7 RETNET: First data release for neuroendocrine liver tumours
Profile: Sarah B White
COLLISION trial analysis suggests for small-size colorectal liver metastases
Recently published in The Lancet Oncology, the randomised, international, multicentre, phase III non-inferiority COLLISION trial demonstrated comparable results between thermal ablation and surgical resection for small-size colorectal liver metastases, initiating re-evaluation of clinical practice and the previously held assumption that ablation should be reserved for unresectable lesions only. Speaking to Interventional News, principal investigator Martijn Meijerink (Amsterdam UMC, Amsterdam, The Netherlands) recognised “completely unexpected” results in their data concerning local control and tumour progression, with the potential to push the needle toward minimally invasive intervention in a broader range of lesions.
Between August 2017 and February 2024, 300 patients were randomly assigned to two groups—148 to the experimental treatment and 148 to the control treatment. Four patients in total were excluded as they were found to have other disease pathology. The trial met predefined halting criteria for early benefit, and it was deemed unethical to continue. It was determined that thermal ablation resulted in fewer side effects (28 cases [18.9%] vs. 67 cases [45.9%]) and shorter hospital stays. Serious side effects occurred in 11 patients (7.4%) in the ablation group and 29 patients (19.9%) in the surgery group—these included bleeding that needed intervention (one patient [1%] vs. eight patients [5.5%]) and infections requiring treatment (six patients [4%] vs. 11 patients [7.5%]). In the researchers’ analysis, local control was found to be superior following ablation—an “unanticipated” result, said Meijerink— with only a single patient in this group for whom local control was not achieved.
When asked if these results were close to his predictions, Meijerink commented that he expected overall survival to be identical. “What was completely unexpected was local control and tumour progression,” he said. “This outcome means that in small-size tumours, the vast majority can be locally controlled with ablation. Even if you had a perfect surgeon, it would still be unacceptable to continue resecting small-size tumours. We should focus on what I think is the next standard of care— ablation—because in high-volume, dedicated centres you can locally control tumours with this technique.”
The path Meijerink and colleagues at Amsterdam UMC took to arrive at this conclusion was one built from “trust”, he described, and was forged from over a decade’s worth of observation showing improved outcomes via thermal ablation.
new standard of care
“We saw the majority of tumours weren’t coming back and our surgeons were completely open to a potential future where resection for smaller tumours is no longer the first option, then we started to make this principle concrete,” Meijerink stated.
Admittedly, he added that this collaborative relationship between interventional radiologists and surgeons at his institution is “unique” and that they are “lucky” to operate in this way. Although, Meijerink stated that part of the reason for initiating the COLLISION trial was to seek an “end to the discussions” between their departments on the best course of treatment.
The COLLISION trial included patients from 14 centres in The Netherlands, Belgium and Italy, with ten or fewer small-size (≤3cm) colorectal liver metastases, no extrahepatic metastases, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, stratified per centre, and according to their disease burden, into low, intermediate, and high disease burden subgroups.
Meijerink reflected that the process of setting up the trial was
This outcome means that in small-size tumours, the vast majority can be locally controlled with ablation. Even if you had a perfect surgeon, it would still be unacceptable to continue resecting small-size tumours”
19 Device forecast: John Kaufman on what’s next for IR
Global survey results deem patient awareness a critical obstacle facing
IR
Transcending region and socioeconomic status, a global survey has revealed patient awareness to be a “universal obstacle” that faces interventional radiology (IR) worldwide. These data have also highlighted disparities in training, practice, education, and reimbursement. The survey was aimed to describe the current global state of IR education and practice in different geographic locations, identify factors limiting development and propose strategies to address these challenges.
“UNDERSTANDING THE factors underlying such disparities is essential in helping to develop IR as a discipline. Such developments will better serve patients in need while also bringing value to the global healthcare system,” write Justin J Guan (Cleveland Clinic, Cleveland, USA) alongside Constantinos Sofocleous (Memorial Sloan Kettering Cancer Center, New York, USA) and co-authors of the survey. According to the World Health Organisation (WHO) in 2021, more than half of the world’s population lacked access to crucial radiology services and even more so departments with interventional capabilities.
Endorsed by the Society of Interventional Radiology (SIR), Guan et al designed an online survey to gather information including respondent demographic information, IR practice characteristics, and respondent opinion on challenges and needs. The survey was distributed among global IR societies and shared on social media platforms, remaining open between June 2022 and
Continued on page 4
Martijn Meijerink
Happy 50th birthday to the Society of Interventional Radiology
How can it be that this specialty society, so associated with concepts of ‘newness’, is old?
We know that in 1974 a group of ‘gadgeteers’ (credit to Mike Dake for the term), dressed in plaid bellbottoms, convened in Key Largo in Florida, USA to talk geek. They munched on that year’s new snack called Skittles, and organised their thoughts and schedules with the new-fangled sticky, but not so sticky, Post-it notes. Fast forward five decades and we have the newest American board-certified discipline, the most competitive primary residency, a thriving pipeline of discovery, robust global collaboration, and many imitators. We do still have the candy and the note pads, but they have not really changed.
So, how did this remarkable transformation happen? Why, of all the millions of good ideas from 1974 did this one not only survive, but thrive? I don’t know, but here’s my best guess.
A good idea
‘Virtual reality’ guidance obviated any need for dissection and exposure. More precise, less risk. Without image guidance we are surgeons. With it, we are superheroes able to access any structure, anywhere. Shazam! Most medical historians place medical imaging high on the list of greatest medical discoveries of the last century—Sven Ivar Seldinger was in the right place at the right time and interventional radiology (IR) as we know it now is a beneficiary.
Visionaries
The Mount Rushmore of IR should show Charles Dotter of course, probably in the centre. Nearby would be, well, a lot of folks, frankly too many to mention. If the idea that we could in fact take the Fantastic Voyage— the 1966 sci-fi thriller where a submarine is miniaturised and injected into a scientist suffering from a clot, was crazy, imagine dreaming up a system for reimbursement from scratch, or inventing the concept of societal quality guidelines. Imagine saying to an incredulous medical establishment that
someday we would be delivering intra-arterial drugs or percutaneously draining abscesses or convening a task force to build a primary specialty and succeeding! The visionaries of the Society of Interventional Radiology (SIR) all deserve to be on that mountain. IR seems to attract a certain type of inventive zealot. We are fortunate for that.
Culture
I think this is where SIR’s light shines brightest. From its earliest days, this society and its meeting was a home for big (outrageous) thinkers, inclusive, open, and representative. We’ve pursued some boneheaded ideas along the way to be sure, and paid for some, but what distinguishes us is our willingness to engage. As our society and specialty mature, the price for taking risks grows, but our future depends upon our ongoing willingness to listen to new ideas.
Teamwork
We are a society of volunteers. It’s extraordinary that in 2023, nearly 10% were active volunteers, and many more were active at the hospital, and local levels. It is also a recipe for operational chaos. That’s where the SIR staff over the years have evolved into essential partners. They mirror the membership. They too believe in the promise of IR. Without the support and guidance of the many association professionals we’ve teamed with, we would be nowhere.
Of course, with any big anniversary one begins to look forward. From the perspective of a past SIR leader, here is what I hope the next 50 years bring:
Introspection
There are some things we do in IR that are not sufficiently complex or risky to justify our very expensive time. To stay competitive, our time spent supervising and developing protocols and practice standards should be maintained, but we must advocate for the best
Continued on page 4
Editors-in-chief: Professor Robert Morgan, Professor Andy Adam, Professor Brian Stainken
Publisher: Stephen Greenhalgh | Content director: Urmila Kerslake
Editor: Éva Malpass | Editorial contribution: Jocelyn Hudson, Will Date, Bryan Kay, Jamie Bell
Design: Terry Hawes, Josh Lyon and David Reekie
Advertising: Michael Broughton michael@bibamedical.com
Subscriptions: subscriptions@bibamedical.com
Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd
The Society of Interventional Oncology (SIO) has announced the launch of the society’s second clinical trial, TRIBUTE, a multicentre observational trial of symptomatic, high-risk bone metastases treated with percutaneous ablation and palliative radiation therapy at its annual scientific meeting (30 January–3 February, Las Vegas, USA). This is the first prospective, multicentre study to evaluate real-world outcomes in adult patients.
For more on this story go to page 6.
n BIORESORBABLE MICROPHERES:
Bioresorbable microspheres are making waves in musculoskeletal (MSK) embolization, challenging the use of permanent embolics. As clinical evidence supporting their safety and efficacy accelerates, these agents could reshape treatment strategies—offering effective pain relief while reducing long-term risks. In an interview with Interventional News, Ziv Haskal (University of Virginia, Charlottesville, USA) speaks on the future of resorbable microspheres in MSK embolization.
For more on this story go to page 11.
n ERECTILE DYSFUNCTION:
Data from a new study suggest that venous leak embolization yields additional clinical improvement and treatment potential in patients with vasculogenic erectile dysfunction (ED) resistant to phosphodiesterase-5-inhibitors (PDE5i) due to mixed arteriovenous disease. These findings were recently published in the journal CardioVascular and Interventional Radiology (CVIR). For more on this story go to page 20.
Subscribe here
If you have comments on this issue or suggestions for upcoming editions write to eva@bibamedical.com
6-MONTH DATA 89.8%
TARGET LESION PRIMARY PATENCY
Happy 50th birthday to the Society of Interventional Radiology
Continued from page 2
care, by the most appropriate trained and supervised providers, both in terms of outcomes and cost. That said, we also must pay more attention to the central operational role we play in nearly every hospital in the country. What percentage of inpatients are touched by IR? What percentage of discharges expedited, complications averted? What savings are attributable to our presence? Core IR merits more attention, tighter definition, better practice models factoring in clinical time, more research, and better economic validation.
Accreditation
The society reflects the field, and its growing diversity. In order to serve membership, the structure of the society must continue to evolve. Pending the future adoption by the American Board of Radiology (ABR), we should follow or join in the Cardiovascular and Interventional Radiological Society
COVER STORY continued
Global survey results deem patient awareness a critical obstacle facing IR
Continued from page 1
September 2023.
Guan and colleagues collected 1,263 responses. Of the 993 respondents who reported speciality affiliation, 811 were interventional radiologists, 85 diagnostic radiologists and 91 identified as both specialties. The majority of respondents were located in Asia, Europe or Africa. Most respondents reported practising in an academic hospital (34.3%), a public hospital (31.8%) or a private hospital (27.9%). The USA was not included in these results, as statistical analyses of US IR practice were used as the basis for comparison.
Over half of the respondents reported having graduated from an accredited radiology training programme, although 24% stated that no structured training programme existed in their country, and 20% indicated that their radiology training offered no exposure to IR. IR teaching responsibilities were least prevalent in Africa (40%) and most prevalent in Europe (83%). Reflecting these disparities, 92% of respondents expressed support for establishing unified global IR training standards.
In terms of IR practice, the most commonly performed procedures worldwide included biopsies, drainages, angiograms, embolization, and venous access procedures. Regionally, biopsies were the most frequently performed procedures in
of Europe (CIRSE)’s example and embrace voluntary society-based accreditation for subspecialised practice areas. Such a scheme should include clinical practice mandates and span the full scope of the specialty.
Full time IR
With the number of trainees and full members approximately equal—as per the 2003 SIR annual report—a primary residency, clinical practice requirements, and evolving specialty focus areas, I expect that market forces will drive this shift, where the potential exists and individuals are willing to take risks. No need for an edict. That said, in a world where no hospital can function without IR, some geographies will always require part-time providers as long as they have the need for clinical time. Leave radiology? Keep the ‘R’, drop the ‘D’. Whether you can evolve into a new department or service line, or should stay as you are is a local issue based on strength, level of leadership support and finances. If you are strong enough to stand alone, fine. However, it’s unlikely that leaving alone will somehow make you stronger. As our specialty evolves toward a collection of subspecialised focus areas, and as we mandate clinical practice, we should grow stronger, and fit and be valued in several departments. It’s good to have many friends.
Asia, North America, and Africa, while venous access procedures were most common in South America and Oceania. In Europe, angiograms and embolization were the most widely conducted IR interventions.
The survey also examined reimbursement models, asking repondents to select all that apply, the authors found that national health plans were the primary source of payment for IR procedures globally, covering 66% of cases. Private insurance was the second most common form of reimbursement at 53%, while outof-pocket payments accounted for 35% and hybrid models 24%. Private insurance was the dominant model in North America, South America, Africa, and Asia, whereas national health plans were the primary source of payment in Europe and Oceania. “Interestingly”, Guan et al write, in Asia, the distribution of payment sources was relatively even, with 54.7% of cases covered by private insurance, 53.7% by national health plans, and 52.4% paid out of pocket.
Global IR
IR is a small specialty until you look at it from a global perspective. Collaboration, adherence to standards, and excellence in research, training and practice are our unifying themes. I believe that our growth and continued evolution opportunities for the next 50 years will come through increasing our efforts to effectively network and share our successes and strategies. We are all in this together.
So, there you have it. Happy 50th Birthday SIR. On behalf of my fellow editors at Interventional News, and for the global IR community, we celebrate your success and look forward to another 50 years of adventure. Stop by the booth—we will be serving up Skittles and Post-it notes.
The society reflects the field, and its growing diversity. In order to serve membership, the structure of the society must continue to evolve”
followed closely with a score of 2.6, reported by 65% of respondents. Other significant barriers included limited IR training (2.5, 57%) and reimbursement issues (2.5, 56%). While patient awareness and referrals were the dominant concerns globally, Africa was the only region where IR training was ranked as the highest priority, scoring 2.8, followed by patient awareness at 2.6.
the USA. Of 1,000 respondents, only 40% knew of IR, and less than half described the specialty correctly. “[The USA has] arguably the most developed IR infrastructure in the world”, Guan et al state, casting awareness of IR in other geographies in stark relief.
72%
of respondents cite patient awareness as the greatest barrier to IR expansion
Among practising interventional radiologists, the study highlighted key professional challenges, with patient awareness and hospital support ranking highest. Competition with other specialties was another major concern cited by respondents. These challenges varied by region—in North America, Asia, and Europe, the primary issues were patient awareness and hospital support, while in Africa and Oceania, patient awareness remained a leading concern.
In South America, competition with other specialties and reimbursement challenges were ranked as the most significant obstacles.
“Ultimately, there must be global recognition of IR as a medical discipline that offers significant value to the healthcare system,” the authors write. “Global collaboration of IR societies with backing from governments, industry, and other supportive entities is crucial in fostering positive changes and overcoming challenges that hinder the development of IR training worldwide.”
The authors highlight IR’s added value to the healthcare system across numerous specialties and state that the “increasing demand for minimally invasive procedures, coupled with patient-centred care, tailored management plans and the rising incorporation of artificial intelligence and robotics, further enhance IR’s market value”.
Guan and colleagues add that, while North America has the largest IR market share currently, the Asia-Pacific region is projected to have the highest future growth rate, while investment from IR societies, government and industry into regions with less robust IR infrastructure such as Africa and South America is set to improve training and education.
Several key barriers to the expansion of IR services were identified via the survey, with patient awareness and education emerging as the most critical issue. On a scale of 1 to 3, where higher values indicated greater relevance, patient awareness received a weighted mean score of 2.7 and was cited as the most significant barrier by 72% of respondents. Patient referrals
In their discussion of the survey results, Guan and colleagues underline that not only is awareness about IR low among patients, but “also among referring and primary care physicians, healthcare workers and the public at large”. The authors reference a 2023 Rodgers et al study which published results of a population survey evaluating public awareness of IR in
In their final summary, the authors direct these results toward guiding organisational and societal efforts in improving access to IR services worldwide, and state that there will be dedicated sessions during upcoming congresses, such as at the SIR annual scientific meeting (March 29-April 2, Nashville, USA), which are aimed at continuing global dialogue.
Brian Stainken
COLLISION
trial analysis suggests new standard of care for small-size colorectal liver metastases
Continued from page 1
lengthy. Having finalised the study protocol in 2015, the search for funding “took a long time”, he said, but believes this extension was “a good thing”.
“We would have had a negative trial because we weren’t as good back then. We would have had more recurrences when compared to surgical resection, whereas now, we are much better at completely eradicating the disease. Even though it was frustrating, it’s good we have the results now and not ten years ago,” Meijerink explained.
In part, Meijerink added that technological advancements such as confirmation software are a central reason for the positive results of the COLLISION trial. “It’s a no-brainer. Eyeballing the tumour is not good enough—sitting down to check the margins and bring the needle back for any residual tumour while the patient is still under anaesthesia dramatically improved our results,” he said.
Despite advancements in devices and targeting software, Meijerink highlighted that inclusion criteria for the COLLISION trial stipulated institutions
have ample experience with thermal ablation and must have performed more than 100 cases to meet this description. Although he believes their data are convincing, he cautioned less experienced centres from changing their practice too quickly, without first achieving recurrence rates below 10% in patients with small-size tumours.
“My suggestion for centres that want to change their practice—and I agree that we should all strive to—is to first look at your last 50 or 100 cases and see if your recurrence rates are below 10%. If they are not, I wouldn’t change anything for now. We cannot generalise the results without first making sure you’re doing a good job,” he stated.
To address the “steep learning curve” institutions can be met with when looking to implement change, Meijerink offered the COLLSION-2 trial, a steppedwedge cluster trial comparing current practices to best practices. From confirmation software to antibiotic use and general anaesthesia, Meijerink et al—via a consensus panel meeting—will seek to define best practice and subsequently randomise centres.
“If your centre is enrolled in the trial, you will receive a call disclosing details of ‘best practice’ in regard to thermal ablation and will be given six weeks to implement it. These trials are very often positive because, not only do you improve your outcomes, but it’s a way for centres to achieve outcomes equal to the best performing centres,” Meijerink described.
“There’s a lot to improve and why should we do that? I think we, as interventional radiologists who are stepping into oncology should realise that we need
TRIBUTE symptomatic bone metastases trial launched at SIO 2025
The Society of Interventional Oncology (SIO) has announced the launch of the society’s second clinical trial, TRIBUTE, a multicentre observational trial of symptomatic, high-risk bone metastases treated with percutaneous ablation and palliative radiation therapy at its annual scientific meeting (30 January–3 February, Las Vegas, USA).
THE TRIBUTE STUDY, A multimillion-dollar project, is also the second multi-industry-supported clinical study to be executed by the society since its first announcement of the ACCLAIM trial in 2021.
The TRIBUTE study is collectively supported by the study’s exclusive pioneer trial partner Varian, a Siemens Healthineers company, the study’s catalyst trial partner, Stryker, and the study’s advocate trial partner, Boston Scientific.
This is the first prospective, multicentre study to evaluate real-world outcomes (e.g., pain, patient-reported outcomes, skeletal-related events, healthcare utilisation) in adult patients treated with both percutaneous ablation and palliative radiation therapy (RT) for symptomatic, high-risk metastatic bone lesions.
The TRIBUTE study clinical leadership will include Jack Jennings (Washington University School of Medicine, St. Louis, USA), Sean Tutton (University of California, San Diego, USA), Clifford Robinson (Washington University School of Medicine, St. Louis, USA) and James Urbanic (University of California, San Diego, USA). “The results from the TRIBUTE trial have the potential to reshape treatment guidelines for metastatic bone disease. Research is the cornerstone of progress in interventional oncology, and SIO remains committed to driving groundbreaking efforts that elevate the impact of clinical research in our field,” said Jennings. Percutaneous ablation and RT have different mechanisms of alleviating pain and causing tumour death that may work synergistically. Radiation therapy is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients. Percutaneous ablation, a minimally invasive therapy for painful metastatic bone disease, can be performed with thermal modalities
to be highly dedicated. The patient is on the table to have their cancer eradicated—it’s not inflating a balloon and maybe it comes back and needs to be reinflated. We have to do a better job. It’s in human nature to say, ‘I think I got it, and if I didn’t, I’ll do it again in six months’, but that’s not our future. Our future is making sure you treated that patient the best way possible and to standardise this care among centres,” said Meijerink.
Meijerink and colleagues’ research efforts to solidify thermal ablation as the new standard of care are ongoing; the COLLISION XL trial, a randomised controlled trial comparing thermal ablation to stereotactic body radiotherapy (SBRT) for larger-size and unresectable colorectal liver metastases 3–5cm, is currently recruiting. “Thermal ablation more often fails to provide local control in larger tumours, but has shown equal recurrence rates to SBRT,” explained Meijerink. Their team is also recruiting for the COLLISION RELAPSE trial, comparing upfront repeat local treatment with thermal ablation and/or surgical resection versus neoadjuvant chemotherapy followed by local treatment for patients with new colorectal liver metastases in the first year after the initial local treatment.
Through these trials, Meijerink hopes to provide data that will place tumours up to 5cm within the remit of interventionalists who can provide minimally invasive, efficacious treatment. “Technological advancements are not stopping. In the future I’m sure we will be able to compete with surgery for patients with larger tumours,” Meijerink stated.
and requires minimal recovery. “This approach combines the strengths of both percutaneous ablation and radiation therapy. By leveraging their complementary mechanisms, we can offer patients an effective and minimally invasive treatment option for pain relief and tumour management in metastatic bone disease,” said Tutton.
Muneeb Ahmed (Beth Israel Deaconess Medical Center, Boston, USA), president of the SIO, commented: “The success of studies like TRIBUTE are fuelled by strong, long-term collaborations with our multidisciplinary physician
colleagues and dedicated industry partners. The TRIBUTE study is not just a step forward—it’s a bold leap in SIO’s vision to further establish the interventional oncology specialty.”
The TRIBUTE study is set to launch in 2025 with the enrolment of 120 patients across sites in the USA.
In an interview with Interventional News, Jennings and Tutton spoke on the trial. Jennings noted that the “combination of radiation and ablation is something that [interventionalists] have been doing for over a decade; however, this has never been
prescriptive, it’s never been shown in a prospective trial like this”. He stated that the population is living longer with painful bone metastases that are creating skeletal-related events. The collaborative trial brings together interventional radiology and radiation oncology, a “first,” Jennings observes, “combining therapies to reduce pain” and address a plethora of secondary endpoints.
Tutton added: “Traditionally, trials have looked at pain relief but what we’re going to address is absence of subsequent fractures and improvement in patient-reported outcomes—such as the patient’s ability to enjoy their day and other functional endpoints. We’re excited to show that the combination of ablation and radiation will benefit these patients in a way that has never been demonstrated in a trial like this before.”
We’re excited to show that the combination of ablation and radiation will benefit these patients in a way that has never been demonstrated in a trial like this before” Sean Tutton
First RETNET data show no difference in progression-free survival between TAE and TACE for neuroendocrine liver tumours
New data from a prospective, multicentre randomised controlled trial show similar hepatic progression-free survival (hPFS) using bland transarterial embolization (TAE) or transarterial chemoembolization (TACE) when treating neuroendocrine tumour metastases in the liver. Michael Soulen (University of Pennsylvania, Philadelphia, USA) presented these findings at the Society of Interventional Oncology (SIO) annual scientific meeting (30 January–3 February, Las Vegas, USA).
SOULEN, FOR THE FIRST TIME, was presenting the results of the Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET). He set out that TAE and TACE have been used to treat neuroendocrine liver tumours for over 50 years and are equally weighted in the National Comprehensive Cancer Network (NCCN) guidelines, due only to lack of controlled comparative data. To gain better insight, RETNET was designed to analyse efficacy, toxicity and patient-reported outcomes for patients with liver-dominant neuroendocrine tumours randomised 1:1:1 to TAE with 40–500μm
microspheres, TACE with lipiodoldoxorubicin 40–500μm microspheres, and drug-eluting bead doxorubicin (DEBDOX) delivery. Patients received clinical imaging and laboratory assessment as well as patient-reported outcome assessments, every three months for two years following treatment.
Highlighting strict safety parameters in their study’s design, Soulen commented on “controversy” that had previously arisen during trials of DEBDOX which were halted early due to high complication rates. To acknowledge this, his team implemented a stopping rule which
Study shows “significant” PSA reduction with cryoablation for recurrent prostate cancer
An 11-year prospective study of magnetic resonance (MR)-guided cryoablation in the treatment of recurrent cancer in the prostate bed has demonstrated “significant” prostate-specific antigen (PSA) reduction at both six- and 12-month follow-up.
THESE FINDINGS WERE PRESENTED by Setayesh Sotoudehnia Korani (Mayo Clinic, Rochester, USA) at the Society of Interventional Oncology (SIO) annual scientific meeting (30 January–3 February, Las Vegas, USA).
Sotoudehnia began by outlining current treatment options and their associated recurrence rates, stating that surgery is estimated to have a recurrence rate of between 15–20%, radiation 20–30%, and hormone therapy, which has a two-to-three-year efficacy rate of approximatley 20%. Of available focal therapies, the speaker listed cryoablation and laser ablation. In order to evaluate the efficacy and safety of MR-guided cryoablation in this patient population, Sotoudehnia and colleagues enrolled 90 patients between September 2011 and September 2023. The patients had a mean age of 73 years and had previously received radiation therapy or
defined a 20% incidence of major complications to be grounds to close an arm.
Soulen and colleagues enlisted 14 sites in the USA, Canada, Argentina and Italy, with a total of 162 patients enrolled. He described that, during an early safety review while enrolling, they elected to close the DEBDOX arm due to a 40% treatment-related serious adverse event rate resulting in two intensive-care unit admissions, two permanent hepatobiliary injuries and two patients who could no longer participate in the trial.
“The good news is that we confirmed that DEBDOX is bad in neuroendocrine tumours,” Soulen told SIO attendees, a fact that has now been reflected in the NCCN guidelines. Going forward, their cohort was comprised of 78 patients randomised to TAE and 73 to TACE, with no significant baseline characteristic differences between groups.
Soulen reported that hPFS at two-year follow-up showed no difference (p=0.2) between TAE and TACE. Further, breaking hPFS down by grade, tumour burden, Eastern Cooperative Oncology Group (ECOG) performance status, and histology, Soulen reported equivalent results between study arms.
prostatectomy.
Patients in the study cohort were treated with four cryoablation needles on average, typically with three freeze/thaw cycles and a urethral warmer for protection during the procedure. Sotoudehnia stated that their team carefully monitored ice ball expansion via magnetic resonance imaging (MRI) to ensure target coverage.
At three and six months post-ablation, patients were assessed via PSA and prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging. Urinary symptoms and sexual health were measured using the American Urological Association Symptom Score (AUASS) and the Expanded Prostate Cancer Index Composite (EPIC).
Sharing the team’s results with the SIO 2025 audience, Sotoudehnia stated that average lesion size was 1.3cm and mean pre-ablation PSA was 3.57±4.38. Following treatment, average PSA levels “significantly decreased”—at six months, average PSA fell to 1.41±3.70, a 60.5% reduction, and at 12 months, PSA was reported as 1.52±4.88, a 57.5% reduction on pre-ablation assessment.
“PSA reduction was maintained through to 12-month follow-up,” Sotoudehnia stated. “Overall, we had 34 of 90 patients show recurrence, and only 12 patients who experienced recurrence within the ablation zone.” The speaker reported that 22 patients experienced out-of-field recurrence, developing new lesions outside of the original treatment area.
Sotoudehnia then detailed a subgroup analysis carried out by their team, evaluating alternative treatments and their recurrence rates in this
His team analysed each arm by objective response rate (ORR), demonstrating TACE to have achieved a 40% ORR at three months which was sustained to two years, while TAE achieved a 60% ORR at three months, which “significantly declined” over two years to 20%, Soulen described.
Detailing “unexpected” insights from their data, Soulen stated that syndromic and female patients had better hPFS than non-syndromic patients or men. “This is an outcome that still remains to be explored,” Soulen told delegates.
Soulen reported a total of 101 severe adverse events in the TAE arm, versus 39 in the TACE arm—a large difference in event rate between groups which is awaiting detailed further analysis.
No difference in two-year hepatic progression-free survival between TAE and TACE
Summarising, Soulen stated TAE and TACE equally provided durable symptom control up to two years which was not influenced by tumour grade, burden or histology. Later, he noted that further analysis of their data is set to be released in due course, focusing on overall survival and patientreported outcomes.
“[These outcomes] are raising a lot of questions that were unexpected. I don’t know the answer, but we will need to pick apart these data in the context of these questions,” Soulen concluded.
patient population. The analysis showed that in-field recurrence rates were highest when patients were treated with combined prostatectomy and radiation (13.9%), while radiation alone (13.5%) and prostatectomy (11.7%) showed lower rates of recurrence.
The speaker noted that they observed a 4% complication rate in this cohort, which included three patients who experienced a breakdown of the posterior urethral wall. Two of these patients had received prostatectomy and radiation combined, while one patient had received radiation alone. Further, another patient with a history of prostatectomy reportedly experienced vesicorectal fistula, Sotoudehnia explained.
Overall, we had 34 of 90 patients show recurrence, and only 12 patients who experienced recurrence within the ablation zone”
Sotoudehnia summarised that their data shows cryoablation to be effective in reducing PSA in patients with recurrent prostate cancer. On reflection, she noted that “cryoablation gives us superior soft tissue resolution for targeting and monitoring,” stating that the modality helped her team achieve minimal in-field recurrence rates in these patients.
Setayesh Sotoudehnia Korani
Awaited first-release data and debates set to address critical challenges in CX 2025 peripheral arterial programme
“These crucial results will help to shape next steps in research, including ongoing randomised controlled trials comparing bioresorbable scaffolds to angioplasty, and eventually, to drugeluting stents.” These are the words of Michel Bosiers (University Hospital Bern, Bern, Switzerland), sharing his initial predictions ahead of several new data releases during the peripheral arterial programme at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK). Set to address critical challenges in the treatment of intermittent claudication and chronic limbthreatening ischaemia (CLTI), the programme will host numerous podium firsts, including breaking data from BASIL-2, BASIL-3 and SPINACH trials.
Bosiers, who will present on day one of the peripheral programme, will deliver three-year results from the MOTIV bioresorbable scaffold (Reva Medical) trial. The trial is aimed to evaluate safety and efficacy of the device for the treatment of patients with rest pain or minor tissue loss due to the presence of lesions of a maximum length of 100mm at the level of the below-the-knee (BTK) arteries.
“Research on bioresorbable scaffolds is crucial because these devices offer unique advantages over traditional treatments, addressing some of the most significant challenges associated with managing peripheral arterial disease in chronic limb-threatening ischaemia patients,” says Bosiers, speaking to Interventional News ahead of this year’s symposium.
To address the increasing incidence of peripheral arterial disease (PAD) worldwide due to ageing populations and rising diabetes diagnoses, Bosiers hopes that “these results will provide crucial insights into the long-term efficacy and safety of bioresorbable scaffolds in treating CLTI patients, significantly contributing to the investigation of advanced treatment options”.
Following Bosiers, Andrew Holden (Auckland City Hospital; University of Auckland, Auckland, New Zealand)— CX co-chair and member of the peripheral arterial executive board— will begin his series of podium-first presentations during the first day of the symposium.
Set to deliver a first data release on drug-eluting resorbable scaffolds in the femoropopliteal segment, Holden comments that there has been “renewed interest” in resorbable scaffolds in lower limb arterial intervention following the LIFE-BTK trial results which facilitated the approval of the ESPRIT BTK (Abbott) scaffold.
“Most companies that are investigating peripheral arterial indications for drug-eluting resorbable scaffolds are focusing on tibial artery
talk on new intravascular lithotripsy (IVL) technologies and trial data for calcified tibial artery disease. He tells Interventional News that, in several vascular territories, IVL has achieved “excellent acute luminal gain” in calcified arteries with a “low incidence of dissection or provisional stenting”. Yet, Holden notes that there has been limited evidence supporting IVL use in tibial arteries, calling for a successful technology which can address calcification in these vessels and achieve better results than when treating with angioplasty.
“These data will help support discussion on the optimum management algorithm for CLTI patients with calcified tibial artery disease,” says Holden, who adds that delegates can expect interesting debate on whether the two technologies presented are “complementary or competitive”.
applications. However, the advantages of drug-eluting resorbable scaffolds— which include providing an acute scaffold to optimise angioplasty results and resorbing without a permanent implant—are even more relevant in the femoropopliteal segment,” Holden describes.
In his talk, Holden will present an interim analysis from the first-in-human Efemoral-1 trial, including six-month follow-up of the Efemoral (Efemoral Medical) device, which was designed to manage the anatomic and restenotic challenges of the femoral artery. “These clinical outcomes will ultimately determine if this device translates from one of promise, to a standard tool for femoropopliteal arterial intervention. I believe these data have the potential to stimulate further interest and excitement around this important advancement in vascular care,” he adds.
Later in the peripheral programme, Holden will also deliver a podium-first
to the application of a drug-coated balloon (DCB).
Zayed comments: “Vessel preparation is an evolving concept which is gaining popularity amongst interventionalists, with the aim to enhance the outcomes of definitive treatment of arterial lesions. It is therefore important that we appraise the available research in order to highlight areas in need of further research to help guide our routine daily practice.”
Zayed states that their first-release data to be presented at CX 2025 will highlight that the current evidence is still heterogeneous, particularly in regard to patient cohort e.g. CLTI or intermittent claudication, lesion characteristics and complexity, as well as duration of follow-up.
During a ‘Challenges in aortoiliac occlusive disease’ session, Maria Antonella Ruffino (IIMSI, Ente Ospedaliero Cantonale, Lugano, Switzerland) will present on new large balloon IVL in the treatment of aortic lesions. Importantly, she will question whether IVL is an effective therapy when used alone or in combination with stenting as a means of vessel preparation.
In conversation with Interventional News ahead of her presentation, she details that there is growing evidence in support of polytetrafluoroethylene (PTFE)-covered stents for the treatment of infrarenal occlusive disease of the abdominal aorta as an alternative to surgical reconstruction.
“Despite the type of stent we want to implant, suboptimal vessel expansion still represents a limit in the treatment of isolated aortic lesions, where neither high-pressure balloon angioplasty nor atherectomy can significantly impact on wall calcifications,” says Antonella Ruffino.
These data will help support discussion on the optimum management algorithm for CLTI patients with calcified tibial artery disease”
Elsewhere in the day one peripheral itinerary, Hany Zayed (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) will present during a session dedicated to vessel preparation techniques, comparing plain balloon angioplasty, IVL and atherectomy prior
Today, with the advent of ‘nonstent’ technology such as IVL that can be applied to large vessels and facilitate vessel expansion, Antonella Ruffino underlines the importance of confirming its safety and efficacy in aortic lesions. She hopes their research will highlight IVL technology as an “additional weapon” to treat very calcified isolated aortic lesions, and demonstrate that the combination of IVL and stenting could “help to overcome the risk of incomplete stent expansion with consequent restenosis”.
The CX 2025 peripheral programme will also showcase several challenging debates on technologies and techniques including vessel preparation devices versus high-quality plain balloon angioplasty, and whether endovascular techniques should only be offered to patients with common femoral artery disease who cannot undergo endarterectomy. Additionally, attendees will see the launch of the CX Hurting Leg campaign—an initiative to reduce amputations through increasing awareness in deprived communities and to promote systemic healthcare reform.
Andrew Holden
Liquid embolics set to redefine tumour therapy but more data needed, GEST panellists conclude
The Global Embolization Symposium Technologies (GEST) group recently hosted a summit which saw a panel of experts convene to discuss the developing landscape of liquid and conformable embolic agents. Addressing key issues such as product selection, cost-effectiveness and technique, their discussion underscored the “advantageous” positioning of liquid embolics in the interventionalist’s toolbox.
A focal point of the panel’s discussion was the comparison of liquid embolics available today, particularly Histoacryl (BBraun) versus Glubran 2 (GEM) versus MagicGlue (Balt). Panellist Romaric Loffroy (François-Mitterrand University Hospital, Dijon, France) noted that while these agents share similar characteristics, differences in speed of polymerisation and viscosity can impact their outcome. Loffroy added that Glubran 2 has been used for longer in Europe, whereas MagicGlue is newer with fewer published studies on its use; however, in practical terms, differences between the agents are “minimal”.
needed to do the job you need to do,” said panellist Guy Johnson (UW Medical Center, Seattle, USA). Discussion then turned to hydrogel embolics, which Gary Siskin (Albany Medical Center, New York, USA) stated have the potential to redefine treatment paradigms by enabling deeper penetration and enhanced therapeutic effectiveness. “We are entering an era where embolization will be tailored across three levels—proximal, distal, and deep. I believe the future of tumour therapy will be drug deliverable liquid or hydrogel, but someone must have the courage to get data approved,” agreed Jafar Golzarian (North Star Vascular & Interventional, Golden Valley, USA), adding that liquid and hydrogel embolics could be expanded beyond the liver and kidneys with trial data to validate their use. The question remained, however, if hydrogel technology will replace traditional embolization techniques for certain indications. Panellist Suvranu Ganguli (Boston Medical Center, Boston, USA) contended that “time will tell”, and that real-world data will be necessary before widespread adoption.
other panellists advocated for mastering a single embolic agent, such as glue, which can be adapted for various applications.
The panel’s discussion moved onto the importance of technique, particularly in managing catheter retrieval when using glue. Loffroy stated that proper training can mitigate the perceived risks, stating that “in arteries, retrieval is straightforward if you control reflux. In veins, patience is key”, adding that practitioners should wait before removing the guiding catheter to avoid unintentional embolization.
As the field advances, panellists restated the importance of education in “demystifying” embolic agents, ensuring that interventionalists are comfortable with new technologies before implementation. “Do what you’re good at—do what you’re comfortable with, and don’t do what somebody else is an expert at. If you’re going to expand into new territory, [liquid embolics] is a great place to start, but start cautiously and deliberately,” Johnson advised, reinforcing the need for a measured approach in adopting novel embolic therapies.
With new materials emerging and a growing emphasis on cost-consciousness, the panel finalises their talk, stating that embolization strategies will continue to evolve, shaped by both clinical evidence and practical considerations.
Beyond embolic selection, panellists acknowledged that cost remains a concern, particularly in institutions with limited resources. While academic institutions may have more flexibility, the rising expense of embolic materials, such as detachable coils, is a continuing challenge. “Everything is expensive. You have to balance the shifting landscape of cost against efficacy, and consider how much product is actually
Then, considering how many embolic agents should be among an interventional radiologists’ arsenal, panellists highlighted that institutional access to resources and concern over cost-effectivness may govern embolic selection. Agreeing with Golzarian’s earlier comment, Siskin stated that interventionalists will “evolve to need one proximal, one distal, and one deep embolic agent,” for their practice. However,
Study shows long-term viability of PAE in treating benign prostatic hyperplasia
A single-centre report of mid- to long-term outcomes following prostate artery embolization (PAE) in a large cohort has found that the treatment shows significant and sustained relief from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
IN A PAPER PUBLISHED IN THE Journal of Interventional Radiology (JVIR), principal investigator Shivank Bhatia (Miller School of Medicine, Miami, USA) et al write that PAE has recently been recognised as a viable treatment for BPH, and has been included within the American Urological Association (AUA) treatment guidelines. Yet, despite its increasing recognition there is a scarcity of long-term research to support its efficacy.
Their study included 1,075 patients with moderate-to-severe LUTS or urinary retention who underwent PAE in the period between January
2014 and July 2023. Patients were assessed at one, three, six and 12 months post-PAE and then yearly thereafter. Bhatia and colleagues used several modes to assess patient progress, including: the International Prostate Symptom Score (IPSS), quality of life (QoL) score, International Index of Erectile Function Score (IIEF-5), prostatespecific antigen (PSA), prostate volume (PV), post-void residual (PVR), benign prostatic obstruction (BPO) medication usage, urinary
Do what you’re good at—do what you’re comfortable with, and don’t do what somebody else is an expert at. If you’re going to expand into new territory, [liquid embolics] is a great place to start” Guy Johnson
catheter status, and further prostate interventions. In addition, adverse events were recorded using the Society of Interventional Radiology adverse event (SIR-AE) severity classification.
Mean follow-up was 458.4 days, and the average patient age was 70.4 years. Median prostate volume was reported as 107g, and median preprocedure IPSS, QoL, IIEF-5 and PSA were 23 (18–28), 5 (4–6), 17 (10–21), and 4.7 (2.6–8), respectively. In the LUTS subgroup, at 1–3, 6–12 and 48–60 months, the median IPSS was 7 (4–12, p<0.001), 6 (3–11, p<0.001), and 9 (4–15, p<0.001).
medication free at one year following initial PAE. In this cohort, 7% of patients with an SIR-AE severity score of severe, which included three patients with transient ischaemic attacks, two with urosepsis (treated via inpatient setting with intravenousantibiotics), and finally, two patients with prostate sloughing. All adverse events resolved without sequelae, state Bhatia et al
65.5%
of patients were benign prostatic obstruction medication free at one year following initial PAE
QoL scores were 2 (1–2, p<0.001), 1 (0–2, p<0.001), 2 (0–3, p<0.001) at the same timepoints. Of patients in the urinary retention cohort, 119 (94%) out of 126 patients were catheter-free at the three-month follow-up.
Up to 60 months post-PAE, 90 patients required reintervention. Overall, 65.5% of patients were BPO-
In their large cohort with long-term longitudinal follow-up, the authors report the significant improvement in LUTS symptoms, highlighting that 94% of catheterdependant patients at baseline becoming catheter-free at three months. They state that PAE is validated as safe and effective for the treatment of BPH, and, given its “efficacy and favourable safety profile”, should be considered equal to traditional surgical treatments. Bhatia and colleagues add that PAE should be more broadly integrated within clinical practice as a standard option for BPH.
Shivank Bhatia
Resorbability, repeatability
and reworking: A case for resorbable microspheres in MSK embolization
Resorbable microspheres are making waves in musculoskeletal (MSK) embolization, challenging the use of permanent embolics. As clinical evidence supporting their safety and efficacy accelerates, these agents could reshape treatment strategies— offering effective pain relief while reducing long-term risks. In an interview with Interventional News, Ziv Haskal (University of Virginia, Charlottesville, USA) gives pragmatic shape to the emerging future of resorbable microspheres in MSK embolization.
IN: Why are resorbable microspheres in the spotlight, particularly for MSK embolization?
We’ve danced around resorbable embolics for decades, mostly for hepatocellular carcinoma and fibroid embolization—and trauma of course. Thus far, there have been no proven therapeutic advantages for resorbables over permanent embolics for tumours, be they benign or malignant. But that does not mean that this paradigm cannot shift. Consider Kichang Han (Yonsei University College of Medicine, Seoul, South Korea) et al’s September 2024 publication titled ‘Resorbable microspheres versus trisacryl gelatin microspheres for uterine artery embolization’ which showed equivalent outcomes. Wouldn’t any woman considering uterine artery embolization (UAE) now lean toward a resorbable agent?
Until this decade, we’ve had a dearth of calibrated resorbable microspheres with task-specific dissolution characteristics, because of both technical innovation and clear opportunity. MSK embolization has remade that landscape. I remind readers how controversial Yuji Okuno’s (Okuno Clinic, Tokyo, Japan) groundbreaking early papers were. As the two-term Journal of Interventional Radiology (JVIR) editor, I discussed his 2013 seven patient imipenem/ cilastatin genicular artery embolization (GAE) paper with nine reviewers and editors, and all insisted the paper was preposterous and should be rejected: an antibiotic injected intra-arterially? Used as an embolic? For treating arthritis? I published it anyway because it was a well done range-finding study—and the scientific literature is a place for controversy and discussion. It’s already been cited 100 times.
Fast forward to now and the literature has been steadily accumulating, mostly in clear support of MSK embolization
of safety surrounding efficacy are much narrower with permanent embolics. When this procedure spreads in ‘the wild’, e.g., is performed widely, then adverse events will definitely increase with permanent embolics only. Okuno has even identified safety differences between three different temporary agents that he’s used.
Thus, we have to maximise safety— excessive embolization will cause skin and nerve injury, pain, and worse. The blowback could stop this in its tracks—pounced upon, “Aha!” by sceptical other specialties and reluctant insurers. Medicine is tribal, and competing therapies are always under unique scrutiny. Even though I’m a sceptical clinical trialist by nature, I’m a believer in this, so we have to proceed methodically and protect our patients and outcomes, because we have millions of patients suffering with painful presurgical OA, joint and tendon pains and injuries—areas where we might provide a meaningful alternative to failing oral or injection therapies.
deny it in nearly every case. When you are innovating in your own specialty space, the parameters are different than when you’re under the suspicious watch of others. So, this means primum non nocere—first, do no harm—and proventus scientificus immaculatus esse debet—the scientific results must be immaculate. Hence fast-dissolving resorbables.
IN: Regarding ‘first, do no harm’—does resorbability need to prove repeatability?
of the neovessels that develop in inflammatory conditions, be they osteoarthritis (OA), epicondylitis, frozen shoulder or other enthesopathies and tendinopathies—all intended to provide meaningful control of pain. My own partly torn rotator cuff was overlaid by painful adhesive capsulitis that cost me eight months of rehab and recovery; I might have had a different outcome had I lived in Japan and seen Okuno. Imipenem/cilastatin is essentially a rapidly dissolving crystal—a short-term mechanical embolic. Amazingly, the clinical effects of MSK embolization are lasting six months to a year—using these rapidly disappearing agents, suggesting that the treated neovessels might remain embolized, beyond the recanalisation of normal vessels, but it’s still an area for deep inquiry. Over-embolization can lead to skin and muscle changes and injury, wounds, and prolonged pain. Beyond proof of concept, imipenem is a therapeutic dead end. There will never be an on-label indication, pursued by a pharmaceutical company, for an antibiotic to be approved as an intraarterial embolic agent. Forget about it. So, we are in the post-imipenem panorama, where a number of resorbable agents are planned for MSK embolization evaluations. There are a lot of skunkworks on this.
Ziv Haskal
IN: A change in technological approach often requires refinement in technique. Is this likely true of embolics in MSK interventions?
Safety, safety, safety—repeat the mantra like a scratched vinyl record. In areas of competitive interventions across multiple specialties, it’s paramount. Endless interventional radiology (IR) examples exist. Consider prostatic artery embolization (PAE)—a procedure designed by interventional radiologists, sought by men, performed in a space owned by urologists. I have been performing PAE continuously for more than 10 years, starting out under our investigatorsponsored investigational device exemption (IDE). Even now, I hear some urologists still describing the procedure as dangerous and investigatory and some US insurers
Prospective trials are being conducted and are imminent worldwide. There are commercial US trials evaluating permanent embolics for GAE. There are pending commercial trials for resorbable agents—some in ‘quiet mode’—or seeking federal funding. The Nexsphere-F RESORB multicentre IDE trial has been approved by the US Food and Drug Administration (FDA) and will be enrolling patients shortly. The embolic is a rapidly dissolving gelfoam microsphere that mechanically dissociates at a rate mimicking imipenem/cilastatin by design. It has been included in trials in South Korea and several multicentre trials set to launch in Europe, as well as a UK National Health Service (NHS) trial. It’s also being used in shoulders and elbows. I expect similar trials with other resorbables and liquids. This multi-front approach is critical—to fully evaluate and protect this field we need a variety and multitude of replicative trials and populations.
IN: Are you in favour of a ‘leave nothing behind’ approach for embolics?
The European Union has at least one widely available rapidly resorbable CE-marked microsphere (Nexsphere F)—I expect others to arrive shortly. US physicians are lagging; we are still limited to permanent embolics. Therapeutic improvement with MSK embolization is certainly achieved with permanent embolics. But the margins
Even though I’m a sceptical clinical trialist by nature, I’m a believer in this, so we have to proceed methodically and protect our patients and outcomes, because we have millions of patients suffering with painful presurgical OA”
IN: There are several resorbable embolics being examined in trial settings so far. What do you think needs to happen to differentiate between their safety and effectiveness? I hope we’ll see strong positive results from multiple resorbable agents. It’s a moving target, as we are also working out the techniques of MSK embolization. How much to embolize, how many vessels, and what are the patient and angiographic-specific embolization endpoints that result in valuable symptom improvement, while avoiding injury. To provide meaningful pain relief in the knee, we might have to treat more vessels than originally thought. There is plenty of opinion, discourse, and argument. What qualifies as an angiographic ‘blush’ warranting treatment? How much do you embolize those vessels—as embolization short of injury is paramount and agent-specific endpoints will vary, as will angiographic embolization endpoints? It’s a recipe for a dog’s breakfast.
IN: Where is standardisation of technique in this landscape? Is GAE a standardised technique? We published a Society of Interventional Radiology (SIR) Research Reporting Standard for GAE and specifically dodged that question; it’s simply too early to answer. We’ll gradually build that answer upon the empirical results of as many resorbable trials as we can get.
Which embolic to use during portal vein embolization
José Hugo Luz
Point of View
Portal vein embolization (PVE) is a crucial preoperative procedure designed to induce hypertrophy of the future liver remnant (FLR) in patients requiring major hepatectomy. Among the embolic agents available, n-butyl cyanoacrylate (nBCA) combined with lipiodol has emerged as one of the most effective options for PVE, shares José Hugo Luz (Brazilian National Cancer Institute, Rio de Janeiro, Brazil), promoting a high yield of liver hypertrophy and requires only a minimal volume of contrast media.
ONE OF THE MOST compelling reasons to advocate for nBCA plus lipiodol in PVE is its high embolic efficiency. Unlike particulate embolics, such as polyvinyl alcohol (PVA) or gel foam, which can migrate or recanalise over time, nBCA polymerises upon contact with blood, forming a durable cast within the embolized portal branches, ensuring complete occlusion and effectively preventing collateral formation and enhancing FLR hypertrophy.
Studies have demonstrated that nBCA plus lipiodol induces faster and more significant hypertrophy of the FLR compared to other embolic materials. This is because it creates permanent vascular occlusion, the liver responds with an accelerated regenerative process, reducing time to surgery. De Baere et al and Tsoumakidou et al published animal studies which compared different embolic materials for PVE.1,2 They were able to show that nBCA plus lipiodol promoted a
greater increase in the size of hepatic lobules and number of hepatocytes per lobule when compared with other embolic materials. Also, an increased hepatocyte and Kupffer cell proliferation in the nBCA-lipiodol group was identified. Tsoumakidou et al evaluated FLR growth with computed tomography (CT) imaging 14 and 28 days after PVE, and demonstrated significantly higher liver hypertrophy at both endpoints. Two systematic meta-analyses were published in 2020 and 2021, together gathering more than 6,000 patients.3,4 In both publications PVE with nBCA plus lipiodol promoted higher liver hypertrophy, shorter procedure times, less radiation, less use of contrast and for the first time, less cost. The BEST FLR trial was a pivotal study evaluating optimal strategies to maximise FLR in patients undergoing major liver resection.5 In this trial, PVE with nBCA plus lipiodol generated greater and faster liver regeneration as seen at CT, compared with PVA particles plus coils, allowing for earlier surgical intervention for liver cancer. In this study of 60 participants with liver cancer, PVE with nBCA plus iodised oil produced greater absolute liver hypertrophy at CT compared with PVA particles plus coils (absolute hypertrophy of 46% vs. 30% at 14 days and 57% vs. 37% at 28 days, respectively). More participants in the
Research finds GAE provides significant relief from osteoarthritis-related knee pain
A minimally invasive procedure provides significant relief from knee pain and may prevent the need for knee replacement surgery in people with osteoarthritis, a recent study has found.
“THIS STUDY ADDRESSES
osteoarthritis, which is a significant public health issue and the leading cause of chronic pain and disability worldwide,” said the study’s lead author and interventional radiologist, Florian Nima Fleckenstein (Charité University Hospital Berlin, Berlin, Germany). “With millions of people affected by knee osteoarthritis, particularly in ageing populations, finding effective, minimally invasive treatments is critical.”
Osteoarthritis, a chronic, degenerative and progressive condition, is the most common cause of chronic joint disorders. According to the World Health Organization (WHO), knee osteoarthritis affects over 365 million adults worldwide.
Most available therapies, such as pain medication and steroid injections, only mask the symptoms of osteoarthritis. They don’t slow progression of the disease. As osteoarthritis worsens and conservative treatments become ineffective, many people turn to joint replacement surgery.
Genicular artery embolization (GAE) is a minimally invasive therapy for patients with symptomatic knee osteoarthritis. The genicular arteries have several branches that form a network
around the knee joint. These vessels are altered in patients suffering from osteoarthritis. In GAE, an interventional radiologist injects small particles into selected branches that correspond to the site of knee pain to block blood flow to that area. Embolization of the abnormal blood vessels helps to disrupt the cycle of inflammation, cartilage destruction and sensory nerve growth that characterises osteoarthritis.
For the study, Fleckenstein and colleagues conducted a retrospective analysis of 403 cases from patients (aged 40 to 90) with moderate to severe knee osteoarthritis that didn’t respond to conservative treatments. All patients underwent GAE at the Charité University Hospital Berlin. The study was designed to evaluate both the safety and efficacy of GAE across a broad spectrum of osteoarthritis severities. The effectiveness of the procedure was measured using the Visual Analogue Scale and the Knee Injury and Osteoarthritis Outcome Score. These standardised scores, which measure pain and quality of life (QoL), were recorded at baseline and during follow-up visits at six weeks, three months, six months and one-year post procedure.
Technical success was achieved in 100% of procedures. Temporary slight skin discoloration and
nBCA plus iodised oil group presented sufficient liver hypertrophy for surgery two weeks after PVE compared with the PVA particles plus coils group (87% vs. 53%, respectively). nBCA plus lipiodol is the gold standard for PVE, offering superior embolization efficiency, superior hypertrophy induction, faster procedure time, less radiation exposure and lower cost.
References
1. De Baere T, Denys A, Paradis V, et al. Comparison of four embolic materials for portal vein embolization: experimental study in pigs. Eur Radiol. Jun 2009;19(6):1435-42. doi:10.1007/s00330-008-1277-2
2. Tsoumakidou G, Theocharis S, Ptohis N, et al. Liver hypertrophy after percutaneous portal vein embolization: comparison of N-butyl-2-cyanocrylate versus sodium acrylatevinyl alcohol copolymer particles in a swine model. Cardiovasc Intervent Radiol. Oct 2011;34(5):1042-9. doi:10.1007/s00270010-0046-1
3. Ali A, Ahle M, Björnsson B, et al. Portal vein embolization with N-butyl cyanoacrylate glue is superior to other materials: a systematic review and meta-analysis. Eur Radiol. doi:10.1007/s00330-02007685-w
4. Soykan EA AB, Lopez-Yurda M, Kuhlmann KFD, et al Predictive Factors for Hypertrophy of the Future Liver Remnant After Portal Vein Embolization: A Systematic Review Cardiovasc Intervent Radiol: Springer; 2021.
5. Luz JHM, Veloso Gomes F, Costa NV, et al. BestFLR Trial: Liver Regeneration at CT before Major Hepatectomies for Liver Cancer-A Randomized Controlled Trial Comparing Portal Vein Embolization with N-Butyl-Cyanoacrylate Plus Iodized Oil versus Polyvinyl Alcohol Particles Plus Coils. Radiology. Apr 2021:204055. doi:10.1148/radiol.2021204055.
José Hugo Luz is an interventional radiologist at the Brazilian National Cancer Institute in Rio de Janeiro, Brazil.
Disclosures: The author decalred no relevant disclosures.
mild knee pain immediately after the procedure were noted in 18% of all cases. No severe complications were reported. The QoL index and pain score improved by 87% and 71%, respectively, at one-year follow-up.
The findings show that GAE is a safe and effective treatment option across all severity grades of knee osteoarthritis, including advanced cases where other treatments have very limited efficacy.
“Our study found that GAE can effectively reduce knee pain and improve quality of life early after the treatment, with these benefits being maintained over the long term, especially for people who haven’t had success with other treatments like physical therapy or pain medications,” Fleckenstein said. “This could potentially offer a new lease on life for many patients who suffer from debilitating pain and mobility issues caused by osteoarthritis.”
The study also showed that GAE is particularly effective in the early stages of knee osteoarthritis. This indicates that early intervention could potentially delay or even prevent disease progression, reducing the need for more invasive treatments, such as surgery.
“GAE has the potential to reduce the need for more invasive surgeries, lower healthcare costs and significantly improve the quality of life for countless individuals suffering from knee osteoarthritis,” Fleckenstein said.
This could offer a new lease on life for many patients who suffer from debilitating pain”
MRI-guided ablation for
the
treatment of prostate cancer, successes and pitfalls
David Woodrum
Point of View
With a focus on magnetic resonance imaging (MRI)-guided procedures and cancer signaling pathways which promote cancer resistance to ablation, David Woodrum (Mayo Clinic, Rochester, USA) discusses how advancements in MRI have solidified its place in the diagnosis and treatment of prostate cancer.
FOCAL PROSTATE ABLATION continues to challenge the standard paradigm for prostate cancer treatment. Prostate cancer was the most common cancer in men in 2024, with 299,010 new cases and 35,250 deaths in the USA alone.1 Standard treatments include surgery or radiation therapy, but no matter how expertly done, these therapies carry significant morbidity and risk to the patient’s
Women experience more severe pain following thermal liver ablation, study reports
A retrospective, singlecentre study has found that women experienced higher maximum pain scores, more frequently reported moderate to severe pain, and more often required analgesics for pain management when compared to men following percutaneous thermal liver ablation.
“THE REASONS WHY WOMEN and men experience different levels of pain are still an ongoing research topic” write the study’s authors— led by Robrecht Knapen (Maastricht University Medical Center, Maastricht, The Netherlands). “Sex hormones, genotype, and endogenous opioid function may all play a potential role in these differences in pain experiences,” however these variables have not been sufficiently borne out in clinical
quality of life, with an impact on sexual, urinary, and bowel function.2 Furthermore, screening programmes using prostatic-specific antigen (PSA) level and transrectal ultrasound-guided systematic biopsy have identified increasing numbers of low risk, low grade “localised” prostate cancer. With this, prostate focal therapies with ultrasound and MRI guidance have become available, fuelling the
research to date, Knapen et al note. Their retrospective, single-centre cohort study was carried out at Maastricht University Medical Center using electronic health records via an online database. Included were 183 patients treated with percutaneous thermal liver ablation for primary or secondary liver tumours between January 2018 and May 2022.
Regardless of anaesthesia technique, all patients received lidocaine or bupivacaine as supplementary locoregional anaesthesia before the ablation procedure, Knapen et al state.
Of the 183 patients included, 67% were men. At recovery, women exhibited a higher average maximal pain intensity (3.88 vs. 2.73) and a higher prevalence of post-ablation pain (numeric ranking scale [NRS] score 4–10) compared to men. Women suffered more from acute post-procedural pain (59% vs. 35%; odds ratio [OR]: 2.50, 95% confidence interval [CI]: 1.16–5.39), and needed analgesics more often at recovery (OR: 2.43, 95% CI: 1.07–5.48) compared to men.
Knapen and colleagues state that, until patient and procedural factors which influence pain have been “thoroughly investigated, anaesthesia care providers need to consider post-procedural pain differences in women undergoing thermal liver ablation” and potentially higher doses of analgesics.
debate on the suitability of focal or regional therapy for patients with low or intermediate risk prostate cancer. Some of the largest unresolved issues include prostate cancer multifocality, suboptimal staging with accepted imaging modalities, limitations of current biopsy strategies, and, most important, whether focal therapies can be safely and effectively used for prostate cancer.3
Advancements in MRI have made it the platform of choice for identifying prostate cancer, whether focal or multifocal, and in disease staging.4 Targeted biopsy of suspected cancer lesions detected with MRI is associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer, particularly with the aid of MRI/ultrasound fusion and direct in-bore biopsy platforms.5
Focal prostate ablation is often considered for patients with low to intermediate risk prostate cancer who may not require radical whole gland treatments like surgery or radiation therapy. Many focal ablation methods can be guided and monitored with ultrasound or MRI. Ultrasound is the most common imaging modality for guiding and monitoring focal ablation, but it cannot reliably depict the prostate cancer target and has limited
capability to real-time monitor during the ablation. Although MRI requires more specialised hardware and training, it provides the most robust targeting and monitoring imaging guidance platform. Use of real-time MRI enables temperature mapping, allows for realtime visualisation of tissue heating, as well as real-time precise imaging of the ice ball as it forms in the case of cryoablation. It is important to note that long-term outcomes of MRI-guided focal prostate cancer ablation compared to traditional treatments are still areas of ongoing research and evaluation.
References:
1. Siegel RL, Miller KD, Wagle NS, et al. Cancer statistics, 2023. CA: a cancer journal for clinicians. 2023;73(1):17-48.
2. Potosky AL, Davis WW, Hoffman RM, et al. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004;96(18):1358-67.
3. Onik G, Vaughan D, Lotenfoe R, et al. “Male lumpectomy”: focal therapy for prostate cancer using cryoablation. Urology. 2007;70(6 Suppl):16-21.
4. Spektor M, Mathur M, Weinreb JC, et al. Standards for MRI reporting-the evolution to PI-RADS v 2.0. Transl Androl Urol. 2017;6(3):355-67.
5. Siddiqui MM, Rais-Bahrami S, Turkbey B, et al. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015;313(4):390-7.
David Woodrum is a professor of interventional radiology at the Mayo Clinic in Rochester, USA.
Disclosures: The author decalred no relevant disclosures.
IceCure Medical interim cryoablation trial results show low recurrence rate for small renal masses
Late last year, IceCure Medical has announced the interim results of the company’s Icesecret study of cryoablation for patients with small renal masses who cannot be offered kidney preserving surgery, revealing “high” procedural success and efficacy.
RESULTS WERE REPORTED AT A MEAN FOLLOW-UP PERIOD OF 36 months for 111 patients with 117 lesions. Presenting these data Keren Boguslavsky (Bnai Zion Medical Center, Haifa, Israel) reported that, in 91 patients (approximately 82%), no tumour recurrence was observed. Following an additional cryoablation procedure for the same tumour in 13 patients, the success rate for the overall population was 83.8%, with a mean follow-up time of 39.6 months. In patients without a history of kidney cancer with one tumour <3cm, the success rate was 88.7%.
Freezing of the renal tumour—with a safety margin of 0.5cm—was achieved in 95.6% of the procedures demonstrating high efficacy in cases without anatomic limitation for ice ball creation. Four procedure-related serious adverse events were reported, three of which were mild and treated conservatively. One severe complication was observed seven months after the cryoablation procedure. Renal function was preserved on an average basis across the patient cohort, with no significant change in creatinine and haemoglobin levels compared to baseline, the authors have stated. The procedure time, relative to the standard of care as supported by and documented in medical literature, was approximately 25 minutes.
“The ability to offer cryoablation for kidney cancer is a large unmet need, particularly in patients who are ineligible for kidney preserving surgery. We are very pleased that Icesecret’s interim results present ProSense as a safe and effective option for these patients,” stated IceCure’s chief executive officer, Eyal Shamir.
In a press release the company has stated that, according to the American Journal of Roentgenology, small renal masses, which may be malignant or benign tumours in the kidney, have been increasing in incidence over the past two decades. The American Cancer Society stated that, in 2024 in the USA, an estimated 81,610 new cases of kidney cancer will have been diagnosed, with approximately 14,390 patients dying from the disease. Globally, there were more than 434,000 new cases of kidney cancer in 2022 and approximatley 156,000 deaths, according to the World Cancer Research Fund International.
Robrecht Knapen
SARAH B WHITE
Sarah B White (Milwaukee, USA) dons many titles, namley she is a tenured professor of vascular and interventional radiology, a professor of surgery and surgical oncology, as well as associate dean at the Medical College of Wisconsin (MCW). Among her designations, White has been recognised as a ‘triple threat’, excelling as a researcher, clinician and professor, breaching brand new territory, not only for women in the field of interventional radiology (IR), but for all, taking on previously unexplored topics. Through research, White’s focus has been interventional oncology (IO), specifically developing new drug platforms and delivery methods to overcome treatment resistance, and to better understand the role of the tumour microenvironment including hypoxia. Here, White speaks to Interventional News about her love for IR and how she built her career in the field.
What attracted you to a career in medicine, and what made you choose IR?
I was born at Oregon Health & Science University (OHSU) in Portland, USA, when Charles Dotter was walking the halls. I am convinced that when I was born, Dotter sprinkled fairy dust on my mother and that’s what drove my ever-present and undying loyalty and devotion to IR. In reality, we had a close family friend, Robert Seigel, who practiced neurointerventional radiology (NIR). I remember being at his house playing with his kids when he came home from work. He told me about a tough case he had, where he performed the balloon procedure on a sick woman. It was at that moment, that I knew there was no other career for me. All these years later, Bob actually called me to refer a patient, who flew across the country to seek care with me here at MCW.
Who have been your mentors throughout your career?
I have had the absolute privilege of having truly amazing mentors throughout my career. After graduating from college with a degree in German, I was lucky enough to attend a post baccalaureate programme and the University of Pennsylvania (PENN) where I completed my prerequisites for medical school. During this time, despite having virtually no experience in research, Frank Lee hired me after I responded to an ad in the newspaper. He was a new principal investigator and needed lab staff. Only two short years later, we published, with me as first author, a truly novel finding in science. Hypoxia-inducible factor 1 (HIF)-1 was modified by a proline hydroxylation. I went off to medical school and had the good fortune of working with Brad Wood, who saw the fire in my belly. He has written letters of recommendation for me for residency, FSIR, and all my promotions. His charisma and undying love of IR was contagious.
During residency, I had the privilege of working with a phenomenal team and was mentored by Rich Schlansky-Goldberg, Scott Trerotola, Bill Stavaropolous, Max Itkin, Jeff Solomon and Aalpen Patel. This team of amazing mentors challenged me every day and made sure that I would be not only a good interventional radiologist, but a good partner, teacher and researcher. I am still in touch with each and every one from PENN IR and continue to learn from them. I do not
include Michael Soulen in the list with the other PENN faculty, because Michael has been more than a mentor. He has been a mentor, a coach, a sponsor, and now, a true friend. His frank feedback and ongoing expectation of excellence helped me grow and led me into a career that I truly love. His best advice was that if you have the fire in your belly, you will be successful.
Now, I have the good fortune or working alongside a brilliant group of interventional radiologists that continue to mentor me today. Bill Rilling stood beside and mentored me as I fumbled through cases early in my career and has helped guide me though all of my leadership roles. Bill has an unending cadre of wisdom. I was on call and called him for advice and he said: “You know what to do, go get ‘em tiger”. Robert A Hieb has been my biggest cheerleader and always answers my calls at 2am when I’m stuck doing a challenging vascular case. Parag Patel has been a quiet voice in the background keeping me sane and helping me through the challenges of academic medicine. Sean Tutton taught me how to have a voice among the many loud voices in academic medicine. Eric Hohenwalter has been the voice of reason and clarity and always showed me kindness and compassion.
Nationally, I have had the good fortune of having a tremendous network of mentors including Alda Tam, Nishita Kothary, Reed Omary, Andrew Larsen, Matt Callstrom to name a few.
Could you describe a case that has been the most memorable thus far?
I have had innumerable memorable cases throughout my career. I will however relay a story of one of the kindest patients I had the honour of treating. She initially presented to me for consideration for a transjugular intrahepatic portosystemic shunt (TIPS), because she had refractory ascites. I reviewed the imaging which revealed that she had a recurrence of her pancreatic cancer, which she believed to be in remission. She walked in thinking that we were having a conversation of fluid management and walked out with the devastating news that her cancer was back. I had never met this patient before that visit and had no relationship with her. I however delicately and carefully explained the situation to her. We ended up agreeing to placing a Denver shunt to manage the ascites.
FACT FILE
CURRENT APPOINTMENTS
2021–present: Professor of radiology and surgery, Medical College of Wisconsin, Milwaukee, USA
2023-present: Senior medical director of programmatic excellence, Froedtert Hospital, Milwaukee, USA
2023-present: Associate dean/ assistant provost, Medical College of Wisconsin, Milwaukee, USA
2023–present: Tenured professor of radiology, Medical College of Wisconsin, Milwaukee, USA
2021-present: Board of directors, Society of Interventional Oncology (SIO)
PREVIOUS APPOINTMENTS (SELECTED)
2018–2024: Vice chair of radiology research, Medical College of Wisconsin, Milwaukee, USA
2020: Programme chair, Society of Interventional Oncology (SIO)
2020–2022: Medical director vascular access team, Froedtert Health
A week later, while doing the procedure, she kept telling me that I was doing a good job. It turned out that she was a seamstress and was making her daughter’s wedding dress for a wedding that was just a few short months away.
She re-presented a week before the wedding and I was called by the intensive care unit (ICU) as she had been admitted with septic shock, and the ICU team were advising that the patient and her family transition to a hospice. She and her family however were unwilling to make any decisions without first talking to me. I immediately went up to the ICU. They believed that the source of her infection was the Denver shunt, and because her daughter’s wedding was just a week away, I convinced the ICU team to aggressively treat her, as we just needed to get to the wedding. I went bedside and removed the shunt, again, all the while her cheering me on and repeatedly telling me what a good job I was doing. The procedure was successful, and she was discharged with enough time to finish the wedding dress and attend the wedding, although in a wheelchair.
After the festivities, she went home to find a kitten eagerly awaiting her, something she had always wanted. She died a few days later, surrounded by family and while petting her kitten. Though we can’t always cure patients, we can advocate for them to achieve their goals, and help them die peacefully and with grace. This dear patient also showed me that complications don’t define you, but how you handle them does.
You were the first in the USA to be accepted and graduate from the direct pathway at the University of Pennsylvania Hospital. How did this come about and what was your experience?
As a medical student, I went to the Society of Interventional Radiology (SIR) conference. They held a medical student breakfast, which was attended by Al Nemcek and Bob White. There were eight medical students at the breakfast. Nemcek told me about this new training pathway that was going through the approval process and would not be ready for me. As soon as I heard about it, I went to the SIR website and emailed all of the programme directors at the schools listed as being part of the direct pathway. Michael Soulen, at the hospital of the University of Pennsylvania, was
the only person to respond. He sent me some detailed information, but told me that he didn’t want to discuss anything further and to contact him “if” I got an interview at PENN. Within minutes of being offered an interview a few years later, I contacted Michael again. Back then, all the interviewees came to PENN during the same weekend. At the dinner on Friday night, Michael found me, and I sat and had dinner with all of the PENN IR faculty. When it came time for the match, Michael called me and told me that I had been selected to join them as the first direct pathway resident in the country. The caveat was that the programme had not been officially approved yet. I jumped at the chance, matriculated that July and luckily, the programme was officially approved.
In 2024 you published a paper outlining why IR and diagnostic radiology (DR) should stay in alignment. If they were to be separated, how do you believe IR would be affected?
As the US healthcare system moves more
towards a work relative value unit (wRVU)based reimbursement structure, IR separating from DR will make us vulnerable by falling short of financial metrics. DR also has a larger footprint and therefore is more often invited to sit at the table with hospital executives and policymakers to pursue the ongoing needs of IR. Globally, IR sees patients have limited access to our specialty, and a break may further prevent access to care. Finally, the core of our specialty is our expertise in marrying imaging with procedures. If we lost the robust education we have in imaging, I believe our specialty would suffer greatly.
What have been some of the most important developments in IR and IO over the course of your career so far?
IR has undergone tremendous change during my career. We have moved from a subspecialty designation, to designation as a primary specialty. Medical students can now match directly into IR residency programmes. We have evolved in the research realm from being perceived as proceduralists, to being perceived
"We have evolved in the research realm from being perceived as proceduralists, to being perceived as true scientists”
as true scientists, by running such pivotal trials as ATTRACT, CTRACT, PE-TRACT and RETNET. We have secured a seat at the table in oncology care by being on the National Comprehensive Cancer Network (NCCN) panels and founding a society solely dedicated to oncology procedures, with the Society of Interventional Oncology (SIO).
What does your life outside of medicine look like?
I am the mother of three amazingly kind, respectful, empathetic and intelligent children. My mornings are filled with making lunches and walking the kids to school. Evenings are filled with lots of laughter, violin practice, homework and reading bedtime stories. My kids constantly remind me to not sweat the small stuff and that joy and fun can be found everywhere. I love the outdoors, hiking, travelling and cooking.
Data and device tweaks herald ‘practicechanging’ future for bioresorbable scaffolds
Pending the results of several trials and “iterative changes” to device design, bioresorbable scaffolds are set to change the treatment paradigm for lower extremity peripheral arterial disease (PAD) within the next decade. So concluded Eric Secemsky (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA) during a presentation at the Leipzig Interventional Course (LINC 2025; 28–30 January, Leipzig, Germany).
SECEMSKY WAS SPEAKING ON the future of bioresorbable scaffolds, providing an overview of the key features of this “ideal” device type for the treatment of below-the-knee (BTK) disease. The first characteristic is drug elution, he noted, which inhibits restenosis and provides drug-modulated healing for sustained patency; second, a scaffold design provides transient support in the vessel and addresses recoil and dissection; and finally, resorbability ensures nothing is left behind.
“The era of bioresorbable scaffolds has really begun with the Esprit drugeluting resorbable scaffold (DRS),” Secemsky commented, noting that this Abbott innovation “is what created the market in the USA”. Esprit DRS is the first device of its kind to receive approval from the US Food and Drug
Administration (FDA), the presenter shared, highlighting positive data from the prospective, multicentre, randomised LIFE-BTK trial that now has results available out to two years.
Secemsky stressed, however, that the technology is still in its infancy. The Esprit BTK device is “only the first step on a long pathway to solving BTK interventions for both US and non-US patients,” he told the LINC audience.
Here the presenter listed a number of other devices with bioresorbable properties that are being evaluated in the USA, focusing in particular on the Motiv (Reva Medical) and Magnitude (R3 Vascular) scaffolds.
The Motiv device, Secemsky detailed, is CE mark approved, has been granted FDA breakthrough designation, and is currently being assessed in the recently completed MOTIV BTK
One-year RESOLV I data highlight promise of bioresorbable scaffold for BTK disease
One-year results from the first-in-human RESOLV I trial assessing the safety and efficacy of the Magnitude bioresorbable drug-eluting scaffold (R3 Vascular) in patients with severe peripheral arterial disease (PAD) demonstrate positive clinical outcomes and a low restenosis rate. Presented by Marianne Brodmann (Medical University of Graz, Graz, Austria) at the International Symposium of Endovascular Therapy (ISET; 2–5 February, Hollywood, USA), these findings suggest that bioresorbable scaffolds could offer “all the advantages” of metallic drug-eluting stents without a permanent implant.
BRODMANN NOTED THAT THERE ARE NO highly-powered randomised controlled trials to date which have shown success with alternative below-
Eric
Secemsky
randomised controlled trial. Led by Ehrin Armstrong (Adventist Heart and Vascular Institute, St Helena, USA) and Andrej Schmidt (University of Leipzig, Leipzig, Germany), the trial enrolled its target cohort of 292 patients across 35 centres in the USA and Europe and is awaiting completion of follow-up.
“We saw results of their early postmarket trial in the EU looking at 60 limbs, 58 patients, and [the device] demonstrated really impressive patency outcomes through three years,” Secemsky shared. Continuing, the presenter stressed the significance of this result: “It’s hard for a BTK device in vessels that are less than 3.5mm to maintain 88% patency through 36 months.”
Moving on to Magnitude, Secemsky disclosed that he is the co-principal investigator for the US pivotal trial of this device. “[Magnitude] is really as resistant to compression and supportive as a metallic stent, but has unique flexibility to optimally perform in challenging anatomical locations,” Secemsky noted, also pointing out
the-knee (BTK) treatments—such as atherectomy, drug-eluting stents, and angioplasty—an optimal approach would involve a drug-eluting scaffold capable of inhibiting neointimal hyperplasia and minimising recoil while ultimately “leaving nothing behind.” This concept formed the basis for the RESOLV I trial objectives.
As part of this prospective, single-arm, multicentre, first-in-human feasibility study, Brodmann and colleagues evaluated the safety and performance of the Magnitude scaffold for de novo or restenotic infrapopliteal lesions in patients with chronic limb-threatening ischaemia (CLTI). Conducted across seven sites, the trial enrolled 37 patients. The inclusion criteria specified a reference vessel diameter (RVD) of 2.75–3.88mm and a lesion length of ≤10cm. Patients underwent angiographic and duplex ultrasound assessments at six months, with clinical follow-up at one, three, six, and 12 months.
Providing insight into patient demographics, Brodmann highlighted that six participants were included in a chronic total occlusion (CTO) subgroup. Across the broader cohort, the majority had medically managed diabetes and hypertension. Most lesions were classified as mildly or focally calcified, and all patients underwent predilatation, with most also receiving post-dilatation.
At 12 months, no cases of clinically-driven target lesion revascularisation
Marianne Brodmann
the device’s ability to “maintain its structure in a compromised situation, including in the infrapopliteal space”.
The presenter continued, considering timelines: “As iterative changes allow for longer scaffold lengths, larger diameters and consistent tensile strength, the treatment paradigm for lower extremity disease may look much different in the next five to 10 years.
“I think we’ll continue to have these conversations over the years, see more data, and I think we’ll see many of these scaffolds make it to clinical practice.”
The era of the bioresorbable scaffold has really begun with the Esprit drug-eluting resorbable”
(CD-TLR) were reported. A reduction in Rutherford Becker class from 5 to 0 was observed in 76.7% of patients, while device patency rates stood at 90.3% and 96% at six-month angiography and duplex ultrasound follow-up, respectively.
Among the CTO subgroup, 50% of patients achieved a Rutherford Becker class reduction from 5 to 0 at 12 months, with a further 25% experiencing an improvement from class 5 to 3. Notably, 100% patency was observed at six-month follow-up via both angiography and duplex ultrasound.
Addressing attendees at ISET, Brodmann emphasised that the trial’s primary safety endpoint— freedom from major adverse limb events and perioperative death—was met across all patients.
Summarising the findings, Brodmann underscored the “significant biomechanical advantages” of the Magnitude scaffold over existing alternatives. She cited its combination of high radial strength with preserved flexibility, its superior fracture resistance, and its capacity for high over-expansion.
At the Leipzig Interventional Course (LINC 2025; 28–30 January, Leipzig, Germany) Eric Secemsky (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA) shared the enthusiasm surrounding these early feasibility results. He described the findings as “very supportive of moving forward to an IDE [investigational device exemption] trial,” concluding that “bioresorbables have the promise to change clinical practice for infrainguinal arterial disease.”
Are we there yet?
Computational advancements in interventional radiology
Judy Wawira Gichoya
Point of View
What computational advancements are set to transform interventional radiology (IR)? Interventional radiologist, Judy Wawira Gichoya (Emory University, Atlanta, USA) weighs in, providing a realistic outlook on developments so far.
The enthusiasm of interventional radiologists for new devices that have enhanced our clinical work reveals a notable gap when considering artificial intelligence (AI) as a significant component of our toolkit.
During the 2024 Western Angiographic Society meeting (21–26 September, Kauai, USA), I surveyed hundreds of practicing interventional radiologists regarding their current or planned use of robotic technology. The prevailing sentiment can be summarised in one word: indifference. In my reflection during the ‘25 years of Computational Advances’ session at the 2025 Society of Interventional Oncology (SIO) annual scientific meeting (30 January–3 February, Las Vegas, USA), I contended that action should be the focus for every interventional radiologist moving forward.
Most AI tools available today are primarily designed for diagnostic radiology and are used by interventional radiologists incidentally. Some of us who participate in pulmonary embolism response teams (PERTs) have indirectly interacted with the triage algorithms that detect incidental pulmonary embolism. Conference exhibitions often mention AI to inform us about the latest advancements, but these systems are not commonly used in our daily work. In fact, after one year of using a percutaneous biopsy robot at Emory University’s IR department, in Atlanta, USA, the robotics company went bankrupt, and our practice has continued without “the robot”. Our residents are happier with their education without the robot. While IR continues to be a lesser-
known branch of radiology, primary care clinics and electronic medical record systems are advancing with AI integration. One such application is ambient listening, where AI transcribes and writes clinical notes, which has become essential for primary care providers in hospitals. The dream of every interventional radiologist who wants to have a working clinic is being achieved outside radiology supported through AI-generated drafts to patient messages, AI-assisted discharge summaries and differential diagnosis, and even end-to-end AI-assisted radiology interpretation. Yet, new data reflect the reality of IR—data showing the impact of workplace injuries from many years of wearing lead in rooms not designed for ergonomic flexibility, lack of evidence to show the value of IR in multidisciplinary care, continued workforce shortage and persistent IR deserts where tele-procedural interventions remain a dream. The call to action begins with understanding the advancements of AI architectures with increased development of foundation models. These models are trained by compressing data like text, videos and pictures into a representation space and then generating content in response to a prompt. The selfsupervised nature of learning, which can be thought of as ‘fill in the blanks’, allows for training of these models with minimal human input. Several models have been developed for radiology, and the same technology developed for IR would overcome prior limits of small datasets for AI development, capture multimodal data, and reduce annotation cost and effort. This model base, if properly
US FDA issues first draft guidance for AIbased medical device development
The US Food and Drug Administration (FDA) has issued draft guidance that includes recommendations to support development and marketing of safe and effective artificial intelligence (AI)-enabled devices.
THE GUIDANCE, IF FINALISED, WOULD be the first comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AIenabled devices, a press release states. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.
“The FDA has authorised more than 1,000 AIenabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognise that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence within the
FDA’s Center for Devices and Radiological Health, prior to his recent departure from the company. “The draft guidance brings together relevant information for developers, shares learnings from authorised AI-enabled devices and provides a first point-ofreference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire lifecycle.”
The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product lifecycle. The FDA has encouraged sponsors to engage with the agency early and often, and to use this guidance, once finalised, to guide their activities throughout the life cycle of the device. Importantly, this draft guidance also includes the FDA’s current thinking on strategies
designed, could then be used to power agents that can participate in tumour board discussions, assist with clinic and procedural documentation, provide infrastructure to develop digital twins for patient trajectory mapping and robot environment simulation.
In 2024, I teamed with authors for a two-part series article on AI for IR.1,2 The articles introduce a patient case for PE thrombectomy that is automatically flagged from the overnight list by an AI triage system. It subsequently touches on all possible points of digital transformation including patient consent and chatbot interaction, multisensory monitoring for physiologic and pain status, 3D printing of a personalised angiographic catheter, AI-generated orders and procedural documentation
While futuristic, I believe that the technological advances are getting there but need the input of the interventional radiologist to not continue to develop monolithic applications in isolation, but envision an enabled future that allows us to provide excellent care to all patients.
References 1. Warren, B.E., Bilbily, A., Gichoya, J.W, et al. An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 1 Foundational Knowledge. Canadian Association of Radiologists Journal, 75(3), pp.558–567. doi: https://doi. org/10.1177/08465371241236376.
2. Warren, B.E., Bilbily, A., Gichoya, J.W, et al. An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 2: Implementation Considerations and Harms. Canadian Association of Radiologists Journal, 75(3), pp.568–574. doi: https:// doi.org/10.1177/08465371241236377.
Judy Wawira Gichoya is an associate professor of interventional radiology and informatics at Emory University,
Disclosures: The author decalred no relevant disclosures.
to address transparency and bias throughout the lifecycle of AI-enabled devices. The draft guidance describes specific recommendations intended to help a sponsor demonstrate that they have addressed risks associated with bias and provides suggestions for the design and evaluation of AI-enabled devices.
The FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products. The agency has stated that the publication of the guidelines demonstrate its efforts to provide transparency and to help ensure product safety and effectiveness.
As we continue to see exciting developments in this field, it’s important to recognise that there are specific considerations unique to AI-enabled devices” Troy Tazbaz
“It sounds crazy”: What’s next for interventional devices
In a recent interview with Interventional News, John Kaufman— Frederick S Keller chair of interventional radiology at Oregon Health and Science University, in Oregon, USA, president-elect of the American Board of Radiology (ABR) board of governors, and chief medical officer for Cook Medical—looked back to see forward, addressing what is next for device development in the interventional arena.
IN: You recently gave a talk at the Society of Interventional Oncology (SIO) 25 Years Past and Future session during this year’s meeting (30 January–3 February, Las Vegas, USA)— what were your main points of your discussion?
The topic that was assigned to me was the kind of overview subject matter you receive when you reach the later period of your career. My talk focused on how we in interventional oncology (IO) evolved from very focused, limited interventions—either the early transvascular, which was all embolization and initially just ischaemic to kill the tumour, then to the delivery of therapies and the evolution of said therapies. That has been one trend that continues to grow, particularly concerning transvascular intervention in the liver and kidney.
I also spoke on ablation becoming much more mainstream than it was 25 years ago. Although there was ablation back then, a lot of it was ill-directed alcohol ablation. Today, ablation technologies have taken off and expanded to new approaches such as the delivery of energy to tumours. What I think will be interesting, is the development of ablation to target malignant disease states that we haven’t had a significant role in, such as pancreatic and lung cancer.
One of the nice things about IO is that the multidisciplinary approach will continue to be important as our interventions are never in isolation. We can use a combined approach with other modalities, immunologic modalities, and oncologic radiotherapy, to expand in a more synergistic direction, so that’s going to be really important.
On the device front, I’m very interested in devices that do more than just deliver treatment. Devices that can help to monitor or share information, can tell you the flow, or give you viability information. It sounds crazy, but a device that can tell you about the local genetic environment it’s sitting in, such as whether you’ve got tumours that are changing — devices that have functionality in addition to delivering therapy, I believe that’s the direction we’re going in.
IN: Artificial intelligence (AI) is
playing a larger role in medical device development and function—do you think AI will play an important role in IO?
In oncology, AI may support screening—figuring out which patients appear to be on a trajectory that is approaching a threshold for treatment. With AI as a background system that can collect data on lung nodules, for example, you can compare data from the entire programme. Radiomics is very important for cancer and the digital information management that AI can provide is crucial at pre- or post-treatment to understand what we’re doing and what results we’re getting. In the visualisation world AI is going to be huge. I think we’re only just getting to the most interesting part of IO, particularly in the image-guided oncology space.
In terms of clinical information processing, in the end we need to realise that programmes like ChatGPT are an echo chamber—it’s just what’s available in the world and all you’re going to get back is information based on what is already accessible. We will always have a level of scepticism, and you have to be a little bit critical.
IN: Do you see 3D-printed medical devices playing a role outside of prototype creation in the future?
Outside of prototypes, 3D printing medical devices is a sort of magical concept that says—I’m going to place a stent, here’s the computed tomography (CT) scan, it goes to your printer and out pops the stent tailored to that patient. That’s the holy grail, but the regulatory pathway for that would be unbelievable—impossible, although it has happened in the aortic space through custom-made devices. The process is becoming more mechanised with inputs from the imaging actually felt throughout the device manufacturing process.
But, will you end up being able to print patient-specific devices on the fly? Where a patient is on the table and you say ‘I need this stent—print if for me!’, That would be awesome, but I’m not sure we’ll get there. In terms of managing inventory, 3D-printed devices would be incredible, but maintaining and certifying them is unlikely.
IN: How often have you seen new devices be applied to treat disease states that have long been managed medically rather than cured?
Portal vein reconstruction is a great example of this. Tumour invasion or adhesion to the portal vein is a disease state that has been sitting in front of us forever. We have been able to image and diagnose the problem, but it is what it is, you just have to live with it, and we manage the complications. Then taking tools from peripheral intervention, taking knowledge from liver access that we use in the biliary area, and portal vein embolization, taking knowledge
and vascular surgery involved in PE? Almost never. The patient was managed medically. Yet now, with the thrombectomy tools at our disposal, we treat patients with PE up to three or four times a week. This is something IR does a lot, where you are always taking tools and skill sets and looking for new applications, which I believe will also play out in the IO world.
IN: US President Trump revealed plans to impose tariffs on imported goods which will affect a significant proportion of available medical devices that are manufactured outside
I believe smart devices that give us feedback, pain scores and procedural followup are going to change people’s lives immensely”
of access and recanalisation, we’ve been able to open up veins no one ever thought could be opened. There’s a tremendous amount of interest because there are many patients with this issue.
Now it’s one of these situations in which you have nothing to offer— you’re not looking for a solution so you’re not paying attention to how often you’re seeing it. When you suddenly have the ability to treat something, you see patients with this all the time.
Another area where I have seen this development is pulmonary embolism (PE). Fifteen years ago, how often were interventional radiology (IR), cardiology
of the USA. What are your thoughts on this?
There is a lot of concern, certainly for any of the international corporations, not over what’s going to come in but what’s going to happen to devices going out. I am concerned that the proposed tariff will drive up the already excessive cost of healthcare. Many companies have moved device manufacturing overseas or across borders, and if this suddenly becomes a much more expensive proposition, it ends up trickling down to the price of available medical devices. It remains to be seen how real this will be.
IN: What has been the most significant area of device development in the last five years, and in the next five, what development will be the most influential?
For me, the biggest change has been within PE intervention. We now have very good devices for dealing with large embolisms, and these devices have been pivoted to in endovascular IR, vascular IR and elsewhere. In the next five years, I believe smart devices that give us feedback, pain scores and procedural follow-up are going to change people’s lives immensely.
John Kaufman
Research supports combined treatment approach for erectile dysfunction due to mixed arteriovenous disease
Data from a new study have found that venous leak embolization yields additional clinical improvement and treatment potential in patients with vasculogenic erectile dysfunction (ED) resistant to phosphodiesterase-5-inhibitors (PDE5i) due to mixed arteriovenous disease. These findings were recently published in the journal CardioVascular and Interventional Radiology (CVIR).
THE SINGLE-CENTRE OBSERVATIONAL study was led by Nicolas Diehm (Vascular Institute Central Switzerland, Aarau, Switzerland) et al, who collected data from 26 patients treated at their institution between October 2019 to September 2022. All patients were diagnosed with ED resistant to PDE5i without significant clinical benefit following arterial revascularisation of erection-related arteries.
In their description of the study, Diehm and colleagues write that endovascular therapy of vasculogenic ED has recently made “significant progress”, and while several studies have investigated clinical outcomes following either arterial revascularisation or venous embolization, data on combined arteriovenous diseases are “scarce”.
The study authors outline that the combination of arteriogenic and venogenic ED may be prevalent in a subset of patients. They describe that arteriogenic ED is often caused by atherosclerosis triggered by cardiovascular risk factors leading to narrowing of the erection-related arteries. Venogenic ED, however, is caused by incomplete relaxation of cavernosal smooth muscle cells during arterial inflow and subsequent failure to occlude the penile venous outflow tracts.
Thus, to investigate the potential combination of therapies, Diehm and colleagues performed 807 procedures—663 arterial and 144 venous interventions. Technical success for arterial revascularisation was defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction. Technical success after venous embolization was defined as complete target vein embolization.
Procedural success was achieved in all patients with no major adverse events at six-month followup. The primary feasibility endpoint was defined as an International Index of Erectile Function-6 (IIEF-6) score improvement of ≥4 points at six-week follow-up post intervention, which was achieved in three of the 26 (11.5%) patients following arterial revascularisation only. Following an additional venous embolization performed 458±424 days after the initial arterial procedure, the authors report that the primary feasibility endpoint was reached in 17 of 26 (65.4%) patients.
In addition to the IIEF-6 score, Diehm et al also requested patients complete the global patient
The role of stem cell therapy in IR: Intervencell
Point of View
Maede Rouzbahani (Tehran University of Medical Sciences, Tehran, Iran) spotlights current innovations in stem cell therapy in interventional radiology (IR) and its potential within precision medicine.
STEM CELL THERAPY HAS emerged as a transformative approach in IR, focusing on targeted treatments for various organ systems and ischaemic conditions. This innovative technique’s integration in IR stems from its ability to precisely deliver therapeutic cells directly to affected tissues, enhancing efficacy while minimising systemic side effects. We named this area of science “Intervencell”.
One of the primary advantages of IR in stem cell therapy is its precision. Intra-arterial delivery is a preferred method and ensures higher retention of stem cells at the target site compared to traditional intravenous methods. Studies in ischaemic heart disease and brain stroke have demonstrated superior outcomes when intra-arterial delivery is employed, such as improved cell engraftment and tissue repair. This precision is particularly
impression of improvement (PGI-I) questionnaire six weeks post intervention. This showed that two (8%) patients with mixed arteriovenous ED had improved post arterial revascularisation alone, whereas 24 (92%) patients had no change or experienced deterioration. Following the additional venous embolization, 15 (57.5%) patients had improved, nine (34.6%) experienced no change and two (7.7%) had deteriorated when compared with baseline. In addition, at six weeks follow-up, 18 (69.2%) patients stated that they would undergo the endovascular procedures again.
In their discussion of the results, Diehm and colleagues note that a staged combined treatment approach for mixed-arteriovenous ED was “safe and feasible”, highlighting the clinical improvement rate of 65.4% in patients who initially failed to respond to arterial ED treatment alone. The authors determine that their results show that venous leak embolization has potential to further improve clinical outcomes in patients with severe ED who have not responded to arterial revascularisation.
In their conclusory statement, Diehm et al write that more stringent exclusion criteria may yield better outcomes in future studies in this area, as, in the current cohort, patients with comorbidities such as diabetes mellitus were not excluded.
Clinical improvement was achieved in 65.4% in patients who initially failed to respond to arterial ED treatment alone”
significant in treating conditions like chronic kidney disease, liver fibrosis, diabetes, and osteonecrosis of the femoral head, where localised treatment is critical for successful outcomes. The results of intra-arterial stem cell therapy in clinical settings are notable. In kidney disease, mesenchymal stem cell (MSC)derived extracellular vesicles have shown the ability to enhance renal function by reducing inflammation and promoting tissue regeneration. Similarly, in liver disease, stem cell injections have reduced fibrosis and improved metabolic control. For neurodegenerative diseases like Parkinson’s, intra-arterial delivery has resulted in enhanced motor function and improved quality of life, highlighting its therapeutic potential. Despite its promise, this approach is not without challenges. Technical limitations, such as the effects of shear stress during catheter-based delivery, can compromise cell viability. Additionally, exposure to contrast agents and radiation during imaging may negatively impact stem cell integrity. Strategies like reducing infusion rates and minimising radiation are essential to mitigate these issues. Furthermore, the inherent risks associated with stem cell therapy—
such as tumour formation in pluripotent stem cells and immune reactions in allogenic transplants—remain key concerns. Ethical considerations also arise, particularly with embryonic stem cells. However, advancements in cell engineering, such as induced pluripotent stem cells (iPSCs), offer solutions by providing patient-specific therapies with reduced ethical and immunological challenges.
Stem cell therapy facilitated by IR represents a cutting-edge approach to precision medicine. While limitations persist, continuous refinement of delivery methods and safety protocols will pave the way for broader clinical application, ultimately improving outcomes for complex diseases and advancing the field of regenerative medicine. This work would not have been possible without the invaluable guidance and support of my mentor Hossein Ghanaati, whose insights and expertise have been instrumental in shaping my understanding of this field.
Maede Rouzbahani is an medical doctor at the Tehran University of Medical Sciences, Tehran, Iran.
Disclosures: The author decalred no relevant disclosures.
Maede Rouzbahani
Study highlights declining venous stent patency rates after one year
A systematic review and metaanalysis of over 1,500 venous stenting procedures—said to be the first study on this topic to date—has highlighted an 18% drop in primary patency rates after one-year follow-up with declining rates beyond 12 months. As a result, researchers highlight the need for surveillance and consideration of reintervention to optimise long-term outcomes.
THE STUDY, PUBLISHED AS AN editor’s choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES), aimed to appraise recent evidence assessing patency outcomes at various time points in patients with superior vena cava, subclavian, and brachiocephalic vein stenosis who had undergone stenting.
As a starting point, Shreya Chawla (Imperial College London, London, UK), Qingwei Zhang (St George’s University Hospital, London, UK), Adam Gwozdz (Imperial College
Large
survey
in Japan
finds
cyanoacrylate
London, London, UK) and colleagues, under the senior authorship of Stephen Black (St Thomas’ Hospital, London, UK), searched PubMed, Scopus, and Cochrane Library databases for studies up to December 2022. The researchers then measured outcomes including technical success rate, and primary, primary-assisted, and secondary patency rates at various time points.
Chawla, Zhang, Gwozdz et al share that they included a total of 39 studies reporting outcomes in 1,539 patients in their meta-analysis.
The authors report that primary patency up to one year after a venous stenting procedure was 81.5%, declining to 63.2% at 12–24 months.
Stenting is an effective intervention for benign and malignant stenosis”
Furthermore, they reveal that primaryassisted patency and secondary patency rates at 24 months and beyond were 72.7% and 76.6%, respectively.
The team also conducted subgroup analyses, in which they found no significant difference for pooled
2023. The authors highlight that the present cohort represents 73% of all CACs performed in Japan. Thromboembolism, phlebitis, hypersensitivity reactions, granuloma formation, infection, bleeding, death, and need for glue resection were documented as unfavourable events or outcomes.
closure for varicose veins “safe” with low adverse event rate
A large nationwide survey conducted by the Japanese Regulatory Committee for Endovascular Treatment of Varicose Veins has demonstrated that cyanoacrylate closure (CAC) for varicose veins is safe with low rates of serious adverse events, such as venous thromboembolism.
CAC IS A MINIMALLY INVASIVE technique for treating axial venous reflux; however, the incidence of serious adverse events related to the procedure is “concerning”, stated lead author Michihisa Umetsu (Tohoku University Hospital, Miyagi, Japan) et al. Due to an increasing number of patients undergoing CAC and insufficient data in Japan, the authors sought to investigate the safety profile of the procedure, tracking type and incidence of adverse events.
Umetsu et al collected data pertaining to 24,209 patients who underwent CAC at 335 institutions between January 2020 and October
Venous thromboembolism was reported in 142 (0.59%) patients, pulmonary embolism (PE), proximal deep vein thrombosis and ablation-related thrombosis extension developed in three (0.01%), nine (0.04%), and 95 (0.39%) patients, respectively. Localised phlebitis that required additional treatment was observed in 1,656 patients (6.8%).
Of the localised hypersensitivity cases, 960 (58%) required oral antihistamines and 268 (16%) required oral and/or intravenous steroids. Furthermore, 65 patients (0.27%) developed systemic hypersensitivity that required systemic steroids. No patients developed a stroke or anaphylaxis; however, one patient died due to PE.
secondary patency rates when comparing the malignant and benign subgroups. However, they note that GRADE analysis determined the certainty of evidence for all outcomes to be “very low”.
“Stenting is an effective intervention for benign and malignant stenosis of the superior vena cava, subclavian, and brachiocephalic veins,” Chawla, Zhang, Gwozdz et al conclude. They reiterate that primary patency rates were “good” up to one year but declined after this time point. “Importantly,” the authors continue, “the results suggest that reintervention before in-stent thrombosis significantly increases patency rates.”
Chawla, Zhang, Gwozdz et al note that there is a lack of high-quality evidence related to venous stenting outcomes, which necessitates further research. In particular, they stress that the merits of surveillance and reintervention programmes should be explored in the interest of bettering outcomes. “This review suggests that systematised strategies to monitor and follow up patients may help optimise long-term patency,” they write.
In the discussion of their findings, Chawla, Zhang, Gwozdz et al acknowledge limitations of their systematic review and meta-analysis. They note that the 39 included studies comprised 36 case series and three cohort studies, which they recognise might have affected data quality, and that “significant data” were not reported in the included studies, such as a lack of data on the criteria for reintervention.
0.30%; p<0.001; OR, 2.5; 95% CI, 1.66–3.77) was significantly higher in low-volume institutions than in high-volume centres, Umetsu et al state.
In their discussion, Umetsu and colleagues highlight that CAC represents a less invasive treatment modality compared to conventional endovenous thermal ablation (EVTA) in this patient population. They highlight that the risks of nerve injury and skin burns that can occur with EVTA can be avoided with CAC, while hypersensitivity to CAC—the most common adverse event associated with the procedure—does not occur with EVTA.
Umetsu and colleagues state that glue resection was performed in nine patients with delayed infection, hypersensitivity reactions or a foreign body granuloma. The incidence of hypersensitivity reactions was similar among institutions, the authors note; however, the incidence of thrombosis-related events “significantly differed” between high- and low-volume institutions. The incidence of proximal deep vein thrombosis (0.13% vs. 0.01%; p<0.001; odds ratio [OR], 12.5; 95% confidence interval [CI], 2.6–60.3) and ablation-related thrombus extension (0.73% vs.
“Most of the reactions observed in our study population seemed to be transient, although a few were prolonged. The incidence of hypersensitivity reactions requiring systemic steroids varied among the institutions in this study, ranging from 0% to 50%. Some institutions treated less than 20% of their patients with steroids, potentially causing an overestimation of the hypersensitivity rates,” state Umetsu et al
While the authors note that the present survey was not conducted to determine the superiority of treatments, and state that CAC would not replace conventional EVTA for saphenous veins, they conclude that the former can be optimised for treatment in select patients. Given their large sample size, Umetsu and colleagues emphasise that their survey provides a “highly accurate” report of the national incidence of adverse events associated with CAC.
Michihisa Umetsu
Clinical News
First patient enrolled in Concept Medical’s MAGICAL BTK IDE trial Concept Medical has successfully enrolled the first patient in the MAGICAL BTK US investigational device exemption (IDE) pivotal trial, a press release reveals.
Following the recent IDE approval by the US Food and Drug Administration (FDA) for the MagicTouch PTA, this enrolment heralds the beginning of Concept Medical’s peripheral clinical trial programme in the USA.
“The enrolment of the first patient in the MAGICAL BTK trial represents an important stride toward improving the standard of care for below-the-knee disease in patients with peripheral arterial disease,” said Prakash Krishnan (Icahn School of Medicine at Mount Sinai, New York, USA), who enrolled the first patient. “Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and patient quality of life. I am honoured to be part of this landmark study and look forward to the meaningful clinical evidence it will generate.”
The MAGICAL BTK pivotal trial is designed to evaluate the safety and effectiveness of the MagicTouch PTA sirolimus-coated balloon compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of below-the-knee (BTK) arterial disease. The primary endpoint, measured at 12 months, is primary patency.
APEX-AV trial results of AlphaVac PE system AngioDynamics has announced the publication of the results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac system—APEX-AV—in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI). The primary efficacy endpoint of the APEX-AV trial was the reduction in right ventricle to left ventricle (RV/LV) ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of major adverse events (MAEs), including events such as major bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury within the first 48 hours. Patients were followed for 30 days post-index procedure. The results demonstrated the device as a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/ LV ratio and clot burden with a low rate of adverse events.
The APEX-AV trial demonstrated a 35.5% reduction in clot burden (via the Modified Miller index score), comparing favourably to other mechanical aspiration devices on the market. The unique design features of the device, including its funnel tip, optional wireless navigation, and blood loss mitigation, contributed to clinically
significant improvements in both safety and efficacy.
AVENTUS trial of thrombectomy system for PE treatment completes enrolment
Inquis Medical has announced completion of patient enrolment in its AVENTUS clinical trial, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of the company’s Aventus thrombectomy system for the treatment of pulmonary embolism (PE). A total of 130 patients with intermediate-risk PE were enrolled in the AVENTUS clinical trial, a multicentre, prospective, single-arm trial conducted at more than 20 clinical sites across the USA.
“This trial is a key step toward delivering a more streamlined, efficient, and precise thrombectomy solution for treating life-threatening blood clots,”
said Jun Li, co-director of the Vascular Center and Pulmonary Embolism Response Team at University Hospitals Harrington Heart & Vascular Institute (Cleveland, USA) and the trial’s national co-principal investigator (PI).
“The Aventus system stands out with its unique combination of streamlined blood return, directional aspiration, and the elimination of multiple dilator or wire exchanges, offering an elegant and efficient solution for removing thrombi in PE patients.”
Argon Medical enrols first patient in CLEAN-PE study
Argon Medical has announced the first patient enrolment in the CLEAN-PE study. The prospective, multicentre CLEAN-PE study aims to evaluate the safety and efficacy of the Cleaner Pro is a catheter-based aspiration thrombectomy system for removing blood clot from the lungs in patients diagnosed with pulmonary embolism (PE). CLEAN-PE is estimated to enrol over 100 patients at various hospital facilities across the USA.
The multicentre study is led by principal investigator Aravinda Nanjundappa (Cleveland Clinic, Cleveland, USA). The first patient procedure took place at Buffalo General Medical Center in Buffalo in New York, USA by David M Zlotnick.
“We are proud to enrol the first patient in the CLEAN-PE study utilising the Cleaner Pro thrombectomy system. Unique treatment options are emerging for the management of this patient population. We are excited to evaluate a new device for patients diagnosed with pulmonary embolism,” said Zlotnick.
Product News
US FDA grants NextBioMedical investigational device exemption for Nexsphere-F GAE trial
NextBioMedical has announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its clinical trial RESORB featuring Nexsphere-F.
Designed to alleviate pain in knee osteoarthritis (OA) patients, the fast resorbable embolic microsphere will undergo a multicentre trial in the USA for market approval, marking a significant milestone in the company’s global expansion strategy.
Knee OA is a debilitating condition affecting over 654 million people aged 40 and above globally, making it one of the leading causes of pain and disability among older adults. While existing treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs) and hyaluronic acid injections, provide temporary relief, their long-term efficacy is limited, and side effects are a significant concern.
The RESORB trial aims to address these unmet needs by introducing a more sustainable and patient-friendly solution through genicular artery embolization (GAE) and Nexsphere-F.
Therapeutics’ SeQure and DraKon microcatheters.
Microcatheters such as SeQure and DraKon are commonly used by physicians to conduct interventional procedures in which therapeutic agents or devices are introduced into the small vessels delivering blood to a tumour or abnormality. As such, physicians often select a microcatheter for a procedure based on the catheter’s ability to navigate to the target and its compatibility with therapeutic agents or devices.
Both the SeQure and DraKon catheters earned a strong reputation for being easy to navigate and broadly compatible, a recent press release states. Further, the company shares that SeQure is the only reflux control microcatheter designed to create a fluid barrier that directs the flow of therapeutic agents and devices toward the intended target.
Cook Medical announces investment in Zenflow urinary obstruction device
Cook Medical has announced a strategic investment in the urology space via Zenflow, a medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate, or benign prostatic hyperplasia (BPH).
Viabahn VBX
Guerbet receives FDA Breakthrough Device designation for Lipiojoint liquid embolic Guerbet has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Lipiojoint, the company’s transient liquid embolic agent designed to alleviate pain and the related burden of reduced mobility in patients with knee osteoarthritis (OA). This recognition highlights the potential of Lipiojoint as a minimally invasive approach for knee OA patients who have not found relief through nonsurgical treatment modalities.
“Being part of the Lipiojoint FDA Breakthrough programme is a major milestone for Guerbet but most importantly for patients suffering from osteoarthritis. Working closely with the US administration will give a unique opportunity to bring an innovative approach aiming to release pain for a large part of the population. A unique collaboration for a medical unmet need” said Dan Raffi, global chief commercial officer and president for Gubert France.
Argon Medical announces acquisition of Accurate Medical Therapeutics’ microcatheters Argon Medical has announced the acquisition of Accurate Medical
“This investment reflects our confidence in the future of Zenflow and the Spring System technology. Zenflow is aligned with our core focus of developing minimally invasive technologies that restore flow,” said DJ Sirota, senior vice president of Cook Medical’s MedSurg division.
Gore receives CE mark for lower profile Viabahn VBX endoprosthesis
Gore has announced CE-mark approval of a lower profile Viabahn VBX balloon-expandable endoprosthesis (VBX stent graft).
Medical Device Regulation (MDR) approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease, the company says in a press release. In addition to offering the longest balloon-expandable stent on the market with its 79mm configuration, and the widest range of stent diameter adjustability, the VBX stent graft now also offers the most 6Fr compatible configurations, the press release adds.
“We are thankful to Gore for being able to be one of the first implanters of the new lower profile VBX stent graft in Europe,” said Michele Antonello (University of Padua, Padua, Italy).
“Combined with the device flexibility, its accuracy and trusted performance, the new lower profile will enable me to treat my complex cases with a 6 or 7Fr device.”
Aventus
Cardiovascular and Interventional Radiological Society of Europe
SUBMIT YOUR ABSTRACT!
Barcelona, Spain
September 13-17
CIRSE 2025
Submit your abstract to the IR congress of the year !
Submitting your abstract to the CIRSE Annual Congress will enable you to share your work at the world’s most comprehensive IR meeting. With the new addition of an artificial intelligence and emerging technology category, CIRSE 2025 will accept more abstract types than ever before. Abstract submission is open until March 20 –so don’t wait ! Scan the QR code below to learn more or to submit your abstract.
Browse the programme
With nearly 200 sessions featuring talks from expert faculty members, CIRSE 2025 covers the full scope of interventional radiology throughout eight topic tracks. With so many lectures and hands-on opportunities to choose from, it’s not too early to get a head start on planning your itinerary !
CIRSE 2025 will also include a robust hands-on device training programme, allowing attendees to gain experience with a vast array of devices. Safe sedation workshops, a GI-Lab, simulation training, and practical courses on a variety of topics will be offered.
See
you in Barcelona!
Barcelona’s CCIB congress centre has witnessed IR history before – and will do so again ! The Catalonian capital will provide an inspiring backdrop as the world of IR meets to connect, share, and learn at CIRSE 2025.
Accommodation
CIRSE’s travel partner Kuoni offers CIRSE 2025 delegates an easy-to-use booking system with exclusive deals on hand-picked quality hotels in various price ranges close to the congress centre.
We look forward to welcoming you to CIRSE 2025 !
Industry News
Stryker completes acquisition of Inari Medical Stryker has announced that it has completed the acquisition of Inari Medical. A press release notes that the addition of Inari brings an established peripheral vascular position to Stryker in the fast-growing venous thromboembolism (VTE) segment.
“The acquisition of Inari Medical marks a significant milestone in expanding our interventional endovascular portfolio,” said Kevin Lobo, chair and chief executive officer, Stryker. “We look forward to welcoming the talented Inari team to Stryker and working together to improve outcomes for patients worldwide.”
The company states in a press release that Inari’s product portfolio is “highly complementary” to Stryker’s neurovascular business and includes two novel mechanical thrombectomy solutions—the FlowTriever system for the treatment of pulmonary embolism and the ClotTriever system for thrombectomy in the peripheral vessels—as well as emerging therapies. “Inari has positively impacted the lives of hundreds of thousands of patients through the development of
Conference calendar
29 March–3 April
Society of Interventional Radiology (SIR) Nashville, USA www.sirmeeting.org
9–12 April
Pan Arab Interventional Radiology Society (PAIRS) Dubai, UAE www.pairscongress.com
purpose-built tools that address unmet patient needs,” said Drew Hykes, chief executive officer, Inari. “With Stryker’s capabilities and global infrastructure, we will be even better positioned to accelerate the development of innovative new solutions and expand our footprint.”
Medtronic expands US carotid market presence with exclusive Contego distribution agreement Medtronic announced that it has entered into an exclusive US distribution agreement with Contego Medical. Under the agreement, Medtronic will be the sole US distributor for Contego’s portfolio of commercially available products, which provide revascularisation treatment for carotid and peripheral vascular disease.
The agreement also includes an increased investment in Contego and an option to acquire the company.
Medtronic has held a minority investment in Contego since 2020.
“Contego’s innovations—backed by excellent data—are transforming how carotid disease is treated, and complement the Medtronic peripheral and stroke protection portfolio,” said David Moeller, senior vice president and president of Medtronic Peripheral Vascular Health, which is part of the company’s Cardiovascular portfolio.
“This strategic agreement with
Contego Medical expands our commitment to this fast-growing carotid market, and exemplifies Medtronic’s steadfast dedication to advancing innovation and enhancing patient care.”
This agreement includes Contego’s portfolio of commercially available products, including the recently US Food and Drug Administration (FDA)approved Neuroguard IEP system—a three-in-one carotid stenting system that combines a high-performance stent, post-dilation balloon, and an integrated embolic protection (IEP) filter—as well as Excipio peripheral thrombectomy devices.
FastWave issued seventh utility patent for its IVL portfolio
FastWave Medical has announced the issuance of its seventh utility patent by the US Patent and Trademark Office (USPTO). This patent covers FastWave’s laser intravascular lithotripsy (IVL) technology, specifically engineered to address calcified arteries.
“Calcified arteries remain one of the most difficult conditions to treat in our field,” said interventional cardiologist
Amir Kaki (Henry Ford St. John’s Hospital, Detroit, USA). “FastWave’s laser IVL platform is a compelling advancement that should provide a more precise, efficient, and predictable way to manage complex arterial disease.”
“This milestone reflects the incredible talent of our entire team and our dedication to equipping physicians with cutting-edge tools for their most challenging cases,” said Scott Nelson, co-founder and chief executive officer of FastWave Medical.
Boston Scientific to acquire IVL developer Bolt Medical
Boston Scientific has announced it has entered into a definitive agreement to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease.
“Representing one of the fastest growing medical device segments, intravascular lithotripsy therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach,” said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. “Bolt Medical is developing a nextgeneration technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients.”
13–16 April
European Conference on Interventional Oncology (ECIO) Rotterdam, The Netherlands www.ecio.org
23–25 April Charing Cross (CX) Symposium London, UK www.cxsymposium.com
15–18 May
Global Embolization Symposium Technologies (GEST) New York, USA www.thegestgroup.com
4–7 June
Vascular Annual Meeting (VAM) New Orleans, USA www.vascular.org/vam-2025
11–14 June
European Conference on Embolotherapy (ET) Porto, Portugal www.etconference.org
30 July–1 August
Interventional Radiology Society of Australasia (IRSA) Melbourne, Australia www.irsaasm.com
13–17 September
Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Barcelona, Spain www.cirsecongress.cirse.org
17–19 October Symposium on Clinical Interventional Oncology (CIO) Miami, USA www.hmpglobalevents.com/cio
