We are in the middle of the spring congress season, and I am just back from the 50th anniversary meeting of the Society of Interventional Radiology (SIR; 29 March–2 April, Nashville, USA) and the Pan Arab Interventional Radiology congress (PAIRS; 9–12 April, Dubai, UAE) to introduce the 98th issue of Interventional News and the latest updates in the interventional world.
The 50th SIR meeting was a great success both in terms of delegate attendance numbers and the scientific programme that was very well put together by the programme chair, Gloria Salazar (University of Carolina Chapel Hill, Chapel Hill, USA), and her team. One of the highlights was the annual Charles Dotter Lecture, which this year was given by Lindsay Machan (University of British Columbia, Vancouver, Canada).
Lindsay’s Dotter Lecture is highlighted as a main feature in this issue. I was reminded by Lindsay during his lecture that he pioneered the use of paclitaxel as an antiproliferative drug in arterial disease in the 1990s; so we vascular specialists are reminded that we have much to thank Lindsay for.
Another highlight of the SIR meeting was the third Global Summit in interventional radiology (IR), which this time focussed on global educational discrepancies impacting the IR workforce and also awareness of IR around the world. The summit contained several presentations from IR leaders from national and international societies providing information on how education is provided for interventional radiologists. The discussion aimed to reach consensus on how to improve the global reach of education and to improve recognition of IR globally.
The PAIRS meeting goes from strength to strength, and this year’s meeting saw a large international and local faculty deliver a comprehensive programme to a well-attended IR audience. The scientific programme included all aspects of IR topics including a prominent focus on aortic and peripheral arterial intervention. The excellent keynote lecture delivered by Salah Qanadli (University of Lausanne, Lausanne, Switzerland) focussed on IR identity and how to improve the profile and recognition of IR.
The third recent IR meeting that I mention is the Indian Society of Interventional Radiology
(ISVIR; 6–9 February, Kochi, India). I went to my first ISVIR over 10 years ago, and I was impressed by how much this meeting has grown in size, attendance and stature. The congress was hosted by Shyamkumar Keshava (Christian Medical College & Hospital, Ludhiana, India) and Ajit Yadav (Sir Ganga Ram Hospital, Rajinder Nagar, India) and credit is due to the scientific programme team for the excellent schedule of sessions. There was a large national and international faculty, and the location in Kerala is certainly worth a visit for leisure purposes when there is no congress in town to absorb one’s attention.
Finally, I would like to highlight key articles in this, another bumper edition of Interventional News. In addition
to the aforementioned piece covering the Dotter Lecture, the other main feature focusses on hot topics within liquid embolic use. This issue’s profile highlights the career of paediatric interventional radiologist Alex Barnacle (Great Ormond Street Children’s Hospital, London, UK). Apart from her busy job and roles in the British Society of Interventional Radiology (BSIR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), Alex is currently in charge of the IR GIRFT (Getting It Right First Time) project, which will complete and deliver its report in the next year or so.
Finally, included are a variety of highlights from the recent 2025 Charing Cross (CX; 23–25 April, London, UK) symposium and European Congress of Interventional Oncology meeting (ECIO; 12–16 April, Rotterdam, The Netherlands), updating on the most anticipated developments across interventional oncology, radiology and vascular intervention.
As always, I hope that you enjoy this edition of Interventional News, and I hope to see as many of you as possible at a future meeting.
ROBERT MORGAN is professor of interventional radiology at St George’s University Hospitals NHS Foundation Trust in London, UK and the president of the British Society of Interventional Radiology (BSIR).
NEWS IN BRIEF THE LATEST STORIES FROM THE INTERVENTIONAL WORLD
n GAE OPINION: Musculoskeletal (MSK) embolization— including techniques such as transarterial microembolization (TAME) and genicular artery embolization (GAE)— has emerged as a novel, minimally invasive treatment for chronic joint and tendon pain. Here, Yuji Okuno (Tokyo, Japan) and Gerard Goh (Melbourne, Australia) collaborate to raise several critical questions that, at present, remain unanswered, and set out steps that must be taken to integrate MSK embolization into clinical practice.
For more on this story go to page 9.
n WAVE TRIAL:
Twelve-month results of the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial show a statistically significant improvement in target lesion primary patency (TLPP) with the Wrapsody (Merit Medical) cell-impermeable endoprosthesis (CIE) when compared to percutaneous transluminal angioplasty (PTA).
For more on this story go to page 10.
n POSTPARTUM HAEMORRHAGE:
A new geographic information system (GIS) analysis of Kenya has found “disproportionate” rates of maternal morbidity and mortality due to postpartum haemorrhage (PPH) in areas without interventional radiology (IR) capabilities. Led by Ryan W England (Princeton, USA) and published in the Journal of Vascular and Interventional Radiology (JVIR), the study employed multilayered GIS mapping to pinpoint healthcare disparities and propose a framework for global IR outreach.
For more on this story go to page 17.
Editors-in-chief: Professor Robert Morgan, Professor Andy Adam, Professor Brian Stainken
Publisher: Stephen Greenhalgh
Editor: Éva Malpass | Editorial contribution: Jocelyn Hudson, Will Date, Bryan Kay, Jamie Bell
If you have comments on this issue or suggestions for upcoming editions write to eva@bibamedical.com
Robert Morgan
The Global Summit session during SIR
Join us for the embolotherapy congress of the year !
ET 2025 will cover the entire range of embolotherapy treatments from well-established therapies to the latest technologies and cutting-edge developments, research, and new indications.
ET 2025 will feature unique session formats and a vibrant programme – browse the full schedule now and put together your personal itinerary !
Highlights this year will include a special focus on MSK conditions, including a dedicated session featuring lectures from the world’s top experts as well as two deep dive sessions.
Other deep dive sessions, which enable participants to interact closely with the experts, will delve into:
• Gastro-intestinal bleeding
• Vascular malformations
• Radioembolization
• Men’s health
• Visceral aneurysms
Register now to join us in Porto to connect with old colleagues and new friends for a meeting focusing on one of interventional radiology’s fastest growing areas.
We look forward to welcoming you to ET 2025 !
from page 1
were able to achieve angiogenesis inhibition, creating their desired exclusion zone.
“We’re back in business, baby,” said Machan. “So, we do some bench, small and large animal experiments, but we needed to deal with one big problem and that was that, at the time, Taxol had up to a 30% anaphylactic rate.” Machan notes that this reaction was considered attributable to a solubilisation agent, Cremophor—a castor oil derivative—but there were lingering concerns it could be related to paclitaxel itself, which threatened “to sink us”, he stated.
During this time, however, Machan described a patient who had oesophageal cancer who had had two failed attempts at dilation.
“His grandkids wouldn’t come to visit him because he couldn’t swallow so was always spitting up. He just said he wanted to be able to eat ice cream and drink scotch. So—and I would go to jail for this now—I went across to our lab and we packed as much paclitaxel and ethylene vinyl acetate as humanly possible onto this removable oesophageal stent,” Machan told the SIR 2025 audience. “I sweated bullets overnight. I went in the next morning and there he was with three little dixie cups on his mail stand, and he threw me this presumed scotch-induced grin, so we knew were in business,” recounted Machan.
In 1992, Machan and his other co-patentors signed a co-exclusive license with Boston Scientific and Cook Medical for their paclitaxel-coated stent, despite five years of talks with various companies. “We had received a cash offer, so I went up to Boston and Cook and said, ‘I don’t know if you guys are just being nice to me but if an alternative doesn’t arise, this deal is going to go through on Monday’. By that Saturday at 9am, we confirmed that FOMO [fear of missing out] is still the most important factor in so many ways,” Machan said.
Now, in everyone’s pocket there is a device that can interface with a digital stethoscope, recognising heart and lung sounds, and can tell you what these represent”
skills,” Machan continued. “But, boy, are luck and timing everything. Then finally, work on a problem that someone will pay for. It’s great to do research, but if you want to get it into a patient, unfortunately you have to have a commercial alliance.” It is this commercial element that has become a larger part of innovation today, stated Machan, but the “cascade of steps” to take “an idea on a napkin to getting it patented and regulated hasn’t changed, and you can’t skip any of them,” he added.
What has changed, however, is where innovators look for opportunities, Machan said. “First of all, you follow the money,” he stated. On one side, there are the “inconvenient truths” of needing to control unsustainable healthcare costs; at the same time there are significant changes set to transform future healthcare, including casting the patient as a consumer and the integration of artificial intelligence (AI) within the treatment algorithm.
“What did I learn from all of this?” His trajectory through innovation taught Machan that observing opportunities for innovation is key, he stated. “‘Honour every opportunity to learn something new’—it’s a fantastic quote. My first instinct was to not go to that premedical presentation because it was on something I didn’t understand, but I went and it changed my life. Work with people who have other
Regarding the former, Machan spoke on the democratisation of cardiovascular care at home. Using the example of smartwatches that can monitor and record your heart rate and sympathetic tone, the speaker stated that “this new era of health has resulted in the combination of digitalisation and consumerisation”. The result of this has meant that companies such as Google and Meta, “who haven’t
gone through the slings and arrows that other medical companies have, and with the irrationality of the business of healthcare,” Machan added, create a new landscape for patients and healthcare providers to navigate.
“But I said follow the money,” Machan continued. “Think about efficiencies, quantum leaps, efficacy and safety, while empowering lesser trained members of the healthcare team.” To exemplify this stance and the democratisation of teaching, the speaker described the history of the stethoscope, and how the tool required specialised expertise which created barriers as to who could deliver healthcare.
“Now, in everyone’s pocket there is a device that can interface with a digital stethoscope, recognising heart and lung sounds, and can tell you what these represent,” described Machan. “This means that every general or nurse practitioner now has the expertise of an Ivy League cardiologist immediately available to them. This reduces, for instance, unnecessary referrals from rural areas or for functional murmurs in children.”
AI in the real world
Machan subsequently touched on AI and the introduction of AI innovation at a societal level. Machan noted how Truveta, among a growing number of comparable companies, is able to extract and interrogate healthcare data from millions of patients daily, drawing on these data to further clinical research. Referencing a publication by Monteleone et al, comparing ultrasound-assisted catheter-directed thrombolysis versus mechanical thrombectomy in over 83 million patients, Machan drew attention to the wealth of procedures and outcomes that can be studied.
With the ability to provide real-world data, these emerging AI programmes are bringing to the fore the realisation that “what happens in the real world doesn’t necessarily happen in controlled company-sponsored trials”, Machan stated.
Finishing his talk, Machan ruminated on what Dotter would say to early career interventional radiologists seeking to innovate today. In his view, Dotter would urge them to be curious, collaborate and record what they learn, and to protect the spirit of IR, leaving the speciality better than they found it.
Lindsay Machan
Machan presenting at SIR
Photo
STRIKE-PE interim analysis shows benefit for acute PE patients with syncope
A STRIKE-PE interim analysis of clinical outcomes of acute pulmonary embolism (PE) patients with or without syncope— an indicator of compromised cardiac output and so increased short-term mortality—has found that patients with syncope who had a higher right/left ventricle (RV/LV) ratio at baseline were restored to a condition similar to patients without syncope following treatment with the Lightning Flash (Penumbra) computer-assisted vacuum thrombectomy (CAVT) device.
“SYNCOPE IS A FREQUENT conundrum,” said John Moriarty (University of California Los Angeles, Los Angeles, USA) during his latebreaking presentation of the featured abstract at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA). “Often we are uncertain whether this is a group of patients with acute intermediate risk, or whether they are within a worse group when considering outcomes or at higher risk of [repeated] intervention, so we felt it was important to study this patient cohort,” he stated.
John Moriarty
Initially powered to evaluate 600 patients, the STRIKE-PE cohort was extended, subsequently enrolling 1,500 patients. The prospective, international, multicentre study included patients with acute PE symptoms of ≤14 days and an RV/LV ratio of ≥0.9. Patients from this interim analysis with (n=72) versus without (n=228) syncope were compared. Moriarty highlighted that there was a statistically significant difference in Miller score of those ≥12 (91.7% vs. 80.7%, p=0.03) in the syncope cohort, taking this to demonstrate a large clot burden, which
was seen more frequently in patients with syncope than in those without. These patients also presented with a shorter time from symptom onset to venous puncture (47.5 hours vs. 81 hours p=0.04), and a higher RV/LV ratio (1.48 vs. 1.37, p=0.03).
At 48-hour post-procedure followup, RV/LV ratio improved in both groups, however improvement was significantly greater for patients with syncope (0.51 vs. 0.37, p=0.004; 31.7% vs. 25.2%, p=0.002). No significant difference was found between the groups for rate of composite major adverse events within this timeframe, nor concerning 30-day mortality.
“In other words, by imaging
When we look at safety, there are essentially no differences between the patients who had syncope and those who didn’t”
characteristics, [patients with syncope] got better, although both cohorts did well,” Moriarty told SIR 2025 delegates. “When we look at safety,
Computer-assisted vacuum thrombectomy device demonstrates “highly” improved device use time
In a subgroup analysis of the STRIKE-PE study regarding patients treated with the latest iteration of Penumbra’s 16Fr Lighting Flash computer-assisted vacuum thrombectomy (CAVT) device, Brian J Schiro (Miami Cardiac & Vascular Institute, Miami, USA) reported improved haemodynamic markers, right/left ventricle (RV/LV) ratio, dyspnoea, and overall, a “highly” improved device use time of 25.5 minutes.
IN THE OUTSET OF SCHIRO’S presentation at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA), he described that the goals of pulmonary embolism (PE) treatment are haemodynamic stability, perfusion restoration and right heart strain relief, among others. “Functional analysis is also important,” Schiro noted, stating that the consideration of long-term issues in these patients is as important as immediate improvement in symptoms.
Initially, he described the evolution of endovascular treatment of PE, outlining the progression from thrombolytics, to continuous aspiration, and now, CAVT, the “next-generation” treatment modality.
The present analysis of the STRIKE-PE study evaluated periprocedural and functional results of the first 164 acute PE patients enrolled and treated with CAVT using the 16Fr Lightning Flash system. The device comprises an aspiration catheter and a microprocessor programmed to optimise regulation of aspiration by using pressure differential and flow-
based algorithms to rapidly detect thrombus from blood flow.
Among their 164 acute PE enrollees, the average patient age was 61.6 years, and 53.7% were male. PE risk stratification was high in 4.9% of patients, intermediate-high in 86.6% and intermediate-low in 8.5%. The median thrombectomy time was 25.5 minutes and median procedure time was 59 minutes. Schiro reported that mean on-table pulmonary artery pressures (PAPs) “significantly decreased”—systolic PAP from 50.8mmHg to 38.8mmHg (23.4%, p<0.001), and mean PAP from 31.2mmHg to 23.5mmHg (24.5%, p<0.001)—demonstrating the device’s effect, providing “quick haemodynamic improvement
there are essentially no differences between the patients who had syncope and those who didn’t. We believe this is going to be clinically important because there has been a theory that patients who present with syncope are at increased risk, whether it’s primary safety or device-related safety outcome during the procedure.”
Both groups had reduced dyspnoea via the Borg scale at rest from baseline to discharge, and no significant differences in dyspnoea were reported between the groups following a sixminute walk test at discharge.
“Syncope is a common problem,” Moriarty described. “We believe that it’s an indicator of compromised cardiac output, and then therefore it portends to people who have a bad outcome due to the severity of their haemodynamic instability or right ventricular outflow tract obstruction, with an increase in RV dysfunction at presentation, an increase in short-term mortality and risk of early PE-related adverse outcomes, making this is a very fertile area of evaluation,” he added.
“So far, we believe that the clinical benefits of CAVT that are shown in this study may be especially valuable for patients who present to this theoretically high-risk cohort,” Moriarty commented. Moving forward, he and his team add that there is need to elucidate clinical markers to further the understanding of patients with acute PE.
and stability”.
Mean RV/LV ratio decreased from 1.34 at baseline to 0.94 at 48 hours (27.8%, p<0.001). The speaker noted that one composite major adverse event (0.6%) occurred within 48 hours; however, no device-related serious adverse events were reported. Six patients required pre-discharge transfusion. “Most of these were related to the patient’s underlying conditions”, Schiro stated; however, no major bleeding required transfusion and there were no device-related transfusions. Additionally, median Borg dyspnoea score at rest decreased from 5 (severe [heavy]) at baseline to 0.5 (very, very slight [just noticeable]) at discharge.
“What we really want to highlight here is the procedure time and the time of thrombectomy,” Schiro told SIR delegates. He compared the 16Fr Lightning Flash to devices used in the APEX-AV, FLASH and PEERLESS trials, which had procedure times of 37.2, 43, and 47.5 minutes, respectively.
Procedure time in minutes
“The most impressive figure really is that short device time. We achieved exceedingly short procedures compared with some of the other trials that have been reported,” Schiro said. “With the [16Fr Lightning Flash] device, we continue to see significant improvements in the patient’s status, including RV/LV ratio, functional status and an excellent safety profile,” he stated.
Twelve-month results of the Wrapsody Arteriovenous Access Efficacy (WAVE) pivotal trial show a statistically significant improvement in target lesion primary patency (TLPP) with the Wrapsody (Merit Medical) cell-impermeable endoprosthesis (CIE) when compared to percutaneous transluminal angioplasty (PTA).
THE PROSPECTIVE, MULTICENTRE, international WAVE trial includes 43 centres in the USA, South America and the UK, concerning arteriovenous fistula (AVF) patients with venous outflow stenosis or occlusion in their peripheral venous outflow circuit.
These results were presented by Dheeraj Rajan (University of Toronto, Toronto, Canada) at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA). Rajan detailed that treatment efficacy was determined by the proportion of patients with TLPP, defined as freedom from clinically driven target lesion revascularisation or target lesion thrombosis. A key secondary endpoint at 12 months was access circuit primary patency (ACPP).
A total of 245 patients were randomised, 122 to treatment with Wrapsody and 123 to PTA. Rajan reported that no statistically significant difference in the proportion of patients free from a safety event was observed through to 30 days post procedure (CIE: 96.6%; PTA: 95%; non-inferiority p<0.001). At six months, the TLPP was higher for patients treated with Wrapsody versus PTA (89.8% vs. 63%; p<0.0001) and remained higher than the PTA cohort at 12 months (70.1% vs. 41.6%, p<0.0001). The six-month
ACPP was higher for patients treated with Wrapsody versus PTA (72.8% vs. 58%, p=0.014) and remained higher at 12 months (58.1% vs. 34.4%, p=0.0003).
“Looking at our 12-month primary patency, you can see the survival benefit is maintained and actually separates over time,” said Rajan, reflecting on their results. “As the curves continue to separate, I argue that there’s a continued therapeutic benefit [with Wrapsody] over time, and for access circuit primary patency as well.”
Rajan added: “Within dialysis access, those of us that do it, we know that the outcomes of vascular access directly contribute to the mortality and morbidity of patients. There’s a really high cost to maintaining these accesses, and to date, all comparative studies still consider PTA as the gold standard for treatment.
“Although PTA has done reasonably well [in trial settings], there has always been
JETi registry reports effective thrombus reduction in lower extremity DVT
Recently presented at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA), data from the Jet Enhanced Thrombectomy intervention hydrodynamic thrombectomy system (JETi; Abbott) registry has demonstrated the device’s effectiveness having surpassed prespecified safety and efficacy thresholds for the removal of thrombus in lower extremity deep vein thrombosis (DVT).
THE JETI SYSTEM IS A hydromechanical aspiration system intended to remove intravascular thrombus. To evaluate its efficacy, the prospective, single-arm, all-comer, real-world venous registry was devised, enrolling 116 patients with iliofemoral DVT from 14 global sites. Mahmood Razavi (St. Joseph Heart & Vascular Center, Orange, USA) presented the results.
Primary effectiveness was assessed by the percent of treated vessel(s) with ≥75% venous thrombus reduction from baseline to final venogram following all primary and adjunctive therapies per core lab-assessed modified Marder score. Safety was assessed by the composite rate of JETi-related major adverse events that included death, symptomatic pulmonary embolism (PE), major bleeding, and re-
thrombosis of JETi-treated vessel(s) up to 30 days post procedure per clinical events committee adjudication.
Patients in this cohort had a mean age of 56.6 years, and half were female. Prior rates of DVT (21.6%) and PE (19.8%) were high in this patient population, with significant rates of other conditions such as hyperlipidaemia, diabetes and hypertension. Nearly three quarters of the population (74.1%) had onset of signs and symptoms within 14 days, 16.4% between 14 and 42 days, and the remaining (9.5%) beyond 42 days.
The total index procedure time was reported as 124.5 minutes, while the JETi device use time was
room for improvement, and we’ve chased that [via the WAVE trial],” Rajan told the SIR audience. “We’ve seen improved TLPP with covered stents in the past, but the access circuit primary patency doesn’t change much. The argument has always been why would you use these devices if you aren’t changing the overall lifespan of the access,” said the speaker.
The WAVE trial is still currently ongoing, said Rajan, stating that 24-month results are forthcoming. In light of the sustained improvement in TLPP and ACPP with Wrapsody, and the “limited options available to restore and maintain access circuit primary patency”, the authors state that these findings are of “high value” to clinicians who treat stenosis/occlusion in the venous outflow circuit of haemodialysis patients, and for the patients themselves.
23.5 minutes; 72.4% of patients were treated in a single session with the device. Concerning adjunctive treatments or additional interventions, 83.6% required a balloon and 55.2% a stent. Two patients required the use of the JETi HyperPulse (Abbott) thrombolytic and 13.8% of patients required a handinfused thrombolytic. Catheter-directed thrombolysis was performed in 25.9% of patients—4.3% prior to JETi use and 21.6% following. Regarding primary effectiveness, at least 75% thrombus reduction was achieved in 84.5% of treated limbs via modified Marder score, which
met the prespecified performance goal of 64%. Major adverse events were reported in 1.7% of patients, including symptomatic PE and rethrombosis of JETi-treated vessels.
Patients reported improved Villalta post-thrombotic syndrome (PTS), leg pain, and quality of life scores at 30 days post procedure. Importantly, despite disclosing moderate to extremely severe pain at baseline, 81% of patients reported that they had no pain to mild pain at follow-up. Meeting its prespecified efficacy and safety criteria, the investigators highlight the marked improvement in clinical and patient-reported outcomes, and state that the registry’s one-year results, which are set to be released in due course, will bear out these data in greater granularity.
Wrapsody
Razavi presenting at SIR
Point of View
Histotripsy: What we know so far
Mishal Mendiratta-Lala
Histotripsy is a non-thermal, non-ionising and non-invasive focused ultrasound technique which relies on cavitation for mechanical tissue breakdown at the focal point. Leading research into the novel technique, Mishal Mendiratta-Lala (University of Michigan, West Bloomfield, USA)—principal investigator for the #HOPE4LIVER trial evaluating histotripsy in liver tumours— provides a deep dive into the treatment option, discussing its application and evolution in the near future.
In 2024, histotripsy has advanced significantly following its US Food and Drug Administration (FDA) approval in late 2023, allowing many institutions to acquire the technology for clinical use. Most systems were delivered this year, leading to the treatment of over 500 tumours with histotripsy.
Although enthusiasm is high among both patients and the medical community, it is still too early to report definitive new findings. The focus must remain on collecting and analysing data to assess long-term efficacy. A key priority moving forward is careful patient selection, ensuring that histotripsy is used appropriately rather than broadly applying it to all cases.
Histotripsy garners “excitement” in the cancer community
For patients deemed suitable for treatment with histotripsy, the procedure has demonstrated several benefits over alternative ablative techniques. These are largely due to the non-invasive nature of the procedure, minimal bleeding risk, and postprocedure pain and recovery times.
There is excitement in the cancer community about histotripsy’s potential to induce an abscopal response— a systemic immune reaction against cancer. However, this effect has not been reliably observed in clinical practice yet and we look forward to emerging research that may bear out evidence of this response.
Current data supporting histotripsy’s efficacy is limited but promising. To date,
there are two peer-reviewed studies that are analysing histotripsy—the first-in-man THERESA trial evaluating histotripsy of hepatic tumours, and the #HOPE4LIVER trial which concerns the treatment of liver tumours with histotripsy. The former is a small early study focused solely on safety. The 36-hour data confirmed that treated volumes were effectively ablated, demonstrating initial safety. The latter #HOPE4LIVER trial involved 44 tumours, and evaluated 30-day safety and efficacy. The results showed that histotripsy successfully treated the target lesions, with no enhancement of the treated tumours, confirming shortterm efficacy.
These studies confirm that histotripsy is safe, but long-term efficacy, survival benefits, and recurrence rates remain unknown. To determine whether histotripsy improves overall survival and delays disease recurrence, more clinical trials and data-sharing across institutions are essential. Treating patients with only 30-day data in 44 tumours is premature for broad clinical adoption, emphasising the need for
further research.
“Challenging” operator learning curve
Leading histotripsy technology innovation, the Edison (HistoSonics) platform has a notable operator learning curve due to its complexity and multiple components requiring proficiency. Challenges include setting up the water bath correctly to prevent leaks, accurately identifying the target, and properly defining treatment boundaries. The robotic head’s large and bulky design adds difficulty in positioning for optimal lesion treatment. Additionally, treatment limitations arise from factors such as lesion depth, adjacent structures, and device voltage constraints.
As for institutional implementation, while the platform can be highly effective when the target is appropriately selected, its adoption requires significant training, experience, and institutional investment in both personnel and infrastructure. Proper
With more institutions purchasing the device, the accumulation of clinical data will be crucial. However, the success of histotripsy will depend on strong collaboration within the clinical community to analyse outcomes and refine patient selection criteria. Not all patients will be ideal candidates, making ongoing clinical trials essential for optimising the technology’s impact in cancer treatment.
Global adoption of histotripsy is likely to grow, but its integration into standard care will require further validation through research. We need more clinical trials with combination therapies and we need more trials looking at treatment of different cancer types.
A key focus for 2025 will be ensuring that histotripsy is implemented effectively and safely. Additionally, while the potential for an abscopal response is intriguing, it remains unproven in patients, and caution is necessary to avoid unintended consequences.
There is excitement in the cancer community about histotripsy’s potential to induce an abscopal response—a systemic immune reaction against cancer”
training programmes and support are essential for successful integration.
I believe a successful histotripsy programme requires institutional commitment and resources, making it challenging to adopt easily.
While institutions can integrate the technology, its success will depend on the presence of a strong clinical team, institutional support, a general anaesthesia team, adequate space and finally, a financial bolster. Insurance reimbursement is not always guaranteed, and thus institutions will need a strong financial team to navigate funding and advocate for coverage.
What’s to come for histotripsy in 2025
The year 2025 will be an exciting one for histotripsy as the field evolves.
In addition, histotripsy is being expanded to renal and pancreas applications which will be very exciting. Overall, histotripsy has significant promise, and 2025 will be a pivotal year in determining its role in the broader clinical landscape. The medical community plays a critical role in shaping the clinical narrative and ensuring responsible treatment decisions. Looking ahead, I hope to be able to lead clinical trials, which will be essential in identifying the ideal patient population and determining whether histotripsy can provide meaningful survival benefits for cancer patients.
Mishal Mendiratta-Lala is an interventional radiologist at the University of Michigan in West Bloomfield, USA.
ALEX BARNACLE
How are children treated at your local hospital? Asks paediatric interventional radiologist Alex Barnacle (London, UK) of healthcare providers today. Her question brings attention to the “insurmountable barriers” which paediatric interventional radiology (IR) faces, even in large, specialised centres. Affecting change, Barnacle’s outreach efforts span the globe, and her involvement with international societies is ongoing. Here, Barnacle—consultant paediatric interventional radiologist at Great Ormond Street Hospital for Children—shares the lasting impact made by her mentors, an early case that changed treatment management for the condition, and the collaborative work that must be done to resolve inequalities in paediatric IR.
What attracted you to a career in medicine, and what made you choose paediatric IR?
I was fascinated by paediatrics even as a medical student, but it took a long time to work out where exactly in paediatric healthcare I would thrive. I trained in neonatal intensive care, paediatric surgery and general paediatrics before being inspired by a wonderful paediatric radiologist and mentor— Jo Fairhurst—to consider paediatric radiology
After obtaining my paediatric qualifications, I transferred into radiology with the firm intention of becoming a diagnostic paediatric radiologist but fell in love with IR along the way.
For a while I was in turmoil, trying to choose between the two. I was fortunate enough to then be introduced to another key mentor, Derek Roebuck, who was developing a paediatric IR service at Great Ormond Street Hospital in London, UK. It was incredible timing, because he was probably the only one practising paediatric IR in the UK at the time and I immediately knew this was the career I had been searching for.
Who have been your mentors throughout your career and what is the best advice they have given you?
I have been inspired and encouraged by so many people along the way, and it continues, of course. Often, all it takes is one small thing someone says or does to leave a lasting impression or prompt us to reflect and change.
I am inspired by colleagues in industry, by the nurses and radiographers I work with, and by trainees as much as I am by senior interventional radiologists. Adam Mitchell was an inspiration in my very first year as a radiology trainee and taught me to be brave. James Jackson instilled in me a passion for treating vascular malformations. Within paediatric IR, Roebuck shaped both my career and my ambitions but I have also been inspired by many senior interventional radiologists within the wider paediatric IR community around the world.
Anna Maria Belli has been a key influence and support in my career, always encouraging me to break down barriers and aim high. And there are many brilliant women in IR who are role models for me and continue to inspire me to pursue excellence in IR and equality in our field—Laura Crocetti, Maureen Kohi, Gloria Salazar, and Tze Wah are just a few of these women.
Could you describe a case that has been the most memorable throughout your career thus far?
Only three years into my consultant career, I was referred a very young child with a lymphatic malformation of her orbit which had caused devastating consequences. I was familiar with treating malformations elsewhere in the body but never in the posterior orbit and I couldn’t find anyone in the UK who had treated one. I reached out to colleagues in the USA and Australia who supported me remotely. I performed three sclerotherapy procedures for her, with great trepidation. But the response of the malformation was truly remarkable and in a very short space of time she was pain free and getting back to being a happy and wonderfully courageous child. Since then, I have treated many, many children with this condition and together with some other interventional radiologists around the world, we have changed the management of this condition and the lives of these children. I am still in touch with this first patient and will always be grateful to her parents for trusting me with their precious daughter’s health when this was such a novel approach.
You are currently involved with the first Getting It Right First Time (GIRFT) initiative for IR in the UK. How has this experience been and what has been learned during the process so far?
It is a really innovative programme in England which takes a very detailed look at individual clinical specialties. Last year, the GIRFT programme for IR was launched and I am honoured to be the clinical lead. We review all the national IR data available and visit every hospital in England that performs IR. So far, my colleague Gill Kitching and I have visited 10 hospitals—only 112 to go!
We are looking for unwarranted variation in practice, particularly in patient outcomes, efficiencies in clinical care pathways and costs. Many departments are facing significant challenges in delivering the level of care they aspire to, particularly with current economic constraints, and we are often seeking support and advocate for them. And there are also teams who have developed novel ways of working and are delivering excellence in some areas of IR; we are mining for those pockets of excellence and aiming to disseminate examples of best practice. It is a privilege to visit so many IR departments and explore these themes with colleagues around the country. We are still in the early stages of the
FACT FILE
CURRENT APPOINTMENTS
2004–present: Consultant radiologist, Great Ormond Street Hospital for Children (London, UK)
2021–present: Committee member, The Royal College of Radiology
2021–present: Advisory committee member and senior mentor, EMERGE programme
2022–present: Executive committee member, CIRSE
PREVIOUS APPOINTMENTS (SELECTED)
2015–2018: Radiology lead, The Portland Hospital for Women and Children (Portland, USA)
2020–2021: President, Society for Paedatric Interventional Radiology (SPIR)
2021–2024: Member, European CORE-MD group
OTHER APPOINTMENTS (SELECTED)
Principal investigator, ICECaP paediatric cryoablation registry
Co-author, European Horizon 2020 COREMD paediatric medical device report
Paediatric IR mentor, Lady Ridgeway Hospital for Children, Colombo, Sri Lanka
programme but emerging themes for me have been the relative disadvantages that some non-vascular IR services encounter compared to vascular IR services, and the lack of specialised training for nurses in IR. At the end of the project, we will publish a national report of our findings and recommendations.
You are currently on the executive committees of CIRSE and BSIR. How do these roles cross-pollinate with your daily practice?
It has been one of the unexpected privileges of my career to work with senior colleagues in the executive committees of the British Society of Interventional Radiology (BSIR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), as well as previously in the Society for Pediatric Interventional Radiology (SPIR). I find it hugely rewarding to collaborate on exploring future directions for our specialty and finding ways to support our talented colleagues at the coalface of IR. Leadership roles like these challenge me to develop very different skills to those typically used at the angiography table, and to broaden my horizons. I love exploring ways to bring people together to achieve their goals. It is an honour.
Are you still involved with ICECaP, the first paediatric ablation registry in Europe? If yes, what is the status of the registry?
The ICECaP registry is recruiting patients undergoing cryoablation for both benign and malignant disease. Our aims are to confirm that cryoablation is safe in small children and to establish which diseases cryoablation is most effective for. Paediatric IR case numbers for procedures like this are always going to be low in individual centres so it is imperative that we collaborate across institutions and countries to collate and examine our practice and provide much-needed outcome data to guide the development of IR for children.
What is an unmet need in paediatric IR today?
There are so many unmet needs in paediatric IR. Paediatricians, paediatric surgeons and children’s hospitals are still frustratingly slow to recognise the value that IR brings for children and their families. There is huge underinvestment in paediatric IR; it is maddening to see colleagues struggling to deliver IR procedures with exceedingly limited resources, even in large, specialist institutions.
There are very few training posts in paediatric IR, especially outside of North America, which of course means a lack of paediatric interventional radiologists.
Paediatric interventional oncology (IO) is significantly hampered by the absence of IR options in almost all treatment and study protocols. And we are held back by the lack of paediatric-specific equipment. Most of the time we can find workarounds with standard adult IR devices and kit, but now even this is heavily impacted by the recent changes in European medical device regulation. There are now almost insurmountable barriers to device development for paediatric use and we are seeing longstanding devices removed from the market or being labelled as ‘contraindicated for paediatric use’.
My colleagues and I recently published a research needs assessment for paediatric IR which highlighted a number of barriers to meaningful research in our field, despite widespread interest within the paediatric IR community for collaborative research.1 The paper emphasises some important areas for us and our clinical teams to
focus on going forward.
In my opinion, the area of greatest need, and an area in which IR can undoubtedly impact children’s healthcare, is in paediatric oncology.
As in adult IO, we need to keep pushing our oncology colleagues for a seat at the table, so that we can demonstrate to them what we can do and together explore how IR can contribute to paediatric cancer care. I am thrilled that the European Society for Paediatric Oncology (SIOP Europe) will be welcomed as part of the CIRSE 2025 congress (13–17 September, Barcelona, Spain). SIOP Europe is the only pan-European organisation representing all professionals working in the field of childhood cancer and our most valuable partner in furthering paediatric IO in Europe.
What is your advice to young interventional radiologists entering the field of paediatrics today?
Paediatric IR is a hugely rewarding career path, and you will be part of an immensely warm and welcoming international community. Seek out paediatric IR colleagues at all of the major IR congresses to develop
"It will take all of us to change many of the current inequalities in paediatric IR care”
links with us and share ideas, and join us at the annual Society for Pediatric Interventional Radiology (SPIR) meeting (14–16 October, Sydney, Australia). Reflect on how children are treated in your local hospitals—are they are being offered the same IR options that adult patients are? Almost certainly not. Can you influence that? It will take all of us to change many of the current inequalities in paediatric IR care.
What does your life outside of medicine look like?
I have a busy and fun life outside of work. My husband Andy and I play a lot of tennis, and we enjoy travelling together. I am passionate about art, exploring and appreciating fine art in galleries around the world, but also drawing and painting myself. I have recently gone back to art school in the evenings and have a very small exhibition coming up at the end of the year.
References 1. Temple et al Fostering research in pediatric interventional radiology: needs assessment and suggestions for support. Pediatr Radiol 2023 Oct;53(11):2245-2252. doi: 10.1007/s00247023-05722-6).
Will registries replace RCTs for kidney tumour ablation?
“Although [real-world registries] seem unsexy, it’s the direction of travel,” said David Breen (Southampton University Hospitals, Southampton, UK), describing the comparative advantages and challenges of randomised controlled trials (RCTs) and real-world registries in providing kidney tumour ablation data.
“LET’S TALK HONESTLY ABOUT RCTS. There are problems,” began Breen, during his talk at the European Conference on Interventional Oncology (ECIO; 12–16 April, Rotterdam, The Netherlands). “Clearly, they set out to avoid bias and establish causality, but it’s a trade-off between experimental rigor and being able to generalise our data for its real-world applicability in daily practice.”
In general, Breen stated that RCTs are becoming “increasingly unaffordable” outside of a pharma industry setting. Conducting research in the interventional space sometimes means that professional “boundaries” will be crossed between surgery and interventional radiology (IR)— “we know that can bring problems for recruitment to randomised trials”.
The “unfortunate truth” is that some major steps in medicine have made it into standard practice without an RCT, Breen said, such as penicillin or resection for colorectal liver metastases, the latter of which exists at the level of 3b on the Evidence (EBM) Pyramid.
Returning to the kidney, Breen added that since
the uptake of robotic-assisted partial nephrectomy, there has been no trial comparing the technique to open or limited-access partial nephrectomy.
Conducting RCTs evaluating ablation for kidney tumours comes with unique challenges, he went on to detail, describing renal cancer as an indolent disease process which negates the investigation of early outcome markers at one to two years.
“digging into electronic health records [EHR]” which record a large volume of real patient data. In the UK, Breen highlighted the National Health Service (NHS) and UK Biobank, which he states are “phenomenally rich” datasets.
“There’s a reason Mark Zuckerberg and Jeff Bezos are our new best friends in the UK,” said Breen. “The NHS owns one of the largest volume and most consistent healthcare datasets exploitable in global healthcare.”
Coupled with the time and cost of setting up an RCT in this space, this often means “your new intervention is an anachronism by the time you’ve got data,” Breen stated.
So, what is real-world data? Breen asked, labelling it naturalistic data, often pulled by
We’ve got to look at large real-world registries”
AI ethics session suggests hybrid approach the future for IO
A keynote session on the future of interventional oncology (IO) brought artificial intelligence (AI) to the forefront of discussion, highlighting both its potential and the ethical, legal, and regulatory challenges it presents. The presentation, delivered by Gianpaolo Carrafiello (University of Milan, Milan, Italy) discussed the concept of “hybrid intelligence” as the likely future model, in which AI augments, rather than replaces, clinical expertise.
BEGINNING WITH A historical definition from AI pioneer John McCarthy, who described AI as “the science and engineering of making intelligent machines,” the speaker framed the discussion around AI’s emerging applications in IO. These include image analysis, segmentation, predictive modelling, decision support systems, and training for interventional radiologists. Particularly in education, AI has shown potential to help standardise and accelerate the training of new interventionists.
The session touched on the responsibility associated with deploying AI in clinical environments. “The decision to accept or override AIgenerated recommendations requires careful justification,” Carrafiello explained, noting that regulation may demand well-documented reasoning from physicians who diverge from algorithmic suggestions.
Responsibility in AI use was broken down into three core elements: accountability, culpability, and liability.
Carrafiello said that, while AI systems can be held accountable to the extent of explaining their processes and outputs, they cannot be held culpable, “as they lack consciousness, intent, or free will”. Legal liability, however, remains a more complex issue, often extending to developers, institutions, or clinicians depending on the case and regulatory framework.
The speaker identified transparency as a key principle in bridging these gaps. Carrafiello advocated for moving from a “black box” model— where internal AI decision-making is “opaque”, to a “glass box” approach where processes are “visible and understandable”.
“This is essential for building explainable AI systems that foster trust and accountability,” he said.
Yet, Carrafiello believes that transparency may come at a ‘cost’: “Simplifying models to enhance explainability can sometimes reduce predictive accuracy.” In healthcare, where outcomes may depend on precise
He went on to highlight the successes and failures of recent registries, highlighting ongoing efforts of the EUropean REnal Cancer CryoAblation Registry (EuRECA), established by a European Hospital network, with which Breen’s centre in Southampton is involved.
Awaiting release, Breen stated the registry team is currently sitting on prospectively collected data from approximately 1,700 patients treated with percutaneous cryoablation.
“Almost 1,500 of them are biopsy-proven, 14% in a single kidney,” said Breen. “There’s no partial nephrectomy series that is so rich with singlekidney data. The data is in preparation; it is clearly chronologically mature, this is going to be the practical direction of data accrual for healthcare providers and commissioners.”
“We’ve got to look at large real-world registries. If granular enough, we should ultimately be able to exploit artificial intelligence to try and get signals from the raw data and then go after those signals with much more targeted and hopefully easier to deliver RCTs,” Breen stated.
treatment planning, this trade-off presents a practical challenge.
The legal frameworks guiding AI use in Europe was another focal point. The European Union’s Medical Device Regulation (MDR) currently classifies certain AI tools as medical devices, requiring CE marking unless developed exclusively for in-house use.
Additionally, the 2021 EU Artificial Intelligence Act introduced a risk-based regulatory system, categorising AI
interventional oncology,” Carrafiello noted. Gaps in legislation may hinder the development and deployment of AI tools in IO and leave gaps in regulation concerning post-market surveillance and algorithm bias, he added.
Expanding on bias in AI algorithms, Carrafiello pointed out that “AI algorithms may be less accurate for underrepresented or marginalised populations, reinforcing systemic inequities in access and outcomes,” and adding that this is particularly “troubling in oncology, where timely interventions can dramatically alter prognosis”.
in healthcare as “high risk” due to its potential impact on patient safety. However, the speaker argued that these policies still fall short: “Current EU legislation does not sufficiently address the specific regulatory needs for AI in clinical specialities like
The speaker then urged that interventional radiologists retain ultimate responsibility, explaining that “AI should be a support tool, not a decision-maker.”
Carrafiello advocated for ongoing development in AI systems in IO, regular audits of AI-driven decisions, and transparent communication with patients about the use of AI in their care.
Carrafiello then suggested that hybrid intelligence, defined as the combination of human expertise with AI augmentation, will define the future of IO, however, interventionists that fail to adapt may fail to keep up, and will be left behind. “AI will not replace interventional radiologists, but those who use AI will replace those who don’t,” he said.
David Breen
Major gaps in IR knowledge must be addressed Mina S Makary
In a paper titled ‘Specialist awareness of interventional radiology: Current state of affairs and opportunities for improvement’, Mina S Makary (Columbus, USA) and his team surveyed specialist provider understanding of interventional radiology (IR) at their tertiary centre, which yielded unanticipated results. Here, he discusses the data they collected and their broader significance for the evolution of the specialty.
Our recent survey has revealed significant gaps in awareness and understanding of IR among specialist providers, raising concerns about missed opportunities for minimally invasive care. The study, conducted at a large academic medical centre, surveyed over 1,400 nonprimary care specialists and received 516 responses. While IR continues to expand its scope across oncology,
urology and women’s health, the findings show that many medical professionals remain unaware of the specialty’s full range of applications.
Nearly 60% of surveyed specialists rated their knowledge of IR as only ‘adequate’ or ‘poor’—a result we did not anticipate. When asked how frequently they offered IR procedures as alternatives to surgery, 20% admitted they never did. Conditions
like abscesses and haemorrhages were commonly linked to IR, but recognition dropped significantly for areas such as infertility, benign prostatic hyperplasia (BPH) and bone cancer—indications where IR can play a critical role.
Advanced practice providers (APPs) demonstrated lower overall awareness than physicians but showed a stronger interest in learning more about IR services. In fact, 75% of APPs expressed a desire to improve their knowledge, positioning them as a key audience for targeted educational efforts.
Interestingly, the study found no significant difference in IR familiarity between surgical and non-surgical specialties, despite the procedural alignment between surgery and interventional radiology. Among specialist physicians, early-career practitioners—interns, residents and junior attendings—were less likely to report high confidence in their understanding of IR.
The results highlight an ongoing need to integrate IR education into medical
training and continuing professional development. Previous efforts—such as presentations at specialty conferences— have been shown to effectively raise awareness, but the study suggests broader strategies may be necessary.
The findings carry clear implications for patient care. Without broader specialist recognition of IR’s expanding capabilities, patients may miss out on less invasive, lower-risk therapeutic options. Bridging the knowledge gap through structured education and interdisciplinary collaboration could significantly improve referral patterns and treatment outcomes.
As IR continues to innovate across multiple domains, its visibility within the wider medical community must keep pace. This study offers a timely reminder that increasing awareness is not just a professional courtesy—it’s a clinical necessity.
Mina S Makary is an interventional radiologist at The Ohio State University Wexner Medical Center, Columbus, USA.
Nearly 60% of surveyed specialists rated their knowledge of IR as only ‘adequate’ or ‘poor’— a result we did not anticipate”
Geographic information mapping identifies IR expansion opportunities to combat postpartum haemorrhage in Kenya
A new geographic information system (GIS) analysis of Kenya has found “disproportionate” rates of maternal morbidity and mortality due to postpartum haemorrhage (PPH) in areas without interventional radiology (IR) capabilities.
LED BY RYAN W ENGLAND (PRINCETON Radiology Associates, Princeton, USA) and published in the Journal of Vascular and Interventional Radiology (JVIR), the study employed multilayered GIS mapping to pinpoint healthcare disparities and propose a framework for global IR outreach.
The authors detail that PPH is a leading cause of preventable maternal mortality globally, particularly in low- and middle-income countries. Minimally invasive endovascular procedures such as uterine artery embolization (UAE), performed as standard for interventional radiologists, can be used to treat severe cases of PPH that are unresponsive to firstline treatments.
“UAE has been shown to be safe and effective, with systematic reviews demonstrating a clinical success rate (as defined by controlled bleeding without need for additional procedure or surgery) of 89%,” write England and colleagues, referencing a 2021 paper by Matthew Brown et al. Although the treatment has been shown to control PPH while preserving the uterus, access to UAE in Kenya is currently limited to just six hospitals—all located in the capital city of Nairobi.
In their analysis, the authors reviewed publicly available Kenyan health and demographic data from 2014–2018. Using county-level statistics, they constructed three key indices: a PPH Risk Index (PRI), a Health Severity Index (HSI) and a Combined
Risk Index (CRI). These indices were derived from variables such as adolescent pregnancy rates, maternal mortality ratios (MMRs), access to antenatal care, insurance coverage and physician density.
A total of f 14,718,288 female Kenyans of childbearing age were included in the geospatial analysis. Between 2014 and 2018, the number of maternal haemorrhages across the country was found to increase from 15,457 to 21,332, rising by 38% over the five-year period.
Notably, the highest MMRs were observed in the southeastern and northwestern counties, with standard deviations 1.5–2.3 above the national mean. This finding correlated with lower densities of healthcare facilities, longer travel times to a healthcare facility, and lack of IR services. In contrast, Nairobi’s MMR fell within the national average, despite housing the country’s only IR-equipped hospitals.
“Geospatial analysis has been successfully used for public health mapping and radiology outreach in the past,” write England and colleagues. “Prior research using GIS has shown that distance to quality healthcare facilities is a substantial factor in the utilisation of clinical services.”
Translating their findings into actionable measures, the authors examined the density of the study target population
within a one-hour drive of each hospital overlaid onto the CRI for each county. By doing so, the authors were able to identify the hospital in which development of IR services may have the greatest impact on decreasing PPH morbidity and mortality. Among them, Homa Bay County Teaching and Referral Hospital in southwestern Kenya was highlighted as a high-priority site for IR development, due to its high CRI score and catchment population of women of childbearing age. Despite Nairobi being relatively better equipped, England and colleagues emphasise that a broader nationwide expansion of IR services is critical. As of 2024, only around 10 practicing interventional radiologists serve the entire country, with all initially trained abroad. “This information only highlights the dramatic need in such a populated city for IR services to grow and expand,” the authors write.
Efforts are underway to bolster local capacity, including a dedicated IR fellowship programme at the University of Nairobi that began producing graduates in 2020.
“Moving forward, further investigation of targeted individual healthcare facilities in Kenya needs to be assessed to better understand the unique needs of each hospital and region. One approach includes performing an ‘IR Readiness Assessment’ to successfully create meaningful and sustainable solutions to each individual hospital’s radiology needs,” England
Ryan W England
“Using a framework such as this may allow for a comprehensive examination of current and future barriers involved in implementing IR outreach and resource allocation in the regions identified through this analysis,” the authors write. They note that further research will aim to correlate GISdriven service expansion with realworld maternal health outcomes as IR capacity in Kenya grows.
Clinical News
IceCure Medical report results for ProSense cryoablation treatment of breast cancer
IceCure Medical revealed findings from investigator-initiated studies of the company’s ProSense system for the cryoablation treatment of breast cancer. The data were delivered in two scientific sessions and one poster presentation at the European Conference on Interventional Oncology (ECIO; 12–16 April, Rotterdam, The Netherlands).
First, Sophie M Wooldrik (Erasmus University Rotterdam, Rotterdam, The Netherlands) presented ‘Review of the indications and results of the different techniques of thermal ablation on breast tumours; the treatment of breast cancer with percutaneous thermal ablation— THERMAC: An open-label phase 2 screening trial.’ The study enrolled 41 women and compared cryoablation to radiofrequency ablation and microwave ablation.
As summarised in the company’s press release, the investigators concluded that only cryoablation met the requirement to proceed to a phase 3 study, with an efficacy rate of 94%, with no complications and a 100% treatment tolerance. Additionally, the study found that 94% of patients were very satisfied or satisfied with the thermal ablation technique, and 95% of patients stated they would choose thermal ablation versus breastconserving surgery.
Cagent Vascular initiates patient enrolment in Serranator vs. plain balloon angioplasty OCT study Cagent Vascular announced its first patient enrolment of the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.
This prospective, randomised, dualcentre study will enrol up to 60 patients and will utilise intravascular OCT imaging to demonstrate the mechanism of action (MOA) of the Serranator and compare the serration MOA to conventional angioplasty across a range of lesion morphologies in belowthe-knee arteries. The study will take place at Columbia University Medical Center and Weill Cornell Medicine led by co-principal investigators Sahil Parikh and Brian DeRubertis.
Microbot Medical shares results from ACCESS-PVI pivotal trial
Microbot Medical shared that it presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA).
The study was performed at three leading medical centres in the USA: Memorial Sloan Kettering Cancer Center (New York, USA), Baptist Hospital of Miami (Miami, USA) and Brigham and Women’s Hospital (Boston, USA). The late-breaking podium presentation was delivered by Francois Cornelis of Memorial Sloan Kettering Cancer Center.
The data concluded that robotic endovascular procedures using Microbot Medical’s Liberty endovascular robotic system are feasible and significantly minimise radiation exposure.
Real-world data show Cook’s Zilver PTX leads to lower rates of in-stent occlusion than Boston Scientific’s Eluvia Cook Medical announced that its Zilver PTX drug-eluting stent (DES) has lower rates of instent occlusions among patients with restenosis at three years than the Eluvia DES (Boston Scientific), according to real-world data from the REALDES study. The company noted that the data, published by Tsuyoshi Shibata (Sapporo Medical University Hospital, Sapporo, Japan) et al in the European Journal of Vascular and Endovascular Surgery (EJVES), are the first to compare Zilver PTX and Eluvia in real-world practice at three years.
“There have been many unanswered questions on the reliability of the current data comparing the different drug-eluting stents on the market. REALDES helps paint a more complete picture on DES differences, evaluated by independent investigators in a real-world setting,” said Alec Cerchiari, director of product management for Cook’s peripheral arterial disease (PAD) and venous specialty.
DeepQure advances clinical trials of its HyperQure extravascular renal denervation system
DeepQure recently detailed progress in clinical trials of its extravascular renal denervation device, HyperQure.
The company is actively conducting clinical trials in both South Korea and the USA, which it says demonstrate “promising” results. In South Korea, seven patients have undergone the procedure, showing meaningful reductions in blood pressure without any adverse events during- or post-operation.
The company aims to complete enrolment for its Korean clinical trial within the first quarter of 2025.
Product News
VentiV Scientific mechanical thrombectomy system granted FDA approval
VentiV Scientific has announced the US Food and Drug Administration (FDA) clearance of VentiV mechanical thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.
“Electric pump-based thrombectomy systems can unexpectedly clog and/ or remove 5–15ml per second of blood before removing blood clots,” said Dan Ryan, board of directors, VentiV Scientific. “The Pulse is designed to instantly start, stop, increase and/or decrease thrombectomy force at the tip, decrease clogging inside the catheter, and decrease blood-loss with use of any aspiration pump currently in the hospital.”
Adept Medical updates its IR platform and overhead arm support ranges
Adept Medical unveiled two updated product launches, coinciding with the Society of Interventional Radiology’s 50th annual scientific meeting (29 March–2 April, Nashville, USA).
This includes the launch of the Retrograde IR Platform-Narrow, a complementary addition to its existing range, and the Overhead Arm Support MR Safe-Small. Both are available commercially from 14 April.
Developed in response to postmarket feedback and extensive research, the new size Retrograde IR Platform-Narrow addresses the need for a more compact over-patient work surface for guidewire management during femoral access procedures.
Inari Medical, now part of Stryker, launches Artix thrombectomy system
Inari Medical, now part of Stryker, recently announced the launch of its Artix thrombectomy system. Purposebuilt for the distinct needs of the peripheral arterial system, Artix is a combined aspiration plus mechanical thrombectomy solution that delivers procedural control and versatility, and is designed to set a new standard for arterial thrombectomy.
Stryker notes that the Artix system builds on the success of Inari’s venous thrombectomy devices and is its inaugural entry into the arterial space.
“Inari offers a comprehensive toolkit approach to arterial thrombectomy
Artix
with an innovative, over-the-wire system that provides physicians with the flexibility to aspirate and/or mechanically extract a clot,” a press release notes.
Shockwave Medical announces US launch of intravascular lithotripsy catheter
Shockwave Medical announced the US launch of its Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a platform designed to modify calcium and cross narrowed vessels in patients with PAD.
The forward IVL platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150cm and features a single distal emitter that creates up to 120 shockwave pulses. Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD investigational device exemption (IDE) trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, the company states.
Philips issues Class I recall for Tack endovascular system
Philips recently announced that it will no longer sell its Tack endovascular system in the USA following a Class I recall issued by the US Food and Drug Administration (FDA).
A Class I recall is the FDA’s most serious classification, which denotes that the continued use of the affected product could result in severe injury or death. The FDA’s decision follows reports that the Tack endovascular system—designed to treat arterial dissections—has posed challenges for users, sometimes necessitating additional interventions to retrieve or remove the implant.
The self-expanding device is composed of nitinol, a nickeltitanium alloy and is used following angioplasty, a procedure that widens narrowed or blocked arteries. Philips has reported 20 injuries linked to the Tack system but has not received any reports of fatalities.
Serranator
Javelin
Advantages of steerable microcatheter use in interventional radiology practice
Conventional pre-shaped microcatheter technology has evolved over the last decade, yet significant limitations still exist. In particular, the shape of a standard microcatheter cannot be changed or manipulated while inside a patient’s vasculature. As a user of this innovative technology, Jason C Hoffman (New York, USA) details his first-hand experience.
Selective cannulation of small arterial branch vessels for targeted/superselective angiography or embolization is commonly performed; however, conventional pre-shaped microcatheter use has limitations when in complex arterial vasculature, including tortuous or angulated vessels.
In these scenarios, the operator must often perform multiple microcatheter and wire exchanges to select the target vessel. This can take a considerable amount of time, require use of numerous devices, and may result in a substantial radiation dose to the patient and procedural staff. If the target vessel cannot be superselected, a less-targeted embolization must be performed, or the procedure is abandoned altogether. In either scenario, the case will take longer, with implications for increased cost and resource use, and has the potential for complications and untoward events.
The development of a steerable microcatheter (SwiftNINJA® steerable microcatheter; Merit Medical Systems) is an innovation that offers an alternative approach to selective cannulation. This technology represents a new class of device, designed with a tip that articulates up to 180 degrees in opposing directions, providing realtime ability to change the angulation of the microcatheter tip while navigating through the vasculature.
The device can be used with or without a microwire which allows the injection of contrast while advancing or manipulating the steerable microcatheter. In my experience, this consistently leads to efficient selective cannulation of small vessels throughout the body, with a level of steerability that simply is not provided by any pre-shaped conventional microcatheter.
procedure time (75 vs. 112.5 minutes), and body-mass index (BMI) adjusted radiation exposure were found in the steerable microcatheter group.
Since publishing my early steerable microcatheter results, I have used the device in hundreds of prostate artery embolization (PAE) procedures, as well as superselective embolization of distal hepatic, renal, bladder, visceral and small pelvic arterial branches in a variety of scenarios. Cases have included treatment of traumatic injury, benign prostatic hyperplasia (BPH), hematuria, malignancy and non-traumatic causes of bleeding. Most of these procedures were performed with only the steerable microcatheter, and no microwire was needed. I continue to find that patients and my team benefit from steerable microcatheter use due to increased efficiency, high technical success rates, reliable target vessel selection and decreased radiation exposure.
Reducing vessel selection time in a prostate artery embolization case
An 85-year-old man with a long-standing history of BPH presented with severe lower urinary tract symptoms (LUTS) and intermittent gross hematuria. Despite multiple medical treatments, including three transurethral resection of the prostate (TURP) procedures over the past two years, the patient’s condition had not improved. His International Prostate Symptom Score (IPSS) was 29 (severe), and his Urinary Quality of Life Score was 5 (unhappy).
I can also inject contrast while advancing or manipulating the steerable microcatheter, allowing for precise control and improved vessel targeting. Decreased time to target vessel selection can have multiple benefits for the patient, primary operator, and procedural staff in the room. Advantages include decreased procedure times, increased procedural efficiency, fewer microcatheter and microwire exchanges, reduced fluoroscopy times, and lower radiation exposure.
SwiftNINJA steerable microcatheter use in moderate and high complexity angiography and/or embolization has routinely helped me to be successful and efficient. In 2019, I published my results, comparing steerable microcatheter to conventional microcatheter use in 40 procedures that involved moderate to highly difficult vessel selection.1 Statistically significant improvements in target vessel selection time—12 vs. 462.5 seconds (Figures 1a and b)—number of microwires used (0 vs. 2), total
Using a 2.4Fr SwiftNINJA through a 5Fr guide catheter, the left prostatic artery was selected in 12 seconds without a guidewire thanks to the steerability of the microcatheter tip. Proximal and then distal embolization of the left prostate artery with 300–500μ Embosphere microspheres (Merit Medical) was performed following the proximal embolization first, then embolize distal (PErFecTED) technique. The right prostate artery was then selected–again using the SwiftNINJA without a guidewire—in nine seconds and embolization was performed using the same technique.
Final angiography confirmed successful embolization of both left and right prostatic arteries. The patient was discharged the same day, with no hematuria or urinary retention reported since the procedure. At one month post-procedure, patient’s IPSS decreased from 29 to 7 and Urinary Quality of Life score decreased from 5 to 1.
Successful gonadal vein embolization through extremely tortuous anatomy
A 43-year-old female presented with chronic pelvic pain. Despite extensive diagnostic work-up, no definitive cause for the pain was found, except for
prominent left parauterine veins/varicosities and an enlarged left ovarian vein.
The patient was diagnosed with symptomatic pelvic venous reflux/pelvic congestion syndrome, and the plan was to proceed with venography and embolization. Due to extreme tortuosity of the gonadal venous vasculature preeminently, a 2.4Fr SwiftNINJA steerable microcatheter was used to efficiently navigate through the extremely tortuous vessels and into the inferior aspect of the left ovarian vein. Embolization was performed with sodium tetradecyl sulfate sandwiched in between packs of platinum microcoils.
Post-embolization digital subtraction venography demonstrated an appropriate angiographic result, with embolization of the left ovarian vein, but brisk antegrade blood flow in the left renal vein. The patient was discharged home in stable condition four hours post procedure, and experienced only mild flank discomfort for 24–36 hours post-procedure, relieved with ibuprofen. Her pelvic congestion syndrome symptoms markedly improved by the time she was seen for a post procedure office visit approximately six weeks later.
References 1. Hoffmann, J.C., Minkin, J., Primiano, N. et al. Use of a steerable microcatheter during superselective angiography: impact on radiation exposure and procedural efficiency. CVIR Endovasc 2, 35 (2019). https:// doi.org/10.1186/s42155-019-0078-9
Jason C Hoffmann is an interventional radiologist with NYU Langone Health in Mineola, New York, USA.
Figure 1. Left prostatic artery selected with SwiftNINJA steerable microcatheter. Initial internal iliac artery angiogram demonstrates Type 1 anatomy, with common origin of the left superior vesical artery and prostate artery (a). The microcatheter was moved from tip of 5Fr catheter to target vessel (distal aspect of main left prostate artery) in 12 seconds (b).
Figure 2. Left renal vein digital subtraction venography (DSV) via 5Fr catheter demonstrates patency of the left renal vein and inferior vena cava, with very prominent, tortuous and enlarged left gonadal vein (a). A 5Fr catheter was only able to select the most superior aspect of the left ovarian vein due to its extreme tortuosity. The SwiftNINJA steerable microcatheter was used to navigate through the multiple 180 and 360-degree turns to easily be passed inferiorly to the pelvis to perform embolization (b).
Jason C Hoffmann
Adaptability for Your Procedure
New sizes available to accommodate a wider range of patient sizes and your workflow needs
New Retrograde IR Platform – Narrow
Designed to bring the clinician closer to the patient for improved access, our new Retrograde IR Platform - Narrow continues to provide a stable area for guidewire manipulation and equipment management. This compact addition complements the existing range, catering to different clinician workflows and procedural requirements.
New Overhead Arm Support MR Safe – Small
Eliminate extreme shoulder flexion, improve patient comfort and reduce artefact during abdominal access and imaging with our new Overhead Arm Support MR Safe - Small. Designed to support the arms of children and small adults, it secures your patient in the arms overhead position during C-arm, CT and MR imaging.
