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07 STRIKE-PE:

Subanalyses yield new data during SIR 2025

14 Profile:

Alex Barnacle

May 2025 | Issue 98 LECTURE

15 ECIO panel:

IO leaders call for better data to confirm ‘fourth pillar’

WORLDWIDE IR

Education and experience are needed to back ‘fascination’ with liquid embolics, experts say

Innovating innovation for better or worse Celebrating the 50th anniversary of the Society of Interventional Radiology’s (SIR) annual scientific meeting (29 March–2 April, Nashville, USA), Lindsay Machan’s (University of British Columbia, Vancouver, Canada) Charles T Dotter Lecture turned to innovating innovation, honouring Dotter to show the strides technology has made since interventional radiology’s (IR) inception.

“I

n the 50th year of SIR, it seems best to talk about how innovation is changing,” Machan said. He recalled how IR pioneer Ernest Ring had described the meeting as ‘a bunch of people excited to see others who were doing the same things they were’—“and that’s actually how I think all of us feel about this meeting today,” Machan reflected.

Sink or swim

Individually, Machan’s relationship with innovation has been unique. He described his first staff job at Hammersmith Hospital in London, UK in 1989, when Hans Walsten was

promoting the Wallstent (then Medinvent, now Boston Scientific). “Over 1,200 had been inserted into bile ducts and virtually every artery throughout the body in Europe.

All the dogma at the time said that there was a 2% failure rate. Especially in certain places, they were restenosis machines, you could see that,” he described. Machan tried various methods of preventing this outcome to no avail, until encountering a medical student presenting his premedical work on cartilage-derived angiogenesis inhibitors in animal models of rheumatoid arthritis.

“The room was empty, almost nobody was there. Bill Hunter began talking about new blood vessel formation and the fact that tissue can’t grow more than two millimetres away from a capillary unless it’s cartilage or cornea—so in essence, inhibition creates zones of exclusion,” said Machan.

Approaching Bill after his talk, Machan admitted that he knew little about animal models of rheumatoid arthritis, but that he believed it would make the ideal stent coating.

Starting their company, Machan, Bill and Larry Arsenault promptly raised CDN$100,000. “And then we made a very important discovery—it didn’t work,” Machan stated.

Consulting an expert in biochemistry, the three founders shortly discovered that by coating their stent with paclitaxel, the active ingredient in the chemotherapeutic agent Taxol, they

This new era of health has resulted in the combination of digitalisation and consumerisation”

“For me, it was essentially love at first sight,” confessed Gary Siskin (Albany Medical Center, Albany, USA), stating his enthusiasm for liquid embolics—an enthusiasm that is shared by an increasing number of interventionists year on year, he says. As with many emerging technologies, however, benefit, risk and research must be considered before widespread adoption.

Here, Siskin and other users speak on the current “fascination” with liquid embolic agents, their future, and the concerns that remain.

FOR SISKIN, THE incorporation of liquid embolics into his practice began with glue, “the earliest embolic agent” that was available to him and his team.

“However, it’s hard to argue the effectiveness of glue,” he stated, due to the “artistry” of diluting glue to ensure successful deployment.

As newer embolic agents emerged, the “idea of diluting the product and tailoring it to the indication that you’re using it for has kind of gone away,” said Siskin, leaving space for premade products.

“I think we’re approaching an easeof-use era, which is going to allow for wider adoption and adaptation of liquid embolics,” he continued.

This, he believes, will provide several benefits to interventionists, including reaching hard-to-access vessels, improved packing density and costeffectiveness.

Enabling him to reach the previously unreachable, Siskin told Interventional News that he frequently uses liquid embolic Continued on page 4

Continued on page 6

May 2025 | Issue 98

2

EDITORIAL

Greetings, dear readers We are in the middle of the spring congress season, and I am just back from the 50th anniversary meeting of the Society of Interventional Radiology (SIR; 29 March–2 April, Nashville, USA) and the Pan Arab Interventional Radiology congress (PAIRS; 9–12 April, Dubai, UAE) to introduce the 98th issue of Interventional News and the latest updates in the interventional world.

(ISVIR; 6–9 February, Kochi, India). I went to my first ISVIR over 10 years ago, and I was impressed by how much this meeting has grown in size, attendance and stature. The congress was hosted by Shyamkumar Keshava (Christian Medical College & Hospital, Ludhiana, India) and Ajit Yadav (Sir Ganga Ram Hospital, Rajinder Nagar, India) and credit is due to the scientific programme team for the excellent schedule of sessions. There was a large national and international faculty, and the location in Kerala is certainly worth a visit for leisure purposes when there is no congress in town to absorb one’s attention.

Finally, I would like to highlight key articles in this, another bumper edition of Interventional News. In addition

T

he 50th SIR meeting was a great success both in terms of delegate attendance numbers and the scientific programme that was very well put together by the programme chair, Gloria Salazar (University of Carolina Chapel Hill, Chapel Hill, USA), and her team. One of the highlights was the annual Charles Dotter Lecture, which this year was given by Lindsay Machan (University of British Columbia, Vancouver, Canada).

Lindsay’s Dotter Lecture is highlighted as a main feature in this issue. I was reminded by Lindsay during his lecture that he pioneered the use of paclitaxel as an antiproliferative drug in arterial disease in the 1990s; so we vascular specialists are reminded that we have much to The Global Summit session during SIR thank Lindsay for.

Another highlight of the SIR meeting was the third to the aforementioned piece covering the Dotter Lecture, Global Summit in interventional radiology (IR), which the other main feature focusses on hot topics within liquid this time focussed on global educational discrepancies embolic use. This issue’s profile highlights the career of impacting the IR workforce and also awareness of paediatric interventional radiologist Alex Barnacle (Great IR around the world. The summit contained several Ormond Street Children’s Hospital, London, UK). Apart presentations from IR leaders from national and from her busy job and roles in the British Society of international societies providing information on how Interventional Radiology (BSIR) and the Cardiovascular education is provided for interventional radiologists. The and Interventional Radiological Society of Europe discussion aimed to reach consensus on how to improve (CIRSE), Alex is currently in charge of the IR GIRFT the global reach of education and to improve recognition of (Getting It Right First Time) project, which will complete IR globally. and deliver its report in the next year or so.

The PAIRS meeting goes from strength to strength, Finally, included are a variety of highlights from the and this year’s meeting saw a large international and recent 2025 Charing Cross (CX; 23–25 April, London, local faculty deliver a comprehensive programme to UK) symposium and European Congress of Interventional a well-attended IR audience. The scientific Oncology meeting (ECIO; 12–16 April, Rotterdam, programme included all aspects of IR The Netherlands), updating on the most anticipated topics including a prominent focus developments across interventional oncology, radiology on aortic and peripheral arterial and vascular intervention. intervention. The excellent keynote As always, I hope that you enjoy this edition of lecture delivered by Salah Qanadli Interventional News, and I hope to see as many of you as (University of Lausanne, Lausanne, possible at a future meeting.

Switzerland) focussed on IR identity and how to improve the profile and recognition of IR. ROBERT MORGAN is professor of interventional The third recent IR radiology at St George’s University Hospitals meeting that I mention NHS Foundation Trust in London, UK Robert is the Indian Society of and the president of the British Society of Morgan Interventional Radiology Interventional Radiology (BSIR).

Editors-in-chief: Professor Robert Morgan, Professor Andy Adam, Professor Brian Stainken Publisher: Stephen Greenhalgh Editor: Éva Malpass | Editorial contribution: Jocelyn Hudson, Will Date, Bryan Kay, Jamie Bell Design: Terry Hawes, Josh Lyon and David Reekie Advertising: Abbie Richardson abbie@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, 2025. All rights reserved.

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NEWS IN BRIEF

THE LATEST STORIES FROM THE INTERVENTIONAL WORLD

n GAE OPINION: Musculoskeletal (MSK) embolization— including techniques such as transarterial microembolization (TAME) and genicular artery embolization (GAE)— has emerged as a novel, minimally invasive treatment for chronic joint and tendon pain. Here, Yuji Okuno (Tokyo, Japan) and Gerard Goh (Melbourne, Australia) collaborate to raise several critical questions that, at present, remain unanswered, and set out steps that must be taken to integrate MSK embolization into clinical practice.

For more on this story go to page 9.

n WAVE TRIAL: Twelve-month results of the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial show a statistically significant improvement in target lesion primary patency (TLPP) with the Wrapsody (Merit Medical) cell-impermeable endoprosthesis (CIE) when compared to percutaneous transluminal angioplasty (PTA).

For more on this story go to page 10.

n POSTPARTUM HAEMORRHAGE: A new geographic information system (GIS) analysis of Kenya has found “disproportionate” rates of maternal morbidity and mortality due to postpartum haemorrhage (PPH) in areas without interventional radiology (IR) capabilities.

Led by Ryan W England (Princeton, USA) and published in the Journal of Vascular and Interventional Radiology (JVIR), the study employed multilayered GIS mapping to pinpoint healthcare disparities and propose a framework for global IR outreach.

For more on this story go to page 17.

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ET 2025 will feature unique session formats and a vibrant programme – browse the full schedule now and put together your personal itinerary !

Highlights this year will include a special focus on MSK conditions, including a dedicated session featuring lectures from the world’s top experts as well as two deep dive sessions.

Other deep dive sessions, which enable participants to interact closely with the experts, will delve into: • Gastro-intestinal bleeding • Vascular malformations • Radioembolization • Men’s health • Visceral aneurysms Register now to join us in Porto to connect with old colleagues and new friends for a meeting focusing on one of interventional radiology’s fastest growing areas.

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4

May 2025 | Issue 98

Top Stories COVER STORY continued

Education and experience are needed to back ‘fascination’ with liquid embolics, experts say Continued from page 1

agents to treat peripheral haemorrhage, vascular malformations, and endoleaks, while having recently expanded to some venous indications. However, “we always need to be comfortable with where the liquid might travel”, he added, noting that this factor plays a large part in identifying a “good” or a “bad” case for the use of a liquid embolic.

“For example, we do bronchial embolization. It might be nice to use a liquid, but there’s a risk of embolizing the spinal cord and sometimes this is not easy to see, so we don’t take the chance,” Siskin said. “I also don’t necessarily think we should be [using liquid embolic agents] in fibroids or knee arthritis—people are starting to use them in prostate embolization, but I think we have a way to go before we can routinely recommend that.”

Siskin described that the “most valuable” quality of liquid embolics are their superior packing density, which he believes rivals coils in both level of occlusion and efficiency. He explained that it is often challenging to fill a vessel with coils, despite only needing to fill a third of the vessel lumen. “It’s difficult to conceptualise that you aren’t filling as much of the vessel as you think,” but with a liquid embolic “if done the right way, it can fill close to 100% of the vessel, maximising packing density in a way that other products can’t ever hope to achieve,”

Siskin stated.

“Generally, the teaching that we give people for liquids is to inject them very slowly, especially agents like LAVA [Sirtex] or Onyx [Medtronic].

Even injecting them as slow as you need to, it still results in an occlusion that takes less time than putting in multiple coils or other embolics. I have found that using liquids is a very efficient way to embolize blood vessels,” said Siskin.

Ascribing improved efficiency to enhanced costeffectiveness, Siskin stated that theirs has become

It’s just a question of the interest in bringing something new into your practice and then getting the education and the experience that gives you the confidence to use it correctly” a “liquid-first” practice. Although liquid embolic agents “look cost prohibitive at first glance”, Siskin revealed that a small amount of product is needed to embolize the average vessel, which initiated a “wholesale change” in his practice.

Siskin added: “The reality is that all of the products that we use are getting progressively more expensive. If you’re using, let’s say, pushable coils and first-generation detachable coils, you’re probably not going to be able to make an economic

PODIUM FIRST

New VenaSeal data suggest cyanoacrylate closure be added to the venous “toolkit” Twelve-month outcomes of the VenaSeal Spectrum venous leg ulcer (VLU) trial, assessing time to ulcer healing following treatment with the VenaSeal (Medtronic) closure system, have demonstrated an 81.3% ulcer healing rate at one year.

MANJ GOHEL (CAMBRIDGE University Hospitals, Cambridge UK) presented the results in a podium-first presentation during a deep venous challenges session at the 2025 Charing Cross (CX) International Symposium (23–25 April, London, UK). The VenaSeal system uses cyanoacrylate glue to treat underlying venous insufficiency.

The single-arm study prospectively assessed time to ulcer healing in patients with an active venous leg ulcer classified as C6 as the primary endpoint, and a secondary endpoint of vein closure through 12 months.

Gohel stated that studies have frequently evaluated the C2 to C5 ulcer population, leaving “an evidence gap”

where C6 ulcers are concerned.

The Spectrum VLU trial included 125 venous leg ulcer patients with a median ulcer age of 169 days and a maximum of 6,816 days (18 years and eight months). Gohel stated that the chronicity of the ulcers included was indicative of the severity of disease in their patient cohort, representing a “much harder to treat population than most other randomised studies”, he said.

On healing potential, Gohel reported 81.3% ulcer healing, 82% anatomic closure and 83% freedom from ulcer recurrence at one year, after healing had occurred. Gohel highlighted safety and effectiveness endpoints, which underwent review by an independent

case for liquids. But, if you are using the next endovascular coils or packing coils, you will find that these are very cost-effective and will make a lot of sense for your practice.”

Several studies have recently provided data on liquid embolic agents, including data from the LAVA (Sirtex) trial (see page 8) which found ethylene vinyl alcohol to be safe and effective for peripheral arterial haemorrhage. For Siskin, gaining these insights through clinical trials is “critical”, especially for the peripheral use of liquid embolic agents, so that “appropriate training can finally be given to interventional radiologists”.

Siskin highlighted that enthusiasm for liquid embolic agents is deserved, but interventionists should take adoption “slow”. In the near future, he hopes that ongoing trials will bear out the safety and efficacy of deeper penetrating embolic agents which he believes will have “big potential” for IR. For now, he asserted that interventionists should aim to understand when is best to use liquid embolic agents: “You’re going to want to look at risk—risk of distal or non-target embolization. Understand the flow in your target vessel. Look at vessel size.

Understand the volume of embolism that we reach.”

“We can play two truths and a lie here and say: interventional radiology [IR] is dependent on technology; there will always be new technology that can be easily taken up by interventional radiologists; and IR will always want these technologies. The lie is that it’s easy. Interventional radiologists are largely always interested in learning something new, but I think it’s concern that may hold people back,” said Siskin. “It’s just a question of the interest in bringing something new into your practice and then getting the education and the experience that gives you the confidence to use it correctly.”

committee. He stated that the VenaSeal system-specific events were consistent with prospective literature, and that events included hypersensitivity (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%).

No device- or procedure-related deaths were recorded; however, eight serious adverse events occurred following treatment.

These were identified as four infections, three superficial vein thromboses, and one granuloma.

Gohel stated that the high rate of other serious adverse events unrelated

I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease”

to the procedure or device, with 8% mortality within one year of the study, demonstrates the level of comorbid conditions prevalent in this patient population. This fact was also seen via quality-of-life measures, as patients often scored poorly across assessments prior to treatment.

These metrics did improve following treatment— however— providing “good evidence across a number of domains”, said Gohel.

“This is the largest prospective study of patients with C6 disease treated with cyanoacrylate in terms of effectiveness.

Healing rates are good and comparable to other studies,” said Gohel. “I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease.”

Following his talk, an audience member queried Gohel on the ulcer recurrence rate in the VenaSeal data.

In response, he highlighted that deep venous reflux and obese patients were included in the study, both of which have venous hypertension for a number of reasons: “That kind of recurrence rate is very typical in this population, and these are patients that are always going to be at high risk of ulceration.”

Issue 98 | May 2025

Conference Coverage

CX 2025

Bioresorbable scaffold technology has ‘potential to be a new paradigm for femoropopliteal endovascular intervention’ In the peripheral arterial programme at this year’s Charing Cross (CX) International Symposium (23–25 April, London, UK), which hosted several podium-first presentations, lower limb drugeluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI). Investigators shared compelling new data from studies ranging from first-in-human trials to large-scale registries, which vie to redefine durability and safety, as well as cost-effectiveness, in the peripheral arterial treatment landscape.

O

pening the session, Sahil Parikh (NewYork-Presbyterian, New York, USA) delivered an economic analysis of the Espirit below-the-knee (BTK) drug-eluting resorbable scaffold (Abbott) in the treatment of patients with CLTI. The two-year results demonstrated superior long-term outcomes for Esprit BTK compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.

Parikh stated that the incremental cost-effectiveness ratio at two years was determined by the difference in total cost divided by the difference in clinically driven target lesion revascularisation (CD-TLR) endpoint failure.

“Esprit BTK showed a lower adjusted event rate compared to PTA [27.5% vs. 49.4% for primary efficacy endpoint; 10.5% vs. 21.6% for CDTLR] showing a sustained benefit,” Parikh stated. He concluded that use of the Esprit BTK device resulted in US$3,206 per primary efficacy endpoint avoided, and US$6,068 per CD-TLR avoided.

Michel Bosiers (University Hospital Bern, Bern, Switzerland) shared an update on the three-year results of the MOTIV-BTK trial. The trial sought to evaluate the Motiv (Reva Medical) bioresorbable scaffold in 58 patients, the majority with Rutherford 4 or 5 lesions, Bosiers added.

At three years, the speaker reported 99% technical success and 80% primary patency for the Motiv device, with 93% freedom from CD-TLR at three years. Limb salvage at follow-up was 95%, with a recorded 16 deaths, although Bosiers notes that these were not device- or procedure-related.

Presenting one-year EFEMORAL I data, Andrew Holden (Auckland City Hospital, Auckland, New Zealand) shared that the trial has the “lowest [percent of] residual stenosis in any reported study of femoropopliteal intervention”.

EFEMORAL I is a first-in-human trial evaluating the Efemoral scaffold (Efemoral Medical) for the treatment of symptomatic peripheral arterial occlusive disease from atherosclerosis of the femoropopliteal artery across four sites in Australia and New Zealand.

Concerning maintenance of arterial patency, even after scaffold dissolution, Holden reported 100% primary patency and freedom from TLR at three years. He also highlighted sustained improvement in clinical outcome and walking tolerance at follow-up. Among other outcomes, the speaker shared a 0–15% post-procedure residual stenosis and no acute or subacute thrombosis—the lowest ever reported for a femoropopliteal trial. Meanwhile, Holden reported that the mean minimal lumen diameter of 4.74mm recorded at six months was the “highest ever reported”.

“This has potential to be a new paradigm for femoropopliteal endovascular intervention,” he added.

The peripheral arterial programme also featured a series of podiumfirst presentations that sought to demonstrate the graduation of devices past ‘proof of patency’, to evidence of their “major clinical benefit” in lower limb arterial intervention for CLTI. Michael Lichtenberg (Klinikum Arnsberg, Arnsberg, Germany) began with the first report of the 12-month SUCCESS-PTA trial data, which evaluated the Selution SLR (Cordis) drug-eluting balloon in patients with CLTI. The trial investigators enrolled 723 patients from 27 sites across Europe, Asia, and South America.

Lichtenberg reported positive 12-month outcomes, including consistent haemodynamic, functional and clinical improvements, with 91.1% freedom from CD-TLR overall, and 90.3% for the CLTI subgroup.

Among other outcomes, the speaker reported sustained improvements in ankle-brachial index (ABI), Rutherford

classification, and EQ-5D from six- to 12-month follow-up.

“These data continue to demonstrate the consistency of positive results across this new technology, even for patients with severe CLTI,” said Lichtenberg, addressing CX delegates.

“This, the largest study of sirolimus drug-eluting balloons in complex peripheral arterial disease patients, is proof that this technology works,” he stated.

Elsewhere in the session, Edward Choke (Northern Heart Hospital, Georgetown, Malaysia) delivered threeyear real-world outcomes from the HOPE registry, evaluating MagicTouch (Concept Medical) sirolimuscoated balloon versus plain balloon angioplasty in the below-the-knee (BTK) subgroup.

“At three years, sirolimus-coated balloons were associated with lower BTK interventions,” Choke reported, showing a 76.5% versus 64.9% freedom from TLR for MagicTouch and plain balloon angioplasty, respectively.

He added that sirolimus was superior to plain balloon angioplasty regarding amputation-free survival (AFS), showing 60.9% and 47.4% rates, respectively, in the two groups.

“Survival was somewhat surprising,” said Choke, who detailed that, at three years, sirolimus was associated with better survival, hypothesising

Next, Brian DeRubertis (NewYorkPresbyterian, New York, USA) shared 12-month amputation and readmission rates between the Eluvia (Boston Scientific) drug-eluting stent versus bare device therapies in a large contemporary real-world peripheral arterial disease (PAD) cohort.

He outlined that their evaluation was based on de-identified electronic health records (EHR) which granted his team access to data for approximately 10,000 patients. Of these, the investigators identified 881 patients treated with the Eluvia device and 5,156 treated with the non-drug-eluting device. They found that race and ethnicity distributions differed between groups, with Eluvia being more frequently used in Black and Hispanic patients.

“This is important because these two groups of patients are known to have worse outcomes in the USA in terms of amputation rates,” DeRubertis said.

Following propensity score matching to “reduce bias associated [with] device selection”, DeRubertis outlined that above-ankle amputation and any readmission within 12 months occurred “significantly more frequently” with non-drug-eluting therapy versus the Eluvia drug-eluting stent.

Considering these results, DeRubertis restated the significance of reducing amputations to “not only save cost to the patient, but to the healthcare

This, the largest study of sirolimus drug-eluting balloons in complex peripheral arterial disease patients, is proof that this technology works” - Michael Lichtenberg that this was due to higher rates of reintervention in the plain balloon angioplasty group, and therefore, “in this high-risk and highly frail group of CLTI patients, any procedures done will confer a risk to life”.

Choke ended pragmatically: “This is real-world data, and there are confounders both known and unknown,” he said. “Although sirolimus was associated with better outcomes, we should wait for the final data to emerge in the next one to two years before making definitive conclusions.”

system”. Showing a decline in amputation and readmission rates, the speaker confirmed the dual benefit of the drug-eluting stent in saving limbs and reducing the economic burden that major amputation places on global healthcare.

Subsequent audience questions and panel discussion focused on differentiating characteristics of these technologies, including lesion coverage protocols and drug aggressiveness, however, consensus determined cost to be the most influential factor dictating device selection.

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May 2025 | Issue 98

Top Stories COVER STORY continued

Innovating innovation for better or worse

Photo by EPNAC.com courtesy of Society of Interventional Radiology

Continued from page 1

Machan presenting at SIR

were able to achieve angiogenesis inhibition, creating their desired exclusion zone.

“We’re back in business, baby,” said Machan.

“So, we do some bench, small and large animal experiments, but we needed to deal with one big problem and that was that, at the time, Taxol had up to a 30% anaphylactic rate.” Machan notes that this reaction was considered attributable to a solubilisation agent, Cremophor—a castor oil derivative—but there were lingering concerns it could be related to paclitaxel itself, which threatened “to sink us”, he stated.

During this time, however, Machan described a patient who had oesophageal cancer who had had two failed attempts at dilation.

“His grandkids wouldn’t come to visit him because he couldn’t swallow so was always spitting up. He just said he wanted to be able to eat ice cream and drink scotch. So—and I would go to jail for this now—I went across to our lab and we packed as much paclitaxel and ethylene vinyl acetate as humanly possible onto this removable oesophageal stent,” Machan told the SIR 2025 audience. “I sweated bullets overnight. I went in the next morning and there he was with three little dixie cups on his mail stand, and he threw me this presumed scotch-induced grin, so we knew were in business,” recounted Machan.

In 1992, Machan and his other co-patentors signed a co-exclusive license with Boston Scientific and Cook Medical for their paclitaxel-coated stent, despite five years of talks with various companies. “We had received a cash offer, so I went up to Boston and Cook and said, ‘I don’t know if you guys are just being nice to me but if an alternative doesn’t arise, this deal is going to go through Wallstent on Monday’. By that Saturday at 9am, we confirmed that FOMO [fear of missing out] is still the most important factor in so many ways,” Machan said.

“What did I learn from all of this?”

His trajectory through innovation taught Machan that observing opportunities for innovation is key, he stated. “‘Honour every opportunity to learn something new’—it’s a fantastic quote. My first instinct was to not go to that premedical presentation because it was on something I didn’t understand, but I went and it changed my life. Work with people who have other

Now, in everyone’s pocket there is a device that can interface with a digital stethoscope, recognising heart and lung sounds, and can tell you what these represent”

gone through the slings and arrows that other medical companies have, and with the irrationality of the business of healthcare,” Machan added, create a new landscape for patients and healthcare providers to navigate.

“But I said follow the money,” Machan continued.

“Think about efficiencies, quantum leaps, efficacy and safety, while empowering lesser trained members of the healthcare team.” To exemplify this stance and the democratisation of teaching, the speaker described the history of the stethoscope, and how the tool required specialised expertise which created barriers as to who could deliver healthcare.

“Now, in everyone’s pocket there is a device that can interface with a digital stethoscope, recognising heart and lung sounds, and can tell you what these represent,” described Machan. “This means that every general or nurse practitioner now has the expertise of an Ivy League cardiologist immediately available to them. This reduces, for instance, unnecessary referrals from rural areas or for functional murmurs in children.”

skills,” Machan continued. “But, boy, are luck and timing everything. Then finally, work on a problem that someone will pay for. It’s great to do research, but if you want to get it into a patient, unfortunately you have to have a commercial alliance.” It is this commercial element that has become a larger part of innovation today, stated Machan, but the “cascade of steps” to take “an idea on a napkin to getting it patented and regulated hasn’t changed, and you can’t AI in the real world skip any of them,” he added.

Machan subsequently touched on AI and the What has changed, however, is where innovators introduction of AI innovation at a societal level. look for opportunities, Machan said. “First of all, Machan noted how Truveta, among a growing you follow the money,” he stated. On one side, there number of comparable companies, is able to extract are the “inconvenient truths” of needing to control and interrogate healthcare data from millions of unsustainable healthcare costs; at the same patients daily, drawing on these data to further clinical time there are significant changes set to research. Referencing a publication by Monteleone transform future healthcare, including et al, comparing ultrasound-assisted catheter-directed casting the patient as a consumer and thrombolysis versus mechanical thrombectomy in the integration of artificial over 83 million patients, Machan drew attention intelligence (AI) within the to the wealth of procedures and outcomes that treatment algorithm. can be studied.

Regarding the former, With the ability to provide real-world data, Machan spoke on these emerging AI programmes are bringing to the democratisation of the fore the realisation that “what happens in cardiovascular care at the real world doesn’t necessarily happen home. Using the example in controlled company-sponsored trials”, of smartwatches that can monitor Machan stated. and record your heart rate and Finishing his talk, Machan ruminated sympathetic tone, the speaker on what Dotter would say to early stated that “this new era of career interventional radiologists health has resulted in the seeking to innovate today. In his view, combination of digitalisation and Dotter would urge them to be curious, consumerisation”. The result of collaborate and record what they learn, this has meant that companies such and to protect the spirit of IR, leaving the Lindsay Machan as Google and Meta, “who haven’t speciality better than they found it.

Issue 98 | May 2025

Conference Coverage

THROMBECTOMY

STRIKE-PE interim analysis shows benefit for acute PE patients with syncope A STRIKE-PE interim analysis of clinical outcomes of acute pulmonary embolism (PE) patients with or without syncope— an indicator of compromised cardiac output and so increased short-term mortality—has found that patients with syncope who had a higher right/left ventricle (RV/LV) ratio at baseline were restored to a condition similar to patients without syncope following treatment with the Lightning Flash (Penumbra) computer-assisted vacuum thrombectomy (CAVT) device.

“SYNCOPE IS A FREQUENT conundrum,” said John Moriarty (University of California Los Angeles, Los Angeles, USA) during his latebreaking presentation of the featured abstract at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA). “Often we are uncertain whether this is a group of patients with acute intermediate risk, or whether they are within a worse group when considering outcomes or at higher risk of [repeated] intervention, so we felt it was important to study this patient John cohort,” he stated.

Moriarty

Initially powered to evaluate 600 patients, the STRIKE-PE cohort was extended, subsequently enrolling 1,500 patients. The prospective, international, multicentre study included patients with acute PE symptoms of ≤14 days and an RV/LV ratio of ≥0.9. Patients from this interim analysis with (n=72) versus without (n=228) syncope were compared.

Moriarty highlighted that there was a statistically significant difference in Miller score of those ≥12 (91.7% vs. 80.7%, p=0.03) in the syncope cohort, taking this to demonstrate a large clot burden, which

was seen more frequently in patients with syncope than in those without.

These patients also presented with a shorter time from symptom onset to venous puncture (47.5 hours vs. 81 hours p=0.04), and a higher RV/LV ratio (1.48 vs. 1.37, p=0.03).

At 48-hour post-procedure followup, RV/LV ratio improved in both groups, however improvement was significantly greater for patients with syncope (0.51 vs. 0.37, p=0.004; 31.7% vs. 25.2%, p=0.002). No significant difference was found between the groups for rate of composite major adverse events within this timeframe, nor concerning 30-day mortality.

“In other words, by imaging

When we look at safety, there are essentially no differences between the patients who had syncope and those who didn’t” characteristics, [patients with syncope] got better, although both cohorts did well,” Moriarty told SIR 2025 delegates. “When we look at safety,

Computer-assisted vacuum thrombectomy device demonstrates “highly” improved device use time

there are essentially no differences between the patients who had syncope and those who didn’t. We believe this is going to be clinically important because there has been a theory that patients who present with syncope are at increased risk, whether it’s primary safety or device-related safety outcome during the procedure.”

Both groups had reduced dyspnoea via the Borg scale at rest from baseline to discharge, and no significant differences in dyspnoea were reported between the groups following a sixminute walk test at discharge.

“Syncope is a common problem,” Moriarty described. “We believe that it’s an indicator of compromised cardiac output, and then therefore it portends to people who have a bad outcome due to the severity of their haemodynamic instability or right ventricular outflow tract obstruction, with an increase in RV dysfunction at presentation, an increase in short-term mortality and risk of early PE-related adverse outcomes, making this is a very fertile area of evaluation,” he added.

“So far, we believe that the clinical benefits of CAVT that are shown in this study may be especially valuable for patients who present to this theoretically high-risk cohort,” Moriarty commented. Moving forward, he and his team add that there is need to elucidate clinical markers to further the understanding of patients with acute PE.

and stability”.

Mean RV/LV ratio decreased from 1.34 at baseline to 0.94 at 48 hours (27.8%, p<0.001). The speaker noted that one composite major adverse event (0.6%) occurred within 48 hours; however, no device-related serious adverse events were reported. Six patients required pre-discharge transfusion. “Most of these In a subgroup analysis of the STRIKE-PE study regarding patients treated with were related to the patient’s underlying conditions”, the latest iteration of Penumbra’s 16Fr Lighting Flash computer-assisted vacuum Schiro stated; however, no major bleeding required thrombectomy (CAVT) device, Brian J Schiro (Miami Cardiac & Vascular Institute, transfusion and there were no device-related Miami, USA) reported improved haemodynamic markers, right/left ventricle (RV/LV) transfusions. Additionally, median Borg dyspnoea ratio, dyspnoea, and overall, a “highly” improved device use time of 25.5 minutes. score at rest decreased from 5 (severe [heavy]) at baseline to 0.5 (very, very slight [just noticeable]) IN THE OUTSET OF SCHIRO’S based algorithms to rapidly detect thrombus at discharge. presentation at the Society of Interventional from blood flow.

“What we really want to highlight here is the Radiology (SIR) annual scientific meeting (29 Among their 164 acute PE enrollees, the average procedure time and the time of thrombectomy,” March–2 April, Nashville, USA), he described that patient age was 61.6 years, and 53.7% were Schiro told SIR delegates. He compared the 16Fr the goals of pulmonary embolism (PE) treatment are male. PE risk stratification was high in 4.9% of Lightning Flash to devices used in the APEX-AV, haemodynamic stability, perfusion restoration and patients, intermediate-high in 86.6% and FLASH and PEERLESS trials, which had right heart strain relief, among others. “Functional intermediate-low in 8.5%. The median procedure times of 37.2, 43, and 47.5 analysis is also important,” Schiro noted, stating thrombectomy time was 25.5 minutes, respectively. that the consideration of long-term issues in these minutes and median procedure “The most impressive figure patients is as important as immediate improvement time was 59 minutes. Schiro really is that short device time. in symptoms. reported that mean on-table We achieved exceedingly STRIKE-PE Initially, he described the evolution of endovascular pulmonary artery pressures short procedures compared APEX-AV treatment of PE, outlining the progression from (PAPs) “significantly with some of the other trials thrombolytics, to continuous aspiration, and now, decreased”—systolic that have been reported,” Procedure time CAVT, the “next-generation” treatment modality.

PAP from 50.8mmHg Schiro said. “With the in minutes The present analysis of the STRIKE-PE study to 38.8mmHg (23.4%, [16Fr Lightning Flash] evaluated periprocedural and functional results of p<0.001), and mean device, we continue to see the first 164 acute PE patients enrolled and treated PAP from 31.2mmHg significant improvements in with CAVT using the 16Fr Lightning Flash system. to 23.5mmHg (24.5%, the patient’s status, including FLASH The device comprises an aspiration catheter and a p<0.001)—demonstrating the RV/LV ratio, functional status PEERLESS microprocessor programmed to optimise regulation device’s effect, providing “quick and an excellent safety profile,” of aspiration by using pressure differential and flowhaemodynamic improvement he stated.

25.5

37.2

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47.5

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May 2025 | Issue 98

Journal Updates EMBOLIZATION

LAVA trial demonstrates high clinical success for EVOH Results from the prospective, multicentre Liquid Embolization of Arterial Haemorrhages in Peripheral Vasculature (LAVA) study evaluating the Lava (Sirtex) ethylene vinyl alcohol (EVOH) liquid embolic have demonstrated a 94.3% primary effectiveness rate, exceeding a clinical performance goal of 72%.

“IN THE PAST FIVE DECADES, many agents have been used in PAH [peripheral arterial haemorrhage], such as coils, plugs, particles, stent grafts, gelatine sponge, and liquid embolics,” write the study’s authors, led by Bulent Arslan (Rush University, Chicago, USA). Their paper, which was recently published in the Journal of Vascular and Interventional Radiology (JVIR), set out to identify whether liquid embolic agents could overcome some of the limitations of nonliquid agents. Liquid materials have been seen in some single-centre experiences to cause “near-complete, predictable, and permanent vessel occlusion, with reduced risk of incomplete occlusion due to coagulopathy and delayed recanalisation”, Arslan et al exposit.

The study included individuals aged 18 years or older with active haemorrhage in the peripheral vasculature, but no previous

embolization in the target vessel and a life expectancy of more than 30 days.

Enrolees were gained across 19 centres in the USA. PAH was defined as the presence of either active haemorrhage or pseudoaneurysm as diagnosed at endoscopy or catheter angiography or by computed tomography (CT) angiography.

Overall, 141 lesions were identified in 107 patients. Patients enrolled had a mean age of 57.4 years and 63.7% were male. Targeted areas included non-gastrointestinal visceral arteries (31.1%), kidneys (26.3%), upper gastrointestinal (GI) (11.5%), lower GI (6.8%), and extremities (6.1%). Arslan and colleagues describe that training was provided to all clinicians prior to the delivery of the EVOH agent.

Ideally, the agent would be delivered via slow infusion not exceeding 0.3ml/ min from distal to proximal, with a gradual pull back to prevent

catheter entrapment.

The primary effectiveness endpoint— clinical success at 30 days—was achieved in 133 of 141 lesions, and in 102 of 107 patients. Clinical success was defined as having satisfied four conditions: no bleeding from target lesion, no emergency surgery, no re-embolization, and no target esion reintervention.

Concerning procedural outcomes, adjunctive embolotherapy was used in 38 lesions. Bleeding following EVOH treatment was reported in nine lesions, while 144 lesions had “less bleeding” following the index procedure. Two target lesions treated with EVOH required subsequent re-embolization.

A total of six (4.4%) adverse events occurred in five of 113 patients and the all-cause mortality rate at 30 days was reported as nine (8.3%) of 109—four

The low rate of adverse events noted with EVOH is encouraging” patients exited the study before 30-day follow-up.

In a subgroup analysis, Arslan and colleagues add that clinical success was higher in males than in females, 98.9%

Nulliparity “strongly associated” with significant post-embolization syndrome following uterine artery embolization Recently published in the British Journal of Radiology (BJR), a retrospective casecontrol study has found nulliparity to be “strongly associated” with the incidence of clinically significant post-embolization syndrome (csPES) after uterine artery embolization (UAE).

“THIS RISK FACTOR HAS NOT PREVIOUSLY confounding, the authors report a trend that shows been shown to be associated with csPES,” write the 13% reduced odds of developing csPES for every authors of the PREDICT-PES study, led by Warren year increase in age.

Clements (Alfred Health, Melbourne, Australia).

The authors note that there have been very few Their cohort, comprised of 69 patients with a mean studies identifying which patients are at higher risk age of 46.2 years and a mean uterine volume of of developing a more significant form of PES. In 393ml, all underwent UAE for symptomatic 2009, Ruuskanen et al assessed 62 patients with fibroids between 1 March 2022 and csPES following UAE and found that a 1 September 2023. larger volume of embolic agent plus more Clements and colleagues defined csPES ischaemia via magnetic resonance imaging as the maximum pain score on visual (MRI) correlated with the level of pain analogue scale of greater than five out of experienced. Thus, it was suggested that if 10, plus at least one of: morphine patientischaemia causes pain, larger fibroids and/ controlled analgesia dose of less than or smaller particles are more likely to cause 10mg, fever, or the use of two or more csPES. Warren Clements antiemetics.

Yet, Clements and colleagues detail that The rate of csPES in their cohort this hypothesis has been refuted in a small was 47.8%, Clements et al report. Most patients number of studies to date, showing that postoperative had a single fibroid and fibroid disease that was pain did not show an association between median largely intramural in location, while previous pelvic uterine volumes. surgery and/or preoperative anaemia was common “While the univariate analysis in this study in both groups. Their results showed that nulliparity did show an association between median uterine increased a patient’s risk of developing csPES by volume and csPES, after adjusting for confounders, 5.5 times compared to patients who are primiparous this was no longer significant and suggests that or multiparous. Additionally, after adjusting for the effect in our cohort was due to the influence

and 86.3%, respectively, although major adverse event rate, technical success and intact retrieval of microcatheter rate at 30 days were similar between groups.

In their discussion, Arslan et al note that liquid embolic agents and mechanical occlusion devices can be “complementary” in certain settings, highlighting that 25.7% of treated lesions in their cohort required adjunctive embolics which were used concurrently with EVOH. Although their study suggests that EVOH is safe and effective in PAH, the authors bring awareness to the diverse range of aetiologies and locations of bleed in their patient cohort which mean that their results cannot be generalised to a population that does not parallel the study’s population.

“The low rate of adverse events noted with EVOH is encouraging,” Aslan and colleagues write. “As with other liquid agents, the successful use of this device is associated with a short but steep learning curve.” The authors reiterate that the clinicians each had experience treating lesions with EVOH, and warn that adverse events may be more common if the operator is not experienced with the liquid agent.

Arslan et al state that these data provide a “higher level of evidence” in support of embolization of PAH than those in prior studies, which work to expand treatment options for the potentially life-threatening condition.

of other variables,” Clements et al write. “This is important as, in the experience of the authors, many women with very large fibroids do not get referred for embolization and are also often not considered suitable for myomectomy. Thus, they may miss out on an opportunity for a uterine-spring treatment.”

Clements et al note several limitations of their study, stating that the Australian demographic and awareness of UAE are reflective of “current referral patterns” resulting in their relatively small cohort size. They state that the short time span of the study was due to the implementation of premedication protocol, which changed from oral to intravenous, meaning the authors were able to evaluate “a controlled group without external influences”.

Practically, the authors state that these results will improve their informed discussion process. As pre-procedure counselling of a patient’s csPES risk is “difficult to predict”, Clements and colleagues note that they previously provided a “more generalised warning to all patients regarding likelihood of pain” following UAE, particularly in nulliparous patients.

“We can use this information to better counsel our patients regarding the odds of csPES when these risks are present, leading to an improved consent process, and the ability to plan more targeted pain management for women who are known to be nulliparous,” the authors conclude.

This risk factor has not previously been shown to be associated with csPES”

Issue 98 | May 2025

Embolization

POINT OF VIEW

Musculoskeletal embolization: Promise, progress, and the path forward

Gerard Goh Yuji Okuno Musculoskeletal (MSK) embolization—including techniques such as transarterial microembolization (TAME) and genicular artery embolization (GAE)—has emerged as a novel, minimally invasive treatment for chronic joint and tendon pain. Initially applied to conditions such as knee osteoarthritis (OA), frozen shoulder, and tendinopathies, these procedures target hypervascular inflammation, a key contributor to chronic MSK symptoms.

While early data are promising, the field is still maturing. Here, Gerard Goh (Alfred Hospital, Melbourne, Australia) and Yuji Okuno (Okuno Clinic, Tokyo, Japan) collaborate to raise several critical questions that, at present, remain unanswered.

Top 5 unanswered questions 1. Generating high-quality evidence

To date, much of the literature on MSK embolization consists of case series and single-arm studies. While these have reported significant reductions in pain and improvements in function, randomised controlled trials (RCTs) remain limited. Notably, the few RCTs published have produced mixed results—one demonstrated clinical benefit, while another showed no significant difference from placebo.1,2 These findings raise concerns about placebo effects and highlight the need for more rigorous evidence. Larger trials in the UK, France, and US are ongoing and may help define the clinical value of these procedures.3,4,5

2. Optimising indications and patient selection

Knee OA is a heterogeneous disorder with varying underlying causes and pathologies. While GAE appears beneficial for many, it is still unclear which patients are most likely to

respond. Pre-procedural magnetic resonance imaging (MRI) findings have shown potential in predicting outcomes, but reliable imaging-based criteria for patient selection remain underdeveloped.6,7 Similar uncertainties exist for other conditions such as frozen shoulder and sports-related injuries, where the roles of contrast-enhanced MRI and other imaging modalities are still being clarified.

Additionally, as pain is a subjective experience, psychological factors such as catastrophising, anxiety, and depression may influence outcomes.

These aspects should be considered in future studies aimed at refining patient selection frameworks.

3. Improving outcome assessment methods

Pain assessment traditionally relies on tools such as the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS), which capture pain at a single time point. However, these tools are susceptible to environmental and emotional factors, leading to variability. Broader functional scoring systems—such as Western Ontario and

McMaster Universities Osteoarthritis Index (WOMAC) or Knee Injury and Osteoarthritis Outcome Score (KOOS)—offer more comprehensive evaluations but depend on retrospective recall and may introduce bias.

Emerging approaches like Ecological Momentary Assessment (EMA) allow for multiple real-time inputs, providing more granular insights into daily symptom variability. Likewise, wearable devices can objectively track activity levels and function. Integrating these multidimensional tools into outcome assessment may improve the reliability and relevance of future research.

4. Refining embolic materials and techniques

One consistent finding in the literature is that embolic materials smaller than 100 micrometers are associated with higher complication rates, irrespective of whether they are temporary or permanent. Beyond this, however, consensus on the optimal type of embolic agent is lacking.

Temporary embolic agents are widely regarded for their safety, while permanent agents may offer longer-lasting benefits, particularly in progressive conditions like knee OA. Some propose combining both— utilising the short-term safety of temporary materials with the durable effects of permanent embolics. This hybrid approach could offer a balanced therapeutic profile.

Outside the knee, evidence is even scarcer. Recent findings suggest that in the elbow joint, using smaller embolic volumes can minimise complications and enhance clinical results. As the field evolves, tailored strategies for each joint and disease type must be developed, accounting for anatomical and physiological nuances.

5. Clarifying long-term outcomes

While many patients report sustained symptom relief for up to two years post-embolization, data on long-term durability remain sparse. It is unclear whether embolization alters the course of disease or simply provides temporary relief. Key questions remain: Can embolization delay or prevent

Comparison finds quick-soluble gelatin sponge particles cause increased at-site pain following TAE for overuse joint disorders A COMPARISON OF THREE biodegradable embolic materials—imipenem/ cilastatin (IPM/CS), quick-soluble gelatin sponge particles (QS-GSPs), and resorbable microspheres— has demonstrated the safety and effectiveness of all three in alleviating symptoms in transcatheter arterial embolization (TAE) for degenerative, inflammatory and overuse joint disorders. Data show that increased

pain at the site of embolization was significantly higher among patients treated with QS-GSPs. Led by Tijmen van Zadelhoff (Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands) et al, the retrospective study included 431 patients; 527 overuse joints with refractory overuse injuries, knee osteoarthritis, frozen shoulder, symptomatic rotator cuff tear, synovitis of the

joint replacement surgery? What is the efficacy of repeat embolizations? And how does embolization affect joint structure over time?

To address these, extended followup of existing cohorts and the establishment of prospective registries will be critical. Understanding longterm safety and efficacy will determine the role of MSK embolization in the treatment continuum.

MSK embolization is an innovative and promising addition to the therapeutic arsenal for chronic musculoskeletal pain. Offering a minimally invasive, targeted alternative for patients unresponsive to conservative care, it has the potential to bridge the gap between medication and surgery. However, its future depends on addressing key uncertainties through robust clinical trials, refined patient selection, optimized embolic techniques, and comprehensive longterm data. The next few years will be pivotal in determining whether MSK embolization becomes a standard of care or remains a specialised intervention for select cases.

Gerard Goh is an interventional radiologist at the Alfred Hospital in Melbourne, Australia and Yuji Okuno is an interventional radiologist at the Okuno Clinic in Tokyo, Japan.

References 1. Bagla S, Piechowiak R, Sajan A, et al. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):210.e2 2. van Zadelhoff TA, Bos PK, Moelker A, et al. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047.

3. Little MW, Harrison R, MacGill S, et al. Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial. Cardiovasc Intervent Radiol. 2023 Sep;46(9):1276-1282.

4. https://www.centerwatch.com/clinical-trials/ listings/NCT06497140/effect-of-genicular-arteriesembolization-in-symptomatic-knee-osteoarthritislipiojoint-2/effect-of-genicular-arteries-embolizationin-symptomatic-knee-osteoarthritis-lipiojoint-2 5. https://www.cms.gov/httpswwwcmsgovmedic arecoverageideapproved-ide-studies/g200303nct04682652 6. van Zadelhoff TA, Okuno Y, Bos PK, et al.

Association between Baseline Osteoarthritic Features on MR Imaging and Clinical Outcome after Genicular Artery Embolization for Knee Osteoarthritis. J Vasc Interv Radiol. 2021 Apr;32(4):497-503.

7. Choi JW, Ro DH, Chae HD, et al. The Value of Preprocedural MR Imaging in Genicular Artery Embolization for Patients with Osteoarthritic Knee Pain. J Vasc Interv Radiol. 2020 Dec;31(12): 2043-2050.

foot joints, and persistent pain after knee joint arthroplasty who underwent TAE between March 2020 and May 2023. IPM/CS, QS-GSPs, and resorbable microspheres were used in 140 patients (176 TAEs), 136 patients (163 TAEs), and 155 patients (182 TAEs), respectively.

Zadelhoff et al reported no serious adverse events; however, increased pain at the site of embolization lasting more than seven days occurred in 7.1, 22 and 5.8% of patients with IPM/CS, QS-GSPs, and RMs, respectively, and most commonly in the elbow joint. They note that numeric rating scale (NRS) improved for all groups at one-, three- and sixmonth follow-up.

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May 2025 | Issue 98

New Data VASCULAR ACCESS

WAVE trial update reports sustained 12-month survival benefit

Twelve-month results of the Wrapsody Arteriovenous Access Efficacy (WAVE) pivotal trial show a statistically significant improvement in target lesion primary patency (TLPP) with the Wrapsody (Merit Medical) cell-impermeable endoprosthesis (CIE) when compared to percutaneous transluminal angioplasty (PTA).

THE PROSPECTIVE, MULTICENTRE, international WAVE trial includes 43 centres in the USA, South America and the UK, concerning arteriovenous fistula (AVF) patients with venous outflow stenosis or occlusion in their peripheral venous outflow circuit.

These results were presented by Dheeraj Rajan (University of Toronto, Toronto, Canada) at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA). Rajan detailed that treatment efficacy was determined by the proportion of patients with TLPP, defined as freedom from clinically driven target lesion revascularisation or target lesion thrombosis. A key secondary endpoint at 12 months was access circuit primary patency (ACPP).

A total of 245 patients were randomised, 122 to treatment with Wrapsody and 123 to PTA. Rajan reported that no statistically significant difference in the proportion of patients free from a safety event was observed through to 30 days post procedure (CIE: 96.6%; PTA: 95%; non-inferiority p<0.001). At six months, the TLPP was higher for patients treated with Wrapsody versus PTA (89.8% vs. 63%; p<0.0001) and remained higher than the PTA cohort at 12 months (70.1% vs. 41.6%, p<0.0001). The six-month

ACPP was higher for patients treated with Wrapsody versus PTA (72.8% vs. 58%, p=0.014) and remained higher at 12 months (58.1% vs. 34.4%, p=0.0003).

“Looking at our 12-month primary patency, you can see the survival benefit is maintained and actually separates over time,” said Rajan, reflecting on their results. “As the curves continue to separate, I argue that there’s a continued therapeutic benefit [with Wrapsody] over time, and for access circuit primary patency as well.”

Rajan added: “Within dialysis access, those of us that do it, we know that the outcomes of vascular access directly contribute to the mortality and morbidity of patients.

There’s a really high cost to maintaining these accesses, and to date, all comparative studies still consider PTA as the gold standard for treatment.

“Although PTA has done reasonably well [in trial settings], there has always been

room for improvement, and we’ve chased that [via the WAVE trial],” Rajan told the SIR audience. “We’ve seen improved TLPP with covered stents in the past, but the access circuit primary patency doesn’t change much. The argument has always been why would you use these devices if you aren’t changing the overall lifespan of the access,” said the speaker.

The WAVE trial is still currently ongoing, said Rajan, stating that 24-month results are forthcoming.

In light of the sustained improvement in TLPP and ACPP with Wrapsody, and the “limited options available to restore and maintain access circuit primary patency”, the authors state that these findings are of “high value” to clinicians who treat stenosis/occlusion in the venous outflow circuit of haemodialysis patients, and for the patients themselves.

Wrapsody

JETi registry reports effective thrombus reduction in lower extremity DVT Recently presented at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA), data from the Jet Enhanced Thrombectomy intervention hydrodynamic thrombectomy system (JETi; Abbott) registry has demonstrated the device’s effectiveness having surpassed prespecified safety and efficacy thresholds for the removal of thrombus in lower extremity deep vein thrombosis (DVT).

THE JETI SYSTEM IS A hydromechanical aspiration system intended to remove intravascular thrombus. To evaluate its efficacy, the prospective, single-arm, all-comer, real-world venous registry was devised, enrolling 116 patients with iliofemoral DVT from 14 global sites.

Mahmood Razavi (St. Joseph Heart & Vascular Center, Orange, USA) presented the results.

Primary effectiveness was assessed by the percent of treated vessel(s) with ≥75% venous thrombus reduction from baseline to final venogram following all primary and adjunctive therapies per core lab-assessed modified Marder score. Safety was assessed by the composite rate of JETi-related major adverse events that included death, symptomatic pulmonary embolism (PE), major bleeding, and re-

Razavi presenting at SIR

thrombosis of JETi-treated vessel(s) up to 30 days post procedure per clinical 23.5 minutes; 72.4% of patients events committee adjudication. were treated in a single session with Patients in this cohort had a mean the device. Concerning adjunctive age of 56.6 years, and half were treatments or additional interventions, female. Prior rates of DVT (21.6%) 83.6% required a balloon and 55.2% and PE (19.8%) were high in this a stent. Two patients required the patient population, with significant use of the JETi HyperPulse (Abbott) rates of other conditions such as thrombolytic and 13.8% of hyperlipidaemia, diabetes patients required a handand hypertension. Nearly infused thrombolytic. three quarters of the Catheter-directed population (74.1%) thrombolysis was had onset of signs and performed in 25.9% of thrombus reduction symptoms within 14 patients—4.3% prior achieved in 84.5% days, 16.4% between to JETi use and of treated limbs 14 and 42 days, and the 21.6% following. remaining (9.5%) beyond Regarding primary 42 days. effectiveness, at least The total index procedure 75% thrombus reduction was time was reported as 124.5 minutes, achieved in 84.5% of treated limbs while the JETi device use time was via modified Marder score, which

75%

met the prespecified performance goal of 64%. Major adverse events were reported in 1.7% of patients, including symptomatic PE and rethrombosis of JETi-treated vessels.

Patients reported improved Villalta post-thrombotic syndrome (PTS), leg pain, and quality of life scores at 30 days post procedure. Importantly, despite disclosing moderate to extremely severe pain at baseline, 81% of patients reported that they had no pain to mild pain at follow-up.

Meeting its prespecified efficacy and safety criteria, the investigators highlight the marked improvement in clinical and patient-reported outcomes, and state that the registry’s one-year results, which are set to be released in due course, will bear out these data in greater granularity.

Issue 98 | May 2025

Technology and Innovation

Point of VIEW View POINT OF

further research.

Histotripsy: What we know so far

“Challenging” operator learning curve

Mishal Mendiratta-Lala Histotripsy is a non-thermal, non-ionising and non-invasive focused ultrasound technique which relies on cavitation for mechanical tissue breakdown at the focal point. Leading research into the novel technique, Mishal Mendiratta-Lala (University of Michigan, West Bloomfield, USA)—principal investigator for the #HOPE4LIVER trial evaluating histotripsy in liver tumours— provides a deep dive into the treatment option, discussing its application and evolution in the near future.

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n 2024, histotripsy has advanced significantly following its US Food and Drug Administration (FDA) approval in late 2023, allowing many institutions to acquire the technology for clinical use. Most systems were delivered this year, leading to the treatment of over 500 tumours with histotripsy.

Although enthusiasm is high among both patients and the medical community, it is still too early to report definitive new findings. The focus must remain on collecting and analysing data to assess long-term efficacy.

A key priority moving forward is careful patient selection, ensuring that histotripsy is used appropriately rather than broadly applying it to all cases.

Histotripsy garners “excitement” in the cancer community

For patients deemed suitable for treatment with histotripsy, the procedure has demonstrated several benefits over alternative ablative techniques. These are largely due to the non-invasive nature of the procedure, minimal bleeding risk, and postprocedure pain and recovery times.

There is excitement in the cancer community about histotripsy’s potential to induce an abscopal response— a systemic immune reaction against cancer.

However, this effect has not been reliably observed in clinical practice yet and we look forward to emerging research that may bear out evidence of this response.

Current data supporting histotripsy’s efficacy is limited but promising. To date,

there are two peer-reviewed studies that are analysing histotripsy—the first-in-man THERESA trial evaluating histotripsy of hepatic tumours, and the #HOPE4LIVER trial which concerns the treatment of liver tumours with histotripsy. The former is a small early study focused solely on safety. The 36-hour data confirmed that treated volumes were effectively ablated, demonstrating initial safety. The latter #HOPE4LIVER trial involved 44 tumours, and evaluated 30-day safety and efficacy. The results showed that histotripsy successfully treated the target lesions, with no enhancement of the treated tumours, confirming shortterm efficacy.

These studies confirm that histotripsy is safe, but long-term efficacy, survival benefits, and recurrence rates remain unknown. To determine whether histotripsy improves overall survival and delays disease recurrence, more clinical trials and data-sharing across institutions are essential. Treating patients with only 30-day data in 44 tumours is premature for broad clinical adoption, emphasising the need for

Edison

Leading histotripsy technology innovation, the Edison (HistoSonics) platform has a notable operator learning curve due to its complexity and multiple components requiring proficiency.

Challenges include setting up the water bath correctly to prevent leaks, accurately identifying the target, and properly defining treatment boundaries.

The robotic head’s large and bulky design adds difficulty in positioning for optimal lesion treatment.

Additionally, treatment limitations arise from factors such as lesion depth, adjacent structures, and device voltage constraints.

As for institutional implementation, while the platform can be highly effective when the target is appropriately selected, its adoption requires significant training, experience, and institutional investment in both personnel and infrastructure. Proper

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With more institutions purchasing the device, the accumulation of clinical data will be crucial. However, the success of histotripsy will depend on strong collaboration within the clinical community to analyse outcomes and refine patient selection criteria. Not all patients will be ideal candidates, making ongoing clinical trials essential for optimising the technology’s impact in cancer treatment.

Global adoption of histotripsy is likely to grow, but its integration into standard care will require further validation through research. We need more clinical trials with combination therapies and we need more trials looking at treatment of different cancer types.

A key focus for 2025 will be ensuring that histotripsy is implemented effectively and safely. Additionally, while the potential for an abscopal response is intriguing, it remains unproven in patients, and caution is necessary to avoid unintended consequences.

There is excitement in the cancer community about histotripsy’s potential to induce an abscopal response—a systemic immune reaction against cancer” training programmes and support are essential for successful integration.

I believe a successful histotripsy programme requires institutional commitment and resources, making it challenging to adopt easily.

While institutions can integrate the technology, its success will depend on the presence of a strong clinical team, institutional support, a general anaesthesia team, adequate space and finally, a financial bolster.

Insurance reimbursement is not always guaranteed, and thus institutions will need a strong financial team to navigate funding and advocate for coverage.

In addition, histotripsy is being expanded to renal and pancreas applications which will be very exciting. Overall, histotripsy has significant promise, and 2025 will be a pivotal year in determining its role in the broader clinical landscape. The medical community plays a critical role in shaping the clinical narrative and ensuring responsible treatment decisions. Looking ahead, I hope to be able to lead clinical trials, which will be essential in identifying the ideal patient population and determining whether histotripsy can provide meaningful survival benefits for cancer patients.

What’s to come for histotripsy in 2025

Mishal Mendiratta-Lala is an interventional radiologist at the University of Michigan in West Bloomfield, USA.

The year 2025 will be an exciting one for histotripsy as the field evolves.

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May 2025 | Issue 98

Interview

PROFILE

ALEX BARNACLE

How are children treated at your local hospital? Asks paediatric interventional radiologist Alex Barnacle (London, UK) of healthcare providers today. Her question brings attention to the “insurmountable barriers” which paediatric interventional radiology (IR) faces, even in large, specialised centres. Affecting change, Barnacle’s outreach efforts span the globe, and her involvement with international societies is ongoing. Here, Barnacle—consultant paediatric interventional radiologist at Great Ormond Street Hospital for Children—shares the lasting impact made by her mentors, an early case that changed treatment management for the condition, and the collaborative work that must be done to resolve inequalities in paediatric IR.

What attracted you to a career in medicine, and what made you choose paediatric IR?

I was fascinated by paediatrics even as a medical student, but it took a long time to work out where exactly in paediatric healthcare I would thrive. I trained in neonatal intensive care, paediatric surgery and general paediatrics before being inspired by a wonderful paediatric radiologist and mentor— Jo Fairhurst—to consider paediatric radiology After obtaining my paediatric qualifications, I transferred into radiology with the firm intention of becoming a diagnostic paediatric radiologist but fell in love with IR along the way.

For a while I was in turmoil, trying to choose between the two. I was fortunate enough to then be introduced to another key mentor, Derek Roebuck, who was developing a paediatric IR service at Great Ormond Street Hospital in London, UK. It was incredible timing, because he was probably the only one practising paediatric IR in the UK at the time and I immediately knew this was the career I had been searching for.

Who have been your mentors throughout your career and what is the best advice they have given you?

I have been inspired and encouraged by so many people along the way, and it continues, of course. Often, all it takes is one small thing someone says or does to leave a lasting impression or prompt us to reflect and change.

I am inspired by colleagues in industry, by the nurses and radiographers I work with, and by trainees as much as I am by senior interventional radiologists. Adam Mitchell was an inspiration in my very first year as a radiology trainee and taught me to be brave. James Jackson instilled in me a passion for treating vascular malformations.

Within paediatric IR, Roebuck shaped both my career and my ambitions but I have also been inspired by many senior interventional radiologists within the wider paediatric IR community around the world.

Anna Maria Belli has been a key influence and support in my career, always encouraging me to break down barriers and aim high. And there are many brilliant women in IR who are role models for me and continue to inspire me to pursue excellence in IR and equality in our field—Laura Crocetti, Maureen Kohi, Gloria Salazar, and Tze Wah are just a few of these women.

Could you describe a case that has been the most memorable throughout your career thus far?

Only three years into my consultant career, I was referred a very young child with a lymphatic malformation of her orbit which had caused devastating consequences. I was familiar with treating malformations elsewhere in the body but never in the posterior orbit and I couldn’t find anyone in the UK who had treated one. I reached out to colleagues in the USA and Australia who supported me remotely. I performed three sclerotherapy procedures for her, with great trepidation. But the response of the malformation was truly remarkable and in a very short space of time she was pain free and getting back to being a happy and wonderfully courageous child.

Since then, I have treated many, many children with this condition and together with some other interventional radiologists around the world, we have changed the management of this condition and the lives of these children. I am still in touch with this first patient and will always be grateful to her parents for trusting me with their precious daughter’s health when this was such a novel approach.

You are currently involved with the first Getting It Right First Time (GIRFT) initiative for IR in the UK. How has this experience been and what has been learned during the process so far?

It is a really innovative programme in England which takes a very detailed look at individual clinical specialties. Last year, the GIRFT programme for IR was launched and I am honoured to be the clinical lead. We review all the national IR data available and visit every hospital in England that performs IR. So far, my colleague Gill Kitching and I have visited 10 hospitals—only 112 to go!

We are looking for unwarranted variation in practice, particularly in patient outcomes, efficiencies in clinical care pathways and costs. Many departments are facing significant challenges in delivering the level of care they aspire to, particularly with current economic constraints, and we are often seeking support and advocate for them. And there are also teams who have developed novel ways of working and are delivering excellence in some areas of IR; we are mining for those pockets of excellence and aiming to disseminate examples of best practice. It is a privilege to visit so many IR departments and explore these themes with colleagues around the country. We are still in the early stages of the

FACT FILE CURRENT APPOINTMENTS 2004–present: Consultant radiologist, Great Ormond Street Hospital for Children (London, UK) 2021–present: Committee member, The Royal College of Radiology 2021–present: Advisory committee member and senior mentor, EMERGE programme 2022–present: Executive committee member, CIRSE

PREVIOUS APPOINTMENTS (SELECTED) 2015–2018: Radiology lead, The Portland Hospital for Women and Children (Portland, USA) 2020–2021: President, Society for Paedatric Interventional Radiology (SPIR) 2021–2024: Member, European CORE-MD group

OTHER APPOINTMENTS (SELECTED) Principal investigator, ICECaP paediatric cryoablation registry Co-author, European Horizon 2020 COREMD paediatric medical device report Paediatric IR mentor, Lady Ridgeway Hospital for Children, Colombo, Sri Lanka

programme but emerging themes for me have been the relative disadvantages that some non-vascular IR services encounter compared to vascular IR services, and the lack of specialised training for nurses in IR. At the end of the project, we will publish a national report of our findings and recommendations.

You are currently on the executive committees of CIRSE and BSIR. How do these roles cross-pollinate with your daily practice?

It has been one of the unexpected privileges of my career to work with senior colleagues in the executive committees of the British Society of Interventional Radiology (BSIR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), as well as previously in the Society for Pediatric Interventional Radiology (SPIR). I find it hugely rewarding to collaborate on exploring future directions for our specialty and finding ways to support our talented colleagues at the coalface of IR. Leadership roles like these challenge me to develop very different skills to those typically used at the angiography table, and to broaden my horizons. I love exploring ways to bring people together to achieve their goals. It is an honour.

Are you still involved with ICECaP, the first paediatric ablation registry in Europe? If yes, what is the status of the registry?

The ICECaP registry is recruiting patients undergoing cryoablation for both benign and malignant disease. Our aims are to confirm that cryoablation is safe in small children and to establish which diseases cryoablation is most effective for. Paediatric IR case numbers for procedures like this are always going to be low in individual centres so it is imperative that we collaborate across institutions and countries to collate and examine our practice and provide much-needed outcome data to guide the development of IR for children.

What is an unmet need in paediatric IR today?

There are so many unmet needs in paediatric IR. Paediatricians, paediatric surgeons and children’s hospitals are still frustratingly slow to recognise the value that IR brings for children and their families. There is huge underinvestment in paediatric IR; it is maddening to see colleagues struggling to deliver IR procedures with exceedingly limited resources, even in large, specialist institutions.

Issue 98 | May 2025

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alisonlang.com

Interview

There are very few training posts in paediatric IR, especially outside of North America, which of course means a lack of paediatric interventional radiologists.

Paediatric interventional oncology (IO) is significantly hampered by the absence of IR options in almost all treatment and study protocols. And we are held back by the lack of paediatric-specific equipment. Most of the time we can find workarounds with standard adult IR devices and kit, but now even this is heavily impacted by the recent changes in European medical device regulation. There are now almost insurmountable barriers to device development for paediatric use and we are seeing longstanding devices removed from the market or being labelled as ‘contraindicated for paediatric use’.

My colleagues and I recently published a research needs assessment for paediatric IR which highlighted a number of barriers to meaningful research in our field, despite widespread interest within the paediatric IR community for collaborative research.1 The paper emphasises some important areas for us and our clinical teams to

focus on going forward.

In my opinion, the area of greatest need, and an area in which IR can undoubtedly impact children’s healthcare, is in paediatric oncology.

As in adult IO, we need to keep pushing our oncology colleagues for a seat at the table, so that we can demonstrate to them what we can do and together explore how IR can contribute to paediatric cancer care. I am thrilled that the European Society for Paediatric Oncology (SIOP Europe) will be welcomed as part of the CIRSE 2025 congress (13–17 September, Barcelona, Spain). SIOP Europe is the only pan-European organisation representing all professionals working in the field of childhood cancer and our most valuable partner in furthering paediatric IO in Europe.

What is your advice to young interventional radiologists entering the field of paediatrics today?

Paediatric IR is a hugely rewarding career path, and you will be part of an immensely warm and welcoming international community. Seek out paediatric IR colleagues at all of the major IR congresses to develop

"It will take all of us to change many of the current inequalities in paediatric IR care”

links with us and share ideas, and join us at the annual Society for Pediatric Interventional Radiology (SPIR) meeting (14–16 October, Sydney, Australia). Reflect on how children are treated in your local hospitals—are they are being offered the same IR options that adult patients are? Almost certainly not. Can you influence that? It will take all of us to change many of the current inequalities in paediatric IR care.

What does your life outside of medicine look like?

I have a busy and fun life outside of work.

My husband Andy and I play a lot of tennis, and we enjoy travelling together.

I am passionate about art, exploring and appreciating fine art in galleries around the world, but also drawing and painting myself.

I have recently gone back to art school in the evenings and have a very small exhibition coming up at the end of the year.

References 1. Temple et al. Fostering research in pediatric interventional radiology: needs assessment and suggestions for support.

Pediatr Radiol 2023 Oct;53(11):2245-2252. doi: 10.1007/s00247023-05722-6).

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May 2025 | Issue 98

Conference Coverage ECIO

“digging into electronic health records [EHR]” which record a large volume of real patient data.

In the UK, Breen highlighted the National Health Service (NHS) and UK Biobank, which he states are “phenomenally rich” datasets.

“There’s a reason Mark Zuckerberg and Jeff Bezos “Although [real-world registries] seem unsexy, it’s the direction of travel,” said are our new best friends in the UK,” said Breen.

David Breen (Southampton University Hospitals, Southampton, UK), describing the “The NHS owns one of the largest volume and most comparative advantages and challenges of randomised controlled trials (RCTs) consistent healthcare datasets exploitable in and real-world registries in providing kidney tumour ablation data. global healthcare.”

He went on to highlight the successes “LET’S TALK HONESTLY ABOUT RCTS. the uptake of robotic-assisted partial and failures of recent registries, highlighting There are problems,” began Breen, during his talk at nephrectomy, there has been no trial ongoing efforts of the EUropean REnal the European Conference on Interventional Oncology comparing the technique to open or Cancer CryoAblation Registry (EuRECA), (ECIO; 12–16 April, Rotterdam, The Netherlands). limited-access partial nephrectomy. established by a European Hospital “Clearly, they set out to avoid bias and establish Conducting RCTs evaluating ablation network, with which Breen’s centre in causality, but it’s a trade-off between experimental for kidney tumours comes with unique Southampton is involved. rigor and being able to generalise our data for its challenges, he went on to detail, describing David Breen Awaiting release, Breen stated the registry real-world applicability in daily practice.” renal cancer as an indolent disease process team is currently sitting on prospectively In general, Breen stated that RCTs are which negates the investigation of early collected data from approximately 1,700 patients becoming “increasingly unaffordable” outside of outcome markers at one to two years. treated with percutaneous cryoablation. a pharma industry setting. Conducting research Coupled with the time and cost of setting up “Almost 1,500 of them are biopsy-proven, 14% in the interventional space sometimes means that an RCT in this space, this often means “your new in a single kidney,” said Breen. “There’s no partial professional “boundaries” will be crossed between intervention is an anachronism by the time you’ve nephrectomy series that is so rich with singlesurgery and interventional radiology (IR)— “we got data,” Breen stated. kidney data. The data is in preparation; it is clearly know that can bring problems for recruitment to So, what is real-world data? Breen asked, chronologically mature, this is going to be the randomised trials”. labelling it naturalistic data, often pulled by practical direction of data accrual for healthcare The “unfortunate truth” is that some major steps in providers and commissioners.” medicine have made it into standard practice without “We’ve got to look at large real-world registries. an RCT, Breen said, such as penicillin or resection If granular enough, we should ultimately be able to for colorectal liver metastases, the latter of which exploit artificial intelligence to try and get signals exists at the level of 3b on the Evidence (EBM) from the raw data and then go after those signals with Pyramid. much more targeted and hopefully easier to deliver Returning to the kidney, Breen added that since RCTs,” Breen stated.

Will registries replace RCTs for kidney tumour ablation?

We’ve got to look at large real-world registries”

planning, this trade-off AI ethics session suggests hybrid treatment presents a practical challenge.

The legal frameworks guiding approach the future for IO AI use in Europe was another focal

A keynote session on the future of interventional oncology (IO) brought artificial intelligence (AI) to the forefront of discussion, highlighting both its potential and the ethical, legal, and regulatory challenges it presents. The presentation, delivered by Gianpaolo Carrafiello (University of Milan, Milan, Italy) discussed the concept of “hybrid intelligence” as the likely future model, in which AI augments, rather than replaces, clinical expertise.

point. The European Union’s Medical Device Regulation (MDR) currently classifies certain AI tools as medical devices, requiring CE marking unless developed exclusively for in-house use.

Additionally, the 2021 EU Artificial Intelligence Act introduced a risk-based regulatory system, categorising AI

BEGINNING WITH A historical definition from AI pioneer John McCarthy, who described AI as “the science and engineering of making intelligent machines,” the speaker framed the discussion around AI’s emerging applications in IO. These include image analysis, segmentation, predictive modelling, decision support systems, and training for interventional radiologists. Particularly in education, AI has shown potential to help standardise and accelerate the training of new interventionists.

The session touched on the responsibility associated with deploying AI in clinical environments. “The decision to accept or override AIgenerated recommendations requires careful justification,” Carrafiello explained, noting that regulation may demand well-documented reasoning from physicians who diverge from algorithmic suggestions.

Responsibility in AI use was broken down into three core elements: accountability, culpability, and liability.

in healthcare as “high risk” due to its potential impact on patient safety.

However, the speaker argued that these policies still fall short: “Current EU legislation does not sufficiently address the specific regulatory needs for AI in clinical specialities like

Carrafiello said that, while AI systems can be held accountable to the extent of explaining their processes and outputs, they cannot be held culpable, “as they lack consciousness, intent, or free will”.

Legal liability, however, remains a more complex issue, often extending to developers, institutions, or clinicians depending on the case and regulatory framework.

The speaker identified transparency as a key principle in bridging these gaps. Carrafiello advocated for moving from a “black box” model— where internal AI decision-making is “opaque”, to a “glass box” approach where processes are “visible and understandable”.

“This is essential for building explainable AI systems that foster trust and accountability,” he said.

Yet, Carrafiello believes that transparency may come at a ‘cost’: “Simplifying models to enhance explainability can sometimes reduce predictive accuracy.” In healthcare, where outcomes may depend on precise

interventional oncology,” Carrafiello noted. Gaps in legislation may hinder the development and deployment of AI tools in IO and leave gaps in regulation concerning post-market surveillance and algorithm bias, he added.

Expanding on bias in AI algorithms, Carrafiello pointed out that “AI algorithms may be less accurate for underrepresented or marginalised populations, reinforcing systemic inequities in access and outcomes,” and adding that this is particularly “troubling in oncology, where timely interventions can dramatically alter prognosis”.

The speaker then urged that interventional radiologists retain ultimate responsibility, explaining that “AI should be a support tool, not a decision-maker.”

Carrafiello advocated for ongoing development in AI systems in IO, regular audits of AI-driven decisions, and transparent communication with patients about the use of AI in their care.

Carrafiello then suggested that hybrid intelligence, defined as the combination of human expertise with AI augmentation, will define the future of IO, however, interventionists that fail to adapt may fail to keep up, and will be left behind. “AI will not replace interventional radiologists, but those who use AI will replace those who don’t,” he said.

Issue 98 | May 2025

Conference Coverage

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Leading voices in IO call for stronger data and better strategies to confirm ‘fourth pillar’ positioning In a discussion among leading figures in interventional oncology (IO), consensus developed around the growing clinical relevance of the field and the pressing need for data to match this. Speaking during a panel debate at the recent European Conference on Interventional Oncology (ECIO; 12–16 April, Rotterdam, The Netherlands), participants tackled the practical and philosophical challenges of positioning IO alongside surgery, systemic therapy, and radiation as the fourth pillar of modern cancer care.

KICKING OFF THE SESSION, Laura Crocetti (Cisanello University Hospital, Pisa, Italy) emphasised the need for guideline inclusion beyond liver-focused indications. “We are involved in the treatment of many kinds of cancer, not only colorectal liver metastases. I’m thinking about thyroid, about kidney—we should be in all the guidelines, but we need research.

We must produce data; this is very important. Research is a major point for us.”

This sentiment was echoed throughout the session, as speakers repeatedly returned to the theme of high-quality clinical service and evidence generation. “We must provide a clinical service—without that, [IO] is never going to fly,” said Mark Burgmans (Leiden University Medical Center, Leiden, The Netherlands). He described that in providing a clinical service, equipped with all of the new tools and techniques the field has gained over recent years, interventional oncologists will need to prove themselves in clinical studies. He cited Martijn Meijerink et al’s COLLISION trial—which was a randomised, international, multicentre, phase III non-inferiority trial which demonstrated comparable results between thermal ablation and surgical resection for small-size colorectal liver metastases, as a benchmark example of how IO

can deliver high-quality randomised controlled trial (RCT) data.

Yet others questioned whether RCTs should be the default path forward.

Dirk Arnold (Asklepios Tumorzentrum Hamburg, Hamburg, Germany) reflected on his shift in thinking that he presented during his ECIO Honorary Lecture in 2023: “Two years ago, I made the claim that you should not focus too much on randomised trials, because it’s a therapeutic principle between widespread metastatic disease and localised metastatic disease, localised disease. You will get so much evidence by optimally treating patients and integrating therapeutic algorithms.

This may be enough.”

However, Arnold stated that the publication of COLLISION results “contradicts” this thinking, acknowledging that RCT data instils greater confidence in situations where it is necessary to compare local ablative treatment to resection. To this, Burgmans stated that RCTs are not always necessary, “but unfortunately we sometimes face debates with colleagues and health insurance, with authorities who say that they want us to provide randomised, phase 3 trials with a survival benefit,” he said.

“Sometimes medical oncologists annoy me a bit with their rigid thinking that we always need RCTs to prove that something is worth doing,” continued

Preliminary experience of single-session Y90 for small HCC sparks optimism “We think that this approach could have a significant impact on interventional radiology and interventional oncology,” were the conclusions of Nima Kokabi (University of North Carolina, Durham, USA) during his European Conference on Interventional Oncology (ECIO; 12–16 April, Rotterdam, The Netherlands) presentation.

HE DESCRIBED HIS CENTRE’S FEASIBILITY and safety study of Y90 transarterial radioembolization

Left to right: Pereira, Burgmans, Crocetti, and Arnold

Burgmans. He added that endpoints like progression-free survival and quality of life should also be accepted, especially where overall survival is difficult to assess.

Phillippe Pereira (SLK-Clinics GmbH, Heilbronn, Germany) reinforced the financial burden of trials, calling RCTs “very expensive” and arguing that real-world data and registries could provide a more feasible evidence base.

“Interventional oncologists are very strong in producing registries. Some

We must collect what we see. We must document and analyse this with artificial intelligence to detect the factors that influence longterm survival, reverting the art of science” Dirk Arnold

papers have shown that there is a very good correlation between the result of [an] RCT and the result of the realworld analysis,” Pereira explained.

Moving on, the panel turned to the increasing complexity of IO, given the rapid innovation in tools and technology, and the workforce’s capacity to keep up. “We all agree that we will need to move forward in a multidisciplinary way, but it will be very complicated,” said Pereira. “There are so many drugs and possibilities— local treatment, sequential treatment, and so on. We will need artificial intelligence.”

Arnold agreed, suggesting a reversal in the traditional scientific methodology.

“We must collect what we see. We must document and analyse this with artificial intelligence to detect the factors that influence long-term survival, reverting the art of science. We don’t bring a theory to an experiment and observe.

We observe, and then we have to ask what led us to this observation,” said Arnold.

Though the discussion ended with cautious optimism, Crocetti stating that they must “continue to dream” for a better future for IO, Pereira pushed for pragmatism. “I don’t like to end the discussion with a dream. We have been dreaming for the last 30 years, but IO has reached a crucial point now,” he said.

(TARE) for small hepatocellular carcinoma (HCC) that single photon emission computed tomography without aggressive features, reporting that a single (SPECT)/CT was to be performed to ensure adequate session is effective and has the potential to reduce tumour targeting and to calculate lower shunt fraction. healthcare costs and patient burden.

Follow-up included a toxicity evaluation and The prospective study enrolled 30 patients with imaging to monitor response according to modified small HCC without aggressive features, response to assessment criteria in solid which Kokabi defined as ≤5cm with no tumours (mRECIST) at two, four, six macrovascular invasion in the outset of his and 12 months. Kokabi also stated that FIRST@ECIO talk. Patients were treated with single-session Y90 costs were compared to Y90 TARE using a single-session approach traditional Y90 during the same period. with a lung shunt fraction calculation using The speaker stated that the team’s technetium-99 macroaggregated albumin. preliminary results show complete tumour During angiography, three-dimensional cone response following single-session beam computed tomography (3D-CBCT) Y90 treatment.

Nima Kokabi was used to confirm complete In their early cases, Kokabi and colleagues tumour perfusion. are optimistic that, at 12-month follow-up, these Then, Kokabi stated that, based on the perfused results will be sustained, and that “cumulative changes volume of the segment/subsegment, a personalised related to streamlined treatment versus traditional Y90 resin-based Y90 dose was calculated using a single will demonstrate a positive outcome for the patient compartment model (≥300Gy) and administered in the with significant reduction of healthcare resources”, same session. Post Y90 treatment, the speaker detailed Kokabi concluded.

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May 2025 | Issue 98

IO

IO

event rate, with a single event attributed to the procedure and not the embolic. Their analysis for technical success was based on 132 vessels in 97 subjects who received HES and 66 vessels in 48 subjects who received standard of care. The speaker detailed that the primary effectiveness endpoint met and surpassed their predefined non-inferiority margin of 10% and technical success was 88.6% and 77.3% Preliminary results from the “first” prospective, randomised, multicentre Instylla Hydrogel for HES and standard of care, respectively.

Embolic System (HES; Instylla) trial show the liquid embolic met primary safety and The Instylla HES data showed a lower numerical effectiveness endpoints, with a 99% freedom from major adverse event rate at 30 days incidence of additional embolization procedures follow-up, compared to a literature-derived performance goal of 75%. beyond the 90-day follow-up, reported at 8.8% for HES and 14.6% for standard of care. Further, THE RESULTS OF THE TRIAL WERE (6%), and renal tumours (24.7%). no clinically significant non-target presented by Nadine Abi-Jaoudeh (University Abi-Jaoudeh defined the trial’s primary embolization was associated with HES, of California, Irvine, USA) at the Society of safety endpoint as freedom from major Abi-Jaoudeh outlined.

Interventional Radiology (SIR) annual scientific adverse events which were “definitely or Speaking to Interventional News about meeting (29 March–2 April, Nashville, USA) during a probably attributable” to the device and/or the significance of these findings, Abilate-breaking abstract session. procedure and Grade ≥3 events per the 2017 Jaoudeh reiterated that this is the first trial Abi-Jaoudeh outlined that the Instylla HES is SIR guidelines. Primary effectiveness was to evaluate liquid embolics in tumours of intended for the occlusion of hypervascular tumours, defined as the delivery of the embolic agent any kind. “Liquid embolics have largely which was compared with standard of care-transarterial to the index tumour feeding vessel with Nadine Abi-Jaoudeh been used in the neurointerventional embolization/conventional chemoembolization stasis of flow assessed by an independent space for malformations or aneurysms (TAE/TACE). imaging core laboratory. and more recently in active haemorrhage, but not in A total of 150 patients presenting with hypervascular Abi-Jaoudeh reported that the team’s preliminary hypervascular tumours, so this is very exciting,” she tumours were enrolled from 22 centres, 84 enrollees results showed a 99% freedom from major adverse stated. “Research has shown that ischaemia is really were men and 66 women, with an average age of what we’re looking for in these tumours, and [when 65.4 years. Inclusion criteria included subjects with using embolics] you want deep uniform penetration. an Eastern Cooperative Oncology Group (ECOG) That’s what’s exciting about this liquid embolic, as it’s performance status of between 0 and 2 (except for made to mould to the vessels and achieve complete metastastic disease which ranged from 0–1) with at embolization,” Abi-Jaoudeh said. least one target vessel <5mm.

Abi-Jaoudeh continued that combining Instylla HES Patients underwent clinical and imaging follow-up with other drugs is where she hopes research will go at 30 and 90 days, with an additional clinical follow-up next, as well as evaluating patients treated with the at 180 days post procedure. The majority of patients embolic long term. “It’s still early,” she stated, but (44.7%) included in the trial presented with primary notes that their team is focused on following up the liver hepatocellular carcinoma (HCC), liver metastases 66% of patients with malignant tumours in (18%), benign liver tumours (6.7%), bone tumours their cohort.

Hydrogel embolic system demonstrates positive safety and efficacy in “first” peripheral application trial

That’s what’s exciting about this liquid embolic, as it’s made to mould to the vessels and achieve complete embolization”

CIREL study finds comparable overall survival between indication for irinotecan-TACE in colorectal liver metastases Results from CIREL—the largest, pan-European, prospective study of irinotecan-eluting transarterial chemoembolization (TACE) for colorectal liver metastases (CRLMs), show a comparably long median overall survival (OS) when used as salvage therapy and “promising” hepatic progression-free survival (HPFS) when used with systemic therapy or thermal ablation as a post-inductive or consolidation therapy.

THE STUDY, PUBLISHED in European Society for Medical Oncology (ESMO) Open, was led by Dirk Arnold (Asklepios Tumor Centre Hamburg, Hamburg, Germany) et al, who sought to evaluate when and for whom irinotecan-TACE should be preferred over other locoregional treatments, or may be added to other treatments.

CIREL was conducted across 11 European countries including 20 centres, and enrolled 152 patients in total between February 2018 and August 2020. All patients underwent at least one treatment session with LifePearl (MicroVention) microspheres and attended follow-up sessions between 4–8 weeks and 12–16 weeks following the last treatment session.

The primary endpoint of the study was

to identify the number of indications that the device is used for, assessed by stage and previous treatment(s). To this end, irinotecan-TACE was categorised into two treatment intentions: salvage therapy, which was defined by the authors as intensification of treatment with concomitant systemic therapy, and salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy, and, as postinductive/consolidation therapy, defined as LifePearl irinotecan as a first-line, consolidation or closing treatment with or without systemic therapy, or as combination treatment with ablation with curative intent. The study cohort had an average age of 66 years, 61.2% of patients were male and extrahepatic metastases were present

in 56.6% of patients. Irinotecanacts directly in the liver, an HPFS of TACE was used in 57.2% of patients 8.7 of the post-inductive/consolidation as salvage therapy for those who had therapy should be highlighted”, state progressive disease after at least one the authors. line of systemic therapy, whereas Following a multivariable analysis, 42.8% of patients received irinotecanArnold et al identified that for PFS, TACE as a post inductive/consolidation progressive disease outside the liver therapy with irinotecan-TACE before/ and liver involvement of 25–50%, after systemic therapy or before/after or >50%, were identified as negative thermal ablation. The prespecified prognostic factors. Health-related treatment plan was completed in 89% quality of life (HRQoL) score was and 72% of patients in each generally stable or improved respective group.

MEDIAN OVERALL overall, Arnold et al add.

Overall, the median OS “In both cohorts SURVIVAL was 14.5 months. of patients receiving In the irinotecaneither salvage or TACE as salvage post-inductive/ therapy group, consolidation MONTHS MONTHS median OS was therapy, HRQoL 9.9 months and considerations can the median PFS contribute to a better SALVAGE POST-INDUCTIVE/ was 3.8 months. understanding of CONSOLIDATION THERAPY patient-oriented THERAPY The median OS for the treatment as treatment selection,” post-inductive or Arnold et al write. consolidation therapy when used in Moreover, the authors emphasise combination with systemic therapy or the potential for irinotecan-TACE thermal ablation was 19.1 months, and to be combined with other treatment the median PFS was six months. strategies to “either intensify the liverArnold et al highlight that the directed therapy or target extrahepatic median HPFS was 6.2% with six- and disease”. However, randomised trials 12-month HPFS rates of 52% and are needed to provide “robust evidence 24%, respectively. In the irinotecanon how irinotecan-TACE can be TACE as post-inductive/consolidation integrated into a treatment pathway therapy group, HPFS was reported as that minimises patient burden while 8.7 months, which “since irinotecanpreserving HRQoL”, Arnold et al TACE is a locoregional treatment that conclude.

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Issue 98 | May 2025

IR Awareness

Point of VIEW View POINT OF

Major gaps in IR knowledge must be addressed

Mina S Makary In a paper titled ‘Specialist awareness of interventional radiology: Current state of affairs and opportunities for improvement’, Mina S Makary (Columbus, USA) and his team surveyed specialist provider understanding of interventional radiology (IR) at their tertiary centre, which yielded unanticipated results. Here, he discusses the data they collected and their broader significance for the evolution of the specialty.

O

ur recent survey has revealed significant gaps in awareness and understanding of IR among specialist providers, raising concerns about missed opportunities for minimally invasive care. The study, conducted at a large academic medical centre, surveyed over 1,400 nonprimary care specialists and received 516 responses. While IR continues to expand its scope across oncology,

urology and women’s health, the findings show that many medical professionals remain unaware of the specialty’s full range of applications.

Nearly 60% of surveyed specialists rated their knowledge of IR as only ‘adequate’ or ‘poor’—a result we did not anticipate. When asked how frequently they offered IR procedures as alternatives to surgery, 20% admitted they never did. Conditions

like abscesses and haemorrhages were commonly linked to IR, but recognition dropped significantly for areas such as infertility, benign prostatic hyperplasia (BPH) and bone cancer—indications where IR can play a critical role.

Advanced practice providers (APPs) demonstrated lower overall awareness than physicians but showed a stronger interest in learning more about IR services. In fact, 75% of APPs expressed a desire to improve their knowledge, positioning them as a key audience for targeted educational efforts.

Interestingly, the study found no significant difference in IR familiarity between surgical and non-surgical specialties, despite the procedural alignment between surgery and interventional radiology. Among specialist physicians, early-career practitioners—interns, residents and junior attendings—were less likely to report high confidence in their understanding of IR. The results highlight an ongoing need to integrate IR education into medical

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training and continuing professional development. Previous efforts—such as presentations at specialty conferences— have been shown to effectively raise awareness, but the study suggests broader strategies may be necessary.

The findings carry clear implications for patient care. Without broader specialist recognition of IR’s expanding capabilities, patients may miss out on less invasive, lower-risk therapeutic options. Bridging the knowledge gap through structured education and interdisciplinary collaboration could significantly improve referral patterns and treatment outcomes.

As IR continues to innovate across multiple domains, its visibility within the wider medical community must keep pace. This study offers a timely reminder that increasing awareness is not just a professional courtesy—it’s a clinical necessity.

Mina S Makary is an interventional radiologist at The Ohio State University Wexner Medical Center, Columbus, USA.

Nearly 60% of surveyed specialists rated their knowledge of IR as only ‘adequate’ or ‘poor’— a result we did not anticipate”

Geographic information mapping identifies IR expansion opportunities to combat postpartum haemorrhage in Kenya

within a one-hour drive of each hospital overlaid onto the CRI for each county. By doing so, the authors were able to identify the hospital in which development of IR services may have the greatest impact on decreasing PPH morbidity and mortality. Among them, Homa Bay County Teaching and Referral Hospital in southwestern Kenya was highlighted as a high-priority A new geographic information system (GIS) analysis of Kenya has found site for IR development, due to its high CRI score and “disproportionate” rates of maternal morbidity and mortality due to postpartum catchment population of women of childbearing age. haemorrhage (PPH) in areas without interventional radiology (IR) capabilities.

Despite Nairobi being relatively better equipped, England and colleagues emphasise that a broader LED BY RYAN W ENGLAND (PRINCETON Risk Index (CRI). These indices were derived from nationwide expansion of IR services is critical. As Radiology Associates, Princeton, USA) and published variables such as adolescent pregnancy rates, maternal of 2024, only around 10 practicing interventional in the Journal of Vascular and Interventional mortality ratios (MMRs), access to antenatal care, radiologists serve the entire country, with all initially Radiology (JVIR), the study employed multilayered insurance coverage and physician density. trained abroad. “This information only highlights the GIS mapping to pinpoint healthcare disparities and A total of f 14,718,288 female Kenyans of dramatic need in such a populated city for IR services propose a framework for global IR outreach. childbearing age were included in the geospatial to grow and expand,” the authors write.

The authors detail that PPH is a leading cause of analysis. Between 2014 and 2018, the number of Efforts are underway to bolster local capacity, preventable maternal mortality globally, particularly maternal haemorrhages across the country was found including a dedicated IR fellowship programme at the in low- and middle-income countries. Minimally to increase from 15,457 to 21,332, rising by 38% over University of Nairobi that began producing graduates invasive endovascular procedures such as uterine the five-year period. in 2020. artery embolization (UAE), performed as standard for Notably, the highest MMRs were observed in the “Moving forward, further investigation of targeted interventional radiologists, can be used to treat severe southeastern and northwestern counties, with standard individual healthcare facilities in Kenya needs to be cases of PPH that are unresponsive to firstdeviations 1.5–2.3 above the national mean. This assessed to better understand the unique needs of each line treatments. finding correlated with lower densities of healthcare hospital and region. One approach includes performing “UAE has been shown to be safe and effective, with facilities, longer travel times to a healthcare facility, an ‘IR Readiness Assessment’ to successfully systematic reviews demonstrating a clinical success and lack of IR services. In contrast, Nairobi’s MMR create meaningful and sustainable solutions to each rate (as defined by controlled bleeding without need fell within the national average, despite housing the individual hospital’s radiology needs,” England for additional procedure or surgery) of 89%,” write country’s only IR-equipped hospitals. et al state.

England and colleagues, referencing a 2021 paper by “Geospatial analysis has been successfully “Using a framework such as this may allow Matthew Brown et al. Although the treatment has been used for public health mapping and radiology for a comprehensive examination of current shown to control PPH while preserving the uterus, outreach in the past,” write England and and future barriers involved in implementing access to UAE in Kenya is currently limited to just six colleagues. “Prior research using GIS has shown IR outreach and resource allocation in the hospitals—all located in the capital city of Nairobi. that distance to quality healthcare facilities regions identified through this analysis,” In their analysis, the authors reviewed publicly is a substantial factor in the utilisation of the authors write. They note that further available Kenyan health and demographic data clinical services.” research will aim to correlate GISfrom 2014–2018. Using county-level statistics, they Translating their findings into actionable driven service expansion with realconstructed three key indices: a PPH Risk Index measures, the authors examined the world maternal health outcomes as IR Ryan W England (PRI), a Health Severity Index (HSI) and a Combined density of the study target population capacity in Kenya grows.

18

May 2025 | Issue 98

Journal Updates ABLATION

COVER-ALL trial highlights superiority of software-based assessment for liver tumour ablation margins New findings from the COVER-ALL trial suggest that software-based assessment of the minimal ablative margin during percutaneous thermal ablation significantly improves treatment precision and may reduce local tumour progression in liver cancer patients.

P

ublished in The Lancet non-randomised cohort, the average margin Gastroenterology & Hepatology, the further increased to 7.2mm, with 84% randomised phase 2 trial represents the achieving optimal coverage. first prospective evaluation of a softwareSecondary endpoints, including the driven margin confirmation method, which two-year cumulative incidence of local integrates artificial intelligence (AI)-based tumour progression, also favoured the autosegmentation and biomechanical software-based group, with a progression deformable image registration. rate of 5%, compared to 16% in the visual Conducted at The University of Texas assessment group. Although the authors note Bruno Odisio MD Anderson Cancer Center in Houston, that this difference did not reach statistical USA, the trial enrolled 100 patients with up to three significance, they believe that the trend is suggestive liver tumours undergoing computed tomography of the software’s potential long-term benefit.

(CT)-guided thermal ablation. Participants were “This is, to the best of our knowledge, the first randomised 1:1 intraprocedurally to receive either randomised trial to establish the feasibility and efficacy standard visual assessment or the experimental of software-based assessment as an intraprocedural software-based margin analysis tool. The primary tool for optimising the minimal ablative margin during endpoint of the study was the post-ablation the thermal ablation of liver tumours,” Odisio et al intraprocedural minimal ablative margin. write. The researchers assert that their study adds Patients were enrolled and treated with thermal to the “growing evidence that this approach allows ablation between 15 June 2020 and 5 October 2023. accurate quantification of the minimal ablative margin, The interim analysis showed that the software-based which is predictive of local tumour progression”. assessment group achieved a mean ablative margin of The COVER-ALL system uses biomechanical 5.9mm, compared to 2.2mm in the visual assessment deformable image registration and AI-based group, which prompted early halting of enrolment in autosegmentation algorithms to quantify the shortest the control group. Only 15% of patients in the control distance between the tumour and ablation zone group reached the optimal 5mm threshold, versus during the procedure. It provides visual feedback and 75% in the experimental arm. real-time margin calculations to guide overlapping or Odisio and colleagues subsequently enrolled a repeat ablations if necessary, the authors describe. further 50 patients to the experimental group. In this Odisio and colleagues conducted a clinical usability

POINT OF Point of VIEW View

Renal cell carcinoma mimicking pseudoaneurysm post cryoablation

Nassir Rostambeigi What should be done if a cryoablation of renal cell carcinoma (RCC) is performed successfully but follow-up imaging demonstrates a possible pseudoaneurysm? Here, Nassir Rostambeigi (Mallinckrodt Institute of Radiology, St Louis, USA) shares details of a case in an attempt to answer this question.

R

enal cryoablation is a wellestablished technique for treating renal masses, offering comparable outcomes to partial nephrectomy while minimising morbidity. However, careful consideration of its safety profile, including both common and rare adverse events, is essential for

care providers.

This case report highlights a rare and significant scenario. An 81-yearold woman with stage three chronic kidney disease initially presented with a left renal mass measuring 2.7cm. Follow-up imaging revealed an increase to 3.1cm, prompting a

survey using the Likert scale, which found that the software was rated “highly” by interventional radiologists, with 91% finding it helpful for evaluating technical success, and 89% agreeing it improved understanding of applicator positioning relative to the target tumour.

The use of software guidance was associated with a greater frequency of overlapping and repeat ablations, reflecting increased precision rather than complexity.

Odisio et al note that procedure times were longer in the experimental arm, but without increased adverse events. The rate of grade 1–3 adverse events was low overall (5%) and comparable between groups.

The study authors note that historical overestimation of the minimal ablative margin using visual methods may explain the high variability in local control outcomes seen across institutions. By introducing a reproducible, objective approach, they believe that the COVER-ALL platform offers a means of “standardising intraprocedural decision-making”.

While acknowledging the study’s limitations— including its single-centre setting and small cohort— the researchers maintain that the evidence supports broader implementation of the software. “These results highlight the potential of integrating software-based assessment into the standard-of-care for liver thermal ablation, given its ability to improve the minimal ablative margin and potentially reduce rates of local tumour progression,” Odisio and colleagues conclude.

This is, to the best of our knowledge, the first randomised trial to establish the feasibility and efficacy of softwarebased assessment as an intraprocedural tool”

multidisciplinary decision to proceed with computed-tomography (CT)guided biopsy and cryoablation.

The procedure was successful, but subsequent imaging uncovered a suspicious arterially enhancing lesion, initially suspected to be a pseudoaneurysm.

Detailed evaluation of contrastenhanced CT phases revealed a round structure at the ablation site, exhibiting contrast uptake similar to the aorta—raising concerns about a pseudoaneurysm. Then, coil embolization was performed to treat this suspected pseudoaneurysm, which initially seemed effective. However, persistent and recurrent enhancement on CT scans soon raised the possibility of residual or recurrent renal cell carcinoma.

Further investigation involved ultrasound evaluation, which identified

Careful evaluation with ultrasound or MRI is crucial”

the lesion as a solid mass without internal vascular pulsatility, ruling out a pseudoaneurysm. To confirm the diagnosis and for planning, an angiogram was performed, and, using lipiodol, the lesion was stained to enhance visualisation under CT guidance. Then, a percutaneous biopsy followed by cryoablation of the focal recurrence, was then carried out under CT guidance.

Pathological examination confirmed recurrent clear-cell renal cell carcinoma. The patient has maintained baseline urinary function and, 30 months after repeat cryoablation, remains free of recurrent disease.

This case underscores the importance of thorough postablation imaging, as recurrence can mimic vascular abnormalities like pseudoaneurysms. Careful evaluation with ultrasound or magnetic resonance imaging (MRI) is crucial in differentiating tumour recurrence from benign post-procedural changes, ensuring timely and appropriate intervention is provided.

Nassir Rostambeigi is an interventional radiologist at the Mallinckrodt Institute of Radiology, in St Louis, USA.

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January 2025 | Issue 105

Featured in this issue:

www.vascularnews.com

3 New editorial board

Vascular News appoints global vascular leaders

11 WAVE trial

New data shared at VEITHsymposium

14 Profile

Vincent Rowe

20 PAD legacy impact award Roger Greenhalgh honoured

US ARC STUDY

98.4%

clinically meaningful benefit

80% rate of ulcer size reduction at 12 months

VenoValve device patency

One-year SAVVE trial results are ‘most encouraging data ever produced for a bioprosthetic vein valve’ The one-year data from the SAVVE trial represent the “most encouraging clinical data that have ever been produced for a bioprosthetic deep vein valve” in more than half a century of attempts at developing such a device, according to leading venous disease specialist Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK).

T

he prospective, non-blinded, single-arm, multicentre Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) pivotal trial enrolled 75 patients with chronic venous insufficiency (CVI) at 21 sites in the USA. The headline findings include 98.4% VenoValve (Envveno Medical) device patency, 85% clinically meaningful benefit and an 80% rate of ulcer size reduction at 12 months.

Fresh from delivering these positive one-year data at the 2024 VEITHsymposium (19–23 November, New York, USA), site principal investigators Matthew Smeds (Saint Louis University, Saint Louis, USA) and Raghu Motaganahalli (Indiana University, Indianapolis, USA) are both ebullient about what the results might mean for the future of the treatment of CVI and venous ulcerations.

The data show that 85% of patients surgically implanted with a bioprosthetic VenoValve reached the one-year milestone having achieved a clinically meaningful benefit of a three or more-point improvement in revised Venous Clinical Severity Score (rVCSS); a 7.91 point average improvement in rVCSS; clinically meaningful benefit across all CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classes of patients enrolled (C4b–C6); 97% target vein patency at one year; and significant resolution in venous ulcerations.

“It is the first device we have had to treat deep venous insufficiency in years,” Smeds tells Vascular News in an interview in the days after presenting at VEITH 2024. “These patients are typically relegated to compression therapy alone.

There are no really great surgical options for this issue.”

Similarly, Motaganahalli describes the novel device as representing a “game-changer” given how previous attempts at developing a surgical option for the CVI patient population failed to take hold. “The procedure does not have a steep learning curve; technically, this is a procedure that can be accomplished by any trained vascular surgeon. It is not technically demanding,” he says. “Before, these were technically demanding operations: if you really look at the

The procedure does not have a steep learning curve.”

Raghu Motaganahalli

New data support role of F/BEVAR for treatment of thoracoabdominal aortic aneurysms A RECENT PROSPECTIVE, multicentre cohort study provides insights into early and late aorticrelated mortality and rupture after fenestrated and branched endovascular aneurysm repair (F/ BEVAR) of thoracoabdominal aortic aneurysms (TAAAs). Researchers claim these are likely to represent the most comprehensive data on the topic for the foreseeable future, citing the unworkable nature of a randomised study.

Gustavo Oderich (University of Texas Health Science Center at Houston–McGovern Medical School, Houston, USA) and colleagues, on behalf of the US Aortic Research Consortium (ARC), write in Circulation that F/BEVAR has been used as a minimally invasive alternative to open surgical repair to treat patients with TAAAs. The authors explain that, despite the widespread use of fenestrated and branched aortic devices worldwide, they are not currently commercially approved by the US Food and Drug Administration (FDA). Access to these devices, they continue, is limited to those centres with ongoing physician-sponsored investigational device exemption (PS-IDE) studies.

The researchers detail that the US ARC has been collecting prospective data from these studies since 2018.

The aim of the present study, the authors note, was to evaluate aorticrelated mortality and aortic aneurysm rupture after F/BEVAR of TAAAs. In order to do so, the research team analysed patients enrolled in eight prospective, non-randomised, PSIDE studies between 2005 and 2020 who underwent elective F/BEVAR of asymptomatic intact TAAAs. The primary endpoints of the study, Oderich et al detail, were Continued on page 4

Continued on page 3

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20

May 2025 | Issue 98

Market Watch

Clinical News

Product News Microbot Medical shares results from ACCESS-PVI pivotal trial

IceCure Medical report results for ProSense cryoablation treatment of breast cancer

IceCure Medical revealed findings from investigator-initiated studies of the company’s ProSense system for the cryoablation treatment of breast cancer. The data were delivered in two scientific sessions and one poster presentation at the European Conference on Interventional Oncology (ECIO; 12–16 April, Rotterdam, The Netherlands).

First, Sophie M Wooldrik (Erasmus University Rotterdam, Rotterdam, The Netherlands) presented ‘Review of the indications and results of the different techniques of thermal ablation on breast tumours; the treatment of breast cancer with percutaneous thermal ablation— THERMAC: An open-label phase 2 screening trial.’ The study enrolled 41 women and compared cryoablation to radiofrequency ablation and microwave ablation.

As summarised in the company’s press release, the investigators concluded that only cryoablation met the requirement to proceed to a phase 3 study, with an efficacy rate of 94%, with no complications and a 100% treatment tolerance. Additionally, the study found that 94% of patients were very satisfied or satisfied with the thermal ablation technique, and 95% of patients stated they would choose thermal ablation versus breastconserving surgery.

Serranator

Cagent Vascular initiates patient enrolment in Serranator vs. plain balloon angioplasty OCT study

Cagent Vascular announced its first patient enrolment of the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.

This prospective, randomised, dualcentre study will enrol up to 60 patients and will utilise intravascular OCT imaging to demonstrate the mechanism of action (MOA) of the Serranator and compare the serration MOA to conventional angioplasty across a range of lesion morphologies in belowthe-knee arteries. The study will take place at Columbia University Medical Center and Weill Cornell Medicine led by co-principal investigators Sahil Parikh and Brian DeRubertis.

Microbot Medical shared that it presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA).

The study was performed at three leading medical centres in the USA: Memorial Sloan Kettering Cancer Center (New York, USA), Baptist Hospital of Miami (Miami, USA) and Brigham and Women’s Hospital (Boston, USA). The late-breaking podium presentation was delivered by Francois Cornelis of Memorial Sloan Kettering Cancer Center.

The data concluded that robotic endovascular procedures using Microbot Medical’s Liberty endovascular robotic system are feasible and significantly minimise radiation exposure.

Real-world data show Cook’s Zilver PTX leads to lower rates of in-stent occlusion than Boston Scientific’s Eluvia

Cook Medical announced that its Zilver PTX drug-eluting stent (DES) has lower rates of instent occlusions among patients with restenosis at three years than the Eluvia DES (Boston Scientific), according to real-world data from the REALDES study. The company noted that the data, published by Tsuyoshi Shibata (Sapporo Medical University Hospital, Sapporo, Japan) et al in the European Journal of Vascular and Endovascular Surgery (EJVES), are the first to compare Zilver PTX and Eluvia in real-world practice at three years.

“There have been many unanswered questions on the reliability of the current data comparing the different drug-eluting stents on the market.

REALDES helps paint a more complete picture on DES differences, evaluated by independent investigators in a real-world setting,” said Alec Cerchiari, director of product management for Cook’s peripheral arterial disease (PAD) and venous specialty.

DeepQure advances clinical trials of its HyperQure extravascular renal denervation system

DeepQure recently detailed progress in clinical trials of its extravascular renal denervation device, HyperQure.

The company is actively conducting clinical trials in both South Korea and the USA, which it says demonstrate “promising” results. In South Korea, seven patients have undergone the procedure, showing meaningful reductions in blood pressure without any adverse events during- or post-operation.

The company aims to complete enrolment for its Korean clinical trial within the first quarter of 2025.

VentiV Scientific mechanical thrombectomy system granted FDA approval

VentiV Scientific has announced the US Food and Drug Administration (FDA) clearance of VentiV mechanical thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.

“Electric pump-based thrombectomy systems can unexpectedly clog and/ or remove 5–15ml per second of blood before removing blood clots,” said Dan Ryan, board of directors, VentiV Scientific. “The Pulse is designed to instantly start, stop, increase and/or decrease thrombectomy force at the tip, decrease clogging inside the catheter, and decrease blood-loss with use of any aspiration pump currently in the hospital.”

Adept Medical updates its IR platform and overhead arm support ranges

Adept Medical unveiled two updated product launches, coinciding with the Society of Interventional Radiology’s 50th annual scientific meeting (29 March–2 April, Nashville, USA).

This includes the launch of the Retrograde IR Platform-Narrow, a complementary addition to its existing range, and the Overhead Arm Support MR Safe-Small. Both are available commercially from 14 April.

Developed in response to postmarket feedback and extensive research, the new size Retrograde IR Platform-Narrow addresses the need for a more compact over-patient work surface for guidewire management during femoral access procedures.

Inari Medical, now part of Stryker, launches Artix thrombectomy system

Inari Medical, now part of Stryker, recently announced the launch of its Artix thrombectomy system. Purposebuilt for the distinct needs of the peripheral arterial system, Artix is a combined aspiration plus mechanical thrombectomy solution that delivers procedural control and versatility, and is designed to set a new standard for arterial thrombectomy.

Stryker notes that the Artix system builds on the success of Inari’s venous thrombectomy devices and is its inaugural entry into the arterial space.

“Inari offers a comprehensive toolkit approach to arterial thrombectomy

Artix

with an innovative, over-the-wire system that provides physicians with the flexibility to aspirate and/or mechanically extract a clot,” a press release notes.

Shockwave Medical announces US launch of intravascular lithotripsy catheter

Shockwave Medical announced the US launch of its Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a platform designed to modify calcium and cross narrowed vessels in patients with PAD. The forward IVL platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150cm and features a single distal emitter that creates up to 120 shockwave pulses.

Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD investigational device exemption (IDE) trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, the company states.

Javelin

Philips issues Class I recall for Tack endovascular system

Philips recently announced that it will no longer sell its Tack endovascular system in the USA following a Class I recall issued by the US Food and Drug Administration (FDA).

A Class I recall is the FDA’s most serious classification, which denotes that the continued use of the affected product could result in severe injury or death. The FDA’s decision follows reports that the Tack endovascular system—designed to treat arterial dissections—has posed challenges for users, sometimes necessitating additional interventions to retrieve or remove the implant.

The self-expanding device is composed of nitinol, a nickeltitanium alloy and is used following angioplasty, a procedure that widens narrowed or blocked arteries. Philips has reported 20 injuries linked to the Tack system but has not received any reports of fatalities.

Issue 98 | May 2025

Advertorial

21

THIS ADVERTORIAL IS SPONSORED BY MERIT MEDICAL

Advantages of steerable microcatheter use in interventional radiology practice Conventional pre-shaped microcatheter technology has evolved over the last decade, yet significant limitations still exist. In particular, the shape of a standard microcatheter cannot be changed or manipulated while inside a patient’s vasculature. As a user of this innovative technology, Jason C Hoffman (New York, USA) details his first-hand experience.

S

elective cannulation of small arterial branch procedure time (75 vs. 112.5 minutes), and body-mass vessels for targeted/superselective angiography index (BMI) adjusted radiation exposure were found or embolization is commonly performed; in the steerable microcatheter group. however, conventional pre-shaped microcatheter use Since publishing my early steerable microcatheter has limitations when in complex arterial vasculature, results, I have used the device in hundreds of prostate including tortuous or angulated vessels. artery embolization (PAE) procedures, as well as In these scenarios, the operator must often perform superselective embolization of distal hepatic, renal, multiple microcatheter and wire exchanges to select bladder, visceral and small pelvic arterial branches in the target vessel. This can take a considerable amount a variety of scenarios. Cases have included treatment of time, require use of numerous devices, and may of traumatic injury, benign prostatic hyperplasia result in a substantial radiation dose to the patient (BPH), hematuria, malignancy and non-traumatic and procedural staff. If the target vessel cannot be causes of bleeding. Most of these procedures were superselected, a less-targeted embolization must be performed with only the steerable microcatheter, performed, or the procedure is abandoned altogether. and no microwire was needed. I continue to find In either scenario, the case will take longer, with that patients and my team benefit from steerable implications for increased cost and resource microcatheter use due to increased efficiency, high use, and has the potential for complications and technical success rates, reliable target vessel selection untoward events. and decreased radiation exposure.

The development of a steerable microcatheter (SwiftNINJA® steerable microcatheter; Merit Reducing vessel selection time in a Medical Systems) is an innovation that offers an prostate artery embolization case alternative approach to selective cannulation. This An 85-year-old man with a long-standing history technology represents a new class of BPH presented with severe lower of device, designed with a tip that urinary tract symptoms (LUTS) and articulates up to 180 degrees in intermittent gross hematuria. Despite opposing directions, providing realmultiple medical treatments, including time ability to change the angulation three transurethral resection of the of the microcatheter tip while prostate (TURP) procedures over the navigating through the vasculature. past two years, the patient’s condition The device can be used with or had not improved. His International without a microwire which allows the Prostate Symptom Score (IPSS) was injection of contrast while advancing 29 (severe), and his Urinary Quality of or manipulating the steerable Life Score was 5 (unhappy). microcatheter. In my experience, this Using a 2.4Fr SwiftNINJA consistently leads to efficient selective through a 5Fr guide catheter, the Jason C Hoffmann cannulation of small vessels throughout left prostatic artery was selected in 12 the body, with a level of steerability that simply seconds without a guidewire thanks to the steerability is not provided by any pre-shaped conventional of the microcatheter tip. Proximal and then distal microcatheter. embolization of the left prostate artery with 300–500μ I can also inject contrast while advancing or Embosphere microspheres (Merit Medical) was manipulating the steerable microcatheter, allowing performed following the proximal embolization first, for precise control and improved vessel targeting. then embolize distal (PErFecTED) technique. The Decreased time to target vessel selection can have right prostate artery was then selected–again using the multiple benefits for the patient, primary operator, SwiftNINJA without a guidewire—in nine seconds and procedural staff in the room. Advantages include and embolization was performed using the same decreased procedure times, increased procedural technique. efficiency, fewer microcatheter and microwire Final angiography confirmed successful exchanges, reduced fluoroscopy times, and lower embolization of both left and right prostatic arteries. radiation exposure.

The patient was discharged the same day, with no SwiftNINJA steerable microcatheter use in hematuria or urinary retention reported since the moderate and high complexity angiography and/or procedure. At one month post-procedure, patient’s embolization has routinely helped me to be successful IPSS decreased from 29 to 7 and Urinary Quality of and efficient. In 2019, I published my results, Life score decreased from 5 to 1. comparing steerable microcatheter to conventional microcatheter use in 40 procedures that involved Successful gonadal vein embolization moderate to highly difficult vessel selection.1 through extremely tortuous anatomy Statistically significant improvements in target vessel A 43-year-old female presented with chronic pelvic selection time—12 vs. 462.5 seconds (Figures 1a pain. Despite extensive diagnostic work-up, no and b)—number of microwires used (0 vs. 2), total definitive cause for the pain was found, except for

prominent left parauterine veins/varicosities and an enlarged left ovarian vein.

The patient was diagnosed with symptomatic pelvic venous reflux/pelvic congestion syndrome, and the plan was to proceed with venography and embolization. Due to extreme tortuosity of the gonadal venous vasculature preeminently, a 2.4Fr SwiftNINJA steerable microcatheter was used to efficiently navigate through the extremely tortuous vessels and into the inferior aspect of the left ovarian vein. Embolization was performed with sodium tetradecyl sulfate sandwiched in between packs of platinum microcoils.

Post-embolization digital subtraction venography demonstrated an appropriate angiographic result, with embolization of the left ovarian vein, but brisk antegrade blood flow in the left renal vein. The patient was discharged home in stable condition four hours post procedure, and experienced only mild flank discomfort for 24–36 hours post-procedure, relieved with ibuprofen. Her pelvic congestion syndrome symptoms markedly improved by the time she was seen for a post procedure office visit approximately six weeks later.

References 1. Hoffmann, J.C., Minkin, J., Primiano, N. et al. Use of a steerable microcatheter during superselective angiography: impact on radiation exposure and procedural efficiency. CVIR Endovasc 2, 35 (2019). https:// doi.org/10.1186/s42155-019-0078-9

Jason C Hoffmann is an interventional radiologist with NYU Langone Health in Mineola, New York, USA.

1a

1b

Figure 1. Left prostatic artery selected with SwiftNINJA steerable microcatheter. Initial internal iliac artery angiogram demonstrates Type 1 anatomy, with common origin of the left superior vesical artery and prostate artery (a). The microcatheter was moved from tip of 5Fr catheter to target vessel (distal aspect of main left prostate artery) in 12 seconds (b).

2a

2b

Figure 2. Left renal vein digital subtraction venography (DSV) via 5Fr catheter demonstrates patency of the left renal vein and inferior vena cava, with very prominent, tortuous and enlarged left gonadal vein (a). A 5Fr catheter was only able to select the most superior aspect of the left ovarian vein due to its extreme tortuosity. The SwiftNINJA steerable microcatheter was used to navigate through the multiple 180 and 360-degree turns to easily be passed inferiorly to the pelvis to perform embolization (b).

22

May 2025 | Issue 98

Market Watch

Industry News Society of Interventional Radiology launches SIR Foundation Endowment

The Society of Interventional Radiology (SIR) Foundation launched the SIR Foundation Endowment, a new funding stream designed to support interventional radiology (IR) research and education.

“Research frequently struggles due to inconsistent financial support, creating significant gaps in critical areas,” said SIR Foundation chair and the Ernest H Wood distinguished professor, Maureen P Kohi (University of North CarolinaChapel Hill, Chapel Hill, USA). “The SIR Foundation is uniquely equipped to tackle this challenge, leveraging its expansive network of dedicated donors and researchers, united in their commitment to advancing IR research.”

A press release issued by SIR states that the endowment offers a reliable and sustainable revenue stream to support the SIR Foundation’s strategic mission to advance IR through research and education that supports research.

Xeltis announces the appointment of nephrology clinicians to its medical advisory board Xeltis announced the appointment of clinical nephrology experts An De Vriese and Haimanot (Monnie) Wasse to its medical advisory board.

De Vriese is currently head of the

division of nephrology and infectious disease in AZ Sint-Jan Brugge, in Brugge, Belgium, and guest professor at Ghent University in Gent, Belgium, while Wasse serves as the interim chair of the department of internal medicine, and the chief of nephrology and director of interventional nephrology at the Rush University Medical Center in Chicago, USA. A press release by Xeltis has stated that both add considerable clinical nephrology expertise to the company’s medical advisory board and will work alongside current members to offer strategic and clinical guidance as Xeltis advances aXess towards commercialisation.

Eliane Schutte, chief executive officer of Xeltis said: “The appointments represent significant validation of the unique and promising nature of our technology from leading experts in the field.”

Life Seal Vascular appoints Matt Thompson as chief executive officer Life Seal Vascular announced the appointment of Matt Thompson as chief executive officer (CEO).

A company press release has stated that Thompson’s career as a vascular surgeon and medical

device executive positions Life Seal Vascular to accelerate the development and commercialisation of its vascular technologies.

“We are thrilled to welcome Thompson as our CEO,” said Robert Mitchell, executive chairman of Life Seal Vascular. “His unique combination of clinical expertise and executive leadership in the vascular medical device industry makes him the ideal leader to drive our next phase of growth. His prior service on our board has provided him with deep insight into our company’s mission, and we are excited for his leadership as we advance our technologies into clinical use.”

Biotronik partners with Egg Medical to bring radiation protection systems to US healthcare workers

Biotronik is partnering with Egg Medical to co-sell the latter’s EggNest radiation protection systems for healthcare workers in the USA. The EggNest Systems—EggNest XR, EggNest Protect & EggNest Complete—are radiation protection platforms that can be used across a wide variety of fluoroscopy procedure types without impacting workflow.

The EggNest Systems are the only products commercially available in the USA able to protect everyone in the interventional Matt Thompson suite, the two companies said

in a press release. Radiation reductions of up to 97% are possible with EggNest XR and EggNest Protect. That reduction reaches 99% with EggNest Complete, they added.

Teleflex announces acquisition of Biotronik’s Vascular Intervention business

Teleflex announced it has entered into a definitive agreement to acquire Biotronik’s vascular intervention business.

The acquisition reflects Teleflex’s commitment to investing in the estimated US$10 billion interventional cardiology and peripheral vascular market. A company press release states that the acquired business will expand the Teleflex portfolio to include a broad suite of vascular intervention devices such as drug-coated balloons and selfexpanding bare metal stents.

“We are excited to announce the acquisition of Biotronik’s vascular intervention business, which we anticipate will enhance our global presence in the cath lab, expand our suite of innovative technologies, and improve patient care,” said Liam Kelly, chairman, president and chief executive officer of Teleflex.

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Conference calendar 15–18 May Global Embolization Symposium Technologies (GEST) New York, USA

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www.hegestgroup.com

22–24 May International Conference on Complications in Interventional Radiology (ICCIR) Pörtschach, Austria

19 May British Society of Interventional Radiology (BSIR) Paediatric IR Birmingham, UK

7–4 June Vascular Annual Meeting (VAM) 2025 New Orleans, USA

www.uia.org/s/ca/en/1300596276

www.bsir.org/events/specialinterest-events/bsir-paediatric-ir-ukannual-meeting/

www.vascular.org/vam-2025

19–20 June British Society of Interventional Radiology (BSIR) IOUK 2025 London, UK

www.bsir.org/events/specialinterest-events/bsir-iouk-annualmeeting/

21 June The Radiological Imaging and Intervention Symposium (RiiSE) Glasgow, UK https://www.bsir.org/events/ special-interest-events/ir-juniorsevents/riise25/

26–27 June British Society of Endovascular Therapy (BSET) Wotton-under-Edge, UK www.bset.co.uk/meetings/bsetannual-meeting-2025

11–14 July European Conference on Embolotherapy (ET) Porto, Portugal www.etconference.org/

30 July–1 August The Interventional Radiology Society of Australasia (IRSA) Melbourne, Australia https://irsa.com.au/education_ events/irsa-annual-scientificmeeting-2025/

Interventional News is a trusted, independent source of news and opinion in the interventional world. www.interventionalnews.com

Interview: Palliative care in IO

Profile: Jack Jennings

SIR GLOBAL

ECIO PREVIEW

First multi-society summit addresses the wants, needs and demands of IR on the global stage

Largest liver venous deprivation registry set to release positive preliminary results at ECIO

April 2024 | Issue 94

SIR: Cryoablation for large tumours page 6

Last month at the Society of Interventional Radiology (SIR) annual scientific meeting (23–28 March, Salt Lake City, USA), interventional radiology (IR) societies from nations worldwide sat around a table to consider the status of IR in their geographies. The Global Society Summit—the first meeting of its kind—heard international IR leaders discuss and define common challenges, to track a path for multinational collaboration and sustain a unified voice for IR in an increasingly competitive global healthcare environment.

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hirteen panellists in attendance, representing IR societies from every global continent, stood and updated the room on the status of IR in their country. “It’s heartening to hear that many of our challenges and thought processes are very similar worldwide,” said Alda Tam (MD Anderson Cancer Center, Houston, USA), SIR president and cocoordinator of the summit. Although at different stages down the path to subspecialty and specialty status, each society reported strikingly similar challenges, namely the recognition of the importance of clinical care in IR, difficulties with standardisation and training, practice economics and specialty distinction.

The IR clinical practice model was first to be dissected by the panel. SIR international division councillor and panel moderator Constantinos T Sofocleous (Weill Cornell Medical College Memorial Sloan-Kettering Cancer Center, New York, USA) began by discussing the value of routine outpatient IR clinical practice with longitudinal care for patients. Taking a poll, the majority of the panel agreed on the value of IR clinics and indicated that they offer this service.

“I think that in the USA,” said Parag Patel (Medical College of Wisconsin, Milwaukee, USA) following this poll, “one of the critical aspects for our recognition as a specialty and from other specialties was the recognition that we take care of patients with the diseases that we manage.” Until the American Board of Medical Specialties recognised the important role that interventional radiologists play in the “longitudinal management of disease going forward”, he said, there was “no path to specialty”. However, he added that a young trainee who wants to take care of patients and do procedures will likely pursue an IR-dedicated training pathway that “involves or invokes” clinical practice as “mandatory”, Patel noted. This, however, is a highly streamlined training modality that is not frequently offered worldwide.

Adding to this point, Robert Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA) noted that these direct training pathways are “critical to the success of [IR] at a global level”. Yet, in an effort to “refocus”, he shared data from a survey his centre carried out which asked US IR chiefs or clinical leads whether or not they provide outpatient clinical services. They found that 76% said yes and 24% said no, and these figures were similar when the same question was asked for inpatient services. “I share these because there are clearly opportunities for improvement, to meet the goal that we’re all stiving for here. We all want IR to have a singular focus on longitudinal clinical care to achieve clinical excellence. Is the distribution of clinical services similar in other countries?” Lookstein asked.

“In Europe, I think that the numbers are much lower,” said Christoph Binkert (Kantonsspital, Winterthur, Switzerland), “but heterogeneity is much higher, not just across Europe but even within my country.” Although Binkert noted that Switzerland is not entirely representative of Europe, he explained that outpatient clinics have become the norm. “All of the big players do it—if you’re not offering outpatient clinical care, patients will not come to you.”

In the UK, Robert Morgan (St George’s Hospital NHS Foundation Trust, London, UK)—British Society of

An advantage of progressing from behind is that you learn from others’ mistakes.”

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IN 2020, A SINGLE-CENTRE STUDY conducted by Kosuke Kobayashi (University of Lausanne, Lausanne, Switzerland) confirmed the superiority of liver venous deprivation (LVD) over portal vein embolization (PVE) alone, inducing faster hypotrophy of the future liver remnant. In April 2024, “exciting” preliminary results from the largest global LVD registry—EuroLVD—are set to be released at the European Conference of Interventional Oncology (ECIO) annual meeting (28 April–1 May 2024, Palma de Mallorca, Spain), setting sights on a soon-to-be reached consensus for this promising treatment modality.

Lead investigator Alban Denys (Centre Hospitalier Universitaire Vaudois [CHUV], Lausanne, Switzerland) and previous chairman of ECIO, spoke to Interventional News on sharing their initial results at the upcoming ECIO meeting.

“I think this could impact the clinical practice of centres that are still not convinced on LVD,” Denys said. “Our main messaging during this presentation will be to not be afraid to start. It’s a safe procedure, it’s not very complex and it enables better outcomes from your patient, so don’t be afraid to go for it—and even participate in the EuroLVD registry if you do implement the procedure.”

EuroLVD is an initiative that has been set up between interventional radiology and hepatobiliary surgery groups in Lausanne to collect information about LVD. “It’s almost copy and pasting what has been done for the associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) technique,” Denys explained. ALPPS is a surgical technique that combines transection of liver parenchyma and the ligation of the portal vein to the diseased liver. It allows higher, “more efficient” degrees of hypertrophy of the future liver remnant (FLR) in a short time, Denys explained. However, studies have shown a high rate of morbidity and mortality associated with Continued on page 6

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Vascular & Endovascular

Consensus Update

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21–23 APRIL 2026 TUESDAY-THURSDAY E XC E L , LO N D O N UNITED KINGDOM

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