Interventional News Issue 86—June 2022 US Edition

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Allison Aguado: TARE in paediatrics

page 16

Eyes on intravascular lithotripsy: Data, approvals and financing bolster calcified peripheral vessel treatment

GEST 2022: (Re)defining curative intent for HCC Global Embolization Oncology Symposium Technologies (GEST; 19–22 May, New York, USA) provided delegates and faculty alike with the opportunity to hear about worldwide approaches to hepatocellular carcinoma (HCC) treatment. The dedicated session comprised discussion of various curative-intent therapies, how to define this as a concept, and how the scope of it might be expanded beyond that which achieves recurrence-free survival. A key takeaway from the session was that the next generation of interventional radiologists hold radiation segmentectomy in high regard, with its advantages now playing out in the form of clinical data.

May 2022 has been the month of intravascular lithotripsy (IVL), with new data, approvals and financing shining a spotlight on this developing technology. Taking centre stage, midterm data for IVL from what is reported to be the largest randomised trial of severely calcified peripheral lesions have just been announced. Elsewhere, companies have revealed expanded approvals of the technology and the closing of financing to advance research and development of IVL systems.

Newly launched Shockwave M5+ IVL catheter

years (Kaplan-Meier estimate: 74.4% vs. 57.7%, p=0.005), respectively.

“Prior to the [Disrupt] PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials,” said Gray, who is co-principal investigator of Disrupt PAD III alongside Gunnar Tepe (RoMed Clinic Rosenheim, Rosenheim, Germany).

Gray continued: “The primary endpoint at 30 days

These new results found that the powered secondary endpoint of primary patency favoured IVL over PTA at one year[...].”

Shockwave Medical

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CX 2022: Transfemoral access

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JUNE 2022 | Issue 86

ew data from the Disrupt PAD III randomised controlled trial (RCT) found that superior vessel preparation with IVL (Shockwave Medical) led to excellent outcomes out to two years with preservation of future treatment options compared to percutaneous transluminal angioplasty (PTA) in the treatment of calcified peripheral arterial disease (PAD).

William Gray (Main Line Health, Wynnewood, USA) presented these outcomes at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (19–22 May, Atlanta, USA) and the results were published simultaneously in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).

As previously published, IVL at 30 days demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30% without flow-limiting dissection, prior to drug-coated balloon (DCB) or stent, with a rate of 65.8% vs. 50.4% (p=0.0065) as determined by an independent angiographic core lab. Additionally, Disrupt PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections (1.4% vs. 6.8%, p=0.03), a reduction in stent implantation rate (4.6% vs.

18.3%, p<0.001) and no distal embolization or perforation events.

These new results found that the powered secondary endpoint of primary patency (defined as freedom from clinically-driven target lesion revascularisation [CD-TLR], restenosis determined by duplex ultrasound and provisional stenting) favoured IVL over PTA at one year (80.5% vs.

68.0%, p=0.017) and remained favourable through two

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Profile: Yasuaki Arai

THE SESSION BEGAN WITH DONNA D’Souza’s (University of Minnesota, Minneapolis, USA) presentation titled ‘(Thermal) ablation is the only curative-intent therapy for early-stage HCC’. However, she immediately offered the disclaimer that, in reality, she does not believe that it is the only way to treat with curative intent, especially now that we are in “the era of radiation segmentectomy”. Robert Lewandowski (Northwestern University, Chicago, USA) followed on the subject of the latter.

D’Souza started by explaining that the updated 2022 Barcelona Clinic Liver Cancer (BCLC) guidelines still recommend ablation for unresectable, small HCC, with the new addition of transarterial chemoembolization (TACE) or radioembolization as a second-line therapy if ablation is not feasible.

Regarding the definition of ‘curativeintent’, D’Souza described it based on a Robert Lewandowski Continued on page 5

Continued on page 2

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June 2022 | Issue 86

Top Story

Eyes on intravascular lithotripsy: Data, approvals and financing bolster calcified peripheral vessel treatment Continued from page 1

showed IVL to be a superior vessel preparation strategy by demonstrating stenosis resolution with significantly fewer complications including severe dissections and the subsequent need for bailout stent implantation. Avoiding unplanned stent implantations allows interventionalists to preserve all their future treatment options should reintervention be necessary.

These new long-term data show that vessel preparation with IVL followed by DCB result in excellent efficacy and durable patency out to two years, and taken together the acute and long-term results reinforce IVL as a preferred vessel preparation strategy for calcified femoropopliteal disease.”

Disrupt PAD III was a prospective, multicentre, randomised study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a DCB or stent. The study enrolled 306 patients randomised between IVL and PTA at 45 sites in the USA, Germany, Austria, and New Zealand. In the IVL arm, 82.9% of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129.4mm.

Shockwave’s technology approved in China

Shortly after the announcement of the new Disrupt PAD III data, Shockwave Medical and Genesis MedTech Group revealed that they have obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL system with the Shockwave C2 coronary IVL catheters and the Shockwave M5 and S4 peripheral IVL catheters in China.

A joint venture between Genesis MedTech and Shockwave was formed in March of 2021 as a partnership to distribute Shockwave’s products in China and to leverage Genesis MedTech’s Wuxi research and development and production base to accelerate the manufacturing of Shockwave’s products for the local Chinese market.

In July 2021, Yundai Chen (Chinese People’s Liberation Army General Hospital, Beijing, China) led a team to perform the first clinical IVL procedure in China to treat a patient with severely calcified

coronary artery lesions. “Shockwave IVL technology is an innovative solution for treating coronary artery calcification, especially when the calcium is deep in the artery. The technology is easy to use, which is good for increasing access,” commented Chen.

In August of 2021, Weiguo Fu and Zhihui Dong (Zhongshan Hospital, Shanghai, China) led their team to successfully complete the first clinical IVL procedure in China on severely calcified lesions in peripheral arteries. Fu said: “Shockwave IVL provides a powerful solution to calcified lesions that could not be effectively treated in the past. It is a promising and indispensable approach for the future.”

New financing bolsters FastWave Medical’s IVL ambitions

Also this month, FastWave Medical, a privately held company incubated by partners of Big Sky Biomedical announced the closing of the second tranche of its Series Pre-A financing.

The second tranche was led by Grand Pharmaceutical Group Limited. According to a FastWave Medical press release, proceeds from the second tranche of funding will be used to further advance research and development for the company’s proprietary IVL systems for the treatment of calcific artery disease. The investment will also help the company achieve key regulatory initiatives for its technology platforms.

“It has been amazing to see our vision for FastWave come to life over the last year and we are extremely proud of our exceptional team of operators and engineers who continue to drive the development of our IVL systems forward. What we have accomplished since FastWave’s inception is outstanding and the speed at which we are moving is truly impressive,” commented Scott Nelson, CEO of FastWave Medical and managing director of Big Sky Biomedical.

Prior to the PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials.”

News in brief

The latest stories from the interventional world

n THROMBOLYSIS VS. THROMBECTOMY: A Podium 1st presentation on the results of the CLEAR-DVT study, which evaluated the use of pharmacomechanical thrombolysis in deep venous thrombosis patients, indicates this treatment can help reduce post-thrombotic syndrome. But there is interest and evidence emerging in the rationale for a move towards mechanical thrombus removal therapies, away from lysis.

For more on this story go to page 7.

n LEAD DUST: Surface lead dust contamination on lead radiation protection apparel (RPA) could pose an occupational health risk. A convenience sampling study results in recommendations for improving conditions for the continued use of lead RPA in order to reduce risk to personnel wearing the garments.

For more on this story go to page 12. n ADVERTORIAL: Radial access adoption has grown exponentially.

This technique change has led to clinicians having to adapt the interventional lab environment, making improvements to patient set-up for the radial approach, protecting the clinician, and considering workspace ergonomics.

This advertorial outlines Adept Medical’s process for identifying and solving ergonomic issues.

For more on this story go to page 26.

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June 2022 | Issue 86

Technological Innovation

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Ultrasound-assisted laser technique vapourises artery plaque Atherosclerosis can lead to heart disease, arterial disease, and chronic kidney disease and is often treated by balloon angioplasty. Other treatments based on lasers can remove blockages rather than simply compressing them but are used infrequently, because they have a high risk of complication and low efficacy, a press release from the Acoustical Society of America states.

ROHIT SINGH (UNIVERSITY OF KANSAS, Lawrence, USA) and other researchers have announced that they have developed a method that combines a low-power laser with ultrasound to remove arterial plaque safely and efficiently.

High-power laser treatments direct thermal energy to vapourise water in the artery and create a vapour bubble, which expands and collapses to break the plaque. Similarly, the technology, pioneered by Xinmai Yang, doctoral advisor for the team, uses a low-power nanosecond pulsed laser to produce microbubbles. The addition of irradiation from ultrasound causes the microbubbles to expand,

collapse, and disrupt the plaque.

Singh described preliminary results in his presentation, “A novel ultrasound-assisted laser technique to remove atherosclerotic plaques,” at the 182nd Meeting of the Acoustical Society of America (23–27 May, Denver, USA).

“In conventional laser angioplasty, a high laser power is required for the entire cavitation process, whereas in our technology, a lower laser power is only required for initiating the cavitation process,” said Singh. “Overall, the combination of ultrasound and laser reduces the need for laser power and improves the efficiency of atherosclerotic

“We need to define and articulate the ethics of IR” Eric J Keller Comment & Analysis

I

nterventional radiology (IR) is a growing, dynamic field, still working to define its professional identity— who we are and where we are going as a specialty. I believe an important part of that maturation rests on our ability to articulate our collective values as a professional group, particularly in regard to challenging questions that arise in our work. Through my ethics graduate education and medical training, I have come to view ‘ethics’ as just that— the collective values of a group of people.

So, to help IR establish itself as a clinical specialty, we need to define and articulate the ethics of IR. Unfortunately, many common approaches to ethics tend not to feel particularly practical or helpful in dayto-day clinical practice. Ethics often feels abstract and verbose and tends to treat clinicians as a monocultural group, assuming that the ethical issues and solutions for IR are the same as internal medicine or gynaecology. Although there are certainly common issues across healthcare, medical specialties have remarkably distinct cultures, workflows, and ways of thinking. As such, my hypothesis has been that the salient ethical issues and means of navigating

them probably vary in important ways across specialties. To make ethics feel more practical and useful, I decided to test out an applied, specialty-specific approach to ethics in IR. Instead of starting with ethical theory and a topdown approach, I work bottom-up, starting with an understanding of how people in IR are approaching an ethical issue and why, and then using that understanding alongside ethical theory to design practical approaches and tools to better navigate those issues. The ultimate goal is to foster an ethics consciousness in IR, a common understanding of our shared values and how best to navigate the sticky situations we face as a specialty.

To do this, I founded a multiinstitutional working group of faculty and trainees focused on research, education, and public relations using this new approach. Creating something new always comes with challenges and setbacks, but we now have approximately 30 people affiliated with the group, and since being founded in 2019, we have published over 20 manuscripts, given multiple invited lectures at major IR conferences, and have a column in Seminars in

plaque removal.” Because it destroys rather than compresses the plaque, the combination technique will have a lower restenosis rate compared to balloon angioplasty or stenting and the control provided by the ultrasound and the low-power laser will lower the risk of dissection and perforation in arteries, the release adds.

The team have performed ex vivo experiments on carotid artery plaque samples and pork belly samples, and they are currently planning to perform in vivo experiments. Both the laser and ultrasound techniques are commonly used by clinicians and should be easy to teach and implement following the in vivo studies.

Combining low-power lasers and ultrasound techniques is not limited to atherosclerosis treatments, and Singh and collaborators are also using the methodology for photo-mediated ultrasound therapy and ultrasound-assisted endovascular laser thrombolysis. The former can be used to remove abnormal microvessels in the eye to prevent blindness, while the latter can dissolve blood clots in veins. Singh expanded upon these additional applications in other poster sessions at the Acoustic Society of America meeting.

Interventional Radiology called the ‘Ethics Corner.’ We have found that IRs face a wide array of ethical issues in their work; the vast majority consider these to be important issues but state that they often feel limited by a lack of tools and specific guidance for navigating them. Common issues include differentiating palliative from futile care, managing complications, consent and surrogate decision-making, conflicts of interest and research ethics, tribalism and medical business ethics, and social media ethics.

For example, consent is a ubiquitous part of our daily workflows and right at the core of our relationships with patients and families. Nevertheless, studies suggest that consent practices tend to be limited in quality and completeness across healthcare. This is important not only ethically, but because poor periprocedural communication and understanding is a common source of medical mistakes and lawsuits. We first completed an exploratory study of consent in IR, finding that the dynamic nature of IR practices and limited baseline public awareness can make truly informed consent particularly challenging in our specialty. To improve consent practices, we have not only been working to develop more engaging educational resources on ideal consent

We have found that IRs face a wide array of ethical issues in their work [and] the vast majority consider these to be important issues.”

practices for IR, but also better patient decision aids (PDA).

PDAs are handouts, videos, or other tools that present balanced information on the risks, benefits, and alternatives of a healthcare decision, ideally at the average reading level (seventh grade in the USA), using patient-friendly, plain language. Unfortunately, current PDAs for image-guided procedures tend to be limited in quality and consistency, so we partnered with a not-for-profit called The Interventional Initiative to create better PDAs via an extensive vetting process.

We then trialled them at two institutions where people were randomised to receive a PDA or not, while waiting to talk to their clinician. This way, clinicians did not have to do anything differently; rather, we took advantage of dead time in the patient flow, which is ideal for sustained adoption. We found that the people who received a PDA were not only more likely to have better understanding and satisfaction, but were also more likely to feel that their clinician had spent enough time with them and answered all their questions.

This is one example of our applied approach. Rather than writing a 50page analysis about how interventional radiologists should ‘do better’ at consent, we instead assume that people are doing their best, try to understand current barriers, and construct environments and workflows that support better consent practices in IR without requiring more time or energy.

We are always looking for collaborators and partnerships to help establish our collective values as interventional radiologists.

Eric J Keller is a resident physician at Stanford University, Stanford, USA and founder of the Applied Ethics in IR working group.

Disclosure: Keller is a board member of The Interventional Initiative.

Issue 86 | June 2022

Top Story

GEST 2022: (Re)defining curative intent for HCC Continued from page 1

comparison with surgical resection, which is widely viewed as “the gold standard” for curative-intent therapy for HCC. She elaborated that the rate of complete pathologic necrosis (CPN) after ablation is also of importance in determining local cure rates.

D’Souza proceeded to detail recent data, including randomised controlled trial data out of Hong Kong, which allocated 109 patients to surgical resection and 109 to radiofrequency ablation (RFA). The paper, published in 2017, comprised data gathered over a median follow-up period of 7.7 years, and showed no difference in local recurrence rate, disease-free survival, and survival to 10 years, between ablation and resection, even for larger lesions. D’Souza highlighted the significance of these findings: “traditionally, surgery outperforms ablation for lesions between three and 5cm”. Moreover, the SURF randomised controlled trial, of which some of the results were published in 2021, demonstrated that

there was, again, no difference in recurrence-free survival, nor overall survival, at five years.

In conclusion, D’Souza underlined how “ablation is the most evidence-based curative-intent treatment modality for HCC for interventional radiologists”, and also highlighted the high complete pathologic necrosis rates that have been achieved in recent studies.

Lewandowski then pivoted to explore the curativeintent capacity of ablative, segmental transarterial radioembolization (TARE), using the case of a 95-year-old female who survived two years after undergoing ablative radiation segmentectomy for HCC. Lewandowski explained that the definition of ‘curative intent’ can and should be expanded beyond

Ablation is the most evidence-based curative-intent treatment modality for interventional radiologists.”

Paediatric interventional radiology in a tertiary care medical centre Kyung Rae Kim Comment & Analysis PULMONARY ARTERIOVENOUS malformation (PAVM) is a rare condition involving direct communication between pulmonary arteries and veins without intervening capillaries. This is usually congenital, with 80-90% of patients with PAVMs having hereditary haemorrhagic telangiectasia (HHT). PAVMs supplied by a single segmental artery are classified as ‘simple’, whereas PAVMs supplied by two or more segmental pulmonary arteries are known as ‘complex’. Complex PAVMs are further classified as ‘diffuse’ if there is diffuse involvement of at least one lung segment. The diffuse PAVMs are reported in less than 10% of patients with PAVMs. Most patients with diffuse PAVMs present more severe hypoxia and neurologic complications. The treatment of diffuse PAVMs is not different from less complicated PAVMs; transcatheter embolization is the first choice, and surgical lobectomy or lung transplant is reserved for unsuccessful embolization treatment. PAVMs have been well described in adults. However, there have been limited data regarding

the treatment of paediatric patients because the presentation of symptomatic PAVM is even less common than in adults. To highlight our experience with paediatric care at a tertiary care medical center, below we describe a recent transfer to our centre from another hospital for a paediatric patient with diffuse PAVM. The patient was a three-year-old previously healthy boy with hypoxia (SpO2=85%) after non-COVID Coronavirus (Coronavirus OC43) infection. The work-up for HHT was negative, and he had no family history of HHT. After his admission to an outside hospital, his clinical condition rapidly deteriorated over the 24 hours that followed: he required intubation, ventilatory support with 100% FiO2, and inhaled nitric oxide.

Chest computed tomography (CT) demonstrated diffuse pulmonary arteriovenous malformation (AVM) in the left upper and lower lungs.

Echocardiogram with bubble study showed significant right to left shunt. He was then transferred to our children’s hospital for an embolization

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its current status: achieving a comparable degree of CPN to surgical resection.The implications of a broader scope of the term could be that it comes to encompass treatments that facilitate bridging or downstaging to transplant, namely TARE. Lewandowski emphasised the role of dosimetry, citing his awareness of threshold doses: targeting HCC with 190 Gray sees almost three times the rate of CPN when compared to lower doses, and targeting a threshold dose of 400 Gray has yielded 100% CPN explant in a retrospective study.

Finally, given the opportunity to field questions from the audience and each other, the panel touched on cryoablation and its performance relative to that of thermal ablation. “There are some pretty good data out there showing that it is effective [and can] outperform RFA,” D’Souza outlined. She also responded to Lewandowski on the topic of SBRT: “in some centres it is becoming more common,” while the existing literature still favours RFA. Panel moderator Nadine Abi-Jaoudeh (University of California Irvine, Irvine, USA) corroborated D’Souza’s “last-resort” approach to using SBRT, but made the point that “younger radiation oncologists are excited about the therapy’s potential.”

procedure and periprocedural supportive care in the paediatric intensive care unit (PICU). He underwent a pulmonary arteriogram and transcatheter embolization of the diffuse PAVM by our paediatric interventional radiology (IR) team, and his respiratory condition improved. However, his hypoxia worsened two days after the procedure due to pulmonary vascular remodeling following the embolization and residual shunt burden within the left lung. He received a venoarterial extracorporeal membrane oxygenation (ECMO) and subsequently underwent a second embolization of the diffuse PAVM. His ECMO support was successfully weaned, and the PICU team decannulated after four days of ECMO treatment. His ventilatory support was discontinued, and he was extubated with no issues. He was discharged two-anda-half weeks after the treatment in our hospital.

He had successfully recovered and has been doing well with no required respiratory support when he visited our clinic four months after the embolization procedure. The medical care of this three-year-old boy highlights the benefit of having a multidisciplinary paediatric team with IR and PICU physicians working in tandem to manage these complex patient presentations with excellent clinical outcomes.

Paediatric IR has been recognised

Paediatric IR has been recognised as a critical specialty in medical centres providing paediatric care.”

as a critical specialty in medical centres providing paediatric care. We established the paediatric IR division a few years ago with the tremendous growth of the case numbers and efficient workflow. While any interventional procedures for paediatric patients can be challenging if the interventional radiologists do not have enough experience, or feel sufficiently comfortable treating children, we have focused on training staff in paediatric care. We have a core group of physicians dedicated to delivering it, to keep procedural competence at the highest level and establish multidisciplinary collaborations with other paediatric sub-specialties. In addition, to maintain the highest quality and safety standards, we have regular multidisciplinary meetings such as the Paediatric Tumour Board, Paediatric Quality Improvement, and the Vascular Anomalies Centre conference.

Collaborating with other paediatric services also allows for timely referrals and an efficient workflow.

The key to getting started is understanding what the available resources in your hospital are for treating paediatric patients. Moreover, in addition to clinical expertise, the attitude of the interventional radiologists to treating children in a familycentred manner is a top priority. While treating paediatric patients requires extraordinary efforts, as outlined above, the professional rewards are invaluable: knowing that you have saved a child’s life and that they can go on to live fully.

Kyung Rae Kim is associate professor of radiology, director of paediatric interventional radiology, and co-director of the vascular anomalies clinic, all at the University of North Carolina, Chapel Hill, USA. The author declared no relevant disclosures.

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June 2022 | Issue 86

New Paclitaxel Data

New long-term data of paclitaxel devices continues to show no increased mortality compared to non-drug coated devices NEW LONG-TERM DATA FROM the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (19– 22 May, Atlanta, USA). The analysis found no meaningful difference in survival between patients treated with a paclitaxel drug-coated device and those treated with a non-drug-coated

device for up to six years after the index procedure, regardless of the patient’s mortality risk and device type.

The SAFE-PAD study was created in collaboration with the US Food & Drug Administration (FDA) to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularisation among a broad, real-world population of patients with peripheral arterial disease (PAD).

Transarterial radioembolization (TARE) with Yttrium-90 in paediatric primary liver tumours Allison Aguado Comment & Analysis

P

rimary paediatric liver cancer is a rare disease, accounting for 1–2% of childhood cancers, or about 150 new diagnoses of paediatric liver malignancy per year in the USA. These include hepatoblastoma (HB), hepatocellular carcinoma (HCC), undifferentiated embryonal sarcoma of the liver (UESL), and rhabdoid tumour of the liver (RTL). Surgical resection is the foundation of cure for all paediatric liver tumours; however, only one-third of patients have resectable disease at diagnosis.

While chemotherapy is effective in making two-thirds of initially unresectable patients with HB resectable, effective standard-of-care chemotherapeutic regimens that render HCC, UESL, or RTL resectable have yet to be described.

Recent reports suggest that orthotopic liver transplant may be required in 20–30% of newly diagnosed paediatric liver tumours who will require lifelong medical therapy with potential episodes of rejection and occurrence of posttransplant lymphoproliferative disease.

The primary staging system used for

paediatric liver tumor is PRETEXT (pre-treatment extent of tumour) classification which describes the extent of tumour in the liver based on Couinaud segmental anatomy and is used to predict overall survival. It is a pre-therapy assessment of HB and HCC but is intended to be applicable to all primary malignant liver tumours of childhood. PRETEXT annotation factors include venous involvement, extrahepatic disease, multifocality, tumour rupture, and metastatic disease. This is used to create the risk stratification system used for the Pediatric Hepatic International Tumor Trial (PHITT) which is based on PRETEXT, metastases, age, α-fetoprotein (AFP), annotation factors, and resectability.

TARE with Yttrium-90 (TARE-Y90) has demonstrated an emerging role in the treatment of primary paediatric liver tumours in several small studies1-3. It was initially used in heavily pretreated children with HB, HCC, and transitional liver tumours (showing features of both HB and HCC) where it showed that it was feasible, safe, and demonstrated

The study included Medicare beneficiaries ≥66 years treated with a drug-coated device or non-drugcoated device from 1 April 2015 to 31 December 2018. Non-inferiority between devices was evaluated for mortality through 21 July 2021. A number of prespecified subgroups, including a cohort at the lowest risk of mortality defined as those aged 66–70 with no chronic limbthreatening ischaemia (CLTI) and ≤2 comorbidities, were evaluated.

“Our goal is to give patients the most durable treatment possible that will keep them out of the hospital and living their lives. Patients with PAD tend to be of lower socioeconomic status, more likely to be underserved minority populations and often need to travel long distances or take time off work to seek treatment,” said Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA). “Not having access to important treatment

anticancer effects by imaging and decreased tumour markers. It has since been used as a component of curative therapy in two paediatric patients with HB who responded to TARE-Y90 with decreased tumour size, decreased tumour marker levels, hypertrophy of the future liver remnant, the facilitation of conventional hepatectomy, and complete remission. It has also been used as part of curative therapy in two pediatric patients with HCC, who were downstaged to hepatic resection; one is alive with no evidence of disease 18 months post-completion chemotherapy and one is alive with evidence of disease 13 months post-resection.

Earlier integration with combination therapies may offer an important option and strategy to improve survival, result in less chemotherapy deliver, decrease rates of orthotopic liver transplantation (OLT), and present potentially curative options for patient with refractory and recurrent disease. While early results are encouraging, more research is required to determine the efficacy of TARE-Y90 in children and to define the clinical scenarios where there is likely to be greatest benefit.

References: 1. Aguado A, Ristagno R, Towbin AJ. Transarterial radioembolization with yttrium-90 of unresectable primary hepatic malignancy in children. Pediatr Blood Cancer 2019;66:e27510. https://doi.org/10.1002/ pbc.27510.

2. Aguado A, Dunn SP, Averill LW. Successful use of transarterial radioembolization with yttrium-90 (TARE90) in two children with hepatoblastoma. Pediatr Blood Cancer 2020;67:e28421. https://doi.org/10.1002/ pbc.28421.

3. Whitlock RS, Loo C, Patel K. Transarterial radioembolization treatment as a bridge to surgical resection in pediatric hepatocellular carcinoma. J Pediatr Hematol Oncol 2021;43:e1181-e1185. https:// doi.org/10.1097/MPH.0000000000002089.

Allison Aguado is a paediatric interventional radiologist at Nemours Children’s Hospital, Wilmington, USA. The author declared no relevant disclosures.

options known to reduce the risk of repeat intervention can have a substantial influence on our PAD patients, ultimately impacting their outcomes and quality of life. The findings add to the growing body of evidence showing these devices are safe for use.”

Of 168,553 patients, 70,584 (41.9%) were treated with a drug-coated device.

Median follow-up was 3.52 years.

The weighted cumulative incidence of mortality at 6.3 years was 63.6% with non-drug-coated devices and 62.5% with drug-coated devices (p<0.0001).

Findings were consistent among all subgroups. In particular, there was no difference in risk among those at lowest risk of mortality (n=4,212; weighted hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.87–1.10).

Researchers note that were will future several reports from the SAFE-PAD study with a final report published in the next two years.

A

B

C

D Images of a nine-year-old male with PRETEXT III hepatoblastoma. Postchemotherapy T2-weighted magnetic resonance image (A), Mapping angiogram demonstrating a central hypervascular tumour (B), Immediate post transarterial radioembolization with TARE-Y90 single-photon emission computed tomography/computed tomography showing deposition of Y90 in the liver tumour (C), Magnetic resonance image one month postTARE-Y90 which demonstrated a 40% reduction in tumour volume (D). Patient went on liver resection six weeks post-TARE-Y90; explant demonstrated 85%–90% necrosis of tumour.

Issue 86 | June 2022

CX 2022

CX 2022

Thrombectomy versus thrombolysis and firstin-human results

As part of the Venous and Lymphatic Challenges session at this year’s Charing Cross Symposium (CX 2022; 26–28 April, London, UK) Emma Wilton (Oxford University Hospitals NHS Foundation Trust, Oxford, UK) outlined the rationale for a move towards mechanical thrombus removal therapies and away from lysis”. This followed Mitchell Silver’s (OhioHealth Heart and Vascular, Columbus, USA) Podium 1st presentation on the results of the CLEAR-DVT study, which evaluated the use of pharmacomechanical thrombolysis in deep vein thrombosis (DVT) patients, and suggests that there will not be a complete change of direction away from thrombolysis. Gary Ansel (OhioHealth Research and Innovation Institute, Columbus, USA), in the Aortic Techniques and Technologies session, drew delegates’ attention to the advantages of thrombectomy, specifically a new non-aspiration-based technology and its positive first-in-human results.

T

he main advantages of mechanical thrombectomy, Wilton highlighted, are that it achieves “rapid symptom resolution” and reduced bleeding. Moreover, because more patients can be treated in a single session, there is less “need for one-to-one nursing or a HDU [high-dependency unit] bed”. Wilton also noted the advancements in device capabilities, meaning that some technologies on the market can now be used for both subacute and chronic thrombus.

However, Wilton spoke to the fact that it is necessary to consider thrombolysis in some cases, namely those of extensive thrombus. Those same complex patients may, equally, prompt recourse to multiple devices “on occasion”.

When questioned by the session moderators on how she goes about choosing which thrombectomy device to use, Wilton stated a preference for the Clotriever (Inari Medical), but reiterated that “one size does not fit all”. Furthermore, in response to expressions of concern over the cost of using multiple devices for one

procedure, Wilton clarified that she only does so in “around 5%” of cases.

Mitchell Silver’s Podium 1st presentation of the results of the CLEAR-DVT study evaluated the use of pharmacomechanical thrombolysis in DVT patients. With initial findings indicating that this form of endovascular intervention can help reduce post-thrombotic syndrome (PTS) in DVT patients, Silver explained, this seems to counter Wilton’s assertion that the move in vascular is, indeed, “away from [thrombo]lysis”. Yet, Silver proceeded to acknowledge the place of thrombectomy devices when questioned by the session’s audience: “[they are] very easy to use, they are quite efficacious, and there is some nuance to doing these interventions in acute DVT.” He concluded his comment on the merits of this multiprocedural approach in treatment of DVT by stating how vascular surgery is “[forever advancing]” and how industry training courses will help surgeons to “understand disease states”.

Swerving from the venous to arterial

beds, Ansel delivered first-in-man results with a novel arterial thromboembolectomy catheter device, via video link. He noted that a “holy grail” device in percutaneous thrombo-embolectomy has been needed “for a long time”, and indicated that the Pounce thrombectomy system (Surmodics)—a low-profile, non-aspiration-based clot removal technology—could be the answer.

According to Ansel, 20 patients with a wide range of arterial blood clot classifications have been treated across six US sites in the study, recording a technical success rate of 100% and an average procedure time of 79.6 minutes, which Ansel reported as being “much shorter” compared to when using other devices. Moreover, all procedures could be done with a 7Fr sheath.

Pounce’s nitinol mesh trumpet, Ansel detailed, allows for fluid excretion, achieving dehydration and a decreased

clot mass, and comes with the additional advantage of being “easy to use” in the 3.5–6mm peripheral vessels for which it is indicated.

He then briefly outlined two clinical cases for the CX audience, relaying “pleasing results” after drug-coated balloon (DCB) angioplasty in a long superficial femoral artery (SFA) occlusion and a good outcome in a proximal tibial chronic occlusion case too. Concluding, Ansel highlighted the device’s ability to deal with a wide range of arterial clots and organised debris, and the fact it is a fully mechanical, “intuitive” solution designed to minimise blood loss.

Furthermore, Ansel acknowledged how the Pounce device complements other devices, for when “you may want to take the residual organised thrombus out”.

Tilo Kölbel (University of Hamburg, Hamburg, Germany), who chaired this part of the session, described the Pounce system as “very promising,” with its dual baskets. Stéphan Haulon (Hôpital Marie-Lannelongue, Paris, France), who was moderating, expressed his anticipation of the device coming over to “this side of the Atlantic,” as it forms a solution to the “worry” of anaemia that aspirationbased devices can cause. Ansel gave Haulon the following assurance: “you are going to love it.”

Thrombectomy devices are very easy to use, they are quite efficacious, and there is some nuance to doing these interventions in acute DVT.”

Venovo venous stent returns to US market after 2021 recall BD recently announced that its Venovo venous stent is back on the US market following a recall last year.

IN 2019, THE COMPANY REPORTED THAT the US Food and Drug Administration (FDA) had granted premarket approval for the Venovo venous stent. In a recall notification dated 12 May 2021, however, BD communicated that the company had expanded a safety notice issued earlier in the year for the Venovo venous stent system to include all sizes

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and lots within expiry date.

The company details that the Venovo stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins to maintain adequate blood flow. The stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-

thrombotic and non-thrombotic iliofemoral lesions.

Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” says Michael Dake (University of Arizona, Tucson, USA), the principal investigator for the Venovo investigational device exemption (IDE) trial.

“Most importantly,” says Dake, “it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are different to those posed by arterial narrowing.”

Dake presented positive one- and two- year results of the VERNACULAR trial of the Venovo stent at meetings in 2018 and 2019, respectively.

June 2022 | Issue 86

Podium 1sts

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Artificial intelligence could make endovascular aortic repair outcomes more predictable

At the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK), Cydar Medical founder Tom Carrell delivered a Podium 1st presentation titled ‘Making endovascular aortic repair outcomes more predictable: Artificial intelligence takes on a 20-yearold challenge’.

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“GIVEN ANY INDIVIDUAL PATIENT WITH some anatomic complexity, do we really know— particularly with the ever-expanding range of treatment options— what is going to be the outcome for them?” According to Carrell, this is the key question at the centre of the 20-year-old challenge the speaker referred to in the title of his talk. Twenty years ago, he detailed, the pioneers of endovascular surgery recognised that anatomic severity was a major determinant of outcomes and therefore probably required reporting standards. “A scoring system would need to strike a balance between having enough granular detail to be useful and also being simple enough to be usable in everyday practice,” he said. A scoring system was built, with the expectation being that subsequent clinical investigations to test the system would be used to modify it.

In the 20 years since then, Carrell highlighted that a number of papers on the anatomic severity grade scoring system have been published, showing that it does indeed predict outcomes and complications.

However, “there has not been quite so much progress in terms of using these data to modify the schemes,”

Carrell pointed out. The speaker noted that there are probably a number of reasons for this, one being that “some of the things that go into the scoring schemes turn out to be rather complicated”. For example, he said, measuring infrarenal neck angulation is “really contentious,” with “very high intra-observer variability”.

“Can artificial intelligence (AI) offer both that detail and simplicity?” Carrell asked, highlighting a key question in 2022. He explained that Cydar Medical is developing an extended capability to operate with what the company calls Intelligent Maps.

“The concept is that when you plan a case, you are being informed by the outcomes of previous patients with similar anatomy and disease,” he explained.

The company’s current product, which is used for planning, guiding, and reviewing endovascular surgery, uses “virtual guidewires”. Carrell elaborated: “We use [virtual guidewires] for planning, but the main function is to identify where you are going to

The concept is that when you plan a case, you are being informed by the outcomes of previous patients with similar anatomy and disease.”

Failure to rescue may complement mortality as an outcome measure for aortic surgery

Failure to rescue may be a suitable quality assessment marker for open aortic and endovascular aneurysm repair (EVAR).

This was the message of Kevin Mani (Uppsala University, Uppsala, Sweden), who delivered a Podium 1st presentation at CX 2022 examining the volumeoutcome relationship in aortic surgery and its association with failure to rescue.

MANI AND COLLABORATORS STUDIED intact abdominal aortic aneurysm (AAA) repairs performed in two large registries, assessing complications after aortic repair, failure to rescue complications, and the relation to surgical volume, including more than 60,000 intact AAA repairs performed in eight countries.

The study team noticed that complications occurred after 4‒5% of all endovascular aneurysm repair (EVAR) procedures, and the frequency of any complication was three times higher after open repair. Whilst the frequency of complications was reduced after open repair with increasing volume, this trend was not present after adjustment for patient characteristics, Mani said. Overall, the adjusted risk of developing a complication after aortic

repair did not decrease with increasing volume.

Failure to rescue occurred in 10‒12% of the patients suffering a complication. When looking at the relationship between volume and failure to rescue, it was clear that increasing volume resulted in a lower failure to rescue rate, Mani told the CX audience.

“In conclusion, the current analysis suggests that the volume-outcome relationship in aortic surgery is driven at least in part by the preparedness to promptly recognise and manage complications,” Mani said.

“As such, failure to rescue is a quality assessment marker that reflects processes of care in aortic surgery for both open repair and EVAR, and complements mortality as an outcome.”

In the discussion following his presentation, Mani acknowledged the controversial nature of the volume-outcome topic, especially when it comes to establishing a guideline for what is acceptable. Setting a requirement of at least 10 open aortic repairs poses challenges, he said, communicating that international data suggest only 30% of centres achieve 10 open aortic repairs nowadays.

Ian Loftus (St George’s NHS Foundation Trust, London, UK) asked the presenter how registries can be made more functional in Kevin Mani at CX

be operating, so that your planning is rendered in the form of a map and overlaid on a live fluoroscopy.

As your real guidewires deform the anatomy, the virtual guidewires deform the map so that you have an overlay that reflects the real-time anatomy.”

Carrell provided some details on where the software is headed: “What we are doing with Intelligent Maps is taking that capability with the virtual guidewires and the AI that we have in the system and the data from all the thousands of patients who have been treated with Cydar EV Maps and building tools to analyse anatomy.” He added that these tools are a combination of deterministic algorithms using the virtual wires and also using simulated neural networks, or deep learning, to not just segment the vessels, but also to label the aorta and the iliacs according to what branches are coming off at each level. “For each patient, you bring these things together so that you have your geometry, but you have it in the context of where you are right the way along the aorta and the iliac system. This is highly deterministic, so you put the CT scan in and these measures come out, put the same CT scan in or a similar CT scan in and you get the same things coming out.”

One of Carrell’s key takeaway messages was that this software has relevance for helping inform decision-making. “You take one patient that produces the analytics and then we use it to match to other patients in the database already, patients who have similar anatomy. It is literally as simple as entering in the CT scan and finding those matching patients. We can then find out what treatment those patients had, what type of approach they had.”

Next, Cydar will be working on bringing in the “final steps” of the technology—the outcome metrics for the surgical strategy that was used. “We want to close that 20-year ambition to have the feedback loop in there to modify the scoring system,” Carrell concluded. terms of yielding better data on complications. In the UK registry, he pointed out that there is “just a tick box” for complications and that quantification is not possible.

According to Mani, there is no standardisation of which complications are recorded in registries.

The presenter noted that, among the 11 countries that participated in the database he outlined in his presentation, only eight had complications adequately registered, and only four had all complications registered. Despite this, however, Mani was keen to reiterate that the key message of his presentation was the need to move further from mortality as an outcome measure. “If you look at volume-outcome for EVAR and use mortality,” he said, “it is very difficult to show that volume can have an effect”. Mani stated that looking at other factors, however, such as hospitalisation or radiation dose, will highlight an effect. “I think failure to rescue, which is probably more clinically relevant than radiation dose, is a very suitable option for that,” he posited.

Michael Jenkins (Imperial College Healthcare NHS Trust, London, UK) posed a question about how “subtle changes” that might result in better EVAR durability in the long term can be measured. Mani acknowledged that a study on volume and long-term EVAR outcomes has not yet been done. He noted that the idea of carrying out such a study has been discussed, but stressed that there are challenges involved in carrying out such an investigation.

In his response to Jenkins, he also pointed out the fact that high-volume centres have a tendency to attract more complex cases and so they might “push the envelope” further with treatment, which may also affect outcomes.

Issue 86 | June 2022

Comment & Analysis

The vascular biology behind endovascular therapies Timothy Clark Comment & Analysis Peripheral arterial disease (PAD) produces a global health burden and remains a leading cause of disability, limb loss and reduced quality of life. PAD is also a proxy for cardiovascular and cerebrovascular death. Endovascular therapies have become widely used among symptomatic patients refractory to medical and exercise therapy alone, including stents, drug-eluting balloons, atherectomy, and vessel modification devices.

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ur current understanding of the biologic mechanisms of these devices remains incomplete.

Endovascular practitioners need a deep understanding of the vascular biology and biomechanics of endovascular therapies to enable critical appraisal, identify gaps in existing knowledge and define unmet needs for their current and future patients.

Chronically occluded lower extremity arteries, particularly longsegment TASC-C and -D lesions, were long considered untreatable with percutaneous approaches and amenable only to surgical bypass. Endovascular techniques which intentionally create an intramural channel within the arterial media, followed by angioplasty with or without stent placement, were first described by Bolia but have since evolved to encompass a wide array of dedicated technologies. This approach, known as subintimal recanalisation, has now become routine for many interventionalists. What is remarkable is that the vascular remodeling following subintimal recanalisation almost completely replicates the histologic elements of a native artery.

Understanding the remodelling changes after this approach can guide selection of subsequent use of other endovascular techniques to maintain vessel patency and limb preservation.

Angioplasty balloons and stents as delivery platforms for anti-proliferative drugs to the therapeutic targets of fibroblasts and smooth muscle cells within the media and adventitia have become widely utilised in endovascular therapy. Interventionalists need to distinguish cytostatic from cytotoxic drugs, understand their pharmacokinetics and mechanisms within the cell cycle. Perhaps as importantly, various coating and polymeric delivery systems (excipients) differ greatly in efficiency and efficacy and are significant determinants of

clinical benefits of these therapies.

Bioabsorbable scaffolds offer enormous potential to provide a stent-like scaffold to optimise arterial remodelling, while resorbing over time to leave no permanent implant behind. These devices gained rapid, nearly global adoption in the coronary vessels until the risks of late thrombosis were recognised and led to their nearabandonment. In the peripheral vascular applications, bioabsorbable scaffolds face a demanding list of attributes: high radial force, predictable resorption without particulate embolization or thrombosis, and sufficient radioopacity to enable precise deployment

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within heavily calcified vessels.

Despite these challenges, several promising technologies may soon yield these devices for the periphery with favourable effects on vascular remodelling.

Atherectomy is a widely utilised technique in endovascular therapy, but randomised trials dating back to first-generation plaque excisional devices have consistently struggled to show a compelling, cost-effective clinical benefit of this therapy. A wide array of atherectomy systems have since evolved, however the extent to which these devices remove significant quantities of plaque, thrombus, or cellular/fibrotic deposits remains insufficiently understood. Vascular remodelling after atherectomy is variable and often unpredictable, and intraprocedural risks of embolic debris worsening underlying limb ischaemia remain an ongoing concern. A broader understanding of the vascular biology behind the purported mechanisms of various atherectomy systems is needed.

Vessel preparation techniques employ devices to score, cut, sonicate, or create microfenestrations in a vessel wall prior to subsequent angioplasty or stent placement. These techniques are considered beneficial when peripheral arteries are highly calcified or extremely stenotic. It is key to understand the vessel wall modifications that occur with these ‘vessel prep’ devices and to what extent these modifications confer a benefit in sustaining vessel patency.

Lastly, self-expanding nitinol stents, including bare-metal, drug-eluting and polytetrafluoroethylene-covered, are widely used in the femoropopliteal artery. The femoropopliteal artery experiences among the highest levels

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of torsion and compression within the body. These stents are typically lasercut, electropolished nitinol tubes which are shape-set to undergo prescribed expansion upon delivery within a vessel. Specific stent design features may be less prone to strut fractures and thereby, intimal hyperplasia and thrombosis. Certain stent designs can create spiral laminar flow, which may reduce wall shear stress and platelet activation.

Each of these topics will be explored within a Categorical Course at the Society of Interventional Radiology Annual Scientific Meeting (11–16 June, Boston, USA). By understanding the biology of vascular remodelling, which occurs following endovascular interventions including angioplasty, subintimal recanalisation of chronic total occlusions, stent placement and atherectomy, we hope to provide further insight to vascular interventionists to distinguish existing endovascular devices based on design, mechanism and performance.

Timothy Clark is director of interventional radiology at Penn Presbyterian Medical Center, University of Pennsylvania, Philadelphia, USA, and professor of clinical radiology in the Department of Radiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. Disclosures: Clark is a consultant for BD, Boston Scientific, Teleflex, B. Braun and Baylis Medical, and receives royalties from Teleflex and Merit Medical. He is founder of Forge Medical and NeuRx Medical.

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A. Angiogram in a patient with rest pain and tissue loss showing flush occlusion of the superficial femoral artery extending from its origin (arrow) through the popliteal artery. This 30cm-long segment occlusion was crossed from a tibial approach.

B. Angioplasty of the subintimal tract in preparation for stent placement.

C. Superficial femoral artery following drug-eluting stent placement.

D. Completion tibial angiogram showing brisk two-vessel runoff.

June 2022 | Issue 86

10 Comment & Analysis

Peritransplant vascular complications: An IR approach Muneeb Ahmed & Vijay Ramalingam Comment & Analysis

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n the USA, liver transplantation continues to be the best chance at long-term survival for patients suffering from the sequelae of endstage liver disease. However, recent data from the Organ Procurement and Transplant Network (OPTN) suggest that there are 13,000 patients in the USA who are listed for liver transplant at any given time. Of that number, a high percentage of patients will either pass away while waiting for liver transplantation or be delisted due to complications of liver disease making transplantation difficult or impossible.

For many of these patients, we have found that interventional radiology (IR) and the techniques we are able to offer can help prolong patient survival on a waiting list or reduce the number of delistings due to technical limitations.

With that said, many of the patients who do go on to receive a successful liver transplant, will end up with post-transplant liver complications.

This could be as many as 30% of patients, and a significant number can benefit from endovascular or percutaneous intervention. The benefit of a multidisciplinary approach and, specifically, the use of endovascular techniques for many peritransplant vascular complications, is the ability to avoid major surgery or revisions.

Although peri-liver transplant patients comprise such a complex group, of whom many could benefit from these IR services, there are data to suggest that a large number are still not being offered interventional services in both a pre- and post-transplant setting.

Some of the contributing factors are

lack of awareness among referring providers regarding the services we can provide; lack of patient awareness; and lack of consensus among interventional radiologists themselves about the best treatment plans for these complex patients.

Our own experience has been that when patients are offered interventional radiology services, the outcomes of liver transplantation for our centre as a whole improves. Formal incorporation of IR into the Multidisciplinary Liver Transplant group (including representation on the Liver Selection Committee), and establishment of an IR and hepatology-led multispecialty portal venous thrombosis clinic are some of the ways in which our IR team has provided access to many of the advanced techniques that should be offered to the Liver Transplant patient cohort. Indeed, use of advanced portal vein recanalisation techniques, pretransplant large portosystemic shunt embolization, and optimisation of liver graft arterial flow through hepatic artery stenting and splenic embolization for portal hyperperfusion are examples of how IR can maximise liver transplant centre outcomes.

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Given the current issues facing pre- and post-hepatic transplantation vascular management, we proposed the ‘Advanced IR hepatic and splenic vascular interventions in peritransplant patients’ course as a new forum for the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting, Boston, USA. We hope that this session will provide a forum for experts in the field to discuss these complex cases in a format that will generate robust discussion and questions.

Muneeb Ahmed is chief of the division of vascular and interventional radiology and vice chair for interventional services at Beth Israel Deaconess Medical Center, Boston, USA. He is also associate professor of radiology at Harvard Medical School, Boston, USA. Vijay Ramalingam is co-director of interventional radiology for the Mesenteric Venous Thrombosis Program at Beth Israel Deaconess Medical Center. He is also an instructor at Harvard Medical School.

The authors declared no relevant disclosures.

Figure 1. Liver transplant in 55-yearold male with rising liver function tests and an abnormal ultrasound. A. Digital subtraction angiogram demonstrates a high-grade focal anastomotic stricture (arrow). B. Subtraction angiogram following placement of a stent shows resolution of stenosis. Liver function tests and ultrasound findings normalised in subsequent follow-up.

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Emerging renal denervation data show promise of device-based hypertension treatment Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension, complementing existing first-line treatments including lifestyle modifications and medication, attendees of the conference heard.

THE PARIS MEETING SAW THE RELEASE of data from three clinical studies assessing the use of renal denervation as a treatment for hypertension.

These included findings from the Global Symplicity Registry and the latest data from the ongoing SPYRAL HTN-ON MED trial, both assessing the use of Medtronic’s Symplicity radiofrequency denervation system. An analysis of ultrasound renal denervation using the Paradise (Recor Medical) system from the RADIANCE HTN SOLO and TRIO trial cohorts was also presented.

“Hypertension can be easily diagnosed and treated but it is often undiagnosed and left untreated,” said Felix Mahfoud (Saarland University Hospital, Hamburg, Germany) in a focused session coinciding with the 2022 World Hypertension Day, a global initiative aiming to raise awareness of hypertension and its serious medical complications, and to provide information on prevention, detection and treatment.

Mahfoud presented the three-year Global Symplicity Registry results, including data from more than 3,000 patients in 42 countries, which looked at blood pressure and major adverse cardiovascular events (MACE) after renal denervation.

The results suggest that improved blood pressure control after radiofrequency renal denervation is associated with lower risk of MACE through three years in real-world patients. According to the registry data, renal denervation patients spent 34.9% time in target range—an independent predictor of reductions in negative outcomes in hypertension management— and also that there was a 16% decrease in MACE associated with every 10% increase in time in target range at six months.

Also presenting data during the same EuroPCR session, David Kandzari (Piedmont Heart Institute, Atlanta, USA) offered three-year data from the SPYRAL HTN-ON MED trial, giving an overview

Hypertension can be easily diagnosed and treated but it is often undiagnosed and left untreated.”

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of the impact of radiofrequency renal denervation on long-term time in target blood pressure range compared with sham control.

With this latest report, a time in target therapeutic range analysis was performed using data comparing the two groups over three years and showed that the renal denervation group had significantly higher time in target therapeutic range with more time in the blood pressure target range at two and through to three years as compared to the sham group, thus affirming the sustained efficacy of renal denervation over late-term follow-up.

Ajay Kirtane (Columbia University Irving Medical Center/NewYork Presbyterian Hospital, New York, USA) later offered findings of the patient-level pooled analysis of ultrasound renal denervation in the RADIANCE HTN SOLO and TRIO trials. The analysis examined data tracking the use of ultrasound renal denervation in a drug-resistant population (three years or more of antihypertensive medications) taken from the RADIANCE-HTN TRIO study, and from RADIANCE-HTN SOLO, in a population with mild to moderate hypertension.

The results of the analysis showed that there was no heterogeneity in effect on blood pressure reduction and medication burden. Those results looking at a mixed population over a six-month period favoured ultrasound renal denervation over the sham population and the pooled analysis of the RADIANCE-HTN trials suggests “the response to ultrasound renal denervation is similar in the presence or absence of medications and consistent across the whole spectrum of hypertension.”

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June 2022 | Issue 86

12 Issues in the Radiology Department

Report recommends taking action within radiology departments to reduce lead dust exposure ‘Surface lead contamination on personal lead radiologic protective apparel’ is a recent report published by Kieran Murphy et al (Toronto Western Hospital, Toronto, Canada). The subject of the report is free lead dust on lead aprons: the study involved testing aprons at a Toronto university hospital, which yielded the finding that 60% of aprons and thyroid shields have free surface lead. Murphy et al draw on their results to make recommendations for addressing this professional occupational health issue.

The contents of the report will be presented at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting (11–16 June, Boston, USA).

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he purpose of the study, information about each the authors outline in specimen: lead equivalency, their abstract, was to manufacturer, quality of lead, evaluate the extent of surface year of purchase and product lead dust contamination on lead type (i.e. lead apron, thyroid radiation protection apparel Kieran Murphy collar, or garments combining (RPA) used in Toronto-based the two). A combination of university teaching hospital radiology visual inspection, fluoroscopy and the departments. They then compared these use of LeadCheck rapid testing was results with those from pre-existing used to assess both the condition of reports that point towards lead RPA the RPA and the extent of surface lead being a biohazard in and of itself, contamination. despite its crucial role in protecting Of the 69 RPA items surveyed, one radiologists and other technicians failed a radiological quality inspection during diagnostic and interventional check, and eight items were in poor procedures. condition—the majority of all garments Murphy et al state having surveyed were over five years old and made a convenience sample of RPA, which from a lead/tin-composite material that was kept mounted on the wall outside had a 0.5mm lead equivalency. The the angiography and emergency authors also break down the RPA items departments. As part of the sampling, in the report by their type: lead aprons the team recorded the following (n=11); lead aprons with thyroid collars

(n=25); and separate thyroid collars (n=8). The key finding is as follows: “The overall prevalence of surface lead contamination on RPA surfaces based on LeadCheck sampling was 60.9% (95% confidence interval [CI]: 49.1%, 71.5%). Surface lead contamination was significantly (p=0.0035) higher on thyroid collars (78.8% [95% CI: 62.2%, 89.3%]) than on lead aprons (44.4% [95% CI: 29.5%, 60.4%]).”

Murphy et al then proceed to discuss the significance of their own clinical findings, drawing the conclusion that they support what previous studies conducted in the USA, Europe, Taiwan and Canada have shown: surface lead dust is “[highly prevalent]” in radiology departments. Two studies referenced in the authors’ report went as far as to look at the potential toxicity of lead dust exposure, sampling blood and hair. On the basis of the sum of these investigations (which found the presence of lead in the technologists’ hair, thus indicating ingestion risk), the authors make recommendations for improving conditions for the continued use of lead RPA, in order to reduce risk to personnel wearing the garments.

Firstly, the authors highlight that their recommendations are all the more necessary as there are no current regulations in place to mandate risk assessment for lead exposure from RPA in workplaces with radiation exposure.

Moreover, Murphy et al underline that all the RPA they surveyed had passed radiologic quality control tests, but that this does not preclude the presence of surface lead dust. The conclusion from

The overall prevalence of surface lead contamination on RPA surfaces based on LeadCheck sampling was 60.9%[...]”

RANZCR releases statement on iodinated contrast media shortage The Royal Australian and New Zealand College of Radiologists (RANZCR) has issued a statement addressing the Australian and global shortage of iodinated contrast media.

THE RELEASE EXPLAINS THAT GE Healthcare—the manufacturer of Omnipaque and Visipaque and the primary supplier of contrast media in Australia—has recently faced supply issues due to the current outbreak of COVID-19 and subsequent lockdown in Shanghai, China, affecting the company’s manufacturing plant.

“RANZCR is liaising with the Therapeutic Goods Administration (TGA), which is seeking alternative supplies of contrast to address the shortfall,” the statement reads, noting that updates can be found on the TGA website.

The release continues: “RANZCR recommends that medical practitioners considering referring a patient for a CT during this time consult with a radiologist for advice on alternative imaging modalities or other

this is that “stringent protocols” must be formulated and followed in terms of cleaning RPA, as well as the shielding structures made of lead. In addition, the authors accentuate the importance of further studies into the toxicity impact of long-term lead exposure among personnel.

Alongside their recommendations, the authors draw attention to the limitations of their investigation, which evaluated “only a small sample of lead aprons and thyroid collars for surface lead dust contamination at a single institution.”

They also point to the inexpensive LeadCheck test as yielding less reliable results than may have been achieved with other methods. Murphy et al add to the limitations the fact that the RPA they surveyed was made exclusively of a lead composite material; for this reason, they suggest that their results may not be wholly applicable to solid lead RPA. Lastly, they acknowledge that, when comparing their results with previous studies’, they may not have included all relevant literature, leading to potential omission of key findings which could have produced a different conclusion.

A final note from the authors in their report is that “there is no established safe level of lead” and, therefore, surface lead dust contamination should be continuously monitored where RPA and lead room shields are being used. Likewise, personnel and those responsible for workplace risk assessment should be aware of any defective equipment which may need to be taken out of use to reduce exposure to lead dust.

strategies that could be used to diagnose and manage their patients.”

In addition, RANZCR communicates that it endorses the recommendations of the American College of Radiologists (ACR) Committee on Drugs and Contrast Media that radiology practices and hospitals implement a range of strategies to conserve current supplies of contrast to manage patient care.

These recommendations include “utilise alternative studies to answer the clinical question such as noncontrast CT, MRI with or without gadolinium-based contrast media, ultrasound with or without ultrasound contrast agents, nuclear medicine, or PET-CT, when feasible,” and “look for alternative versions of contrast agents, which may be marketed under a different brand name or intended clinical use”.

Finally, the release notes that RANZCR further endorses the recommendations in the recent article

by Joseph Cavallo and Jay Pahade (both Yale School of Medicine, New Haven, USA), titled “Practice management strategies for imaging facilities facing an acute iodinated contrast media shortage” published in the American Journal of Roentgenology, which provides details to support practice management during this contrast shortage.

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June 2022 | Issue 86

14 Podium 1sts

New drug-coated balloon data provide further encouragement in vascular access Late-breaking data from clinical trials assessing drug-coated balloon (DCB) technologies have provided encouragement that these alternatives to plain-balloon angioplasty in vascular access care are safe, and can enable sustained freedom from reintervention over time. Findings from the IN.PACT AV Access (Medtronic) and ISABELLA (MedAlliance) trials were both delivered for the first time at the recent Charing Cross Symposium (CX 2022; 26–28 April, London, UK).

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he former was presented by Andrew Holden (Auckland City Hospital, Auckland, New Zealand), who disclosed 36-month data from a global randomised controlled trial (RCT) assessing the IN.PACT AV DCB (Medtronic) as part of the CX 2022 Vascular Access Masterclass.

In a Podium 1st presentation, Holden told audiences that end-stage kidney disease (ESKD) patients treated with the IN.PACT AV DCB remained intervention-free for longer than those who received a standard percutaneous transluminal angioplasty (PTA). He noted that a “significant difference” in target-lesion primary patency (TLPP) between the trial’s DCB and PTA treatment groups was seen through the three-year follow-up timepoint, maintaining the trend observed in the 24-month IN.PACT AV Access data, which Holden delivered virtually at last year’s CX Symposium.

The investigational device exemption (IDE) trial is seeking to assess the safety and efficacy of the IN.PACT AV DCB, which delivers the antiproliferative drug paclitaxel to inhibit neointimal hyperplasia and treat this leading cause of arteriovenous fistula (AVF) stenosis in ESKD patients. Specifically, the trial is comparing the use of the IN.PACT AV DCB in a treatment group to standard PTA in a control group, and enrolled 330 patients with a de novo or non-stented restenotic native fistula undergoing haemodialysis.

IN.PACT AV

Three-year data from IN.PACT AV Access

Building on positive results seen at previous timepoints in this prospective, single-blinded, randomised IDE trial, Holden relayed a TLPP rate of 43.1% in the DCB group, compared to 28.6% in the PTA group, through 36 months.

He also reported that a 21.3% reduction in reinterventions was associated with DCB use, with 255 reinterventions to maintain TLPP being required through 36 months in the DCB group versus 324 in the PTA group.

Holden then moved on to detail 36-month access circuit primary patency (ACPP) rates—stating that a “similar trend” was observed here, with a rate of 26.4% in the DCB group and 16.6% in the PTA group. He labelled this difference as being “significant” too, and noted a similar reduction (20.7%) in the number of reinterventions required to maintain ACPP within the DCB group. There were 311 necessary reinterventions in the DCB group and 392 in the PTA group.

After briefly alluding to mortalityrelated safety concerns that have been raised regarding paclitaxel in the past, Holden reported all-cause mortality findings—following a vital status update—that did not represent a statistically significant difference between the two treatment groups. He noted an all-cause mortality rate of 26.6% in the DCB group and 30.8% in the PTA group, and highlighted the fact that the mortality rate among “all-

36-month

IN.PACT AV

ACCESS DATA

43.1%

TLPP rate:

DCB All-cause mortality rate:

comer” haemodialysis patients from the United States Renal Data System (USRDS) through three years is higher than in both groups, at 41.9%.

Holden also stated that these findings compare favourably to those seen in the Lutonix AV IDE trial (BD) too, but noted that direct comparisons are difficult to draw because this trial concluded after 24 months. Having shown a sustained and superior performance with DCB versus PTA, IN.PACT AV Access is now “the only randomised pivotal trial of a device treating dysfunctional AVFs to demonstrate consistent and sustained clinical benefit through 36 months”, according to Holden. Summarising the data, he added that ESKD patients in IN.PACT AV Access had a median time to reintervention that was 14.7 months longer when they were treated with DCB compared to PTA. As such, Holden concluded that these findings represent durable, long-term data supporting the use of the IN.PACT AV DCB as “a standard of care” for AVF maintenance in this patient population.

v

28.6% PTA

26.6% v 30.8% DCB

PTA

sirolimus—an alternative anti-restenotic drug to paclitaxel—to reduce neointimal hyperplasia.

A total of 34 patients were ultimately evaluated at the 12-month follow-up timepoint in ISABELLA, Tang detailed, with the most common indication for intervening being a drop in access flow (61.5% of cases). Moving on to 12-month trial data, he reported a TLPP rate of 44% (16/36 lesions) and an ACPP rate of 31% (10/32 lesions), which represented decreases from 72% and 63%, respectively, at six months. In addition, he stated that the overall rate of secondary patency— defined as freedom from access circuit abandonment—was 94.1% (32/34 patients) at 12 months compared to the 97.2% (35/36 patients) observed at six months.

Tang, who was awarded the CX 2022 Senior Clinician Abstract Prize for this presentation, concluded by highlighting “excellent” technical and clinical success rates of 100%, and positive safety outcomes, in the ISABELLA trial.

He also relayed that the use of Selution

Encouragement in spite of “potentially disappointing” results

A second Podium 1st presentation at CX 2022 saw Tjun Tang (Singapore General Hospital, Singapore) deliver late-breaking data from a small-scale pilot trial that indicate “potentially disappointing” results—but, according to Tang, still offer encouragement in the treatment of dysfunctional dialysis accesses with DCBs. Tang presented 12-month findings from the prospective, single-centre ISABELLA trial, which assessed the safety and feasibility of the Selution SLR sirolimus-eluting balloon (MedAlliance) for minimising the effect of neointimal hyperplasia. While its goal of treating AVF stenosis, and ultimately preventing fistula failure, is broadly the same as that of IN.PACT AV Access, a key difference is that the DCB being evaluated in ISABELLA uses

I do not think it is actually a setback at all.

In fact, I think it is very encouraging.”

Tjun Tang

Issue 86 | June 2022 SLR in patients with AVF stenosis appears safe, with no serious adverse events, such as pulmonary embolism or bronchopneumonia, being associated with its use in the trial. And, in terms of efficacy, Tang added that, while the results are “potentially disappointing”, this is a small, exploratory investigation and alluded to possible confounding factors within its findings.

“We do need longer-term data and randomised controlled studies […] if we are going to move forward seriously within this field, and with this

Podium 1sts 15 technology,” he added. And, speaking to Interventional News, Tang noted the importance of being careful when interpreting the results of an exploratory pilot trial—especially one designed to power a future RCT. “I do not think it is actually a setback at all,” he continued. “In fact, I think it is very encouraging.

I think the fact we are not getting any serious adverse events with the balloon […] is reassuring.” Tang also told Interventional News that, with the exception of the IN.PACT AV Access

trial, a similar drop-off in patency rates between six and 12 months had been observed in several previous studies using paclitaxel to treat dysfunctional dialysis access.

Do the data stack up?

In a discussion at CX 2022, Ounali Jaffer (Barts Health NHS Trust, London, UK)—while clarifying that the IN.PACT AV Access trial was not adequately powered for the information he was seeking—enquired as to whether there was a signal for different areas within

CX Roundtable: The impact of IN.PACT AV on quality of life, procedure costs and first-line practice In a roundtable discussion (sponsored by Medtronic) of the three-year data, also at CX, with Alexandros Mallios (Hôpital Paris Saint-Joseph, Paris, France), Kate Steiner (East and North Hertfordshire NHS Trust, Stevenage, UK) and Tobias Steinke (Schoen Klinik, Düsseldorf, Germany) Holden summarised that the data are now showing a “highly significant patency advantage and no safety concerns out to three years”.

Elaborating on his previous statement, Holden quantified this: there was “over a 20% advantage” regarding reinterventions to maintain patency out to three years “for patients randomised to the DCB arm of the trial”. Holden labelled this as “very impressive”, acknowledging the advantages seen not only in the target lesion, but also in the whole access circuit.

Turning then to his fellow discussants, Holden posed the question of how this durability

data will impact on practice. In response, Steinke admitted that he was “surprised at how good these data are at three years”.

Steinke commented that “every [reintervention] that can be avoided is beneficial for the patient”.

Steiner offered an answer to Holden’s next question on quality of life. She asserted that the IN.PACT AV results demonstrate the need for less frequent interventions. For patients who are already going to the dialysis centre three times a week, this decrease in interventions could have a “significant impact” on quality of life. Speaking of the patients she has treated with DCBs, Steiner stated how patients often comment they are attending hospital much less frequently.

Given the improvements in quality of life that the trial suggests DCBs can offer, Steiner put forward the suggestion that it should be measured in future trials.

From left to right: Andrew Holden, Alexandros Mallios, Kate Steiner and Tobias Steinke

Mallios was asked about whether the upfront cost of using this DCB compared to standard angioplasty could be justified. “We always get this question,” Mallios admitted. However, his example of comparative costs over time for the two procedures provided an answer. In France, IN.PACT AV proves more cost-effective than standard angioplasty once the cost of the hospitalisations necessitated in the follow-up of the latter are factored in. The reduction in reinterventions achieved by using IN.PACT AV prompted Mallios to conclude by saying that he thinks that “we are definitely going to be saving money” with the DCB. Holden then asked where those with no prior experience of the technology should start. Steinke replied simply that it is best used “where there will be most benefit”.

For example, in the cephalic arch, there is at least as much patency advantage as with a stent graft.

the access circuit that may benefit the most from DCB therapy. “The numbers are going to be smaller at three years, but we would say that restenotic lesions certainly have a higher response; the arteriovenous anastomosis and cephalic arch [are observed to benefit most],” Holden responded. “For people who want to start introducing DCB into their practice, these would be lesions that we would be able to support [for DCB treatment].” Following up with a question on the different populations outside of the USA treated in IN.PACT AV Access, Jaffer said: “You had more radiocephalic fistulas, and one of the findings is that there is more neointimal hyperplasia within that area. Do you think that had a profound effect?”

“I was pleasantly surprised because I think, while we know that, with radiocephalic fistulas, the patency is often better than with upper-arm fistulas, the focal stenoses—particularly at the arteriovenous anastomosis with smaller calibre vessels—are the worst performing,” Holden noted. “And, we found that it is a group that actually differentially did the best. The smaller the calibre of the vessel, the better the drug-coated effect, so it was reassuring to see that.” Here, CX executive board member Nicholas Inston (Queen Elizabeth Hospital, Birmingham, UK) highlighted that the safety signal with paclitaxel-coated balloons seen in the trial was particularly reassuring too.

When asked by Peter Gaines (Sheffield Hallam University, Sheffield, UK) to compare the ISABELLA data with results from IN.PACT AV Access, Tang said that the “all-comer” population of dialysis patients in his trial reflects everyday practice in Singapore—also noting that the lesions observed in patient populations from Asia tend to be greater in number and longer than those seen in European and US studies. “I think the IN.PACT [AV Access] data are fantastic and it is a unique trial in terms of showing a positive effect in its primary endpoint,” Tang continued, but added that the IN.PACT AV Access dataset may be more “sanitised” and stems from a randomised trial as well. ISABELLA is promising, and demonstrated safety, but is still only exploratory, he concluded, stating a belief that, as such, this may be akin to “comparing apples and oranges”.

Robert Jones (Queen Elizabeth Hospital, Birmingham, UK) then pressed Tang on which of the two leading drugs he favours in his practice—paclitaxel or sirolimus. Tang said that, when it comes to AVFs specifically, “all the data there are with paclitaxel”. He noted that he has access to all the established DCBs in his centre, including the MagicTouch sirolimus-coated balloon (Concept Medical), and stated: “My instinct would be to just use paclitaxel for the time being—I think there needs to be more data with sirolimus, but the signal we are getting is better.” Tang said this belief is also supported by encouraging results from the MATILDA trial of the MagicTouch device.

June 2022 | Issue 86

16 Interview

PROFILE

Yasuaki Arai

“I do not want interventional radiology to be a treatment for the rich, nor for those who live in the wealthiest countries.”

Yasuaki Arai is an interventional radiologist who was, until recently, executive advisor to the president at Japan’s National Cancer Center in Tokyo, where he is currently a member of the interventional radiology centre. He founded the Japan Interventional Radiology in Oncology Study Group (JIVROSG) and is a prolific physician-inventor, including of the tipdeflecting microcatheter. He answers some of Interventional News’ questions.

IR attracted me because it was an area where I knew that my enthusiasm, skills, ideas and efforts could improve patient distress directly and quickly. No other medical specialty ever really appealed to me as much, but prior to deciding to become a doctor, I did think I would like to be a chef.

Who are, or were, your mentors?

When I started in IR, the specialty did not exist in Japan yet. So, I did not have a mentor. I learned angiography from a book, but I did the rest while thinking for myself. For me, my patients may have been a kind of mentor, as it was their conditions and also the patients themselves that would tell me whether the procedure I had done was right or wrong, good or not so good for them.

Could you describe a particularly memorable case of yours?

Selecting one case is not easy, but doing novel procedures that no one anywhere in the world has done before is always memorable. For example, the implantation of a catheter and port system via the left subclavian artery for hepatic arterial infusion chemotherapy; extra-anatomical shunt creation between the hepatic vein and the ascites cavity, the portal vein and the splenic vein, between biliary trees, and so on.

You founded the JIVROSG: what prompted you to set this group up?

I learned the importance of clinical trials and evidence in discussion with medical oncologists when I presented the results of hepatic arterial infusion chemotherapy for liver metastasis at a conference. It was one of the international conferences of locoregional treatment that took place during the 80s in Europe. The oncologists I met taught me that randomised controlled trials (RCTs) are necessary for proper scientific evaluation of emerging treatments. It made sense to me then that conducting clinical trials and presenting evidence is something that we should be doing in Japan too.

And what are some of the most exciting findings to come out of the JIVROSG?

There are two purposes of JIVROSG clinical trials.

One is to answer clinical questions in IR. Another is to be able to use evidence to obtain approval for IR devices that, until that point, did not have sufficient evidence to support approval. In the case of the former, the positive results of an RCT of palliative IR procedures such as percutaneous vertebroplasty for painful bone metastases and percutaneous transoesophageal gastric tubing (PTEG) to relieve

patients of the pain associated with standard nasogastric tubes were very exciting. An example of an exciting finding of the latter variety was a clinical trial of conventional transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) in collaboration with scientists in South Korea. With this clinical trial, lipiodol for TACE was approved in Japan, and then approved all over the world. Similarly, a clinical trial of the liquid embolic material N-butyl 2-cyanoacrylate (NBCA) is due to be approved in Japan. We hope it will go on to have an even widerreaching impact on the world of IR.

What are the most challenging aspects of using IR techniques to diagnose and treat cancers?

Progress in IR happens at a rapid pace and sometimes this is even too fast for the evidence to be recognised by physicians outside of IR. As a result, sometimes IR procedures are not recommended, even when the patient is a good candidate for IR treatment. This is probably one of the most challenging aspects of using IR to diagnose and treat cancers. We will need to put in continual effort to make IR a standard treatment in modern medicine.

You have been involved in research and development to bring a number of medical devices to market such as the implantable port and the tip-deflecting microcatheter. What is an example of a cutting-edge device that is currently transforming how you treat patients in your field?

There are many fascinating, unsolved problems. Of most interest to me is how we treat stenotic lesions of the small intestine. With advances in endoscopy, the gastrointestinal tract and bile ducts are becoming less the domain of the interventional radiologist, and more the field of endoscopists. However, the small intestine, which the endoscope cannot reach, remains the realm of IR. I hope to establish techniques and devices to treat stenotic lesions of the small intestine percutaneously.

It will not be easy, but it would be great if we could start discussing how we go about bringing ‘cheaper IR’ into worldwide medical practice.”

alisonlang.com

What attracted you to a career in interventional radiology (IR)?

As former executive advisor to the president at Japan’s National Cancer Center, what are your hopes for the future of interventional radiology in oncology?

The recent progress of systemic medical treatments with molecular target agents and immunotherapies is tremendous. However, I feel that the importance of regional treatments such as surgery, radiation therapy and IR are sometimes forgotten about. There are not many cancers that can be completely treated with systemic medical therapy alone. So, I think it is very important to work on establishing guidelines for the appropriate combinations of systemic therapy and IR for particular types of patients. I hope that IR will, before too long, be recognised as one of the undisputed standard therapies in oncology.

Issue 86 | June 2022

Interview 17

You were named a distinguished fellow at Cardiovascular and Interventional Society of Europe (CIRSE) 2017.

What would you like to see the 2022 meeting’s programme include?

Unfortunately, there is a big gap within the world of IR, not only between IR and other specialties. It is the gap between the economically rich and less rich countries. The progress of IR is great, but the costs involved are also growing rapidly. I do not want IR to be a treatment for the rich, or those who live in the wealthiest countries. I think it is very important to enable patients who live in poorer countries to be treated with IR. It will not be easy, but it would be great if we could start discussing how we go about bringing ‘cheaper IR’ into worldwide medical practice.

This year, the Japanese Society of Interventional Radiology (JSIR), the Asia Pacific Society of Cardiovascular and Interventional Radiology (APSCVIR), and the International Symposium of Interventional Radiology (ISIR) are holding a joint meeting. What are the most common issues facing IR in the widespread geographical region that is Asia and the Pacific?

The area of Asia is very large, and the economic situation, medical systems and social attitudes are very different country to country. So, the biggest problem with IR in Asia is that it is difficult to all come together as professionals working in diverse countries to make unified recommendations or establish common practices. However, more IR doctors than ever before will participate in APSCVIR 2022, which is a step in the right direction. Also, APSCVIR has been playing a central role in promoting educational programmes through webinars, and this has allowed IR professionals to share ideas and practices across geographical, cultural and economic borders.

What are your hobbies and interests outside of medicine?

Mountain climbing, playing music and cooking are some of my favourite pursuits. Mountain climbing and cooking are similar to IR, because I must make decisions quickly in order to achieve the best results; the results will clearly reveal whether my decision was a good one or not. As for music, I perform in a live ‘Beatles Night’ concert with professional musicians every four months. I play bass, piano and do vocals, and I think that music is more difficult than my work as an IR.

Medical education Current appointments

Member of interventional radiology centre, National Cancer Center, Tokyo, Japan Guest professor, Jikei University School of Medicine, Tokyo Guest professor, St Marianna University, Kawasaki, Japan Guest professor, Saitama Medical University, Moroyama, Japan

1990: Doctor of Medical Science, Nagoya City University Graduate School of Medicine, Nagoya 1979–83: Internal Medicine residency, The Second Tokyo National Hospital, Tokyo 1979: Medical degree, Jikei University School of Medicine, Tokyo

Society positions

2014–17: Japanese Society of Interventional Radiology (JSIR)

Founder, Japan Interventional Radiology in Oncology Study Group (JIVROSG) Fellow, Society of Interventional Radiology (FSIR)

Previous appointments

Executive advisor to the president, National Cancer Center, Tokyo Chair, Interventional Radiology Center, National Cancer Center, Tokyo Director, National Cancer Center, Tokyo

June 2022 | Issue 86

18 CX 2022

PERIPHERAL

NESIC investigates exercise therapy and neuromuscular stimulation for the treatment of intermittent claudication Neuromuscular electrical stimulation (NMES) may be effective as a standalone treatment for intermittent claudication (IC), and in conjunction with supervised exercise therapy (SET), attendees heard at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK). Alun Davies (Imperial College London, London, UK) delivered results of the NESIC randomised controlled trial in a Podium 1st presentation. The trial studied the place of NMES for IC in a sample of 192 patients treated in 11 sites across England.

D

avies began outlining some clinical background to IC and details of how it is currently treated: it affects exercise tolerance and quality of life, and in some cases can lead to chronic limb-threatening ischaemia (CLTI), and, consequently, limb amputation. Under current guidelines, Davies noted, SET is strongly advocated, as it is known to help patients with IC increase the distance they are able to walk. Despite this, SET is not available to all patients in the UK. Pilot studies yielded both

improvement in patients’ maximal walking and initial claudication distance after six weeks of daily NMES, Davies explained, with higher quality of life as a result.

The primary outcome measure of the NESIC study, Davies detailed, was to demonstrate that standard medical care for IC, alongside NMES, allowed patients’ absolute walking distance (measured on a treadmill) to improve more after three months than in those who received standard care alone. Davies added that in the participating sites where SET formed

Majority of CX audience sees future for paclitaxel amid US FDA hesitancy THE PROXIMAL PERIPHERAL ARTERIAL Challenges session at the CX 2022 (26–28 April, London, UK) concluded with the results of an audience poll on the question of whether paclitaxel had “had its day”. With 87% of the audience of the opinion that paclitaxel should continue to be used in peripheral arterial treatments, the consensus reflected the assertion from speaker Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) that “a lot has changed since [the US Food and Drug Administration (FDA)’s last advisory panel conclusion in] 2019”. While the 2019 advice from the FDA for “clear and transparent discussions regarding the benefits and risks of [paclitaxel]” stands today, the session’s speakers provided nuance to this caution, citing the lack of any mortality signal from significant datasets.

In this session, Eleni Whatley (US FDA, Silver Spring, USA) gave an FDA regulator update on paclitaxel and Aloke Finn (CVPath Institute, Gaithersburg, USA) delivered a presentation on the vascular response of a polymer-free paclitaxelcoated stent versus a polymer-coated, paclitaxeleluting stent in healthy swine femoropopliteal arteries. An edited case by Jacob Budtz-Lilly (Aarhus University, Aarhus, Denmark) on overcoming the challenge of treating the aortoiliac bifurcation also featured.

part of standard IC treatment, they also provided this for the purposes of the study.

Secondary outcomes included initial claudication distance (ICD), quality of life and haemodynamic assessments.

The baseline characteristics (mean age and body mass index, sex and smoking) were comparable from the control group to the NMES group, Davies elaborated.

Summarising the primary endpoint results, Davies explained that whether SET, NMES or both treatments helped patients was found to be dependent on whether they were a short-, medium-, or long-distance claudicant.

Short-distance claudicants saw improvement neither after SET nor NMES; medium-distance patients benefited from SET but not NMES, and in longAlun Davies distance claudicants, both the standard treatment and the NMES device yielded an increase in patients’ absolute walking distance.

Regarding quality-of-life measures, patients saw a significant improvement at three months, according to the EQ-5D-5L health scale, but there was no notable difference between the improvement seen in the control versus the treatment group. This improvement, Davies noted in addition, was not sustained at six- nor

at 12-month follow-up. The SF-36 mental component yielded the same results for both groups, and, while the corresponding physical component showed significant improvement among the treatment group at six months, this did not last to 12 months.

Davies proceeded to acknowledge the following limitations of the trial: there was a wide range of baseline absolute walking distances among both groups, but there was no stratification by baseline for primary outcome analysis; of the 192 patients enrolled, only 160 had analysable primary endpoint data (others’ were missing); there was also no sham device comparator.

Concluding, Davies stated that the study showed the obvious benefit that patients with IC stand to gain from SET. In addition, NMES and SET yield the greatest benefit for patients with mild claudication.

The takeaways from the study, Davies noted, are that SET provision should be prioritised by providers and payors to give more IC patients access.

Furthermore, NMES may be effective as a standalone treatment, as well as in conjunction with SET, provided patients have a good walking distance as baseline.

Researchers develop predictive model for risk of amputation in diabetic foot patients In the Hurting Leg session at CX 2022, Ryan Tan (Singapore) outlined how he and colleagues used artificial intelligence (AI) to develop a predictive model for risk of amputations in patients with diabetic foot disease. Tan and principal investigator of the study, Joseph Lo (Singapore) speak to Interventional News about the pros, cons, and future of AI in this arena.

Could you briefly summarise the talk you delivered at CX 2022?

interactions between the multitude of factors that play into determining our patients’ outcomes, especially so within vascular patients who often present with multiple comorbidities. I believe a big strength of AI, in particular machine learning, allows us to try to recognise patterns within, and predict outcomes from, these complex relationships.

Although some AI technology adopts black box machine learning algorithms, we strived to utilise explainable AI within our machine learning model.

Our team from the National Healthcare Group (Singapore) teamed up with the data scientists from Holmusk to develop a predictive model for the risk of Joseph Lo amputations in our patients with diabetic foot disease using data generated directly from our Electronic Health Records as well as wound data from eWounds, a nursing-led wound management database. We used various machine learning models to develop an algorithm that could accurately predict the risk What do you think the future Ryan Tan of amputations and found that with the of AI in this area looks like?

Neural Ordinary Differential Equations, we AI is an exciting new world for the field of were able to generate the most accurate predictions medicine in general with much untapped potential. with an AUROC [area under the receiver operating I think that it will potentially change the way we characteristic curve] of 0.8. practise medicine and interact with our patients, using big data. I see it not only being used in predicting What do you think are the main pros outcomes, improving administrative processes, and and cons of using AI as a predictive helping to ensure guidelines-based clinical decisions, model for risk of amputation in but also in the interactions between healthcare patients with diabetic foot disease? providers and patients/carers. For example, AI bots The big advantage of using AI to develop a predictive could help guide patients to take charge of their own model would be the ability to analyse the complex health at home, hence improving health literacy.

Issue 86 | June 2022

CX 2022 19

PERIPHERAL

Non-optimal therapy for CLTI “more prominent in women” A real-world claims data analysis of nearly 200,000 patients with chronic limb-threatening ischaemia (CLTI) showed that female patients were older, underwent vascular procedures less often, and received guideline-recommended drugs less frequently.

However, it also highlighted that female sex was associated with better outcomes. The study was recently published in the European Heart Journal.

AUTHORS LENA MAKOWSKI (University Hospital Münster, Münster, Germany) et al state that the prevalence of CLTI is increasing, adding that available data often derive from cohorts with various selection criteria. “In the present study,” they communicate, “we included CLTI patients and studied sexrelated differences in their risk profile, vascular procedures, and longterm outcomes”.

The researchers analysed 199,953 unselected patients of the AOK Health Insurance Fund—which they describe as the largest public health insurance in Germany—hospitalised between 2010 and 2017. They detail that female CLTI patients were older and more often diagnosed with hypertension, atrial fibrillation, chronic heart failure, and chronic kidney disease, while male patients suffered more frequently from diabetes mellitus, dyslipidaemia, cerebrovascular disease, and chronic coronary syndrome, and were more likely to smoke. Within hospitalised patients, Makowski et al note that females represent the minority (43% vs.

57%; p<0.001).

Writing in the European Heart Journal, Makowski and colleagues report that, during index hospitalisation, women underwent less frequent diagnostic angiographies (67% vs.

70%) and revascularisation procedures (61% vs. 65%; both p<0.001).

Furthermore, they reveal that women received guideline-recommended drugs like statins and antithrombotic therapy

In contrast to randomised trials, observational studies, and registries, the studied health claims data are not subject to selection bias by the sponsor or implementer.”

SCAI releases multisociety position statement focused on core competencies for endovascular specialists providing care for CLTI THE SOCIETY FOR CARDIOVASCULAR Angiography & Interventions (SCAI) has released a position statement outlining competencies for endovascular specialists who provide care for chronic limb-threatening ischaemia (CLTI).

The first-of-its-kind document, “SCAI/ACR/ APMA/SCVS/SIR/SVM/SVS/VESS position statement on competencies for endovascular specialists providing CLTI care”, published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of the American Podiatric Medical Association (JAPMA), Journal of Vascular Surgery (JVS), and Vascular Medicine (VMJ), is a collaborative effort from eight societies representing

less frequently at baseline—35% vs.

“In contrast to randomised trials, 43% and 48% vs. 53%, respectively observational studies, and registries, (both p<0.001). the studied health claims data are not “Interestingly,” the authors subject to selection bias by the sponsor underline, “after including age or implementer.” and comorbidities in a Cox In addition, the authors regression analysis, female communicate that followThe researchers sex was associated with up was good, both in analysed 199,953 increased overall survival terms of length and data unselected patients (hazard ratio [HR], 0.95; availability. “Patients were of the AOK Health 95% confidence interval included until 2017 and Insurance Fund [CI], 0.94–0.96) and the follow-up phase was amputation-free survival until 2018, displaying the (HR, 0.84; 95% CI, 0.83–0.85; current care situation under both p<0.001).” current guidelines with a longer In the discussion of their findings, follow-up to nine years. A very low loss Makowski et al weigh up various to follow-up was determined, since the strengths and limitations of their change in the health insurance is rather research, noting in particular that their rare, especially in older age groups.” choice of claims database was a key Moving on to limitations, Makowski strength of the investigation. They et al acknowledge that their analysis explain that the almost 200,000 lower is somewhat hindered by the use of extremity arterial disease patients health claims data, in that there may included in the study were insured by be missing information on factors such the AOK Health Insurance Fund, which as clinical status and parameters, the they note covers almost 32% patients success or failure of interventions, or in Germany. Makowski and colleagues patient compliance. Moreover, they add that the AOK consists of 11 note that the basis for the analysis was independent regional Health Insurance diagnostic codes, which they used Funds, which covers healthcare for validation reasons. “This means nationwide in Germany. However, they non-billable diagnoses were often not highlight that AOK-insured patients present and thus not included in our have a lower socioeconomic status analysis,” Makowski and colleagues and higher migration background detail. Another limitation was that and presence of cardiovascular risk differences depending on biological sex factors, found in all regions compared (e.g. hormone status), socioeconomic, with other health insurances. “These financial, or health educational aspects differences,” they write, “probably could not be included in the analysis. leading to different healthcare supply “[CLTI] should be considered as depending on the regional Health a multi-organ disease with an ever Insurance Fund, can influence the increasing prevalence and a poor data but demonstrate a nationwide prognosis,” the investigators posit healthcare supply in a heterogeneous in their conclusion. They stress that patient population”.

CLTI patients “do not receive optimal The researchers also point to the therapy,” and that this is “more study design as another strength. prominent in the female sex”.

many specialties engaged in the care of CLTI patients.

The expert writing group aims to standardise expected competencies for endovascular specialists to help ensure patient-centric and evidence-based therapy is delivered to this unique patient population.

“Care for patients with CLTI is typically complex, multifaceted, and multidisciplinary. Standardising expected competencies for endovascular specialists is an important step to ensure that patient-centric and evidence-based therapy is delivered,” said Beau M Hawkins (University of Oklahoma Health Sciences Center, Oklahoma City, USA), chair of the writing group for the document. “This new framework is a starting point to enable training programmes, professional medical societies, and other entities to develop curricula that address the needs of this unique patient population.”

The position statement details the key skills that all endovascular specialists should possess to deliver successful outcomes for CLTI patients. The skillsets are categorised into six core competencies based on the Accreditation Council for Graduate Medical Education (ACGME) core competencies framework: medical knowledge, patient care and procedural skills, systems-based practice, practice-based learning and improvement, professionalism, and interpersonal and communication skills. To account

for a range in complexity across the competencies, the writing group also provides examples stratified into “fundamental” and “advanced” categories.

“This unprecedented collaborative effort among these eight multidisciplinary medical societies is another step forward towards advancing care for patients with CLTI,” said Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), co-chair of the writing group. “I hope that these efforts will evolve and translate into better care for these high-risk patients at risk of limb loss,” he continued.

The statement also discusses institutional requirements and resources necessary for learners to obtain the necessary skillsets.

Recommendations for formal training or independent courses in a post-training practice are also included.

The position statement was endorsed by the American College of Radiology (ACR), American Podiatric Medical Association (APMA), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Interventional Radiology (SIR), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), Society for Clinical Vascular Surgery (SCVS), and Vascular and Endovascular Surgical Society (VESS).

June 2022 | Issue 86

20 CX 2022

CommunityHurting focused Leg approach required to tackle global issue of unnecessary amputations CX 2022

A roundtable discussion at the recent 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK) recognised a need to discover patients with a “hurting leg” sooner. Experts from across the globe also highlighted the importance of raising awareness and improving access—with approaches that are specific to individual communities—in order to tackle what the panel and audience agreed is a global and pressing issue.

A

nchor Roger Greenhalgh (Imperial College, London, UK) highlighted a “very concerning” trend of amputations taking place “without any investigation whatsoever”. The aim of the CX roundtable, he stated, was to tackle this problem head on.

Naseer Ahmad (Manchester University Foundation Trust, Manchester, UK), who joined virtually, opened the roundtable discussion with a presentation on inequalities in the epidemiology of amputations across England. The vascular surgeon highlighted regional, gender, and ethnic variations, and also underlined the importance of looking beyond diabetes when discussing amputation.

He first outlined a 2019 paper by Maria Davies (Bolton NHS Foundation Trust, Bolton, UK) titled “The epidemiology of major lower-limb amputation in England: a systematic review highlighting methodological differences of reported trials” based on 25 years’ worth of data. The paper found that it was difficult to compare changes over time, Ahmad told the CX audience, as basic epidemiological data within studies was “very poorly described”. The presenter noted that one thing was clear, however, and that was the fact that half of all major amputees do not have diabetes.

“Amputation inequality extends

beyond diabetes,” he stated.

While the presenter stressed that few detailed inequality data have been published over the last seven years, a paper by Ahmad et al gives an insight into 10 years of hospital data for the period 2003–2013. The study included 42,294 major and 52,535 minor amputations, as well 255,545 revascularisations and described variations across England, Ahmad told CX attendees. He reported that the amputation rate in those aged 50 and over was 26.3/100,000 across England, but noted that the average varied across the country; in London it was below the national average, in the Midlands it was around the same, and in the north of England, it was above the national average. The investigators found the same pattern with revascularisation.

In addition, Ahmad revealed that the overall major amputation rate actually went down over that same time period, but that inequalities between north and south and between men and women remained the same.

Ahmad summarised that the variation in amputation prevalence is as important as actual rates, and stressed that looking at variation within populations is key to reducing the rate, stating the crucial figures of 30% more amputations in the north compared to the south of England, nearly three times more amputations

in men than women, and 70% more in Black than White populations. He also reiterated the statistic that half of major amputates do not have diabetes.

He concluded that there is an “urgent need” for new data on this topic, but pointed to the latest findings from Greater Manchester—from 2015– 2022—showing that inequality patterns remain.

Following Ahmad’s presentation, the panel gave their thoughts on the scope of the issue, adding global perspectives and nuance to the issue of variation, as well as highlighting other aspects of the problem, such as patients being referred too late, and patients not going to see a specialist about their hurting leg in the first place.

“You are describing a problem in England that reflects a problem internationally,” said Andrew Holden (Auckland City Hospital, Auckland, New Zealand), pointing to the global nature of the issue. He expanded on this point with data from New Zealand: “In my city—Auckland, New Zealand—the Maori and Pacific Island population of south Auckland has 2.5 times the amputation rate of the North Shore population, which is predominantly of European origin.”

Manjit Gohel (Cambridge University Hospitals, Cambridge, UK) said that he would break down the regional aspect even more. “You have looked at regions,” he said to Ahmad, “but even within regions, within cities, there is enormous variation,” referencing a particular part of Norfolk in the UK that has double the amputation rate.

“What we need to do is use these data to drive changes and promote early

We need to use these data to drive changes and promote early diagnosis, which is the only way we are going to make a big difference.”

Manjit Gohel

diagnosis, which is the only way we are going to make a big difference,” Gohel suggested.

Also on the subject of variation, Michael Edmonds (King’s College Hospital, London, UK) highlighted the importance of considering the socioeconomic element of the amputation levels. He referenced Hurst et al’s data from Glasgow in the UK that showed specific “hot spots and cold spots” for amputation linked directly to degree of deprivation.

“Education and access” are key to change

The focus of the discussion shifted from problem to solutions, with Keith Harding (Cardiff University, Cardiff, UK) suggesting public awareness campaigns. Brooks reiterated the importance of this as a solution, but added that “we have got to have somewhere for the patients to go and be assessed”. He noted that, in the UK, patients come into the system via “too many pathways”. In this vein, Edmonds stated that “there should be timely access to the multidisciplinary foot clinic, which can act as a focus of care, especially in areas of socioeconomic deprivation”. Murphy proposed the idea of problem-based clinics as opposed to speciality-based ones, giving her experience of setting up an acute deep vein thrombosis (aDVT) clinic.

“The two things that are being discussed are education and access,” Holden summarised. He pointed out that the medical community has successfully delivered the message that chest pain might be a heart attack. If a patient has a hurting leg, however, “they do not think that they might have severe venous disease or an arterial insufficiency that has a consequence,” he highlighted. Social media, Holden proposed, might be a good way to reach patients.

On the topic of social media, Erin Murphy (Sanger Heart and Vascular Institute, Atrium Health, Charlotte, USA) proposed the idea of patientcentred symposia, while Edmonds pointed out that “a lot of our population are digitally deprived,” and reiterated the importance of facilitating ready access to specialised care for patients in the community. Ahmad stated that is it important to ask the population what works for them, with Murphy defining this idea as a “tailored approach to the community”.

Adding a final element to the discussion, Armando Mansilha (University of Porto, Porto, Portugal) suggested that it is important that universities also address the issue, noting that medical students are taught about stroke and myocardial infarction, but not about the hurting leg.

The CX Hurting Leg roundtable panel

Issue 86 | June 2022

Anaesthesia in IR 21

“Vocal anaesthetic”: The key role and unique challenges of anaesthesia in IR Pele Banugo, Nazia Khan & Sanya Patel

Education and training

Comment & Analysis As interventional radiology (IR) evolves and expands, so too does the role of anaesthetic support to get these patients safely through their procedures. Where previously anaesthetic support was reserved for only the most acute and complex patients, now, some centres have regular anaesthetic lists supporting elective, urgent and emergency work.

Maintaining standards

Anaesthesiologists’ experience in the traditional ‘theatres’ means they can bring that knowledge across, setting standards for anaesthesia, such as recommended emergency airway equipment, a go-to box for anaesthetic emergencies like malignant hyperpyrexia, and stockage of appropriate medication. Having a regular anaesthetist also means these standards are regularly reviewed and revised.

It also brings across a culture of theatres, championing morning huddles or team briefs; completion of the WHO [World Health Organisation] checklist and debriefing sessions; efficient turnaround time between cases and better list utilisation overall.

The presence of anaesthetists within the IR suite permits the teaching of skills critical to safe patient management, airway management skills, for example, and the transfer of knowledge that will enhance patient satisfaction.

Postoperative pain management is an example of such knowledge, the importance of which will be seen in years to come as the repertoire and complexity of IR procedures continues to grow.

Patient population

Studies have shown that the mean age of patients in IR is 3.5 years higher than those having surgery. With increasing age, you see increasing co-morbidities.1 Certainly, in the surgical population there has been a significant increase in patient complexity as reflected in their American Society of Anaesthesiologists (ASA) Physical Status grade.

Previously, ASA 1 patients made up 35% of the surgical population whereas now they make up just 15%.

Naturally, the percentage of ASA 2, 3 and 4 patients has increased, and overall, patients have increased numbers of

the duration. Additionally, the type of work in IR is often a mixture of elective, urgent and emergency work, meaning it is a hybrid of a traditional elective lists and emergency lists from theatres: a combination of stable patients having minor procedures, like sclerotherapy and unstable patients having life-saving procedures like embolization. A flexible and adaptable mindset is therefore needed when working in IR. The challenge, and possibly the enjoyment, of anaesthetic lists in IR is that no two lists are alike. Patient demographics differ wildly from one to the next and procedures vary significantly from gastrointestinal procedures to vascular work.

health conditions and poorer control of existing conditions.2 Certain subsets of IR patients may demonstrate this heightened risk more clearly than others. A recent threemonth audit of patients presenting on the anaesthetic list for lower limb angioplasty at a major teaching hospital in London, revealed that 23% of patients were octogenarians, 23% were ASA 4 and above, and 17% were not for resuscitation in the event of a cardiac arrest. Many of these patients present as urgent cases—best practice national guidance recommends that they should be revascularised within five days of their admission to hospital.3 Strict adherence to this practice leaves little time to optimise them prior to their procedure.

The nature of IR means that the patient considered too high-risk for a surgical procedure, or an open technique, is referred for a minimally invasive one instead. High-risk refers to the anticipated surgical insult associated with major surgery, which the team intend to mitigate through a minimally invasive technique, thus reducing physiological stress on the body. However, there remains an associated risk from anaesthesia, which is independent of the surgical or procedural approach. This anaesthetic risk may be significantly prolonged, in some cases, with procedures taking many hours to complete.

When anaesthetising patients in IR, it is important to strike the right balance between anaesthetic approach, procedural technique and patient risk factors. Often “a less is more” approach suits the high-risk patient better.

Type of work

The challenge comes when anaesthetists are unfamiliar with the nature of the procedure, particularly the approach and

Anaesthetic training has not kept pace with the growth in demand for anaesthetic involvement in delivering care in the IR environment. Remote-site anaesthesia is given consideration within the anaesthetic curriculum, however, the concentration of IR services, mainly in larger teaching institutions, and the relative lack of specific focus on this subject in the training syllabus, means that most anaesthetic trainees have little to no exposure to IR until their final years of training, or until they become consultants.

The knowledge and experience gap that needs to be crossed, as a consultant, is therefore significant. The initial learning curve is steep and there is a lack of resources to support the education and training of anaesthetists who are interested in this field. It may take months to years for consultants to become comfortable with IR procedures and practices, and to acquire the mindset and techniques required to operate effectively within the IR environment.

A wholesale change in thinking is needed to address this, from the teams who create the training curriculum, to the rota makers who assign trainees to theatre lists. Going forward, training lists in IR need to be seen as mandatory rather than just a tick-box option.

Location and space

One of the obstacles that face anaesthetists who work in IR is the unfamiliar environment. IR suites are often in a remote location in the hospital and away from the main theatre complex. The anaesthetic support that can be found in main theatres is not available in IR and the anaesthetist must work closely with their anaesthetic assistant to deliver care.

In an emergency, help from a fellow anaesthetist is not close at hand. This much is also true for the IR anaesthetist who needs relief for a lunch break or to review a patient.

In addition, the configuration of IR suites has often not taken the needs of the anaesthetic team into consideration, with limited space for the anaesthetic machine, which can be far from the head end of the table. Access to an anaesthetic room is preferable but again with limited space, a luxury that the IR suite cannot

always afford.

A combination of the above challenges breeds a reluctance in anaesthetists to deliver regular anaesthetic lists in IR.

Safety

The lack of regular anaesthetistsupported lists has led to many procedures being completed under local anaesthetic or “vocal anaesthetic”, when ideally, they should have anaesthetic involvement.

There is much debate over whether procedures, such as oesophageal dilatations, should be done under “vocal anaesthetic” with (or without) radiologist-delivered sedation, or under general anaesthetic. Centres all across the country use a different approach and each have their merits. The benefits of anaesthesia delivered by an anaesthetist is that the radiologist and their team can focus on the procedure, whilst the anaesthetist can focus on the patient, ensuring they are adequately analgised, anaesthetised and monitored.

This is ever more important when dealing with sick patients. Regular exposure to emergency work, and benefitting from formal training in intensive care medicine, anaesthetists are well versed in the management of medical emergencies that may be encountered both inside and outside of the operating theatre. Their leadership qualities come to the fore when dealing with the unstable or deteriorating patient.

Summary

Anaesthetists are uniquely placed to collaborate with IR teams on patient safety and maintaining the same standards of practice as theatres to ensure effective care is delivered.

Though there are many unique challenges to providing care in this setting, with increase in workload, it is certain that more and more centres will recognise the value of regular lists.

Supported by the Society of Anaesthesia and Radiology, undoubtedly some of these challenges, like a lack of familiarity with the environment and procedures, will be rectified.

Overall, as a speciality, consideration needs to be given to adopting a surgical theatre approach to delivering care and at the centre of this is anaesthetic support.

References: 1. Nagrebetsky A, Gabriel RA, Dutton RP, Urman RD. Growth of nonoperating room anesthesia care in the United States: a contemporary trends analysis. Anesth Analg. 2017;124:1261–1267.

2. Khan N, Carvalho C. To digital or not to digital. RCoA Bulletin. 2022; 131: 34 - 35 3. https://www.vascularsociety.org.uk/_userfiles/pages/ files/Resources/PAD%20QIF%20March%202019%20 v2.pdf

Authors Nazia Khan and Pele Banugo are consultant anaesthetists at Guy’s and St Thomas’ NHS Foundation Trust, London and Sanya Patel is an anaesthetic trainee at Lewisham and Greenwich NHS Trust, London, UK. The authors declared no relevant disclosures.

June 2022 | Issue 86

22 CX 2022

Transfemoral Aortic access takes centre stage at Aortic Techniques and Technologies session CX 2022

The Charing Cross Symposium’s (CX; 26–28 April, London, UK) Aortic Techniques and Technologies session saw a range of presentations, including those from Luca Bertoglio (Ospedale San Raffaele, Milan, Italy) and Tilo Kölbel (University of Hamburg, Hamburg, Germany), which compared percutaneous and cutdown upper extremity access during aortic procedures. Bertoglio left delegates with the recommendation that where possible, upper extremity access should be avoided, paving the way for Kölbel to detail alternative means of access and how they work in practice in an endovascular thoracoabdominal aortic repair setting.

B

ertoglio’s presentation, titled ‘Percutaneous versus open transaxillary aortic procedures’, first turned to address the question of whether percutaneous and surgical femoral access during aortic procedures see different rates of blood loss and reduction of complications.

Referencing Gustavo Oderich’s (University of Texas Health Science Center, Houston, USA) paper, he concurred that there are “different advantages to a percutaneous approach”.

Bertoglio noted that, since the beginning of his hospital’s aortic programme, he has “tried to go percutaneous for upper proximity access”—a technique “pioneered by cardiologists in Hamburg for [transcatheter aortic valve replacement]”. In addition, Bertoglio informed delegates that the Journal of Vascular Surgery (JVS) publication of his preliminary results describes the technique in detail.

Different papers specify a preference for puncturing the axillary artery at the first segment regardless of which procedure they have chosen to perform. “The key aspect is where to puncture the axillary artery,” Bertoglio

Maani Hakimi presents during the CX Aortic Techniques and Technologies session

elaborated, and it is equally important to take care not to puncture the pectoralis minor in the process.

With regard to his method, Bertoglio described how he likes to use “one 6Fr sheath” and then to “insert one that is 10–12Fr.” And, when it comes to closing the access site, Bertoglio’s approach is “push the sheath from the femoral within the axillary region in order to avoid arch manipulation”.

Expanding on this description, he outlined how he uses a guidewire over the axillary puncture site. So as to “remove the sheath in a dry condition”, Bertoglio inflates a balloon, which is sized according to the artery dimensions.

There are a few contraindications: “we avoid puncturing the subclavian or axillary artery donor of cardiac bypasses”, Bertoglio shared with the audience. He went on to include avoiding the technique for arteriovenous fistulas and patients with excessive calcification.

“We published our results in the EJVES […] 90% of patients had closure success”. Bertoglio then noted that in the future, he sees the technique outlined in the paper as being applicable to other procedures, such as

when using the axillary artery to place impellers during transcatheter aortic valve replacement (TVAR). “Even [… for] parallel grafts if we perform them in emergency situations,” he added.

The results, Bertoglio underlined, are those from eight centres in Europe and the USA, where percutaneous transaxillary access was used in all cases. “We were able to observe the same closure success rates here in San Raffaele.

“We know from Gustavo Oderich’s first publication that […with] open access […the rates] of stroke are quite high,” Bertoglio continued. “So as to collect more data, we invited centres also doing open cutdown for upper extremity access”—they were able to include 1,400 cases in the registry. “The endpoint of the study was to assess the stroke rate, access complications of the percutaneous versus cutdown approach.” The stroke rate was 3%, Bertoglio proceeded to detail, “with no difference between cutdown and percutaneous”, however, he conceded that there is a difference in the localisation of cerebral embolization with the percutaneous approach.

In terms of failure, he reported the rate to be 7%, for both types of procedure. “There were more occlusive complications for the cutdown,” Bertoglio elaborated, specifying in addition that most of the complications that occurred after the percutaneous approach could be managed endovascularly.

When it comes to comparison, the

Transfemoral access offers a high technical success rate, a faster procedure time, lower stroke and access complications and low radiation […]” two cohorts of patients were quite different in terms of operative risk factors, and therefore a propensity matching was perforned: “there is no difference between cutdown and proximity access, but there is a greater need for endovascular adjunctive procedures” for the percutaneous approach, Bertoglio reiterated.

“To conclude, if we discuss upper extremity access, there is a nonnegligible rate of stroke and access complications.” The ultimate goal, therefore, Bertoglio emphasised, is to reduce the need for upper extremity access.

Kölbel followed, with his presentation ‘How to avoid upper extremity access in endovascular thoracoabdominal and arch repair’, promising to provide a means of

achieving the objective that Bertoglio latterly set out. “The techniques session at CX was always the most interesting session from my perspective”, Kölbel began. “We have already heard that upper extremity access may be avoidable”, although it has always been “the standard for branched endovascular aneurysm repair [BEVAR]”, Kölbel acknowledged.

“For some time, we have been discussing whether we should use left or right upper extremity access”, especially with regard to stroke rates, Kölbel asserted. There is, however, “no significant difference” between the right versus left means of access. But the question remains, in his opinion, whether or not to take an upper extremity access, and all the more so in cases of “significant thrombus in the aortic arch and upper extremity access vessels”.

“We started about five years ago using a transfemoral sheath for branches […and] the technique has improved […] A weakness of the steerable sheath was, initially, achieving stability at a 180-degree curve, which is necessary to deliver bridging covered stents.” Kölbel continued by highlighting a stabilisation technique that they have adopted: “[inflating] a balloon in the endograft during certain steps of the procedure in order to get support for the sheath.” But the easiest approach is to put a wire through the ipsilateral sheath, Kölbel affirmed, and it is a suture that affords the “best stability in any steerable sheath access from the groin.

“We have also looked at previous techniques for upper extremity access”, Kölbel underlined, detailing how these have been compared with transfemoral techniques over 150 cases.

“Working from the groin”, the data showed a “lower radiation dose” and “the procedure also became faster”.

Furthermore, the cohort had “zero stroke rate”.

Referring to an exemplar case, Kölbel described the course of action he advocates for when both open and percutaneous transfemoral access is contraindicated. A 68-year-old man with a suprarenal aneurysm had lymphomas in both sides of his groin and so, despite the fact that Kölbel “would not recommend” the following approach, they chose to do [superficial femoral artery] access, which worked well. “The [stabilising] wire […] also really [did] its job,” Kölbel added. “In the coeliac artery, there was initially an unstable sheath in this patient” and the length of the sheath can be too short in some cases to resolve the issue.

However, pulling on the suture provides a helpful solution.

Kölbel concluded by opining that “transfemoral access offers a high technical success rate, a faster procedure time, lower stroke and access complications and low radiation, so it is probably the way to do [BEVAR] in the future.”

Issue 86 | June 2022

IR Innovations 23

CX: Showcasing innovation in the age of the pandemic and AI This year’s CX Innovation Showcase brought together an array of talent from across the globe to inform the physician-inventor on how to take their early-stage idea forward, from prototype to commercialisation. Industry experts, engineers, medtech investors and start-up companies took part, all of whom are focused on improving vascular disease management.

“THE CHARING CROSS (CX) SYMPOSIUM is about delivering world-class vascular education, considering the evidence and showcasing innovation,” course director Stephen Greenhalgh tells Interventional News. “The CX Innovation Showcase is dedicated to highlighting innovation, what it takes for a physician-inventor to succeed and for innovative ideas in the vascular and endovascular arena to thrive.”

The Innovation Showcase programme began with a series of presentations and discussion covering the challenges facing innovators in the pandemic era. The session opened with Christopher Zarins (Stanford Medical School, Stanford, USA) who offered lessons for the physician-inventor. Matt Thompson (Cleveland Clinic Foundation Ohio, Cleveland, USA) continued, with a talk asking “Where do you look next for vascular innovation?”, followed by a presentation from Kieran Murphy (Western Hospital, Toronto, Canada) who detailed the three things a physician inventor needed to succeed. This morning session concluded with a high-level industry roundtable delving into vascular innovation in the COVID-19 era.

Later, attendees heard updates on early-stage technologies for peripheral, cardiovascular, aortic, and venous interventions, and learned about the impact of artificial intelligence (AI) on vascular disease management.

Greenhalgh added: “With my fellow course directors Bob Mitchell and Frans Moll, we have

put together a one-day programme that highlights cutting-edge peripheral technologies such as sirolimus-coated balloons and high-intensity focused ultrasound (HIFU) treatment; aortic innovation with the concept of aortoporosis and its implications for abdominal aortic aneurysm (AAA) treatment; and venous innovation with the first-in-human data of a bioprosthetic valve for venous insufficiency.”

Edward Choke (Sengkang General Hospital, Singapore), who presented a siroliumus drug-coated balloon update during the peripheral innovations session, told Interventional News that this is a “cutting-edge” peripheral technology. “Chronic limb-threatening ischaemia (CLTI) is a disease which increases risk of death and limb amputation,” Choke explained. “We are currently facing an epidemic of CLTI and this burden is likely to worsen given the rising trends in risk factors such as age and diabetes.

“Revascularisation is fundamental to successful

outcomes, but this is often hampered by high rates of restenosis and reintervention after conventional balloon angioplasty. There is a large unmet need for better solutions,” he conveyed.

His presentation highlighted differences in the biological activities between sirolimus and paclitaxel, focusing on the advantages and disadvantages of these antiproliferative agents. The main commercially available sirolimus-coated balloons formed part of the discussion, including the technology used to optimise the deliverability and absorption of sirolimus into the vessel wall.

“Early data and experience on the efficacy of sirolimus-coated balloons from small studies are encouraging but they need to be confirmed or refuted,” said Choke. He outlined the importance of the large sirolimus-coated balloon randomised controlled trials currently ongoing, and provided updates on their progress. The final results, he stated in his presentation, “will establish whether sirolimuscoated balloons will emerge as the new standard of care for peripheral arterial disease.”

Among the highlights of the Innovation Showcase is the Dragon’s Den-style competition, in which developers of early-stage vascular technologies present their innovations to a panel of experts, who then judge which is the most promising new technology. The developer of what is judged to be the winning entry takes away a £1,000 prize.

Winner of the 2022 competition was an entry from InVera Medical, described by the company’s chief medical officer and co-founder Nigel Phelan, who presented the innovation at CX 2022, as the world’s first exclusively mechanical venous ablation device.

InVera Medical was the winner of this year’s CX Innovation Showcase

Spotlight on: Endovascular Aneurysm Stabilization Treatment (EAST) First-in-human results of the EAST system were presented by Stephen Cheng (University of Hong Kong, Hong Kong) during the aortic innovation session. Developed by Nectero Medical, the catheter-based treatment is intended to delay progression and prevent rupture in small and mid-sized AAA. Cheng spoke to how a one-time dose of 1,2,3,4,6-pentagalloylglucose (PGG) administered intraluminally via the EAST catheter had a 100% technical success rate in his study, which aimed to prove the technology both safe and effective for use in the aforementioned patient group.

PATIENTS WITH SMALL AND MID-SIZED AAA, implant behind. The soft and porous stabiliser balloon, have until now, lacked treatment options, Cheng which delivers the PGG into the vessel over three acknowledged, and so run the continuous risk of minutes, is one component of the technology that sets rupture. EAST, therefore, was designed to reduce aortic EAST apart. growth rate and stabilise the elastin which makes up He proceeded to share results from clinical studies aneurysm tissue, thus preventing aneurysmal rupture demonstrating the safety and efficacy of the system. and creating a new solution to this clinical problem.

One of studies he cited examined the inhibitory effects Cheng went on to underline some key parts of the of aortic intraluminal PGG infusion for AAA. The catheter technology. Derived from plant aim of the study, Cheng described, was to polyphenols, the compound which EAST demonstrate that a one-time dose of PGG delivers—1,2,3,4,6-pentagalloylglucose administered intraluminally via the EAST (PGG)—is hydrophilic, binds with elastin catheter was able to safely and effectively and collagen in vessel walls, preventing stabilise small to mid-sized AAA. it from being degraded by enzymes.

“The therapeutic strategy is that, if we Moreover, Cheng elaborated, it delivers a can reduce the growth rate of aneurysm, minimally invasive treatment, that leaves no Stephen Cheng even by 50%, […] we can extend the

time to treatment from five to 10 years, therefore reducing the need for endovascular intervention for small aneurysms,” Cheng relayed to the Innovation Showcase audience, who were subsequently shown video footage of the technology in operation.

Cheng then shared the outcome of this study, which took place between June 2019 and November 2021 in Hong Kong and Columbia, in eight patients, of whom seven were male (mean age=59.5). There was a 100% technical success rate, with one access site infection and one unrelated (COVID-19) death among the patients. The average growth in AAA diameter, Cheng elaborated, was 2.3% over 24 months, and the AAA volume increase over the same time period was 9.6%.

“With this early data, we can conclude that the EAST procedure is safe in humans, there is potential to control growth of aneurysms, […] there are no visible implants, and all treatment options remain open.” This was Cheng’s summary of the advantages of using the EAST technology, although he did acknowledge two disadvantages: it is invasive and requires monitoring.

When asked by Stephen Greenhalgh whether he saw the technology as having potential to eliminate the need for endovascular intervention for AAA in its entirety, Cheng responded: “this [technology] is targeted towards early treatment”, while postulating the possibility for future iterations to work in conjunction with an endograft to promote sac shrinkage. For now, Cheng underlined, the focus remains on safety studies.

Issue 86 | June 2022

Market Watch 25

Product News CATHI joins with VSS to launch world’s first online training programme for endovascular simulation

Germany-based endovascular simulator supplier CATHI has joined forces with UK-based Vascular Simulation Solutions (VSS) to offer the world’s first online training masterclass using endovascular simulation coupled to a structured curriculum, the company said in a press release At its heart is the CATHIS simulator, which is fully functional with all standard software systems including every iOS system and Oculus VR (virtual reality).

The training is supported by a structured curriculum, delivered by specialist endovascular instructors with many years‘ clinical experience. The programme is targeted at specialist trainees in every year of their course, medical students on a condensed course, and interested interventionists.

The scope of the package includes endovascular aneurysm repair (EVAR) and carotid, renal, iliac, femoral and tibial artery angioplasties. In addition, the curriculum includes training on emergency vascular cases such as ruptured aneurysms and visceral bleeding and trauma.

“The importance of periodical continuous education, training and structured curricula of interventional procedures has been confirmed by numerous clinical experts around the globe,” noted CATHI managing director of marketing and sales Manuela Werner. “With this joint venture between VSS and our company we are combining top-level expertise with our near-to-reality simulation systems.“ Consultant vascular surgeon Abdullah Jibawi (Ashford and St Peter’s Hospital NHS Foundation Trust, Chertsey, UK), who is involved with delivering the new programme, added: “We have built our curriculum with the end user in mind in every minute detail.

We want to answer the real need for training by allowing a layer-by-layer build-up of skills and decision-making […] Our programme introduces the ability to train interventionists over a specified period of time, followed by a customised exposure to a specified product line to fine-tune their experience as needed.”

the American Urological Association (AUA) 2022 Conference (May 13–16, New Orleans, USA).

The system is designed to work with multiple MR/US fusion image guidance systems for precise and accurate ablation in a minimally invasive setting, while preserving healthy prostate tissue.

“CLS is pleased to introduce its office-based, fusion-guided Tranberg Thermal Therapy System at this year’s AUA conference,” stated Michael Magnani, president of CLS Americas.

“We are commercialising this innovative technology so that patients can benefit from being treated with focal laser ablation in a urology office or clinic instead of a hospital.”

“While treating prostate cancer tumours successfully is the primary goal, some current treatment options expose patients to unacceptably high risks of complications such as erectile dysfunction or urinary incontinence,” said Fernando J Bianco, investigatorin-chief for the Urological Research Network, and principal investigator of the phase I clinical study running at Urological Research Network, Miami Lakes, USA. “Based on my initial clinical trial experience with the Tranberg laser, I believe that partial gland fusion ablation provides the precision to successfully treat the cancerous lesions while offering patients a superior side effect profile.

The ongoing study will provide us with more information on this.”

Micromate now available to use with CT guidance thanks to planning and navigation station

The new addition to Micromate makes it possible for physicians to rely on pre- and intraoperative scans to plan the intervention, the company behind the robot, Interventional Systems, announced in a press release. These planning capabilities can then be leveraged to navigate and guide instruments to the trajectory automatically with submillimetre accuracy. All features fit into a one square metre console, with the robot being manoeuvered from afar, and relying on a miniature, table-mounted camera. This substantially reduces radiation exposure to physicians and patients, the number of interoperative

CLS Americas debuts fusion-guided Tranberg focal laser ablation system at AUA 2022 CLS Americas announced it will debut its office-based, magnetic resonance (MR)/ultrasound (US) fusion-guided, TRANBERG Thermal Therapy System for high-precision focal laser ablation of soft tissue, such as prostate cancer tumours, at

Micromate robot

rescans, and does not negatively impact the available space in the room.

“For years, we have been discussing making Micromate the control panel of the entire medical workflow.

This solution is the first step in that direction”, says Michael Vogele, Interventional Systems’ founder and CEO. “We have developed this planning and navigation system while bearing in mind all constraints related to practicality and cost […] We are looking forward to what is to come.”

Reto Bale (Medical University Innsbruck, Innsbruck, Austria) will be one of the earliest adopters of the technology: “Planning and navigation tools are fundamental for successful percutaneous procedures and clinical efficacy depends on them. I am looking forward to incorporating the Micromate robot in my practice and further developing new applications whose outcomes can be improved with robotics”.

A current user of Micromate at the (Ordensklinikum Linz BHS, Linz, Austria) Alexander Kupferthaler, adds: “Precise image-driven targeting and highest accuracy while reducing radiation exposure are the ultimate goals in interventional radiology procedures. The Micromate all-in-one planning and navigation station with its intuitive handling and seamless integration to the angio-suite or CT workflow is a unique platform to add to patient safety and further perfect my interventions.”

Boston Scientific receives FDA clearance for the Embold fibred detachable coil

Boston Scientific has received US Food and Drug Administration (FDA) 510(k) clearance for the Embold fibred detachable coil, which is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The first procedure using the device was performed recently at the University of Alabama (Birmingham, USA).

The newest addition to the interventional oncology portfolio, the Embold fibred coil was designed for use in a variety of embolization procedures.

“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” explained Theresa Caridi, director of Division of Vascular and Interventional Radiology from the Heersink School of Medicine at the University of Alabama, and the first physician to treat a patient with the Embold fibred detachable coil. “The multicatheter compatibility of the Embold fibred coil provides physicians with […] catheter choice and helps reduce the number of potential device exchanges, which may [in turn] improve procedure efficiency and enable better patient outcomes.”

In addition to the multicatheter compatibility of the Embold fibred coil, the device also features a nitinol delivery system that prevents kinks from forming in the device during the

Embold coil

procedure: this is intended to reduce treatment complications. These design attributes may also reduce preparation and procedure times by limiting the amount of equipment and additional products required to complete treatment, which may reduce the overall cost of the procedure.

Penumbra announces European launch of the Indigo system with Lightning 7 and Lightning 12 intelligent aspiration

Penumbra has announced that its Indigo aspiration system with Lightning 7 and Lightning 12 have secured CE mark and are now commercially available in Europe. Both technologies are part of Penumbra’s Indigo aspiration system— now with Intelligent Aspiration for mechanical thrombectomy—and are designed for single session arterial and venous thrombus removal, including the treatment of pulmonary embolisms.

“Technology advancements such as Lightning 7 and Lightning 12 are critical to improving patient outcomes and expanding use of mechanical thrombectomy to a broader range of patients,” said Andrew Wigham, interventional radiology consultant at John Radcliffe Hospital, Oxford, UK. “Lightning enables us to remove blood clots in the body quickly and efficiently, often in a single session, while also minimising blood loss and potentially reducing the need for thrombolytics and prolonged ICU stays.”

Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. The system designed to reduce blood loss and the need for clot-dissolving drugs.

The company states that the Lightning technology also provides an alternative to other surgical options.

“CAT7 is a high-power, low-profile catheter that features laser-cut hypotube technology and circumferential sweep designed for dependable delivery and maximal clot extraction,” a press release detailed.

Penumbra Indigo system with Lightning 7

June 2022 | Issue 86

26 Advertorial THIS ADVERTORIAL IS SPONSORED BY ADEPT MEDICAL

Advancing radial ergonomics Outlining Adept Medical’s process for identifying and solving ergonomic issues in the cath lab.

W

ith technological advancements over the last 10 years rapidly changing the scope of atrial treatment, radial has quickly become the access point of choice for clinicians globally. Between 2011 and 2018, radial access adoption for diagnostic angiograms increased from 17.5% to 60.4%, and from 14% to 51.8% for percutaneous coronary intervention (PCI) procedures1, and this trend is set to rise.

This change of technique has led to clinicians having to adapt the interventional lab environment, making improvements to patient set-up for the radial approach, protecting the clinician, and considering workspace ergonomics. As designers of advanced patient supports, Adept Medical has been collaborating with industryleading experts to address identified needs in improving the interventional lab working environment.

Adept Medical first launched the STARBoard as part of the STARSystem in 2013. After seeing the need for a device to facilitate ease of radial access during interventional cardiology procedures, the company developed a solution alongside experts in the interventional cardiology field, allowing for quick, effective presentation of the patient’s wrist for radial access. Since its launch in 2013, Adept Medical has successfully placed upwards of 2,600 units of the STARBoard in market globally and experienced a positive uptake for a device to provide ongoing procedural repeatability in the cath lab.

After surveying existing users, spanning from New Zealand to the UK, Adept Medical has gathered insight into the benefits the STARSystem has provided clinicians in the cath lab, when compared to their previous way of working.

Wire/device manipulation and security

When first witnessing procedures without a device to manage radial access, Adept Medical noticed that often the equipment and wires would be placed over the patient, causing concern of the wires kinking during advancement, or dislodgement of wires from the access site completely. When using the Adept Medical STARSystem, clinicians can easily position and place the wire for ease of manipulation on the work surface of the STARTable.

In a recent study, completed by Adept Medical, the company found that users of the STARSystem had an 87% satisfaction rate with the ergonomic

eliminating the need of having to bend over the patient and consequently causing back issues.

In a recent study conducted by Adept Medical, it was discovered that users of the STARSystem have an 81% satisfaction rate in the ergonomic procedural position of back straightness using the device, compared to when not using it.

Managing patient restlessness and movement

The Adept Medical STARSystem handle design provides reassurance for the patient, limiting movement during radial access procedures

procedural position of wire/device manipulation and an 83% satisfaction rate with wire/device security when using the STARSystem, compared to not using it.

Ergonomic procedural position for the clinician

Without correct positioning of the patient, the clinician is often left having to bend over to gain radial access and complete wire manipulation, particularly in instances when leftarm access is required. Using a rigid arm board or rolled towels offers little flexibility when considering patient management, and often leaves the clinician restricted in movement throughout the procedure.

The STARSystem has been designed to improve the clinician’s posture by having a rotatable arm board that can be positioned correctly to their working preferences. The left arm support allows radial access to be gained on the left-hand side, with the patient's arm then able to be draped across the abdomen so the clinician can continue to work as normal on the right-hand side. This allows for better working ergonomics for the clinician,

During procedures where the patient is under conscious sedation, the risk of restlessness and movement is a concern for clinicians who manage patient safety and imaging outcomes.

After understanding the requirements of the clinician, Adept Medical noticed that patients often need a security reminder to avoid excess restlessness and movement. The handle design of the STARSystem allows the patient to grip an object which provides reassurance throughout the procedure and therefore limits movement compared to not using any methods of patient security. The concaved channel also assists with forearm containment preventing it rolling sideways.

In Adept Medical’s recent study, the company found that clinicians had a 81% satisfaction rate in the STARSystem’s ability to control patient restlessness and movement when compared to their previous method.

the device, when compared to their previous method.

Product set-up time when performing left and right arm radial access

Having to create custom solutions for each procedure to set the patient up for radial access is less than ideal. Rolling towels for support, or taping patients to homemade arm boards is a lengthy process for the clinical team, affecting the time to set-up and procedural repeatability. These solutions offer less procedural flexibility, which can also cause delays in gaining access to begin the procedure.

The length of the STARSystem adapts to each patient's size once they grip the handle. Adept Medical designed the STARBoard to allow for multiple levels of adaptability to comfortably suit most patient sizes.

Clinicians in Adept Medical’s study rated their level of satisfaction with product set-up time when performing right arm and left arm radial approach at 77% and 75% respectively using the STARSystem compared to their previous method.

Gaining hyperextension of the wrist for access

One of the STARSystem’s key features is its ability to present the patient’s wrist quickly and effectively for proximal radial access when hyperextension is required for ease of puncture. The STARSystem handle is designed to be manipulated to rotate the patient’s wrist from a medially rotated position to a hyperextended position, allowing the radial artery to be presented for puncture. This can often be a cumbersome process without having the degree of manipulation and rotation that the STARSystem provides.

In Adept Medical’s recent study, clinicians had an 85% satisfaction rate in the STARSystem’s ability to hyperextend the patient’s wrist using

The Adept Medical STARSystem offers an ergonomic procedural position for safe wire/device manipulation

The Adept Medical STARSystem presents the patient’s wrist effectively for proximal radial access when hyperextension is required for puncture

The solution

Adept Medical’s development journey of designing a complete radial solution for left and right access has been one derived from strong clinical input. With Adept Medical adopting a solution when radial access was first gaining traction, it allowed the company to understand pain points and offer benefits to a technique that was novel for many clinicians.

According to the company, its findings show that the STARSystem forms a complete and effective ergonomic solution that offers benefits to the clinician during radial access for both patient management and clinician workflow and comfort.

All of Adept Medical’s patient positioning equipment and operator supports are proudly designed and manufactured at the company’s site in New Zealand.

References: 1. Doll, J, Beaver, K, Naranjo, D, et al. 2022. Trends in Arterial Access Site Selection and Bleeding Outcomes Following Coronary Procedures, 2011–2018. Circulation: Cardiovascular Quality and Outcomes.

Issue 86 | June 2022

Market Watch 27

Clinical News VentureMed completes enrolment of Flex Vessel Prep system randomised controlled trial in arteriovenous fistulas

VentureMed Group recently announced that it has completed enrolment of a randomised controlled trial (RCT) titled ‘Flex Vessel Prep prior to PTA for the treatment of obstructive lesions in the native AVF’. This RCT was conducted to assess primary patency at six months when using Flex Vessel Prep system prior to percutaneous transluminal angioplasty (PTA) versus PTA alone for the treatment of obstructive lesions of native arteriovenous fistulas (AVFs) in the upper extremity.

The FLEX RCT was a prospective, multicentre, randomised study conducted in seven sites across the USA. Seventy-five patients were enrolled and includes 30-day, threemonth, and six-month follow-up.

“Although fistula are the preferred access for haemodialysis, fistula dysfunction and failure remains a significant issue in AV dialysis access care. Balloon angioplasty considered the gold standard by most, still has its limitations due to the resistant and recurrent nature of these hyperplasic lesions, often requiring the use of high-pressure balloons,” said Sanford Altman (Open Access Vascular Access, Miami, USA). “These highpressure balloon treatments can cause vessel wall damage accelerating restenosis and shortening the time between interventions. By utilising the Flex Vessel Prep prior to angioplasty, we are hoping to see improved vessel compliance, reducing the need for highpressure balloons while reducing the barotrauma to the vessel wall thereby extending the primary patency and time between interventions.”

“This RCT builds upon the rich and diverse data we are gathering for the Flex system. The rapid enrolment of these 75 patients at seven US centres during a COVID-19 surge is encouraging”, said Denis Harrington, president and chief executive officer of the VentureMed Group. “We are excited to report our previous study, the FLEX AV Registry, will be presented at the VASA 2022 Symposium (6–9 June, Charleston, USA). 2022 is becoming a very impressive year for Flex Vessel Prep”.

First patient enrolled in PERIO-02 trial of SD-101 delivery via pressureenabled drug delivery for hepatocellular carcinoma or intrahepatic cholangiocarcinoma

TriSalus Life Sciences announced the enrolment of the first patient in its Pressure-Enabled Regional ImmunoOncology (PERIO-02) clinical study in

a press release.

The trial is evaluating SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

SD-101 will be administered using the Pressure-Enabled Drug Delivery (PEDD) method in combination with systemic checkpoint inhibitors.

Initiated at The University of Texas MD Anderson Cancer Center (Houston, USA) with additional sites anticipated, the study is the second in a series of clinical trials assessing TriSalus’ immunotherapy platform across multiple indications.

The initial trial using this platform, the PERIO-01 study, is actively enrolling and is evaluating the safety of SD-101 administered by PEDD in combination with checkpoint inhibitors in patients with uveal melanoma with liver metastases.

“Patients with advanced HCC or ICC often have limited options when seeking treatment, as checkpoint inhibitors have had some success in these indications but results are not what we want them to be in most cases,” said Steven C Katz, chief medical officer at TriSalus. “The PERIO-02 clinical trial has potential to advance the scientific foundation required to help address this unmet need, deliver new therapies to improve clinical outcomes, and ultimately, give patients a better chance to respond more reliably to different forms of immunotherapy.”

While immunotherapy has yielded significant advances in cancer treatment, unique properties of liver tumours, including immune response suppression and high intratumoral pressure, can prevent optimal delivery and performance of therapeutics and limit the overall effectiveness of immunotherapy for patients with liver cancers.

“With the PERIO-02 trial, we are striving to enable immunotherapy for the most common primary liver tumours,” said Katz. “The study is implementing a multifaceted approach by testing the integration of an immunotherapeutic, SD-101, with a [US Food and Drug Administration]cleared delivery device, to hopefully induce the type of immune response that we are so eager to see for patients with HCC and ICC.”

and pulmonary embolism, presented successful first-in-human (FIH) results showing safety and feasibility of the eTrieve system, a catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE).

The data, presented at Biomed Israel 2022, the international life science and healthtech conference in Israel (May 10–12, Tel Aviv), showed a significant reduction in right ventricle/left

The eTrieve system

ventricle ratio and alleviation of PEassociated symptoms.

“Magneto provides intermediate and high-risk PE patients with a unique solution for safely and effectively removing large clots blocking the arteries in the lungs,” said Piotr Musialek (John Paul II Hospital, Krakow, Poland) and an investigator in the study. “The combination of a largediameter ‘vacuum cleaner’ with electromechanical thrombus extraction, allows an immediate resolution of dyspnoea and swift recovery of the cardiorespiratory system.”

The prospective, single-arm, multicentre first-in-human study assessed the initial safety and performance of eTrieve in treating patients with acute PE. The study enrolled 10 participants across three sites in Denmark and Poland. Results show that the procedure, performed under light sedation only, was safe with no device related complications. The primary performance endpoint was also met, with significant reduction of right ventricle to left ventricle volume 48 hours post-intervention. Significant clot volumes were removed, and alleviation of PE-associated symptoms was demonstrated. The catheter removed both fresh and organised clots and successfully removed blood clots of all sizes and types, from locations that

Magneto Thrombectomy Solutions announces successful first-in-human results for treatment of pulmonary embolism

Magneto Thrombectomy Solutions (Magneto), a medical devices company developing thrombectomy solutions for the treatment of ischaemic stroke

iliCo study live case presentation

could not have been safely reached using other techniques.

Asger Andersen (Aarhus University Hospital, Aarhus, Denmark), principal investigator of the study, added: “Large bore aspiration of central clots with possibility to retrieve segmental clots with the eTrieve catheter, optimises the possibility for complete pulmonary revascularisation in acute PE.”

First patients enrolled in iliCo study of iVascular’s iCover stent

iVascular has announced the initiation of its first trial with the new generation covered stent iCover—the iliCo study. The study has the objective of evaluating the safety and effectiveness of iCover for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs.

The first iliCo patient was enrolled

by Elias Noory (University Heart Center Bad Krozingen, Germany) part of the team of the co-primary investigator of the study, Thomas Zeller (University Heart Center Bad Krozingen, Germany). The case was transmitted live at the 2022 Charing Cross (CX) Symposium in London, UK (26–28 April, London, UK).

The case presented by Noory was a patient with an occlusion in the right common and external iliac artery.

Three iCovers were implanted successfully, achieving an excellent flow after the procedure.

The iliCo study is a prospective, multicentre, non-randomised, singlearm observational study led by Coinvestigators Zeller and Bahaa Nasr (CHU Brest, Brest, France). The study will evaluate the efficacy and the safety of the iVascular iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in 214 patients with symptomatic arteriopathy of the lower limbs across 18 sites in Germany, France, Belgium, and Spain.

Patients will be followed up for up to two years. The primary endpoint of the study is primary patency at 12 months. Secondary endpoints include 30-day complications, major amputation at target limb, target lesion revascularisation (TLR), target vessel revascularisation (TVR), and quality of life.

Issue 86 | June 2022

Market Watch 29

Clinical News Instylla first-in-human study demonstrates technical success and persistent embolization

Ten embolizations were performed in eight patients with a range of tumour types, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and angiomyolipoma (AML). Tumour sizes ranged from 2.1–7.5cm in size and were treated with Embrace HES volumes from 0.4 to 4.0mL, with an average delivery time of 15 minutes.

Instylla has announced the publication of results from the first-in-human clinical trial of the Embrace hydrogel embolic system (HES) for the treatment of hypervascular tumours in the Journal of Vascular and Interventional Radiology (JVIR). This prospective, single-arm multicentre study demonstrated that the Embrace system effectively embolized malignant and benign hypervascular tumours by blocking tumour blood supply with technical success and persistent embolization, as noted in imaging follow-up at 30-days, in all eight patients treated on this study.

“This phase I first-in-human study of Embrace HES in the embolization of a range of hypervascular tumours has shown promising results,” commented Gerard Goh, head of Interventional Radiology at The Alfred Hospital and associate professor at Monash University, Melbourne, Australia, lead author on the study. “Embrace HES holds great potential with its ease of use, technical success in all patients, and no tumour revascularisation in the 30-day follow-up imaging.”

Five-year data reinforce safety of Biotronik Passeo-18 Lux PTX DCB angioplasty

New long-term data presented at Charing Cross (CX) demonstrated the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) in infrainguinal arteries.

The independent analysis was led and presented by Ron Waksman, Clinical Professor of Medicine, Georgetown University/Associate Director of Cardiology, MedStar Washington Hospital Center, Washington DC, USA. Individual patient-level data were pooled from three trials in the Passeo-18 Lux DCB clinical programme: the BIOLUX P-I and P-II randomised controlled trials

and the BIOLUX P-III all-comers registry. Five-year follow-up data from 943 patients treated with Passeo-18 Lux DCB and 66 patients treated with percutaneous transluminal angioplasty (PTA) were evaluated.

The analysis showed that the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with an increase in all-cause mortality at five years compared to standard PTA (33.56% for DCB versus 43.79% for PTA; P=0.47).

“Our recent analysis adds to the body of long-term evidence supporting paclitaxel-coated balloons, which are an essential and safe tool for the treatment of patients with PAD,” commented Ron Waksman on the results. “In line with previous clinical data, the Passeo-18 Lux DCB has been

shown to be safe at five years when compared to PTA.” These results confirm the previous analysis of this dataset, published last year, which reported similar mortality at one year irrespective of the treatment with DCB or PTA and clear reduction in the incidence of the composite endpoint of any amputation and target lesion/vessel revascularisation compared to standard PTA. Other recent data have also shown similar mortality rates in patients treated with paclitaxel-coated balloons compared to PTA. The BIOPACT RCT clinical trial, which completed enrolment last year, will provide a head-to-head comparison of Passeo-18 Lux and IN.PACT Admiral DCBs. The primary endpoint will be presented upon completion of 12-month follow-up.

Comparative all-cause mortality after treatment with Passeo-18 Lux and standard PTA

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October 2021 Issue 01 www.renalinterventions.net

In this issue:

Twelve-month Wrapsody results at CIRSE 2021 page 4

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).

Profile:

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

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

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“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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June 2022 | Issue 86

30 Market Watch

Industry News Vivasure Medical announces Series D financing

Vivasure Medical has announced the closing of the first tranche of €22 million (US$23 million) as part of its Series D financing round that could reach up to €52 million (US$54 million) in total.

The company states that the financing, led by a multinational strategic corporation, includes an option to buy Vivasure upon certain milestones. Other participants in this Series D financing round include a second strategic corporate investor as well as existing investors, Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.

The financing will support the US and European clinical development and regulatory approval of the company’s portfolio of fully absorbable, patchbased large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures, a press release details.

These devices include PerQseal and PerQseal+ for arterial closure and PerQseal Blue for venous closure.

Vivasure’s PerQseal technology consists of a proprietary bioabsorbable intravascular patch that seals the vessel from the inside, returning the artery or vein to its natural state without leaving behind the remains of any materials such as collagen, metal implants or sutures commonly used in other closure technologies.

According to Vivasure, the PerQseal device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe for use in transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aortic repair (TEVAR) and endovascular aneurysm repair (EVAR).

Calendar of events 6-9 June 2022 Leipzig Interventional Course (LINC) 2022 Leipzig, Germany & virtual www.leipzig-interventional-course.com/ visitors/linc-2022

STAR network to collaborate with Avail surgical telepresence platform

Avail Medsystems, a healthcare technology company whose surgical telepresence platform facilitates realtime, interactive collaboration during live procedures among a network of physicians and medical device industry representatives, announced that it has entered into a partnership with the Stroke Thrombectomy and Aneurysm Registry (STAR).

STAR supports the global tracking and study of health outcomes after endovascular treatment for stroke, brain aneurysm, or other cerebrovascular diseases, with the goal of improving physicians’ precision in choosing effective therapies for patients with these conditions. Researchers at 94 participating institutions across the world use the registry data to publish papers, describing new techniques, devices, and expertise that have the potential to boost neurosurgical acumen and patient care.

STAR principal investigator Alejandro Spiotta (Medical University of South Carolina, Charleston, USA) a STAR registry co-founder, believes that physicians who share experiences with their colleagues are better prepared to improve their skills, adopt cuttingedge ideas, and help patients who previously would have been considered untreatable. Yet, collaboration typically requires travel, and for many physicians, the burdens of cost and time mean that these trips can only happen a few times a year.

To promote STAR members to engage in the collaboration and storytelling needed to advance neurological care, Spiotta decided to implement a technology that would allow STAR members to observe and collaborate during each other’s procedures and offer guidance any time—without leaving their own practices. He selected the Avail system because it allows surgeons immediate,

22-25 June 2022 ET 2022—European Conference on Embolotherapy Nice, France www.etconference.org

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

15-18 June 2022 Society of Vascular Surgeons (SVS) 75th Vascular Annual Meeting (VAM) 2022 Boston, USA

13-17 July 2022 The European Congress of Radiology (ECR) 2022 Vienna, Austria

www.vascular.org/vam-2022/registration-info

EDDA Technology announces trial agreement with SIO

EDDA Technology, a provider of advanced imaging-guided precision treatment solutions, announced it has entered into an agreement with the Society of Interventional Oncology (SIO) for its ACCLAIM trial. IQQABodyImaging Interventional will be used to provide 3D assessment of the ablation zone and margin for selected colorectal liver metastases.

In this prospective, multicentre, international trial, SIO proposes to establish microwave ablation (MWA) as the preferred treatment option for selected colorectal liver metastases that can be ablated with sufficient margins.

The study will be the first global, prospective trial to use an objective and reproducible technical outcome in its study design, which the SIO believes will drive important changes to future treatment guidelines. The ACCLAIM study will estimate disease-free survival of colorectal liver metastases treated with MWA incorporating 3D ablation software (EDDA Technology) margin confirmation intraoperatively and through a subsequent independent review centralised validation process.

The IQQA platform provides comprehensive 3D image analysis using magnetic resonance (MR) and computed tomography (CT), and has been used in over 80,000 cases worldwide for surgery and treatment with substantial time-saving. This solution supports in-depth quantitative volumetry with fast, dependable results and allows for versatility of transplantation, resection, or interventional procedure planning.

“IQQA is a proven innovation to support physicians in providing individualised and optimised treatment

solution. Powered by our precision 3D capabilities, IQQA aims to facilitate the next generation of precision surgery and treatment,” said Jianzhong Qian, CEO of EDDA Technology. “We are glad that the IQQA platform was chosen by SIO for this global trial, which will bring important clinical information for future interventional treatment guidelines.”

Cydar Medical announces strategic collaboration with Medtronic

Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and case support, with the goal of improving patient care.

The Cydar EV Maps software harnesses the latest in cloud graphics processing unit (GPU) computing, computer vision and machine learning technology to advance surgical visualisation and decision-making in theatre and across the care pathway.

This enables clinicians to create detailed patient-specific 3D maps for procedure planning, image-guided navigation, and post-operative review, resulting in less radiation exposure to the patient and the clinical team, reduced procedure time, and increased delivery confidence. This pilot programme will also inform the future development of predictive analytics to support procedure planning, by assessing factors such as the risk of endoleaks.

Medtronic is the first medical technology company to enter a public strategic collaboration in digital endovascular technology to advance aortic patient treatment decisions. The collaboration is part of Medtronic’s ongoing commitment to innovation in aortic care for physicians and t heir patients.

“Medtronic aims to revolutionise endovascular aortic treatment with digital solutions with this phased approach,” Carolyn Sleeth, a Medtronic vice president, explained.

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.

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

on-demand connection both within the STAR network and across Avail’s broader network of physicians and industry, at the touch of a button through high-definition video, two-way audio, and surgical imaging views.

“Sometimes, we just need to talk a procedure through with a peer or see someone else do it to know it is possible; that’s how we push each other to improve,” stated Spiotta.

www.bset.co.uk

www.myesr.org/congress

10-14 September 2022 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2022 Barcelona, Spain

23-25 September 2022 Symposium on Clinical Interventional Oncology (CIO) 2022 Miami, USA

20-23 September 2022 European Society for Vascular Surgery (ESVS) Annual Meeting 2022 Rome, Italy

31 October-3 November VIVA (Vascular Interventional Advances) 2022 Las Vegas, USA

www.cirse.org/events/cirse-2022

www.esvs.org/events/annual-meeting/esvsannual-meeting-2022

www.theiomeeting.com/cio-2022

www.viva-foundation.org

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