Interventional News Issue 85—April 2022 US Edition

www.interventionalnews.com

15 April 2022 | Issue 85

Tze Min Wah Renal ablation

Profile: Karim Valji page 18

Profligacy and dangerous misconceptions in dialysis access Scott Trerotola (University of Pennsylvania, Philadelphia, USA), who will be awarded a Society of Interventional Radiology (SIR) Gold Medal in June 2022, raises some issues with the 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines and interrogates some dubious dialysis access interventions. Trerotola, who is the Stanley Baum professor of Radiology and associate chair and chief, Interventional Radiology, sat down with Interventional News to share his views on the current vascular access landscape.

A first word on the guidelines

I

It just makes no sense whatsoever and opens the doors for a variety of complications that we literally have not seen (and for good reason) in 30 years. So, if we now allow interventionists to start putting catheters in the subclavian, the harm that is going to come to this patient population is really significant.

Another important element is that they raised transfemoral above translumbar access to the inferior vena cava. Both of these access types have been studied independently and the infection rate is three times higher for transfemoral; it takes a viable access site and/or potential transplant site and, at least a quarter of the time, destroys it by virtue of venous thrombosis. It is also much more of an issue when somebody develops catheter-related venous thrombosis in a femoral vein. All this just does not happen with translumbar access. Of course, not everyone is suitable for translumbar, but for those who are, it is a much better access route. Now, is this supported by randomised Good medicine struck down by lack data? No—and it never will be. But, it is supported by level of evidence two evidence that the evidence team just seems to Guidelines by their very nature become have ignored. They essentially seem to have a research workbook for the next refused to consider lower-level evidence. generation. There is a fundamental What we (prior KDOQI teams) did problem associated with any in the past, repeatedly, was to then guideline formation. The fact of apply expert opinion, especially the matter is that committees are when we saw something we felt a victim of the evidence team, was good medicine being struck which changes, and looks at down by lack of evidence. the exact same evidence with a Charmaine Lok (University of different eye.

Toronto, Toronto, Canada) and A lot of evidence had team did that here as well such changed by the time the KDOQI as in surveillance of dialysis guidelines were updated in 2019, access—I just wish they had done and it appears that the evidence that in a few more places, but that is team tried to really push as hard as my opinion. they could, even when there was not all One of the areas that the KDOQI that much evidence. In doing so, they backed guidelines did not go strongly enough on off on a lot of existing beneficial guidelines. I am Scott Trerotola (in fact, backed off on compared to 2006) was not sure that was the right thing to do. One of the promoting and preserving the concept of overmost significant examples of this is in the vessel of choice the-wire exchange for infection. We have toed this line for dialysis catheters and the order in which they should for all of the 20-plus years I have been here at Penn and be used. Previously, the guidelines essentially said internal we simply do not see people who are crippled by a lack jugular first, then external jugular, and we can all agree of vascular access options such that all of their upper on that. But, the subclavian vein was listed as being the extremity and lower extremity access has been used up absolute last choice and it was made clear that it should not and they are on dialysis with a transhepatic catheter. We be used except in extreme situations. In the latest update, it see very few people in whom all of their upper extremity was actually moved to the third position, on the basis that veins are gone. And, when we do, they are from outside of there was no high-level evidence precluding this, which is the health system. Why? Because we are so careful about insanity as there will never be a randomised controlled trial of subclavian versus other tunneled dialysis catheter sites.

Continued on page 5 nterventionalists need to read the guidelines. Whilst there will soon be several different tools out there that will be easy to digest, such as a YouTube video or a podcast, there is no substitute for reading the guidelines.

They are the result of a 25-year process of refinement, iteration, research and opinion, so they are the best thing we have got right now. I love the way that the most recent KDOQI update looks at access as a ‘life plan’—because you cannot take a 99-year-old patient, and compare them to a 25-year-old patient who is going to be on dialysis for many years until they eventually, hopefully, get a transplant. And, if you are practising dialysis access interventions, it behooves you and your patient to read those guidelines. Not doing so really means that you are not practising evidence-based medicine—and you should be.

Alik Farber: Industry relationships page 25

SIO 2022: ‘Controversies’ in current cancer treatment One of the sessions at this year’s Society of Interventional Oncology (SIO) meeting (24–28 March, San Francisco, USA) comprised four debates moderated by David Breen (University Hospital Southampton, Southampton, UK) and William Rilling (Medical College of Wisconsin, Milwaukee, USA). One of the key takeaways from the session was that radiation oncology has seen much innovation, and that this must continue in order to provide the best outcomes for patients into the future.

Another was that “response assessment [can be] challenging”.

Peripheral colorectal lung metastases: SBRT vs. ablation

Abraham Wu (Memorial Sloan Kettering Cancer Center, New York, USA) and Thierry de Baere (Institut Gustav Roussy, Villejuif, France) took to the podium in turn—Wu as a proponent of stereotactic body radiation therapy (SBRT), and de Baere of thermal ablation, as a means of treating peripheral colorectal lung metastases.

“SBRT has really ushered in a revolution in radiation oncology.” Wu began his side of the argument by dubbing SBRT a “new standard for early-stage inoperable lung cancer”, citing the therapy as particularly successful in metastatic tumours.

Wu proceeded to highlight the non-invasive benefit of SBRT—there is “no cutting, needles, pain, nor a need for anaesthesia.” Furthermore, there are no medical contraindications, with patients free to continue on anticoagulant drugs alongside receiving SBRT. The toxicity profile, Wu assured, is also “favourable”, with “essentially no mortality risk” associated with using the therapy to treat peripheral lesions, including when treating multiple lesions, and retreating the same one.

It is also easily adaptable to large tumour sizes, and complicated tumour shapes and locations, Wu emphasised. The convenience of the therapy is also a draw when it comes to SBRT, now that it is available relatively widely in “most modern radiation facilities”.

Wu’s bottom line is that “high-level control is achievable with a sufficient dose”, which is Continued on page 7

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April 2022 | Issue 85

Veterinary Interventional Radiology

The interventional radiology treatments giving animals a lifeline Interventional radiologist Peter Littler (The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK) talks to senior clinician in interventional radiology (IR) Gerard McLauchlan (Fitzpatrick Referrals, Surrey, UK) and consultant radiologist Alex Horton (Royal Surrey Hospital, Guildford, UK) about IR in animals. The discussion followed a special session titled ‘All Creatures Great and Small: IR for animals’ at the British Society of Interventional Radiology (BSIR) annual scientific meeting (8–10 December 2021, Glasgow, UK). In the course of their discussion, Horton and McLauchlan covered their notable cases, the differences between IR treatments for humans and animals, the uniqueness of their service, as well as the challenges its delivery poses.

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ittler began the discussion by asking Horton about some of his most interesting cases: “We do a whole mixture of things, from intrahepatic shunts, prostate embolization, and big [arteriovenous] malformations in the liver.” He went on to reference further procedures he has performed, which include intra-arterial chemotherapy in the bronchial artery and bladder.

He noted that although the “fundamental IR techniques are identical” when treating humans and animals, who can have similar medical problems, there are still some “adjustments” that need to be made.

“Not just the size, but the types of pathology.” Horton added that “there is [also] a learning curve with anatomy.”

When asked by Littler how his and McLauchlan’s IR service operates, Horton responded with the following: “[He] has got the animal experience […] and I have the experience of the crazy liver stuff.” McLauchlan went on to explain that Horton approached him, saying that he had “always been interested in helping animals,” and that from there, their joint service “all came together quite organically,” aided by the fact that their respective Surrey hospitals are based over the road from one another.

Together they have been able to “offer the animals and their owners a lifeline that they previously would not have had” anywhere else in Europe. McLauchlan went on to state that “around 80% of our hospital caseload is oncological, so what we now see more than anything for IR is prostate cancer in dogs. It is really uncommon, making up 0.6% of all dog cancers, but we are seeing at least one case a week come in to us because we now offer embolization as a treatment.”

They proceeded to identify some of the unique issues that arise when working with animals in this field of medicine, pinpointing equipment as one of the main areas in which they encounter challenges.

They use “a lot of human equipment” but this often means adjusting the length of catheters, for example.

Paediatric equipment also solves the issue of equipment sizing in certain cases.

Peter Littler

Gerard McLauchlan

Alex Horton

Beyond the equipment itself, there is the obstacle of pricing. McLauchlan explained that it can be “difficult to justify” purchasing certain equipment. “We do not have an NHS for animals” and therefore, “we are not buying in bulk,” he said. Consequently, they end up working “in a bit of a negative profit sometimes.”

The fact that the service is one of its kind in Europe also means that follow-up for the animals is more complicated. With “referrals out of area, out of country,” McLauchlan highlighted the particular difficulty in “[repeating] procedures when [the patients] have come from so far away.”

Moreover, “variation in patient size” presents its own challenges to overcome, as does the reality of having animals as patients. McLauchlan and Horton treat a range of animals (of whom most are dogs) “from a 2kg Chihuahua to a 70kg St Bernard.” Adding to this complexity when carrying out the procedures is that it is not possible to “tell the dog to lie still and keep its leg elevated for 24 hours [afterwards].”

Littler’s concluding question prompted an explanation from McLauchlan of why there are so few IR specialists in veterinary medicine. “IR in animals is not what it is in the human field,” and so few people have the requisite training to carry out the procedures.

“It is a very new discipline,” with Horton comparing it to how “IR was 50 or 60 years ago” when treating humans.

“The romantic dream moving forward,” according to Horton, would be to train others so that there are more specialist veterinary IR centres in the UK.

Variation in patient size presents its own challenges to overcome, as does the reality of having animals as patients [...] “from a 2kg Chihuahua to a 70kg St Bernard.”

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Issue 85 | April 2022

Profligacy and dangerous misconceptions in dialysis access Continued from page 1

over-the-wire exchange preservation of venous access sites. It is well-established that over-the-wire exchange is just as effective as removal and replacement.

And, yet, we have to fight with infectious disease specialists every single day in our practice. This was an opportunity for the KDOQI team to come out very strongly and really advocate for patients, but it is not as strong as it should be. It is a horrible battle that we should not have to fight, and having this remain clearly spelled out in the guidelines, as it was in 2006, would have helped when communicating with the infectious disease doctors.

Do even well-intended guidelines have inadvertent negative consequences?

Yes, 100%. The ‘Fistula First’ message from the prior guidelines is a great example. We were very strong with that message, which was the right thing to do and I will stand by this to my dying day. A quarter of all US dialysis patients had fistulas at the time of the first guidelines in 1997; patients across the rest of the world had 60–80%, so the USA was a vast outlier.

And we needed to fix that. If we had not gone with that message, we would not have gotten the wholesale swing toward us having the 60–70% fistula rate that we have today. But, the pendulum swung a little bit too far, and the guidelines placed a lot of penalties, especially on nephrologists, which caused them to have economic disincentives. Sometimes people could start with a fistula, just for the sake of having a fistula, but it would never get used. So, I do think that the pendulum needed to swing back a little bit from the prior guidelines to say that there are patients in whom grafts are appropriate, and there are patients in whom catheters are appropriate, and the 2019 KDOQI reflects this.

We also did not necessarily want very prescriptive thresholds, and one of the big changes in the current guidelines was that they moved away from thresholds and absolute numbers. The primary reason for that was that, in the USA, our Medicare system uses those guidelines as weapons against those on the front lines.

When payers weaponise guidelines, then nobody benefits—patients the least. That is why I think Lok and her team did a very good job of making the update kinder and gentler so that, in the appropriate patient for whom a graft (or catheter) is the right thing to do when it fits with their life plan, they will get that, as opposed to saying, ‘you have to have a fistula first’.

So, yes, guidelines can have negative, unintended consequences.

Common misconceptions

There are incredible misconceptions that surround aneurysm formation and high flow. One is that central venous or downstream stenosis causes aneurysms to form, which is simply wrong. The thing that causes aneurysms to form is high flow. And the problem is that the people who are fixing stenoses think that is helping.

Indeed, they are only making things worse by increasing flow and thereby exacerbating that vicious cycle of flow that results in aneurysm formation. We need practising interventional radiologists, surgeons and nephrologists to understand the relationship

Dialysis Access between flow and aneurysm formation in a very visceral way, so that they stop perpetuating the problem now. Gerald Beathard (University of Texas, Austin, USA) has gotten on board here with cephalic arch stenosis—not necessarily related to aneurysm formation, but just broadly related to high flow—and was speaking about not overtreating these stenoses at the most recent Controversies in Dialysis Access (CiDA) meeting in Dallas, USA. I think this is a great step forward because he is such a respected leader in this community. It is vital to recognise that we should not just do a one-size-fits-all stenosis treatment of the terminal arch but, rather, we need to use important tools (such as direct measurement of flow) to dial in the right size of stenosis to fix the clinical problem or not intervene at all.

I think the lack of relationship between central venous stenosis and access dysfunction is another point worth making clearly. We still have people treating asymptomatic central venous stenosis because they think it affects access function, which is frankly just not true. I think the most important thing about stenosis in any circuit is that you need to understand that you should not treat it unless it is symptomatic.

If we stopped applying the oculotherapeutic reflex and just treating every stenosis, we would, first of all, treat far fewer stenoses, and we would probably have a lot less restenosis too. So, we absolutely do not want to treat a stenosis that is quiescent. Treatment such as percutaneous transluminal angioplasty should be applied only to stenoses with a matching clinical indicator. We have published studies on these in the interventional radiology literature, but maybe not in the kidney space, and because of this we just need to get different types of specialists starting to answer these big questions.

The one thing that I will reiterate is that using a US$10,000 device to do a thrombectomy is profligate.”

Common sense and vein preservation

We need to preserve access and I still think we do a terrible job of venous preservation in the USA—and probably the rest of the world. The concept of devicecreated fistulas (i.e. EndoAVF) is in its infancy, but it is very clear that in the right hands it can make a massive difference and revolutionise the way dialysis access creation takes place. However, it can only get there if it is coupled with the basic techniques of venous preservation. If everybody had a good forearm cephalic vein, we would not be talking about upper arm fistulas; patients would all get forearm fistulas that would last 10 or 20 years. Forearm fistulas require the least amount of maintenance, have the best outcomes, and patients do not generally get high output heart failure with them. I mean, why not have more of those? The reason is because people that have good cephalic veins have them used up indiscriminately by people putting in intravenous (IV) lines.

Device-created fistulas address that to some extent, as some of the deeper veins are still accessible because they have not been torn up. But, ultrasound-guided IVs, while very good for patients, are also tearing up

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those same veins because, again, they are being used indiscriminately by people who should be exercising venous preservation. It is a big picture thing. I have been promoting and practicing venous preservation for going on 35 years now and you start to see trends. And all the new technology in the world will not help us if we do not practice basic things like common sense and vein preservation. Fortunately, this is an area where the current KDOQI team diverged from the evidence team and kept a strong expert opinion-based statement about vessel preservation in the 2019 guidelines. Indeed, this stance is highlighted as an example of divergence from the evidence team recommendations on page S20 of the document.

Plain balloon angioplasty—the mainstay for access stenosis

In our practice of over 1,000 interventions per year, we use stent grafts in perhaps 5% of cases, and that includes central venous stenosis. Our use of stent grafts is very low. Yet, we have the same outcomes (which have been published repeatedly) as everybody else. If you look at, for example, the control arms in both the drug-coated balloon (DCB) trials—Lutonix AV (BD) and IN.PACT AV (Medtronic)—and you compare them to the treatment arm of, say, the AVeNEW study (BD), which is stent grafts in fistulas vs. percutaneous transluminal angioplasty, they are the same. The control arm in the AVeNEW study has terrible results.

Bart Dolmatch (El Camino Health, Mountain View, USA), principal investigator of the latter, told me: “That is real-life angioplasty.” I disagree. I think real-life angioplasty has been properly defined in the two large US DCB trials—it should be judicious and properly executed, maximising the bang for the buck that you get when you open that high-pressure balloon.

Prolonged angioplasty, if done correctly, takes time and dedication, but when you do that, as evidenced by these large trials, which were subjected to expert core lab evaluation, the results are outstanding. Using plain balloon angioplasty saves a huge amount of money over stent grafts, and I firmly believe the latter buy short-term patency at the expense of long-term patency.

Thrombectomy using a US$10,000 device is profligate

I am obviously a proponent of mechanical thrombectomy. Unfortunately, after a good, 25-year run, the Arrow-Trerotola percutaneous thrombolytic device (Teleflex) has now been withdrawn from the market—although there are other thrombectomy devices we are using. On the subject of aspiration, I think that using large, expensive suction thrombectomy devices is an utter waste of money when you can get a mechanical thrombectomy device for US$500–600 that will do the job. Suction thrombectomy has been studied many times over the years and decades. The challenge with suction is that the adherent clot material is still there and getting that stuff off the wall is still a problem, which is why wall contact thrombectomy devices are so popular. The bottom line is that there are lots of different ways to do this, as outlined in the literature. The one thing that I will reiterate is that using a US$10,000 device to do a thrombectomy is profligate. When I see it presented at meetings, it makes me cringe.

SIR Gold Medal

I am extremely honoured and humbled to be receiving the SIR Gold Medal. It is a lifetime achievement, and wonderful. When I look back, I am really happy about the paper trail and evidence basis that my colleagues and I have generated. We adopted a philosophy of practising what we preach, and publishing on and disseminating that. We really believe that the best way to get a message out there is to study it and publish a paper about it. I decided to do that a long, long time ago when I was young and I would not change a thing.

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April 2022 | Issue 85

Interventional Oncology

Selective internal radiation therapy gains ground as hepatocellular carcinoma treatment Speaking to Interventional News during the British Society of Interventional Radiology (BSIR) Annual Scientific Meeting 2021 (8– 10 December, Glasgow, UK), Jon Bell (Christie NHS Foundation Trust, Manchester, UK) explains how increasing numbers of interventional radiologists will be opting for selective internal radiation therapy (SIRT) when treating hepatocellular carcinoma (HCC) patients.

BELL BEGINS BY OUTLINING the “importance of personalised dosimetry”, which data from the past couple of years has brought to the fore as a way of treating HCC patients. He then goes on to speak about seeing radioembolization in the Barcelona

Clinic Liver Cancer (BCLC) for the first time as of 15th November 2021.

“It is there because of LEGACY data,” Bell details, and dosimetry is a “core component.” Moreover, within the UK, SIRT will now be reimbursed under new 2021 NICE multiple technology

appraisal guidance, where previously, such funds were not available for HCC treatment. This will, according to Bell, “change the landscape” within the field.

outcomes” and it allows clinicians to fulfil their roles: “it is all about patient care at the end of the day.”

“Data, evidence and guidelines”

Promoting SIRT into treatment pathways

It is the inclusion of SIRT in HCLC and National Institute for Health and Care Excellence (NICE) guidance that Bell identifies as crucial for the consistency and quality of patient care.

Dosimetry guidelines, in particular, will allow “different centres [to treat] the same patients in the same way,” he predicts. Awareness of “data, evidence and guidelines” however, facilitates care of “the very highest level,” Bell explains. This Jon gives patients the “best Bell

Melphalan percutaneous hepatic perfusion for the treatment of metastatic uveal melanoma exhibits “excellent response rates and improved survival”

Bell points out that it has taken time to see patients referred appropriately, but that these new guidelines will pave the way for the “education of oncologists on the appropriateness of SIRT and where it should sit in the patient pathway.”

He adds that “we now have a great opportunity to educate and influence interventional radiologists to go out and promote the therapy and really embed it in the patient pathway.”

A total of 7/81 (8.6%) patients presented the best overall response—CR. A total patient number of 42/81 (51.9%) demonstrated PR, 16/81 (19.8%) for both SD and PD. Hepatic-only CR was seen in 10/81 (12.3%) patients and PR was present in 9/81 (11.1%) patients.

In conclusion, the analysis presents an overall response rate of 60.5% (49/81), hepatic disease control rate of 88.9% (72/81), and hepatic response rate of 66.7% (54/81) with M-PHP. The median overall PFS and OS were 8.4 and 14.9 months, respectively.

Percutaneous hepatic perfusion with melphalan for the treatment of metastatic uveal The authors report no fatal treatment-related adverse melanoma (mUM) offers a hepatic response rate of 66.7% and good progression-free effects (TRAE), however, 43 grade three (n=29) or survival (PFS). This is the main concluding finding of a recent retrospective analysis four (n=14) TRAE occurred in 23 (27.7%) patients, published in Melanoma Research—which the authors claim includes the largest number presenting a significant reduction in these events in of mUM patients treated in a single centre with melphalan percutaneous hepatic procedures performed between 2016–2020 vs. 2012– perfusion (M-PHP) to date worldwide.

2016 (0.17 vs. 0.90 per patient, p<0.0001). Modi et al suggest M-PHP for mUM exhibits “excellent response arrying a poor prognosis, uveal 6‒12-week intervals, on the presentation of no rates” and PFS, compared to available treatments. melanoma (UM) is the most common disease progression.

Stedman remarks: “With such a large series the primary ocular malignancy in adults, A total of 252 treatments with M-PHP were Southampton team have now demonstrated this according to Sachin Modi and Brian Stedman performed across 83 patients (aged 18‒80), treatment can be delivered safely with very few side (University Hospital Southampton NHS with a median of three M-PHP cycles per effects [...] Having proved the technology works on Sachin Modi Foundation Trust, Southampton, UK) et al. patient—two patients experienced a single one of the most chemo-resistant cancers, the team are According to the authors, 50% of patients incomplete treatment, resulting in a total keen to demonstrate its efficacy in other tumour types.” with UM develop metastatic disease, which patient number of 81. The median patient age “We are happy to report these findings which show has a 10‒25% one-year survival rate with no was 59.3 years old (±12.2 years), consisting impressive response rates with improvement in safety standard established treatment. They note that of 36 (44.4%) males. It is noted that 69 and complications with experience. We hope that these previous studies have demonstrated M-PHP to (85.2%) patients presented only intrahepatic new data and the upcoming data from the international be effective for mUM for liver predominant FOCUS study (due to be reported Q4 2022) will lead Brian Stedman disease at the time of workup, however, 12 disease, however, existing research is limited (14.8%) patients had both intrahepatic and to better access for this treatment for patients on the by small sample populations. Modi et al single organ extrahepatic disease.

NHS and worldwide,” adds Modi. specify that their analysis, therefore, illustrates Modi et al report a median From an oncologist’s perspective, cofindings on the safety and efficacy of M-PHP follow-up time of 12.9 months author Matthew Wheater (University in a sample population of 83 patients, which, across all patients, with Hospital Southampton NHS they claim, is the largest number treated in a a median time of 13.9 Foundation Trust, Southampton, single centre with M-PHP to date worldwide. months follow-up time UK) comments that “metastatic Matthew Wheater All patients with diagnosed mUM who for patients still alive. uveal melanoma has been a real received M-PHP between August 2012 At the data collection challenge to treat, with little and September 2020 at the University Hospital cut-off date (1 January 2021), a response to the agents that have Southampton NHS Foundation Trust were included total of 15 (18.5%) patients were shown such promise in cutaneous in this retrospective study. Patients with the nonstill alive, three were continuing melanoma. The randomised data progressive single-site extrahepatic disease were also M-PHP treatment, with 66 showing a survival benefit for included. All patients received 3mg/kg of melphalan, (81.5%) deaths. The overall tebentafusp is a significant step which was delivered with the Hepatic Chemosat survival (OS) median was 14.9 forward [...] Our paper shows that Delivery System (Delcath Systems) with the Gen 2 months from the first treatment—and melphalan-PHP can induce significant filter. The authors note that liver function and full OS rates were 62% and 27% at one and responses in liver metastases, is safe to blood count were monitored in all patients weekly two years, respectively. deliver, and well tolerated by patients, The overall survival following treatment, with repeat computed tomography The authors note that the OS was providing meaningful quality of life. We (OS) median was 14.9 eagerly await the final survival results (CT) and magnetic resonance imaging (MRI) every significantly different (p<0.0001) across 6‒12 weeks to monitor the tumour and overall hepatic responses, with the overall months from the first of the FOCUS trial and hope that if response, as per RECIST guidelines. The disease response rate at 49/81 (60.5%) patients. confirms our findings then M-PHP treatment—and OS this control rate (DCR) was calculated as the proportion For CR, the response time was 34.7 will become a mainstay of treatment rates were 62% and for ocular melanoma with wider of patients with complete response (CR) to treatment, months, compared to 16.9 months 27% at one and two availability of treatment to benefit partial response (PR), or stable disease (SD) for at least for PR, 10.6 months for SD, and 7.7 nine weeks. Further M-PHP sessions were planned at months for progressive disease (PD). more patients.” years, respectively.

C

OS

14.9 months

62% 27%

Issue 85 | April 2022

Controversy and (In)equality

SIO 2022: ‘Controversies’ in current cancer treatment Continued from page 1

safe for peripheral lesions. He contended that “SBRT is the preferred treatment” for peripheral colorectal lung metastases, stating that there is a larger and longer-term evidence base when compared to ablation.

De Baere began his counterargument by explaining that he “fully [agreed] with the previous speaker in that what matters is local tumour control”.

However, defining local tumour control is another matter entirely. He argued that ablation sees total control in the longer term, when compared to SBRT, which, de Baere suggested “puts some smoke around the tumour”, then making it difficult to have local response criteria. Where it may be tempting to look at imaging for two years post-SBRT

and declare a complete response, he ablation, if you “mistarget with cryotherapy” underlined the need to “look past two or give “too low a dose”. However, he years”, and once one does that, in the maintained that while SBRT may seem case of SBRT, he believes that it is low-toxicity in the short term, in the middle “always the same story”—the tumour or long term, “it is a different story” and one is still growing, just very slowly. starts to see a decrease in lung function.

One can get a more reliable picture Given the opportunity to answer his of the ongoing success of treating via Abraham Wu opponent’s comment, Wu thanked de Baere ablation, de Baere highlighted, as it for a “strong and thoughtful response”, can be obtained with pathology, as agreeing that “response assessment with opposed to the imaging that indicates SBRT is challenging” and that it is a in SBRT cases whether it is working. “limitation” of the treatment when compared De Baere brought nuance to his side of to other modalities. Wu went on to outline the debate, acknowledging that different that administering a sufficient radiation types of cancer, for example, primary vs. dose can resolve the issues with SBRT that metastatic, warranted different treatment de Baere pointed to, but, given his chance Thierry De Baere approaches. Likewise, the observed for rebuttal, de Baere doubled down on his success of a particular approach depends preference for ablation—that a high enough on the dosage given. It is perfectly possible, de Baere dose may well “kill the tumour [with SBRT], but admitted, that a tumour can continue to grow after maybe you will also kill the patient or the lung.”

Promoting equality in interventional radiology Elika Kashef (Imperial College NHS Trust, London, UK) speaks to Interventional News regarding the lack of accessibility for women into interventional radiology (IR), the subsequent workforce issues this creates and implications it may generate for the delivery of care. She discusses the ongoing efforts of the British Society of Interventional Radiology (BSIR) Diversity, Equity and Inclusion (DEI) Committee—formerly the Women and Diversity Committee— to mirror the broader agenda of equality for all, which was an important theme discussed at the BSIR 2021 Annual Scientific Meeting (8–10 December, Glasgow, UK).

“WE KNOW THAT 60% OF students in medicine are women, yet in IR there are only 12% women—based on the Royal College of Radiology (RCR) 2020 consensus we are going to be 3,000 interventional radiologists short by 2025,” Kashef tells Interventional News. Explaining the need for equal access to IR, she states that “there is a lack of accessibility into IR that exists both before students are accepted into medical school, as well as those students moving into IR from radiology and medical school”.

This workforce issue should not just mean we focus on gender or race, but should ensure that people from all walks of life are able to enter the field, she relays.

In line with the actions of the RCR to increase workforce numbers and promote equality, the BSIR committee has created a specialist interest group (SIG) to address the inequalities of women in the specialty. Kashef explains that “to increase access and numbers is challenging. We would need around 300 more interventional radiologists in the UK to offer a 24-hour service”.

This means there is a “postcode lottery” when it comes to accessing emergency and life-saving care.

According to Kashef, the NHS is working to ensure the homogeneity

7

Elika Kashef

of care, and the RCR has also increased the number of training posts to increase accessibility and enable those who were not aware of IR or medicine to join.

“The issue of women in IR still needs to be of focus, and we need to fully understand why we are losing women [from the workforce],” Kashef explains. With 40% of women in surgery—a figure that has improved over time—Kashef concludes the interview by sharing her hope that “...in the next few years we will see some noticeable changes in the numbers in IR.” The full RCR consensus report (‘Clinical radiology UK workforce census 2020’) is available on the Royal College’s website.

ECR 2022: IO is the fourth pillar of oncology—a shift is needed With cancer cases growing worldwide and an increased number of late-stage diseases in elderly patients, there is a a pressing need for an integrated approach. “Through evidence, cost, effectiveness and acceptance of interventional oncology, we can create value-based care and shift the treatment focus from volume to value,” was Thomas Helmberger’s (Public Hospital, Munich, Germany) main take-home message at the European Conference of Radiology (ECR) 2022 (2–6 March, virtual).

STARTING OFF THE presentation, Helmberger provided some background on the future of patients with malignant diseases, with increasing patient cases currently in countries worldwide. He explained that “this growing number of patients translates to increasing cost and this demographic impact will challenge our healthcare systems.” He went on to explain that, for example, in colorectal malignomas, 20–25% of patients exhibit stage four cancer, with the majority being elderly patients. He pointed out that this, therefore, means that we have to “deal with not only cancer but also comorbidities.” Discussing the “wave” of elderly patients, he explained the “Sisyphus effect”—more elderly expect to be fit and independent into older age, requiring more medical resources, and thus creating more elderly patients.

Discussing the current developments in IO, Helmberger explained that IO techniques are resembling other already known techniques, for example, radioembolic techniques are resembling radiotherapy.

He drew attention to current issues in IO by making reference to an early closed randomised controlled trial (RCT) comparing surgery and percutaneous thermal ablation for hepatic metastases that had just recently illustrated drawbacks such as misconceptions about the eligibility criteria, unconscious bias towards surgery, and a lack of dedicated research nurses to name a few. “The currently ongoing COLLISION RCT is dealing with the same comparison, however, it can be questioned to what

extent artificial RCTs are still necessary for comparison to real-life data,” he said.

In addition, Helmberger highlighted the fact that numerous studies over the past 15 years pointed to no difference in the overall survival in percutaneous thermal ablation compared to surgery in primary and secondary liver malignancies with diameters up to 3cm (Otto et al, 2010; Lee et al, 2016). He also explained that combining transarterial therapies such as chemo- and radioembolization can even enhance the therapeutic benefit of surgical and percutaneous ablative therapies (Hholami et al, 2020).

Helmberger raised the important factor of costs, noting that healthcare costs present differently in each country and between interventional approaches, with local ablation therapies usually being less expensive. However, in the sense of cost-effectiveness, Helmberger explained it is of limited use to analyse only a single procedure cost, as this does not provide sufficient information on the overall process costs. According to Helmberger, the effectiveness of IO is proven through evidence and cost, but is still not widely accepted, since “many guidelines and recommendations from professional societies are reluctant to implement interventional radiology techniques.” However, he stressed that IO embedded into interdisciplinary therapy concepts will optimise treatments to be given at the right time during a disease continuum. In doing so, he claims we can create more and more “value-based care”, which remains a central challenge in times of increasingly limited resources.

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April 2022 | Issue 85

10 New Research

Second-generation drugcoated balloon superior for opening blocked arteries in the leg

demonstrating the superiority of the Chocolate Touch device. In terms of safety, the trial found no statistical difference between Chocolate Touch and Lutonix, with a rate of major adverse events of 11.1% in the Chocolate Touch arm and 15.4% in the Lutonix arm. Major adverse events included a composite of death related to the Chocolate Touch balloon catheter (Trireme Medical) outperforms targeted limb, major amputation and Lutonix (BD) device for efficacy, matches on safety, a press revascularisation procedures. release from the American College of Cardiology (ACC) reveals.

Shishehbor said that estimates of mortality on a cumulative, year-by-year PATIENTS TREATED FOR A For me, this study makes the case that basis are consistently lower in those blocked artery in the leg were this [Chocolate Touch] will be the patients treated with Chocolate Touch significantly more likely to have an open device of choice between these two as compared to those receiving Lutonix. artery without further interventions at devices for patients who require drugFor patients who have reached the three12 months if they received the secondcoated balloon therapy.” year follow-up, estimated mortality generation paclitaxel-coated balloon Alexandra Lansky (Yale University is 6.8% among patients receiving the catheter known as the Chocolate Touch College of Medicine, New Haven, Chocolate Touch device, which device compared with those receiving USA) and the other triallists was also well below the the commercially-available Lutonix enrolled 313 randomised trial’s prespecified goal of drug-coated balloon catheter, according patients treated for superficial 13.2%. This finding offers to a study presented at the ACC’s femoral and popliteal artery reassurance that the paclitaxel annual scientific sessions (2–4 April, disease—conditions that coating used in the device had Washington DC, USA). involve blocked arteries a favourable safety profile.

The trial met its primary efficacy in the upper leg—at 34 “At a minimum, this Mehdi Shishehbor endpoint for non-inferiority and sites in four countries. All [Chocolate Touch] device showed an improvement in terms of the patients underwent balloon is as safe as the Lutonix, with proportion of patients with adequate angioplasty. In half of the a trend for lower mortality blood flow through the artery without patients, operators used the rates,” Shishehbor said. subsequent procedures. The trial also Lutonix drug-coated balloon, The Chocolate Touch found the Chocolate Touch device was and the other half were treated device is designed to provide non-inferior to the Lutonix device in with a Chocolate Touch a more even and controlled terms of safety. balloon. The Chocolate widening of the artery. This Alexandra Lansky “I am very excited that we now have a Touch device is designed design allows operators head-to-head comparison of a secondwith a structure that constrains the to use a slightly larger balloon to open generation vs. first-generation drugballoon, creating pillows and grooves the artery wider and provide increased coated balloon and data that we can rely that are reminiscent of the shape of a contact between the balloon surface on to make decisions for our patients,” chocolate bar, the release adds. with the paclitaxel coating, said Mehdi Shishehbor, president of the At 12 months, 78.8% of the patients Shishehbor said.

Harrington Heart and Vascular Institute who received the Chocolate Touch Although balloon angioplasty is the at University Hospitals of Cleveland and device and 67.7% of those receiving preferred treatment for blocked arteries the study’s lead author. “I think that the the Lutonix device achieved the in the leg, many patients experience superiority of Chocolate Touch indicates primary endpoint of patency, or blood recurring blockages, requiring that as we improve the technologies, flow as measured by the peak systolic additional procedures. there is additional benefit to be gained. velocity ratio, a significant difference “If we are able to offer patients

ACC 22: Three-year data show “durable blood pressure reductions” through renal denervation Long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial have been presented during a featured clinical research session at the American College of Cardiology’s annual scientific sessions (ACC 2022, 2–4 April, Washington DC, USA).

THE DATA, WHICH WERE SIMULTANEOUSLY published in the Lancet, “underscore confidence” in renal denervation (RDN) as a treatment for hypertension, according to Medtronic, the sponsor of the study.

In the first 80 patients of the SPYRAL HTN-ON MED trial, the data demonstrated that patients who were prescribed antihypertensive medications and treated with the Symplicity Spyral (Medtronic) RDN system continued to show durable, clinically significant blood pressure reductions through three years.

The results demonstrated an 18.7mmHg reduction in RDN patients versus 8.6mmHg in sham for 24-hour systolic ambulatory blood pressure (ABPM), as well as 20.9 mmHg reduction in RDN patients versus 12.5mmHg in the sham arm for office systolic blood pressure (OSBP).

“Across the latest trials, consistent blood pressure reductions have been observed in patients with

uncontrolled hypertension treated with the Medtronic Symplicity Spyral RDN system,” said Felix Mahfoud (Saarland University Hospital, Homburg, Germany) and member of the SPYRAL HTN executive committee. “For the first time, we now have randomised data that demonstrate that in a typical patient population—hypertension patients who are on antihypertensive medications and treated with RDN— we are seeing the continued, long-term blood pressure lowering effect. Lowering blood pressure can have meaningful clinical results for patients, including a decrease in the risk of cardiovascular events.”

The trial also demonstrated procedural and long-term safety with the Symplicity Spyral renal denervation catheter, with zero major device or procedural safety events through three years.

“With the ON MED randomised data presented and published on 4th April, Medtronic has now demonstrated the long-term benefit of renal

therapies that can keep the artery open for as long as possible, that will be welcome news,” Shishehbor said. “As we advance our technologies and get more patency, or blood flow, over time, the patients will enjoy that benefit and have a lower likelihood of needing repeat procedures.”

Shishehbor said that the trial paused enrolment for six months in response to industry-wide concerns over the safety of paclitaxel but said that the study ultimately achieved a high follow-up rate of 94%. The trial is also the first to allow operators to combine the drug-coated balloon treatment with atherectomy, in which a blade is used to first remove plaque from the vessel prior to drug-coated balloon use. Shishehbor said that while only a small number of patients was treated with atherectomy, the patency rate were promising. Future studies could determine whether the Chocolate Touch device may have an even greater advantage when used to treat longer and more complex blockages.

This study was simultaneously published online in Circulation at the time of presentation. The study was funded by Trireme Medical.

[Chocolate Touch] will be the device of choice between these two devices for patients who require drug-coated balloon therapy.”

denervation against a backdrop of an anti-hypertensive medication, with continued demonstration of a safe procedure,” said Jeffrey Popma, chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic.

“This highlights the importance of additional treatment options such as renal denervation.”

Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is limited to investigational use in the USA, Japan, and Canada.

SPYRAL HTN-ON MED is a global, randomised, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Medtronic Symplicity Spyral system in hypertensive patients prescribed one to three antihypertensive medications. The long-term ON MED data presented at ACC 22 studied the same cohort of patients as the six-month primary endpoint analysis that was previously published in the Lancet in 2018.

Medtronic also announced it recently completed randomisation for the full cohort of its SPYRAL HTN-ON MED trial and closed enrolment. The full analysis cohort targets up to 340 randomised patients.

Medtronic expects the six-month post procedure follow-up for the full cohort will be complete in the second half of calendar year 2022.

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October 2021 Issue 01 www.renalinterventions.net

In this issue:

Twelve-month Wrapsody results at CIRSE 2021 page 4

Alexandros Mallios page 12

Dialysis:

Latest debates in dialysis care page 17

Transplantation:

Healthcare disparities in the spotlight page 20

Renal community reckons with removal of race variable in kidney disease diagnosis

Bioartificial device receives KidneyX award after reaching preclinical testing AN IMPLANTABLE BIOARTIFICIAL kidney device (iBAK) has moved closer to becoming a reality after being awarded a US$650,000 prize from KidneyX. The device’s creator, the Kidney Project, received this award following the first ever demonstration of its functional prototype.

The Kidney Project is a US-wide collaboration led by Shuvo Roy (University of California San Francisco [UCSF], San Francisco, USA) and William Fissell (Vanderbilt University Medical Center, Nashville, USA).

In the past few years, it has successfully tested the two essential components that make up its artificial kidney technology—a haemofilter, which removes waste products and toxins from blood, and a bioreactor, which replic ates other kidney functions, like the balance of electrolytes in blood—in separate experiments.

To secure KidneyX’s Artificial Kidney Prize, the team married these two units in a scaled-down version of the artificial kidney that is roughly the size of a smartphone and evaluated its performance in a preclinical model following successful implantation. The units worked in tandem, powered by blood pressure alone, to provide continuous renal replacement therapy without the need for blood thinning or immunosuppressant drugs. This technology, which is intended to provide patients with improved mobility and physiological outcomes compared to dialysis, will now be upscaled for more rigorous preclinical testing and, eventually, clinical trials.

For the latest step forward in the development of this device, the Kidney Project team was awarded KidneyX’s Phase 1 Artificial Kidney Prize—becoming one of six winning teams selected from a field of innovators across Canada, Israel, Japan, The Netherlands, Portugal, Singapore, South Korea, the UK, and the USA. Other recipient technologies included a wearable, lightweight, dialysate-free artificial kidney (US Kidney Research Corporation) and genetically engineered pig kidneys designed to increase supplies of transplantable organs (Makana Therapeutics).

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iBAK device

(Credit: UCSF)

Follow Renal Interventions on all our social media platforms for the latest news, insight and events in kidney care

The National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) have jointly released a report outlining a new race-free approach to diagnosing kidney disease. In its report, the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease recommends the adoption of the new estimated glomerular filtration rate (eGFR) 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation that estimates kidney function without a race variable.

and subsequent treatment of kidney diseases,” said ASN president Susan Quaggin. “By recommending the CKD-EPI creatinine equation refit without the race variable, the task force has taken action and demonstrated how nephrology continues to lead the way in promoting healthcare justice.

It is time for other medical specialties to follow our lead, and NKF and ASN stand ready to help however we can.”

In the USA, more than 37 million adults have kidney diseases and 90% are not aware they have diminished kidney function, the NKF-ASN statement adds, with a disproportionate number of these patients being Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, and Native Hawaiian or other Pacific Islander. These patient groups also face “unacceptable” health disparities and inequities in healthcare delivery.

he task force has also recommended the increased use of the protein cystatin C—a commonly used biomarker of kidney function—combined with serum (blood) creatinine as a confirmatory assessment of GFR or kidney function. The final report, which has been published online in the American Journal of Kidney Diseases (AJKD) and the Journal of the American Society of Nephrology (JASN), was drafted with “considerable input” from hundreds of patients and family members, medical students and other trainees, clinicians, scientists, healthcare professionals, and other stakeholders, to “achieve consensus for an unbiased and most reasonably accurate estimation of GFR”, according to a joint statement from the NKF and the ASN. “This recommendation by the NKF-ASN task force is an important step forward in assuring health and healthcare equity,” said NKF president Paul Palevsky. “We commend the task force for the time, thought, thoroughness and effort it took to explore this issue deeply, and recommend the best path forward for us all. The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move towards a consistent method of diagnosing kidney diseases that is independent of race. While the work of the task force is an important initial path forward, both of our organisations are committed to continuing to work to eliminate disparities in the diagnosis and treatment of kidney disease.”

“As the largest organisations representing kidney patients and health professionals, NKF and ASN are committed to eliminating health disparities that harm kidney patients, and ensuring that racial bias does not affect the diagnosis

Developing race-free recommendations Over a 10-month period, the NKF-ASN task force organised its work into three phases. The first involved clarifying the problem and evidence regarding eGFR equations in the USA; the second involved evaluating different approaches to address the use of race in GFR estimation; and the third involved providing recommendations based on this.

In April 2021, the task force published its interim report on reassessing the inclusion of race in diagnosing kidney diseases in AJKD and JASN, asserting that race modifiers should not be included in equations used to estimate kidney function, and that current, race-based equations should be replaced by a substitute that is “accurate, representative, unbiased and provides a standardised approach

T

“The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move towards a consistent method of diagnosing kidney diseases that is independent of race.”

Paul Palevsky Continued on page 2

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April 2022 | Issue 85

12 New Guidelines

New consensus guidelines will facilitate interventional oncology research Robbert S Puijk Comment & Analysis We are facing several problems in the field of clinical oncology research: study results are being collected, analysed and reported in many different ways, and we tend not to speak the same language within our discipline, writes Robbert S Puijk (Amsterdam University Medical Centers and OLVG Hospital, Amsterdam, The Netherlands). He believes that these shortcomings are the reason we took the initiative to develop new guidelines regarding preferred clinical outcome measures following image-guided tumour ablation.

I

mage-guided thermal and nonthermal tumour ablation techniques have become indispensable therapeutic options for a variety of cancer types. For smaller-size malignant tumours, international guidelines have already adopted thermal ablation as a first-line treatment option.1-7 The continuing emergence of novel treatment options and growing demand for minimally invasive image-guided tumour ablation techniques have raised the need for evidence-based interventional oncology, and with that comes the need for clear documentation of oncologic outcome parameters.

Shortcomings in how to collect, analyse and report data were the motive for our team to develop a modified Delphi consensus project8 in order to provide a framework of key opinion leader recommendations on patient-, procedure-, and tumour-related definitions, starting and ending time definitions, survival time definitions, time-to-event end points, and patientreported outcome measures. The project was initiated by Martijn R Meijerink and myself, among others. The team consisted of members of the Society of Interventional Oncology (SIO), two independent epidemiologists and Carine Bellera, biostatistician from the French Definition for the Assessment of Timeto-Event End Points in Cancer Trials (DATECAN) group.

A total of 62 IO experts from Europe, the USA and Asia, working in 48 centres, joined the evaluating committee. The panellists were asked to rate multiple statements and to provide additional comments. The article can be found online as open-access publication in the Radiology journal.

To make the purpose and final results

of this project clear, I can provide a few common practical examples, which we hoped to have solved by now. One of the most straightforward, but misleading, situations is when overall survival, for example for locally advanced pancreatic cancer, is analysed using the date of diagnosis to the date of death in one study, and the date of the interventional procedure to the date of death in another study. In order to compare survival probabilities in terms of Kaplan-Meier estimates and avoid misinterpretations, the experts reached consensus on starting and ending time definitions by documenting the time from the date of detection of disease (diagnosis), the date of the start of neo-adjuvant or induction therapy, and the date of the first intervention.

Another confusing situation might occur when different outcome measures are misused or used interchangeably, such as local tumour progressionfree survival (LTPFS), primary- or secondary technique efficacy, and local control. LTPFS is intended to reflect the effectiveness of the first local treatment, while local control should be used to reflect the final success after additional overlapping (completion) procedures (+/- alternative treatment methods).

Furthermore, we tend to analyse and report a variety of outcome measures and procedure- or tumour-related outcomes per patient only while results of this article show that this, strictly speaking, is incorrect. To overcome this issue, the experts reached consensus on whether to address outcomes per patient, per session or per tumour.

As previously published by Muneeb Ahmed and colleagues, efficacy of a certain ablation device or image-guiding technique to eradicate tumours can be

illustrated by comparing the time to local tumour progression.9 Suppose a situation where a patient has been locally treated for three liver metastases and local tumour progression is being analysed and reported on a per patient basis. In this case, progression of one of the three tumours already counts as an event while the other two tumours were treated successfully, leading to an impractical LTPFS curve while comparing data analysed and reported on a per tumour basis. Therefore, and for the fact that multiple index tumours in one patient cannot be regarded as independent as these tumours are potentially correlated, the experts agreed that one should address and report several parameters both on a per patient and per tumour basis.

Furthermore, prior to our article, no clear agreements have been made concerning the documentation of complications in the field of IO, as opposed to surgical series where the Clavien-Dindo classification is established to be used.10 Although consensus was not reached for the preferred validated classification system to document, analyse, and report complications and adverse events, the experts have agreed that one should indicate the most recent version of a certain validated classification system so that complications and adverse events can be categorised consistently according to severity, time of occurrence, and likelihood of the event

LTPFS

is intended to reflect the effectiveness of the first local treatment, while local control should be used to reflect the final success after additional overlapping (completion) procedures (+/- alternative treatment methods).

being related to the procedure.

We believe that the clear definitions in these comprehensive guidelines will undoubtedly provide a necessary

foundation for scientific reproducibility between randomised and retrospective studies, as they will ensure an objective interpretation of results, allow for accurate comparison of outcomes, and avoid misinterpretations among physicians and researchers. The interchangeable setup of this current consensus document allows us to follow up on this project regularly and, hopefully in the near future, will help us to extend these guidelines to regional and systemic cancer treatments. Therefore, we encourage all of our colleagues to adopt the recommendations outlined in this proposal in order to facilitate universal communication of scientific advances in the field of clinical oncology research.

References: 1. Meijerink MR, Puijk RS, van Tilborg A, Henningsen KH, Fernandez LG, Neyt M, et al. Radiofrequency and microwave ablation compared to systemic chemotherapy and to partial hepatectomy in the treatment of colorectal liver metastases: a systematic review and meta-analysis. Cardiovasc Intervent Radiol.

2018;41(8):1189-204.

2. Nieuwenhuizen S, Puijk RS, van den Bemd B, Aldrighetti L, Arntz M, van den Boezem PB, et al.

Resectability and ablatability criteria for the treatment of liver only colorectal metastases: multidisciplinary consensus document from the COLLISION trial group.

Cancers (Basel). 2020;12(7).

3. Forner A, Reig M, Bruix J. Hepatocellular carcinoma.

Lancet. 2018;391(10127):1301-14.

4. Xu XL, Liu XD, Liang M, Luo BM. Radiofrequency ablation versus hepatic resection for small hepatocellular carcinoma: systematic review of randomized controlled trials with meta-analysis and trial sequential analysis. Radiology. 2018;287(2):46172.

5. Uhlig J, Ludwig JM, Goldberg SB, Chiang A, Blasberg JD, Kim HS. Survival rates after thermal ablation versus stereotactic radiation therapy for stage 1 nonsmall cell lung cancer: a National Cancer Database study. Radiology. 2018;289(3):862-70.

6. Uhlig J, Kokabi N, Xing M, Kim HS. Ablation versus resection for stage 1A renal cell carcinoma: national variation in clinical management and selected outcomes. Radiology. 2018;288(3):889-97.

7. Feng K, Yan J, Li X, Xia F, Ma K, Wang S, et al. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012;57(4):794802.

8. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311(7001):376-80.

9. Ahmed M, Solbiati L, Brace CL, Breen DJ, Callstrom MR, Charboneau JW, et al. Image-guided tumor ablation: standardization of terminology and reporting criteria–a 10-year update. Radiology. 2014;273(1):24160.

10. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187-96.

Robbert S Puijk is an interventional radiology resident at the OLVG Hospital (Amsterdam, The Netherlands) and researcher at the Amsterdam University Medical Centers, location VUmc (Amsterdam, The Netherlands).

The author declared no relevant disclosures.

The clear definitions in these comprehensive guidelines will undoubtedly provide a necessary foundation for scientific reproducibility between randomised and retrospective studies, as they will ensure an objective and reliable interpretation of results, allow for accurate comparison of outcomes, and avoid misinterpretations among physicians and researchers.”

21003B

Issue 85 | April 2022

Renal Interventions 15

Shifting paradigms in diagnosing and treating small renal masses In light of recent and upcoming developments in the space, Vinson Wai-Shun Chan and Tze Min Wah (Leeds, UK) explore the evidence and latest progress in renal tumour biopsy (RTB), and discuss the treatment of small renal masses (SRMs) more broadly.

T

he optimal diagnostic pathway and treatments for small renal masses (T1N0M0) is controversial. Due to the lack of tumour markers and inability to determine malignancy from benign pathologies, SRMs are often over-treated. Yet, RTB has not been widely implemented into the diagnostic pathway of SRMs. In terms of treatment, partial nephrectomy remains the gold standard for curative surgery but is associated with significantly reduced renal function and high complication rates. Although high-quality evidence is lacking, percutaneous imageguided ablation (IGA) provides excellent oncological, perioperative, and renal function outcomes.

As a result of increased used of abdominal imaging, the rates of incidentally discovered SRMs have gone up over the past decade. However, there is no reliable imaging or tumour markers to determine the lesion’s malignant potential. Further, it was shown that over 20% of these treated masses are benign in histology, suggesting significant overtreatment of patients without malignant disease. A systematic review and metaanalysis have reported that diagnostic core biopsies have a sensitivity and specificity of 99.1% and 99.7%, respectively, for malignancy. Despite the proven accuracy and safety profile of RTB, there is reluctance to implement RTB within the urological community.

The benefits of performing RTB before treatment is at least twofold. First, this can guide patient decision-making on whether to receive treatment.

More than 90% of interviewed patients with SRMs have expressed that they believe knowing the mass’ histology status will aid decision-making for the optimal treatment. Secondly, given a malignant result for RTB, an RTB can guide the best treatment for the patient, where low-grade SRMs could be suitable for active surveillance or IGA; and high-grade SRMs could be suitable for partial or radical nephrectomy.

In fact, the latest study of the EuRECA registry1 showed that, amongst patients undergoing ablation, the pre-cryoablation biopsy rate rose from 42% in 2015 to 72% in 2019 (p<0.001). Subsequently, patients are less likely to be overtreated for benign disease when more biopsies are performed (odds ratio [OR]=0.64, p<0.001).

This has shown promising potential in extending the use of preoperative RTB to other forms of SRM Vinson Wai-Shun Chan

Tze Min Wah

Urologists and interventional radiologists should work closely together to embrace and produce optimal outcomes for patients presenting with renal cell carcinomas.” treatment—especially partial nephrectomy—avoiding the significant decline in renal function and high complication rates post-nephrectomy. However, it is important to stratify patients who will benefit the most from biopsies. For example, patients over the age of 70 or who are unfit to undergo definitive treatment for SRM may not benefit from RTB; while those with complex tumours or comorbidities may benefit from RTB to prevent complex, high-risk treatments in these patients.1 Since the introduction of image-guided radiofrequency ablation (RFA) in 1998, the technology of IGA has developed significantly to include multiple different energy sources including cryoablation, microwave, and irreversible electroporation.2 The advantages of IGA compared to partial nephrectomy are at least twofold. Firstly, IGA is significantly less invasive compared to partial nephrectomy, with significantly reduced complication rates.3 Secondly, IGA is associated with a significantly smaller drop in renal function, which is crucial in patients with bilateral (synchronous or asynchronous) disease, or those who require repeat treatments—such as VonHippel Lindau (VHL) syndrome patients.

However, there is a lack of high-quality evidence to support the oncological non-inferiority of IGA compared to partial nephrectomy. This could be due to a few reasons. Firstly, previous recruitment of various trials involving IGA has failed, notably in the SURAB and the CONSERVE studies, which could be a result of patient preferences and lack of evidence at the time to support the recruitment process. Secondly, as pointed

out by a review performed by the European Association of Urology (EAU) Renal Cancer working group, the quality of observational studies and systematic reviews on the area is poor, notably affected by severe selection bias whereby younger and fitter patients tend to receive partial nephrectomy, compared to old and frail patients receiving IGA. Similarly, the latest systematic review and meta-analysis, published in the International Journal of Surgery, has suggested the same.3 Based on the limited quality of evidence on T1a SRMs, ablation is associated with similar cancerspecific survival, metastasis-free survival and diseasefree survival compared to partial nephrectomy.

Local recurrence-free survival is similar to partial nephrectomy patients with a follow-up of more than five years.3 Patients undergoing ablation also experience significantly less postoperative complications (risk ratio [RR]=0.72, p=0.02) and significantly smaller decline in renal function postoperatively (mean difference [MD]= -7.42, p<0.01).

Similarly, the long-term outcomes at our centre from 2003 to 2020 have shown similar outcomes, with overall survival, cancer-specific survival, local-recurrence free survival and metastasis-free survival in IGA at least as good as partial nephrectomy, with significantly better renal function preservation.4 Specifically, IGA is useful in patients with VHL syndrome—shown in the 17 patients who underwent IGA for VHL-associated renal cell carcinoma (RCC) and experienced excellent oncological outcome without the need for renal dialysis over 10 years of follow-up.5 The role of RTB and IGA has developed significantly throughout the last two decades; however, further research is required to consolidate the role of RTB and IGA in the treatment of SRMs. Firstly, RTB needs to be implemented in both research and clinical pathways. RTB can act as index tests for future diagnostic studies to facilitate development of new imaging modalities. For future interventional studies of new treatments, RTB will also allow focused research on RCC, rather than undifferentiated SRMs alone to improve the quality of evidence. Secondly, studies reporting outcomes from interventional oncology studies must conform to the CONSORT guidelines to allow for meta-analysis and further discussion of the data. Finally, urologists and interventional radiologists should work closely together to embrace and produce optimal outcomes for patients presenting with RCCs. Upcoming results from the NEST trial comparing the effectiveness of nephron-sparing surgeries and future research studies are highly anticipated.

References: 1. Chan V W-S, Keeley F X, Lagerveld B et al. The changing trends of imageguided biopsy of small renal masses before intervention—an analysis of European multinational prospective EuRECA registry. Eur Radiol. 2022; 5:1–12.

2. Wah T M, Lenton J, Smith J et al. Irreversible electroporation (IRE) in renal cell carcinoma (RCC): a mid-term clinical experience. Eur Radiol. 2021; 31:7491–9.

3. Chan V W-S, Abul A, Osman F H et al. Ablative therapies versus partial nephrectomy for small renal masses—a systematic review and metaanalysis of observational studies. Int J Surg. 2022; 97:106194.

4. Chan V, Osman F, Cartledge J et al. Percutaneous image guided cryoablation and radio-frequency ablation versus partial nephrectomy for small renal cell carcinomas: A ten-years, single centre observational study.

J Urol. 2021; 206(3): 770–1.

5. Chan V W-S, Lenton J, Smith J et al. Multimodal image-guided ablation on management of renal cancer in Von-Hippel-Lindau syndrome patients from 2004 to 2021 at a specialist centre: A longitudinal observational study. Eur J Surg Oncol. 2021. Doi: https://doi.org/10.1016/j.ejso.2021.10.022.

Vinson Wai-Shun Chan is a final year medical student in the School of Medicine in the Faculty of Medicine and Health at the University of Leeds in Leeds, UK. Tze Min Wah is a professor, and senior consultant diagnostic and interventional radiologist, in the Department of Diagnostic and Interventional Radiology in the Institute of Oncology at St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, in Leeds, UK. The authors declared no relevant disclosures.

April 2022 | Issue 85

16 Forgotten Stents

“Dramatic increase” in patients with gastrointestinal stent breakdown “Over the last few years, we have seen quite a dramatic increase in patients who present with a structural failure of their stent in the upper GI [gastrointestinal] tract.” Speaking to Interventional News during the British Society of Interventional Radiology (BSIR) Annual Scientific Meeting 2021 (8–10 December, Glasgow, UK), Hans-Ulrich Laasch details why more patients are presenting with broken GI stents and what patients’ follow-up care may look like going forward.

THE “STRUCTURAL FAILURE” OF THESE stents is caused by corrosion of the metal that they are made of: the superalloy nitinol. Due to exposure to hydrochloric acid in the stomach, over time, the nitinol corrodes “to the extent that the stents break and fall apart,” Laasch (The Christie NHS Foundation Trust, Manchester, UK) says. The wires making up the stent’s structure fracture and, eventually, the whole stent loses its shape and can no longer function as it should, he explains.

Follow-up patterns behind under-recognition

do not see these patients again, because they get referred to regional cancer centres for follow-up,” Laasch elaborates. Oncologists at regional centres, such as Laasch himself, are those who oversee the stent retrieval procedures, as opposed to the professionals responsible for fitting them in the first instance.

Tracking stent breakdown is, therefore, harder to achieve.

Laasch believes that, rather than continuing with the current process for replacing stents, the interventional radiologists or endoscopists involved in the initial insertion should play more than just a technician’s role.

“These are the people who have the relevant expertise and should be involved in the follow-up,” he opines.

Computed tomography (CT) scanning can be effective in identifying stents in the early stages of breakdown. Yet, without the professionals who specialise in imaging, the stents are only identified once the damage is already significant. In practice, this is when the patient presents with recurrent problems swallowing, he states.

“A few years ago, it used to be a very rare event,” but now, Laasch says, the Christie team are doing at least one or two stent procedures a week to replace or revise stents damaged by corrosion. This is partly because medical professionals now know to look out for the failing stents that previously would go undiscovered. But patients’ increased longevity is also a factor.

However, “the problem is still very much under-recognised. Part of that is that the operators often Hans-Ulrich Laasch

Towards a twofold stent solution

Improving interdepartmental communication to avoid forgotten ureteric stents There are some very serious risks associated with forgotten ureteric JJ stents. David Maudgil (Slough, UK), outlines why and when these devices are used, as well as explaining the risks a forgotten stent might pose and providing some guidance on how to mitigate them.

INTERVENTIONAL RADIOLOGISTS routinely place large numbers of ureteric JJ stents for a number of different indications, including ureteric blockage or ureteric injury. This is often when retrograde attempts have failed or when there is no available retrograde route from the bladder. The patients who require this come from a wide range of non-urological or nephrological specialities, particularly general surgery, gynaecology, and medicine, but will usually require follow-up and change of the stent by urologists within three-to-six months.

If the stent is not removed or changed in a timely fashion, there is a high risk of encrustation of stone material around the stent, which may not only block the stent but also make it extremely difficult to remove without damaging the kidney, ureter and bladder. There is also a small risk of the stent fracturing within the ureter, causing acute blockage with probable added infection. For these reasons, a forgotten ureteric stent constitutes a “never” event and a serious

untoward incident (SUI).

Although guidelines and procedures exist for routine monitoring and change of stents placed retrogradely (by urologists), we did not have a robust system for handing these patients promptly to urology for follow-up of their stent (the Healthcare Safety Investigation Branch [HSIB] report, “Unplanned delayed removal of ureteric

Consequently, Laasch recommends that interventional radiologists are the professionals best placed to follow up on the stents: “They understand the clinical problem, they understand the stents, and they have access to the imaging that shows the changes the earliest.” In order for this to be possible in the future, however, Laasch states that the interventional radiologists need to be allocated more time in their schedules to take on this clinical role.

In addition, Laasch clarifies that there is a focus on the future of GI stent manufacturing in terms of the materials used: “We at the Christie are leading research projects into material [nitinol] failure,” Laasch communicates. This is in collaboration with two Manchester universities, and one in Prague.

“It is a small, niche market. Funding is difficult.”

But Laasch concludes by explaining that the Christie, has been lucky enough to form an umbrella with the Minnova Medical Foundation—a community interest company that has been fundraising to support the

The problem is still very much underrecognised. Part of that is that the operators often do not see these patients again, because they get referred to regional cancer centres for follow-up.”

stents”, was published in October 2020 and can be found online).

We performed an audit showing that, of 50 patients in 2019 who had antegrade stents inserted (67% as emergency admissions), 40% subsequently had stents replaced retrogradely, while 45% had them removed, and 15% had extra-anatomical stenting or died before readmission. The mean time from stent insertion to planning removal was 13 days, which appeared unacceptably long and increased the risk of the patient being lost to urological follow-up.

These findings were discussed at a joint interdepartmental meeting and we agreed that a logbook should be kept where all antegrade stents would be recorded. Moreover, a standing item at the weekly uroradiological meeting was discussion of every antegrade stent insertion and formulation of an agreed plan for urology to follow up the patient.

Subsequent re-audit three months later showed that all patients had been discussed in a timely manner, with mean interval from stent insertion to planning removal reduced to 3.3 days. It was clear that interdepartmental communication regarding these patients was much improved and that a safe system of working had been developed.

This audit, with subsequent significant improvement after discussion, was presented at the 2021 British Society of Interventional Radiology (BSIR) annual scientific meeting (8–10 December; Glasgow, UK).

David Maudgil is a consultant interventional radiologist at Wexham Park Hospital, Frimley Health NHS Foundation Trust in Slough, UK. The author declared no relevant disclosures.

The UK HSIB published its report, “Unplanned delayed removal of ureteric stents”, in October 2020. It made the following safety recommendations: Safety recommendation R/2020/091:

Safety recommendation R/2020/092:

Safety recommendation R/2020/093:

Safety recommendation R/2020/094:

Relevant specialities to develop national standards which support electronic and paper-based systems for stent logging/tracking.

These standards should include guidance on monitoring and human oversight.

Review stent patient information leaflets. This should include accessibility and clinical considerations, especially with regards to side-effects and complications, and advice on the action to take should concerns arise.

Provide guidance for staff working within the stone care pathway to promote consistent advice to patients as part of discharge planning.

Include information in discharge letters and other communication sent to GPs [general practitioners] and patients regarding patients’ stent status, potential complications, and the possibility of a retained stent.

Issue 85 | April 2022

Interventional Oncology 17

New technologies in malignant ureteric obstruction Malignant ureteric obstruction (MUO) poses several tangible threats to cancer patients—and these threats translate, in turn, to challenges for the interventional radiologist and other treating physicians. Here, Conrad von Stempel and Tim Fotheringham (London, UK) describe a number of alternative techniques to common approaches via percutaneous nephrostomy (PCN) or with polymeric JJ stents, while also assessing currently available evidence in this space.

U

reteric obstruction is a common sequela of genitourinary and other malignancies. Patients with MUO have a poor overall prognosis, with a median life expectancy of <12 months. MUO is a feature of advanced cancer and progressive bilateral obstruction leads to irreversible deterioration of renal function. The development of MUO may also preclude chemotherapy and other cancer therapies.

A multidisciplinary approach in the management of MUO patients is required, as treatment selection is dependent on the prognosis of the patient, and the patient’s performance status combined with available cancer treatment options. Although some MUO can be treated with a retrograde approach, many patients require an antegrade approach by an interventional radiologist. MUO is commonly treated with PCN or polymeric JJ stents—however, there are other management options available.

Permanent PCN may be required when there is extensive tumour infiltration in the bladder or when the ureteric obstruction cannot be crossed. PCN drainage is a relative contraindication for chemotherapy, requires regular exchanges, and is an undesirable outcome for most patients. Frequent tube dislodgement can occur with PCN, even when using larger-diameter

Conrad von Stempel

Tim Fotheringham

stent (Cook Medical), which is a metal JJ stent made from a cobalt-chromium-nickel-molybdenum alloy and has a maximum indwell time of 12 months before exchange is required. The Resonance has improved primary patency to polymeric stents in some studies with >90% patency at one year, owing to less risk of extrinsic compression and encrustation. In a systemic review, the reported migration is low, at 1%—however, stent obstruction at 17% was seen and patients are prone to the same symptoms of bladder irritation seen with JJ stents.

Dedicated covered, self-expanding ureteric stents have become available, which can be inserted either retrogradely or antegradely, and offer alternatives to JJ stents requiring fewer exchanges. Devices currently available include Uventa (Taewoong Medical), which is a double-layered, coated, self-expandable metallic

mesh stent. The Allium (Allium Medical Solutions) is a fully covered, self-expanding nitinol stent. The entire stent is covered with a biocompatible, biostable polymer, making it a nonpermeable tube, to prevent tissue ingrowth and early encrustation stent. The Hilzo stent (BCM) has a polytetrafluoroethylene (PTFE) cover in spiral configuration—intended to help prevent stent migration. It is designed with soft and smooth ends to minimise hyperplasia.

While it is difficult to draw too many conclusions from a limited number of studies, the self-expanding, covered ureteric stents do appear to be more effective in treating MUO, and with better long-term outcomes, compared with JJ stents. Complications seen include occlusion from hyperplasia, encrustation, migration and fistulation. The cost of the devices is offset by the reduced need for reintervention as compared with JJ stents.

In conclusion, there are more options for treating MUO patients beyond PCN and JJ stents. Avoiding permanent PCN is advantageous to the patient, and significantly reduces readmission for either exchanges or managing arising complications. Interventional radiologists should consider alternatives, such as extraanatomical stents and self-expanding covered stents, when dealing with MUO. Conrad von Stempel is a consultant interventional radiologist at the University College London (UCL) Hospitals NHS Foundation Trust in London, UK. Tim Fotheringham is a consultant interventional radiologist at Barts Health NHS Trust in London, UK. The authors declared no relevant disclosures.

...Self-expanding, covered ureteric stents do appear to be more effective in treating MUO, and with better long-term outcomes, compared to JJ stents.” nephrostomy tubes, placing the nephrostomy in a tunnel, or attempting to secure the tube with sutures and dedicated drain-fixation devices. The loop/circle nephrostomy is an alternative in such patients, using a double calyceal puncture, as it has greater security with less chance of accidental displacement and requires less frequent routine tube changes than standard PCN. If the bladder still functions, extra-anatomical stenting can be considered through a subcutaneous tunnel and suprapubic access. Extra-anatomic stenting is seldom offered in PCN-dependent patients with MUO. A dedicated device, such as the PatersonForrester subcutaneous urinary diversion stent (Cook Medical; 8.5Fr, 65cm) can be placed and exchanged at three monthly intervals under local anaesthetic.

JJ stenting with 6–8Fr polyurethane devices fail to relieve MUO at three months in up to 51% of patients and require regular routine exchange via the retrograde route at three-to-six-month intervals. Stent primary patency is between 40% and 60% at one year. An alternative to a polyurethane JJ stent is the Resonance

8F loop nephrostomy

8F extra-anatomic stent

7mm 12cm Uventa stent

7mm 12cm Hilzo stent

April 2022 | Issue 85

18 Interview

Profile

Karim Valji

“I took a giant leap of faith and applied for a radiology residency with the sole intention of doing interventional radiology (IR). I was lucky—it turned out to be the perfect specialty for me,” Karim Valji, professor of radiology at the University of Washington (Seattle, USA) and professor Emeritus at the University of California, San Diego (USA) tells Interventional News. Valji is also the former editor-in-chief of the Journal of Vascular and Interventional Radiology (JVIR).

In medical school, I was drawn more towards the doctors who were ‘thinkers’ rather than ‘doers’.

I started an internal medicine residency at UCSF [University of California, San Francisco], but by the end of my internship I realised that I really wanted to work in a procedure-driven field. Ernie Ring and Bob Kerlan were there running one of the premier IR sections in the country, and I watched them do several cases on my patients. Having spent no time whatsoever on an IR service, I took a giant leap of faith and applied for a radiology residency with the sole intention of doing IR. I was lucky–it turned out to be the perfect specialty for me.

Your 2020 Dotter Lecture focused on a fundamental question—why are we doing this procedure? Could you outline recurring scenarios in which this question should be at the forefront of a proceduralist’s mind?

In the busyness of our hectic workday, it is so easy just to do the cases listed on the board without stepping back to consider what we are really doing for every patient. We really need to have a different mindset.

Like a surgeon, we must always start by looking at a patient’s clinical problem and consider how IR might benefit him or her. Sometimes it is as simple as deciding that a tunnelled catheter is more appropriate for this person than the port that was requested.

On one end of the spectrum are the referrals that require help with a complex situation. In that scenario, there may be a tendency to get swept up in the details of a proposed procedure—or a desperate patient or provider can make us feel compelled to do something.

But we need to stop and ask these questions: Is the procedure likely to help the clinical situation? Are the potential benefits worth the risks? Is there a better option, perhaps even doing no intervention at all? And will it help the patient in the long run?

The polar opposite is the routine elective tube change. The case is totally mundane and so easy to do, but frankly, our responsibility goes beyond just changing out the catheter. We need to advocate for the patient and make sure there is a long-term plan that will, if possible and desired, allow the external catheter to come out. If that is not the case, we need to help the patient and family understand why the device may be in place for the long run. So, we must work with referring providers to advance treatment that will optimise the patient’s ultimate quality of life.

Having been the editor-in-chief of JVIR and having written three textbooks for IR, in 2022, what are ways to best educate the IR community?

Of course, when I started in IR over 30 years ago, the resources for learning the substance of IR were limited.

To pick up the basics of interventional radiology, many current residents tell me that they still prefer print textbooks and ‘linear reading’ to study a particular topic or learn the fundamentals of our field more

broadly. But frankly, I think many also rely more on various online sites for ‘bites’ of information that are short and well illustrated, and preferably interactive.

While those sources are usually more enticing and up-to-date than print books, I do wonder about the accuracy of some of that material.

The quality of research being published in JVIR has never been higher. There is no better authority for learning about the newest advances in our field.

However, I think we should always have a healthy dose of scepticism about any new technique or concept that we read about, even in venerated journals. In that same vein, I have found that many interventional radiologists (especially very experienced ones) can get dogmatic about the procedures they do and how they do them. It brings to mind the warning that a former dean at Harvard Medical School gave to an incoming class: “Half of what we are going to teach you is wrong and half of it is right. The problem is we do not know which half.”

I took a giant leap of faith and applied for a radiology residency with the sole intention of doing IR. I was lucky—it turned out to be the perfect specialty for me.”

What is your advice to a young trainee or interventional radiologist with an interest in academic medicine?

First, find a mentor—a person who can inspire you and guide you as you start doing research or getting involved in some other academic pursuit. It is not necessary to find someone with an international reputation or a CV a mile long. It is much more important to choose a person whom you respect and enjoy working with.

Second, if you have no experience with research, try your hand at a simple case report or short review article. Unfortunately, the sheer act of writing seems to turn off many aspiring young interventional radiologists. But, please believe that with some effort almost anyone can learn to write reasonably well.

Finally, do not reject the idea of academics simply because you think it means years of churning out papers. In many institutions, an interventional radiologist with an aptitude for teaching or an interest in leadership can have a rewarding and successful career as an educator or an administrator with minimal requirements for publication.

In the last few years, what research paper has particularly caught your attention?

In a JVIR article several years ago, my colleague Jeff Chick reported results of a national survey that he

alisonlang.com

What attracted you to a career in IR?

conducted to assess burnout among interventional radiologists. The findings were sobering. Burnout is a serious and growing concern for healthcare providers of every sort. Lack of energy, disengagement from colleagues, loss of satisfaction with work, a short temper with staff or even patients—these are some of the signs. There certainly are a number of strategies for helping prevent or deal with burnout. But the first step is admitting to yourself that there may be a serious problem brewing, and that it should not be taken as a personal failure. Unfortunately, the ‘superman’ ethos that is common among interventional radiologists can make it hard to accept that reality. At the very least, interventional radiologists concerned about their negativity towards work need to share these feelings with family or with close, trusted peers. And, just as important, all IR groups should confront this issue openly and directly, and make a real effort to identify and support colleagues who seem to be at risk.

Issue 85 | April 2022

Interview 19

What is one important way interventional radiologists can improve the quality of patient care they deliver?

Better communication. Not just with patients and families, but also with other providers who make up the medical team. Many surveys show that poor communication is one of the biggest complaints by the public about the modern healthcare system. We sometimes fail to be explicit about what a patient should expect during and after a procedure. Or, we do not provide clear and thorough information about how to manage a catheter, for example, when the patient is recovering. Or, we do not make it easy to reach us when a patient or family has concerns.

But on a broader level, the many individuals and teams caring for a patient sometimes give mixed or confusing messages about care plans and expectations for the future. The IR doctor gives the patient instructions about nephrostomy catheter management, and the IR nurse tells the family member something different. We do a complex venous reconstruction, but the procedure fails when another provider stops anticoagulation prematurely because the long-term plan was not well communicated. The problem is daunting. But we need to do our best to make the system work for each of our patients.

What gives you the most pleasure from travelling and teaching in different countries?

My most satisfying teaching experiences overseas have involved showing unknown cases to IR residents and fellows. These young trainees are so eager and grateful for teaching from someone from the USA who works in a leading centre for IR. And, any preconceived notions about the quality of training in some lessadvantaged countries are quickly dispelled after a short time spent with some of their smart and enthusiastic interventional radiologists-to-be.

What are your interests outside medicine?

I am a voracious reader, gym junkie, and avid theatergoer. My husband Jon and I spend as much time as we can visiting San Diego to see our two children and grandkids (now aged six, three, and one). And we are both lifelong travel fanatics. We spend hours and hours on Kayak putting together our own trips. We know exotic airport codes like sports fans know players’ stats. And our interests complement one another’s really well. I have made him appreciate all that world cities have to offer, and he entices me to places I could once barely find on a map...The Gambia, anyone?

Current appointments

Professor of Radiology, University of Washington, Seattle Professor of Radiology, Emeritus, University of California, San Diego

Society positions

Previous appointments

2015-present: Chairman, 2011-20: Chief of Subcommittee on International Interventional Radiology, IR Fellowship, Training and University of Washington, Board Certification, Society of Seattle Interventional Radiology 2009-12: Chief of 2001-2005: Editor-in-chief, Interventional Radiology, Journal of Vascular and Harborview Medical Center, Medical education Interventional Radiology Seattle 1988-89: Angiography/ 1989-90: Research Fellow, 1993-1996: Chief of Interventional Radiology Radiological Society of Interventional Radiology, Fellow, University of California, North America University of California, San Diego San Diego 1982: Medical degree, Harvard Medical School

April 2022 | Issue 85

20 CX 2022

CX 2022 highlights new data in the vascular world

Hospital, Arnhem, The Netherlands), who will deliver three-year ANCHOR study results on wide aortic necks as well as an edited case on the topic. ● Wednesday 27 April

give a presentation on how endovascular repair computed tomography (CT) scans can predict patients at risk for failure after ruptured abdominal aortic aneurysm.

As part of the Vascular Access Masterclass, Tjun Tang (Singapore General Hospital, Singapore) will deliver 12-month results from the ISABELLA trial on endovascular salvage of failing arteriovenous fistulas (AVFs) utilising sirolimus-eluting balloons, and Andrew Holden (Auckland City Hospital, Auckland, New Zealand) will present 36-month results from the IN.PACT AV Access study.

The abdominal aortic programme features three Podium 1st presentations: Cydar executive director Tom Carrell (Barrington, UK) will speak on how artificial intelligence can make aortic A series of 15 Podium 1st presentations repair outcomes more predictable; Fadi Taher will punctuate the comprehensive CX 2022 (Klinik Ottakring, Vienna, Austria) will outline the programme, highlighting new data in all technical success of fenestrated endovascular vascular domains. aortic repair after prior endovascular ● Thursday 28 April repair, and Kevin Mani (Uppsala ● Tuesday 26 April University, Uppsala, Sweden) will In the thoracic aortic session, Jeandiscuss the relation between Pierre Becquemin (Hospital Paul In the peripheral arterial session, Alun Davies volume and outcome in aortic D Egine, Champigny-sur-Marne, (Imperial College London, London, UK) will surgery and failure to rescue.

France) will deliver a Podium speak on the place of neuromuscular electrical Speaking on type II endoleak 1st on the validation of thoracic stimulation for intermittent claudication, challenges, Hence Verhagen endovascular delivering results from the randomised controlled (Erasmus Medical Centre, aortic repair results across multiple NeSIC trial.

Rotterdam, The Netherlands) will diseases based on a French Scheduled to address the audience of the offer key insights from the ENGAGE experience. deep venous session, Mitchell Silver (Riverside registry, detailing how sac regression at Radiation reduction will be a key 15 Podium Methodist Hospital, Columbus, USA) will deliver one year affects all-cause mortality at topic on the aortic agenda, which 1st presentations new results from the CLEAR-DVT trial, designed extended includes a Podium 1st on the role to assess contemporary endovascular therapies time points. of intravascular ultrasound (IVUS) for in situ in the treatment of acute iliofemoral deep vein Results from the CARIBE study on sizing and technical assessment of directional thrombosis (DVT). preservation of the iliac arteries, due to be branches during branched endovascular aortic The aortic programme will feature a session on delivered by Fabio Verzini (University of Turin, repair, due to be presented by Michele Antonello techniques, during which the CX audience will Turin, Italy), will also feature on the aortic (University of Padua, Padua, Italy). Finally, have the opportunity to watch Wei Guo (Chinese programme. addressing chronic limb-threatening ischaemia PLA General Hospital, Beijing, China) perform a In the ruptured abdominal aortic session, challenges, Andrew Holden will outline a G-Branch (Lifetech Scientific) live case. Viewers Jean Paul de Vries (University Medical Centre first-in-human experience with an ai16486549595_CX2022 EVENING RECEPTION-INHOUSE-HALFPAGE-220X153.pdf 1 30/03/2022 16:42:39 will also hear from Michel Reijnen (Rijnstate Groningen, Groningen, The Netherlands) will intravascular lithotripsy system.

Join us at one of London’s most unforgettable and unique venues, the Natural History Museum, to celebrate the return of CX coming together, sharing ideas, best practice and consensus. Taking place on the Tuesday night of the CX Symposium, guests will enjoy an evening of drinks and canapés in the venue’s most iconic event space.

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CX2022 EVENING RECEPTION

Tickets are subject to availability online and onsite at registration, £50 per person. www.cxsymposium.com/cx2022reception Location: Natural History Museum, Cromwell Road, SW7 5BD

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Date: Tuesday 26th April 2022

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T U E S D AY 2 6 A P R I L 2 0 2 2

Timings: 7pm - 9pm

N AT U R A L H I S T O R Y M U S E U M

Coaches will be provided from the Hilton London Metropole from close of programme on the 26 April

www.cxsymposium.com/cx2022reception

Dress code: Smart casual

WWW.CXSYMPOSIUM.COM

Issue 85 | April 2022

CX 2022 21

The Hurting Leg Challenges

CX 2022: A conversation with Robert Hinchliffe 10:30–12:30 Thursday 28 April Kensington 2

Robert Hinchliffe (University of Bristol, Bristol, UK) shares his excitement about attending the upcoming CX Symposium in April. “CX has always represented an unprecedented opportunity to share new techniques and to analyse the latest and best clinical trials across vascular interventions,” the CX 2022 executive board member tells Interventional News. This year, a highlight for Hinchliffe will be a session on the “hurting leg,” which is due to take place on the final day of the in-person and virtual meeting.

“We would all agree that a large component of our practice is patients who present with lower

Vascular Access Challenges

Vascular Access Masterclass to address challenges in creation, maturation, maintenance and salvage Wednesday 27 April Richmond This year’s Vascular Access Masterclass will cover challenges in creation, maturation, maintenance and salvage of vascular access.

New approaches, new devices and new evidence that have come to the forefront in recent years will also be discussed.

An array of case studies in access, featuring interactive, multidisciplinary discussion with the CX audience, will complement a series of presentations.

limb problems,” says Hinchliffe, emphasising Finally, Hinchliffe highlights an ongoing need the significance of the topic. He also highlights to raise awareness of the hurting leg. He notes the fact that patients are presenting late in many that, in other cardiovascular arenas in the UK, cases—which could well explain high a number of campaigns to raise the amputation rates. In light of this, he awareness and timely treatment of stroke, previews that CX 2022 “will be a really appeared to be “very effective”. “Clearly, fantastic opportunity to assess these there needs to be research to understand really troublesome patients”. how to make the biggest difference “Hurting legs are a very emotive issue and how to reach those hard-to-reach for patients,” Hinchliffe relays, adding groups,” he urges. “Fundamentally, I think that they are a “common problem” Robert Hinchliffe it is a question of raising awareness both for vascular specialists. Unfortunately, however, he highlights that “these problems are not managed particularly well within vascular centres, and it is unclear why this is the case”.

Hinchliffe hopes that “CX 2022 will really shine a spotlight on the need to improve evidence in this area, and give an opportunity to share the latest ideas and cutting-edge research”.

In his own practice, Hinchliffe recognises outcome variation between regions and within regions. He points out that while this is “complex problem,” patient engagement is “really quite key”. Another issue lies in the interdisciplinary nature of patient management, says Hinchliffe. He elaborates that patient management spans primary care, all the way among patients and healthcare professionals and through to more specialist interventions by other usually in primary care.” vascular surgeons, interventional radiologists, or This year, the CX Symposium will be held in cardiologists. “We really have not fostered good person for the first time since 2019. After a tworelationships between professionals,” he says, year COVID-19-induced hiatus, Hinchliffe is keen underlining the problem. Hinchliffe believes that to get back to face-to-face meetings. “It will be CX 2022 “presents an opportunity to deal with, really fantastic to be back at the CX Symposium,” and shine a light on these problems, providing he says, describing it as “an opportunity to meet the opportunity to improve communication and old friends and hopefully meet some new ones” pathways between groups of professionals”. in addition to its educational offerings.

Robert Jones (University Hospital Birmingham NHS Foundation Trust, Birmingham, UK) will talk through a case entitled “When lines don’t work”, Robert Shahverdyan (Asklepios Clinic Barmbek, Hamburg, Germany) will speak on non-maturing endovascular arteriovenous fistulas (AVF), Alexandros Mallios (Groupe Hospitalier Paris Saint Joseph, Paris, France) will outline a procedure featuring perforator stenosis in a percutaneous AVF, and Ulf Hedin (Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden) will address haemodialysis vascular access in elderly patients.

Non-dialysis vascular access will be another topic on the agenda, covering issues such as vascular access hyperlipidaemia and therapeutic apheresis, vascular access and haemorrhagic and thrombotic disorders, vascular access and sickle cell disease, and vascular access and neurological diseases.

In addition, CX viewers will hear presentations on new technologies and new sites, including an edited case

by Panagiotis Kitrou (University of Patras, Patras, Greece) entitled “Not just creating an endovascular AVF, making a difference”.

The CX audience can expect to see Podium 1st presentations on 12-month results from the ISABELLA trial and on 36-month results from the IN.PACT AV Access study in this session.

CX 2022 will really shine a spotlight on the need to improve evidence in this area, and give an opportunity to share the latest ideas and cutting-edge research.”

Venous & Lymphatic Challenges

Venous and lymphatic session to tackle appropriate care conundrums

Tuesday 26 April Kensington 2 CX 2022 executive board members Stephen Black (King’s College London, London, UK), Manjit Gohel (Addenbrooke’s Hospital, Cambridge, UK), Armando Mansilha (University of Porto, Porto, Portugal), and Erin Murphy (Sanger Heart and Vascular, Atrium Health, Charlotte, USA) have designed a comprehensive venous and lymphatic programme spanning the superficial, deep and pelvic veins, as well as the lymphatic system and venous wounds. This year’s programme will cover various challenges in the field—ranging from appropriate care conundrums to venous challenges in relation to the “hurting leg”.

Addressing appropriate care challenges, experts will speak on the extent of the ‘overtreatment’ problem in venous disease, consider the value of the recently published European Society for Vascular Surgery (ESVS) venous guidelines for promoting evidence-based care, deliberate how to curtail inappropriate care in venous disease interventions, and highlight the importance of registries in promoting good venous management.

Another subject on this year’s programme is venous stenting. While this is “primarily a deep venous intervention,” says Murphy, she stresses that the superficial and deep venous systems are related and that both need to be taken into account in the patient interest. “It is really not unusual anymore that we need to be considering both interventions,” Murphy believes.

New to this year’s venous and lymphatic programme will be the inclusion of a series of edited cases within the main programme to illustrate data, a change endorsed by Murphy, who explains that she will be presenting cases focusing on the recognition and management of some venous complications that have recently come to the attention of specialists. “We are starting to see some very unusual things along with stent occlusions,” she notes. Murphy stresses the importance of seeing not only how these complications can be fixed, but also how they can be prevented in the first place.

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Issue 85 | April 2022

VENOUS

Venous Highlights 23 retrospective review of all patients who underwent iliofemoral venous stenting for acute thrombotic, post-thrombotic and non-thrombotic indications at their institution between 2014 and 2021, grouping patients based on the use of novel dedicated venous stents versus non-dedicated stents during their treatment.

The team measured 30-day stent failure and one-year patency rates as primary outcomes, Tran after iliac vein stenting rely on detailed, adding that secondary multiple technical considerations outcomes included stent sizing and stent attributes. “In and extension. addition to adequate sizing and A total of 135 patients (186 consistency in deployment, […] limbs) were treated in the Lillian Tran venous stents must establish a study, Tran told AVF attendees, balance between radial force, flexibility specifying that 63 limbs were treated and crush resistance,” she informed the using novel dedicated stents, while audience. Tran detailed that dedicated, 123 were treated using the traditional nitinol-based stents have been developed Wallstent or another non-dedicated stent. to meet these requirements and are now The team noted no preference in stent on the market in the USA and Europe.

Four of these stents have been approved by the US Food and Drug Administration (FDA) for venous indications, the presenter relayed, noting however that the Vici (Boston Scientific) and the Venovo (BD) stents were recalled last year.

Outcomes data from investigational device exemption (IDE) trials of the four dedicated venous stents have demonstrated excellent patency rates, Tran communicated. However, she highlighted that head-to-head, comparative performance data against the more traditional Wallstent (Boston Scientific) and other non-dedicated stents are limited.

Tran et al therefore performed a

Dedicated vs. non-dedicated: Researchers place venous stenting under the spotlight at AVF 2022 VENOUS STENTING WAS A HOT topic on the agenda of the recent American Venous Forum (AVF) annual meeting (23–26 February, Orlando, USA). Catching the audience’s attention, one presenter highlighted a head-to-head study of dedicated versus non-dedicated stents.

“Iliofemoral venous obstruction, when not adequately treated, results in chronic debilitating disease and poor quality of life,” said Lillian Tran (University of Pittsburgh Medical Center, Pittsburgh, USA), who noted that deep venous stenting is “increasingly preferred” as the mainstay treatment over medical therapy alone.

According to Tran, this move towards stenting necessitates studies comparing the performance of novel, dedicated venous stents with more traditional, nondedicated stents. At AVF, Tran reported the findings of such a head-to-head study at a single centre, detailing that the use of dedicated venous stents was associated with a significant reduction in extension into the inferior vena cava (IVC) without reduced early patency rates compared to non-dedicated stents.

The presenter stressed that outcomes

We found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel dedicated venous stents.”

Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus Six-month outcomes from the ongoing CLOUT registry demonstrate the “safety and efficacy” of the ClotTriever thrombectomy system (Inari Medical) in a real-world deep vein thrombosis (DVT) population regardless of clot chronicity level, the 2022 annual meeting of the American Venous Forum (AVF; 23–26 February, Orlando, USA) heard.

DAVID DEXTER (EASTERN VIRGINIA Medical School and Sentara Vascular Specialists, Norfolk, USA) was delivering the latest subgroup analysis update from the prospective, multicentre study on behalf of the CLOUT registry investigators based on the first 250 patients enrolled at 24 sites.

“We were able to meet the performance goal of greater than 75% in all three [chronicity] groups,” Dexter told attendees. “We had remarkably low device-related serious adverse events at one month. And our rates of post-thrombotic syndrome [PTS]—including moderate to severe—at six months were similarly low.”

The data from the registry show 33% of the 250 patients with acute thrombus, 35% with subacute and 32% with chronic.

Almost all procedures were single session, with an average of four passes using the ClotTriever device for all chronicity subgroups, Dexter said. No patients required adjunctive thrombolytics. Adjuvant angioplasty was used in 73% (acute: 70%; subacute: 68%; chronic: 84%) and stents in 47% (acute: 46%; subacute: 42%; chronic: 50%) of cases.

Complete or near-complete thrombus removal was

achieved in 85% (acute: 90%; subacute 81%; chronic: 84%) of limbs, including 51% (acute: 54%; subacute: 49%; chronic: 49%) with 100% thrombus removal.

The post-thrombectomy median hospital stay was one day for all subgroups.

At six months, 90% (acute: 86%; subacute: 89%; chronic: 96%) of the treated limbs had flow present, and 90% (acute: 84%; subacute: 90%; chronic: 91%) were compressible. Any PTS at six months was about 20% in the acute, 25% in the subacute and 30% in the chronic arms.

“Statistically, this has a p value of 0.5—we will see how that holds out in another two years when we have finished enrolment of 500 patients,” Dexter said. On the other hand, moderate-tosevere PTS, “was remarkably low at 5% in the acute arm, and about 10% in the subacute and chronic arms.”

Major adverse events and serious

type in treating acute thrombotic or postthrombotic lesions at their institution, however they did observe that novel dedicated venous stents were more likely to be used in non-thrombotic lesions.

Addressing the AVF audience, Tran reported that fewer stents were deployed per limb with the use of novel dedicated venous stents. In addition, she revealed that one patient had a stent fracture without thrombosis, and that there were no cases of deployment failure or stent migration in either group.

Additionally, larger size was observed in limbs using the Wallstent alone compared to novel dedicated venous stents and proximal stent extension into the IVC greater than 50% was significantly reduced with the use of novel dedicated venous stents compared to the non-dedicated stents, Tran detailed.

The presenter relayed some further key outcomes from the study: “Overall, dedicated venous stent use was not significantly associated with differences in early stent patency rates, nor was it a predictor of 30-day stent failure using a logistic regression analysis.”

In addition, she reported that primary patency rates remain comparable between novel venous stents and nondedicated stents at one year.

“In our experience, we found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel dedicated venous stents compared to Wallstents alone,” Tran concluded. In addition, she recapped that there were no significant differences in early outcomes between the two stents.

adverse “were similar and also rare,” Dexter added.

“All-cause mortality was three patients throughout the first 250.”

Furthermore, in terms of venous clinical severity score (VCSS) scores, at 30 days and six months numbers were “nicely low” at 3 and 2 for the acute group, 4 and 3 among subacute patients, and 4 and 4 in the chronic subset, Dexter pointed out. Pain score numbers were “essentially zero across the board.”

We had remarkably low device-related serious adverse events at one month. And our rates of post-thrombotic syndrome [PTS]— including moderate to severe—at six months were similarly low.”

The same was true when measuring quality of life, he said. “The average quality of life went back to the patient’s baseline regardless of the chronicity believed to be in the clot for acute, subacute and chronic.” The CLOUT registry’s follow-up out to two years is ongoing. Total enrolment of 500 patients at up to 50 sites has the intention of probing all-comers—across acute, subacute David and chronic clot subgroups.

Dexter

Issue 85 | April 2022

Conference Spotlight 25

SCVS 2022: ‘We should not allow our industry relationships influence how we choose to treat patients’ Industry players and device makers have helped spark new science and innovation in vascular surgery amid flatlining National Institutes of Health (NIH) funding, but physicians must pay heed to the conflicting agendas in the partnerships formed with these companies, a focus session on ethical issues in practice at the 2022 annual symposium of the Society for Clinical Vascular Surgery (SCVS 2022, 19–23 March, Las Vegas, USA) heard.

“I

ndustry sponsors a huge transparent about them, he said. The amount of significant comments came as Farber delivered research and NIH funding a presentation entitled, “Are we has been stable for a long time,” too cosy with industry?”

Alik Farber, head of vascular Farber used signposts from and endovascular surgery his own career to demonstrate at Boston Medical Center, how industry had aided certain Boston, USA, told the SCVS aspects of his own trajectory, 2022 gathering. “Given such as the beginning of his NIH funding, that is limited, endovascular practice in which and given the pay lines that an industry representative have been decreased recently, provided him with the devices industry-sponsored research adds he needed, as well as the BESTnew science and innovation. I am CLI (Best endovascular versus sure industry leadership, when they best surgical therapy in patients with plan their trials, try to do everything they critical limb ischemia), of which he is a Alik Farber can to make useful clinical trials to try to help principal investigator. “BEST-CLI ran out of physicians and patients. But [industry’s] clear primary money,” he explained. “We approached societies and fiduciary duty is to get their devices through the everybody gave—including the SCVS—but we also regulatory process to market, sell them and optimise approached industry. Initially, we did not want industry profits.” involved at all but we had no choice, facing a disaster, It is therefore incumbent upon surgeons participating and they helped us.” in industry-sponsored trials and partnerships Yet, the two-way relationship is much more to “understand the conflicting agendas” and be problematic than benefits to care, Farber continued.

Brain-computer interface device “holds great promise for people with paralysis” The results of a study in which four people with amyotrophic lateral sclerosis (ALS) received an implant of Synchron’s Stentrode device were presented on 29 March as part of an exclusive press briefing highlighting breakthrough science at the American Academy of Neurology’s 74th annual meeting (AAN 2022; 2–7 April, Seattle, USA). The Stentrode is a small, mesh-like material inserted within a patient’s blood vessel that does not require invasive, open brain surgery.

RESEARCHERS MONITORED participants for one year and found the device to be safe, with no serious adverse events that led to disability or death. The Stentrode device also stayed in place for all four patients and the blood vessel in which the device was implanted remained open. Receiving the implant allowed participants to use a computer to communicate by text, and perform daily tasks, such as online shopping and banking.

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. People with ALS lose the ability to

initiate and control muscle movement, which often leads to total paralysis.

“People with ALS eventually lose their ability to move their limbs, making them unable to operate devices like a phone or computer,” said study author Bruce Campbell (University of Melbourne, Melbourne, Australia). “Our research is exciting because while other devices require surgery that involves opening the skull, this brain-computer interface [BCI] device is much less invasive. It receives electrical signals from the brain, allowing people to control a computer by thought.”

Rather than drilling through the skull,

Bruce Campbell

There are incentives on both sides, he said, but those are not necessarily aligned.

Farber referenced a study carried out at his institution that sought to capture a snapshot of the financial relationships between academic vascular surgeons and industry. They found that in 2017, US$8.5 million went to 997 academic vascular surgeons—86% of those captured under the academic vascular surgeon designation. Some 115 of that number accounted for US$7 million of the total figure, he noted. “We concluded that most academic vascular surgeons have received payments from industry,” Farber told SCVS 2022. “The top decile of surgeons received more than 80% of the transactions.”

To balance these relationships and ensure they are lawful, “we should accept the fact we have our own agendas” he added, and that “we are not exempt from the influences of human nature,” meaning that “gifts have an effect.” Be aware of laws and rules in the jurisdictions in which we practise, Farber emphasised.

Importantly, he said: “We should not allow our relationships to influence how we choose to treat patients. I could repeat that 10 times. This is critical.”

Returning to his initial question, Farber asked once more: “Are we too cosy with industry? I think as a specialty we are not, but I think, individually, we need to look at ourselves in the mirror and figure it out.”

Are we too cosy with industry? I think as a specialty we are not, but I think, individually, we need to look at ourselves in the mirror and figure it out.”

the Stentrode is fed through a patient’s vein until it reaches the brain. The device, comprised of a net-like material with 16 sensors attached, expands to line the vessel wall. That device is connected to an electronic device in the chest that then relays the brain signals from the motor cortex—the part of the brain that generates signals for movement—into commands for a laptop computer.

“These results are a huge advancement for the field of BCI. We have shown that our endovascular BCI approach is safe, and allows patients to accomplish daily online tasks without invasive brain surgery,” said Thomas Oxley, CEO and co-founder of Synchron.

Researchers also report that a decoder developed during the study allowed one

study participant to control a computer independently without an eye tracker.

The machine-learning decoder was programmed as follows: when a trainer asked participants to attempt certain movements, like tapping their foot or extending their knee, the decoder analysed nerve cell signals from those movement attempts. The decoder was able to translate movement signals into computer navigation.

“Our research is still new, but it holds great promise for people with paralysis who want to maintain a level of independence,” said Campbell. “We are continuing this research in Australia as well as in the USA in larger groups of people.”

While other devices require surgery that involves opening the skull, this brain-computer interface [BCI] Bruce Campbell device is much less invasive”

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Issue 85 | April 2022

Advertorial 27

THIS ADVERTORIAL IS SPONSORED BY COOK MEDICAL

Hear new data on fibered versus bare metal embolization coils in veins at SIR 2022 Attendees of the Society of Interventional Radiology annual meeting (SIR 2022; 11–16 June, Boston, USA) will hear latest data on fibered versus bare metal embolization coils in veins. Ahead of these data, Scott Trerotola (University of Pennsylvania Medical Center, Philadelphia, USA) revisits the first arterial study to compare fibered and nonfibered platinum coils, which he says shows “very convincingly” that fibers made a huge difference in terms of acute occlusion.

D

oes this settle the debate on fibers on coils?

Trerotola discusses the findings of the arterial fiber study, using Nester® embolization coils (Cook Medical) in porcine arteries.

How would you summarise the approach and strengths of the arterial fiber study?

This is a study of fiber versus nonScott Trerotola fiber coils and the real strength of this study was to try to eliminate as many variables as possible. By doing an animal study, we were able to do that. The operator, which was me, was blinded to whether the coils had fibers on them or not and that is an important strength of this study. Having chosen the vessels of the same diameter, four different vessels in each animal, we then put either fibered or unfibered coils into those vessels and looked at the rate of occlusion and then how many coils it took to get the occlusion to occur. At that point, we then put the animals into follow-up. We looked at them at one-month follow-up in one subset of animals and at three months follow-up in another subset looking for whether the occlusion was persistent or whether recanalisation had occurred.

the course of several minutes as opposed to typically putting as many coils in as we need to get acute occlusion. We were trying to test a little bit more broadly to see whether we can get this done with just a single coil or just two coils as opposed to the three or four that we might normally put in. It does make sense to do this in an experimental setting because you have

What was the reasoning behind using a non-fibered Nester coil for the nonfibered device?

One of the real strengths of this experiment was to control as many variables as possible. Since we were studying Nester embolization coils and since Cook was the study sponsor, Cook had the ability to make the coils without the fibers. By doing that we could keep just the fibers and no other variable differing between the two.

The study involved some waiting between coil deployments which in the real world of embolization is not typical. So why was that done for this study?

One of the things that we do in any experimental study is to try to learn as much as we can and sometimes it does not exactly match what happens in the clinical setting. We chose to wait between coil deployments to see whether in fact occlusion would occur over

What benefits might fiber coils have for follow-up imaging?

One of the potential benefits is that if you have less metal in there and if you are following up with computed tomography (CT) scanning, you are going to get less metallic artefact. Metallic artefact may make the difference between being able to see whether a pseudo aneurysm has resolved or whether there is persistent flow beyond the coil nest as is important in, for example, pulmonary arteriovenous malformation (PAVM) embolization. So the ability to have less metal in there really does enhance our ability to do follow-up imaging.

Were you surprised by these findings?

I was not surprised because they were essentially consistent with what we have all thought we knew for a long time. If you had asked me before I did this study ‘do fibers make a difference on coils?’ I would say, ‘well of course we know that’ and then you start looking in the literature and it turns out there is this gigantic niche where it really had not been studied in great detail. Most of the research that was done back in the 70s and 80s was done with a variety of different coils including silk and wool. There was not as much done with nylon and when it was done with nylon it was with stainless steel. There really was no research done with nylon fibers on platinum coils and so this was the first to do that.

Why is this study significant?

1.3 fibered coils versus 3.2 bare-metal coils to reach acute occlusion1

Describe what you found generally?

The most important finding was that the number of coils needed to achieve acute occlusion was lower with fibers than with non-fibers and that was on average one coil versus three coils. That is a big difference. Essentially all the vessels had some degree of recanalisation and there was no difference between the groups. So, the short-term outcome of the study was faster occlusion but no difference in recanalisation.

procedure time and radiation dose to a variable degree depending on the patient.

the ability to wait whereas in a trauma setting or a gastrointestinal (GI) bleed setting you might not have that ability to wait.

The study concludes that coils with fibers are more thrombogenic. How can we extrapolate from that result?

One of the limitations of the study is that because we decided to control the experiment by waiting for occlusion to occur three minutes after each coil, we were not doing a real-world study of time.

Normally, if I am treating a GI bleeding patient or a trauma patient, I am going to put in coils in rapid succession until I achieve occlusion. As you have to make choices in any scientific experiment, we chose to try to answer that other question, ‘do these vessels occlude if we give them a few minutes to do so?’

Because of that experimental design, we did not have the ability to truly compare time to embolization from the coil with the fibers to the non-fibered coil. To the extent that we can extrapolate, I would say that, obviously it takes less time to put in one coil than it takes to put in three coils, which we averaged between the two, and time is always radiation because we are always watching under fluoroscopy while we are doing that. So, I think it is reasonable to extrapolate for the variable of acute occlusion which is where we saw a difference. There would be a reduction in both

First of all, his study is significant because it is the first to directly compare fibered and non-fibered platinum coils in any live model situation in any kind of scientific way. Second of all it showed very convincingly that fibers made a huge difference in terms of acute occlusion compared to non-fibered coils.

To read the full article published in the Journal of Vascular and Interventional Radiology, visit jvir.org.

1. Trerotola SO, Pressler GA, Premanandan C. Nylon Fibered versus Non-Fibered Embolization Coils: Comparison in a Swine Model. J Vasc Interv Radiol.

2019; 30(6): 949-955.

Scott Trerotola is a paid consultant of Cook Medical.

Some opinions expressed may represent those of the physician and are based on their own clinical experience in their practice. Results may vary in human use. Nester is a registered trademark of Cook Medical. For complete prescribing information including indications for use, warnings, precautions, adverse events, and deployment/use instruction, please visit your respective regional Cook Medical website at cookmedical.com or cookmedical.eu.

Disclaimer: Nester® Embolization Coils

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). INTENDED USE: Nester Embolization Coils are intended for arterial and venous vessel embolization procedures. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. CONTRAINDICATIONS: None known. WARNINGS: Positioning of Embolization Coils should be done with particular care. Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible. A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensures permanent fixation. The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstructing a normal and essential arterial channel. • Nester Embolization Coils are not recommended for use with polyurethane catheters or catheters with sideports.

If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently through it. Use of a polyurethane catheter may also result in lodging of the embolus within the catheter. • If difficulties occur when deploying the embolization coil, withdraw the wire guide, coil and angiographic catheter simultaneously as a unit. PRECAUTIONS: Perform an angiogram prior to embolization to determine correct catheter position. • Prior to introduction of the embolization coil, flush the angiographic catheter with saline. • If using a .018 inch MicroNester™ embolization coil, ensure that the delivery catheter has an internal diameter (ID) between .018 and .025 inch. See instructions for use for full product information. AB_T_CE_NEC_REV1

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INTERVENTIONAL NEWS www.interventionalnews.com

Thromboaspiration: More options for pulmonary embolism

April 2022 | Issue 85

page 8

CAVA RCT delivers powerful evidence Embolization supporting use of PORTs tocomes supply systemic knocking chemotherapy

13

Cryoablation: Freezing out lumpectomy

Profile: Laura Crocetti page 18

European Society of Medical Oncology these devices enabling prompt placement (ESMO nor the American Society of and removal by nurse-led teams, local Clinical Oncology (ASCO) make specific availability of devices, technical issues recommendations regarding the type of such as the avoidance of the vital device to be used. structures in the neck, and perceived CAVA showed that PORTs were lower up-front costs—but there is a associated with a reduction in sketchy evidence base behind this uptick, complication rate of about 50% when the authors say. “PORTs, by contrast, are compared to a PICC line, and the most expensive and least when compared with the frequently used of the three Hickman line. “There was a devices,” Moss emphasises. fairly strong preference for On stemming the tide of PORTs, amongst both the PICC use, the lead author patients receiving them and also continues: “Changing policy In the trial, radioembolization (also the healthcare staff who look institutions like the For most patients receiving systemic anticancer treatment (SACT), called selective in internal radiation after them. These were basically NHS is never easy. There totally implanted ports (PORTs) are more effective and safer than therapy [SIRT] or sometimes felt to be better devices and the will be all sorts of reasons both Hickman-type tunnelled catheters (Hickman) and peripherally transarterial radioembolization only downside is the cost and why people inserted central catheters (PICCs). The CAVA trial’s results, [TARE]) using glass beadsdo not want to Jonathan G whether these services are set change—with costs being recently published online in The Lancet, recommend reshaping (TheraSphere; Boston Scientific) Moss up and geared to deliver these one and who is going to be current guidelines and practice, so that most patients requiring containing radioactive yttrium-90 devices compared to the other in the PORTs [being chemotherapy for solid tumours receive a PORT within the UK (Y-90) was used putting as a secondtwo in a timely manner,” Moss added.line treatment another], and quickly they can be National Health Service (NHS), foreshadowing a pivot in practice in how combination put in. […]of There aresystemic lots of nurse teams that might be “slow to start with”. with standard care at the moment have been trained Resetting UK practice maychemotherapy forwho patients who hadto place PICC lines. We need toorbeafter able to “The bottom line is, for a solid cancer, he CAVA (Central venous not be a brisk business disease progression during sell chemotherapy. the message to them that we are not if you are going to need intravenous access devices for the delivery With the exception of five patients in first-line saying they should not provide a service chemotherapy for three months or of systemic anticancer therapy) the PORT group who received a general for patients, but trying THEREFORE, to persuade them more, you should be offered the trial is a National Institute for Health anaesthetic, all devices were inserted THE EPOCH TRIALISTS, put inona different device.

I think we Researchopen-label, under local anaesthetic. set theirtosights determining the impact A wealth(NIHR-) of datafunded emerging in the option of a PORT. We should try and need to try andand move away from doctors empower patients so that that this will multicentre, randomised controlled triala Moss outlines that decision-makingof radioembolization second-line last 18 months, including from putting in in patients the PORTs nurses putting be something they think will be best for that compared complication rates and processes behind the choice of devicechemotherapy withand colorectal liver small multicentre, randomised, in the PICC lines. These are all fairly them,” Jonathan G Moss (Institute of costs of the three devices usedoftogenicular deliver are “poorly understood” globally. metastases who progressed on oxaliplatinsham-controlled study straightforward procedures to place, anticancer drugs via a central vein. pain Cardiovascular and Medical Sciences, Eye-catchingly, PICC use has been or irinotecan-based first-line therapy. artery embolization for knee and I have prospective great confidence Glasgow, UK), chief investigator, tells Reported to to be osteoarthritis, the largest randomised captured to be buoyant. “PICC usage The has international, phasethat 3 we can secondary brings in nursingtrial teams to place all three Interventional News on the subject of trial to date to compare all threeofdevices, increased over the past decade and is now EPOCHempower pivotal clinical randomised 428 its slipstream a glimpse other similar increased PORT take-up.

CAVA set outinvasive to establish acceptability, the dominant strategy in many westernpatients.devices, but particularly PORTs.” minimally options to Moss thatwere the The paucity of good evidence clinical and cost-effectiveness of the European countries and the USA.” Findings fromacknowledges the trial, which treat disability in the entire comparing central venous access devices for patients receiving SACT This spike in PICC popularity may bepresented at the European Society for Medical musculoskeletal system.

At one month, Disability devices (CVADs) entails that neither the for three months, or more. underpinned the ease of insertion of Oncology (ESMO) congress (16–21 September Continued on page 2 embolization improvementbywas 2021) and published in the Journal of Clinical mbolization, which is rapidly surfacing significantly also significantly reduced pain more greater in the Oncology, showed that the addition of SIRT as a safe and effective procedure for the than the sham treatment group met both itsON primary including HE treatment of patients with osteoarthritis COMMENTING THE endpoints, MAIN BENEFITS treatment did (p=0.02) survival (PFS) hepatic of the knee, has been shown to be technically foreseesprogression-free as a result of being granted this and recognition, (p<0.01) progression-free survival (hPFS)will of patients achievable, with very promising outcomes at early Brown says: “The IASIOS accreditation allow with colorectal cancer to (mCRC) of follow-up. It is thought to bring down pain by reducing our centre to metastatic promote our high standards patients, The administrators. trial did not show synovial arterial hypervascularity. referrersthe andliver. hospital Thesignificant process of procedures for interventional radiologists in the near future in overallallowed survival patients A multicentre, randomised, single-blinded, shamseeking improvement IASIOS accreditation usoftothe review and and make a substantial impact in the lives of millions of criticallyinappraise the SIRTour arm. controlled study published online ahead of print in October existing practices, and to ensure patients. The data from our study demonstrate that that how we The addition of TheraSphere treatment 2021 in the Journal of Vascular and Interventional work is aligned with the international the effect of embolization in reducing pain and standard.significantly both PFS (p=0.0013) Radiology (JVIR) showed that, in patients with The promiseincreased of accreditation provided us with improving function is far greater than the effect the motivation and hPFS (p<0.0001).

Patients SIRT mild-to-moderate knee osteoarthritis, embolization to examine every facet ofreceiving our practice, of a sham procedure or placebo. This study will including with second-line were to 31% less results in symptomatic improvement greater than areas where wechemotherapy needed to improve comply be useful in convincing potential referrers as with thelikely to show disease progression or death the sham procedure did, with clinically significant IASIOS requirements.” well as insurance companies that this procedure (hazard ratio [HR]=0.69) and 41% less likely to reduction in pain and disability (as measured by should bedirector part of theat osteoarthritic knee pain hepatic disease progression or death vs. the Visual Analogue Score [VAS] and Western Ten centres have achieved the International Brown (clinical I-MED, The Continuedshow on page 4 algorithm.

What is most exciting is that with chemotherapy alone (HR=0.59). Median Ontario and McMaster Universities Osteoarthritis Accreditation System for Interventional Wesley treatment Hospital, Queensland, Australia) this procedure justitbe the first of many overall survival was 14 and 14.4 months Index [WOMAC]).

In the 21-patient all Oncology Services (IASIOS)study, accreditation, on this achievement andmay how certifies embolization procedures (p=0.7229). There were 68.4% grade 3 adverse those assigned to the group failed a benchmark ofsham quality standard and that this hospitaldifferent is providing the highest that will be oncology utilised to treat events reported after radioembolization as toassurance, show significant improvements at since 2018. I-MED Radiology, standards of interventional (IO)pain throughout the musculoskeletal compared with 49.3% in those who received one month and crossed over to the just achieved The Wesley Hospital, has care. “Personally, I am convinced that system,” Ari J Isaacson, adjunct chemotherapy alone. Both groups received the treatment arm. this recognition to become the first clinic IASIOS will bring game-changing renewal faculty at theradiology University of North “Genicular artery embolization has to do so. in the Southern Hemisphere and evolution to interventional the potential to be one of thespeaks most to Nicholas Continued on page 2 Interventional News practice around the world,” he says.

Ari J Isaacson commonly performed embolization Continued on page 4

EPOCH trial reignites radioembolization as treatment for colorectal liver metastases

on knee pain’s door

T

p<0.01 p=0.02

EWesley hospital

becomes first in Australia to achieve IASIOS accreditation in historic global milestone for CIRSE

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April 2022 | Issue 85

30 Market Watch

Product News Artio Medical receives US FDA clearance for Solus Gold embolization device

Artio Medical recently announced that it has received US Food and Drug Administration (FDA) clearance for its Solus Gold embolization device, a next-generation product for peripheral vascular occlusion.

“Current occlusion devices can be difficult to position, often require multiple implants, and completely occluding the target vessel usually takes time. This can be a problem when controlling or preventing bleeding,” commented Blaise Baxter, the vice president of Neurovascular and Peripheral Vascular Interventions for Artio Medical. “The Solus Gold device aims to overcome these limitations with a single implant designed for precision placement and immediate occlusion, even in high-flow vessels.”

The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. Following a controlled expansion and simple mechanical detachment, the non-porous, balloonlike gold implant provides 360-degree vessel apposition for immediate and complete occlusion, and resists

migration and recanalisation, providing physicians with a “one-and-done” solution for peripheral vascular occlusion. As demonstrated in a preclinical study, the Solus Gold device achieved immediate occlusion in >90% of cases, including in large and high flow vessels, and demonstrated 0% migration and 0% recanalisation in testing out to three months.

“When I first learned to embolize vessels using small metal coils more than 20 years ago, I thought [that someone would have to] come up with a better device. I am excited to have the opportunity to provide physicians and patients with an improved peripheral vascular embolization experience later this year with the Solus Gold device,” Nicholas Franano, president and CEO of Artio Medical announced.

Cordis invests in E2, developer of nextgeneration thrombectomy devices

Cordis has announced a strategic investment venture that will expand the scope of the global cardiovascular technology company into the venous thromboembolism (VTE) market with a strategic investment in Endovascular

Engineering (E2), a developer of next-generation thrombectomy devices to treat patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).

“Our investment in E2 positions Cordis at the vanguard of innovation in venous interventions,” said Duke Rohlen, executive chairman of Cordis and CEO of Cordis-X, an independent accelerator created to drive innovation and growth for the company. “We are proud to support the team’s efforts to define a new standard of care for patients suffering from thromboembolism.”

Cordis is partnering with Santé Ventures and another strategic investor in the E2 transaction.

According to Cordis CEO Shar Matin, “DVT and PE affect patients young and old […] Growing our venous offerings expands our capacity to improve outcomes and deliver better quality of life to more patients around the world.”

E2, based in Menlo Park, USA, was founded in 2019 to focus on development of advanced mechanical thrombectomy solutions. CEO Mike Rosenthal said: “The E2 team is thrilled to welcome Cordis and our other investment partners as we join together to help us further the pursuit of developing healthcare solutions that matter [...] to serve patients and physicians in the under-served peripheral indications.”

Merit Medical wins FDA breakthrough nod for microspheres for treating knee osteoarthritis

Merit Medical announced that it has received US Food and Drug Administration (FDA) breakthrough device designation for its Embosphere microspheres.

Utah-based Merit Medical’s breakthrough nod covers the Embosphere microspheres for the genicular artery embolization (GAE) indication for reducing blood flow to the knee to reduce pain and disability caused by knee osteoarthritis.

Merit Medical said in a news release that Embosphere microspheres are the most clinically utilised and clinically studied spherical embolic.

“We are pleased with the recognition and partnership of the FDA, making it possible for new and innovative products to reach the market faster,” Merit Medical chairperson and chief executive officer Fred P Lampropoulos said in the release. “We believe this breakthrough designation allows us to accelerate our programmes to study and obtain FDA clearance for the GAE indication for Embosphere microspheres, ultimately expanding treatment options for patients.”

In October 2021, Varian received an FDA breakthrough device designation for microspheres under the same indication for GAE in treating knee osteoarthritis.

April 2022 | Issue 85

32 Market Watch

Clinical News

VasQ device

Largest real-world experience to date with VasQ device indicates longterm benefits in forearm fistula creation

The VasQ external support device (Laminate Medical) has demonstrated long-term benefits for radiocephalic (forearm) arteriovenous fistula (AVF) creation in a retrospective analysis of 150 consecutive procedures. Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) and Dirk Hentschel (Brigham and Women’s Hospital, Boston, USA) have published these data in Seminars in Dialysis.

The VasQ device is implanted around the connection between the vein and artery of an AVF to promote maturation into a functional access for haemodialysis. Standard fistulas have reported failure rates to become functional for haemodialysis as high as 60% within the first year, according to a press release from Laminate.

However, the newly published data demonstrate that implanting VasQ resulted in 90% of fistulas being used for dialysis within a median of 41 days, and 84% maintaining secondary patency out to 36 months. The results suggest, according to Laminate, that the addition of VasQ to Shahverdyan and colleagues’ standard of care has helped haemodialysis patients receive more functional fistulas that are durable over the long term.

“I am excited to share these data, which build on my previous publication that demonstrated the short-term benefit of VasQ to reduce my primary failure rate,” Shahverdyan said. “Now, we see the early success with VasQ translated to the long-term benefit of more patients retaining a functional fistula out to three years.”

Laminate is currently completing a US pivotal study and preparing its submission for market clearance to the US Food and Drug Administration (FDA) for review.

Cardiovascular Systems announces first in-human experience with peripheral everolimus drug-coated balloon

Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies (CVT).

DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal lesions in patients with peripheral arterial disease. Everolimus, the active drug in CVT’s DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.

The first patient was treated

by Benjamin Honton, principal investigator at the Clinique Pasteur, Toulouse, France. The peripheral DCB was used to successfully treat a 69-year-old male with a 7.5cm lesion in his superficial femoral artery (SFA).

“We are honoured to enrol the first patient in the CVT-SFA trial,” said Honton. “We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral arterial disease.”

CVT intends to enrol 75 patients at a minimum of four sites in France and Germany to support an investigational device exemption (IDE) submission to the US Food and Drug Administration (FDA) and a subsequent US pivotal clinical study.

InspireMD announces the inclusion of its CGuard carotid stent in CREST-2 trial

InspireMD has announced that its CGuard embolic prevention stent system (EPS) will be included as a device option for stenting in CREST-2 (Carotid revascularisation endarterectomy or stenting trial).

Following the recent approval of the CREST-2 investigational device exemption (IDE) supplement application from the US Food and Drug Administration (FDA), the company states that it will be evaluating strategic sites to enable expediated access.

The study first enrolled patients in 2014, as two parallel multicentre randomised, observer-blinded endpoint clinical trials with the purpose being to determine the best way to prevent strokes in patients with high-grade carotid stenosis but no stroke symptoms related to that blockage.

According to an InspireMD press release, the trial will enrol an estimated 2,480 participants who will remain in the study for four years following the start of intervention.

“The CREST-2 executive committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” said Thomas Brott (Mayo Clinic, Jacksonville, USA), principal investigator of the National Institute of Neurological Disorders and Stroke (NINDS)sponsored trial. “It is critical to remain

aligned with evolving technology and relevant devices. After examining the extensive clinical experience with the CGuard stent and the large body of evidence to its effectiveness, the study executive committee felt it appropriate to include this stent as a treatment option. Patients that agree to participate in the CREST-2 trial, depending on accessibility and operator training and discretion, will now have access to this state of the art, carotid stent device.”

RenovaRP paracentesis management system decreases procedure time and improves patient experience, new research shows

Recently released clinical data has outlined the benefits of the RenovaRP paracentesis management system (GI Supply) for patients with ascites.

The study, which was published in the Diagnostic and Interventional Radiology journal by Shane Weber (Dearborn, USA) et al, found that there was a substantially higher fluid flow rate during paracentesis using the RenovaRP system as compared to wall suction.

The purpose of the study was to investigate if the use of RenovaRP as a treatment for ascites would reduce procedure time compared to standard wall suction without increasing adverse effects, such as hypotension or abdominal pain.

Procedure room time decreased from 53 minutes with wall suction to 31 minutes with RenovaRP (p<0.001). The paper’s authors noted that the RenovaRP pump is portable, simple to use, requires little staff training, and can be used to perform paracentesis outside of interventional radiology. The authors also highlighted that, as a selfcontained system, it avoids exposing medical team members to patients’ body fluids, which may occur during exchange of wall-suction canisters.

Karen Brown (Salt Lake City, USA), a co-author of the research paper, said: “Exposure to a patient’s body fluids is a risk faced by healthcare professionals that must change cannisters or open cannisters to pour in the material that solidifies the removed fluid.”

Brown added that the patient experience “was comparable to conventional wall suction. Patients said they liked Renova better, which might have been due in part to it being a faster procedure” The study authors also noted that on certain high-volume centres where paracentesis procedures are performed frequently, the RenovaRP pump

RenovaRP system

can be expected to provide superior through-put with relatively minimal added procedural costs. In addition, the pump offers providers and patients substantially faster procedure times without adverse outcomes.

Peripheral arterial disease symptoms differ between sexes, meta-analysis finds

In future peripheral arterial disease (PAD) research, clinicians should not consider men and women as a single population and should instead report their data separately. This is the main conclusion of a systematic review recently published in the European Journal of Vascular and Endovascular Surgery (EJVES), which found that symptoms of lower leg PAD present differently between men and women.

Authors Cindy P Porras (Utrecht University, Utrecht, The Netherlands) and colleagues write that while PAD has traditionally been labelled as a predominantly male disease, recent studies suggest that women are affected at least as often as men.

Some of these studies also describe differences in the clinical presentation of lower extremity PAD between the sexes, however the authors note that there has been no systematic review collating this information. Therefore, the present study aimed to collate the available evidence in order to evaluate differences in symptoms between men and women who present with lower limb PAD. Using PubMed, EMBASE, and the Cochrane Library, Porras et al identified all relevant studies, collecting data on study design, source of data, population characteristics, and the outcome of interest using the Newcastle–Ottawa scale and Cochrane risk of bias tool. The authors note that, using the GRADE methodology, the evidence quality was rated as high, moderate, low, or very low based on the risk of bias, inconsistency, indirectness, and imprecision.

Porras et al relay that among the eligible study populations with diagnosed PAD, women represented 43.9%.

The 21 studies eligible for qualitative analysis reported on 1,929,966 patients with diagnosed PAD. According to the authors, the data from these studies show that women presented with intermittent claudication less often than men (25.9 vs. 30.2% with OR 0.78 [95% CI 0.72–0.84]; p<0.001; very low quality of evidence). In contrast, Porras et al communicate that rest pain and atypical leg symptoms were more prevalent in women (12.8% vs. 9.2%; OR 1.4 [95% CI 1.22–1.6]; very low quality of evidence, and 22.8% vs. 19.8%; OR 1.18 [95% CI 0.96–1.45]; very low quality of evidence, respectively).

Looking ahead, Porras et al suggest that future studies are needed to understand the reasons for differences in clinical presentation in women and men with PAD, and how this influences diagnosis, treatment, and outcomes.

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April 2022 | Issue 85

34 Market Watch

Industry News

Guerbet headquarters

Guerbet expands portfolio with microcatheters and guidewires for interventional imaging and embolization

Guerbet announces it will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions becoming available.

The company obtained its original offering of 18 references of SeQure and DraKon microcatheters as part of their acquisition of Accurate Medical Therapeutics in 2018. It received the CE mark in April 2019, and was US Food and Drug Administration (FDA) cleared in 2018.

Guerbet now expands the portfolio, adding 20 versions for a total of 38, and launching a new line of Axessio guidewires with two diameters. A limited market evaluation began in the USA during the fourth quarter of 2021, paving the way for a commercial launch rollout in the second quarter in select markets.

Both the SeQure and DraKon technologies offer interventional radiologists optimised navigation capabilities which is expected to enable access to difficult anatomies and reach further. Additionally, SeQure is the only reflux control microcatheter enabling a fluid barrier technology for flowdirected embolization. The new models are designed to deliver more targeted

treatment and use a wider range of beads, from extra-small to large.

“Innovation means everything to us, because it means everything to our physician partners and to their patients,” explains Jean-François Blanc, Guerbet’s senior vice president for interventional imaging. “The more we see the results, the more we see opportunity to improve lives, and we just want to keep pushing forward. With strategic acquisitions that helped create a unique toolkit of microcatheters and this latest portfolio extension, we are advancing options for the interventional radiology community.”

Cardiovascular Systems partners with Innova Vascular to develop full line of thrombectomy devices

Cardiovascular Systems Inc (CSI) recently announced it has partnered with Innova Vascular (Innova) to develop a full line of novel thrombectomy devices According to a press release, CSI intends to acquire and commercialise novel thrombectomy devices from Innova targeting peripheral vascular disease, including deep vein thrombosis (DVT) and pulmonary embolism (PE).

Sanjay Shrivastava, CEO of Innova said: “We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of Innova products. CSI’s commercial presence in this space makes it an excellent fit for accelerating the commercialisation of Innova’s products post regulatory clearances.”

CSI claims that, pending regulatory clearance in the USA, the company could begin to commercialise a portfolio of manual aspiration and clot retrieval devices for the treatment of peripheral vascular disease in 2023.

The portfolio and corresponding

Calendar of events

indications for use are expected to be expanded to include treatment of DVT and PE following the completion of subsequent clinical trials.

Scott Ward, chairman, president and CEO, said: “The commercialisation of these thrombectomy devices will be an important addition to our growing pipeline of products. In total, developing novel drug-coated balloons, intravascular lithotripsy, mechanical circulatory support, and thrombectomy devices target some of the fastestgrowing segments within interventional cardiology.”

Under the terms of the agreements signed with Innova, CSI has provided financing to Innova for the development of thrombectomy devices. Under an acquisition option agreement, upon Innova’s completion of key technical, regulatory, and clinical milestones in the development programme, CSI will have exclusive rights to acquire the thrombectomy devices, subject to the satisfaction of closing conditions set forth in the agreement.

Availability expansion of Front Line Medicals COBRA-OS aortic occlusion device

In a press release by Front Line Medical Technologies, the company have announced the expanded availability and distribution of their COBRA-OS (control of bleeding, resuscitation, arterial occlusion system), as more physicians, including interventional radiologists, continue to implement the life-saving aortic occlusion device for various applications.

The COBRA-OS, which is approved

by Health Canada and cleared by the

COBRA-OS device

Please be advised that the events listed below are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

24–27 April 2022 European Conference on Interventional Oncology (ECIO) 2022 Vienna, Austria

26–28 May 2022 Canadian Association for Interventional Radiology (CAIR) Montreal, Canada

22–25 June 2022 ET 2022—European Conference on Embolotherapy Nice, France

26–28 April 2022 Charing Cross Symposium (CX) 2022 London, UK & virtual

6–9 June 2022 Leipzig Interventional Course (LINC) 2022 Leipzig, Germany & virtual

23–24 June 2022 British Society of Endovascular Therapy (BSET) Annual Meeting 2022 Wotton-under-Edge, UK

www.ecio.org/

www.cxsymposium.com/

19–22 May 2022 Global Embolization and Oncology Symposium Technologies (GEST) 2022 New York, USA www.gestweb.org/gest2022

US Food and Drug Administration (FDA), is the first 4Fr REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) device and has the lowest profile on the market, according to the company. The device is guidewire-free and has a 25mm diameter compliant balloon with a uniquely designed Safety Shoulder Reservoir incorporated into the device to help prevent aortic rupture during inflation. Despite being so small, the device is also strong enough to hold back aortic pressure and allows for permissive hypotension in bleeding areas below the balloon. The device can be deployed quickly, in just over a minute, which is key in emergency situations, according to the press release.

In addition to permitting interventional radiologists the time to perform internal iliac artery embolization in hypotensive patients with unstable traumatic pelvic fractures, the COBRA-OS has been recently used prophylactically to treat a pregnant patient with placenta accreta, significantly reducing the risk to both mother and child, the press release also states.

Adam Power (Victoria Hospital in London, Ontario, Canada), vascular surgeon and co-inventor of the COBRA-OS, has successfully utilised the device with his interventional radiology colleagues in traumatic bleeding cases to help stabilise patients.

As the device is so low profile, he has even been contacted to help with paediatric patients with uncontrolled bleeding.

“The COBRA-OS is a versatile tool that can be a swiss army knife for interventionalists. There is no other compliant balloon medical device in the world that goes through a 4Fr sheath and can expand to 25mm diameter. I have even seen it be used coaxially in larger sheaths to occlude the aorta and allow interventions through the same single sheath which was pretty impressive,” said Power. “Access site complications are the bane of my existence as a vascular surgeon and I want to help lower their incidence, especially in extremely sick patients.”

cairweb.ca

www.leipzig-interventional-course.com/ visitors/linc-2022/

11–16 June 2022 Society of Interventional Radiology (SIR) 47th Annual Scientific Meeting Boston, USA www.sirmeeting.org/

www.etconference.org/

www.bset.co.uk/

13–17 July 2022 The European Congress of Radiology (ECR) 2022 Vienna, Austria www.myesr.org/congress

10–14 September 2022 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2022 Barcelona, Spain www.cirse.org/events/cirse-2022/

23–25 September 2022 Symposium on Clinical Interventional Oncology (CIO) 2022 Miami, USA www.theiomeeting.com/cio-2022