with local distributors, and eventual local manufacturing of equipment in LMICs. This is an investment that is bound to be mutually beneficial for industry and the growing practice of IR in LMICs. Chidubem Ugwueze is an associate professor of interventional radiology at the Dotter Institute of Oregon Health and Sciences University in Portland, USA. From left to right: Hammed Ninalowo, Peter Adenigba, Chidubem Ugwueze

Join us at CIRSE 2024

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LECTURES AND FACULTY WRAPSODY™, the game changer designed for AV access long-term patency M. Razavi (Orange/US) World’s first results: 6-month outcomes from the WAVE clinical trial R. Jones (Birmingham/GB) WRAP Clinical Registry: enrollment updates in a real-world population D. Rajan (Toronto/CA) Real-world results: 12-month clinical outcomes from SAVE registry T. Barroso (Brasilia/BR) Long-term clinical experience with WRAPSODY™ P. Kitrou (Patras/GR) Closing remarks M. Razavi (Orange/US)

M. Razavi (Orange/US)

R. Jones (Birmingham/GB)

D. Rajan

T. Barroso

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Before using any product, refer to the Instructions for Use (IFU) for indications, contraindications, warnings, precautions, and directions for use.

Issue 95 | August 2024

Near Death Account 19

From both sides of the table: How interventional radiologist Philip Dombrowski saved Sebastian Junger from a rare fatal aneurysm “Dombrowski finally determined that the rupture had happened in the pancreatic branch of the inferior pancreatic-duodenal arcade, a minor and rarely problematic artery. All that remained was to run a catheter down the artery and embolize it with a series of coils that are left in place to create a massive blood clot. A guide catheter was advanced to the site of the occlusion in the celiac. Dombrowski forced his way through the blockage, to reach the rupture.”

sure’. This process was frankly far more traumatic than the original aneurysm rupture and really should be guarded against. I opted against surgery, and I am fine.”

Junger stated that, following his treatment, he experienced mild radiation burns on his back—“an unavoidable consequence of saving my life”. his extract, taken from his latest book, In My which means the patient is in a semi-awake state.

Although rare, he highlighted how important Time of Dying, Sebastian Junger—acclaimed I know that Junger has spoken on being awake information sharing is on radiation exposure journalist and best-selling author of The Perfect for different parts of the procedure and and the associated risk of cancer. “The Storm—exemplifies a visceral departure from his could hear and was aware of what was vast majority of survivors are going to usual exploration of conflict and war. Here, he happening. It’s interesting to read.” be externally grateful to the doctors offers a sobering first-person account of his nearJunger describes how, during his for saving their lives, but still deeply death experience and the interventional radiological treatment, he was visited by his traumatised by the events. This leaves treatment that saved his life. deceased father who invited him to join them wide open to paranoid fears In stark contrast to the gravity of Junger’s him. He recounts that this is the last about their health that only full, open experience, to Phillip Dombrowski (Cape Cod thing he remembered before coming to conversations can alleviate.”

Hospital, Hyannis, USA)—the interventional the following day in the intensive care In Nantucket last month, radiologist who treated Junger—these events unit. This ordeal prompted him to research Dombrowski and his family attended were somewhat routine. Yet, when told from the the IR techniques that prevented his death Philip Junger’s talk on his experience, meeting for perspective of the patient on the table, the pioneering and provoked his near-death experience.

Dombrowski the first time since his treatment. For Junger, interventional techniques used to treat critical Junger began reviewing medical literature this meeting was emotional, describing conditions such as Junger’s are brought to life. and interviewing retired interventionists, seeking a Dombrowski as a “sweet, compassionate and humble Speaking to Interventional News, Dombrowski better understanding of what had happened. man, and an unbelievably skilled interventionist”. recounted the incident.

“Everyone in the audience knew that they could “It was during the beginning of the COVID-19 have been me in the IR suite that day. After the talk, pandemic, and I got a call for our interventional Dombrowski and I hugged and chatted for a bit. It service for a late-50-year-old male with a ruptured brought the entire terrifying ordeal full circle and aneurysm in his pancreatic artery. Haemodynamically, allowed for a bit of closure,” Junger said. he was in a very guarded condition in terms of his Reflecting on Junger’s near-death experience, blood pressure, and I had been given prior warning as Dombrowski admitted that he doesn’t necessarily he was being resuscitated in the emergency room at believe in life after death. “I tend to approach things that time. in a very scientific way and need some proof before We were still perplexed over the source of his believing. But there are situations that have occurred —Sebastian Junger bleeding, and a computed-tomography [CT] scan that make you wonder if there is something beyond was ordered which ultimately showed that he was what we can understand or grasp.” bleeding from the bed of the pancreas and had a large Yet—suspending his disbelief—Dombrowski intraperitoneal haematoma. I got a call from Dan In conversation with Interventional News, Junger anecdotally shared how he came to realise that he was Gorin, the vascular surgeon on call, and Steve Kohler, shared that he was “strongly averse” to literature on the interventionist described in Junger’s book. the emergency room physician, who felt he was near-death experiences for a long time. “It’s hard “I got a message from Michael Hallisey saying not a good candidate for surgical exploration. overstate how psychologically debilitating this ‘Good job—I’ll call you in two hours’. Hallisey is an We considered approaching this from an was for many months afterwards. I was interventional radiologist I’ve known for 30 years. intravascular standpoint, and when very worried, against all evidence, that We were at the forefront of training in the 1970s we were able to isolate the area from I could develop another aneurysm very and 80s—it was a relatively new profession, and we the CT scan, the issue appeared to be quickly that would rupture and kill would both call to discuss cases and bounce ideas off a pseudo-aneurysm occurring from me. I was very worried that I had died each other. Hallisey told me that he had recently seen the pancreatic or duodenal artery that but didn’t know I had, and was some the New York Times article about Junger’s experience supplies the pancreas. We determined kind of spirit—I know how crazy this and was heading to his book signing in Atlanta and that an endovascular approach would sounds—” Junger explained. had listened to his talk, not realising that I was the be best to try to embolize or block the “Apparently, this kind of derealisation one who had performed the procedure until after. He aneurysm.” is a well-known consequence of near-death called me on his drive home.

Dombrowski noted that this type of Sebastian experiences. A mass was later detected The fact that we have known one another and aneurysm is rare, accounting for only 2% Junger against my pancreas, which was clearly the collaborated for years—and Hallisey had even of all visceral artery aneurysm cases and remnants of the haematoma, and was tested published a paper on the specific aneurysm Junger carries a mortality rate of between 20–30%. as a possible tumour. That, of course, was absolutely experienced 20 years earlier—makes me think there “After resuscitation, his vital signs had improved terrifying. The testing went on for months and wound is probably more out there in space than we realise, and so we were using what we call conscious sedation up with a recommendation of surgery ‘just to make something pulling the strings.”

T

I was very worried that I had died but didn’t know I had, and was some kind of spirit—I know how crazy this sounds”

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Issue 95 | August 2024

UAE Updates 21

Survey finds women with uterine fibroids offered hysterectomies over minimally invasive treatments A recent survey conducted by The Harris Poll on behalf of the Society of Interventional Radiology (SIR) has revealed that more than half (53%) of women diagnosed with uterine fibroids were primarily offered a hysterectomy. In contrast, fewer than 20% were presented with less invasive alternatives such as over-the-counter non-steroidal antiinflammatory drugs (NSAIDs; 19%), uterine fibroid embolization (UFE; 17%), oral contraceptives (17%), and endometrial ablation (17%). Additionally, 17% of women surveyed “mistakenly” believe that hysterectomy is the only available treatment, a misconception held by over 27% of women aged 18–34.

THE SURVEY HIGHLIGHTS A “SIGNIFICANT lack of awareness” among women regarding uterine fibroids. Approximately 72% of women are unaware of their risk for developing fibroids, despite up to 77% of adult women developing them at some point in their lifetime. The incidence of fibroids is notably higher among women of colour, with Black women experiencing the highest rates.

John C Lipman (Atlanta Fibroid Center, Smyrna, USA)—advisor for the report—emphasised the importance of informing women about all available

treatment options. He noted that the survey results indicate a gap in education, as minimally invasive treatments like UFE are not being consistently offered.

Lipman criticised the tendency to prioritise surgical options over minimally invasive ones.

“The survey findings, coupled with the low number of women who were offered a minimally invasive treatment like UFE, indicate that women are not being given all of the information they need to make their own healthcare decisions,” said Lipman. “Not offering minimally invasive treatments like UFE in addition to the surgical treatment options is a significant oversight.

Women need to be informed about the complete range of options available for treating their uterine fibroids; not just the surgical options as is most commonly done by gynaecologists.” The survey included over 1,000 women in the USA, including those diagnosed with uterine fibroids, and are part of the report titled ‘The fibroid fix: What women need to know’ which serves as a resource to inform women about minimally invasive treatment options for uterine fibroids.

UFE is a minimally invasive, image-guided, non-surgical, outpatient treatment that is often just as effective as other uterine fibroid treatments and doesn’t require the complete removal of the uterus.

Even though several studies have noted the long-term efficacy of UFE, this survey shows that women are not learning about UFE from their doctors. Among women

Many patients don’t want a hysterectomy and they’re left to suffer in silence, even though their lives could be transformed back to normal if they only knew about UFE”

How does uterine artery embolization affect reproductive outcomes?

Jessica K Stewart Point of View Jessica K Stewart (University of California, Los Angeles, Los Angeles, USA) shares what is currently known about reproductive outcomes following uterine artery embolization (UAE) through recent exemplar studies.

U

nderstanding the impact that UAE for the treatment of symptomatic uterine fibroids may have on future reproductive outcomes is essential in helping patients choose a treatment that aligns with their goals. Though data regarding these outcomes is limited, several studies have provided information that might be useful in counselling patients considering UAE who have not yet completed their families.

A randomised controlled trial (RCT)

by Maskova J Mara (Charles University, Prague, Czech Republic) et al compared

reproductive outcomes between women undergoing myomectomy or UAE for uterine fibroids.1 In this study, more women undergoing myomectomy attempted to conceive compared to those undergoing UAE (40 vs. 26). There were significant differences in reproductive outcomes in favour of myomectomy, including a pregnancy rate of 78% vs. 50%, a delivery rate of 48% vs. 19%, and an abortion rate of 64% vs. 23%. This study was limited by small numbers, follow-up time, loss to follow-up, potential lack of generalisability, and lack of information

who have heard of or are familiar with UFE, only two in five (40%) first heard or learned about the procedure from a healthcare provider.

The survey also found significant gaps in awareness across different demographics. More than half of women aged 18–34 (56%) and 35–44 (51%) reported being unfamiliar with uterine fibroids. Among Hispanic women, 50% were unaware of fibroids, compared to 37% of Black women. Furthermore, 22% of Hispanic women and 36% of Black women incorrectly believe that they are not at risk for developing fibroids, despite the condition being two and three times more common in these groups, respectively. The survey showed that in women with uterine fibroids who are seeking treatment, 48% prioritised prevention of recurrence and 46% proven effectiveness.

“The survey noted deep disparities in awareness and access regarding fibroids and fibroid treatments among Black and Hispanic women, who have a higher risk factor for developing uterine fibroids,” said Robert J Lewandowski (Northwestern Medicine Feinberg School of Medicine, Chicago, USA), president of the SIR. “The data serve as a guiding light for improving physician and patient educational efforts on various treatments to ensure all women, regardless of background, are informed about their risks and the full range of treatment options available.”

UFE involves inserting a thin catheter into an artery and guiding it to the fibroid’s blood supply. Small particles are released to block the blood vessels, causing the fibroid to shrink and die. Most patients can leave the hospital the same day and resume normal activities within a week. Studies show that nearly 90% of UFE patients experience significant or complete symptom resolution.

“Women suffering from fibroids are often given only one treatment option by their gynaecologist— hysterectomy—without being informed of less invasive treatments, like UFE,” said Lipman. “Many patients don’t want a hysterectomy and they’re left to suffer in silence, even though their lives could be transformed back to normal if they only knew about UFE.”

about any fertility treatments utilised. The randomised trial of treating fibroids with embolization or myomectomy to measure the effect on quality of life (FEMME), led

by Isaac Manyonda (St George’s University Hospital, London, UK), included reproductive outcomes as a secondary endpoint and found a pregnancy rate of 15% after UAE vs. 6% after myomectomy, but was also limited by small sample size.2 These conflicting RCT results underscore the need for additional investigation of the factors impacting reproductive outcomes.

One interesting recent study focused on ovarian function after UAE, and the impact that protective coiling might have on pregnancy rates.Their results found that 108 of 398 patients undergoing UAE had a “dangerous utero-ovarian anastomosis”, of which 33 underwent protective coil embolization. In patients desiring pregnancy, this occurred at a rate of 0.95 with ovarian protection versus 0.61 without ovarian protection (p=0.001), and remained significant when adjusting for age.3 Another study found that of five out of six women with increased follicle-stimulating hormone (FSH) levels after UAE had type IB or III utero-ovarian anastomoses, while none of the 21 women undergoing protective coiling for these anastomoses developed ovarian failure.4 These studies suggest that changes in technique could mitigate effects of UAE on ovarian function, which may impact fertility.

There are several challenges in attempting to design RCTs or large registry to evaluate reproductive outcomes in patients undergoing UAE. Enrolment is unlikely to be achievable, given that most women seeking pregnancy are counselled to undergo myomectomy based on the existing, low-quality data. Alternative approaches to studying reproductive outcomes should be considered in the future, such as studies of proxy metrics of fertility that could provide information to patients and physicians that would be valuable in shared medical decision making.

References: 1. Mara, Maskova J, Fucikova Z et al. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovascular and Interventional Radiology. 2008 Jan;31:73-85.

2. Daniels J, Middleton LJ et al. Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial. European J Obstet & Gynecol and Reproductive Biology: X. 2022 Jan 1;13:100139.

3. Serres-Cousine O, Kuijper FM et al. Clinical investigation of fertility after uterine artery embolization. Am J Obstet Gynecol. 2021 Oct;225(4):403.e1-403.e22. doi: 10.1016/j. ajog.2021.05.033. Epub 2021 May 29.

4. Sheikh GT, Najafi A, et al. Angiographic Detection of Utero-Ovarian Anastomosis and Influence on Ovarian Function After Uterine Artery Embolization. Cardiovasc Intervent Radiol. 2020 Feb;43(2):231-237. doi:10.1007 s00270-019-02305-7. Epub 2019 Sep 17.

Jessica K Stewart is an assistant professor of interventional radiology at the University of California, Los Angeles, Los Angeles, USA.

August 2024 | Issue 95

22 New Data

INTERVENTIONAL ONCOLOGY

Thermal ablation versus resection in colorectal liver metastases: COLLISION final results An international trial evaluating the potential non-inferiority of thermal ablation compared to surgical resection for patients with small-size (≤3cm) resectable colorectal liver metastases (CRLM) has been halted at halftime after meeting predefined halting rules. The findings from the COLLISION trial showed no evidence for a difference in overall survival (OS) between surgical resection and thermal ablation.

THE DATA WERE PRESENTED BY MARTIJN Meijerink (Amsterdam University Medical Center, Amsterdam, The Netherlands) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting (31 May–4 June, Chicago, USA). Meijerink detailed that a total of 342 patients were included in the multicentre, phase three Dutch Cancer Group trial; 300 were randomly assigned—148 of whom were assigned to thermal ablation and 148 of whom to surgical resection, with four exclusions.

Inclusion criteria for COLLISION required patients be aged 18 years and older with previously untreated CRLM, collected from 12 centres in the Netherlands, one in Belgium, and one in Italy.

Patients with ≤10 CRLM, no extrahepatic metastases and Eastern Cooperative Oncology Group (ECOG) performance status scale score of between 0–2 were stratified to low, intermediate and high disease burden subgroups and randomly assigned to undergo surgical resection or thermal ablation.

The primary outcome was overall survival (OS), secondary outcomes included distant and local

tumour progression-free survival (PFS), local control, safety, length of hospital stay, quality of life and cost-effectiveness.

Following median follow-up of 28.9 months, Meijerink and colleagues found no difference in OS (hazard ratio (HR) 1.051; 95% confidence interval (CI), 0.695–1.590; p=0.813) with a conditional probability of >90% to prove the hypothesis of noninferiority. All-cause 90-day mortality was 2.1% after resection versus 0.7% after thermal ablation.

Considering secondary variables including total number of adverse events, length of hospital stay, and eventual local control, the data were in favour of thermal ablation. Further, the investigators found no significant difference regarding local and distant PFS. Following the release of these results, current Society of Interventional Radiology (SIR) president, Robert J Lewandowski (Feinberg School of Medicine, Chicago, USA) issued a statement congratulating Meijerink and his team for the “tremendous news” this is for patients globally. He

CROSSFIRE pancreatic cancer trial shows no significant survival difference between SABR and IRE Final results from the magnetic resonance imaging (MRI)guided stereotactic ablative body radiotherapy (SABR) versus computed tomography (CT)-guided percutaneous irreversible electroporation (IRE) for locally advanced pancreatic cancer (CROSSFIRE) trial have identified no difference in overall survival or incidence of adverse events between modalities.

The findings were presented at the European Conference on Interventional Oncology (ECIO; 28 April–1 May, Palma de Mallorca, Spain).

FLORENTINE E TIMMER (Amsterdam University Medical Center, Amsterdam, The Netherlands) et al commented that pancreatic ductal adenocarcinoma remains an aggressive disease with a “dismal” prognosis. Currently, stage three locally advanced pancreatic cancer is considered unresectable and palliative treatment algorithms only modestly improve survival outcomes.

“Guidelines suggest chemoradiation or SABR could be beneficial in certain circumstances. Other local treatments such as IRE could enhance patient outcomes by extending survival while preserving quality of life,” the authors detail. Via the CROSSFIRE trial, Timmer and colleagues aimed

to compare the efficacy and safety of MRI-guided SABR versus CT-guided percutaneous IRE following standard FOLFIRINOX chemotherapy.

During the ECIO presentation, principal investigator Martijn Meijerink attested that chemotherapy should always be sought as a firstline treatment, “to select out early progressors, but also if you observe a good response, there is a good chance that the tumour will become resectable”. This is preferable, as the results after downstaging to resection are “much better” and should not be substituted for SABR or IRE, he stated.

CROSSFIRE was an open-label, phase two superiority trial conducted at the Amsterdam University Medical

stated that “interventional radiologists are uniquely suited” to offer thermal ablation due to their extensive training in imaging, imaging-guided treatments and clinical care”.

Lewandowski continued, stating that these data exemplify how Martijn Meijerink ablation as standard of care can reduce complications and improve local tumour control, without compromising disease-free survival and OS. He hopes that through this research thermal ablation can be “operationalised” in the field, to move standard of care forward and give patients “new hope for not just treatment but recovery”, and praised the study’s coordinators Susan van der Lei, Robbert S Puijk, Petrousjka van den Tol, and Meijerink, at Amsterdam University Medical Center.

Interventional radiologists are uniquely suited to offer thermal ablation due to their extensive training in imaging, imagingguided treatments and clinical care”

Centre in Amsterdam, The Netherlands, concerning patients with confirmed histological and radiological stage three locally advanced pancreatic cancer.

Included tumours were required to be smaller than 5cm and 3–8 pretreatment cycles of FOLFIRINOX were carried out for each patient.

The trial was stopped at the predefined halfway point for futility, Meijerink told ECIO delegates, as the likelihood of one technique being superior was determined as less than 20%.

Between 1 May 2016 and 31 March 2022, 68 patients were enrolled and randomly assigned to SABR or IRE, 53% of whom were male and 47% of whom were female. The median age of this cohort was 65 years. Median overall survival—the trial’s primary endpoint— was shown to be 16.1 months in the SABR group versus 12.5 months in the IRE group. Adverse events were recorded in 20 of the 32 patients in the SABR compared with 19 of 32 patients in the IRE group. One patient in the SABR group and one in the IRE group died due to a treatment-related adverse event.

Summarising their results, Meijerink noted that distant progression-free survival seemed to favour IRE, “but somehow this did not translate to a survival benefit—we need more research on that”. He did point out that both techniques induced a T cell

Median overall survival

16.1 12.5 Months vs Months

in the SABR group

in the IRE group

immune response following treatment, with activation of CD4 and CD8 T cells, and a decrease in regulatory T cells.

When posed audience questions at ECIO, Meijerink was asked whether he has data to show superiority of local treatment for pancreatic cancer in comparison to systemic treatment alone. To this he responded that, although pancreatic cancer is referred to as “locally advanced”, it remains a systemic disease and there is, to date, no “hard evidence” that any local treatment will be effective. To this, Meijerink stated that the CROSSFIRE results will be compared to the pancreatic locally advanced unresectable cancer ablation (PELICAN) trial data once this is released to evaluate local and systemic treatment in this patient population.

Issue 95 | August 2024

Advertorial 23

THIS ADVERTORIAL IS SPONSORED BY GE HEALTHCARE

Electromagnetic navigation system using CBCT takes leap toward automisation for percutaneous interventional procedures “For us, the main clinical objective is accuracy. Precision is key for interventional radiology [IR] procedures,” said Lambros Tselikas** (Gustave Roussy, Villejuif, France), who discussed how he and his team have leveraged cone-beam computed tomography (CBCT)-guided navigation to elevate their procedural efficiency.

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BCT-guided percutaneous procedures have gained prominence over the last decade across interventional oncology, radiology and pain management. Real-time CBCT imaging is used to guide the insertion of needles and other instruments to target specific regions of the body, with applications ranging from biopsies and drainages, to the delivery of treatments such as cryoablation.

In Lambros’s practice, procedures that involve the placement of a needle tend to be more technically challenging, more specifically when the needle trajectory is angulated and deep, which is increasingly the case for bone procedures. Most commonly, Lambros and his team perform diagnostic and therapeutic interventions using the Alia IGS 71 for augmented imaging, in combination with the Imactis system—both developed by GE HealthCare—to plan and navigate the patient’s anatomy during percutaneous procedures.

One of the key benefits of CBCT-guided procedures is their ability to provide detailed, cross-sectional images of internal structures. This capability allows for precise navigation to the area of interest, reducing the risk of complications and improving overall procedural outcomes.

The Imactis Navigation system collects detailed CBCT images to create a virtual, three-dimensional model of the patient’s anatomy. The system uses electromagnetic navigation to increase the accuracy of procedures ensuring that clinicians can navigate complex anatomies while avoiding critical structures and organs.

“What I find interesting when using the Imactis system with the addition of CBCT is, due to the wide bore, you can very easily jump from one modality to another,” he detailed. In practice, Lambros is able to plan the trajectory of the needle on the initial CBCT scan while the patient’s arms are down, and then precisely choose the entry point using Imactis.

This way, Lambros and his team can view the virtual anatomical mapping alongside the real-time control images to proceed with absolute confidence.

“We know based on our clinical experience that a good entry point can really make the difference, especially for a tricky case—with Imactis, this is a huge advantage,” Lambros said. “Then, following the needle insertion, we can continue using our advanced guidance tools such a Needle ASSIST2 (GE HealthCare) which can help to reduce dose and increase the number of patients we can treat. The key benefit of using Imactis Navigation for CBCT with the GE HealthCare Angio system, is to bring together complementary navigation and guidance tools in an easy-to-use, versatile manner, to make difficult cases easy.”

The key benefit of using Imactis CT-Navigation with the GE HealthCare Angio system, is to bring together complementary navigation and guidance tools in an easy-to-use, versatile manner, to make difficult cases easy” Although centres today seek to offer the highestquality treatment to their patients, investment in new technologies can appear unattainable due to costefficiency and time to installation. GE HealthCare

interventional chief executive officer Arnaud Marie told Interventional News hat he heeded this challenge, and explained that their vision for Imactis was to be able to “integrate with already available CT-scanners and innovations emerging from start-ups, academics and other large companies, so we can leverage our ecosystem to seamlessly provide the best-in-class solution”. With this ethos in mind, Marie explained how GE HealthCare has collaborated with companies such as Centerline Biomedical—a provider of X-ray navigation technology—to help to bring beneficial solutions to market.

To Marie, IR is a dynamic field defined by exponential growth in clinical advancement, exemplifying this through the development of genicular artery embolization (GAE) and musculoskeletal (MSK) interventions. In response to these leaps, new navigation software using X-ray and electromagnetic energy, as well as robotic elements has rapidly evolved.

“My vision is that there will be a convergence of technologies to provide integrated systems that will enable delivery of these procedures in a much more predictive, democratised and safer way for both for the patient and the interventionalist through reducing exposure to radiation.”

Marie shared that their intent is to initiate a “strong step toward automisation”, using the Imactis CTNavigation system in collaboration with “several” companies who specialise in robotics. He believes that “lighter, portable and flexible” robotic technology can achieve improved needle placement in combination with GE HealthCare’s navigation software, producing an all-in-one solution.

While maintaining quality of care, Imactis CTNavigation is aimed to give interventional radiologists better control over patient care. As minimally invasive procedures become more frequently used for a wider range of patient cases, Marie believes this technology can provide confidence of care, making complex procedures accessible to more clinicians while maintaining quality of care.

In early 2023, GE HealthCare acquired Imactis—a France-based company developing ergonomic stereotactic needle guidance through CT-navigation and CBCT-navigation—which the company states is a part of a broader strategy to improve the workflow of interventional radiologists and become standard of care. The Imactis CT-Navigation system, which includes an integrated workstation, guidance software, and disposable procedure kit, is currently approved under the European Union’s Medical Devices Regulation (MDR).

Disclaimer: *IMACTIS CT-Navigation is CE Marked and US Food and Drug Administration (FDA) approved. IMACTIS CBCT-Navigation is CE Marked but not yet FDA approved and is not available for sale in the USA. IMACTIS Navigation may not be available in all countries. Refer to your sales representative for more information. **Tselikas Lambros is a paid consultant for GE HealthCare and was compensated for participation in this article. The statements by Lambros described here are based on his own opinions and on results that were achieved in his unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc. there can be no guarantee that other customers will achieve the same results.

1. IGS 7 refers to Discovery IGS 7 and Allia IGS 7 system.

2. Needle ASSIST solution includes TrackVision 2, stereo 3D and requires AW workstation with Volume Viewer, Volume Viewer Innova. These applications are sold separately.

The Imactis CT-Navigation system provides realtime procedural mapping

BSIR 2024 6 TH – 8TH NOVEMBER | BRIGHTON, UK The annual scientific meeting of the British Society of Interventional Radiology provides a platform for knowledge exchange and networking for interventionalists throughout Britain and beyond.

CATCH THE EAR LY FEE !

BSIR 2024 will feature a range of interventional radiology topics, from established to cutting-edge.

We hope to see you this autumn in Brighton, England !

Register

BSIR 2024 registration includes both onsite and on-demand access to scientific content. It’s not too late to catch the early fee !

Register before 5th September to access a discounted rate.

Programme

BSIR highlights will include sessions on emergency procedures, lymphatic intervention, paediatric IR, MSK embolization, the future of IR, and much more. Scan the QR code to browse the programme !

Accommodation

BSIR’s official travel partner has secured a number of hotel rooms in the Brighton area for the benefit of conference participants.ClotTriever: for wall-to-wall mechanical thrombectomy Use the interactive booking map to find your perfect room.

Spread the word !

BSIR 2024 posters, social media graphics, wallpapers and more are available for download – share them with your colleagues !

www.bsirmeeting.org

Issue 95 | August 2024

Advertorial 25

THIS ADVERTORIAL IS SPONSORED BY INARI MEDICAL

Mechanical thrombectomy shifts the needle toward interventional management of PE and DVT Evaluating the current standard of care for the management of acute pulmonary embolism (PE) and deep vein thrombosis (DVT), Michael Kostrzewa (Cantonal Hospital Baden, Baden, Switzerland) and Rashid Akhtar (Barts Health NHS Trust, London, UK) discuss the efficacy of mechanical thrombectomy and its expanding application.

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ntil today, mortality rates for PE remain unacceptably high, sitting between 6–15% for intermediate-high risk and 25–50% in high-risk patients. A similar trend can be observed in patients with DVT, where residual thrombus after treatment can cause long-term issues, with approximately 50% of patients developing post-thrombotic syndrome (PTS) as a result. Standard treatment for PE has typically involved thrombolysis, and for DVT, anticoagulation. However, via technological advances, a better understanding of the importance of new predictors in choosing the right treatment option, and the availability of new tools have begun to shift the focus towards interventional management.

“There are several reasons why we are increasingly intervening on PE and DVT. We have previously never been able to fully extract the clot and characterise its type, let alone describe the efficacy of tissue plasminogen activator (tPA) on collagen-rich thrombus. Would that clot have been completely dissolved?” Akhtar said. “With the updated toolkits that are now available, such as the FlowTriever ® or ClotTriever ® systems (Inari Medical) for venous thrombectomy in PE and DVT respectively, it makes treatment more approachable,” Kostrzewa added. In his opinion, these technologies, paired with the positive clinical data and growing evidence, provide treating physicians with the necessary confidence of a reliable and predictable outcome.

At present, data from the FLASH and FLAME registries—which collected data on the use of

ClotTriever: for wall-to-wall mechanical thrombectomy

ctomy

FlowTriever: designed for lytic-free thrombectomy

Rashid Akhtar

Michael Kostrzewa

mechanical thrombectomy with the FlowTriever system for the treatment of acute PE—have shown low rates of all-cause mortality at 30-day follow-up and significantly lower rates of in-hospital adverse events. Similarly in the treatment of DVT with the ClotTriever system, the CLOUT registry shows safety and effectiveness of wall-to-wall thrombus removal, with 93% of patients having no or mild symptoms of post-thrombotic syndrome (PTS) symptoms at two years.

“There’s still a lot to be done,” Kostrzewa said, “but we have good evidence at present and there is very exciting data to come, with the DEFIANCE trial for DVT and the PEERLESS II trial for intermediatehigh risk PE patients, as it is often difficult to decide between conservative or interventional treatment.

These results will hopefully bring clarity and change the guidelines.”

Touching on the current guidelines and changing the status quo, Kostrzewa believes that awareness is a prevailing issue, which, in his experience, has prevented him and his colleagues from using new and more effective treatment strategies, and has led to a reduced influence on guidelines. “We need to build awareness to change guidelines,” he said, “but I do believe that awareness is changing in the venous thromboembolism [VTE] space, both among the treaters and the noninterventional stakeholders [NISH]. It is all about building an effective and efficient team.”

In Akhtar’s experience, the frequency of mechanical thrombectomy procedures he performs is increasing. “We are in a unique era with the right devices and evolving guidelines, and we are no longer ignoring the mortality figures for PE patients or the prolonged complications that DVT patients face.” Importantly, updates to the European Society of Cardiology (ESC) Guidelines for the diagnosis and management of acute pulmonary embolism from 2019 on mechanical thrombectomy were “a step in the right direction” for Akhtar, helping his team to better assess patients and decide on an informed treatment pathway.

In his institution, he explains, admitted patients are typically administered low molecular weight heparin. Treatment is escalated towards intervention, if the patient shows signs of deterioration within 24–48 hours. They consider factors such as the ratio between right and left

ventricle (RV/LV ratio), lactate levels, clot burden and concomitant DVT—all these parameters are essential in their interdisciplinary case discussions and the decision-making process, also known as PE response team (PERT) meetings.

“In the treatment of PE and DVT treatment, interventional radiologists can take the clinical lead, because we see many of these patients and are experts in this field,” Akhtar said. “In my practice, I review patients pre- and post-intervention. You’re getting a DVT procedure with ClotTriever device done within the hour, which is swift and not tedious.”

By integrating devices such as the FlowTriever into clinical practice, interventionalists can improve procedural efficiency, Akhtar explained: “It’s useful for interventionalists to do both DVT and PE treatments—I often use the FlowTriever device in DVT interventions. I encourage offering both PE and DVT treatment, as the procedures are straightforward for experienced interventional radiologists. Plus, it’s rewarding. I find that both PE and DVT interventions have renewed my job satisfaction,” he shared.

Kostrzewa points out that the lack of clear guidelines in DVT is a major challenge for referring physicians, as it is not always easy to differentiate between patients who will benefit from interventional treatment and those for whom it is not indicated. “As clinicians, we now have a better understanding of both conditions and what can happen with these patients in the longterm. We also have better tools for PE and DVT to safely and efficiently remove thrombus in the lungs and lower extremities,” he states. “Still, we rely on referring physicians to ensure that all VTE patients who are eligible for mechanical thrombectomy, receive this treatment.”.

In Akhtar’s view, a multidisciplinary approach is key to provide PE and DVT patients with optimal care, as interventional techniques such as mechanical thrombectomy shift to become commonplace. Akhtar and Kostrzewa agree mechanical thrombectomy is a game changer in the minimally invasive treatment of PE and DVT, rapidly restoring blood flow and reducing associated risks. Advances in technology, along with further studies, is expected to establish mechanical thrombectomy as a key tool in the management of venous thromboembolic disease, which is expected to be reflected in the future guidelines for the treatment of PE and DVT. At this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal) Inari Medical will be hosting a hands-on workshop on Saturday 14 September, demonstrating the FlowTriever and ClotTriever systems. In addition— on Sunday 15 September—an expert panel will be exploring the impact of mechanical thrombectomy in the management of venous thromboembolism at the 1pm Symposium in Auditorium 2.

We are in a unique era with the right devices and evolving guidelines, and we are no longer ignoring the mortality figures for PE patients or the prolonged complications that DVT patients face” Rashid Akhtar

Cardiovascular and Inter ventional Radiological Societ y of Europ e

REGISTER NOW !

Lisbon, Portugal September 14-18

CIRSE 2024 featuring

Get ready for CIRSE 2024!

Offering 340+ presentations from nearly 300 international expert faculty members and over 70 hands-on training sessions, CIRSE 2024 is the world’s largest meeting focusing on minimally invasive, image guided procedures. You cannot afford to miss it! Register today to secure your spot and take advantage of the greatest learning and networking opportunity of the interventional year.

IDEAS 2024

IDEAS, the Interdisciplinary Endovascular Aortic Symposium, takes place every year at the CIRSE Annual Congress, promoting multidisciplinary collaboration in aortic treatment and featuring experts from both interventional radiology and endovascular surgery.

Get hands-on

CIRSE 2024 will feature dozens of opportunities for attendees to try out the latest tools and devices. With formats including hands-on device training sessions, an IDEAS practical course, simulation training sessions, and GI-lab sessions, physicians at all stages of their IR careers will be able to benefit from these valuable opportunities.

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Browse our interactive hotel map to find the perfect accommodation for your stay in the beautiful Portuguese capital!

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Issue 95 | August 2024

Advertorial 27

THIS ADVERTORIAL IS SPONSORED BY ARGON MEDICAL

CLEANER™ Rotational Thrombectomy system optimises effective clot maceration and patency restoration The CLEANER Rotational Thrombectomy system (Argon Medical) used for arteriovenous fistula and grafts seeks to provide interventionalists with an all-in-one tool to treat a range of percutaneous thrombectomy cases. This is according to general surgeon Jason Beaver (Surgery Center South, Dothan, USA) and interventional radiologist Amr Elsaadany (Barts Health NHS Trust, London, UK), who discuss their experiences macerating organised or difficult-to-access thrombus with the device.

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he CLEANER device is indicated for the mechanical declotting of native vessel dialysis fistulae, synthetic dialysis access grafts, and peripheral vasculature. Additionally, the device can be used for controlled and selective infusion of physician-specified fluids in the peripheral vasculature. It works via a self-sizing sinusoidal wire that rotates at 4,000 rpm, breaking apart wall-adherent thrombus. This design creates a fluid vortex that forces clot burden to macerate into small particles without causing endothelial damage and has had proven success in patients with pseudoaneurysms and stents .

Procedurally, Elsaadany notes that one of the most “challenging” elements of native AV fistula treatment is the tortuosity of the vessel—especially with longstanding fistulas with aneurysmal dilatation. He adds that challenges also arise due to pseudoaneurysms, as these can often contain thrombi of different ages, from acute to sub-acute and chronic.

“That’s why you need a powerful machine. I usually perform the entire procedure under ultrasound, and, using the CLEANER device, you can massage or compress the rotational wire against the vessel wall,” Elsaadany says. “With its adaptive function, you can ensure that you are going from wall to wall, taking the entire thrombus.”

For Beaver, the adaptability of the system is a key benefit. He believes CLEANER’s self-sizing ability is invaluable when macerating thrombus from a native fistula. Eliminating this thrombus can be challenging, as an inflammatory response can be triggered when the vein clots, creating a more organised, rubbery, defined clot. With the CLEANER device, labelling it the ‘Keep it Cleaner’ system, Beaver asserts that the “appropriately aggressive” rotational function allows for safe and effective thrombus maceration in the first instance. “With other devices, the fistula can often re-clot sooner,” he says.

“The CLEANER device helps you get a large percentage of the clot out quickly, re-establishing flow,” Beaver adds. In doing so, he has seen fewer patients needing a secondary thrombectomy two or three days following the initial procedure. This, he believes, is the effect of the CLEANER device, which provides “more comprehensive clot clearance from the access.”

Continuing, Elsaadany and Beaver agree that macerating clot efficiently minimises procedural time.

“Having used several mechanical thrombectomy devices,” Elsaadany states, “the CLEANER device has provided the most efficiency. Graft cases should not take more than 20–30 minutes. Having a patient in your angio suite for over an hour will restrict

the number of patients you can treat daily. The CLEANER device, in my experience, provides a higher level of efficiency.”

Particularly in dialysis patients, Beaver notes that streamlining procedures with the CLEANER system is important to minimise time “on the table” and decrease the disruption to the patient’s regularly scheduled treatment and their daily lives. “The device helps to improve procedure times,” he says.

Jason Beaver

Amr Elsaadany

We need equipment that is fast, efficient, and powerful and that reduces clot recurrence rates, which I have seen with the CLEANER device” Amr Elsaadany

“I’m big on not keeping these dialysis patients on the table longer than they need to be, and I can usually do a straightforward declot in around 10–15 minutes. Efficiency-wise, the CLEANER device helps tremendously.”

Selecting patients for mechanical thrombectomy can be complex. Beaver points out, “Often we are working with a patient population that is very frail, with several comorbidities.” For this reason, complication rates are paramount when selecting a device. For difficult cases, such as those involving large, dilated fistulas, Beaver explains that he first injects alteplase to dissolve some of the clot before using the CLEANER device to ensure a more successful outcome.

Elsaadany agrees that careful patient selection is necessary when planning a mechanical thrombectomy.

He details that, when using a thrombolytic agent, the

three-way infusion port of the CLEANER device effectively delivers the injection to the patient.

Alternatively, Elsaadany highlights his recent experience using the device without a thrombolytic agent in cases where it may be risky, noting that these procedures have been successful.

“Before choosing the most appropriate equipment for a procedure and patient, you will ask yourself— which tool has the potential to cause the fewest complications?” Elsaadany says. In his experience, the CLEANER device has reduced side-effects in his patients undergoing thrombectomy, mainly due to its “atraumatic” tip and rotational wire. “There’s no risk for any perforation or injury to the vessel wall as it macerates the thrombus into minute parts, which also means there is little to no concern about pulmonary embolism [PE],” Elsaadany states.

Citing the risk of PE, Beaver underlines the importance of macerating the entire clot while reducing procedure time to improve patient outcomes. He states this can be helped by combining visualisation techniques with the CLEANER device during thrombectomy procedures. The system’s compatibility with the latest imaging and fluoroscopy technology allows visualisation of the thrombus and surrounding vasculature in real time to ensure interventionalists can make informed decisions and monitor the procedure’s progress. “If you’re de-clotting an access in which you aren’t sure which side is the venous and which is the arterial,” he details, “you can go across with the CLEANER device, inject some contrast and figure out which side you are on—that’s a nice bonus.”

Summing up, Elsaadany reflects that: “The dialysis fistula is the lifeline of chronic kidney disease patients.

We need equipment that is fast, efficient, and powerful and that reduces clot recurrence rates which I have seen with the CLEANER device.” To this, Beaver agrees, noting that since moving to CLEANER, he has provided safer and more effective treatment, seeing fewer patients returning re-clotted for a repeat procedure. Using CLEANER for a “multitude” of thrombectomy cases, Beaver attests to the device’s “versatility across a spectrum of indications” and ability to optimise mechanical thrombectomy procedures for the benefit of patients and physicians.

References 1. Vega, F. Safety Comparison of Cleaner™ Rotational Thrombectomy System Versus Arrow PTDTM in Native Vessel. San Carlos, CA: Isis Services, LLC; 2010.

2. Webb A, Zacharias K, et al. Dialysis Shunt Thrombectomy Utilizing a Rotational Thrombectomy Device in Patients with Pseudoaneurysms. The Arab Journal of Interventional Radiology. 2020;4(02):87-91. https://doi. org/10.1055/s-0041-1729018).https://doi.org/10.1055/s-0041-1729018).

Driven by Innovation. Inspired by Patients Bringing SIRT to the next level

Announcing The First Innovation in Y-90 Delivery.*

*The SIROS™ Delivery System, from Sirtex, is the first innovation in the Y-90 Delivery System space.

To see a SIROS demonstration, scan here.

Indications For Use: SIR-Spheres Y-90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) or unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy. Consult the Instructions for Use (www.Sirtex.com) for a complete listing of indications, contraindications, side effects, warnings, and precautions.

Manufacturer Sirtex Medical Pty Ltd Shop 6, 207 Pacific Highway St Leonards NSW 2065 Australia Tel: +61 2 9964 8400 Fax: +61 2 9964 8410 Europe, Middle East & Africa Sirtex Medical Europe GmbH Joseph-Schumpeter-Allee 33 53227 Bonn Germany Tel: +49 228 1840 730 SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. ©2024 Sirtex Medical Europe GmbH APM-EMEA-028-03-24

Issue 95 | August 2024

Advertorial 29

THIS ADVERTORIAL IS SPONSORED BY SIRTEX MEDICAL

Multidisciplinary panel supports the positive role of SIRT at SUMM90YT conference The SUMM90YT conference (23 February, Frankfurt, Germany)—hosted by Sirtex— gathered leading experts in selective internal radiation therapy (SIRT) utilising SIRSpheres Y-90 resin microspheres (Sirtex Medical). The conference facilitated discussion and debate on the appropriate selection of patients with unresectable hepatocellular carcinoma (HCC) and metastatic liver tumours from primary colorectal cancer (mCRC) refractory to or intolerant of chemotherapy, as well as the latest technical advancements in the field.

O

rganised into three distinct sessions— SIRT in HCC, SIRT in mCRC, and key technical considerations—the SUMM90YT programme fostered dialogue through a modelled multidisciplinary tumour board. Speaking to Interventional News, moderator Macarena RodríguezFraile, nuclear medicine physician (Clínica Universidad de Navarra, Pamplona, Spain) and speaker Irene Bargellini, interventional radiologist (Cuneo Hospital, Cuneo, Italy) reflect on their key takeaways from the conference.

The day’s first session was dedicated to HCC, as speakers including surgeon Claire Goumard (University Hospital Pitié Salpêtrière, Paris, France), surgeon Pietro Addeo (Hôpital de Hautepierre, Strasbourg, France), radiation oncologist Maria Hawkins (University College Hospital, London, UK), Bargellini herself, and others, described what is known to date regarding research and treatment options. Predominantly, speakers used patient cases to illustrate the use of SIRT for bridging or downstaging to transplantation and downsizing to resection, inducing contralateral hypertrophy, and explored the potential of combining SIRT with systemic therapies.

In this segment, Bargellini presented on the applicability of SIRT for intermediate to advanced stage HCC. “Thanks to the refinement of indications and the development of personalised dosimetry, SIRT has become a highly appealing and potentially curative treatment across all stages of the Barcelona Clinic Liver Cancer (BCLC) staging system for HCC, evidence showing most benefits in early-stage HCC, in patients with single lesions, to the advanced stage, in patients with portal vein tumour thrombosis,” she told Interventional News. Bargellini added that the speakers in the morning session suitably described the “value in downsizing tumours with SIRT or to induce contralateral hypertrophy—which is now fully demonstrated—making it a valid tool to convert patients to surgery”.

In agreement with Bargellini, Rodríguez-Fraile detailed the “progressive expansion” of SIRT from advanced HCC to earlier stages, through its potential to reclassify disease status. “Growing evidence of the benefits of using SIRT as a facilitator of surgery were shown during SUMM90YT. This was either to reduce tumour size for resection or to bridge/downstage for liver transplant, allowing for surgery that was initially inadvisable. SIRT can also be performed to increase the future liver remnant evaluating the biology of the tumour through the “test of time”, she said.

“Numerous trials and recent prospective registries from the USA and Europe—namely, RESiN (Radiation-emitting SIR-Speres in non-resectable liver tumor) and CIRT (CIRSE registry for SIRSpheres therapy)—have demonstrated the safety and efficacy of SIRT with Y-90 resin microspheres in HCC patients,” Rodríguez-Fraile conveyed. “Speakers looked at the real-world evidence gained in these registries and concluded that SIRT is a safe and effective bridging therapy.”

Summarising the panel’s thoughts, Rodríguez-Fraile noted that patient and tumour features—including tumour biology, personalised dosimetry and patient preference—should be considered above all when considering SIRT for mCRC.

Technical advancements in personalised dosimetry

In the final session of the day, speakers including nuclear medicine physician Michael Kreißl (Universitätsklinikum Magdeburg, Magdeburg, Germany), interventional radiologist Manuel González-Leyte Hospital General Universitario Gregorio Marañon, Madrid, Spain), and interventional radiologist Roberto Iezzi (Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy) provided Clinical characteristics must define various insights into the technical facets of SIRT, multidisciplinary decision-making offering practical guidance on optimal usage In the programme segment which followed, speakers strategies. including medical oncologist Elena Elez (Vall Rodríguez-Fraile recalled how prominent focus was d’Hebron University Hospital, Barcelona, Spain), placed on dosimetry and microsphere distribution. interventional radiologist Franco Orsi (European She explained that microsphere distribution is not Institute of Oncology, Milan, Italy) and surgeon only related to blood flow and parameters that the Simeon Ruiter (University Medical Center Groningen, interventional radiologist has control over, such as Groningen, The Netherlands), among others, injection velocity, or type of catheter used, but also to introduced SIRT for chemo-intolerant or the number of microspheres injected and the -refractory mCRC patients. specific activity per sphere.

Here, the multidisciplinary panel and “It has been demonstrated that microsphere audience-member participants concluded distribution has a direct impact on dosimetry that SIRT “can have a role” in controlling such as radiobiological effect, e.g. toxicity mCRC in advanced settings, Rodríguez-Fraile and efficacy,” she said. To achieve this explained, as SIRT can be used to enable flexibility, Rodríguez-Fraile noted that Macarena surgery through contralateral hypertrophy the FLEXdose Delivery programme by Rodríguez-Fraile induction or by applying radiation Sirtex enables modulation of microsphere segmentectomy. “Consensus was made that properties (number of microspheres and SIRT can be used to maximise metastases specific activity per sphere) and can facilitate control to improve progression-free tailored, patient-specific treatments. survival and overall survival, as well as for “Depending on the goal of the treatment, chemotherapy breaks, and chemo-intolerant the volume of the liver to be treated, and the patients,” she said. tumoral characteristics (vascularity, size, “Although we still need better designed volume), it is possible to use a different Irene and well-conducted clinical trials,” Bargellini day of calibration vials to maximise the Bargellini said, “there is clear evidence that SIRT is effect. For example, for the same prescribed safe and effective for mCRC and should be a part activity, as the precalibration day increases, the of our armamentarium, and that came across at activity per sphere is greater and the number of SUMM90YT.” Expanding on this conclusion, she spheres to be injected will be smaller. This type of vial detailed how speakers in this session exemplified can be especially useful in selective treatments, as it how radiation segmentectomy is able to induce a reduces the risk of reflux and allows greater activity to “complete and durable” response in patients who be administered,” Rodríguez-Fraile explained. are unfit for surgery or excluded from ablation, and The importance of the work-up phase to precisely further, how radiation lobectomy may play a role as a plan each treatment was foregrounded at during conversion strategy in unresectable patients. the session, Bargellini noted. “Today, we know that personalised dosimetry, based on tumour type, extension and treatment goal, is key to achieve high local control and reduce hepatotoxicity.”

“Discussion at SUMM90YT called for a standardised and streamlined workflow, which has been seen through the flexibility of SIR-Spheres in sparing time by exploiting the potential of single-day 90 or single-stay procedures, while better tailoring our treatments to each patients’ clinical and anatomical conditions.”

Overall, Bargellini stated that to be “actively Processing points given throughout SUMM90YT, integrated” into the modern therapeutic landscape Rodríguez-Fraile believes the future of SIRT will for mCRC, “adequate patient selection needs to be be defined by personalisation, combining optimal mandatory to avoid unwanted toxicities and futile clinically informed selection of patients with targeted treatments”. In Rodríguez-Fraile’s recollection, dosimetry-driven treatments. For Bargellini, a central this was a central takeaway of the session, the takeaway for the future was the “strong potential multidisciplinary panel placing emphasis on decerning synergistic effect” between SIRT and immunotherapy, clinical characteristics when selecting appropriate the integration of which will be better understood via patients for treatment. She emphasised however, that the results of ongoing studies, she states. patient selection can be optimised through tailored As these promising applications develop through profiles A, B and C. Patients in these profile groups research, Bargellini believes that implementation of a she described as: chemo-intolerant with desire for standardised treatment protocol for SIRT is required more quality of life (QoL) (A), chemo-refractory, but to reach landmarks in its use, to increase safety and willing to undergo treatment (B), and aggressive liver- efficacy, and to broaden the number of centres that dominant disease with poor prognosis (C). have access to this technology.

Growing evidence of the benefits of using SIRT as a facilitator of surgery were shown during SUMM YT”

August 2024 | Issue 95

30 Market Watch

Clinical News

Product News

First results of SOL Japan highlight “extraordinary performance” of Luminor DCB in Japanese population Luminor DCB

iVascular has announced that “outstanding” results from the SOL Japan study were recently presented at the Japan Endovascular Treatment (JET) conference (14–16 June, Fukuoka, Japan).

SOL Japan is a clinical trial aimed at evaluating the efficacy and safety of the Luminor 18 drug-coated balloon (DCB) in treating femoropopliteal arteries within the Japanese population.

A press release notes that this pivotal study marks a significant milestone for the Luminor DCB in Japan. The trial has been conducted in collaboration with Medico’s Hirata, a company from Japan that iVascular states has vast experience and knowledge of medical devices.

The SOL Japan study, under the guidance of principal investigator Yoshimitsu Soga from Kokura Memorial Hospital (Kitakyushu, Japan), is a prospective, multicentre, single-arm trial. A total of 122 patients were enrolled, with 57.4% of the participants being diabetic. The study focused on femoropopliteal lesions, presenting a mean lesion length of 11cm.

Transit Scientific announces first case using embolic delivery microcatheter Transit Scientific announces the successful clinical deployment of XO Cath, an embolic delivery microcatheter intended for interventional procedures.

Richard Saxon (North County Radiology Associates, San Diego, USA), performed the inaugural procedure utilising the XO Cath 2.0Fr 130cm microcatheter with a Bern-shaped tip. The prostatic

artery embolization (PAE) case involving significant vessel tortuosity demonstrated the microcatheter’s capabilities, a recent press release states, specifically its manoeuvrability while navigating tortuous anatomy.

Saxon commented on the procedure: “The pushability, visibility, and trackability of the XO Cath were notable, enabling precise manoeuvrability even in challenging anatomical conditions. It tracked incredibly well around tight turns and bends, allowing for distal and precise embolic delivery. In addition, the microcatheter’s luminal size allows for strong injection rates and highquality imaging.”

XO Cath

Microbot Medical announces first patient treated with endovascular robotic surgical system

Microbot Medical has announced that Baptist Hospital of Miami, USA— which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute—has completed its first clinical procedure in a patient utilising the Liberty endovascular robotic surgical system.

Baptist Hospital is the second clinical site to perform a clinical procedure, following the announcement earlier this week of the first clinical case at Brigham & Women’s Hospital in Boston, USA. The principal investigator at Baptist Hospital of Miami is Ripal Gandhi who performed this clinical case.

The trial is part of the investigational device exemption (IDE) for Liberty, and the company expects its results will support the future submission to the US Food and Drug Administration (USA) and subsequent commercialisation.

Penumbra announces European launch of neuro access catheters

Penumbra has announced that it has received CE mark approval and so has initiated the European launch of BMX81 and BMX96, devices which are designed for neurovascular management of ischaemic and haemorrhagic stroke.

This announcement further expands the company’s neuro portfolio in Europe, following the news in early May when Penumbra launched three new RED reperfusion catheters (RED 43, RED 72 with SENDit technology, and RED 78).

“Physicians in Europe now have more options to serve their patients using our expanded portfolio. With five innovative devices introduced in Europe in a matter of months, our dedication to improving stroke care enables us to provide physicians with customised stroke solutions,” said Joan Kristensen, head of the Europe, Middle East and Africa region for Penumbra. Penumbra’s BMX81 and BMX96 are made using laser-cut stainless steel hypotube technology, offering stability and trackability.

They are designed to allow physicians to navigate the brain’s complex anatomy and can be used from either a femoral or radial access approach (i.e. via groin or wrist), expanding intraprocedural options in both ischaemic and haemorrhagic stroke.

BMX catheters

Xeltis receives IDE approval from US FDA for haemodialysis vascular access conduit

Xeltis has announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess. aXess is a restorative conduit that enables the creation of a

new, permanent, living vessel for haemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG) a recent press release has stated. The aXess vascular access conduit is said to offer an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.

Xeltis’ implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients’ own living healthy tissue.

AVS console

AVS receives IDE approval from US FDA for pivotal intravascular lithotripsy study

Amplitude Vascular Systems (AVS) has announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.

The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL system for the treatment of patients with severely calcified peripheral arterial disease (PAD) in the USA. POWER-PAD-II will enrol up to 120 patients who will be followed for up to six months. This new trial follows the success of POWER-PAD-I, which was presented by Jon George (Pennsylvania Hospital, Philadelphia, USA) at TCT 2023 (23–27 October, San Francisco, USA). POWER-PAD-I demonstrated clear benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk.

Conference calendar 14–18 September The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2024 Lisbon, Portugal https://cirsecongress.cirse.org/

26–27 September Vascular Access Society of Britain & Ireland (VASBI) 2024 Cardiff, UK https://www.vasbi.org.uk/annualscientific-meeting-2024/

27–29 September The Portal Intervention Symposium 2024 Chicago, USA

https://portal360meeting.com/

17–19 October SIR EDGE 2024 Denver, USA

https://www.sirweb.org/learningcenter/meetings/sir-edge/

6–8 November British Society of Interventional Radiology (BSIR) 2024 Brighton, UK

20–22 February International Multidisciplinary Endovascular (IM Endo) Forum 2025 Florence, Italy

13–16 April European Conference on Interventional Oncology (ECIO) 2025

www.imendoforum.com

Rotterdam, The Netherlands https://www.ecio.org/

16–18 January SPECTRUM 2025 Miami, USA

29 March–3 April Society of Interventional Radiology (SIR) 2025 Nashville, USA

11–14 July European Conference on Embolotherapy (ET) 2025 Porto, Portugal

https://www.bsirmeeting.org/

https://thespectrumconference.org/

https://www.sirmeeting.org/

https://www.etconference.org/

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References: 1. Valgimigli M et al. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial.

Lancet. 2018;392(10150):835-848.

2. Diego-Nieto A et al. Safety and feasibility of transradial access for percutaneous coronary intervention in chronic total occlusions. Rev Esp Cardiol (Engl Ed). 2022;S1885-5857(22)00140-2.

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