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First@ CIRSE: CLTI, BTK, VTE November 2023 | Issue 92

SIO President Muneeb Ahmed

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You can’t always get what you want, but you may get what you need: IR and the global path to primary specialty

Minimallyinvasive procedures

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ntroducing the ‘Applying for IR specialty status: lessons learned’ session at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark), Michael Lee (Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland) asked: “What is wrong with IR?” Among his responses, Lee noted “there is little recognition, little visibility and most importantly, little credibility”. Speaking to Interventional News, Lee expanded on his statement, averring that visibility remains a “big issue”, rendering IR “completely invisible” to the health authorities who provide vital funding, as well as medical students in training who may elect to subscribe to IR. “We are fishing in the wrong pond,” Lee averred, “[medical students] do not know what IR is. There is little mentorship or teaching—I am generalising, as there are excellent medical student educational programmes in certain large academic centres, but in the real world, outside of these large centres, medical students do not know who we are.” He described how, often, their “pond” is synonymous with trainees who enter diagnostic radiology but “not to do a hands-on specialty” like IR, they then must be “[convinced]” otherwise by interventional radiologists like Lee advocating for the specialty. In New Zealand and Australia, the line between diagnostic and IR is equally blurred—Nick Brown (The Wesley Hospital, Auchenflower, New Zealand) explained that interventional radiologists are recognised as ‘special diagnostic radiologists’, which is the only specialty title available to fellows of the Royal Australian and New Zealand College of Radiologists (RANZCR). Brown is advocating for the creation of a ‘Specialist interventional radiologist’ title which would provide “an identity” to “elevate [IR] status and promote the high-value care that interventional radiologists provide to patients”.

Paediatric interventional radiologists call for intendedfor-use device development

Patient consultations

Imaging techniques

Technological innovation

Image interpretation

Over several decades, interventional radiology (IR) has scaled to significant heights, leading technological advancements and minimally-invasive techniques. As these milestones have been reached, however, historical pitfalls have deepened, prompting international discussion about the current structure of IR and the value of obtaining clinical specialty status. Building a figurative heatmap of IR’s progress to specialty today, Interventional News spoke to interventional radiologists around the globe to track the field’s burgeoning recognition, concurrent problems and future stability.

Interview

Radiation mitigation

Patient follow-up

To gain formal recognition for IR at his centre however, practice must be accompanied by an accredited training programme, said Brown. “Thus, RANZCR is working with the Society for Interventional Radiology in Australia and NZ (IRSA) and the Australian and New Zealand Society of Neuroradiology (ANZSNR) to develop, for the first time, two specialist training programmes in IR and interventional neuroradiology (INR).” Having an “identified pathway” to IR specialism Brown said, will “unlock the full clinical capacity of IR”, including the creation of clinical units and consulting rights, and could “attract appropriate funding and reimbursement for their departments and hospitals”, he stated. Issues with ill-defined IR training pathways are also reported in the UK, as Raman Uberoi (The John Radcliffe Hospital, Oxford, UK)—recipient of the British Society of Interventional Radiology (BSIR) 2023 Gold Medal for his ‘outstanding contribution to the work of both the society and interventional radiology’—explained, outlining a culture of “jumping through hoops” to access IR in the UK. He noted how entrance to the field can be “vague”. Often trainees enter into radiology and learn about imaging for the first three years before having the

There is little recognition, little visibility and most importantly, little credibility.” Michael Lee

LAGGING BEHIND THE RAPID advancements within the speciality as a whole, a 2023 study titled ‘Is there really no kit for kids?’ has identified the continuing “unmet need” for paediatric interventional radiology (IR) devices. Although off-label device usage has been standard in paediatric cases, Premal Patel (Great Ormond Street Hospital, London, UK) told Interventional News of “changing regulations” in Europe— with repercussions worldwide—which has forced manufacturers to state a definitive ‘yes’ or ‘no’ in device instructions for use (IFU) in reference to children. In light of recent international device withdrawals and license regulation updates, Patel, Fernando Gómez Muñoz (Netherlands Cancer Institute, Amsterdam, The Netherlands) and Alessandro Gasparetto (The Hospital for Sick Children, Toronto, Canada) surveyed the current state of paediatric IR and the global device deficit. In May 2021, the European Medical Devices Regulation (MDR) introduced an update stating their intention to “bring EU legislation into line with technical advances, changes in medical science and progress in law-making”, stating that all medical devices must meet “robust”, “internationally recognised” safety criteria and apply for new certification. The directive requires that manufacturers explicitly state whether devices can be used in paediatric patients, as well as additional costs to obtain certification for product lines. In 2023, the European MDR extended the deadline for manufacturers to comply with the requirements to 2027–2028 depending on the device. “They are making it harder for companies to keep licenses,” Patel said, “the way companies typically got around this is by just not saying anything”. Looking at this in greater depth, Patel et al’s cross-sectional analysis of device IFU assessed the inclusion of children in vascular access, biopsy, drainage and enteral feeding devices from 28 companies who sponsored the British Society of Interventional Continued on page 4

Continued on page 6

November 2023 | Issue 92

Updates

EDITOR’S LETTER

News in brief

Interventional News welcomes new editor-inchief Robert Morgan Interventional News is delighted to welcome professor of interventional radiology Robert Morgan (St George’s Hospital NHS Foundation Trust, London, UK) as editor-in-chief. Morgan is currently a clinical director for diagnostics at St George’s, clinical lead for the South West London Integrated Care System (ICS), and chair of the Royal College of Radiologists Academic Committee.

organ has held several prestigious roles, which include but are not limited to his appointment as president of the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) in 2018, and is now chair of the Endovascular Subcommittee of CIRSE. Of his active positions, Morgan is the current vice president of the British Society of Interventional Radiology (BSIR) and will become BSIR president in November 2023. Of his contributions to academia, Morgan has previously acted as deputy editor-in-chief for the scientific journal CardioVascular and Interventional Radiology: Endovascular, and was instrumental in the creation of the European Board of Interventional Radiology (EBIR) examination which is now sat by interventional radiologists around the globe. Furthermore, Morgan has written 197 peer-reviewed articles, edited four books, authored 47 book chapters and delivered over 300 invited lectures. His research and clinical interests focus on imaging and the endovascular treatment of aortic and peripheral vascular disease; and non-oncologic embolization including haemorrhage, visceral artery aneurysms and endoleaks. His distinguished service to his specialty has been recognised by several bodies—Morgan was awarded the Gold Medal of the BSIR in 2020 and, recently, the Gold Medal of CIRSE in 2023. On joining as editor-in-chief of Interventional News alongside Professor Andy Adam (King’s College London, London, UK), and Professor Brian Stainken (Stamford, USA), Morgan writes: “It is a great privilege and honour to join the senior

Robert Morgan accepting his 2023 CIRSE Gold Medal

editorial team in Interventional News. I have read this publication since its inception and look forward to its arrival in my inbox or through my letterbox every month. Interventional News and its sister publications, including Vascular News, fulfil important roles for the interventional radiology landscape. They are able to present in a readable informal manner current hot topics in interventional radiology, and to summarise for readers key points and highlights from recent major interventional radiology congress programmes and speaker presentations at meetings. There are few better ways for interventional radiologists to learn about newsworthy items, from the literature and congresses, without actually reading the scientific papers or attending the meetings.

There are few better ways for interventional radiologists to learn about newsworthy items.” In my new role as co-editor-in-chief for Interventional News, I would like to continue the excellent work by Professors Andy Adam and Brian Stainken. I would like to assist in further improving the quality of the editorial content and in time to introduce new editorial concepts to ensure that Interventional News continues to be the ‘great read’ that it already is.”

The latest stories from the interventional world

n CMS CONFIRMS BROADENED MEDICARE COVERAGE OF CAROTID STENTING: The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS). CMS outlined in the decision memo, dated 11 October, that it had found “coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary”.

For more on this story go to page 5.

n “THE SOLUTION IS AN IR SPECIALTY”: ANDREAS GRUENTZIG LECTURE AT CIRSE 2023 Raman Uberoi (The John Radcliffe Hospital, Oxford, UK), gave this year’s Andreas Gruentzig Lecture at CIRSE 2023. Central to his lecture was the designation of specialty status in interventional radiology (IR), and the liberty this may provide clinicians to affect innovation in the field, as well as furthering its “vital” evolution for the next generation of interventional radiologists.

For more on this story go to page 6. n CRYOABLATION FOUND TO “SIGNIFICANTLY REDUCE PAIN” IN ENDOMETRIOSIS PATIENTS Published in the Journal of Vascular and Interventional Radiology, a recent retrospective study which evaluated pain relief after percutaneous image-guided cryoablation in patients with symptomatic extraperitoneal endometriosis (EE) has found the treatment to be “safe and effective”.

For more on this story go to page 22.

Editors-in-chief: Professor Robert Morgan, Professor Andy Adam, Professor Brian Stainken Publisher: Stephen Greenhalgh | Content director: Urmila Kerslake | Head of Global News: Sean Langer Editor: Éva Malpass | Editorial contribution: Jocelyn Hudson, Will Date, Bryan Kay, Jamie Bell and Adam Pearce Design: Terry Hawes, Wes Mitchell and David Reekie Advertising: Michael Broughton michael@bibamedical.com Subscriptions: subscriptions@bibamedical.com Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd | BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2023. All rights reserved.

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November 2023 | Issue 92

Cover Story

COVER STORY continued

Paediatric interventional radiologists call for intended-for-use device development Continued from page 1 Radiology (BSIR), the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the Society of Interventional Radiology (SIR) between 2019 to 2020. Their results show that 190 devices with IFUs from 18 medical device manufacturers were assessed—26% mentioned children, 3% explicitly stated that the device was not for use in children, and 29% implied they could be used in children with caution—the most common caution (14%) being the size of the device that could be accommodated in a child. Patel and colleagues’ conclusion draws attention to the 29% of devices that may be suitable for paediatric use but lack explicit manufacturer support—“typically [IFUs] do not mention children, but manufacturers workaround this by stating ‘use an appropriate size for the patient’ which you can interpret how you want,” Patel explained. Now, however, manufacturers are “specifically saying no to children,” he updated, even stating that their data—collected in June 2023—are inaccurate due to recent Cook Medical withdrawals which have taken many of their device lines “off the shelf” for Patel and his team. “We have already seen the effect, the data in the paper are now out of date,” he said. Device withdrawals and IFU criteria changes have left paediatric interventional radiologists with little option but to “look for avenues around these regulations” and treat patients effectively via off-label device use. In having to seek these avenues, Gómez Muñoz reflected that “children are being prevented from getting treatment,” in the event of no appropriate device being accessible, as well as “the impact of cost to both the interventional radiologist and the patient”. “You do not want to risk your license or your future doing something that, despite knowing it is completely safe and effective, is not plainly indicated for use in children,” he continued. Sharing his experiences in treating paediatric patients, Gómez Muñoz stated that it is commonplace to use “homemade solutions” in IR due to the absence of any children-specific devices. “If you have to perform biliary drainage, the size of the drain can sometimes be the same size as the kid. You end up making your own holes or using drains that are not intended for internal use, risking the safety of the procedure,” he conveyed. Additionally, he expanded that placing a stent in a child is “completely different” to placing a stent in an adult— “an adult is not going to grow, but the kid may have an artery of 3.5mm, that, over the course of 18 years, may double in size”. “This is something we suffer every day,” Gómez

Muñoz said, and reading Patel et al’s 2023 research in the world. We are nowhere near where surgery is spurred him to write a ‘plea’ to the regulatory authorities or even where adult IR is.” Where “inventiveness” and and medical device companies, urging them to take “[adaptation]” reach their end, however, Gasparetto is action. His letter, titled ‘A plea to solve the unmet needs hopeful that, as paediatric interventional radiologists in paediatric IR devices’ begins by asking: “Are we grow in “manpower” they will be able to put pressure on truly upholding the notion that our manufacturing companies to mass children are the most valuable good produce smaller and shorter devices. of our society?” He argues that the He commented: “As we grow, more lack of adequate medications and IR evidence will become available, and devices for children “tells a different we will be able to push for paediatricstory” and recalls a summit which specific devices. But where we are took place a few years ago that heard standing right now, we do not yet a board member plainly confirm “we have the numbers.” have no interest in funding research Indicative of this growth, in 2023, for children”. Although childhood the US Food and Drug Administration cancer is thankfully “rare,” Gómez established the Paediatric Device Muñoz’s exposits in his plea, the Consortia which has funded ”unfortunate” stance of medical device development of medical devices Alessandro Gasparetto manufacturers that states children are for children, and brings together not a “lucrative market” has driven “experts from various fields, including a data deficit, risking interventional clinicians, engineers and researchers, radiologists’ licenses in the event of to promote the development and complications when using off-label accessibility of paediatric devices”, IR devices in low-complexity cases. Gómez Muñoz writes in his plea. For Gómez Muñoz, in some cases Referencing Patel’s research, Gómez merely downsizing an existing adult concludes that regulatory bodies device “will not suffice”, however he must “collaborate with the increasing believes that “regulatory bodies should number of paediatric interventional be aware of the situation at hand—if radiologists worldwide” to further you have a catheter that has been research and innovation. Fernando Gómez Muñoz approved for 30+ years in adults, Discussions on this topic are [medical device developers] just need increasing, although “intimate” as to reduce the size, and it should not Gasparetto put it, the Society of need to go through the MDR approval Paediatric Interventional Radiology process, as then it is not cost-effective (SPIR) meeting in recent years has and will take years—I do not see the facilitated “more conversations about necessity for that”. this issue, gaining a voice”. Patel In Canada, Gasparetto is in also relayed SPIR’s significance in agreement with Gómez Muñoz that the UK, and to the wider international conducting clinical trials to collect data specialty. “It was discussed at on paediatric IR device effectiveness SPIR last year, although these are would be “very difficult”. “It is very European regulations, once this tough to run these studies to prove a change is implemented and affects a Premal Patel certain piece of equipment is safe and manufacturer’s ability to sell in Europe, effective because there are enough they will withdraw non-viable products treatments that doctors and parents are comfortable from the USA and UK markets too—and this is not just with, and to try something new? Using a new device? affecting IR worldwide, but interventional cardiology and This would require convincing families to take part, and others”, Patel underlined. this is very difficult,” he explained. With sights set on the near future, Gasparetto believes “Paediatric IR is an emerging specialty right now, there that the development of medical devices indicated are not enough paediatric interventional radiologists explicitly for children will occur “soon”, given the “rate of growth [paediatric IR] is experiencing” today. Although, proceeding with more trepidation, Gómez Muñoz stated that “more measures need to be considered”, such as the use of large registries for device clearance and the inclusion of children in IFUs, which will “improve treatment outcomes and patient satisfaction”. Pushing further, however, Gómez Muñoz concluded that the “final answer must come from a common effort from regulatory parties, private companies, public entities and healthcare providers” to support research and device innovation for paediatric IR.

Are we truly upholding the notion that our children are the most valuable good in our society?”

UK MHRA adds capacity for medical device certification The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new Approved Bodies to increase the country’s capacity to certify medical devices. TÜV SÜD, INTERTEK, AND TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK, MHRA says in a press release. TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations

2002. TÜV Rheinland UK has also been designated to assess and certify general medical devices as well as in-vitro diagnostics in accordance with Part IV. With the exception of the very lowest risk devices, manufacturers must apply to a UK Approved Body for the UK Conformity Assessed (UKCA) certification. Products can only be placed on the market in England, Wales

and Scotland after they have achieved certification. Laura Squire, MHRA chief healthcare quality and access officer said: “By almost doubling capacity for medical device assessment in the UK, we are supporting patients to access the safe and effective products they need to protect their health.

“Approved Bodies play a critical role in the supply of medical devices and expanding capacity has been a key priority for us to support manufacturers to bring their products to the UK.” Before appointing an Approved Body, the MHRA conducts a detailed assessment to ensure organisations are stable and able to undertake impartial and objective conformity assessments, that they have an appropriate quality management system, the capacity and competence to undertake assessments and the processes they use meet regulatory requirements. After successful designation, the MHRA monitors UK Approved Bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.

Issue 92 | November 2023

News

CMS confirms broadened Medicare coverage of carotid stenting in final decision memo The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in July in a proposed decision memo. CMS OUTLINED IN THE decision memo, dated 11 October, that it had found “coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary with the placement of a US Food and Drug Administration [FDA]-approved carotid stent with an FDA-approved or cleared embolic protection device” for Medicare patients who have symptomatic carotid stenosis ≥50% and asymptomatic carotid stenosis ≥70%. In the July proposed decision, the federal agency detailed an expansion that would significantly broaden coverage for carotid stenting, expanding Medicare coverage to individuals previously only eligible for coverage in clinical trials, removing the limitation of coverage to only high-surgical-risk individuals, and removing facility standards and approval requirements.

What is next?

Looking ahead, new evidence is on the horizon for carotid artery stenosis patients, with data from the carotid revascularisation and medical management for asymptomatic carotid

stenosis (CREST-2) trial due to be released next year. CREST-2 consists of two independent multicentre, randomised controlled trials of carotid revascularisation and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. “Speaking on behalf of the Society for Interventional Radiology (SIR), immediate past president Parag Patel (Medical College of Wisconsin, Milwaukee, USA) provided the following comments: SIR applauds the decision to expand coverage for PTA with CAS to include individuals of standard surgical risk, patients with symptomatic carotid artery stenosis ≥50%, and patients with asymptomatic carotid artery stenosis ≥70%. SIR supports the decision to allow operators trained in performing these procedures to also complete the requisite neurologic assessments prior to and following treatmentThis underscores the expectation and requirement for ownership of the clinical management of the patients that we treat. We support the

“This expansion will allow comparable therapies to be offered in a balanced discussion with patients.”

requirement for shared decision-making processes among physicians and the patient in determining an appropriate treatment. This expansion will allow comparable therapies to be offered in a balanced discussion with patients as they determine with their doctors the best course of action. By expanding coverage to patients at standard surgical risk, Medicare is allowing all to benefit from the advantages of a minimally invasive procedure. It is clear that we are improving in our knowledge and use of medical

AUA 2023 guideline amendment published for the treatment and management of BPH and LUTS First published in 2019, the American Urological Association (AUA) have recently amended their guideline on management of male lower urinary tract systems (LUTS) secondary to benign prostatic hyperplasia (BPH) to capture eligible and influential literature published between September 2020 and October 2022. Within their resulting peer-reviewed amendments, changes to statements and supporting text regarding combination therapy, photoselective vaporisation of the prostate (PVP), water vapor thermal therapy (WVTT), laser enucleation, and prostate artery embolization (PAE) have all been made.

n their summary of the changes, the 2023 amendment panel consisting of Jaspreet S Sandhu (Memorial Sloan Kettering Cancer Center, New York, USA), Ramy Goueli (The University of Texas Southwestern Medical Center, Dallas, USA) and John T Stoffel (University of Michigan, Ann Arbor, USA), state the “prevalence and severity” of LUTS and BPH in the ageing male can be progressive, and is “an important diagnosis in the healthcare of patients and the welfare of society”. “BPH is nearly ubiquitous in the ageing male with worldwide autopsy-proven histological prevalence increases starting at age 40–45 years to reach 60% at age 60, and 80% at age 80,” the authors note. Parallel to BPH, Sandhu et al state that LUTS is also associated with age, but believe it is important to recognise that

the condition is “non-specific” and can occur in both men and women. To review the current recommendations for surgical management of BPH/LUTS, the Minnesota evidence review team searched the Ovid Medline, the Cochrane Library and the Agency for Healthcare Research and Quality (AHRQ) databases, identifying studies indexed between 2020 and 2022. Terms included in this search were medical subject headings, keywords for pharmacological therapies, drug classes, and terms relating to LUTS or BPH. Subsequent to this, collected evidence was then assigned a strength rating of A (high), B (moderate), or C (low) for support of strong, moderate, or conditional recommendations. Of their results, the authors assert that 5α-reductase

management—CREST-2 is comparing differences between intensive medical management (IMM) alone compared to CAS plus intensive medical management for patients with severe asymptomatic carotid stenosis. Prior studies have demonstrated positive results but were not followed long enough to sufficiently determine long-term benefits. We should be in the business of disease prevention, and I suspect that we will see significant advantages with intensive medical management for many patients and likely prevention of many requiring any intervention at all.”

inhibitors (5-ARI) in combination with an alpha blocker “should be offered as a treatment option only to patients with LUTS associated with demonstrable prostatic enlargement”. Concerning surgical therapy options however, transurethral resection of the prostate (TURP) remains the “historical standard” due to its ability to reduce urinary symptoms associated with BPH. Allocated a grade B evidence level and moderate recommendation, the authors assert that TURP continues to be the most frequently taught and utilised. Although recent research focus has been placed on PAE in the management of LUTS/BPH, Sandhu et al were unable to find “substantial evidence to recommend PAE over more widely available minimally invasive therapies”. Gaining a grade C evidence level and assigned a conditional recommendation, the investigators assert that their review did show shortterm benefits of the procedure, however continued investigation of PAE should be sought to further define its use. Reflecting on the resulting amendments, the authors convey that these guidelines “seek to improve clinicians’ ability to evaluate and treat patients with BPH/LUTS” based on the most recent evidence. Yet, they believe there are still “enormous gaps in knowledge; therefore, there are also significant opportunities for discovery”. “Many unanswered questions exist, including but not limited to the role of inflammation, metabolic dysfunction, obesity, and environmental factors in aetiology, as well as the role of behaviour modification, self-management, and evolving therapeutic algorithms in both the prevention and progression of disease”.

November 2023 | Issue 92

Cover Story

COVER STORY continued

You can’t always get what you want, but you may get what you need: IR and the global path to primary specialty Continued from page 1

option to broach IR, “and of course that [traces] many challenges,” Uberoi asserted. With distinct IR specialty status, he stated, trainees could bypass these challenges and “learn about imaging, but relevant to IR techniques and procedures, with a clearer distinction of what we are about and what we are going to do—it makes it much more attractive”. Implementing a training curriculum that includes clinical practice and IR procedural skills “from day one” is crucial, agreed Lee: “That is why IR specialty status is so important. We must have a dedicated training pathway from the get-go to attract trainees interested in a ‘hands-on specialty’ like IR or the field will continue to be impoverished of trainees. In addition to trainee impoverishment, the other main limitation of current training programmes is the difficulty of producing IR specialists with the clinical expertise required to deliver the necessary patient care associated with current IR practice.” In a co-authored article published in CardioVascular and Interventional Radiology (CVIR) earlier this year, Lee and Uberoi collectively discuss the third and latest edition of the CIRSE European Board of Interventional Radiology (EBIR) curriculum, which forms a distinct syllabus and examination of IR competence throughout Europe. The latest iteration places focus on “greater clinical responsibility for patients”, defining “core competencies [..] to improve the future training and quality of interventional radiologists worldwide, improving patient outcomes and care”. Parag Patel (Medical College of Wisconsin, Milwaukee, USA) who also presented at CIRSE, spoke

to Interventional News to provide insight on behalf takes “ownership” of their patients, interventional of IR in the USA, which gained primary specialty radiologists are left with “unrealistic” and ineffectual status in 2012. Patel explained that recognition for IR practices today, said Lee. in the USA enabled the specialty to “not just highly Equally, this remains an issue in the USA, encourage or strongly suggest, but require, base-line Patel conveying that “if IR is not given the same competencies in training for interventional radiologists. [recognition] in its ability to see patients and manage “Primary specialty recognition allowed us to them in a multidisciplinary format, then we are not fundamentally change those requirements, expanded supported and frankly our treatments will not be the training to two full years of IR training, not just advocated for”. He explained it is a “rare instance” that procedural but clinical intensive care unit management a specialty will advocate for another’s procedures, and admission discharge,” Patel highlighted. that only your own specialty will be willing to do so, Certification of this programme by the Accreditation proving that ultimately “if you are not at the table, you Council for Graduate Medical Education (ACGME) are on the menu, as they say”, Patel punctuated. and IR specialty recognition from the As the frequency of these conversations American Board of Medical Specialties (ABS) increase, the “deficiencies” in IR are thrown has also improved recruitment, with Patel into light, Lee conveyed, but the “chance to noting an uptick in senior medical students talk to the right people about what IR is all applying to join the clinical specialty. “These about and its problems” has been instrumental are future leaders—these are bright, young in sparking progress. “We now have a national individuals who would have been leaders in programme for IR in Ireland to look at the vascular surgery, cardiology, oncology, and current situation. Over the next 10–15 years, are now going to be leaders in IR,” he said, IR should be a robust part of Irish healthcare emphasising their “elevated workforce and hopefully a primary specialty. This may of talent”. have never happened if we had not embarked Yet, Patel remarked, “there are always on this—I always remember that song and growing pains”, explaining how IR is Mick Jagger singing: You can’t always still “[appropriately]” housed within the get what you want, but you may get what department of radiology. Although their you need.” chairman, who oversees their division, Despite positive conversations, the speakers understands imaging, they “do not always concurred that unanimous action to strengthen understand how to support [IR] clinical the field of IR “not because you feel it is From top: Michael Lee, practice” he stated. better, but based on what is best for patients” Parag Patel, For Lee, clinical practice and longitudinal as Patel stated, is still crucial. For Brown, a and care represents a clear distinction that strategy of “good planning and perseverance” Nick Brown can be made between the needs of IR and has promised a formal training programme diagnostic radiology, but without primary specialty by 2026, with specialty status to shortly follow, which or a chairman who is an interventional radiologist, he believes will be the “single greatest boost to IR asking for dedicated time for clinical practice “is practice in recent times”. met with friction and confrontation” he said. Uberoi Finally, the speakers agree that these changes must added that longitudinal care is a “critical” feature of happen to secure IR practice for the future, in Lee’s IR, and for patients, knowing that the doctor who words: “If we do not take control and if we do not take initially assesses you will be the one to treat you and to charge of our own destiny, we will be jeopardising the whom questions can be directed is essential. Without future sustainability of IR. Maybe I am being a little the “trust and communication” that is built through nihilistic, but I believe that we must start changing regular touchpoints with a dedicated specialist who things and it needs to happen sooner rather than later.”

presented by the technician “The solution is an IR specialty”: challenges versus clinician dichotomy that faces interventional radiologists today, and Raman Uberoi gives Andreas has ultimately influenced “who is responsible for the patient”. Gruentzig Lecture at CIRSE 2023 clinically “The best outcomes for patients come

Interventional radiologist and medical director for The Royal College of Radiologists, Raman Uberoi (The John Radcliffe Hospital, Oxford, UK), gave this year’s Andreas Gruentzig Lecture at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark). Central to his lecture was the designation of specialty status in interventional radiology (IR), and the liberty this may provide clinicians to affect innovation in the field, as well as furthering its “vital” evolution for the next generation of interventional radiologists. IN A PRESENTATION TITLED ‘Interventional radiology: The next generation’, Uberoi began by making no uncertain parallel between the “futuristic and technologically-driven” evolution of Star Trek’s computer-generated imagery (CGI)—a passion of his—and the evolution of IR, which is “reshaping and changing, with new horizons, challenges and frontiers”, he told the CIRSE 2023 delegates. Before looking ahead however Uberoi explained that “it is important to look back”, giving

a brief overview of the evolution or, “the roots”, of IR to date, spanning from the first angiography conducted in 1923, to the development of stents and contemporary tools used today. “We are involved with just about every aspect of clinical practice, we have roles in patient safety, service improvement and patient outcomes— we would be forgiven for thinking ‘we are really in a nice position, we are doing exceptionally well’, but there is a problem.” Uberoi then introduced the

when we are clinical interventional radiologists”, said Uberoi. “We must gain control of our working lives, our practices, and our future”. Signalling a central theme of his lecture, he introduced the potential ways in which IR becoming a speciality could provide “solutions” to many of the field’s prevalent challenges. Among these challenges are the few UK trusts which have resource to provide 24/7 IR services—48%, Uberoi revealed, alongside the growing prevalence of burnout which has reduced the retirement age of interventional

We must gain control of our working lives, our practices, and our future.”

radiologists today to 44. This “shocking” statistic reaffirms the importance of giving the new generation of interventional radiologists “control of their working future and working lives” which, he stated, means “rationalising the workload” and placing more focus on “core IR activities”. Leaving no stone unturned, Uberoi conveyed that the “strongest message” he can impart is that, with specialty status, interventional radiologists will be able to “control [their] destiny and future”, and this will enable clinicians to “gain control” over training and patient safety. Imparting his final thoughts, Uberoi highlighted that there are “hugely powerful drivers for change”, reiterating that evolution and speciality status are “vital” to the future survival of IR. “It is about improving training, the visibility of IR, improving workforce planning, and ultimately, high-quality patient-focused care”, Uberoi said, concluding that these crucial developments will only be achieved by fundamentally “improving the lives of interventional radiologists”.

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Cardiovascular and Interventional Radiological Society of Europe

November 2023 | Issue 92

CIRSE 2023

CIRSE ROUND UP

FIRST@CIRSE sessions impart “valuable” insight into CLTI and BTK artery disease treatment strategies In a series of sessions featuring ‘firsts’ at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark), “excellent results” were presented for the MOTIV (Reva Medical) bioresorbable scaffold (BVS) for below-theknee (BTK) artery disease and 90-day outcomes in the STRIKE Lightning 12 (Penumbra) pulmonary embolism (PE) study, providing “valuable insight” into computer-aided mechanical aspiration thrombectomy as an alternative to thrombolytics.

Twelve-month sirolimuseluting balloon results for treatment of complex infra-inguinal atherosclerotic disease Tze Tec Chong (Singapore) presented results from the PRISTINE registry to CIRSE delegates, which aimed to investigate the performance and safety of the Selution (MedAlliance) SLR sirolimus-eluting balloon (SEB) for the treatment of complex occlusive lesions in chronic limb-threatening ischaemia (CLTI) patients in Singapore. He highlighted their “[achievement] of 100% technical success and freedom from device- or procedure-related mortality”, which Chong reported were 100% respectively at 12-month follow-up. First expositing the intentions of the trial to the audience, Chong described the prospective, single-arm, single-centre study, which includes patients with a Rutherford category between four and six, and TASC II C or D lesions. He defined their primary endpoints as freedom from mortality, major amputation and clinically-driven target lesion revascularisation (CDTLR), and procedure-related mortality through to 30 days, and to six months. Detailing patient demographics, Chong then conveyed the collected Wound, Ischemia, and foot Infection (WIfI) classification data, revealing an average score of 4.07 in their population, which, he stated, is indicative of “severe” disease. Additionally, he continued to note that, based on this average, these patients are “at significant risk of amputation” and fall within moderate- to high-risk risk categories. Of their outcomes, Chong stated that 100% technical success was achieved in all patients, as well as device or procedure-related mortality, although two patients were lost to followup. Looking at the data with more granularity, Chong highlighted that

amputation-free survival at 12 months was 72.6%, which he asserted is “in line with the type of patients we treat, and quite reasonable in a population that is more than 90% diabetic and 30% with renal failure”. Furthermore, he underlined that complete wound healing was achieved in 79.2% of their population at 12 months. Concluding his presentation with a case study from their patient cohort, Chong reiterated the key continued patency of the Selution SEB from six to 12 months, noting finally that, “in these difficult to treat vessels, this target lesion primary patency rate is quite acceptable.”

“Optimistic” outcomes for bioresorbable scaffold in BTK artery disease treatment

Presenting data from the MOTIV BVS BTK study during Saturday’s FIRST@CIRSE session, Thomas Rand (Klinikum Floridsdorf, Vienna, Austria) underlined the “promising future applications” of the device for the treatment of BTK arteries in patients with rest pain or minor tissue loss due to CLTI, which allowed for “full recovery of vasomotor and endothelial function” at 24-month follow-up, the investigators assert. Theirs was a prospective, multicentre study, with a total of 58 patients, 60

Tze Tec Chong

study limbs and 76 Motiv scaffolds (Reva Medical). The study involved patients with lesions in BTK arteries of a maximum length of 100mm, with Rutherford classification scores ranging from four to five. Referencing Chong and fellow presenters in this session, Rand stated that their patient demographics are “more or less the same”, consisting of “many” diabetic patients. Presenting their updated results, Rand conveyed their “excellent” outcomes, underlining data which show a 2% clinically-driven TLR rate and 95% limb-salvage rate among their patient cohort. Continuing, he reported “high primary patency rates”—81.7% at 24 months—and presented a 98.3% CD-TLR outcome, including a case study to visually bolster these data and display the positive healing results of an individual in their patient population. “We are very optimistic for the future,” Rand told the CIRSE 2023 audience, concluding that: “Excellent tracking and visibility provided problem-free delivery and demonstrable [improvements] in Rutherford classification and wound healing”. Finally, Rand made mention of a “new concept” which promotes a “leave-nothing-behind” best approach, which he stated the Motiv scaffold can facilitate, allowing for “full recovery of vasomotor and endothelial function”.

“Rapid reduction” in right and left ventricle ratio following computer-aided mechanical aspiration thrombectomy

Presenting real-world population data in patients with PE, John Moriarty

Excellent tracking and visibility provided problemfree delivery and demonstrable improvements in Rutherford classification.”

Thomas Rand

(University of California Los Angeles Medical Center, Los Angeles, USA) demonstrated results from the STRIKEPE study which, he stated, provides “valuable insight into functional patient outcomes and quality of life measures”, and displays “significant improvements” in generic and diseasespecific patient symptoms. Foregrounding the study for delegates in attendance, Moriarty made clear note that venous thromboembolism (VTE) is “both incredibly common and rising in prevalence” today, exhibiting a graph which depicts its “substantial financial impact” in Europe—nearly €8.5 billion annually—and presents “a morbidity and mortality that ranks as the third highest among all of the cardiovascular disorders”, he explained. “These trials have been designed to investigate the real-world applicability of computer-aided mechanical aspiration thrombectomy,” Moriarty relayed to delegates, describing their study design which, to date, includes 55 sites and 600 patients. Their interim, 90-day analysis included 87 patients with a mean age of 59.4 years, 59.8% of patients were male and 94.3% have submassive PE, and a right/left ventricle (RV/LV) ratio of less than 0.9. Expanding on their primary and secondary endpoints, Moriarty began by making “important” mention of their finding of zero all-cause mortality at 30 days, which he concluded is “impressive given the background mortality risk in these patients”. Additionally, he noted two major adverse bleeding events within their interim cohort, however reiterated that there were no mortalities. Of their interim results, Moriarty highlighted that the observed change in the RV/LV ratio was “statistically significant”, and showed a 0.43 or 27.5% decrease. Investigators also saw a decrease in intraprocedural systolic pulmonary artery pressure (sPAP) of 9.4mmHg or 18%. He stated that these results are “similar or better than most of the investigation device trials done on this patient population previously,” concluding that STRIKE-PE to date has provided “valuable insight” into patient functional outcomes and EQ visual analogue scale (EQ VAS), showing “improvements” in qualityof-life measures.

John Moriarty

Issue 92 | November 2023

CIRSE

Thyroid thermal ablation “comes of age” internationally The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) saw presenters explore where thyroid thermal ablation treatments sit within practice today and how guideline recommendations worldwide have shifted to encompass the treatment option for patients today.

Consistent “near-zero” complication rates with thermal ablation techniques

Teresa Dionisio (Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal) began her presentation by setting out contemporary techniques for thyroid thermal ablation, expositing radiofrequency, microwave and laser ablation as the three “most applied” methods used today. After brief description of each technique, Dionisio poses her central question: “What do we know about these different techniques?” In past guidelines such as the American Association of Clinical Endochronologists’ (AACE) Dionisio explains, microwave ablation has often been placed as a secondary treatment option due to the “higher risks of minor and major complications”. “At that time we only had access to 40–60 gauge needles, so it was like killing a fly with a canon—it worked but caused a lot of collateral damage”. Recent guidelines however have stated that laser, radiofrequency and microwave are “similarly safe and effective”, Dionisio said, broadening treatment options for patients dependant on “individual competencies and the research of the hospital”. Adding to this, she shares that overall complication rates for these ablation techniques are less than 4%, major complications less than 1% and there have been no life threatening complications reported to date. Concluding Dionisio stated: “Thyroid ablation is a very safe procedure, if you plan for these events and understand the neck anatomy well, you can keep the complication rate near to zero”.

“Optimum” characteristics presented for successful thermal ablation of benign lesions

“Patient selection is of central importance,” Bulent Cekic (Antalya Education and Research Hospital, Antalya, Turkey) underlined, placing this among his key messages when describing the current indications and contraindications for thermal ablation of benign thyroid lesions during his presentation at CIRSE 2023. “We do not ablate every nodule” when considering the best candidates for thermal ablation Cekic explained, nodule features such as spongiform echostructure, nodules with a liquid component, and soft nodules, are all elements that crucially increase volume reduction rate (VRR).

Patient selection is of central importance.” Continuing, Cekic conveyed his approach to treating toxic adenomas below 10ml in volume, noting the primary factor which affects the success of thermal ablation in these cases is the volume of the adenoma before treatment. Supporting this, Cekic references a study conducted by Roberto Cesareo (Santa Maria Goretti Hospital, Latina, Italy) et al, who divided their toxic adenoma group into two—those with a volume of more than 12ml and less than 12ml. Their results showed that, in the smaller volume group,

euthyroidism via thermal ablation was achieved in 86% of patients, compared to 45% in the large volume group. Supported by this research, Cekic’s clinic have found a “solution” that informs “ongoing clinical training” which stipulates, for adenomas below 10ml, thermal ablation is performed initially, followed by an injection of 4–5 cubic centimetres (cc) of 90% ethanol. By using this technique Cekic tells the audience, they “always have a 95% VRR” with a recurrence rate of adenomas of 1–2%. Cekic adds that “careful anatomical assessment should always be performed before the procedure”, reiterating that clinicians must understand and apply their “[knowledge of] managing potential complications following the procedure” to have the best results.

Thermal ablation for malignant thyroid lesions has “come of age” worldwide

Closing out the session, Myrsini Gkeli (Agios Savvas General Anticancer Oncological Hospital, Athens, Greece) describes how “thermal ablation for malignant thyroid lesions as come of age around the world”, however “optimal” ablation techniques and “proper indications” remain as “challenges” for the future. First, Gkeli cast an eye over global radiofrequency ablation (RFA) guidelines for the treatment of recurrent thyroid cancers in years past. Reaching 2022, he outlined an international multidisciplinary consensus statement which recommended RFA for the treatment of both benign and malignant thyroid disease. Displaying a range of meta-analyses and longterm studies which have investigated the safety and effectiveness of RFA for these patients, the speaker relayed how these data demonstrate “significant tumour volume reduction” at six months, seven and nine years follow-up, respectively. “The use of thermal ablation may be considered as an alternative option to active surveillance in incidentally discovered low-risk papillary thyroid microcarcinoma patients who are not eligible for surgery,” Gkeli told CIRSE delegates.

#HOPE4LIVER trial demonstrates safety and efficacy of histotripsy for liver tumours The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) played host to another FIRST@ CIRSE session, which saw new data releases from various interventional radiology trials. Mishal Mendiratta-Lala (University of Michigan, West Bloomfield, USA) presented “much awaited” data from the #HOPE4LIVER trial which demonstrated the “successful, non-invasive destruction” of liver tissue using hepatic histotripsy. MENDIRATTA-LALA, providing key background for the study, began by highlighting limitations of locoregional therapies for primary and metastatic hepatic malignancies, including the “degree of invasiveness, inability to treat near clinical structures, lack of realtime visualisation during treatment, collateral damage, and variability in local tumour control”. “If we had technology which could address these concerns, this could be a major clinical advancement in

the treatment of liver tumours,” the presenter averred, then introduced histotripsy—a non-thermal, mechanical process of focused ultrasound through precisely controlled acoustic cavitation. In order to evaluate the efficacy of histotripsy, Mendiratta-Lala proceeded to describe their prospective, multicentre, single-arm investigational device exemption (IDE) trial, using the HistoSonics system (HistoSonics) for the treatment of liver tumours. Two iterations of the study were carried out, in Europe and the USA respectively,

HistoSonics System

comprised of six European and eight US sites. Hepatic histotripsy was performed on 44 tumours in the first 40 evaluable subjects enrolled between the two trials, with a primary endpoint of technical success at ≤36 hours postindex procedure, or of 70%, and a primary safety endpoint of no major complications up to 30 days post procedure. The speaker underlined that positive results were required for both primary endpoints for the trial to be considered “successful”. Of their technical success endpoint, the speaker told CIRSE delegates that

“based on the 44 treated tumours, 42 were successfully treated giving us a primary efficacy of 95.5%.” Mendiratta-Lala pointed out that the two tumours that were not successfully treated were due to “user error, not device error”. Concerning their safety endpoint, Mendiratta-Lala explained that the investigators encountered three complications (6.8%), due to the “known risks of focal liver therapies and [these were] not unique to histotripsy,” a result which still [met] the pre-specified performance goal of less than 25%. Of their limitations, Mendiratta-Lala emphasised their “small, heterogeneous patient cohort”, and made clear that the majority of this patient population were recorded to be at an advanced stage of disease, and although their findings “show the effect of histotripsy tissue destruction,” its direct effect on the disease process “was not evaluated”. The presenter concluded however, that both safety and effectiveness endpoints were met in the #HOPE4LIVER trials, “demonstrating successful, noninvasive destruction of liver tissue via histotripsy”.

November 2023 | Issue 92

10 Obituary

OBITUARY

Roger M Greenhalgh (6th February 1941– 6th October 2023)

oger Malcolm Greenhalgh, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on 6th October, aged 82. At the time of his death, he was emeritus Professor of Surgery at Imperial College in London and head of its Vascular Surgery Research Group. Professor Greenhalgh received recognition for his lifelong contributions to vascular surgery from multiple prestigious groups, including, most recently, an honorary Fellowship of the American College of Surgeons in October 2018 and the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in June 2018 after being nominated by the European Society for Vascular Surgery (ESVS). Enrico Ascher (New York University, New York, USA), who presented the award and is a past president of the SVS, said of Professor Greenhalgh at the time: “He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person.” The ESVS has since shared that his pioneering work will have a “lasting impact on patient care, surgical techniques, and the advancement of evidence-based medicine in the field”. In the days following his passing, Professor Greenhalgh’s brilliant surgical skills were recognised

by innumerable international surgical societies, Gross)—who died in April 2020 from COVID-19. including the Cardiovascular and Interventional They were happily married for over 55 years and her Radiological Society of Europe (CIRSE). CIRSE constant support was integral to his success. president Christoph Binkert (Kantonsspital, Gallen, To read the full obituary please visit Switzerland) alongside chairperson of the CIRSE interventionalnews.com/obituary-roger-mEndovascular Subcommittee Robert Morgan greenhalgh-6th-february-1941-6th-october-2023/ (St George’s Hospital, London, UK), wrote that The Professor Roger M Greenhalgh book of Professor Greenhalgh condolence can be found here: http://tinyurl. was “not only a pioneer com/2ubsymf9 in the operating theatre and in the advancement of vascular surgery, but also a compassionate and dedicated physician who touched 2 the lives of countless individuals”. On behalf of CIRSE, they 1 added that his legacy will “inspire and benefit generations of medical professionals and patients alike”. British Society of Interventional Radiology (BSIR) president Phil Haslam (Freeman Hospital, Newcastle upon Tyne, UK) and 4 vice president Robert Morgan, 3 shared their condolences on behalf of the society, recounting 1. Princess Anne attends the Professor Greenhalgh’s CX Symposium in 1982 “outstanding” contribution to 2. Michael DeBakey (far left), Karin Greenhalgh the treatment of vascular disease and Roger Greenhalgh in 1989 and in the “education of vascular 3. Greenhalgh operating specialists everywhere”. 4. Greenhalgh receiving the first Living Legend or International Professor Roger Greenhalgh, Lifetime Achievement Award from the Society for Vascular MA MD MChir FRCS, was Surgery (SVS) in 2018 from Enrico Ascher married to Karin Maria (née

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November 2023 | Issue 92

12 Interview

“We started off with chinagraphs”: The evolution of radiation oncology Liz Kenny of the Royal Brisbane and Women’s Hospital (Brisbane, Australia) gave her radiation oncologist’s take on the “120-oddyear” history of radiation therapy, how to plan it, and its delivery at the 2023 European Conference on Interventional Oncology (ECIO; 16–19 April, Stockholm, Sweden). “We—and you—stand on the shoulders of giants,” was one of her key take-home messages for delegates, specifying that these giants span many scientific disciplines and nations and have enabled the development of radiation oncology into the area of medicine it is today.

“E

very single advancement in radiation therapy has been made hand-in-hand with physicists, industry, physicians, and radiation therapists across nations,” Kenny began. “The aim has always been to work out how we can maximally treat cancer tissue, while maximally protecting normal tissue.” In order to advance this area of clinical practice, Kenny elaborated on the “unwavering commitment to quality assurance” has also been necessary, alongside “our understanding of cancer biology and radiobiology” and “minimising shortand long-term complications, while knowing what they are”. Kenny paid homage to Rod Withers (University of California, Los Angeles, USA), who she described as “a father of radiobiology who led us to understanding the relationship between the overall treatment time, total dose and the number of treatments. Lester Peters (University of Queensland Medical School, Queensland, Australia) was next in Kenny’s roll call of significant contributors to radiation oncology, as someone who spearheaded the need to embed quality assurance, in both trials and daily clinical practice, demonstrating the increased cure that this brings. Vincent Gregoire (Léon Béard Cancer Center, Lyon, France) was then attributed with the sage advice that intensity-modulated radiotherapy needs daily image guidance. Computed tomography (CT) scanning was one of the advancements that

Kenny credited with “revolutionising everything” in the field of cancer care. “The basic design of linear acceleration cannot really change,” she pointed out, “but how we manage it, how we rotate the treatment beams around patients, shaping the beams and modifying the dose coming through are all factors that can be altered as we treat. And, of course, computers, they have changed the world,” Kenny emphasised, before highlighting that planning systems, likewise, “have evolved apace” with “our ability to manage motion and reproducibility”. Machine learning also featured on Kenny’s list, which she explained “allows us to be 85% ready before we even start”. Then addressing the audience, she opined that “that has direct applicability in the [interventional radiology] world. “We started off with chinagraphs, drawing on orthogonal films, and with two-dimensional planning, so we had a massive risk of geographic miss,” Kenny recalled. She commented that, even with the evolution to 3D planning, collateral damage was by no means a thing of the past. “So, with medical physicists we waged the war on normal tissue damage.” She charted the move from static to rotational beams, Liz to changing the Kenny dose delivered

in those beams, and changing the shape. “That is what allows me to treat someone’s very complex nasopharynx cancer, or ablate a patient’s lung cancer,” Kenny celebrated, all the while knowing “what outcome and side effects I expect, and what the cure rate has the potential to be”. “Once we have made a decision to treat, the first step is planning, and planning is designating the right dose to the right place and determining what dose we will allow normal tissue to receive,” Kenny proceeded, referring to the capabilities nowadays for calculating the dose to different parts of the surrounding tissue ahead of delivery. However, she conceded that there may well still be plenty of scope for evolving diagnostic and functional imaging further.

It has been a wonderful journey, with our equipment following suit through to helical devices and protons, like something out of Star Trek.” Kenny called planning a “multistep process that involves a cast of thousands” to enable quality assurance at every step, from simulation, image fusion, to mapping out dose on every CT scan slice, to peer review, final acceptance of the treatment plan and then testing on a phantom “which is not so easy for [interventional radiologists]”. Planning and delivery can also be tailored according to whether the patient will be free breathing

Award-winning MSK embolization research In an exclusive interview, Ziv Haskal (University of West Virginia School of Medicine, Charlottesville, USA)—emeritus editor-in-chief (2011–2020) of Journal of Vascular and Interventional Radiology (JVIR)—on behalf of Interventional News, speaks to Yuji Okuno (Okuno Clinic, Tokyo, Japan), winner of the Award of Excellence and Innovation in Interventional Radiology during the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 meeting (9–13 September, Copenhagen, Denmark). Together, they discuss Okuno’s pioneering work on the treatment of chronic musculoskeletal inflammation and pain. OKUNO PREVIOUSLY PUBLISHED research in CardioVascular and Interventional Radiology (CVIR) in 2014 examining the shortterm clinical outcomes of transarterial embolization (TAE) for knee osteoarthritis using imipenem/

cilastatin microspheres, reporting improvements in pain scores up to 12-month follow-up. To watch the full video visit interventionalnews. com/award-winning-msk-embolization-researchshows-higher-safety-profile-and-broader-indication/

Left to right: Ziv Haskal and Yuji Okuno

or assuming a deep breath hold or tracking the tumour during the delivery of treatment. Kenny supplemented, going on to detail that for stereotactic brain treatment, the immobilisation system with thermoplastic shells is “very exacting”. Concluding, Kenny walked the audience through her radiation oncologist’s approach to delivering dose to patients, using image guidance: “There is no consolation for missing the target volume, no matter how sophisticated the technique of planning and delivery”. This, she summed up, by saying that “you have to be in the right place”. This is all the more critical when performing stereotactic ablative treatment in the brain, where there is a “0.02 to 0.05mm” tolerance. “We have evolved in the last 40 or 50 years from 2D planning and treatment to 3D conformal planning to Intensity Modulated Radiation Therapy, all image driven. We can now sculpt and manipulate dose,” were among Kenny’s closing remarks. “It has been a wonderful journey, with our equipment following suit all the way through to helical devices and protons, with treatment rooms now looking like something out of Star Trek”. Kenny believes that machine learning through cloud-based sharing will enable continuous improvement in the field of planning and delivery of radiation therapies. “As imaging advances, we will become more accurate again and even now we are starting to be able to adapt during treatment.” Liz Kenny is a professor at the University of Queensland and senior radiation oncologist at the Royal Brisbane and Women’s Hospital (Queensland, Australia).

Issue 92 | November 2023

News 13

PERIPHERAL

Multi-society guidelines on varicose vein management published The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations, which update the 2011 SVS and AVF guidance on the topic, were published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL). THE NEW DOCUMENT FOCUSES ON THE following topics: ● Evidence supporting the prevention and management of varicose vein patients with compression ● Treatment with drugs and nutritional supplements ● Evaluation and treatment of varicose tributaries ● Superficial venous aneurysms ● The management of complications of varicose veins and their treatment The publication—authored by Peter Gloviczki (Mayo Clinic, Rochester, USA) and 19 other members of a multispecialty guideline writing committee— follows last year’s release of part one of the guidelines, which addressed duplex scanning and treatment of superficial truncal reflux. Gloviczki and colleagues outline in their introduction Peter the reason behind the two-part Gloviczki publication of the updated guidelines. They note that all recommendations in part one were based on a new, independent systematic review and metaanalysis that “provided the latest scientific evidence to support updated or completely new guidelines on evaluation with duplex scanning and on the management of superficial truncal reflux in patients with varicose veins”. However, the authors recognised “several additional important clinical issues” needed to be

US FDA approves LimFlow system for treatment of CLTI The US Food and Drug Administration (FDA) recently announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limbthreatening ischaemia (CLTI). LIMFLOW’S FDA APPROVAL FOLLOWS New England Journal of Medicine publication of results from the PROMISE II multicentre prospective study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute (Cleveland, USA), which found that the therapy enabled most patients treated to keep their leg and experience wound healing. Mehdi Shishehbor, president of UH Harrington Heart & Vascular Institute, and Angela and James

addressed, despite many having varying levels of scientific evidence associated with them. For this reason, when a systematic review was not available, the writing committee based ungraded statements on a comprehensive review of the literature, combined with unanimous consensus of the expert panel. Alongside a series of recommendations, the writing committee highlight “several” knowledge gaps on the natural history, evaluation, prevention and treatment of patients with varicose veins, highlighting their top 20 recommendations for future research. The most important three they identify are comparative studies of polidocanol endovenous microfoam versus physician-compounded foam for treatment of varicose tributaries, comparative studies of polidocanol endovenous micro-foam versus other techniques of thermal and nonthermal ablation of incompetent superficial truncal veins, and best metric of axial reflux to determine ablation of superficial truncal veins. Speaking to Interventional News following the publication of these guidelines, Gloviczki commented: “These up-to-date, evidence-based recommendations are made by a 20-member multidisciplinary expert panel of three leading North American societies, dedicated to the care of patients with acute and chronic venous disease. This comprehensive document includes a list of practical

Hambrick chair in Innovation, as well as lead author and co-principal investigator of the study, said: “LimFlow is a unique alternative to major amputation, providing hope to hopeless cases. The results from this study are excellent, and expanding LimFlow’s availability beyond the hospitals participating in the clinical study has the potential to save many more limbs and lives.” A press release details that LimFlow takes a new approach to treating patients who are facing major amputation because they have no other suitable treatment options, such as traditional bypass surgery or endovascular revascularisation, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein into an artery. This shift rushes blood back into the foot. The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialisation of the deep veins (TADV) using LimFlow therapy. All patients had non-healing wounds on their feet and were facing inevitable amputation before the procedure. At six months post-procedure, the rate of limb salvage was 76%. Within the same time period, 76% of patients had

recommendations, ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with the best and most appropriate management of patients with lower extremity varicose veins. It emphasises the superiority of endovenous techniques over conventional surgery, endorses both thermal and non-thermal ablation techniques and defines the role of compression, drugs and nutritional supplements. The guidelines address management of ablation-related thrombus extension (ARTE) after endovenous procedures and recommends best management of superficial thrombophlebitis, bleeding varicose veins and treatment of superficial venous aneurysms.” Providing additional rationale for the guideline amendments, the authors state that varicose veins of the lower extremities are among the “most frequent” medical conditions affecting millions worldwide. Gloviczki and colleagues also note that chronic venous disease (CVD) may cause “minimal symptoms”, but comparatively, varicose veins is “often the source of discomfort, pain, swelling thrombosis, bleeding and ulcerations”, subsequently causing disability and negative impact on quality of life and normal social functioning. Furthermore highlighting the severity of these conditions, they describe that patients with chronic venous insufficiency (CVI) may progress to phlebolymphedema, skin changes with chronic inflammation, and venous leg ulcerations.

These up-to-date, evidence-based recommendations are made by a 20-member multidisciplinary expert panel of three leading North American societies.” The full guideline document can be accessed on the JVS-VL website.

completely healed or healing wounds. Freedom from all-cause mortality was 87% at six months. “Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said Shishehbor. “At UH Harrington Heart & Vascular Institute, we are proud to have led the research that showed the US FDA that LimFlow works, so that patients have another option to keep their leg and improve their quality of life.” Vein becoming artery with LimFlow crossing stent

November 2023 | Issue 92

14 Point of View

Interventional radiology and radiotheranostics: When talent meets innovation

Islam Elhelf Point of View Interventional radiology (IR) is a main player in modern clinical oncology practice. Almost every tumour board has a seat for IR. Clinical oncology is a rapidly evolving field as well; new therapies are being introduced frequently allowing for treatment of a wide spectrum of cancers. Among these treatment options, radiotheranostics represent a unique platform where diagnostic and therapeutic purposes are combined into a single paradigm. This allows diagnosis and treatment of advanced stages of cancer with high precision, fitting very well into the modern concept of personalised medicine.

eptide receptor radionuclide therapy (PRRT) is the most common radiotheranostic form in clinical practice. The two most widely available radiopharmaceuticals currently are Lutathera for treatment of gastroenteropancreatic neuroendocrine tumours (GEP- NETs) and Pluvicto for treatment of castration resistant metastatic prostate cancer. Different clinical specialties, including nuclear medicine, IR, medical and radiation oncology have high interest in radiotheranostics. With many specialties digging into this field, it is extremely important for the interventional radiologists to be updated about the advances in radiotheranostics. The aim of this article is to update IRs about the

key concepts of radiotheranostics and to explore ways by which IR remains a key player in modern oncology practice. To start with, most interventional radiologists are familiar with the use of yttrium-90 (Y90), loaded on resin or glass microspheres, for transarterial treatment of liver tumours. However, there are significant differences between Y90 therapy and PRRT. Resin or glass loaded Y90 microspheres are essentially flow directed therapists; blood flow dynamics are the main factors controlling microspheres distribution. PRRT have the additional advantage of being linked to receptor specific ligands. This allows these radiopharmaceuticals to attach to active, disease specific, receptors which can be

IASIOS reports significant increase in global interventional oncology centres The International Accreditation System for Interventional Oncology Services (IASIOS), a membership-based accreditation programme, announces its continued advancement in a recent press release, reporting that their network has tripled since its 2021 inception. THE PROGRAMME SEEKS TO FURTHER establish interventional oncology (IO) as a “fundamental pillar within comprehensive cancer care”. IASIOS has been developed to recognise facilities that adhere to the CIRSE Standards of Quality Assurance in Interventional Oncology which aim to establish the highest standards for patient care

easily screened for and quantified using advanced PET/CT imaging tracers. Additionally, there are key differences between Lutetium-177 (177Lu) (a common radionuclide for clinical PRRT radiopharmaceuticals) and Y90. While both are beta particle emitters, Y90 is known to have a longer penetration range (maximum=11mm, mean=3.9mm) and higher energy (mean of 0.94MeV) compared to 177Lu which has a mean energy of 0.15MeV and shorter penetration range in human tissues (maximum=1.7mm, mean=0.23mm). These differences may have implications on patients selection for either therapies, as detailed later herein. Interventional radiologists need to be aware of the fact that, as more clinical theranostic therapies become available, the decision-making process regarding the best treatment option in specific clinical scenarios will become more sophisticated. For example, many metastatic NETs present with liver metastatic disease. These patients have historically been treated by liver directed therapies (LDTs) and thermal ablation. With Lutathera now on board, questions may arise about whether metastatic liver disease would respond better to LDTs versus PRRT. The answer to this question is onerous and requires expertise in the field, sometimes even extended discussions in multidisciplinary tumour boards. A higher somatostatin receptor expression, reflected by a higher Krenning score of 3 or 4, is a

Theranostics therapy is a rapidly evolving field with lots of potential in modern oncology practice.”

and treatment, as well as safety and efficiency of interventional procedures involved in the management of cancer patients. The standards are also intended to account for the whole process of patient care and treatment and what is required to deliver it safely and effectively. What sets IASIOS apart, the press release states, is its multi-tiered accreditation system. Facilities can earn the ‘Enrolled Seal’ by actively implementing necessary changes to meet the core criteria required for accreditation. Upon successfully demonstrating compliance with the core criteria through the IASIOS application process, facilities are awarded the ‘Accredited Seal’. For those that go above and beyond to meet both core and extended criteria, the ultimate recognition comes in the form of the Centre of Excellence Seal. A dedicated steering board and committee has been appointed to the IASIOS programme, with further support from a network of representatives from leading IO hospitals across the globe. Moreover, with support from over 40 interventional radiology societies worldwide, the IASIOS community seeks to drive advancements in IO and patient care.

good predictor of favorable response to PRRT. On the other hand, lower Krenning score metastatic deposits reflect lower receptor expression and may respond better to LDTs. Another factor to consider is the extent of metastatic disease. In our experience, patients with extrahepatic widespread metastatic disease are good candidates for intravenous PRRT therapy, while liver only/dominant metastatic disease may be better candidates for early LDTs, preserving PRRT for later advanced stages. The higher penetration range and beta particle energy of Y-90 spheres may favor the use of Y-90 intra-arterial therapy for large infiltrative tumours and may explain that tumours >2–3cm in size may not respond well to PRRT. An exciting potential opportunity for interventional radiologists is the possible intra-arterial administration of PRRT, combining the high selective advantage of catheter-directed therapy with precise receptor-targeting potential of PRRT. Several studies have demonstrated a higher tumour to background uptake using the intra-arterial approach. However, more studies are needed to investigate how this may reflect on progression-free and overall survival. If proved to add survival benefit, intraarterial PRRT can be a unique niche for those interested in this field. To conclude, theranostics therapy is a rapidly evolving field with lots of potential in modern oncology practice. Interventional radiologists, who are already key players in interventional oncology practice, need to realise the added value of this innovative paradigm and make necessary changes to their practice in response to the advances in the field. Radiotheranostics should not be visualised as a source of threat for IR practice, but rather a gateway to one of the most revolutionary treatments of cancer in the coming years. Islam Elhelf is a clinical assistant professor and programme director at Augusta University (Augusta, USA).

Since its launch in 2021, IASIOS has reported positive growth. Starting with just 12 participating facilities, IASIOS has increased to 55. IASIOS Accredited Seals have been awarded to 16 centres from countries spanning Australia, France, Germany, Greece, Italy, The Netherlands, Singapore, Switzerland, Turkey, the UK and the USA. Now, in 2023, IASIOS intends to make its mark in new territories, welcoming facilities from South America, the UAE, Belgium and Ireland to its network. Through the implementation of the membership annual benefits programme, IASIOS offers a number of initiatives for career and professional development, networking, mentorship, workshops, promotion, recognition, and valuable survey opportunities, aiming to elevate the standard of care for a greater number of cancer patients worldwide.

November 2023 | Issue 92

16 Interview

PROFILE

JONATHAN MOSS

With decades of experience, interventional radiologist Jonathan Moss (Queen Elizabeth University Hospital, Glasgow, Scotland) has managed a fellowship which he initiated in Glasgow and UK interventional radiology (IR) training courses. He was chief investigator for the ‘Cancer and venous access’ (CAVA) trial, a co-investigator for the CardioVascular and Interventional Radiology (CVIR) award winning ‘Randomised trial of embolization with surgical treatment in patients with symptomatic fibroids’ (REST), and was a National Institute for Health and Care Excellence (NICE) committee member. Moss shares his experience of IR across decades and continents with Interventional News, and his memory of revolutionary developments such as endovascular aneurysm repair (EVAR). Moss provides insight on the “Achilles heel” of IR today and shares his pragmatic take on driving the specialty into the future.

What attracted you to a career in IR?

To be absolutely honest I was training to be a surgeon and had already done five years. I then got married and life changed. Radiology in those days (1985) was a much easier career pathway than general surgery, at least in the UK, so, I cancelled a surgical fellowship at Massachusetts General Hospital (Boston, USA) with Ronald Malts unit and joined the radiology programme in Edinburgh. It was a harsh transfer and I was not sure I could cope with reporting plain X-rays and barium studies for the rest of my career. My last surgical attachment was vascular surgery and during that I became aware of IR and that interested me. I never looked back.

Who were your mentors?

I guess my first mentor was “Skip” Van Sonnenburg whilst doing a Cook fellowship in San Diego. Julio Palmaz and his colleague Frank Rivera followed, and I did an IR fellowship with them in San Antonio in 1991. I learnt so much from those guys, they were just ace. Others were Andrew Bradbury who had and has a keen interest in evidencebased medicine and I admired his fortitude sometimes against unpleasant voices. Richard Edwards, one of my contemporaries, was a great support and often ahead of the game pushing the envelope to the limit. In clinical research I have worked with key people and my friend Olivia Wu, who is a health economist, springs to mind.

Could you describe a memorable case of yours?

Goetz Richter performed the first transjugular intrahepatic portosystemic shunt (TIPS) using a stent (Palmaz) in 1988. It was a huge thing, the first one taking 13 hours. My friend Richard Edwards (Glasgow) called me to say he had a suitable patient and did I want to help. Palmaz was coming to Edinburgh to give a talk and we tried to get him to help us but he had a tight schedule. So, we went ahead without him. We tried hard but after several hours had to give up. It is worth remembering we were both senior registrars at the time and it was the first attempt in the UK! Failure is success in progress. We went on to perform many TIPS in Glasgow.

You were an investigator for the CVIRaward-winning randomised trial comparing long-term results of uterine artery embolization (UAE) with surgery

for women with symptomatic uterine fibroids (FEMME). What led you to become involved in this research and what did you take away from the trial?

There was a need, having compared UAE with hysterectomy (REST), to compare it with myomectomy—another uterus preserving procedure. So, the REST investigators joined our colleagues from St George’s, London (Anna Belli) and under the management and support of the Birmingham Clinical Trials Unit, we got the trial funded and approved. It was a rough road and many said it could not be done. Both REST and FEMME were published in the New England Journal of Medicine which speaks for itself. UAE can now be seen as an effective alternative to either hysterectomy or myomectomy. Yes, there is a higher reintervention rate, but it is much less invasive and patients like it. The challenge as always is to put the trial evidence into clinical practice.

You were also involved in the largest randomised trial comparing three central venous devices for the delivery of longterm chemotherapy (CAVA). Results showed that totally implanted ports (PORTs) are more effective than Hickman or peripherally inserted central catheters (PICCs). What was your experience conducting this study and how have the results influenced your practice?

Like REST and FEMME it was a UK-wide trial (the days of single-centre randomised controlled trials is well over). Attitudes varied widely from centre to centre with strongly held but differing views. Equipoise, as always, was king, and we gradually got centres to “open their minds”. Yes, it showed PORTs are better and cheaper, but again like UAE, the challenge is to change clinical practice based on this new evidence.

Throughout your career in IR you have seen the development of novel techniques such as TIPS, stenting, EVAR and fibroid embolization. What has been the most transformative technique to emerge that has influenced how you treat patients to date? The stent has to be there. In those early days with Palmaz we were coating them with silicone and treating surgically created abdominal aortic aneurysm (AAA) in a dog model. Little did I realise at the time how much these devices would be used in medicine

FACT FILE CURRENT APPOINTMENTS 2007–present: Honorary professor of interventional radiology, University of Glasgow, Glasgow, Scotland

PREVIOUS APPOINTMENTS (SELECTED) 2012–2016: Chairman of Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Renal Denervation Task Force 2012–2014: Comittee member of the National Institute for Health and Care Excellence (NICE) interventional procedures advisory panel 1992–2016: Consultant interventional radiologist, Queen Elizabeth University Hospital, Glasgow, Scotland

CLINICAL TRIALS (SELECTED) Chief investigator, CAVA, National Institute for Health and Care Research (NIHR) trial Chief investigator, REST, British Society of Intervetional Radiology (BSIR) trial Co-investigator, NIHR, FEMME study Co-investigator, Medical Research Council, ASTRAL study

whether it be obstructive cancers, aneurysmal disease, occlusive arterial disease, venous disease, trauma, adding coverings, coatings, drugs and so forth.

Having undertaken a fellowship in the USA, what advice would you give to interventional radiologists-in-training who are considering training abroad?

Go and do it, do not wait a minute more. To see medicine in another country is always an eye opener and a unique privilege a medical career offers. In the USA, I learnt so much— the amount of supervised hands-on tuition was fantastic. In the UK, in both surgery and IR I witnessed the senior doctor on multiple occasions either performing the procedure or taking over at an early stage. In Texas I was once told, if the “staff“ has to scrub up he has failed, not you. A good tutor talks you through a practical procedure, only the most accomplished can do that.

You have set up IR training courses in the UK which include live cases. What do you hope interventional radiologists will gain from these courses? What was your intention when putting these together?

I had seen a few live case demonstrations, mainly at conferences, and I liked them. It puts you on the spot, it is all happening in front of the audience. There is no “fake news” with a live case. It can, however, be challenging for the operator and the patient, particularly when it comes to questions (Ted Dietrich never allowed them). We teamed up with our colleagues in Sheffield and ran the UK Interventional Course for several years, we had overseas guys like Van Sonnenburg, Palmaz, Rivera doing stuff too. Everything has its lifetime though and live cases became a bit politically incorrect and video pre-recorded stuff took over. It was great sporting fun at the time though. One of the aims was to let the audience see how we work as a team, so it was not just about the procedure, but how the theatre worked, who did what, how the operating scrub table was set up, patient monitoring and sedation so, the whole package of care in the theatre.

What are the challenges facing IR in the 21st century?

We need to mature. We have been riding on the crest of a wave over the last 20 years or so with new procedures, new technology. What we need now is two things: First we

Issue 92 | November 2023

Andy Watt/NB Illustration

Interview 17

need evidence to support our procedures. There is no better example than the huge field of interventional oncology but so few randomised controlled trials—that needs to change. The solution is simple really—we need to work much more closely with our oncology colleagues. They have already been there and have massive experience in randomised controlled trial (RCT) design and delivery. We need to develop good working relationships with clinical trials units, statisticians, health economists, the appropriate clinicians, and apply for funding. Radiologists cannot do this alone so team working across multiple sites and possibly multiple countries is crucial. Second, we need recognition of who are, what do we do, and how do we work. This is more challenging and our Achilles’ heel is clinical care and responsibility. Too often we still do what is written on the request card, and are not involved in clinical follow-up and the initial consultation. Dedicated IR beds are rare. That needs to change and change fast if we are to survive. We need a new curriculum. We can

do it, look at haematology for example and how they pulled themselves out of laboratory medicine to a full-blown clinical specialty. We need to separate ourselves from diagnostic radiology, we must do this or tumble.

What fascinates you about IR to this day? IR can be thought of as “surgery without the knife”. It is amazing what can be done through a tiny incision, we can breech almost any barrier—if you think of tiny prostatic arteries, aneurysms in the brain and malignant tumours almost anywhere. The kit continues to hold one’s attention as we see ever smaller devices loaded with the latest technology. You cannot take a snooze if you are an interventional radiologist, the game is constantly changing, RCTs are popping up all the time strengthening the evidence base for what we do. It is fascinating to see the range of other specialties who come knocking on our door—oncologists, urologists, general surgeons, breast surgeons, renal physicians, cardiologists, stroke doctors, paediatricians,

“I think we now need to mature. We have been riding on the crest of a wave over the last 20 years or so with new procedures, new technology.”

obstetrics/gynaecologists, vascular surgeons, to just name a few. In fact, just about everyone in the hospital—except perhaps the psychiatrists—knows you. So there are lots of doors for us to knock on, some will remain closed due to lack of evidence, for example, renal artery stents but many, many more are wide open, waiting and welcoming. We need to stay awake, constantly question ourselves and what we do, look for opportunities, continue a close relationship with other specialties and tell others, especially the public, who we are and what we can do.

What are your hobbies and interests outside of medicine?

I like getting outside and everything that goes with that. I have a lovely partner, Fiona, and we do quite a bit of sailing together. We did an Atlantic circuit last year, crossing over to the Caribbean then up the east coast of the USA to Canada and back via the Viking route. I like fishing but rarely catch much. Mountains, bikes and occasional diving are all good.

November 2023 | Issue 92

18 Point of View

Interventional approaches to benign bone tumours

Alan Sag Point of View Patients diagnosed with benign bone tumours will be relieved to know that these are not malignant, and some tumours will involute spontaneously. However, this natural history can be unpredictable, and tumours can be associated with significant pain, pathologic fracture, or potential for growth and compression of critical structures such as nerves. INTERVENTIONAL APPROACHES are increasingly being applied to this domain after multidisciplinary discussions. Two common indications that interventionists may encounter are:

Osteoid osteoma and osteoblastoma

Most often these lesions are treated due to pain. Single-session biopsy and thermal ablation has become a standard of care at many institutions. The majority of cases will be treated with general anaesthesia as instrumentation of the nidus can create significant involuntary patient movement

Bariatric embolization: What we know so far

Raphael Braz Point of View Obesity has been steadily increasing worldwide for at least 50 years. It directly contributes to the rising incidence of cardiovascular, musculoskeletal, and oncological diseases. Becoming one of the most concerning public health issues, obesity accounts for a majority of healthcare expenditures in Western countries, causing approximately three million deaths per year globally. While lifestyle interventions such as diet and exercise remain the foundation of weight management, only around 2% of individuals can sustain weight loss over a 12-month period. FOR INDIVIDUALS WITH morbid obesity (BMI [body mass index]> 40kg/m²) or obese patients with significant comorbidities (BMI between 30–39.9kg/m²), bariatric surgery is considered the gold standard. This surgical procedure has demonstrated long-term weight loss and substantial improvements in metabolic syndrome, and overall survival. However, it is associated with a direct mortality rate of up to 2%, a high incidence of early complications including gastrointestinal fistulas, abdominal abscesses, thromboembolic events, as well as

long-term nutritional deficiencies that can lead to chronic anaemia and bone fractures, among others. It is also a very expensive procedure, costing an average of US$38,000 without complications and US$64,000 with complications, which makes it almost impossible to be offered in public health systems of developed countries. Over the past decade, we have witnessed the emergence of new drugs such as GLP-1 agonists, initially designed to treat diabetes, but now predominantly used for weight loss purposes. While they have been

due to pain. Utilisation patterns of radiofrequency (RF), microwave, and cryoablation, and other options such as laser ablation and high-intensity focused ultrasound will be dictated by operator preference and device availability, and local insurance coverage. RF ablation has the benefit of a long track record in the literature and colloquial familiarity in the orthopaedic surgery and neurosurgery domains. Use of cooled RF systems may be helpful to prevent carbonisation in heavily sclerotic lesions. Cryoablation has emerged as a convenient alternative as it can provide a larger zone of ablation per probe chance to visualise the extraosseous extent of the ice ball and extrapolate the intraosseous treatment zone.

Aneurysmal bone cyst

Most often these lesions are treated due to impending pathologic fracture. Depending on the size and location of the lesion, multiple sessions and modalities may be applied to achieve osseous consolidation of the lesion. Intralesional sclerotherapy is a valuable option and can serve as a monomodal therapy, sometimes requiring multiple sessions. In cases where there is halted progression but slow osseous consolidation, augmentation associated with weight loss of up to 15% within one to two years, they also come with a high incidence of adverse effects, including nausea, vomiting, diarrhoea, abdominal pain, and headache. Additionally, these drugs are costly, leading to treatment discontinuation and subsequent weight regain. Hence, there is a need for minimally invasive, cost-effective, and longlasting procedures for obesity treatment, and this is where bariatric artery embolization (BAE) comes into play. BAE aims to induce ischaemic changes in the gastric fundus, reducing the number of viable orexigenic cells and consequently lowering the concentration of acylated ghrelin in the bloodstream. Ghrelin is the sole peripheral orexigenic hormone responsible for increasing appetite in the human body and is directly associated with fat accumulation and metabolic syndrome. From the first prospective clinical trial conducted in 2015 to the present, we have been able to demonstrate that BAE is a very safe procedure, with only 3% of serious adverse events and no reported deaths thus far. It consistently leads to a sustained decrease in plasma

There is a need for minimally invasive, cost-effective, and long-lasting procedures for obesity treatment.”

with osteoconductive cements may be considered; compared to polymethylmethacrylate these biologic agents will allow natural bone ingrowth. Thermal ablation can be considered if loculations limit spread of sclerotherapy agent, with cryoablation serving a unique role as the ice-ball can be completely visualised and some of these lesions are in proximity to important nerves or open physes. Embolization has a role in lesions that are particularly high risk for thermal ablation due to adjacent structures, have insufficient cortex to contain sclerotherapy agents, and are in surgically unfavourable locations (such as the pelvis). Embolization can be a monotherapy or enable other aforementioned therapies by allowing interval consolidation and remodelling of the cortex to contain injectable agents. In summary, benign bone tumours serve as an opportunity to apply a broad range of interventional techniques to achieve pain relief and prevent skeletal events such as pathologic fracture. Alan Sag is an interventional radiologist and spine specialist at Duke Interventional Radiology Clinic, Durham, USA. ghrelin levels of up to 32%, and a total body weight loss of approximately nine to 10% within 12 months. Most trials conducted so far have utilized microspheres ranging between 300–500µm in size. While shallow ulcers are often observed during upper gastrointestinal endoscopy within one week post-procedure, they are mostly asymptomatic and disappear entirely within one month. In our trial titled ‘Bariatric embolization in the treatment of patients with a body mass index between 30 and 39.9kg/m2 (Obesity class I and II) and metabolic syndrome: A pilot study’, although we target multiple feeders of the gastric fundus (left gastric, short gastric, and gastroepiploic arteries) in 90% of the participants, the majority of ulcers were found in the lesser curvature, possibly due to unnoticed reflux of the embolic agent, while none were detected in the gastric fundus itself, making it a safe target for embolization. This trial also demonstrated the direct impact of the procedure on insulin resistance, with normalisation of mean fasting blood glucose and a significant reduction in homeostatic model assessment for insulin resistance (HOMA-IR) from 7.3 to 3.7 within six months. More robust data from randomised, prospective trials are forthcoming, which will probably establish BAE as an essential tool in the clinical management of obesity in the near future. Rapael Braz is an interventional radiologist at the Real Medical Center (RIVOA) in Rio de Janeiro, Brazil.

Issue 92 | November 2023

Interview 21

SIO president sets sights on becoming “strongest voice for the IO community” Muneeb Ahmed is an interventional radiologist specialising in interventional oncology (IO) at Beth Israel Deaconess Medical Centre (Boston, USA) and current president of the Society of Interventional Oncology (SIO). Speaking to Interventional News, Ahmed describes the nature of his appointment to date, his past clinical experiences which valuably inform his role, and what he hopes to achieve throughout his presidency.

Please introduce yourself—what does your clinical practice look like?

I am currently the chief of interventional radiology (IR) at Beth Israel Deaconess Medical Center (BIDMC), professor of radiology at Harvard Medical School, and current president of SIO. Originally from Pakistan, I completed training in diagnostic radiology here at BIDMC, IR training at the Johns Hopkins Hospital, and have been a practicing attending IR physician at BIDMC since then. I lead a busy clinical IR practice, with 12 IR faculty and multiple residents every year at a large academic medical centre. My own clinical focus is on IO, including all forms of image-guided tumour ablation and transarterial therapies, and in the treatment of complex portal hypertension. In addition, I oversee a translational research laboratory where we study the effects of thermal ablation on tumour biology.

Why did you want to become involved in the board of SIO? How did this come about?

The Society of Interventional Oncology (SIO; 25-29 January, 2024, Long Beach, USA) annual scientific meeting—formally known as the World Conference of Interventional Oncology (WCIO)—was developed more than 25 years ago out of a desire for the IO community to come together to discuss clinical practice, research and education. I originally became involved as a resident, presenting my research at WCIO and seeing leaders in the field who had similar interests in IO. As an attending interventional radiologist, I continued to volunteer—joining the annual meeting program committee, and ultimately, serving as program chair for the 2017 WCIO meeting. As the WCIO progressed into the more formal SIO, I have continued to volunteer for larger roles, which has led to holding positions on the SIO board, such as treasurer, and now president. Throughout my 20+ years of involvement with the WCIO/SIO, the core values of the society—its commitment to advancing IO and how effective it has been in fostering research

and education—have continued to impress me. My own positive experiences highlight the opportunity for all of us in the field to contribute and help advance IO, and the SIO has been a great place to do just that.

You became president in January of this year—how has it been so far? What have you been working on?

Assuming the role of president of SIO is both very exciting and daunting at the same time. I have the privilege of continuing the work of many prior successful and well-known previous presidents, most recently Matt Callstrom (Mayo Clinic College of Medicine, Rochester, USA), our immediate pastpresident. It has been a very busy year already, as the SIO is working on many fronts to meet the needs of IO. First up, we launched the SIO’s first clinical trial—the ‘Ablation with confimation of colorectal liver metastases’ (ACCLAIM) trial, which is a prospective international multicentre trial designed to demonstrate the importance of intraprocedural ablation margin confirmation. We just announced a new call for grant proposals in Y90 radioembolization and immunotherapy, sponsored by AstraZeneca. At the same time, we continue to build on our exciting IO master class educational programs, having successfully held our Y90 radioembolization master class in June, and another in-person musculoskeletal IO master class in the fall. On top of this, we are working on engaging with more members of the IO community by partnering with IR societies in Asia

Ultimately, I would like to see the SIO build an even bigger tent, so that anyone doing IO will see the SIO as their home and community.”

and Latin America. The SIO team and our group of volunteer physicians has been very active and I have been busy keeping track and making sure we are progressing on all of these fronts.

Do you feel like there are aspects of your clinical practice that complement your position as president? How has your career as an IR thus far set you up for taking on this responsibility? Definitely. Clinically, I have always had a strong focus on IO, including the introduction of new treatments at my institution, building a robust practice through tumour board participation, and developing novel multidisciplinary clinics at a large academic institution. In fact, our multidisciplinary liver tumour clinic is one of the most well-rounded and busiest growing practices within our own cancer centre. At the same time, we have an active IR training program, teaching residents how to practice evidence-based, comprehensive clinical IR. Finally, I have always had a strong interest in translational research, leading a basic science and transitional animal lab with a focus on studying interventional oncology related tumour biology, and now strategies to augment IO induced immunotherapy. All of these experiences have provided me with a comprehensive perspective on the opportunities within the IO specialty, and what the day-to-day challenges are that practicing interventional oncologists face. This has really influenced my thoughts on where the society can help serve its membership and its broader patient and physician constituencies. My own experiences in working in every day with medical, radiation, and surgical oncologists to accommodate different perspectives and offer the best clinical care for each patient has also taught me the value of successful collaboration, which I bring to my work as SIO president in continuing to build out our own partnerships and relationships with many different collaborating organisations and individuals.

What are your goals for the rest of your presidency?

It is an exciting time to be in IO and leading the SIO in particular. My overall goal is to leave the SIO better off at the end of my presidency than when I started. To this end, I want to continue to grow SIO as the strongest voice for the IO community, meeting the needs of physicians and our patients by advancing innovative research, providing the best possible educational programs and training, and advocating for IO inclusion in clinical practice guidelines. Ultimately, I would like to see the SIO build an even bigger tent, so that anyone doing IO will see the SIO as their home and community, just as I have all these years.

SIO Presidential timeline 2017

2019

2021

2023

Stephen Solomon “To drive safety and deliver quality resources to medical professionals in the IO field.”

William Rilling ”The opportunity to promote IO as an emerging field of cancer medicine, helping patients with minimal invasiveness”

Matthew Callstrom “To advance IO as the fourth pillar of cancer therapy, alongside medical, surgical and radiation oncology wolrdwide.”

Muneeb Ahmed “Our collective goal is to grow SIO as the strongest voice for the IO community.”

November 2023 | Issue 92

22 News

ABLATION

Cryoablation found to “significantly reduce pain” in endometriosis patients with abdominal wall lesions

Published in the Journal of Vascular and Interventional Radiology, a recent retrospective study which evaluated pain relief after percutaneous image-guided cryoablation in patients with symptomatic extraperitoneal endometriosis (EE), has found the treatment to be “safe and effective”. Lead author Francois H Cornelis (Memorial Sloan Kettering Cancer Center, New York City, USA) and colleagues detail that the minimally invasive procedure “significantly reduced pain” and succeeded in obtaining local control of EE in their patient population.

skin or bowel”. Although previously demonstrated, Cornelis and colleagues note that their findings confirm cryoablation “can be performed safely” in patients under local anaesthesia and on an outpatient basis, “reducing the length of hospitalisation and postoperative recovery”. Moreover, Cornelis et al convey the effectiveness of cryoablation for EE in their results, but conclude that the procedure “must be evaluated in multidisciplinary committees to ensure adequate selection and follow up of women”. They state that prospective trials must be carried out to confirm the technique so that it can be incorporated into future guidelines for the therapeutic treatment of EE.

ffecting around 190 million women of reproductive age worldwide, EE is a chronic disease that many women have “limited awareness” of, the study authors state. For this reason, they believe that lengthy delays can occur between symptom onset and diagnosis. Therapeutic options most commonly offered to these patients are hormonal agents or surgical excision. However, among the minimally invasive procedures developed during the last decade, Cornelis et al explain, cryoablation has become a “promising option” for the treatment of abdominal wall EE, with “satisfactory outcomes and low morbidity”. “Cryoablation of soft-tissue lesions may be performed safely because the ice produced remains visible using the imaging techniques used in interventional radiology [IR] to guide the procedure,” Cornelis and colleagues explain, noting the improved precision cryoablation can provide when assessing the margins of ablation, thus reducing risks. Conducted between 2017 and 2022, their observational and retrospective study employed the database of a single institution identifying patients who were referred to the IR department for cryoablation of symptomatic EE. The authors identified a total of 42 women from the database with whom had a median age of 37 years. Among this cohort, 47 lesions were treated. The median follow-up duration was 13.5 months after cryoablation, the authors convey that the median pain-free survival rate post-procedure was 93.8% (95% confidence interval [CI], 77.3–98.4) at six months and 82.7% (95% CI, 58.8–93.5) after 12 months. Pain decreased from a median of eight out of 10 on the visual analogue scale, to zero at last followup. Additionally, their results show the efficacy rate of cryoablation to avoid secondary surgery was recorded

Review reports increase in hysterectomy risk after endometrial ablation A recent publication in the journal Obstetrics & Gynaecology has reported an increase in the risk of hysterectomy after endometrial ablation from one to five years post-procedure. THE RISK ASSESSMENT WAS CONDUCTED by Tamara J Oderkerk (Maxima Medical Center, Eindhoven, The Netherlands) et al, who used the EMBASE, MEDLINE, ClincalTrials.gov and Cochrane databases to search for eligible articles

The median pain-free survival rate postprocedure was 93.8% a 2% rate of adverse events

Francois H Cornelis

as 92.8%. Cornelis et al reported a 2% rate of adverse events in this cohort, noting four patients who reported pain in the days following the procedure, and one patient that reported a recurrence of symptoms a year following. Restating the “excellent safety profile” of cryoablation seen in their results, the authors emphasise that due to the freezing procedural temperatures, the ice is visible under real-time imaging guidance, reducing the “risks of injuring the from inception, to June 13, 2022 to present. To do so the investigators note that search terms included endometrial ablation and hysterectomy, and described the incidence of hysterectomy within a specific time after ablation with a minimum follow-up duration of 12 months. Yielded from their search, the authors identified 3,022 articles, with a total of 53 studies that met their inclusion criteria. These articles consisted of six retrospective studies, 24 randomised controlled trials and 23 retrospective studies. A total of 48,071 patients underwent endometrial ablation between 1992 and 2017, with a follow-up duration that varied between 12 and 120 months. Oderkerk et al’s analysis by follow-up found a 4.3% hysterectomy rate at 12 months (n=29 studies), 11.1% at 18 months (n=1 study), 8% at 24 months (n=11 studies), 10.2% at 36 months (n=12 studies), 7.6% at 48 months (n=2 studies), and 12.4% at 60 months (n=6 studies). The authors state that two studies reported a mean

Pain decreased from a median of eight out of 10 on the visual analogue scale, to zero.” hysterectomy rate at 10 years after ablation of 21.3%. Concluding their review, Oderkerk and colleagues state that clinicians “can use the results of this review to counsel patients on the 12% risk of hysterectomy five years after endometrial ablation”. A statement which garnered response from Vance McCausland (George Washington University School of Medicine, Washington, USA) et al—author of the 2007 paper ‘Long-term complications of endometrial ablation’— who addressed the issue of postablation intrauterine scarring and contracture which can “obstruct persistent or regenerating endometrial tissue trapped behind the scar”. McCausland and colleagues relay however that entering the uterus for diagnostic purposes after endometrial ablation in order to exclude carcinoma for example, “appears to be a useful diagnostic tool” within practice today. Furthermore, in their response, the authors supplement that further investigation will be required to “better understand long-term postablation problems”.

Issue 92 | November 2023

CIRSE 23

CIRSE radiation protection sessions address geographical disparities and mitigate perceived risks for interventional radiologists in training The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) hosted sessions dedicated to radiation protection, contemporary risk management strategies for staff and patients, and challenges faced by interventional radiologists in the developing world. Among key takeaways across Sunday and Monday of the meeting was the assertion that optimisations for radiation mitigation must be implemented universally, although “steps should be taken by national and international institutions” to ensure these needs are met so that radiation exposure no longer represents a deterrent to entering the field of interventional radiology (IR).

Radiation protection for interventional radiologists in developing countries with resource-limited facilities

Presenting in Sunday’s ‘Radiation protection: a worldwide challenge’ session, Gabriel Bartal (Tel Aviv University, Tel Aviv, Israel) began by situating his focus in Africa, where he asserted problems in radiation protection are “most prominent” today. Providing an overview of the current measures in place in these countries, Bartal stated first that “IR has changed clinical medicine worldwide”, however “incorporation of IR methodologies in these countries is much behind where is desired, if at all”. Aiming to improve conditions, Bartal referenced the International Atomic Energy Agency’s (IAEA) multinational prospective study which surveyed 55 hospitals in 20 low-resource nations, reporting that workloads have doubled in 30% of countries within the last three years. Kerma-area product (KAP) measures were only available in half of the institutions included, and “none” of the surveyed clinicians stated prior experience with its use. To Bartal, these data display the “requirement of more certified interventional radiologists, radiation protection and training”, to meet the “rising” demand for imageguided interventions in African countries. Addressing strategies to improve radiation protection conditions in Africa, Bartal described a survey conducted by Wilbroad Muhogora (Tanzania Atomic Energy Commission, Arusha, Tanzania) et al, which reported that lead aprons are used in all participating African hospitals. However, only 44% reported the additional use of lead goggles. In concurrence with Muhogora et al’s findings, Bartal reiterated that, although optimisation steps have been taken, challenges faced by interventional radiologists in low-resource settings are “incomparable” to high-income

countries, concluding that efforts to implement further safety measures and collect crucial maintenance data must be bolstered by international IR societies. Meanwhile, he stated that several leading interventional radiologists from North America and Europe are training radiologists from several African countries on site, to safely perform complex interventional procedures. Of his final thoughts, Bartal stated that voluntarily assisting IR training worldwide is “the way to make sure that the patients will undergo minimally invasive procedures without complications and without needing lengthy hospitalisation—interventional radiologists are encouraged to join these valuable efforts via Road2IR.org”, Bartal concluded.

Does low dose always mean low radiation?

Eliseo Vano (San Carlos University Hospital, Madrid, Spain) gave his presentation in Monday’s session titled ‘Protecting yourself, protecting your staff!’, describing the links between occupational and patient radiation doses in IR, and in what circumstances low dose procedures may involve high exposure for clinicians. Central to his discussion was the relationship between procedural radiation dose and exposure to the clinician. Vano stated that understandably high patient doses involve a high level of scatter radiation, which inevitably increases occupational exposure. However, in low patient dose procedures—which he noted are “usually the most frequent”— occupational doses may remain high if “protection tools are not used properly”. To this end, Vano emphasised the importance of communication around radiation protection to the CIRSE audience, which, if compromised, should be “alerted, corrected and discuss[ed] in training sessions”.

Furthering his proposal for dose mitigation, the speaker asserted that an audit of occupational doses should be made monthly, referring to a study he led that described the added importance of dose management systems (DMS) when auditing dose more closely over time. In their study, Vano et al collected data from C-arm dosimeters in five international IR facilities, surveying patient dose indicators, occupation dose values, the ratio between occupational doses, and the doses measured by the reference dosemeter at the C-arm, and the ratio between occupational and patient dose values. Among the 4,500 procedures and 8,000 records of occupational exposures included within their review, Vano and colleagues note that patient and staff dose data was available for 3,043 procedures, which the investigators positively conclude provides an “advantage”, integrating both staff and patient dose for a clearer outlook on procedural exposure. Finalising his presentation, Vano added that implementation of sensitised alerts should be central to future education programmes for interventional radiologists.

The IR gender gap: Mitigating radiation hazard perception

Opening her presentation, Maureen Kohi (University of North Carolina, Chapel Hill, USA) described a prospective online survey carried out by CIRSE evaluating the gender gap in IR and the barriers facing women trainees specifically. “There is a paucity of women in IR in CIRSE and around the world,” Kohi noted, foregrounding a key and perhaps influential finding from the survey which pointed to women’s concern about radiation, particularly during pregnancy. However, Kohi made clear that concern over radiation exposure is not singularly attributed to women— referencing a survey carried out by Yarelis Vazquez Perez (University of Maryland, Baltimore, USA) et al, she drew attention to the equal percentage of male and female respondents who

rated radiation exposure as a the main deterrent to pursuing a career in IR. “Men are also worried about radiation exposure—it is not unique to the female sex,” Kohi continued, but “as females are the only sex that can be pregnant, it is a big concern during this time”. “But what do we know about occupational radiation exposure?” Kohi asked the CIRSE 2023 audience, briefly describing the variations that exist in regulations concerning occupational radiation exposure during pregnancy. Currently, in the USA, maximum foetal dose is set at five millisieverts (mSv), although in Europe this limit is 1mSv. “But when you look at more data,” Kohi expands—referencing a study conducted by Stephane ManzoSilberman (Pitié-Salpêtrière Hospital, Paris, France) and colleagues—“and you look at the dose that would be required to cause [prenatal] effects, we are so beneath that threshold”. To this Kohi emphasised Manzo-Silberman et al’s finding which marked 100mGy of radiation as the occupational dose threshold after which foetal effects were reported. “The theory exists, but it is virtually not possible,” Kohi averred, to which she reiterated that “radiation exposure should not be a barrier for female or male trainees in becoming interventional radiologists”. Concluding, Kohi underlined that education is needed for female trainees on the safety of prenatal radiation exposure. She stated: “We need to mentor our pregnant female trainees so that they are not afraid— we want these women to continue their career while pregnant.”

Radiation exposure should not be a barrier for female or male trainees in becoming interventional radiologists.”

Maureen Kohi

November 2023 | Issue 92

24 News

‘Minimal differences’ in clinical outcomes between stroke thrombectomy with or without thrombolysis, metaanalysis signals There are likely to be minimal differences in clinical outcomes between acute stroke patients presenting directly to endovascular treatment centres who undergo mechanical thrombectomy alone, and those who receive intravenous thrombolysis (IVT) plus thrombectomy. That is according to a meta-analysis examining six randomised controlled trials (RCTs) and more than 2,300 patients, which is now published in The Lancet, and ultimately found that non-inferiority of thrombectomy alone could not be established in these patients.

utlining the latest data from the Improving Reperfusion strategies in Ischemic Stroke (IRIS) collaboration, Charles Majoie, Yvo Roos (both Amsterdam University Medical Centers [UMC], Amsterdam, The Netherlands) et al initially note that IVT is recommended before endovascular thrombectomy treatment, but its value “has been questioned” in patients who are admitted directly to centres capable of both treatments. “Existing RCTs have indicated noninferiority of endovascular treatment alone or have been statistically inconclusive,” they add—also stating

that the IRIS collaboration has been formed to assess the non-inferiority of endovascular thrombectomy alone, as compared to IVT plus thrombectomy. To this end, Majoie, Roos et al conducted a systematic review and individual participant data metaanalysis, searching PubMed and MEDLINE for relevant articles published from database inception to 9 March 2023. They identified six RCTs on the topic of interest—DIRECT-MT, DEVT, SKIP, MR CLEAN-NO IV, SWIFT DIRECT and DIRECT-SAFE— with the respective authors of each agreeing to take part, and individual

participant data from all the trials being 1–4) in patients who received IVT provided and collated centrally. plus thrombectomy, with an adjusted The researchers’ primary outcome common OR of 0.89 (95% CI 0.76– was the 90-day modified Rankin 1.04). In addition, any intracranial scale (mRS) score, they detail. haemorrhage (ICH) occurred less Non-inferiority of endovascular frequently with thrombectomy alone as treatment alone was assessed using compared to IVT plus thrombectomy a lower boundary of 0.82 for (adjusted common OR 0.82, the 95% confidence interval 95% CI 0.68–0.99), while (CI) around the adjusted symptomatic ICH and common odds ratio (OR) mortality rates did not differ for a shift towards improved significantly between the functional independence two patient cohorts. outcomes with ordinal As the researchers regression. The researchers were unable to exclude Charles Majoie report using mixed-effects the possibility that models for all their analyses. omitting IVT could The six RCTs deemed lead to worse outcomes, eligible for analysis further investigations provided data on 2,313 are now planned—for patients—1,153 of whom example, via dedicated were randomly assigned substudies—to explore the to receive thrombectomy impact individual patient alone and 1,160 of whom differences may have on the Yvo Roos were randomly assigned to efficacy of thrombolysis. receive IVT plus thrombectomy. The researchers conclude: “It is “The risk of bias of the included crucial to recognise that the actual studies was low to moderate,” Majoie, benefit of additional IVT is likely to Roos et al relay. “Variability between be small and may vary. It is imperative studies was small, and mainly related to that IVT does not cause any delays, the choice and dose of the thrombolytic restrict access to, or take precedence drug and country of execution.” over endovascular treatment, The researchers found a median considering the limited and uncertain 90-day mRS score of 3 (interquartile effect it has compared to the range [IQR] 1–5) in the thrombectomy- large impact of endovascular only cohort of patients and 2 (IQR treatment itself.”

Multicentre study points to favourable safety and efficacy of radial access for peripheral interventions New research examining the safety and efficacy of using radial access for peripheral artery interventions has found that radial access allows early ambulation and sameday discharge with no serious adverse events. THESE ARE THE CONCLUSIONS OF A study published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), conducted by a team of researchers from eight prominent US medical centres, aimed at examining the safety and feasibility of radial artery access for complex endovascular lower extremity interventions. Peripheral artery interventions are commonly performed to treat vascular conditions that obstruct blood flow to the lower extremities, though traditionally these procedures have used a femoral artery access approach. In recent years, there has been increasing interest in using radial access, which involves accessing the arteries of the wrist or forearm, as an alternative approach. From June 2020 to June 2021, 120 patients at eight centres were enrolled. The mean age of the patient population was 68.7 years and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%) and tibial (19.5%) vessels. The primary efficacy endpoint, procedural success, defined as the successful completion of the procedure without conversion to femoral access and without radial access complications peri-procedure, was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the

procedure. Thirty (25%) patients required one or more additional access to facilitate crossing and/ or to complete the planned treatment (five femoral, 10 tibial, and 17 pedal). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same day discharge. At 30 days, 97.2% of patients had ultrasound-confirmed radial access patency. The findings of the study also demonstrate that radial access for peripheral artery interventions was associated with favourable safety profiles. Notably, the incidence of access site complications and major adverse cardiovascular events was significantly lower compared to the traditional femoral access approach. The results also showed comparable procedural success rates and long-term clinical outcomes between the two approaches. Additionally, radial access was found to have the potential to be a safe and effective alternative for performing peripheral artery interventions. The researchers believe that the wrist and forearm offer several advantages over the traditional femoral access site, including improved patient comfort, reduced Mehdi Shishehbor

bleeding complications, and faster ambulation. Further research and clinical trials are warranted to validate these findings and establish radial access as a mainstream approach in this field, the study’s authors note. “This study contributes to the growing body of evidence supporting the use of radial access for peripheral artery interventions,” stated Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), lead author of the study. “As medical professionals continue to explore different approaches, advances in technology and techniques are expected to further enhance the safety and efficacy of these procedures. With its potential to improve patient outcomes and satisfaction, radial access may revolutionise the field of peripheral artery interventions.” The study’s authors conclude that their research shows the safety and efficacy of the radial access approach for treating complex, multilevel peripheral arterial disease (PAD). “Radial approach allowed same day discharge for most patients with no serious adverse events,” Shishehbor et al write. “Future randomised trials should examine the clinical and cost effectiveness of this approach compared with femoral access for patients with PAD.”

With its potential to improve patient outcomes and satisfaction, radial access may revolutionise the field of peripheral artery interventions.”

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November 2023 | Issue 92

28 Clinical News

Clinical News Delcath Systems announces publication of study comparing chemosaturation and SIRT

Delcath Systems, an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, have announced the publication of an article entitled ‘Selective internal radiotherapy (SIRT) and chemosaturation percutaneous hepatic perfusion (CS-PHP) for metastasized uveal melanoma: A retrospective comparative study” in the peer-reviewed oncology journal Cancers. This retrospective study compared two cohorts of patients with liver dominant uveal melanoma treated at the University Hospitals Tubingen, Germany with multiple cycles of either CS-PHP (N=28) or SIRT (N=34). Patients included in the study were treated between December 2013 and February 2020. Allocation to treatment was determined by a multidisciplinary team. Presence of extrahepatic disease at baseline favoured the SIRT group (68% and 41%, CS-PHP and SIRT, respectively), as did the hepatic tumour load (0–25%: 57% and 76%; 26%–50%: 29% and 24%; >50%: 14% and 0%, for CS-PHP and SIRT, respectively). Tumour responses were evaluated by consensus reading by two experienced radiologists.

Robocath completes CARE clinical trial evaluating robotic carotid stenting

Robocath announce the results of its CARE clinical trial focusing on robotic carotid stenting—the first phase of a research programme launched in July 2021 by Robocath and Rennes University Hospital (Rennes, France), which, in the long term, is aiming to enhance current and future generations of robots used in the treatment of neurovascular diseases. The prospective, single-arm, nonrandomised CARE trial, launched in November 2021, saw François Eugène and Quentin Alias (both Rennes University Hospital, Rennes, France) perform a total of seven robotic procedures using R One, an innovative robotic platform developed and marketed by Robocath. This firstgeneration robot is designed to improve precision, reducing staff’s exposure to X-rays, the press release states.

The R-One robotic platform

Artivion announces meaningful all-cause mortality reduction in AMDS PERSEVERE trial

Artivion has announced presentation of interim results from the Ascyrus medical dissection stent (AMDS) PERSEVERE clinical trial in a latebreaking science session at the 37th European Association for CardioThoracic Surgery (EACTS) annual meeting (4–7 October, Vienna, Austria). Fernando Fleischman (Keck Hospital of the University of Southern California, Los Angeles, USA) delivered data from the PERSEVERE US investigational device exemption (IDE) trial in a late-breaking presentation titled, “Interim results of AMDS hybrid prosthesis in acute DeBakey Type I [ADTI] dissection with malperfusion”, including interim data on 52 study participants at 30 days post-implantation and an additional eight participants in total follow-up. As Artivion details, these interim data demonstrate a clinically meaningful reduction of all-cause mortality and primary major adverse events (MAEs), with 79% of participants experiencing no target MAEs at 30 days (41 of 52 patients). In PERSEVERE, rates of all-cause mortality (13.5%), new disabling stroke (9.6%), new onset renal failure requiring dialysis (7.7%) and myocardial infarction (0%) all compared favourably to ‘historical reference’ rates, according to Artivion.

Biotronik announce two-year results from DCB catheter registry

Biotronik has announced the twoyear results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (Ghent University, Gent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark). The prospective, international, multicentre post-market registry evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, The Netherlands, and Luxembourg with Rutherford 2–5 disease and at least two centimetres of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%. At 24 months freedom from clinically driven target lesion revascularisation (CD-TLR) was 81.6%, freedom from major target limb amputation was 98.0% and freedom from all-cause of death was reported as 89.4%. Significant improvement of Rutherford classification was observed for 88.1% of the patients.

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November 2023 | Issue 92

30 Product News remarks: “This clearance is a longawaited milestone for us, and it allows us to meet the growing demand for our system in the USA.”

Product News Cardio Flow announces US FDA 510(k) clearance for its FreedomFlow orbital atherectomy peripheral platform

Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform. The company details in a press release that the FreedomFlow platform is designed with a mechanism of action to clear plaque blockages in the arteries of the legs, its proprietary, catheterbased design leveraging the physics of angular momentum. According to Cardio Flow, this unique approach gives physicians a highly efficient, effective, and flexible way to treat complex peripheral arterial disease (PAD) in a wide range of vessel diameters—from 2mm in the ankle to 8mm in the hip—and greater versatility in treating multiple arteries and multiple blockages in the same vessel, all with a single device.

FreedomFlow

HistoSonics receives FDA clearance for Edison histotripsy system

Micromate

Interventional Systems announce US FDA clearance for robotic system

Interventional Systems have announced that Micromate has been granted a new 510(k) clearance, allowing the commercial sale of the robotic system in the USA for percutaneous procedures using computed tomography (CT) optical navigation, such as biopsies and ablations, to diagnose and treat conditions in the chest, abdomen, and musculoskeletal structures. This latest US Food and Drug Administration (FDA) clearance further expands the scope of Micromate, which has been available in the USA since 2021 for any percutaneous needle intervention performed under live imaging using cone-beam CT, CT fluoroscopy, or a fluoroscope. As Pedro Costa, CEO of Interventional Systems,

HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, has announced the marketing authorisation of its “breakthrough” platform via the US Food and Drug Administration’s (FDA) de novo classification request process, a rigorous pre-market review pathway for medical devices with no existing predicate. “This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception in 2001, overcoming what was once thought to be impossible”, commented Mike Blue, President, and CEO of HistoSonics. FDA authorisation was based, in

HistoSonics therapy platform

part, on data from the #HOPE4LIVER trials in 13 trial sites across the USA and Europe. Data pooled from both the USA and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumours. Histotripsy was noted to have achieved both primary safety and efficacy endpoints in the pooled data where 44 subjects were evaluated for safety and 44 tumours treated were evaluated for efficacy.

Merit Medical announces expanded microcatheter line for radial embolization

Merit Medical Systems, a leading global manufacturer and marketer of healthcare technology, today announced the expansion of its Maestro microcatheter product line to now include a new longer length for radial embolization procedures. The Maestro is part of a comprehensive offering of embolotherapy solutions, which includes embosphere microspheres, the most widely studied and clinically utilised round embolic on the market. Embolization is a minimally invasive procedure that blocks one or more blood vessels or abnormal vascular channels to treat a number of clinical conditions. The new 165cm Maestro length will be available in 2.1French (F), 2.4F, 2.8F, and 2.9F catheter diameters to support a broad range of embolization procedures.

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Issue 92 | November 2023

Industry News 31 modification, and will also be a valued asset in the evaluation and development of novel transformational technologies to augment our portfolio in the years to come.”

Industry News Sirtex Medical announces Magle Group EmboCept S collaboration agreement

Sirtex Medical, a leading manufacturer of interventional treatment solutions, has announced the establishment of a collaboration and exclusive worldwide distribution agreement with Magle Group, a Sweden-based contract development and manufacturing organisation as well as degradable starch microspheres (DSM) sales and marketing company. Under the terms of the agreement, Sirtex will exclusively distribute Magle Group’s chemoembolization product, EmboCept S DSM 50μm, in the existing and new geographic areas to support expanded patient access to the product. Together, Sirtex and Magle also intend to establish a joint development plan to increase product range in the field of embolization by utilising Magle Group’s DSM platform.

Delcath Systems announces additional funding for Hepzato Kit FDA approval

Nick West

Nick West appointed to associate CMO role at Shockwave Medical

Shockwave Medical has announced that Nick West has joined the company in the role of associate chief medical officer (CMO). He will report to current CMO Keith Dawkins, and will be based in Santa Clara (USA) with plans to succeed Dawkins as CMO in mid-2024. “Dr West brings to Shockwave a wealth of expertise in the interventional cardiology space,” said Dawkins. “Having known Nick for many years, I am confident that his expertise will be highly influential in further developing intravascular lithotripsy (IVL) as the standard of care for calcium

Delcath Systems, an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, has announced that it raised approximately US$35 million through the exercise of all the Tranche A warrants issued as part the previously announced 29 March, 2023 private investment in public equity (PIPE) financing. The warrants were exercisable until the earlier of 3 March, 2026 or 21 days after the US Food and Drug Administration (FDA) approval of the Hepzato Kit (melphalan) for injection/hepatic delivery system, which occurred on 14 August, 2023. Tranche B warrants, also issued as part of the PIPE financing, could

generate approximately US$25 million in additional proceeds and are also exercisable until the earlier of 3 March, 2026 or 21 days following the Company’s public announcement of recording at least US$10 million in quarterly US revenue from the commercialisation of Hepzato.

MedAlliance acquired by Cordis

MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront closing payment of US$200 million, together with regulatory achievement milestones of up to US$125 million and commercial milestones of up to US$775 million through 2029, for a total consideration of up to US$1.135 billion. “The Cordis acquisition will accelerate access to this breakthrough technology for patients around the globe suffering from coronary and peripheral disease,” said Jeffrey B Jump, founder, chairman and CEO of MedAlliance. “I want to thank our entire MedAlliance team—including physicians, distributors and clinical patients—who have succeeded in disrupting the coronary and peripheral markets to provide a safe and effective new technology. The arsenal of SELUTION SLR DEB clinical data is designed to change medical practice and improve patient outcomes.”

Conference calendar 8–10 November 2023 British Society of Interventional Radiology (BSIR) Newport, UK www.bsirmeeting.org

18–20 January 2024 International Himalayan Vascular Conference (HIMVAS) Kathmandu, Nepal

10–13 February 2024 Pan Arab Interventional Radiology Society (PAIRS) Dubai, United Arab Emirates www.pairscongress.com

www.himvas.com

14–16 March 2024 IM Endo Forum - International Multidisciplinary Endovascular Forum Edition Florence, Italy

25–29 January 2024 Society of Interventional Oncology (SIO) Long Beach, USA

23–28 March 2024 Society of Interventional Radiology (SIR) Salt Lake City, USA

www.sio-central.org

www.imendoforum.com

www.sirmeeting.org

23–25 April 2024 Charing Cross Symposium London, UK www.cxsymposium.com

16–19 May 2024 Global Embolization and Oncology Symposium Technologies (GEST) New York, USA

28 April 2024 5th Annual Endovascular Interventions Symposium Palm Springs, USA

28–31 May 2024 Leipzig Interventional Course (LINC) Leipzig, Germany

www.na.eventscloud/website/53519/

28–01 May 2024 European Conference on Interventional Oncology (ECIO) Palma de Mallorca, Spain www.ecio.org

www.thegestgroup.com

www.leipzig-interventional-course.com/ visitors/linc-2024/

05–07 August 2024 The Interventional Radiology Society of Australasia (IRSA) Christchurch, New Zealand www.irsa.com.au

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